docket_agency,docket_title,docket_date,comment_id,comment_url,comment_date,comment_title,commenter_name,comment_length,comment_text SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0511,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0511,2016-07-26T04:00:00Z,Comment on FR Doc # 2016-16069,G Thibault,3872,"I am a physician who has run an outpatient buprenorphine-naloxone treatment program for 5 years now, limited to a maximum of 100 patients at a time, so welcome the increased access proposed. Since you are seeking comments primarily related to the reporting requirements for those that choose to treat up to 275 patients, one comment I have is that the "burden" of reporting has less to do with the questions being asked than with the reporting method. If there is a 15 page paper form to complete each month, that would be burdensome. I would not consider it burdensome, though to complete a one page on-line form with blanks to fill in for: 1) Numbers of patients seen per month; 2) Number who are currently in or have completed outpatient drug counseling; 3) Number who have left the program and reason.
Other comments:
1)Part of your proposed rule is unmanageably vague:
"b. Percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to:
1. Treatment initiation
2. Change in clinical status"

--What does 'psychosocial or case management service' include? If you mean group outpatient drug treatment or individual counseling, it should say that.
--What does 'change in clinical status' mean?
--When you are looking for percentages, is there a certain "benchmark" we are being required to meet?
2)Another part of your proposed rule is also vague and burdensome the way it is worded:
"c. Percentage of patients who had a prescription drug monitoring program query in the past month"
--We query the PDMP for every single controlled substance prescription, so I am not sure how writing "100%" every month is going to help you. If we were to accidentally miss someone, I am not sure how we would know it. It would seem to me the PDMP for each state would have a better handle on that information.
3)There should be some oversight of HOW patients are being treated with buprenorphine and none of this data gathering includes that. The makers of Suboxone, for instance, recommend no more than two 8-2mg films daily as the usual maintenance dose, and that up to three a day can be given for extenuating circumstances, yet many doctors in New York City are well known for prescribing three a day consistently, for months, if not years, and giving 30 days of medication at a time. Most opioid addicts know they do not need three a day, so the extra medication is just a source of income to them. Where is the oversight on that?
4)One of the biggest burdens likely to keep some providers from wanting to see more than 100 patients is the prior authorizations required by most insurance companies (particularly all versions of Medicaid) prior to starting buprenorphine and, for some companies, quarterly. Some will only pay for the generic buprenorphine pill, which is difficult to split in order to taper someone down over time, and will not pay for Suboxone or its competitors. Others will stop paying for buprenorphine altogether if someone tests positive on a urine drug screen for marijuana (which is not even treated with buprenorphine). Yet others have a 3 to 5 day wait for approval for a new patient we have just seen who has stopped the heroin and wants their buprenorphine that first day. What are they supposed to do for 3-5 days, continue heroin? The insurance companies need oversight as wellor at least we providers should have a 24 hour hotline phone number to call to have SAMHSA intervene with the insurance company.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0012,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0012,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,"Lee Tannenbaum, M.D.",1566,"This is a good start but it does not go far enough. As an Addiction Specialist I am capable of providing significant services to a large number of patients. When I was a Family Practitioner I use to manage more than 5000 patients. There is no limit on the number of patients that any other type of specialist can treat. Endocrinologists are not limited in the amount of insulin dependent patients that they can treat.

Addiction is a medical disease and it needs to be treated by medical specialists. I can treat more people and provide fantastic care. I can provide full time counseling services, 24 hour phone coverage, evening, weekend, and holiday coverage, integrated electronic medical records with real time following of prescriptions that patients are filling, etc. However, I cannot expand to provide these services if my ability to see patients is limited to only 200. Please allow me to practice to my full potential and to be able to provide the services that patients need and are entitled to at a reasonable cost. I can only do this if I have the ability to increase the volume of my practice thus dispersing the cost of services across more patients. I would urge you to consider eliminating a treatment limit all together for appropriately certified physicians, or at the very least increasing to number permitted to be treated to a more significant 500 or 1000 patients. Note that Senate bill S.1455 (TREAT Act) was recently amended to allow a 500 patient limit. Perhaps this rule could be changed to be consistent with that initiative. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0015,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0015,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Angie Geren,504,"Persons suffering from Opioid Use Disorder have a difficult time finding treatment in the current system. Not only are Medication Assisted Treatment locations few and far between, they also have enormous waiting lists leaving those who want treatment, unable to secure it. The current limit of 100 patients per prescriber is not enough to handle the amount of persons affected. Please support increasing this limit to 200 and also continue to look into other ways we can make treatment easily accessible." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0022,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0022,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Charles Atkins,1326,"Thanks so much for sending this out and furthering efforts to increase access to medication assisted treatment. I was a Suboxone prescriber for over seven years, though I currently work as a medical administrator for a multi-site mental health and substance abuse agency in CT. We do offer Suboxone in one of our outpatient clinics; this is a part of a program that includes Intensive Outpatient, relapse prevention, and much co-occurring behavioral health treatment.

I am in total support of raising the limit from 100 to 200. I also think the added requirements for prescribers are reasonable, though I would want a crisp definition of what constitutes an acceptable setting. I am board certified but have never pursued additional certification from ASAM or in addiction medicine or psychiatry. I have however always prescribed in a clinic setting where counseling, at various levels of intensity, are provided. This also includes diversion strategies, lots of urine collection, and focus on treating co-occurring mental health problems, which are rampant in this population.

As a final comment, where the need is greatest, is among the Medicaid population. I'm hopeful that this increase in the limit will allow those few clinics that take Medicaid reimbursement, help meet this tremendous unmet need." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0024,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0024,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Thomas Grinley,137,"With the shortage of prescribing physicians and the overwhelming opioid crisis, this would seem to be a rule change that is long overdue." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0035,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0035,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,James Murray,574,"I support the rule to change to the highest patient limit from 100 to 200 patients per qualified doctor.

I am employed as a chemical health intake coordinator, a common call from an opiate user seeking help is frustration of trying to find an outpatient provider of bupronorphine thiat is accepting new patients. There is not enough providers to meet the needs of this community. Increasing the volume of allowed patients per provider will assist with opening more doors for this population to get they initial help they need so they can begin a recovery process. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0098,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0098,2016-04-22T04:00:00Z,Comment on FR Doc # 2016-07128,Rick Campana,556,"I am a Board Certified Addiction Specialist and this bill is essential to helping the large numbers of opioid addicted patients who do not have access to MAT. Every patient who calls my office to get in my Suboxone program is asking for help and to save their lives. When I have to refuse treatment w Suboxone because of the current patient limit, I am depriving a life saving medication to a patient who may return to the street and overdose on heroin. PLEASE AT A MINIMUM RAISE THE CAP to 500 patients.

Dr. Rick Campana
Diplomate ABAM, FASAM" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0227,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0227,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Kent Seitz,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0101,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0101,2016-04-25T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Sherrick,616,"I am a physician, Board Certified in Addiction Medicine, practicing in the field for over 20 years. I work for the VA, providing buprenorphine services across the entire state of Montana using TeleHealth technology, as well as serving as Medical Director for 3 Opioid Treatment Programs (OTPs) and on the staff at Pathways Treatment Center, a psychiatric and addiction treatment facility. I have treated all kinds of addictions, both inpatient and outpatient, and am familiar with the state of the art in Addiction Medicine and the scientific literature.

Please see the attached file for my comments.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0009,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0009,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Nancy Rubio,2090,"I am a board certified psychiatrist with added Qualifications in Addiction Medicine. I have treated patients suffering from addiction for over 25 years and have trained many future clinicians in this field. Currently I treat United States veterans exclusively in a VA substance abuse program in the tri-state area of Kentucky, Ohio and West Virginia. This VA is one of two VA hospitals with highest percentage of prescription drug abuse. We are trying to correct the poor prescribing practices of our predecessors. Also the tri-state area tops the nation in drug overdoses. Unlike the private sector we cannot close admissions to our opiate treatment program to veterans suffering from opiate dependence when I reach my 100 limit. We also cannot hire physicians willing to prescribe Suboxone to our veterans since they have lucrative private practices where they charge an average of $300 monthly just for their service (does not include cost of medication and $25 toxicology screen.) We cannot outsource these veterans to the private community because the government pays Medicare rates which are much lower than the $300/month. The private doctors can easily fill their 100 slots with folks willing to pay $300/month in cash.

I have not been able to convince my administration to apply for SAMSHA official OTP program with institutional license which would allow us to expand services. The same lack of knowledge in this area which lead to the problem seems to be impeding the solution. So I am chronically frustrated and worry about welfare of our veteran population. Some of the pressure has been alleviated by outsourcing of patients to local methadone programs.

I applaud President Obama's push to expand training of pain management in medical schools. I would favor increasing the limit to 200 for clinicians board certified in addiction and for VA hospital programs. I do have some concerns about private clinicians with little experience in treating addiction profiting from those addicted to pain medications without providing appropriate care. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0113,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0113,2016-04-28T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,490,"We need the help of Addiction Specialists. Patients with Opioid Addiction have other addictions like Alcoholism, Cocaine, and Benzodiazepine Addictions. Moreover, they have co-occurring Psychiatric Disorders which complicate the outcome of given treatment. It is helpful to increase the capacity of addiction specialists to provide much needed service. A physician who spent his career in training, and treating addictions will be a vital resource to improve the quality of treatment.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0127,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0127,2016-05-06T04:00:00Z,Comment on FR Doc # 2016-07128,Carol Bojorquez,2088,"Docket ID: SAMHSA-2016-0001
Agency: Substance Abuse and Mental Health Services Administration (SAMHSA)
Parent Agency: Department of Health and Human Services (HHS)

To Department of Health and Human Services:
This comment is in regard to "Medication Assisted Treatment for Opioid Use Disorders"

I would like to thank you for attempting to pass this federal rule. I am a registered nurse, in a busy rural Emergency Department. I have witnessed the catastrophic results that can come from opioid use disorders first hand. I have learned that an ED is not the appropriate place to take care of this patient; however, my community has less than a handful of primary physicians who treat and manage patients with opioid use disorders. I am hopeful that the passing of this federal rule will increase patients' asses to qualified physicians.

The United States is currently crossing an opioid epidemic. Although, the United States of America is only 20% of the world's population, we consume 80% of opioid medications. I whole heartedly support increasing the patient limit to 200 for those physicians qualified to take care of patients with opioid disorders and can prescribe buprenorphine treatment along with counseling and other supportive services. This action will allow qualified physicians to treat more patients who urgently need treatment and may possibly save their life.

I do hope that the possibility of diversion is also addressed with ample oversight of the use of this medication along with best practices and evidence based treatments for opioid use disorder treatment. This will be crucial in the prevention of a future abuse and dependence of buprenorphine.

In summary, I support this federal rule; am hopeful that this federal rule will pass and have a positive effect on outcomes for individuals who are struggling with opioid abuse.

Thank you,

Carol Bojorquez, BSN, RN, CEN
Cbojorquez1997@gmail.com
San Diego State University
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0244,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0244,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Andre Chen,5030,"May 17, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Andre S Chen, MD, MBA
The Austin Diagnostic Clinic
2400 Cedar Bend Drive
Austin, TX 78758

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0348,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0348,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Garrett Stenson,1221,"I am all for increasing access to MAT. I do have concerns about buprenorphine prescribing practices and oversight. Most patients that we encounter that were receiving buprenorphine prescriptions from an approved physician have not received ANY counseling services. Many MDs do not even perform urinalysis tests, which increases the likelihood of diversion and accidental pediatric exposures. I would encourage SAMHSA to gather data re: linkage to counseling and drug screen testing practices from MDs who prescribe buprenorphine prior to increasing the # from 100 to 200. With less oversight and enforcement of requirements, the more diversion will occur. If this gets approved, I feel requirements and guidelines that are enforceable are in place. Many issues that contribute to continued drug use get addressed in counseling sessions, such as psychological, social, vocational, legal, and medical issues. Counseling is a necessary and key component to addicts in the recovery process. This has been proven over and over in multiple studies and brain imaging comparisons. Counseling services must be required along with monthly drug screen testing. Please strongly consider these concerns prior to approving. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0377,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0377,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous MD Anonymous MD,1839,"I am a long-time addiction medicine provider in Sonoma and Contra Costa Counties in Northern California holding the current waiver. I have had my full quota of 100 buprenorphine/Suboxone patients for over a year. I have a long waiting list of addicted applicants, and patients referred by their physicians or their rehabilitation programs, asking urgently for help. I receive calls from patients requesting Suboxone treatment every work day that I have to turn away because of the current limit on buprenorphine patients.

Additionally I have been asked to provide Suboxone treatment at the only methadone program in another county, which accepts MediCal patients, as well. I cannot do it because my quota is full. There are many patients there and nationally who do not qualify for methadone maintenance because they cannot prove at least a one year history of addiction, specifically continuous opioid dependence with abuse. They are good immediate candidates for Intensive Outpatient Treatment with workshops, counseling and buprenorphine whom I would be happy to enroll in our team treatment and take care of if only the limit is lifted to 200 patients.

Nationally there are many cities and counties without methadone treatment but with an abundance of heroin and prescription opioid abusers who would benefit from treatment, if it were available. The Courts are often willing to remand offenders into treatment, if it was available.

It is ironic in the face of the current epidemic of opioid addiction and overdose deaths, that essentially all physicians can have unlimited numbers of patients treated with opiates, but addiction specialists have a limit on the number we can treat with opiate replacement therapy.

PLEASE LIFT THE CAP ON TREATMENT OF ADDICTED PATIENTS WITH BUPRENORPHINE.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0398,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0398,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Zachariah Todd,418,"As an addiction treatment professional working in California, I whole heartedly support raising the patient cap limit to 200 for Doctors who are prescribing Buprenorphine for opiate use disorders. Many persons with OUDs have a difficult time finding a doctor who is able to prescribe this medication and when they do, doctors are unable to accept new patients. Raising the limit will alleviate some of these problems. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0513,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0513,2016-07-27T04:00:00Z,Comment on FR Doc # 2016-16069,"Shelly Fingerhood, M.D.",262,"Turning in reports annually will just be one more burden on the Doctors and their time. DEA performs audits. That's enough.
I don't even understand why there was a 100 client limit before, and now 275.
How did you ever come up with that number?" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0057,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0057,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Patrick Sherman,1048,"Dear Sirs;
I have been working as a counselor in an outpatient agonist therapy clinic for 3 1/2 years and have seen the demand for this
type of service climb steadily to the point where we always have a waiting list. This concerns me in particular when I
am speaking to someone who is using IV heroin and thus subject to even more dangers. Our two waivered physicians would
gladly seem more patients if they were permitted to and they are just as frustrated as the rest of the treatment team with the
current regulations. I have personally been working for over two years trying to recruit another doctor to join us in the fight but
have, thus far, been unsuccessful. While I am very pleased with this proposed change in regulations, I am sad that it will take
at least another 60 days before any improvements might be seen. Thank you for suggesting this much needed change.
Sincerely,
Patrick Sherman, M.A., CAADC-DP
D.O.T. Caring Centers, Inc.
510 S. Washington Street
Owosso, MI 48867
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0027,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0027,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,711,"I work in an acute care setting in which we see many patients come through the ED requesting detox from opiates. For those who could benefit from buprenorphine maintenance, availability is limited due to the current strict restriction of 100 patients per provider. Due to the limited availability, it is difficult to refer a patient in need and they end up presenting in other areas of the healthcare system which taxes the system and ultimately, society. Increasing the limit from 100 to 200 would be a good starting point in making more resources available for this population by essentially doubling the number of patients that can be treated. Thanks for the opportunity to comment on this important subject." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0050,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0050,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Brad Anderson,2149,"I have been practicing full time addiction medicine as a physician for 23 years and while I am glad there is movement to improve the access to buprenorphine for patients in need with the proposed patient limit increase, it doesn't go nearly far enough to meet the demand.

Here are the real changes the federal government needs to make if it serious about increasing MAT:

1. Extend prescribing of buprenorphine to nurse practitioners and physician assistants.

2. Abolish the patient limits.

When I tell my patients and their families that I or NPs and PAs in my state can prescribe opioids to an unlimited number of patients but that only I, and not the NPs and PAs, can prescribe buprenorphine, and that to only 100 patients, they look at me like I'm joking. When I tell them that sadly, I am not, they ask "Why? What sense does that make? It should be the other way around!"

The federal government is established OF the people, BY the people and FOR the people and I am telling you that the people who have this disease, who are touched by it and treat it DO NOT WANT THESE RESTRICTIONS!

President Obama has recently said that opiate addiction is as big a threat to this country as terrorism. Then why are the medical people in this country limited by their very own government in using the most effective agent against that threat?

I've heard the diversion arguments, but I've also talked to thousands of patients, none of whom ever bought buprenorphine on the street to get high. They bought it to stop using heroin, other opiates or to treat withdrawal. And why didn't they simply go to an ER or physician for this help? Because there are so few physicians who can prescribe it and those who can have no more room because of the limits! Establishing the limit actually created the need for diversion, not preventing it.

So HHS needs to do the right thing for the people of the USA and push harder. Push for passage of the TREAT Act. Get this story out, let America hear what the real issue with buprenorphine is. It is a life or death matter." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0070,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0070,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,"Mark Fettman, MD, MMM",680,"I am a Board Certified Addiction Psychiatrist in Columbus, Ohio. I have been working with suboxone patients since 2007 or 2008. The number of patients in our area far exceeds the number of practitioners who are willing to work with this difficult population. I am hopeful that increasing the number of patients each physician could treat would help toward alleviating this problem. It's a complex problem and I do not think increasing the number of patients per doctor alone will be a panacea. But it will be a movement in the right direction, if doctors are permitted to proceed according to their professional training and governmental regulation is not excessively onerous." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0079,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0079,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Cameron Maneese,91,Please make this happen. It is needed to curb the crisis that is impacting our communities. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0081,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0081,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Marilyn Schmidt,671,"PLease do consider letting more doctors prescribe medication to counteract opioids. There are many people out here struggling with addiction. The most effective way to treat this addiction is with opiate blockers. Unfortunately, there is a dearth of physicians who are licensed to dispense or prescribe such drugs. If it is easier and thus more profitable for them to do so, I am sure that more would be willing to do so.
It would be a huge step in the right direction if there were more doctors willing to help with the ongoing fight for the sobriety of all of the people who are willing to take this step towards their future in freedom from addiction.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0085,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0085,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Donald Hall,482,As Ohio continues to see increasing numbers of those who are addicted to opiates. The proposed change would be very beneficial as it would allow more people the opportunity to have a means and a way to battle the opiate addiction. Known and effective treatments using this medication can help to stem the tide of yearly increases in opiate deaths here in Ohio and nationally and benefit in the road to recovery.

This is an opportunity that should and can not be passed up. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0099,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0099,2016-04-22T04:00:00Z,Comment on FR Doc # 2016-07128,Mary Stoecker,984,"In rural areas of the country, we can't even find physicians, let alone physicians who are willing to open their practice to large numbers of opioid addicts for MAT. We currently have ONE physician in a four-county, 65,000 population region who is certified and willing to see opioid addicts for MAT. He will by choice only see up to 25 .... could see the full limit per his certification level.

We have one other physician coming on board to this certification, we HOPE.

What the new rule needs is not just an increase in the number of opioid patients a physician can treat with MAT, but rather, permission FOR MID-LEVEL PROVIDERS to provide this treatment after they pass the certification, etc.

Addressing the physician shortage is necessary. Mid-levels, especially Nurse Practitioners who can have their own practice in NM and I would suspect most states, need to be given the access to treat this population.

Thank you.
Mary Stoecker" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0119,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0119,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Jim Walsh,1140,"Two concerns

As an Addiction Medicine Fellowship Training Program director I am worried that the pathway to prescribe buprenorphine to 200 patients takes two years, even for specialty trained physicians. These fellowship graduated specialists may be recruited into comprehensive addiction treatment programs where they are needed to prescribe to 200 patients, and might even be replacing outgoing docs who currently have 200 patients.

I am also concerned that the program may be interpreted as mandating treatment that is not evidence based. The requirement to report on the "percentage of active buprenorphine patient that received psychosocial or case management service" could be considered as implying that psychosocial or case management service is the standard of care for buprenorphine treatment. A recent review of the efficacy of behavioral treatment in conjunction with buprenophine MAT does not support this view.

References
A Systematic Review on the Use of Psychosocial Interventions in Conjunction With Medications for the Treatment of Opioid Addiction J Addict Med 2016;10: 93-103" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0174,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0174,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Stuart Wasser,1044,"I have been informed by ASAM that the regulation as written can be interpreted as not apply to a practioner like me- ASAM certified & Board certified in Addiction medicine since 1992 as ABAM certification is not a Subspecialty of ant board. It may be reasonable in 5 or so years to limit this to to the new addiction specialty (as well as addiction psychiatry). However, while I have every intention of pursuing the new specialty status, it may be 2017 or later before this will be achievable.

In the meanwhile, I had planned to expand my treatment in two of the clinics I work in (serving a medicaid population) on top of my private practice. If the language is not clarified I may not be able to. Since the clinics are located in medically underserved areas in Brooklyn and long island, many patients will not be able to find affordable alternatives.

Although 200 is a step in the right direction, it will still limit the total # of patients I can enroll into the 2 clinic systems for which I am medicl diresctor" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0181,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0181,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Brian Grahan,4931,"Dear sir or madam:

I am an internist completing an addiction medicine fellowship in June 2016, and have been hired by a large urban safety net health system to create an outpatient addiction medicine service that includes office-based opioid treatment using buprenorphine. I'm very concerned about the proposed rule because it would prevent me from increasing my buprenorphine limit until 2019, at earliest, due to ongoing changes in the board certification of addiction medicine specialists. Please allow me to explain my concerns in more detail below.

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

-- ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.

-- Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).

-- Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)

Given that it will be at least one year until I, or any other physician, can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Thank you for your consideration,

Brian Grahan, MD, PhD
Minnesota Addiction Medicine Fellow" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0197,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0197,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Bhimavarapu K. Reddy,1568,"I am a triple board certified pain specialist and board certified in addiction medicine & practicing addiction medicine for more than 7 years. Our center has a Phd with LPCC and 2 drug counselors with bachelors degree. ASAM and ABAM through its certification & organizational skills unified and pioneered the examination maintaining high standards. It appears that proposed changes unintentionally added "Subspeciality" term to the board certification thus eliminating the most qualified needed board certified(ABAM) huge pool of experienced caregivers. Current proposal will eliminate the needed qualified physicians. This needs to be amended and corrected.
On the average patients are seen every 10 days (Some 3 times a week initially to some every 2-3 weeks). Keeping this in mind a well qualified addiction specialist could absorb about treat 250-300 patients maintaining excellent care. This will provide increased access to needed patients filling the gaps in the needed patient care.
Current and proposed rules does not address the emergency situations where the physicians need to provide script on an emergency basis for collegues who are overseas or out of town. The current proposal does appear to address the sudden death or retirement of a colleague, but does not address this situation with out possibly getting penalized due to limitation of numbers. There should a way to provide coverage for other physicians with out getting penalized by adding emergency coverage for collegues. This request is reasonable and practical. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0206,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0206,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,853," I believe that increase the patient limit to 200 for addiction specialist is a great direction. I don't support increase to 500 patients because Opioid treatment is not merely giving Suboxone to everyone who wants it, it is an interactive interpersonal process that includes medication and therapy to get patients out of the trap of addiction and recover their abilities to succeed in life.

Mass production concept will not make improvement in addressing the epidemic, but it will undermine the existing system.
I don't think it is helpful to the patients to have physician with limited training on Buprenorphine and no training on addictions to qualify for 200 limit. How are they going to treat huge number of opioid addicts with high likelihood to have alcohol and other substance dependence as well psychiatric disorders." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0273,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0273,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Tom Gibbs,5124,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Dr Tom Gibbs, D.O.
CommQuest Services, Inc.
Community Services of Stark County
Quest Recovery and Prevention Services
1660 Nave Rd. SE
Massillon, OH 44646
330-837-9411

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0354,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0354,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Monica Percy Edgar APRN,499, A majority of patients are seen by Nurse Practitioners or Physician Assistants but we are still unable to prescribe buprenorphine. Here we are in national crisis and it should be all hands on deck. The bureaucratic posturing on not allowing NP's or PA's prescribe is irresponsible.Folks are dying from this disease that is treatable. Why can not a NP or PA prescribe respectively to their state prescription authority with completion of the x waiver requirements (8 hour course and etc..)? SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0406,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0406,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Carolyn Ross MD,3425,"I am a physician board certified in Preventive Medicine and Public Health and also in Addiction Medicine by ASAM. I've been treating addictions in Denver for the past 10 years and have witnessed the heartbreak of patients who want help but can't find doctors in the community who want to work with addicts and who are qualified to prescribe Suboxone / Buprenorphine. I am shocked that your agency would consider eliminating Addictionologists such as myself from the increase in the treatment cap for medication assisted treatment. I can tell you that my qualifications equal or rival many of my colleagues in the field and I have been treating 100 patients for over 4 years.
You would be eliminating a very devoted segment of the population of doctors who treat people with addictions if you do not recognize the ASAM qualifications. This seems like more of a political move than one designed to help our patients.

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:


I strongly urge you to include ABAM certified Addiction Medicine doctors in your decision to increase the cap - for the benefit of the patients who need help!

Carolyn Coker Ross MD, MPH" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0442,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0442,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,1017,I am a board certified psychiatrist practicing for 45 years. I have been prescribing Suboxone since 2004. I am almost always at the 100 patient limit and have to turn away patients needing treatment almost every day. This feels and is horrible. All opioid dependent patients should be able to get the treatment they need. I strongly support raising the limit to 200. In addition I am against having more requirements if one is practicing in a "qualified practice setting". The additional requirements place extra burdens not required (it seems) by those with specialty board certification. By the way there was only one subspecialty board (Child) when I was certified in the 1970's. Please do not make it more difficult for me to increase the number of patients I can treat in helping the community that this bill is meant to serve. Anyone who has been certified to treat 100 patients should be permitted to treat 200 patients without additional requirements other than having to apply for this. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0345,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0345,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Narendir Soorya,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0340,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0340,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Georgia Jones,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0351,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0351,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Linda Rosenberg,4868,"The National Council for Behavioral Health (National Council) is pleased to submit comments on the proposed rule to increase access to opioid use disorder treatment while reducing the opportunity for medication diversion.

The National Council is the unifying voice of America's community mental health and substance use treatment organizations. Together with our over 2,500 member organizations employing 1,000,000 staff, we serve our nation's most vulnerable citizens - more than 10 million adults and children living with mental illnesses and addictions.
SAMHSA's Proposed Rule is timely given the current state of the opioid epidemic in our nation today. As the President correctly stated, our country is in the midst of a "public health crisis of opioid addiction, misuse, and related morbidity and mortality."

The National Council offers comments on the questions that SAMHSA included in its NPRM, while also noting that many of the quality and reporting requirements that it is proposing for practices seeking to serve over 100 patients would also benefit patients served by practices not seeking this waiver. For example, new requirements related to diversion control, overdose prevention and reporting on referral to treatment would benefit all patients served in OTPs.

Question 1: Evidence Supporting an Optimal Patient Prescribing Limit

The National Council supports SAMHSA's proposal to increase the patient limit to 200 patients for certain practitioners who meet certification standards, or who are working in qualified practice settings. The National Council suggests, however, that the list of qualified practice settings explicitly include state licensed specialty behavioral health centers that have the capacity to provide the holistic treatment called for in this proposed rule.

While a condition of receiving a waiver to treat over 200 patients is tied to that practitioner working in a qualified practice setting, there is currently no requirement that the prescription be written by the practitioner while at that qualified practice setting. It is quite common for practitioners to work part time at many locations, some of which may not meet the standard of a qualified practice setting as defined by SAMHSA. We urge the department to clarify that the prescription, if written, be confined to the qualified practice setting.

We also suggest that SAMHSA recognize that emergency situations include the death, relocation of practitioners, and sudden practice closures and that lack of access to qualified practitioners can happen in any part of the country. We suggest that SAMHSA more explicitly define "emergency situation" and do so in a broad enough way to capture the variety of challenges facing patients, families, and organizations.

In addition to recognizing state-licensed behavioral health organizations, we also suggest that SAMHSA include standards for qualified practice settings that ensure that these organizations allow patients to appropriately adapt and modify their treatment plans over time, including, when it is clinically appropriate, for the use of non-opioid alternative medications and non-pharmacologic interventions. Also, given the well-established risk for relapse and overdose within weeks following discontinuation of buprenorphine, all waivered practitioners should be required to ensure that all of their patients receive relapse prevention medication and counseling prior to their patients' cessation of treatment.

Question 2: Potential New Formulations

The National Council recognizes that additional formulations are being developed, such as sub-cutaneous delivery, which in their method of delivery meet SAMHSA's standard of improving access while also minimizing diversion potential. We would suggest that the 200 patient cap not apply to any such formulations.

Question 3: Practitioner Training for 200 Patient Limit

The National Council supports SAMHSA's proposal that the advanced waiver only be available to physicians with board certification in addiction medicine or psychiatry. We hope this proposal will lead more physicians to seek such certification.

Question 4: Alternate pathways to qualify for 200-patient prescribing limit

The National Council cannot support alternative pathways outside of SAMHSA's proposals for physicians to seek treating more patients. SAMHSA's proposed approach seems appropriately balanced between access and diversion control. As one of our members observed, "We have suboxone pill mills in Ohio. The pain clinics closed and suboxone clinics opened."

Question 5: Process to request a patient limit of 200


** comments continue in PDF attached. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0499,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0499,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Pucher,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0466,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0466,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0494,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0494,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Kate Berry,288,"On behalf of America's Health Insurance Plans, we are pleased to submit comments on the proposed regulations governing
medication assisted treatment (MAT) for opioid use disorders as published in the Federal Register on March 30, 2016.
Our comment letter is attached below." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0240,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0240,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Nels Kloster,557,"I practice in a rural area with a shortage of physicians to treat opioid addiction. My staff is capable of treating many more than 100 patients, so our contributions to the community's health are hampered by the current limits. There are many more persons seeking this treatment, but we have to turn them away due to this artificial restriction to our services.
I have also been made aware by the American Society of Addiction Medicine that the current rule may exclude me and many colleagues from the proposed solution. Please see the attached." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0433,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0433,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0428,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0428,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Bridget Early,1908,"See attached file(s)
As a physician who has treated patients with opioid dependence with buprenorphine since 2005, and a proud member of the American Society of Addiction Medicine, I am writing to echo and support ASAMs letter of May 22 to you regarding the proposed rule changes to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 200. I agree with the thoughtful comments in that letter including the importance of allowing experienced physicians with adequate training in addiction medicine to increase the number of patients they treat, to 250 to 500; and with not limiting those qualified to addiction psychiatrists.
Every day my practice in rural Missouri receives plaintive phone calls from people caught in the grip of addiction who are reaching out for help. There is a medication, buprenorphine, which can greatly improve their chances of controlling their illness. Yet my hands are tied by the 100 patient limit and I am unable to help the vast majority of them. Today our clinic was closed for Memorial Day and calls were forwarded to my cell phone so I spoke with 2 such people today. I had to tell them to try calling somewhere else, which they both had already tried.
I also work at a residential treatment center where we have to ration the state of the art treatment (buprenorphine), and offer the less effective injectable vivitrol, or absence which is the least successful treatment for this life threatening illness.
Deaths from opioid overdose continue to rise. Our state is particularly hard hit. A whole generation of young adults is being decimated. We have the tools to address this, we just need the will to do so. A powerful first step would be to expand the treatment limits for physician prescription of buprenorphine.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0468,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0468,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Cynthia Reilly,932,"The Pew Charitable Trusts is pleased to offer the attached comments to the Substance Abuse and Mental Health Services Administration (SAMHSA) on the proposed rule to increase the patient limit for qualifying physicians to treated opioid use disorders under Section 303(g)(2) of the Controlled Substances Act. Pew is an independent, nonpartisan research and policy organization dedicated to serving the public. Our work to address substance use disorders focuses on developing and supporting policies that 1) reduce the inappropriate use of prescription drugs while ensuring that patients have access to effective pain management and 2) expand access to effective treatment for substance use disorders including through increased use of medication-assisted treatment (MAT). Should you have any questions or if we can be of assistance with your work, please contact me by phone at 202-540-6916 or via email at creilly@pewtrusts.org. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0478,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0478,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Art Van Zee,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0464,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0464,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,David Schwartz,40,See attached comment letter. Thank you. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0190,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0190,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Warren Morris MD FASAM,646,"To Whom it may Concern:

I am an addiction specialist in rural Ohio. We have a massive opiate addiction problem and we are currently forced to turn patients away who are in urgent need of treatment. I would ask you to please allow expanded prescribing of buprenorphine for doctors board certified by the American Board of Addiction Medicine and Fellows of the American Society of Addiction Medicine.

I will be training to use the upcoming buprenorphine implant, but to reach even a fraction of patients trapped in addiction in our area I must have the expanded capacity to prescribe.

Thank you for your consideration." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0224,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0224,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Chantal Nouvellon,1074,Hi

I have treated patients with addiction to opiate since 2006 and I always set up 1.5 hour for an intake adn 45 min for follow up. I am a Child and adolescent and adult psychiatrist and not board certified in addiction. I hear of many doctors spending 10 min per patient and seeing 6 patients per hour for 2 days a week : 100 patients : they are OB-GYN and practice in MA. I hear of Clean Slate that use the license of the MD to have the Physician assistant and Nurses practice and see the patients: the doctors see the patients once for 20 min. I have never seen 100 pt in one month on suboxone as I believe they need more time. I really don't believe that a certification is going to make the doctors do the right thing.I believe it takes time to evaluate and treat properly the patients who are addicted to opiates. Yhe insurance will not pay for more than one psychiatrist visit a week and when I try to move patients to vivitrol it takes 2-3 months for the insurance to approve the treatment: it is a joke to see how the insurance dictate the treatement. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0272,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0272,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Anne Pylkas,1159,"To whom it may concern,

I am an ABAM certifed Addiction Medicine Physician. 129 people per day die of opioid overdoses. Why is it that I can give 10,000 patients OxyContin, yet I cannot meet the need in my community to treat addiction? No other specialty of medicine, no other physician, has any limit on any prescribing, especially during an Epidemic. I wonder what would happen if we had an epidemic of an infectious disease and the government limited the number of patients a physician could treat? It would seem ridiculous. It is ridiculous.

I am not a thief, I am not a charlatan or a quack. I am not a pill mill. I take insurance. I do not make millions on the backs of the helpless. Suboxone harms very few, as opposed to the millions of opioids that are prescribed EVERY DAY for chronic pain, which addict and kill thousands. I have passsed all my tests. I am qualified to treat addiction, yet I am limited. To what end?

If addiction is to be treated as the chronic disease that we now know it is, we, as providers and leaders, must lead the way in treating it as such.

Thank you,
Anne Pylkas, MD

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0355,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0355,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,"Tina Gleadall, RN, CPC",4983,"I too am a nurse who watched my own daughter become quickly addicted to prescribed pain medication supplied through first her dentist, then her obstetrician, and lastly by many walk in clinics. After confessing her affliction to me, she chose to be treated for her drug addiction by a provider that offered Suboxone. She went from bad to worse after starting that treatment. It is a POWERFUL drug that is often sought after deliberately just to get a prescription for it. It was much stronger drug than the opioids that she had previously been addicted to. She would constantly be in a state of sleepiness, and had trouble taking care of her two year old. After 3 months of treatment and starting to be weaned down, she became pregnant with her second child. She was not permitted to take herself off completely until after she had the baby. It was horrible to watch your own child taking a drug that put her in a Zombie like state and not being able to care for her 2 year old, and your unborn grandbaby becoming addicted to buprenorphine as well. The baby was in the hospital for almost 5 weeks after birth to slowly wean her off the Suboxone. It is unimaginable to witness your own grandchild tied up to so many machines. And be disallowed to hold or comfort the fussy infant while going through the 10 days of withdrawal. It was the worse pain that I had ever experienced in my entire life, not to mention my daughter and son-in-law's lives. I just don't understand how replacing one drug with a stronger drug is a good idea (although I can see it's good potential for use with heroin addicts). If I could save even one mother from this heart wrenching experience it is worth me asking you not to increase the limit of patients that the physicians can treat. Buprenorphine is very addictive; as I first-hand witnessed my child and grandchild go through a horrifying withdrawal from it. I found the following source (from the National Institute for Drug Abuse) that explains how intense and closely monitored the treatment needs to be for this type of rehab. "To be effective, treatment must address the individual's drug abuse and any associated medical, psychological, social, vocational, and legal problems. It is also important that treatment be appropriate to the individual's age, gender, ethnicity, and culture. The appropriate duration for an individual depends on the type and degree of the patient's problems and needs. Research indicates that most addicted individuals need at least 3 months in treatment to significantly reduce or stop their drug use and that the best outcomes occur with longer durations of treatment. Recovery from drug addiction is a long-term process and frequently requires multiple episodes of treatment. As with other chronic illnesses, relapses to drug abuse can occur and should signal a need for treatment to be reinstated or adjusted. Because individuals often leave treatment prematurely, programs should include strategies to engage and keep patients in treatment. Behavioral therapies vary in their focus and may involve addressing a patient's motivation to change, providing incentives for abstinence, building skills to resist drug use, replacing drug-using activities with constructive and rewarding activities, improving problem-solving skills, and facilitating better interpersonal relationships. Also, participation in group therapy and other peer support programs during and following treatment can help maintain abstinence. A patient may require varying combinations of services and treatment components during the course of treatment and recovery. In addition to counseling or psychotherapy, a patient may require medication, medical services, family therapy, parenting instruction, vocational rehabilitation, and/or social and legal services. For many patients, a continuing care approach provides the best results, with the treatment intensity varying according to a person's changing needs. Although medically assisted detoxification can safely manage the acute physical symptoms of withdrawal and can, for some, pave the way for effective long-term addiction treatment, detoxification alone is rarely sufficient to help addicted individuals achieve long-term abstinence. Thus, patients should be encouraged to continue drug treatment following detoxification. Motivational enhancement and incentive strategies, begun at initial patient intake, can improve treatment engagement. Knowing their drug use is being monitored can be a powerful incentive for patients and can help them withstand urges to use drugs. Monitoring also provides an early indication of a return to drug use, signaling a possible need to adjust an individual's treatment plan to better meet his or her needs. Source: Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition). Those statements do not lead me to believe that a patient load of 200 can be adequately cared for by one physician. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0370,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0370,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,JOHN HARSANY,1064,"Regarding Diversion Control

There are currently a number of buprenorphine products available on the market, and they vary significantly in the amount of buprenorphine contained due to differences in bioavailability. Advocating for the use of products with lower buprenorphine per dosage unit could be beneficial from a public health standpoint by potentially enhancing safety and reducing diversion.



1) The lowest buprenorphine content in a dosage unit may provide an added margin of safety in the event of accidental ingestion by a child.

2) From a diversion perspective, a lower buprenorphine content per dosage unit may contribute to a lower street value (therefore less preferred in a diversion situation).

3) Products with the lowest buprenorphine content may be less likely to be misused or abused, and, if misused or abused, providing less drug is preferable to limit the potential for adverse reactions and the risk of accidental overdose
JOHN HARSANY,JR.M.D.(D.F.A.S.A.M.)
ADDICTION MEDICINE" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0373,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0373,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,John Mattocks,466,I am very concerned about the lack of oversight that is seen in the practices of many providers. I regularly see patients getting buprenorphine from multiple providers. I also see providers not following up in any way with clients other than prescribing medications. Somehow the criteria for clients to participate in office based treatment needs to be more stringent or the services and oversight provided by office based providers need to be more comprehensive. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0414,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0414,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Taufik Kassis,623," Include ABAM-certified physicians among those who would qualify for the higher limit based on their medical education and training by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients and thus would have a very limited impact on access to specialist care." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0424,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0424,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,rae murphy,490,"I am a pharmacist practicing at a Behavioral Health hospital. We have a very busy outpatient detox practice with only one physician working full time to see all these patients and prescribe medication, which is often Suboxone. Many of these patients are long time clients and it would be very beneficial if more patients could be seen and treated. The quality of care would not be compromised and with the lack of behavioral health providers this would be very beneficial to the community." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0452,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0452,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Stacey Pearce,4074,"Dear Secretary Burwell,

I am writing as an OTP owner in the state of Georgia. My facility has been open fourteen years and I have worked in medication assisted treatment for twenty-one years. There have been many changes to the treatment modality during this time, some for the good and some have made working in this field more difficult. I continually strive to provide consistent and effective care to my patients and feel this is not always the case in treating persons with opioid use disorder.

In the beginning of office based treatment using buprenorphine, the idea as proposed by the federal government was to de-stigmatize opiate dependence disorders and integrate some of the patients into "regular" medical practices. This does not appear to be the case, and many of the providers currently prescribing buprenorphine do not seem to be providing treatment. Many of the people being treated are there because they abused prescriptions for opioids, how does giving them another prescription help them get better. "Effective treatment attends to multiple needs of the individual, not just his or her drug abuse. To be effective, treatment must address the individuals drug abuse and any associated medical, psychological, social, vocational and legal problems." (NIDA) I too believe this statement and treatment without counseling and accountability is not treatment, it is giving the person a prescription. This does nothing to de-stigmatize patients and if doctors are incorporating more patients on buprenorphine into their practices this does not seem to normalize the condition, only create buprenorphine practices.

Given the increase in the available buprenorphine on the streets, many of the patients who come to treatment at OTPs have already taken buprenorphine illegally. It is difficult to treat a person with opioid use disorder with a medication that they have been able to abuse. Some doctors are on record as saying this is because ist so hard to get into a buprenorphine doctor for treatment. I do not believe this is true, and I have not seen any published evidence that this research has been done to indicate it is true. If a physician wants to treat over 100 patients with buprenorphine, why doesn't he/she establish an OTP and get licensed through the state and federal government as such. The physician would then be able to treat an unlimited amount of patients. This seems like a logical solution to the problem. If a doctor is interested in providing comprehensive treatment and truly helping people, this would be a viable option. Another option would be for the doctor to work in partnership with a local OTP to create a system of care that would allow the transition of patients between the OTP and the physicians office as higher or lower levels of oversight, accountability, and care are needed by the patient. Neither of these two options would open up the potential for more illicit burprenphine to be on the streets. Illicitly obtained buprenorphine is not treatment, it is abuse of the drug used to treat opioid dependence.

I believe that not only should DHHS and SAMHSA establish standards of care that DATA 2000 providers must follow, but also that a third party monitoring mechanism for DATA 2000 providers to ensure compliance with these standards should be created. This would provide a much more comprehensive structure than currently exists and would allow for the treatment to be monitored in a manner that would improve outcomes for patients. The current proposed recommendations are just that, recommendations since there is no oversight mechanism included. The proposed regulations do not go far enough to ensuring quality, effective care is provided to patients.

I do not feel it would be in the best interest of the public, the patients, the treatment modality, or treatment providers to move forward with approving the proposed regulations as currently written.

Thank you for reviewing my letter.
Stacey Pearce
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0040,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0040,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,263,"Due to the lack of availability of qualified physicians who can prescribe Suboxone, opiate users can strain valuable emergency room resources. Please approve the proposed rule to increase the number of patients that physicians can treat for Suboxone maintenance. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0086,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0086,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Jeffrey Capitummino,976," I feel this is a very important step forward for a proven medication and therapeutic tool. I work as an admission counselor for a substance abuse rehab in the capital region and I receive numerous calls(usually daily)from desperate Opiate addicts,clinicians,and concerned family members in a desperate attempt to access Buprenorphine maintenance. The consensus is that the standard response they are getting,from the few physicians willing to prescribe this vital medication in our community,is that they are unfortunately at the "100 patient limit" and can't take anymore clients. I also hear accounts of doctors with room for Suboxone clients that they do not accept insurance and will only take clients that are able to pay a ridiculously inflated and exploiting amount for this desperately needed therapy.It's a shame that in the midst of a serious health epidemic we have limitations like this in place that are being put on a life saving medication." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0104,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0104,2016-04-25T04:00:00Z,Comment on FR Doc # 2016-07128,Neal Lakritz,759,"This regulation is long overdue. It is a small step toward improving the poor access to care that is an embarrassment for our society.
The requirements for an increased patient cap make sense, except one. What relevance are Electronic Records in this regulation? Most studies have shown no improvement in quality of care with EMR. My paper charts, with templates and flow sheets, are more efficient and less costly than most EMR's. I will be able to provide the requested data reporting with little difficulty.
This regulation will not affect me since I am board certified, but may restrict some physicians that may be excluded simply because they use paper charts. Please reconsider this requirement.
Sincerely,
Neal Lakritz M.D. FASAM" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0130,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0130,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Reah High,5109,"To whom it concern,
May 4, 2016

Addiction is not a more important medical issue than all the people, Vets, failed back surgery patients,( 50%-65% failure rate). the number one surger performed in the world is gallbladder removal, and it has a whooping 69-70% failure rate leaveing more and more people a victim of the for profit medical system! Hundreds of thousands of people are suffering from chronic pain for a multitude of reasons! At the top of the list is, war, vets, then bad surgeries in expensive hospitals that leave the patient unable to function, work, care for there families! The real secret is the medical system is creating permaninent pain patients and discarding them when the insurance is gone or they have more pain and the doctor doesn't want to flag the FDA even though he or she may have caused that patients pain, unfortunately, they just pass you off to Pain clinics who practice for profit medicine with questionable procedures. Giving shots after shot of steroids into you until you turn into a mess that can't be fixed at that point!
Your efforts to try and save one group, people who become drug addicts, at the price of every another group that is impacted by permaninent pain! The numbers are not even close when you have 50%failure fates on some of e most frequently done surgeries! PErmanant Pain victims are created every day by Doctors and then kicked to the curb! But not even half of all pain paitirnts will become addicts! They will manage their madications appropriately because this is theire last line of defense. I am the victim of a failed back surgery, and post Cholesectomy syndrome. The Back surgeon broke my back again during surgery, with a screw and left it in there bone chips, then he put me back together all wrong. I was paralyzed on the left side, I have already had one hip replaced and will need another, and a new knee, all because one doctors mistake, it happens EVERY DAY! I am also the mother of a autistic child and I am unable to get out of bed with out pain medication. I have tried every form of alternative treatments and pain medication was my last resort! I could not care for my son with out my pain medication! Would you start building and filling up homes for all the Autistic children and adults that are being cared for someon with chronic pain? Please consider how many people will be harmed by this if it is allowed to pass. Addiction can be screened for with a little attention, chronic pain paintents have NO WHERE ELSE to go! As last option pain patients, we don't have ANY OTHER options, no other place to turn, There is NO Malabu Center for chronic pain! I fear many will turn to suicide as a way to end the pain.

Physicans are already afraid to treat patients who are victims of pain. The DEA targets them and instills fear in how they choose to treat their patients and what they prescribe. More and more, Doctors are refusing to treat their patients who have chronic pain. Patients are far too often considered "Malingering" or "Doctor Shopping", not to mention if the Doctor has a had a surgical failure with them, the patient become frightened and lest trusting of all Drs.

Elderly patients who suffer pain every remaining day of their lives are told by their Doctors' that "They are concerned about a possible addiction". What happened to the quality of their life? Their right to live their life to live without debilitating pain? Their only option may be to consider suicide or trying to find medication anywhere they can? The potential for untold deaths is unimaginable, but by a different group of the population! The up till now law abiding, insurance carrying, compliant patients who do not fill there prescriptions early ever! Who trus threr Doctor and follow his instructions and get the surgery when he reccamendigng it, but he never mentioned 50+% failure rate, or what he will do,if you fall into that group. Mostly they get rid of you and pass you to the pain clinics that seem shadier and the Staff is less that professional, as they expect every one is an addict, Maybe they need to cut down on these high failure surgeries that leave so many patients as pain patients. You would cut the need for pain medication drastically. And they must first remember do no harm. Not just when the money is good enough, don't try fixing things you can't fix! Or that risk making people worse. Third world countries don't have the same pain as they don't have the doctors creating more than half the pain problems!

Physicians are taught (since the very beginning of medical school) that any patient requesting pain medication is to be Scrutinized" and to be "Wary" of them. They are taught what sort of drug seeking behaviors to look out for, and screen their patients regularly. The DEA is not a Doctors and has no business practicing medication or telling Doctors how to do their job!

Respectfully,
Mrs. Reah High
2662 Golden Fawn trail
Shingle Springs, CA 95682
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0132,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0132,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Joseph Mott,251,"ABAM-certified physicians should be eligible for the higher patient limit based on their extensive and rigorous education and training in addiction medicine.

Joseph A. Mott, M.D., J.D.
Diplomate of the American Board of Addiction Medicine" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0149,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0149,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Jerry Lee,514,I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0138,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0138,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,"Ayaz Khan,MD",411,"It was OK if prescribers were prohibited from charging Medicaid or Medicare patients if USA had a universal government funded health care system not run by for -profit private insurance companies who only are in the business to make millions of dollars in profits for their CEO'a and the Board and have the policy of Delay,Deny and Defend when it comes to paying the physicians for the services rendered." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0155,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0155,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,SRINIVAS ERRAGOLLA,4528,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0143,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0143,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Mark Jameson,392,Physicians who are Board Certified in Addiction Medicine should continue to be exempt from the training requirements as they are now. Board Certified Addiction Medicine physicians undergo advanced training far beyond the level of any required course for primary care doctors regarding Buprenorphine. Taking a basic course in Buprenorphine is simply redundant and completely unnecessary.
SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0152,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0152,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Darrin Mangiacarne,835,"There should be NO limit on the number of patients that a licensed, waived physician can treat. There is no limit on the number of patients I can treat with oxycontin. All having an arbitrary limit is RATION care to patients with a legitimate medication condition. Too many people are dying waiting for care because there are not enough spots for them (and the ones that have openings charge way too much money for office visits). Patients with opioid addiction are still stigmatized and having a patient limit of any kind perpetuates that myth. There would be OUTRAGE if we decided to limit the number of patients any doctor can treat with insulin. However, bureaucrats seem to thing it is okay to do this with opioid addicted patients. I have no issue with needing a waiver to treat them, but there should be NO limits at all." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0171,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0171,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Terrence Alley MD DFASAM DABAM MRO,4573,"

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
Terrence Alley MD DFASAM DABAM MRO" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0191,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0191,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,William Forsythe,305,"Perhaps allowing osteopathic physicians who are also Boarded in other areas, to be board-certified in addiction medicine would be beneficial as well. Currently they are not being allowed to do so despite, more often than not, additional training then those who chose the more traditional allopathic route." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0194,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0194,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Daniel Sumrok,3388,"Thanks for solicitation of comments.

Please remember that the original intent both under DATA 2000 and this proposal is to expand treatment access.
Buprenorphine providers must not be overburdened with legislation that is too onerous.
Overly onerous requirements will drive physician behaviors away from willingness to become specialists in this field.
I am Chair of Addiction Sciences at the University of Tennessee Health Sciences Center College of Medicine.
I must be able to inspire and convince young students and residents that there is a viable career path addressing this epidemic of substance use disorders.
They ,having large student loan debts must be able to see this path as attractive and available.

In my case I have just started this new department with 4 mission
priorities. 1.Education of addiction fellows,residents in all specialties and students. I have two fellows about to begin a year long training in July. How will they be treated as prescribers?2.Treatment from the streets and suburbs of Memphis to the rural counties where treatment is especially scarce.
I have started University clinics for prenatal care of addiction, urban adult populations,suburban population and rural citizens. I consult in hospitalized patients that are everywhere disguised as abdominal pain or vomitting.
Shall I as an ABAM certified, FAAFP, DFASAM,director of four clinics in 4 distinct locations, serving different populations,be restricted to 200 clients?
If the counseling requirements are practice locale specific then so should the allowance for 200 at the locale.
The fixed expenses in geographically remote locations will require a revenue stream to support the requirements.
I support responsible prescription and risk mitigation via REMS.
3.A third leg here is the research mission and we have currently begun work siding the genetics of NAS. We have persuaded our high risk ob maternal fetal medicine providers to become buprenorphine providers and opened University clinic with local social and psych support.
Should they be restricted to 30 for a year or even 200?
Please don't let the unintended consequences of this rule making be restrictions rather than opening access to care.
Please remember the key role new training programs play in the newly recognized ABMS specialty of addictions and let us do what we do most effectively; take care of our fellow citizens.
If as we propose addiction is a disease like diabetes or hypertension or asthma, as will there be efforts to restrict endocrine specialists to 100 or 200 clients on insulin? How about pulmonologists and Chantix ?
There was 850,000 tobacco related deaths and 50,000 opiate related deaths last year.
Unintended consequences can hamstring addressing this epidemic and kill a newly emerging and much needed specialty of addiction medicine.
The Senate committee suggested a number of 500 versus 200. I suggest some provision be made to allow academics and teaching physicians expand their numbers beyond 200 and perhaps unlimited but reviewed regularly regards outcomes and quality.
Thanks again.
Respectfully,
Daniel Sumrok MD FAAFP DABAM / DFASAM
Director, Center for Addiction Sciences
UTHSC College of Medicine
Memphis TN

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0210,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0210,2016-05-12T04:00:00Z,Comment on FR Doc # 2016-07128,Lynn Lytton,5381,"11May2016

The Honorable Lamar Alexander
455 Dirksen Senate Office Building
Washington, DC 20510

The Honorable Fred Upton
2183 Rayburn House Office Building
Washington, DC 20515

The Honorable Patty Murray
154 Rayburn House Office Building
Washington, DC 20510

The Honorable Frank Pallone
237 Cannon House Office Building
Washington, DC 201515

RE: RIN 0930-AA22

Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Congressional Leaders,

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services
Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope
SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-
based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA (1) raise the
patient cap above the proposed 200 patient limit and (2) consider the potential impact that a formulation-
based "counting" methodology might have on physician/patient decision-making and patient-driven recovery.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy
supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As
a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is hard to
identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any
other specialty or set of medications.

SAMHSA has worried that expanding access to MAT due to concerns that increased use will
mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of
trepidation that office-based treatment and take-home medication would open the floodgates to poor quality
addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has
revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" due to lack of access. From 2000 to 2014, nearly 500,000 Americans died from opioid overdose. The number of U.S.
deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and
only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to
accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know -
patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of
services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond
addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource
in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that
each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to support SAMHSA to raise the DATA 2000 patient limit to one that meets the needs of our
communities, both with respect to the limit and eligible clinicians. It is worth noting that the clinician time
required during induction is far greater, and the risks potentially higher, than what is required during maintenance
and tapering. SAMHSA should consider a "counting" methodology that captures the realities of patient care and
associated time requirements, dosing, and risks throughout the stages of recovery. This type of approach may offer
greater precision and increase overall capacity without increased diversion risk. Clinicians who have reached their
patient capacity, and are primarily managing a patient population through maintenance and tapering could "count"
these lower-dose maintenance patients at a specified fraction and would be able to offer treatment to new patients.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals
recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program
generally.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed
in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people
will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the
DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to
address SAMHSA directly. If you have any questions, please contact me at

lelyttonmd@gmail.com

or
512-474-5904

Sincerely,

Lynn E. Lytton, MD" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0218,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0218,2016-05-13T04:00:00Z,Comment on FR Doc # 2016-07128,Stephen Byrd,4534,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0225,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0225,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,William Stewart,2469,"RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

I was trained by the US Navy in the diagnosis and treatment of alcoholism in 1991. In the past 35 years, I have treated patients with addiction to alcohol and other drugs. When I began working with these patients, there was no specialty professional society or board for addiction medicine.

As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients.

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification or appropriate training and experience.

With the current cap of 100, a provider can see all of the permitted medically assisted treatment patients in 4 days per month, or 1 day per week. I and most of my colleagues are forced to turn away dozens of persons seeking treatment each month. Many of us have waiting lists of over a month. Many of the persons we defer will die because of lack of available treatment. Raising the cap to 200 will only minimally impact this access to care crisis. A cap of 500 would allow practitioners specializing in addiction treatment to see a reasonable number of patients requiring medically assisted treatment each workday, and improve access to care for those suffering from addiction to opioids.

I urge you to request that SAMHSA (1) raise the patient cap above the proposed 200 patient limit and (2) consider the potential impact that a formulation-based counting methodology might have on physician/patient decision-making and patient-driven recovery.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSAs efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at 615-934-9894. My email address is safe4bill@yahoo.com.

Sincerely,

William R.C. Stewart, III, MD, MPH
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0231,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0231,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,David withers,298,"Please include AMERICAN BOARD OF ADDICTION MEDICINE diplomates among those qualified for the increased limit. Pretty important. I have as the fellowship training director for addiction medicine at Geisinger/Marworth seen extraordinary ability in this group.

Thanks,
David Withers MD" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0233,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0233,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,John Harris,274,ABAM board certified physicians are the most qualified physicians to treat patients with buprenorphine. The increase limit from 100 to 200 patients will best be served by ABAM certified physicians. Please insure that ABAM certified physicians qualify the the limit increase. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0274,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0274,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Molly Rutherford,5047,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Molly Rutherford, MD, MPH, FASAM
6225 W. 146, Suite 1
Owner, Bluegrass Family Wellness
Crestwood, KY 40014

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0459,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0459,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Scott Weidle,2918,"I lost my son to the Disease of Addiction Dec 26 2016. My son had successfully been on Vivitrol for 8 months. This is after 4 years of battling opiate addiction. My son and I fought this disease very hard and seriously. 5 months of residential rehab , 2-3 efforts of using the addictive type MAT meds without much success. Problems with street value of this MAT drug , its abuse potential along with the mandatory IOP classes that force complaint patients in with non compliant patients and the peer pressures created by that environment is very detrimental to some patients
We then discovered Vivitrol and it made a big difference. The second month in, my son states " Dad I don't crave opiates anymore ! " The problem occurred when his MAT doctor closed up shop unexpectedly. We were left without a referral. We called our local Community for Alcohol and Drug Addiction Services ( CADAS ) looking for referral. After they searched for two days they called and said they could not find a provider. We called the Vivitrol web site provider locater , no luck , we ask his family physician to intervene only to be told no.
The Center for Disease control press release March 2016 : Opiates are still being prescribed at a rate that is doing more harm than good
Former head of FDA just released a statement : Opiates are one of the greatest mistakes of modern medicine .
Two novel suggestions to consider
1. Any medical facility offering MAT meds SHALL offer both types of MAT meds. The Addictive type and the NON Addictive type ( Vivitrol ).
Yes it is very hard to understand why this does not already occur especially since the 100 patient rule with the addictive type med is at this stage of discussion
2. Require Family Physicians to offer treatment for opiate addition IF they desire to maintain their authority to write opiate prescriptions
This would increase treatment availability and decrease the over prescribing of Opiates which IS the two main issues.
SAMSHA does offer on its WEB site : Procedures for Medication -Assisted Treatment of Alcohol or Opioid Dependence in Primary Careby Rand Health. This needs to be aggressively pursued in order to create better availability for care for the Disease of Addiction.
Its hard for the experience I went through to even consider the current MAT med that has been used for the past 6 + years and used 95 % more than any other MAT med is working when we have allowed this opiate based situation to become the epidemic that it is. The current system is not working. The statistics are clear.
Scott Weidle
Weidle@aol.comfacebook : In Loving Memory of Daniel Weidle
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0531,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0531,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Bradley Anderson,1576,"As an addiction medicine physician for the past 23 years, I have seen how buprenorphine have saved and changed
thousands of lives. The fact that the federal government has placed such draconian restrictions on the prescribing
of this life saving medication since its approval in 2001 is a national shame and disgrace. The current changes in
legislation to allow the expansion to NPs and PAs as well as the increase in the patient limit are improvements, to
be sure.

However, placing reporting requirements on physicians for buprenorphine is ridiculous, meaningless and
will only cause more physicians to opt out of prescribing. This will lead to more Americans not getting the needed
treatment they deserve.

The Big Book of AA says "Half measures availed us nothing." Take a page from the Big Book, stop with the half
measures, let physicians, NPs, and PAs do their jobs or more Americans will die needlessly.

Are there such restrictions for the prescribing of opiates? NO! Then why on Earth are there for the prescribing of
buprenorphine? This is a question I get every week from patients and their families. I AM TIRED OF HAVING NO
GOOD ANSWER! The diversion argument is flawed and wrong. Limiting something CREATES a market for it, it
does not PREVENT a market for it.

NO LIMITS! NO REPORTING REQUIREMENTS!

Doctors don't want them, patients don't want them, families don't want them, pharmacists don't want them.
We all want health, and recovery.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0046,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0046,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Judy Peterson,276,YES!! This is LONG overdue! Many substance abuse providers are turning away between five to ten patients on a daily basis. Many practices also have Advance Practice Nurses who are trained in treating addiction. If they can prescribe pain treatment why not addiction treatment? SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0075,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0075,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Susan Mathur,93,Increasing the number of patients to 200 is imperative because of the rising opiate epidemic! SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0509,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0509,2016-07-26T04:00:00Z,Comment on FR Doc # 2016-16069,Anonymous Anonymous,85,Is the DEA audit program not sufficient to ensure compliance with the new rules?
SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0516,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0516,2016-07-29T04:00:00Z,Comment on FR Doc # 2016-16069,Anonymous Anonymous,740,"With the growing number of addicts in this country, there has to be some consideration when considering limiting the number of patients a provider can treat. In an ideal world, the providers treating a greater number of these patients is more familiar with this population and best equipped in managing their condition. The DEA follows these providers in an effort to decrease inappropriate prescribing. It cannot sound wise to suggest turning down an addict for treatment simply because a provider is "maxed out" on the number of pateints they are currently treating. This again brings out the issue of shortage of providers in the United States and may prevent patients in rural areas from receiving appropriate treatment. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0536,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0536,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Nyla Gardner,539,"The reporting documentation appears excessive. I am a psychiatric NP and have been working with Suboxone patients for over 12 years now. I have not found the reporting system to be accurate; not a reliable indicator. Since I will be doing both mental health care prescribing and hopefully MAT, it would be time-saving if a check off sheet including both elements would be supplied meeting the requirements. These are typically complex folks, so the less time spent on paperwork allowing more time with the patient is definitely preferred. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0489,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0489,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Carmela Castellano-Garcia,19,See attached file. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0498,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0498,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Samantha Pellon,143,"California Medical Association's submitted comments on SAMHSA's proposed rule, Medication Assisted Treatment for Opioid Use Disorders. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0486,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0486,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Vicky Bass,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0487,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0487,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Daniel Raymond,90,Harm Reduction Coalition submits the attached comments on the proposed rule RIN 0930-AA22. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0314,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0314,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Anthony Barrueta,276,"RE: Medication Assisted Treatment for Opioid Use Disorders [RIN 0930-AA22]

Kaiser Permanente offers the following comments on the Medication-Assisted Treatment for Opioid Use Disorders,
Notice of Proposed Rulemaking.

Please see attached letter.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0292,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0292,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Mary Tipton,1101,"
I am a concerned American who has watched many friends and acquaintances ruin their lives by getting hooked on Opiates. I myself was asked by my family physician if I needed pain killers for small aches and pains and I turned him down, because I have seen too many people ruin their lives. I have since changed physicians.

I feel that the laws that allow doctors to prescribe these medicines like candy have caused the Opiate epidemic in our nation. These laws or regulations need to be changed so these addictive pills are used for people in real pain. Cancer patients as an example.

When my generation was growing up doctors were not allowed to prescribe opiates because they knew they were addictive. How can educated people in the FDA and Pharmaceutical Companies say they didn't realize Opiates were addictive?

Now we have Rehab Centers everywhere. Americans have died by the thousands. Why has it taken 20 years to stop this thing? I understand that we probably do need the Medically Assisted Treatment now, but what will that create?

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0300,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0300,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,"Scott Miles, M.D.",1073,"I echo ALL the points set forth in the letter from the ASAM president (see attached). I am currently practicing full time as an addiction medicine physician as medical director of a medication assisted treatment dispensing program. I currently hold the DATA 2000 waiver to treat up to 100 patients and I passed the ABAM certifying examination in October 2015. Additionally, I hold board certification in OB/Gyn through the ABOG and practiced this specialty for 28 years. Our current plan is to offer a comprehensive treatment facility that is able to treat and monitor patients both in the dispensing setting as well as the transitional outpatient prescribing (Buprenorphine) setting. The patients receiving prescriptions will be subject to the same requirements as the dispensing setting; including counseling, random urine drug screening, recalls for medication counts, referral for mental health services etc. I feel that, as an ABAM certified physician working full time in this setting, I am uniquely qualified to provide high quality services to these patients." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0462,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0462,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Amelia West Suermann,49,The Joint Commission's comments are attached. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0381,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0381,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,156,"The APA, AAAP, and AOAAM are pleased to submit comments regarding medication assisted treatment for opioid use disorders. Our formal comments are attached. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0391,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0391,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,74,The comments of the American Medical Association are attached. Thank you. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0469,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0469,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Saira Sultan,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0481,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0481,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Laura Burns-Heffner,4638,"Submitted by the State of Maryland, Department of Health and Mental Hygiene, 5/31/16

Regulatory Information
Number (RIN) 0930-AA22

General Comments:

At the state level, we are responsible for balancing access to services for those with an opioid use disorder against patient and community safety. Raising the limit on number of individuals on buprenorphine in a practice is an important step in increasing access. However, the requirements for those prescribing over 100 are onerous and will naturally suppress the number of physicians willing to increase beyond 100. In a time of a severe and worsening opioid crisis, it seems that the increase allowed through these rules is overly cautious and not in proportion to the public health crisis we're experiencing through opioids. The relief from the crisis should involve immediate access to the medication that prevents an overdose. When the relief includes limits on the number to be served, an application to prescribe the medication, a wait time to increase the cap, and reporting requirements, it is of limited assistance. We recommend that the prescribers of this medication have the same requirements as those imposed on the prescribing of any other CDS. However, if the Department continues to feel that they must impose additional requirements on providers who wish to treat using buprenorphine, then those requirements should not vary by the patient cap. The Department should not impose additional requirements for those wishing to treat up to 200 patients. Requirements should be uniform whether the provider is limited to treating 100 or 200 patients.

C. Definitions ( 8.2)

Comments: The overly restrictive nature of requiring that cross covered patients be added to a practitioner's caseload is another layer of complication that will suppress physician involvement. I recommend that we manage cross covering in the same manner as those prescribing other CDS.

E. Which Practitioners Are Eligible for a Patient Limit of 200? ( 8.610)

Comments: The rule does not include physicians who are board certified in addiction medicine by the American Board of Addiction Medicine (ABAM). Based on their extensive education and training in addiction medicine, they should be included as eligible for the higher patient limit. In addition, waiting one year between approval to prescribe to 100 and receiving approval to prescribe to 200 does not take into account the significant opioid crisis in our communities. It is difficult to understand how the delay will enhance a provider's capacity to manage the requirements, as they have already waited one year between initial approval to prescribe for 30 and approval to prescribe for 100. The protective factors are the additional subspecialty or practice setting requirements. Waiting a year is not value added.

G. Process to request a patient limit of 200? ( 8.620)

Comments: If a renewal is necessary, align it with other renewals that must be completed (ie, DEA license). The Request for Patient Limit Increase form takes one hour to complete. This isn't a reimbursable activity. Every additional requirement (time intensive forms, reporting requirements, etc) result in shrinking the number of physicians willing to expand their practice. Reaffirming of eligibility should be consistent with other renewal application terms for regularly waivered physicians.

J. What are the reporting requirements for practitioners whose request for patient limit increase is approved under 8.625?

Comments: This seems to be the most onerous of new requirements. Because a prescriber would need administrative staff to enter and track the data, it will create a barrier to significant uptake. No other disease specialty treatment places this level of burden on providers. For example, physicians in pain management clinics or anyone who prescribes (other) opioids don't have to adhere with reporting requirements anything like this. We recommend the same data be collected on buprenorphine as is collected for other prescribed CDS. If data must be collected, we recommend that it be retrieved through a state's PDMP, or at a timeline to match reporting to the DEA.

K. Process for renewing a practitioner's request for patient limit increase approval? ( 8.640), p. 17647

Comments: A 90 day timeline is too long. Language should be added regarding when a response to request will be provided by SAMHSA and what one does if the response does not come by the stated time.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0492,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0492,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Ashley Thompson,156,Please accept the attached Comment Letter regarding Medication Assisted Treatment for Opioid Use Disorders from the American Hospital Association.

SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0271,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0271,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Jeffrey Katz,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0252,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0252,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Nicklas,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0535,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0535,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Linda Rosenberg,3310,"

August 5, 2016

Ms. Kana Enomoto, MA
Principal Deputy Administrator
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane
Rockville, Maryland 20857

Re: Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements (RIN 0930-AA22)

Dear Principal Deputy Administrator,

I am writing on behalf of the National Council for Behavioral Health and our 2,750 community-based mental health and addiction treatment member organizations. This letter intends to offer supplemental feedback and comment on the Substance Abuse and Mental Health Administrations Final Rule for Medication Assisted Treatment for Opioid Disorders, published on July 8, 2016.
As we reviewed the Final Rule, it was clear that the Department has made a determination that increasing access to this service is the most important concern. The National Council and its members share this desire and believe that reporting requirements are important for the physicians and practices that are serving 275 patients, while also being important to inform policy decisions for the department.

Therefore, the National Council suggests that SAMHSAs data collection requirements be parsimonious, and focused on data that will be important for high quality clinical practice. We would like to point out that physicians working in qualified practice settings would be much more likely to have the capacity to collect and report this data, as well as provide high quality care.

Pertinent Data to Collect
In an effort to collect all relevant and important data, the National Council suggests the following baseline data points to monitor and collect: total number of patients admitted that year, total number of patients carried over from the previous year, and total number of patients discharged.

Moreover, we would like to recommend the use and distribution of the following questions - specific to the prescription of buprenorphine. Please note, we suggest that these questions be asked using a six point Likert Scale. Answers for the Likert Scale can include: Always; Very Frequently; Occasionally; Rarely; Very Rarely; Never.

The questions for prescribers include:
I refer patients for behavioral health services.
I require patients to be engaged in behavioral health services in order to continue to receive buprenorphine.
I directly provide behavioral health services integrated with the provision of medication
I utilize our state's Prescription Drug Monitoring Program (PDMP).
I use drug-use monitoring screening tests (e.g., urinalysis, patches, etc.) to detect opiate drug use by my patients receiving buprenorphine.

We appreciate your time and consideration of this feedback. Please contact Chuck Ingoglia, Senior Vice President of Policy and Practice Improvement, if you have any questions, at ChuckI@thenationalcouncil.org or 202-641-3242.

Sincerely,

Linda Rosenberg
President and CEO
National Council for Behavioral Health

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0539,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0539,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Rachel Capeder,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0534,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0534,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Dan Elling,196,"On behalf of the Opioid Treatment Program Consortium, I am submitting their comments on the proposed DATA 2000 reporting requirements.

Thank you,

Dan Elling
Alston & Bird" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0072,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0072,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Bobbi Douglas,966,"My name is Bobbi Douglas and I have been Executive Director of an addiction treatment facility for over thirty years. During that time, I have not seen anything to rival the epidemic of opiate addiction during the past five years. This epidemic has been an incredible challenge to our system as we struggle to meet the demand for treatment, particularly treatment utilizing medications. We have a Board Certified Addictionologist who currently is only able to prescribe Suboxone to 100 people with addiction disease. Meanwhile, there is no limit to her ability to prescribe opiates such as Oxycontin, Vicodin, etc. - the very drugs initially used by many of our patients at the onset of their addiction. I support the expansion from 100 patients to 200 patients and I also support that the physicians have to possess certain training requirement to be eligible to prescribe to 200 patients.

Thank you for your attention to these comments.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0084,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0084,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,stanley harrell,641,I ask for tougher regulations on despensed suboxen and provide documentation similar to Sudafed in order to regulate the medicine that kills your pain. And the amount of pain a prescribed allowed to numb . Cause if addicted after treatment uneven the jail needs to treat even if hospitolazation when detox for them. And paperwork by licensed family practice to show were treatment being administered properly. You only can kill feelings for so. Long and then you feel nothing. . Limit kill quanity to 8 mg per day and also provide detox if necessary for the medicine since prescribing. Cause I see were suicide is a factor in many cases SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0120,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0120,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Scott Golden,4858,"
Hi All.
My name is Scott Golden, MD and I am an addiction psychiatrist who has been prescribing buprenorphine since 2003 when suboxone/subutex became available on the market. I am trained as a general psychiatrist and did an added year in addiction psychiatry in 1996. When I trained, the only option for opioid maintenance was methadone through a federally credentialed program with significant structure involved such as daily dosing, frequent toxicology and mandated counselling.

Although I consider myself an advocate of opioid maintenance treatment, I have had a very ambivalent relationship with this medication over the years. I remember in the late 1990's getting surveys asking if I would approve of office based opioid maintenance with a drug (buprenorphine) that had low potential for abuse, blocked other opioids and would have little illicit values. I was very enthusiastic at the time but my experience with buprenorphine has been very different than what was advertised and I have often wondered if I am part of a broad social experiment by the federal government to decrease the power of drug cartels and enrich the coffers of pharmaceutical companies.

There are a number of misrepresentations physicians were told in the initial marketing of buprenorphine. First is that it could not be abused - especially through an IV route. Obviously this has proved to be a significant error as it has become a drug of abuse and has an illicit value. Perhaps buprenorphine does not have the potency and euphoric effect of a full agonist but it certainly has an intoxicating effect which is more pronounced when used IV. Second, this drug can be used sublingual and IV without the "blockade" which was part of its initial marketing as long as individuals wait for a period of 12 - 24 hours after using a full agonist. Also the vast majority of suboxone patients use the drug to "get through" periods where they do not have a full agonist such as heroin or prescription opioids. I certainly admit that if used within 12 hours of using a full agonist, it can be a miserable experience for an individual with opioid use disorder. Finally, as I Google buprenorphine in the news it seems that most arrests for opioid possession often include the presence of buprenorphine which again demonstrates it a drug of diversion and abuse.

Another point of concern about buprenorphine is that its use as an opioid replacement therapy was approved during a period in this country when opioid use for pain was being significantly liberalized. As history has shown, this has led to the most problematic use/abuse of opioid medications in this country in our history which has been described as an epidemic. My concern is that the liberalization of opioid maintenance for addiction and the approval of suboxone was part of the broader liberalization of opioid prescribing for pain and, in retrospect, was not fully evaluated and vetted due to the liberal era of the times. In fact, there was already significant evidence that buprenorphine had become a drug of abuse in many of the regions where it was already being used such as Europe and Australia. I am a federally employed physician and prescribe buprenorphine as an employee and have no financial incentive to prescribe more of increase my numbers. However the model I see most often used in the prescribing of buprenorphine is physicians with little training in addiction treatment prescribing buprenorphine in cash for script business. This is not the model that was being visualized at buprenorphine was being evaluated in the late 1990's. Addiction was supposed to become part of mainstream medicine and the primary care physician would have patient with hypertensions, diabetes, emphysema or other chronic illnesses along with the addict in their waiting room. This has certainly not been the direction that buprenorphine has taken and I am concerned that buprenorphine "pill mills" will become the norm if the patient limits are increased.

Truly I would hate to see buprenorphine vanish as a therapeutic tool for opioid use disorder. However it certainly needs to be more regulated and controlled and I am concerned that the increase in buprenorphine patient limits will only increase the number of cash for drug businesses (buprenorphine pill mills) and decrease the legitimacy of the treatment. There needs to be more oversight of the use of this medication and nation-wide best practices and evidence based treatments that become the model of opioid use disorder treatment. Otherwise I am concerned that the next evolution of the opioid epidemic will be the use, abuse and dependence of the "miracle cure" buprenorphine.

Scott Golden, MD
Tuttle537@gmail.com

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0133,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0133,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Robby Hutchinson,4523,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0168,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0168,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Edward Eskew DO,329,"Physicians currently board certified through The American Board of Addiction Medicine and who are currently prescribing Suboxone/subutex and currently have a buprenorphine waiver should be allowed to increase their client numbers to the 200 proposed by SAMHSA. Thank you, Edward W. Eskew DO identification number XE5561724" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0262,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0262,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Fuhrman,4993,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

S. Michael Fuhrman, DO
363 Delaware Ave
Delmar, NY 12054

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0282,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0282,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Jonathan Kamien,4544,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0298,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0298,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Uma Rao,233,I strongly think that ABIM physicians are more capable to treat opiate addiction patients and should have higher number of patients. Their specialty itself speaks that they are trained especially in Addiction Medicine.
Thank you. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0322,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0322,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Drake,389,I believe it is of utmost importance to raise the limits the limits of patients but it must be given to those physicians who have been trained and scrutized by ASAM . They should be board certified otherwise you'll be opening drug clinics throughout the country and only creating more problems. Please follow the advice of ASAM they have great expertise . Thank you. Andrew Drake DO SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0364,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0364,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Juliana Wisher,625,"I am a clinical nurse specialist working in an addiction medicine consult service in a major university hospital. I see the life saving impact that Suboxone has made in the lives of patients with Opioid Use Disorder on a daily basis, many of those with chronic pain who we in the medical community have been responsible in part for the creation of their opioid use disorder. I fully support the increase in the number of patients that physicians are able to serve in their buprenorphine practice, and hope that one day advanced practice practitioners with prescriptive authority will be able to provide buprenorphine as well." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0401,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0401,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,453,"As a Peer Support Specialist working in California in the field of Alcohol and Other Drugs Division,
I encourage the Medication Assisted Treatment for Opioid Use patient cap limit be raised to 200 for doctors
who prescribe Buprenorphine for those persons with an Opioid Use Disorder. Many individuals are
waiting to find a available doctor to prescribe this very effective medication for their recovery and wellness.



" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0503,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0503,2016-06-01T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Gordon,1282,"It is obvious that a great many people have put a great deal of effort into remedying the barrier to access for opioid addiction medication-assisted treatment imposed by the 100 patient rule. This is commendable. However, it seems to me that the concern about potential abuse of buprenorphine continues to have more power in the administrative decision-making process than the concern about stemming the tide of opioid addiction and accidental overdose deaths in this country. Otherwise, why would there be even consideration of such a limited raise in the number of patients that one physician may treat? Why would there be more restrictions on the prescribing rights of mid-level providers for this schedule III drug than any other? Why are we not talking about limiting the number of patients that one provider can treat with oxycodone or hydrocodone, both far more dangerous drugs than buprenorphine in overdose situations, and responsible for vastly more deaths? And why are physicians Board-certified in Addiction Medicine not included in the limit increase to 200 patients? Why is there a limit at all on the prescribing of this life-saving drug? I am astonished and baffled, and more than a little angry about this disregard for common sense and the well-being of society." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0034,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0034,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Thomas Muije,1354,"I'm neither a practitioner nor a policymaker, I'm just a college student tasked with writing a comment on regulations.gov. However I'm also a former patient with 8 years clean, so while searching for a business regulation to comment on. I found this and was compelled to comment.

(1)Evidence Supporting an Optimal Patient Prescribing Limit As of previously stated I'm not well versed on the subject but to my knowledge there's no limit on the number of patients a doctor may see and prescribed opiates for various reasons. Why is the cause of the addiction (albeit necessary in many forms of pain management) so widely available from dentist to general practitioners to Physical therapist to which begs the question why are they able to prescribe cause of this disease and unable to prescribe the cure without special government oversight. The only benefit I find is the likelihood of a facility attempting to create a continuous revenue stream by means of indefinite care is limited by his ability to grow the patient base. Which as a former patient truly worries me as I seen the difference between indefinite care and a needle exchange program.
9) Estimation of the Time Required to Seek Approval to Treat up to 200 Patients. From the patient perspective, I see this as an increase to my overall cost of care.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0045,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0045,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Franny Barry,229,"There are not enough providers of suboxone in mn!!! Please increased the number of client that Dr's can see.
These poeple are seeking help and do not need to be seen in the hospital, ER, or back on the streets.
Thanks" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0207,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0207,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Bruce Rosenblum MD,22,0930-AA22. 0930-AA22. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0164,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0164,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,"Jacquelyn Starer, MD",1076,"It is absolutely essential that physicians who are boarded by the American Board of Addiction Medicine be included among the physicians who may apply for the higher limit.
The American society of Addiction Medicine( ASAM) no longer administers the certification exam and this function was taken over by the American Board of Addiction Medicine(ABAM) several years ago.
ABAM was established by ASAM as a an independent credentialing board as an essential step in achieving recognition by ABMS, which has recently recognized addiction medicine as such. As some point in the near future the board examination will be taken over by the Board of Preventative Medicine , the specialty which sponsored addiction medicine as a sub specialty.
It is important that requirements for higher prescribed utilize not only past means of achieving certification in addiction medicine but also present and future.
Thus The American board of Addiction Medicine and the American Board of Preventive Medicine certification in addiction medicine should be included in the new law." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0172,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0172,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Raymond Denny D.O. Med Director,1533," I am a board certified Addiction Medicine Specialist certified by The American Board of Addiction Medicine. I practice in an outpatient setting and most of my clients are Department of Mental Health, Department of Human Services, or Drug Court related referrals. I strongly agree that waiver limits desperately need to be increased due to the difficulty of access to qualified providers. I have reviewed the proposal and would ask that a couple of areas be considered.

1. Practice specificity is important when considering a waiver increase. As I'm sure you are aware, client's with addiction are very costly in resources including physician contact time, counseling, urine screen collection, and interpretation.
In my opinion, any physician practice without being specifically dedicated to the practice of Addiction Medicine will unfortunately fall tragically short of being able to provide safe and comprehensive services to those suffering from addiction.
2. Include Board Certified physicians who have completed training in American Society of Addiction Medicine approved programs and those Certified by the American Board of Addiction Medicine.

In summary, increase the waiver limit for practitioners who are ABAM and SAMSHA Certified and who practice Addiction Medicine as a FULL TIME focus.

Thank you for your time.

Raymond Denny D.O. DABAM, AOAOS Board Certified in Addiction Medicine and Orthopedic Surgery (ret.)." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0229,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0229,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,"Kathie Watson-Gray, MD",313,Please change the bill so that certification from the ABAM also qualifies for the increased limit. This group encompasses physicians who have made the effort to provide quality care for addiction for many years and if they are not included you will be trying to fight this epidemic without a valuable resource. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0293,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0293,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Steve Weaver,128,Opening this up to PA's and NP's is inviting disaster similar to when you allowed them to open "pain" clinics. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0296,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0296,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,"Robert Reeves, MD, diplomat ABAM",396,"I endorse increasing the DATA 2000 patient limit, but do not feel that including prescribing privileges for PA's or NP's is warranted at this time. I feel those board certified by ABAM already seeing the current limit of 100 patients should be the first ones to expand capacity, and only if they are unable to meet the demand should non-physician providers be given prescriptive capacity." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0336,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0336,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,646,"Unfortunately, it isn't that simple to start MD's prescribing buprenorphine to fix the opioid/opiate problem in this country.
Many have been doing it for years. That happens when a client has solid toxicology from a MMTP proving they can stay away
from all the other drugs they may be taking. Then, move on to buprenorphine. Otherwise it will get abused and people will start selling their medications or trade
, etc. (unless they have to go to the doctor 5-7 days a week.) Most are every 30 days which could complicate things further unless they are truly serious about ending their addiction(s). Some do well, many do not." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0341,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0341,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Roberto Flecha,597,"My major concern with this expansion is the lack of accountability of the physicians to request their patients attendance to counseling services. I believe that physician records shall be monitored to assure that the clients are enroll in formal substance abuse counseling at least in ASAM level 1 with random laboratory tests. In my experience as a substance abuse counselor, there is a population of clients who are successful in this modality, but their is a great segment of the population that are diverting the medication as well as using alcohol and other substances while on buprenorphine." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0344,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0344,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Walter Walters,145,"Dear SAMHSA,

As long as the physician is able to provide optimal care for all of their patients then I am in favor of this rule change. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0352,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0352,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,131,In my opinion this is a step in the right direction. Opioid abuse is at an all time high and affects us all in one way or another. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0358,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0358,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Vanessa Charlton,291,Please increase the patient number for drs. The amount of people who are becoming addicted to drugs is increasing. It is very important for them to have access to medical treatment. Drug addiction and mental health services are limited in the United states because due the stigma around it. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0389,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0389,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Sandra Villarreal,701,"Why are the pharmaceutical companies who lied about opiods being addicting and the drug pushing doctors who over prescribed them and murdered so many people not being prosecuted? The way our U.S. Government protects these doctors is sickening and then the pharmacy industry creating shell companies to get out of lawsuits is even more corrupt. All the patients and non-patients addicted to opiods prescribed by so called 'caring' doctors who take industry bribes should be given FREE help no matter what form it is. I'm disgusted with the level of greed and murder for profit from pharmaceutical companies, our FDA, and our government who protects them. Sickening, appalling and shameful. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0484,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0484,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Laura Burns-Heffner,1570,"Submitted by the State of Maryland, Department of Health and Mental Hygiene, 5/31/16

Regulatory Information
Number (RIN) 0930-AA22

SPECIFIC AREAS - Continued from previous submission

N. Can a practitioner request to temporarily treat up to 200 patients in emergency situations? ( 8.655)

Comments: The Governmental Authority should be the one to make the request on behalf of a provider. The documentation and justification should be from the Authority, not the physician willing to cover temporarily. Likewise, for the request to receive an extension. The Governmental Authority has oversight responsibility for the overall system of care, and would need to know when there was an emergency is an area, and what the most appropriate response would be to provide coverage. It would be a burden to the provider to provide the documentation and justification. In addition, the proposed rule should state how swiftly SAMHSA will respond to these emergency requests such as when a physician's license is unexpectedly suspended by the state, or a physician becomes ill. It would be critical to allow for a speedy approval of a temporary extension of a willing provider as there may be very few other prescribers in the area to assist with coverage. In addition, a physician who is covering in an emergency situation should not be required to meet all the higher level of requirements for a physician treating more than 100 patients; that could be a burden if that physician is not already waivered to provide for over 100.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0157,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0157,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Eric Petterson,4544,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0192,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0192,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,John Sorboro MD,1599,It would be a huge mistake to expand the increase in the number of patients a Buprenorphine Waived Dr can see unless that Dr has Board certification in Addiction Medicine/Psychiatry. There is proposed legislation increasing the number of patients to an absurd 500 per month. This means each Dr would have to see 125 pts a week or 25 per day! Do you want the streets flooded with Buprenorphine? If so let any Dr with modest training prescribe to 500 addicts.

I support expansion of the patient limit but only for qualified Drs who are Board certified. This increase should be no more than 200 patients. These are complex difficult people to work with and increasing the number beyond this will promote a pill mill style practice. The requirements for a Buprenorphine waiver are ridiculously limited and certainly not extensive enough for Drs to see more than 100 addicts. Taking a 24 hour course as one proposal in congress suggests is not the same as spending a year working full time in addiction and then taking the Board exam. I am Board Certified in Psychiatry as well and I believe it is only with such extensive training that one can see how complex the needs of the patients are and that there should be strict limits on how many any Dr can see.

You don't know what you don't know and many who think they are qualified to see huge numbers of these addicts are grossly mistaken!

Leave the proposal at only 200 and only for Board Certified Addiction Medicine Specialists!

Please.

Sincerely

John Sorboro MD ABPN
Diplomate ASAM SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0202,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0202,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Fox,547,"please include addiction certified docs by asam/abam.there are not enough qualified addiction psychiatrists to dent this epidemic. you can't even get in to see a psychiatrist unless your hospitalized and these guys don't have offices. if they do,they are not using bup,and if they are, you can't get into see them for 30 days.why would you exclude the real experts with a passion for treating addiction ,NOT in the context 50% of the time with co-existing depression who have always been in the trenches from the limit change? tell ME!" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0235,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0235,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Jon-eric Baillie,4523,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0251,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0251,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,David Nelson,861,"I have been at the 100 patient limit for a few years now and consequently have had a long waiting list for patients needing help that I can not accept nor serve. I agree with most of the proposed rules changes, but I disagree with the proposed requirement to accept insurance. I have a small practice. Accepting insurance would mean adding an insurance clerk or contracting with a billing service, neither of which I can afford. It would also likely mean adding - again, at additional ongoing expense - an electronic medical record, since many insurance companies either already require, or are moving towards requiring an EMR. I simply can not afford to add these costs to my overhead while simultaneously accepting the reduced reimbursements involved in accepting insurance, which would apply to not only the new patients but my existing patient base as well." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0267,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0267,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Sheila Stallings,5027,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Sheila C. Stallings, MD
Triad Behavioral Resources
810 Warren St
Greensboro, NC 27403

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0286,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0286,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Frost,2592,"As a physician Board Certified through the American Board of Addiction Medicine I am strongly in favor of allowing qualifying physicians have an increase in the numbers of patients they are allowed to treat with medication-assisted treatment. I do however, have concerns that the current language referring to qualifying physicians as those with a "subspecialty in addiction medicine," may not include those with board certification through ABAM (American Board of Addiction Medicine). ABAM diplomates represent the single largest group of addiction medicine specialists in the nation and all have passed a rigorous board examination and are required to engage in an ongoing maintenance of certification process. While the American Board of Medical Specialties (ABMS) now recognizes addiction medicine, diplomates will not be able to officially use the language of "subspecialty in addiction medicine" until the ABMS process is fulled enacted which may not be until 2018. In the meantime, ABAM diplomates remain the key leaders in the practice and understanding of addiction medicine. It is therefore vital to the success of this proposed rule and the increase in access to care for those suffering with opioid addiction, that ABAM certified physicians be included in the proposed expansion of patient limits. No specialists practicing in other areas of medicine are limited in the numbers of patients that they are permitted to treat and addiction medicine specialists should not be singled out in this regard.
Additionally, I support the language in the proposed rule that calls for the implementation and use of a medication "diversion plan." It is reasonable that prescribers be asked to play a role in being responsible for limiting misuse, abuse and diversion of medications where possible. I am in favor of including in such a diversion plan that the physician take into consideration the use of products and medications to treat opioid addiction which may contribute to reduced diversion. Products that contain less overall buprenorphine, has less street value, or include technology that make the products less prone to abuse should be preferred. Also included should be the requirement that physicians access Prescription Monitoring Programs in states where it is available.
In summary, addiction medicine specialists with board certification through the American Board of Addiction Medicine must be included in the expansion of numbers and that a diversion plan that includes the adoption are less diverted buprenorphine products be favored." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0289,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0289,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Ashwin George,694,"I am an addiction specialist who is certified by ABAM currently practicing in Burnsville, MN. Our practice is committed to providing care for all including patients with medical assistance, medicaid and managed care medicaid. I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2. As written, the eligibility requirement is unclear and will not adequately serve the needs of opioid dependent patients.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0306,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0306,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Kamal Artin,617,"If bupernorphine is one of the most effective choice for substanse user and makes them function and have a normal life, it is unreasonable to limit the number of patients who need help from their doctors. We donto limit people who need antidepressant, anxiolytics, antiopsychotics. The same concept should be apllied to bupernorphine. During the course of treatment I suggest during each visit reminding the patient on bupernorphine to consider tapering off and stop it, if possible. If it is impossible then the patients should not suffer and obtain what they need to make them have a comfortable life on the street." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0301,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0301,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Harry Haus MD,989,The increase to 200 must include doctors board certified in Addiction Medicine or the change will not really do anything to help the the large number of people on waiting lists to get MAT. Also the the bill should include rules for pharmacies since many put in place barriers to treatment such as not carrying medicine or asking requiring patients to be weaned of in 6 month. Some require the date of the next appointment and the date of the last urine with the date and location of counseling. For example National chain in greater Erie area are requiring diagnosis written with the added ICD 10 code and with date of last visit and next visit. They also require date of counseling and when patient will be weaned off. They do not require this for patients using opioids or buying needles to shot up IV drugs. These rules are there to discriminate and encourage people not to be in recovery. Sadly two pharmacist told me people addicted are more profitable for the pharmacy. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0443,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0443,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Ken Yager,1117,"I oppose amending the pertinent federal rules to allow physicians to expand the number of Suboxone patients in the office or outpatient clinic setting.

We are experiencing problems with such clinics in East Tennessee. Suboxone is as addictive as oxycodone and for many is the replacement drug of choice. Unscrupulous medical doctors are pandering to this trade, resulting in large numbers of addicts loitering around the offices and making a general nuisance and threat to public safety. Local law enforcement is unable to do anything because current federal regulations protect the doctor, the office, and the clientele.

Liberalizing the current rules would aggravate the current problem. In light of the problems with growing opioid addiction and the troubling issues associated with use of Suboxone, the federal government should reconsider its lax enabling of the use of Suboxone in treating people with opiate addiction rather than changing the rules to allow doctors to expand the clientele.

Sincerely,
Senator Ken Yager
12th District
Tennessee State Senate
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0441,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0441,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Peter Rao,3992,"May 30, 2016
Health and Human Services
Re: The CAP restricting prescription of Suboxone by doctors for opiate addiction
Dear Sirs:
Thank you for taking the time to read this letter.
Oklahoma has one of the highest rates of opiate addiction in the nation. We also have one of the highest rates of overdose deaths from opiates in the nation. People in the throws of this addiction are powerless to stop themselves. It is urgent that we make safe and effective treatments immediately available to all Americans who suffer from this.
I have been treating patients with opiate dependence for over 20 years. Without question, the safest and most effective treatment is buprenorphine (brand name SUBOXONE). We are seeing success rates approaching 90% when prescription of this medicine is combined with effective drug counseling and psychotherapy. However, the federal government prevents me from prescribing this treatment to more than 100 patients at a time (the 100-patient "CAP"). I strongly oppose this regulation because it ties my hands--and the hands of every other physician in this country--in the face of a national epidemic of opiate addiction and death.
What if I were to go to my office today and there were 1000 patients with pneumonia waiting for me. You (and every single American) would expect me to see every patient and give them a prescription for antibiotics. However, what if I only saw the first 100, giving them a prescription for antibiotics, and then turned to the other 900 and said, "Oh, I would like to help you, but the Federal government prohibits me from helping more than 100 patients at a time. By the way, pneumonia is 90 percent fatal without antibiotics."
You find this scenario quite appalling, don't you? However, that is exactly the position that I and all other addiction doctors are put in because of a regulation which is simply absurd.
The Drug and Addiction Treatment Act of 2000 (DATA 2000) authorizes the Secretary of the Department of Health and Human Services to lift the 100-patient CAP limitation imposed on doctors. However, she has failed to do so. There currently is debate about raising that limitation of doctors to 200. That is a mistake. The CAP (regardless of its size) stigmatizes people who need this treatment and people who prescribe this treatment. You cannot promote a treatment when government has an irrational stronghold on use of a drug. One cannot advocate to the public a treatment that is, for all practical purposes, unavailable. In addition, who is going to believe that buprenorphine treatment is as safe and effective as it is when the DEA has put this "black mark" on the product.
Buprenorphine is a Schedule III drug. By the FDA's very own criteria, buprenorphine is a far safer treatment compared with the Schedule II drugs to which Americans have become addicted in record numbers, e.g. hydrocodone (Lortab, Norco), oxycodone (Percocet, OxyContin), fentanyl and methadone.
We need a large public campaign to inform Americans about opiate dependence, advocate safe and effective treatments and encouraged them to seek treatment. We cannot begin to do that if the drug is not readily accessible from physicians.
Would you please REMOVE THE CAP ENTIRLEY! Do what is right for the American people. Please do not give Big Pharma any more control over this issue. Please do right by those Oklahomans who are hopelessly entrapped by addiction and who need up-to-date information and proper treatment.
Thank you for your consideration.
Sincerely,
Peter A. Rao, MD
Peter Alan Rao, M.D., PLLC
Diplomate, American Board of Psychiatry and Neurology
Diplomate, American Board of Addiction Medicine
5544 S. Lewis Avenue, Suite 600
Tulsa, OK 74105
(918) 747-4900 (o)
(918) 747-4903 (f)
(918) 640-6445 (c)
DrRao@PeterAlanRaoMD.com
www.PeterAlanRaoMD.com
www.TulsaTMS.com
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0467,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0467,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Darius Rastegar,1894,"I have concerns about the following section:

"The higher patient limit would carry with it greater responsibility for behavioral health services, care coordination, diversion control, and continuity of care in emergencies and for transfer of care in the event approval to treat up to 200 patients is not renewed or is denied. The new Request for Patient Limit Increase process would require providers to affirm that they would meet these requirements. The proposed definitions of behavioral health services, diversion control plan, emergency situation, nationally recognized evidence-based guidelines and practitioner incapacity would be provided in 8.2 to assist practitioners in understanding what is expected of them in making these attestations. These responsibilities would be aligned with the standards of ethical medical and business practice and would not be expected to be burdensome to practitioners. Resources exist to help in the development in patient placement in the event transfer to other addiction treatment would be required, for example, if a provider chose to no longer practice at the 200 patient limit. Examples of these resources would include but are not limited to: Single State Authorities and State Opioid Treatment Authorities. Practitioners approved to treat up to 200 patients would also be required to reaffirm their ongoing eligibility to fulfill these requirements every 3 years as described in 8.640."

This seems burdensome to me and will discourage practitioners from increasing the number of patients they treat. There is no other medication that is so highly regulated in this country. Doctors (and others) can prescribe unlimited quantities of much more dangerous drugs (i.e., oxycodone). There is a need for more access to this treatment and we need to encourage and support the expansion of treatment, not create barriers." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0502,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0502,2016-06-01T04:00:00Z,Comment on FR Doc # 2016-07128,Nichole Quick,758,"As a physician board certified in Preventive Medicine and Public Health as well as Addiction Medicine I feel that it is crucial that ABAM-certified physicians be among those who would qualify for the higher limit
based on their medical education and training by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the
opportunity to treat additional patients and thus would have a very limited impact on access to specialist care." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0109,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0109,2016-04-26T04:00:00Z,Comment on FR Doc # 2016-07128,"Joseph Koenigsmark DO, MBA",490,"I agree with Neal Lakritz M.D. FASAM in his earlier comment. Their are several requirements in the Proposed Rule that do not add to Quality Patient Care. There is no reason that a physician wanting to treat additional patients with Buprenorphine should be required to use an Electronic Medical Record, EMR, or that they should be required to be in any Insurance program. Although some Doctors may do these things in their practice it does not improve the outcome of the patients they treat." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0126,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0126,2016-05-05T04:00:00Z,Comment on FR Doc # 2016-07128,Sylvester Sviokla MD ABAM,340,"As an ABAM certified physician, I heartily endorse raising the Suboxone patient limit to 200 patients per qualified physician. Providing total on site services (lab, counseling, psych testing) is an asset to our patients and I am delighted at the prospect of being able to provide total care to more patients in the future.
Skip Sviokla" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0156,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0156,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,"Val Finnell, MD, MPH",4543,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.

Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).

Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)

Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0248,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0248,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Stephen Shaner,5003,"May 17, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Stephen Shaner, MD
592 Creek Rd.
Bulger, PA 15019
412 979-6640

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0324,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0324,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Eric Petterson,379,ASAM urges SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) 5 and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

I submit the above as reflective of my own opinion.

Eric Petterson FABAM SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0331,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0331,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Mary Lou Hamill,875," Our hospital runs an active outpatient MAT program which is helping members of our community lead productive lives. I think it is important to increase the number of patients that our providers can see. MAT patients frequently come into and out of treatment so a prescriber needs flexibility in regards to the size of the practice. Since opioid addiction is an expanding problem in our country, it is important to increase access to MAT for patients. One barrier to access is the limitation on the numbers of patients a prescriber my have on their "list". The proposed change is designed to strike a balance between expanding access to this important treatment, encouraging use of evidence-based medication-assisted treatment (MAT), and minimizing the risk of drug diversion. Please help our patients overcome their addiction and regain control of their lives." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0378,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0378,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Diane McClintock,487,"I urge you to increase the limit for appropriate doctors to prescribe bupenorphine. We must do everything we can to address the opiate epidemic. Every day, people are seeking help and being turned away due to current limits. Some people need long-term medication assisted treatment and are extremely compliant yet because they occupy a slot on a doctor's caseload, new people must be turned away. Increasing limits will help, although it is not enough. Please approve this increase." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0380,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0380,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Elizabeth Kane,1081,"I believe there are pros and cons to medical assisted treatment. We have seen an increasing number of individuals suffering substance use disorders there needs to be steps made to make treatment more accessible. If this is to move forward, I believe there needs to be strict guides on how it can be prescribed (i.e. prescribed to be tapered, not prolonged).

If we are to increase the number of doctors who are able to prescribe buprenorphine, there needs to be more education provided on addiction and recovery. Taking an individual who is actively addicted to opioids/heroin and presscribing buprenorphine will not allow that individual to find recovery alone. They will need to be apart of a treatment program, whether that be AA, NA, CA, residential or outpatient.

To conclude, I see value in MAT, however I do not believe it is the answer to the epidemic our nation is facing. We need to allow these individuals to find a treatment program that works for them. MAT may be a part of their recovery, but I do not believe that if it is a stand alone treatment." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0385,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0385,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Meliah Schultzman,2458,"Thank you for the opportunity to submit comments on SAMHSA's proposed rule regarding medication-assisted treatment (RIN 0930-AA22). Central City Concern ("CCC") has provided recovery services for homeless and low-income individuals for more than 30 years and offers medication-assisted treatment at multiple sites. CCC's programs include inpatient and outpatient recovery services, subacute detoxification, culturally specific programs, community mental health services, and integrated primary and behavioral health care.

We strongly support SAMHSA's proposal to increase the buprenorphine patient prescribing limit to 200. In our experience, medication-assisted treatment has been a critical tool for helping patients achieve abstinence while they develop the skills and healthy peer communities needed for sustained recovery. The current 100-patient cap unnecessarily limits providers' ability to serve the growing number of individuals who could benefit from this treatment.

To further improve access to medication-assisted treatment, we recommend that SAMHSA strike the language in the proposed rule that would require a practitioner to hold a subspecialty board certification in addiction psychiatry or addiction medicine. Physicians who have been certified by the American Board of Addiction Medicine have the knowledge and skills needed to provide this treatment and should be eligible for the 200-patient limit, regardless of the initial board track that brought them to eligibility. Additionally, we suggest that SAMHSA decrease obstacles for providers who prescribe buprenorphine for 30 patients or fewer by reducing or waiving the fee for the DEA X number.

We appreciate SAMHSA's efforts to ensure greater access to medication-assisted treatment. Please let us know if there is any additional information we can provide that would help inform SAMHSA's development of these regulations.

Sincerely,

Rachel Solotaroff, MD
Chief Medical Officer
Central City Concern

Jessica Gregg, MD, PhD
Medical Director for Substance Use Disorders
Central City Concern
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0430,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0430,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Kimberlynn Richards,2635,"I am a physician who was initially board-certified in Internal Medicine until about 10 years ago when I received my DATA Waiver and I began to treat substance abuse patients. Since that period of time, I have seen my practice grow exponentially and the need for my services far outweighs what I can provide. When I realized that this was in fact my calling, I returned and became board-certified in Addiction Medicine. All while this was happening, the referrals to see me increased. It is painful for me to turn potential patients away because of the cap. My practice is in an area that is known to have some of the highest heroin overdoses in the state. I often wonder whether the next person I turn away is the next one to succumb to overdose.

There are many providers with DATA Waiver numbers who either aren't very comfortable treating substance abuse patients, or really did realize the time and effort that it takes to do it right. This is my passion; to see a patient's face at the second visit when they are on MAT and finally gaining control of their lives is priceless. For me to be limited in what I do and who I treat not because of any fault of my own or the patient's, makes me both saddened and annoyed.

I would like to propose that for those of us who are board certified, as long as we keep our certification and CME's current, make sure patients are going to therapy either group or individual, paid or free, and checking urine drug screens and pharmacy profiles to avoid diversion, we should not have a cap on the number of patients that we treat. This is an epidemic that we are losing because of limited manpower, and to actually limit the treatment of the few dedicating their life to it means that it will take longer to control, costing even more lives. It is a problem that is multi-faceted and restricting those of us who are trying to bring this crisis to a halt.

Insurance companies need to acknowledge that Addiction Medicine is a specialty and initiate reimbursements at specialists' rates. That should also attract more attention and physicians to the field. Currently, we are doing the work of specialists but getting paid no more.

To see the look of gratitude on a patient's face after being dependent on opiates for so long and feeling that they had no way out and no one who understands their plight and can empathize with them is priceless. I wouldn't change it for the world, but there are so many more that I could help and currently my hands are literally tied. Please free them so I can do what I can to help. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0530,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0530,2016-08-05T04:00:00Z,Comment on FR Doc # 2016-16069,Meg Chaplin,840,"I understand the importance of collecting information however as a practicing clinician in a publicly funded not for profit clinic i am also painfully aware of the reporting burdens we already face so I would just plead with you to look to minimize reporting requirements and look to redundant sources of information. For instance, regarding the PDMPs I suspect the states can provide information on who is looking and how often. Likewise, I am certain the pharmaceutical companies are well aware of who is prescribing what....our existing EMR could easily tell you how many patients we are treating with buprenorphine and how many of them began treatment in a given reporting treatment and probably even how many were in treatment and no longer are though there are many reasons someone might be out of treatment- some good, and some bad. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0066,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0066,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Edith Thomas,4741,"Docket ID: SAMHSA-2016-0001
Agency: Substance Abuse and Mental Health Services Administration (SAMHSA)
Parent Agency: Department of Health and Human Services (HHS)

As a citizen and resident of the State of Maryland, I appreciate the work being done by the Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration concerning the issue of opioid abuse in our communities. I appreciate the opportunity to submit comments to the Substance Abuse and Mental Health Services Administration (SAMHSA) at the United States Department of Health and Human Services (HHS) related to its March 30, 2016 proposed rule, "Medication Assisted Treatment for Opioid Use Disorders." Being a nurse for over fifteen years and working with substance abuse patients, sometimes I find it very troubling to see patients readmitted with the same diagnoses because of limited resources and therapies out there to help them overcome their addiction.

In section VII, question number 1, "Evidence Supporting an Optimal Prescribing Limit," HHS is proposing an increase in the patient prescribing limit for qualified physicians from 100 to 200 to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA). As the National Alliance of Advocates for Buprenorphine Treatment rightly argue, it is now obvious that instead of being rampantly diverted as previously feared, buprenorphine, an addiction treatment medication, has helped the black market to bloom because patients who desperately need the drug for treatment are forced by the 100 patient-cap rule to obtain the drug by unlawful means. This has resulted in the arrests of many people who needed the drug to treat their addiction. Rationale for the proposed rule change includes prevention of unlawful acts and overdose, and the expansion and faster access to life saving addiction medication. The increase in patient cap will make it possible for physicians to provide life saving treatment to more patients and under-served communities, and prevent patients from seeking unsafe and ineffective therapies. It is anticipated that once the cap is increased, more doctors will devote their practice to addiction treatment and research.

In the interest of patient safety and delivery of quality service, it is important to address factors that undermine the safety of patients and often lead to adverse events. Ballard (2003) states that patient safety is an essential and vital component of quality care, yet, healthcare providers face many challenges in trying to keep patients safe. One such factor which is still a concern to those likely to oppose the proposed rule is overworked practitioners who may jeopardize patient safety. As Rettner (2013) reports, when the patient to doctor ratio is high, doctors, driven by the desire to get results for their patients, may not fully explore the treatment options available to patients. When that happens, doctors may prescribe unnecessary tests and even medications since the heavy workload prevents them from thoroughly evaluating patients.

An increase in caps will offer more opportunities for people to have access to a drug which, combined with behavioral health services, saves lives (Yokell et al., 2011). To prevent diversion and other unintended consequences, a system should be developed for the cap to increase automatically by a certain number on a yearly basis, subject to periodic reviews. To prevent diversion and pediatric exposures, doctors, and hopefully nurse practitioners and physician assistants, must participate in rigorous training on patient counseling and steps to promote safe use, storage, and disposal of buprenorphine.

References

Ballard, K. (2003). Patient Safety: A shared responsibility. Online Journal of Issues in Nursing. Vol 8 (3). Retrieved from
www.nursingworld.org
National Alliance of Advocates for Buprenorphine Treatment (2015). End the 30/100 patient limits on care. Retrieved from
https://www.naabt.org/reasons.cfm
Rettner, R. (2013). Overworked doctors may jeopardize patient safety. Scientific American. Retrieved from
http://www.scientificamerican.com/article/overworked-doctors-may-jeopardize-patient-safety/
Yokell, M. A., Zaller, N. D., Green, T. C., & Rich, J. D. (2011). Buprenorphine and buprenorphine/naloxone diversion,
misuse, and illicit use: an international review. Current drug abuse reviews, 4(1), 28.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0089,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0089,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Joel Anonymous,254,I agree with the proposed rule increase the cap that physicians will have. This will is an important step for the continued treatment of citizens with opioid use disorders. No reason to not give physicians the tools they need to help out their patients. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0223,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0223,2016-05-16T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,493,"Let's not kid ourselves. The difference between physicians who practice State of the Art Addiction Medicine and those who practice sloppy, careless, pill miil, REMS absent addiction medication prescribing is not whether they are board certified. It is a matter of each physician's integrity; some doctors just don't have it no matter what their credentials. I'll put my ABAM diplomate practice up to scrutiny if you'll put your Addiction Psychiatry practice up to the same." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0259,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0259,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Alan Robbins,4649,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Additionally, it is important that physician extenders continue to be excluded from the prescribing buprenorphine. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0270,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0270,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Jack Woodside,2249,"The requirement to accept third-party payments should be expanded to include all individuals with the 200-patient limit, not just those using the "qualified practice setting" exception. This would help remove a significant economic barrier to patient access to MAT.
In Northeast Tennessee, I am not aware of any buprenorphine provider that accepts insurance. Here buprenorphine clinics charge $100 cash at the time of service and require weekly visits for refills. This amounts to a cost to patients of over $5000 yearly for medical services (plus the additional cost of the medication). This is a significant economic barrier for patients who typically have little or no income. In some cases, patients sell a part of their medication to cover these costs.
From the provider's perspective, collecting $5000 yearly from 100 patients amounts to an annual gross income of $500,000, with low overhead and no costs associated with billing insurance. This economic bonanza is causing many physicians to abandon traditional medical practices. A primary care physician remarked that he earns as much in one day in the buprenorphine clinic as he does the rest of the week in primary care. A former emergency room physician says he can work two days a week and earn more than in full-time ER practice. Although this excessive income is attracting physicians to provide MAT, the cost is being borne by patients. These practices are exploiting patients who are already suffering the economic, social/family, medical, legal and other consequences of their disease. These physicians are held in such low regard by the medical community that it has become difficult to convince mainstream physicians to add MAT services to their practices.
I do not believe the requirement for subspecialty board certification is any guarantee of quality. Most of these physicians have obtained certification by ABAM in anticipation of it becoming a regulatory requirement. In fact certification by ASAM (which existed prior to DATA 2000) is likely a more reliable indication of a legitimate interest in addiction medicine. I suggest that all providers with the 200-patient limit meet the requirements of a "qualified practice setting."
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0329,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0329,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,"Steven Stoller, M. D.",1151,"
Regarding RIN 0930-AA22

As I understand it, physicians certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM) are not included among those who qualify for the new 200 patient limit. I am such a physician, board-certified by ABAM. As is the case for other ABAM diplomats, my certification required an immense amount of learning. Continued certification requires significant CME work, and my knowledge and expertise in addiction medicine are considerable. We therefore bring a high level of expertise to the care of addicted patients in our area, which is in the midst of a severe heroin epidemic. Sadly, we have a long waiting list in a markedly underserved area, and it pains us to know that people are suffering and sometimes dying because we cannot bring them into our program.

Please adjust the wording of the proposed rule to qualify physicians certified by the American Board of Addiction Medicine for the new 200 patient limit. I believe that ABAM certification represents an expertise in addiction medicine that meets or exceeds that obtained through other avenues. Thank you.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0007,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0007,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Jessica Anonymous,1427,"As a local pharmacy, I feel it is important that we address the issue that the DEA limits and monitors our sales of buprenorphine and the like. That being said an entire local city ( Lancaster Ohio ) has stopped carrying the medications completely, thus flooding our area of patients in search of the much needed medication. In the last month alone our dispensing has increased to almost our limits, where we had only a few patients on it prior to the local changes. That being said I feel that many in the pharmacy field would agree before pushing to allow an increase in doctor / patient loads that the DEA should review what acceptable levels are for pharmacies, otherwise these patients will be able to have prescriptions written but will have no where to fill them. Furthermore perhaps doctors and pharmacies should be allowed to enter into contracts to be sure that all of the appropriate measures are being taken to give the patients the best chance of recovery. All to often we see patients on these incredibly high doses for months and even years and after talking with patients you realize that they are not going to consoling or behavior therapy, just simply medicating. As many pharmacists have a corresponding responsibility this would be of great value to all parties involved. As a whole I feel there are many facets to this issue that should be worked out before allowing an increase in the patients being seen." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0011,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0011,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,jill diodato,297,as a specialist on a drug hotline I think this change is excellent. So often I have people calling who want treatment but can not find an open clinic to get drugs as offices are filled to capacity. It would also be helpful to enhance coverage through insurances as many can't afford treatment. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0052,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0052,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Felicitas Amador,339,"It is well over do and it should have been implemented years ago!

The need and access to treatment should have no borders! And with the variety of medications and therapies available (mental health, groups and psychotherapy)access is one of the most important tools to combat this disease!" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0064,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0064,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,693,"As a health care professional working at Fairview Riverside Hospital I have a high degree of contact with patients in
need of opiate dependent services. Whether they are in need of immediate detox services or are looking for an
outpatient provider, the need far outwieghs the ability of our services to provide the necessary help. By increasing the amount of patients a provider can treat will greatly diminish the amount of patients that end up in our Emergency Room seeking help. A large percentage of patients seen and treated by the ED staff would be better served if they had a provider helping them on an outpatient basis. Thank you for your attention to this issue.
JPP" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0189,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0189,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,James Doherty,4528,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0284,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0284,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,"peter rogers, MD MPH, DFASAM",889,"For those of us who have been treating addicts/alcoholics and this activity
has been a significant part of our professional lives and have become Board Certified in Addiction Medicine, we should have an immediate increase in the number of opiate addicts/heroin addicts we can treat with Buprenorphine. We should have an unlimited number of patients we can treat.
If we are Board Certified in Addiction Medicine, we have developed an expertise
that is unequaled and should be allowed to increase our numbers and help keep these patients from dying.
I believe that this is the best way to keep Bup products from being diverted by keeping the number of patients being treated by those physicians
who have developed and demonstrated the highest level of competence in Addiction Medicine.

Thank you for considering my e-mail.

Peter D Rogers, MD, MPH, DFASM" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0294,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0294,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,992,"I am a physician practicing addiction medicine. In our practice we receive several patients that have been treated by other physicians certified through ABAM by simply taking an exam and claimed practice experience. They have had no formal fellowship/residency training in this field. They have had no formal mentorship from an experienced fellowship / residency trained addictionologist. Reports we receive from former patients of these practices indicate the visits with those physicians lasted less than 5 minutes. Put simply, they are pill mills. I would STRONGLY caution against raising the patient limit to 200 for any practitioner that has not completed an accredited fellowship or residency in addiction medicine. The incentive for greed by these other practiotners is too great. The treating physicians responsibility can not simply begin and end with writing a prescription. To allow this would simply shift the problem of full agonist abuse to partial against abuse/diversion." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0312,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0312,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Vinayak Shukla,510,"This proposal is in the right direction but as with any other field in my professional opinion physicians who are board certified in addiction medicine (ABAM) should be clinically trusted and allowed to increase the limit to 200 patients, they should be trusted to make their own expert clinical decision if they would like to increase the capacity. This is no different than any other subspeciality where we have guidelines but at the same time have confidence in the clinical expertise of the sub specialist." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0308,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0308,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Kaylor,307,Those who areboard certified in Addiction Medicine through the American Board of Addiction Medicine have undergone intensive training and study. These are the majority of doctors who work with patients with substance use disorders. I don't understand why they would not be included in the expansion. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0309,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0309,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Margaret Jarvis,728,"I certainly hope that the final rule will be written in such a way that all physicians who currently have specialization in treating addiction will be included in the increased patient cap. Given the small number of doctors in the country who have this specialization, it seems nonsensical that any group who might have the requisite knowledge and training be left out. This would include:
ABAM certification
ASAM certification
ABPN addiction psychiatry certification
AOA addiction certification.

I am grateful that the Department has brought this proposed rule forward and I am hopeful that this will be one of many steps taken to better address the opiate (and other) addicted people in our country." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0326,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0326,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Magdy Gad,2610,"Dear Secretary Burwell,

I am happy to hear that your administration is considering increasing the limit on the number of patients that DATA 2000 waivered doctors can treat. Understanding the pharmacology of mu receptor agonists, it seems counter intuitive to limit partial agonists and yet continue to place no restrictions on full mu agonists. I personally continue to see doctors throughout our region use chronic pain codes and documentation to treat what is actually surreptitious substance use disorders. Chronic pain is far less regulated, and full opioid agonists do not suffer the bureaucratic scrutiny applied to the long acting partial agonist of buprenorphine. When naloxone is added to buprenorphine, the abuse potential is reduced even further and yet the double standard driven by stigma remains.

While buprenorphine and naloxone have revolutionized medical assisted treatment for opioid dependence, diversion remains a serious concern. I believe that it is critical that all prescribers of controlled substances have a formal (written) diversion mitigation strategy in place utilizing policies like the following:
1.Wrapper counts - patients must bring in their opened and unopened film wrappers. This will reduce hoarding and diversion.
2.Random wrapper/ film counts and random drug testing.
3.Insurance companies should be compelled to allow for increased drug testing instead of placing caps on the number of times that a person can be tested in a year. Now is the time for increased testing until our current epidemic is reversed.
4.The Parity Law should be enforced allowing for treatment, counseling and early intervention into behavioral disorders.
5.The use of more efficient and lower dose, dual therapy (with naloxone) preparations like Bunavail should be favored over older buprenorphine products especially monotherapy, to reduce street value and the amount of buprenorphine milligrams on the street.
The potential of future products like implants and injections hold great promise to mitigate the harmful impact of diversion. Doctors must be educated that the controlled medication they prescribe are commonly sold, shared, or traded. They should be trained to reduce this risk.

I am grateful for your efforts in dealing with this complex but important public health issue. As a pain management doctor I must sadly report that this epidemic has had a devastating effect on our entire region. Thank you for working to remove the barriers to treatment and to reverse this trend that has damaged our society over the past 20 years." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0537,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0537,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Mark Covall,35,Please see attached comment letter. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0131,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0131,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Beverly Anonymous,1195,"I think it's a great idea to raise the number of patients per doctor. If I knew how to change suboxone laws and regulations I would. I honestly think there should be no limit just like every other medication. Just let the individual doctor decide how many patients she wants to have like normal. Let each pharmacy decide how many suboxone scripts to accept. They don't have to turn people away for example, if they want to get a cholesterol medicine. My problem just happens to be addiction not cholestorol. I don't protest against medicine that helps you. And other things I'm wondering why do suboxone patients have to have counseling and patients who get antabuse (for alcoholism) don't have to have counseling. Suboxone makes such a hudge difference in my life. It's the difference in me having a life or not. It is frustrating, us addicts don't have easy lives to start with. If we actually decide to get sober, it's amazing how many hoops we have to jump thru. I just think less people doing drugs (greater acces to suboxone) would be good for everyone, drug users and nondrug users alike. Anyway, I wish all addicts good luck-you CAN get through it. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0136,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0136,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Lee Tannenbaum,2417,"
Please be aware that the current bill, as worded, excludes ABAM certified physicians from being eligible for the proposed expanded limit. This is due to the wording in 8.610(b)(1)that requires "sub-specialty" certification in addiction medicine to be eligible to receive the higher limit. There is no more knowledgeable physicians in the field of addiction than those who are certified as "specialists" in the field of addiction by the American Board of Addiction Medicine (ABAM).

Please consider revising the qualifications for a higher patient limit to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear and contradictory to other provisions in the proposed bill.

There are currently 3,644 U.S. physicians "specialists" certified by ABAM, but only 1,095 physicians with an "subspecialty" certification from other boards. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce, who have been on the forefront of treating the most addiction patients and fighting to have treatment limits removed, from the opportunity to treat additional patients. This does not seem consistent with the intent of the bill to expand access to treatment, particularly from those physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap, and this is not the intention of the bill.

It is imperative that SAMHSA remove the requirement that physicians hold subspecialty" board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit, which, as I have previously commented regarding, needs to be significantly greater than 200 patients.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0147,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0147,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Shore,402,"As a Physician and Psychiatrist who is certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM) I would like to point out that having this ABAM certification should allow for the increase limit to 200 to treat patients with Buprenorphine. Thank you. Michael W. Shore, M.D.; 1500 N. Kings Highway, Suite 106, Cherry Hill, NJ 08034 (856) 428-8190. michaelwshoremd@comcast.net" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0144,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0144,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Theodore Fifer,894,"I believe this is an excellent step forward but would advocate against acceptance two of the proposed provisions.

1. The requirement for HIT (EMR) use is unnecessary and unfairly burdensome to a part time buprenorphine and counseling practice such as ours. The expense of deployment and use of this changing technology would bankrupt our practice.

2. The required acceptance of all third party payors is, in our State, Illinois, also a recipe for insolvency. The State of Illinois has not paid providers for many months claiming an inability to do so from a "budget impasse". We have local Boards of Health and other agencies closing doors because of Illinois' malfeasance. There is no end visible to this theft at present.

Absent the two proposed provisions above I heartily endorse adoption as administrative law.

Theodore D Fifer MD FACS" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0176,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0176,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Randolph Holmes,495,"Randolph P Holmes MD,FASAM
I support ASAM's proposal to remove the subspecialty
term from &8.610(b)(1).
I have practiced addiction medicine in a community setting
for years. I am Board Certified in Addiction Medicine and I
feel it is most important to include qualified physicians
into the battle against opiate addiction.Limiting the number
of patients a qualified physician can treat will hamper our
ability to provide access to all that need treatment." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0178,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0178,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Brandan Stark,180,"It is imperative that ABAM board certification be added to the language of this bill. Strictly by number of providers, we do the lion's share of addiction care in the country." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0182,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0182,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Mary-Anne Kowol,4696,"To Whom It May Concern,

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Sincerely,

Mar-Anne Kowol, MD
PS: I am board certified in Addiction Psychiatry and by the board of addiction medicine" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0183,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0183,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Adam Lake,859,"I would specify in the "nationally recognized evidence-based guidelines" if this requires in-office induction or not. Home induction is widely practiced, and some countries include it in their guidelines. This greatly decreases the commitment of the provider doing the induction, as it can mean that a patient occupies a room in the office for up to 2 days in a row in some cases - the opportunity cost of this type of induction is not accounted for in the proposed rule.

There is no strong evidence showing superiority of the in-office method:
http://www.ncbi.nlm.nih.gov/pubmed/25254667

And the more patient-centered approach of home induction has positive evidence: http://www.ncbi.nlm.nih.gov/pubmed/21310583

I would urge clarification as many providers might not be able to meet this requirement if it is implied." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0185,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0185,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Rick campana,1092,"My name is Dr. Richard Campana and I am a Diplomate of ABAM and a Fellow of ASAM. I have been providing MAT services for the past 12 years. It is absolutely critical that HHS allow doctors with my specialty to treat unlimited opioid addicted patients with Buprenorphine. There is truly a critical need in my community for MAT services. In my community we have had a significant number of patients die recently from Fentanyl laced Heroin. I get over 10 calls a week from patients requesting enrollment in my Buprenorphine program. Sadly, I must turn these patients away, due to cap on patients I can treat, knowing that many of them will most likely overdose or become incarcerated. MAT WORKS!!!! Please don't limit doctors like myself from treating as many patients as I can with this life saving medication. I will be happy to personally testify to any governmental agency who wants to hear what I am having to face everyday with this opioid epidemic. WE ARE LOSING TO MANY PATIENTS that could be saved if the limit on Buprenorphine patients was lifted.

Rick Campana, MD FASAM" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0200,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0200,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,RENNEE DHILLON,657,"I am a Family Physician and have been practicing Addiction Medicine for almost 6 years now, i feel an increase in the limit to 200 patients per physician is really needed given the epidemic size of this problem , however it should not be limited to practices able to bill third party payors as it would then again limit a lot of physicians from providing care for this immense problem .

I have helped people turn into a new leaf and lead normal lives on Buprenorphine and we definitely need to expand and grow treatment facilities to get a grip of this issue and prevent it from growing out of proportion.

Rennee Dhillon, MD
Tennessee" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0238,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0238,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Tom Kosten,5212,"May 17, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Thomas Kosten MD
Waggoner Chair and Professor of Psychiatry, Neuroscience, Pharmacology, Immunology & Pathology
Co-Director, Dan Duncan Institute for Clinical and Translational Research
Baylor College of Medicine, Michael E DeBakey VAMC
Houston, TX 713 794 7032

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0256,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0256,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Jan Widerman,1443,"As a physician who has been treating opioid substance abuse for 8 years, I am supporting and requesting an increase in the life saving medication buprenorphine. I receive 4-5 calls a day asking for help. No other disease state restricts proper treatment with medication. Why is the chronic disease state of substance abuse singled out? By allowing unlimited use by a trained physician of this medication, this will allow that physician to devote the time needed to help. Restricting physician access to this drug also inhibits further fellowship training in Addiction Medicine. What physician would go into a specialty that only allows you to treat 100 patients? As a Pediatrician in solo practice for 35 years, I presently and diligently care for over 2500 patients.
I care for my 100 buprenorphine patients plus 100 more VIvitrol patients. I am able to sit, counsel, advise, and direct these patients to a better life. In that it takes 1-2 years of medication to treat the physical effects of the brain in this disease, physicians should be the ones to lead the battle. Congress should not be the ones to make the decision. Physicians are trained to treat diseases. Congress should allow us to do that. The cost of not treating Is greater to lives lost and cost to the health care system without medications.
Jan Widerman DO
10800 Bustleton Ave
Phila., PA 19116
215-969-6277
jwiderman@comcast.net
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0285,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0285,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Shariff Shakir,252,I fully support the increase from 100 to 200 patients for DATA 2000 wavered providers. People are suffering from addiction and the effects on their life while on waiting lists. In my community their aren't enough spots to help everyone.

SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0295,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0295,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,"Sayonara Baez, MD, ASAM Certfied",383,"I am a board certified psychiatrist and addiction specialist, we are limited in our abilities to save lives and we are requesting to be included in the expansion of patients that we can treat at a given time and others as outlined by the American Society of Addiction Medicine.
This law will make a different in those of us that daily face these patients in need of treatment. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0317,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0317,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Mandeep Singh,2082,"Dear Ms. Enomoto,

I am pleased to submit my comments on the proposed rule to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 200.

I am a suboxone waiver certified physician for 8 years in a 3 county area in rural wisconsin with epidemic of opioid dependence.

I request SAMHSA to help ALL addiction specialists both those physicians with subspecialty board certification in addiction medicine or addiction psychiatry as well as those who have achieved certification through the American Board of Addiction Medicine (ABAM) and permit them to treat additional patients in an effort to combat this deadly epidemic.

I request the following changes be incorporated into the final rule:
Include ABAM-certified physicians among those who would qualify for the higher limit based on their medical education and training by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients and thus would have a very limited impact on access to specialist care.
Raise the patient cap to 500 for board-certified physicians and those who have completed additional and ongoing training. To make a meaningful impact on the current epidemic, the proposed rule needs to go further in expanding access to treatment.
Clarify the requirements to be a qualified practice setting. Additional detail is needed for physicians to understand if their practice meets the requirements of the rule.

I appreciate the efforts and will be grateful for consideration of my and my colleagues requests

Mandeep Singh, MD
Ministry Medical Group,
Rhinelander.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0472,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0472,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Steve Morgan,1458,"Thank you for the opportunity to comment on the proposed changes to the regulations regarding "office based opiate treatment".
First I would like to point out the absurdity of first acknowledging that our response to need for treatment is great, and then proposing to expand the potential numbers of patients that an individual physician may treat but then limiting the number who will provide the service by heaping more requirements on them.
Requiring acceptance of third party payer payment will only serve to further limit potential providers. At my office of 5 providers, we take pride in the fact that we are the lowest cost providers in our area, but when we have looked at the cost of overhead for this service (rent, heat and air, preauthoristions for medications not to mention EHR costs) we find that we would be unable to provide it at typical payor rates.
If expanded service is truly the goal here, then an continuing medical education based effort to include more providers, and to insure closer adherence to the original goals of the program would better meet the need. Certainly we are all aware of offices that have become little more than "methadone clinics using Suboxone", but if the goal remains to have treatment of opiate addiction integrated into the normal practice of medicine, then requiring board certification for addiction and EHR and third party payment is not the way to accomplish this goal" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0510,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0510,2016-07-26T04:00:00Z,Comment on FR Doc # 2016-16069,LISA NOYES-DUGUAY,525,I think that if providers have been seeing patients at their 100 patient limit for greater than 3 years that they should qualify for the increased limit of 275. I have a waiting list of over 100 people who are waiting for treatment. I have been prescribing buprenorphine since 2003. There is no reason that other providers in my same circumstance should not be allowed the patient increase. Please consider this in your qualifying measures. Thank you. And thank you for increasing the limit!!! TREATMENT SAVES LIVES!!! SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0524,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0524,2016-08-04T04:00:00Z,Comment on FR Doc # 2016-16069,Ashish Patel,573,"Why the mandate to accept a 3rd-party payer?...was this put in due to lobbying by insurance industry?
As a concierge medicine physician who has practiced medicine with and without 3rd-party payments, I can tell you first hand that accepting 3rd-party payment takes away significantly more time from actual patient care.

I, like most physicians, place a higher importance on actual patient care than complying with insurance regulations and paperwork. I would ask to please remove the requirement to accept 3rd-party payers as part of the final rule. Thank you." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0512,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0512,2016-07-26T04:00:00Z,Comment on FR Doc # 2016-16069,David Schwartz,35,Please see attached comment letter. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0514,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0514,2016-07-27T04:00:00Z,Comment on FR Doc # 2016-16069,Mark Jameson,678,"This requirement is simply another example of "mission creep" and needless imposition of regulatory burden on the medical practitioner. The is NO BENEFIT to the patient from these regulations. The only benefit of this complex reporting requirement is to allow a government employee, typically a doctor, to publish a study in the New England Journal of Medicine or JAMA and further their own career.
No other branch of medicine is faced with these reporting requirements. For example, Pain Medicine physicians do not have to report how many patients receive opioid prescriptions. Again, there is NO BENEFIT to the patient from these regulations. - Mark Jameson, MD" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0517,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0517,2016-08-01T04:00:00Z,Comment on FR Doc # 2016-16069,Christine Krause,2095,"STOP VIOLATING THE RIGHTS OF PEOPLE WITH CHRONIC PAIN TO EFFECTIVE TREATMENT.

The DEA narcotics-prescribing guidelines MUST be LIMITED to patients with SHORT-TERM PRESCRIPTIONS ONLY! This indiscriminate application of the guidelines to both short-term prescriptions and for patients with chronic pain is causing unnecessary suffering to 11.4% of Americans who struggle to maintain as normal a life as possible through the incredible challenge of chronic pain. Limiting their access to prescriptions that they've taken for years, when the problem is with those who become addicted after short-term treatment, violates the right of patients with chronic pain to effective treatment

An NIH study published in the March 20, 2016 issue of JAMA found that the people who die of narcotics and heroin overdoses are patients who received inappropriately high doses of narcotics for short-term treatment. They resort to buying narcotics on the street, then progress to heroin, which provides the cheapest high. Thus, the frighteningly high number of overdose deaths.

But how does rescheduling oxycodone to Class II help? A much more effective way to reduce overdose deaths would be to limit the doses prescribed to people who need only short-term treatment with narcotics. Rescheduling oxycodone to Class II is another violation of the right of patients with chronic pain to effective treatment.

Given that hundreds of thousands of patients with chronic pain safely take their prescriptions for years without needing constant increased doses, this indiscriminate application of the DEA prescribing guidelines and the rescheduling of oxycodone to Class II VIOLATES the RIGHTS of patients with chronic pain to EFFECTIVE treatment of their pain!

Rescheduling oxycodone to Class II should be repealed, and the DEA Narcotics Prescription Guidelines should be limited to patients who need only short-term treatment with narcotics.

Not addressing these issues violates the right of patients with chronic pain to effective treatment modalities.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0036,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0036,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,325,As a mental health professional I fully support this proposal. The opiate dependant population is increasing rapidly and the lack of outpatient resources are greatly impacting the relapse rate. Increasing the patient load for qualified doctors would have a much needed impact on this population receiving the help they need. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0051,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0051,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Teresa Tate,1539,"Those of us who care for patients suffering from opiate addiction have long been looking forward to a time when anyone seeking treatment need only call and schedule an appointment with their primary care provider. Much like someone with hypertension, diabetes, or any other chronic disease would be able to do. Unfortunately, this proposed rule will do little if anything to alleviate the suffering of those addicted to opiates. In fact, it may further stigmatize those individuals. Small private primary care practices should provide care for patients regardless of their presenting problem. The diagnosis of opiate addiction should be not be singled out but rather included and addressed along with any other issue in need of attention. When I see a diabetic patient for the first time, I do a complete physical and make sure the patient is referred for a diabetic eye exam, consult with a dietician, and any other specialty that may be indicated. Why would I treat a person addicted to opiates any differently. To have government regulations stipulate the plan of care for a patient is excessive. If our government would step back and allow providers to practice in a prudent, patient centered fashion, we may be able to solve this problem. Removing the requirement for an XDEA number in order to prescribe buprenorphine would make it more available for patients and decrease diversion. Anyone needing treatment would be able to receive it. It is a simple matter of supply and demand. It really is not that complicated. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0053,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0053,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,2029,"I am a nurse in Baltimore, Maryland. I see patient's every single day that use heroin and/or other drugs. I've seen people lose their lives, their families and friends,their limbs, etc. by using intravenous drugs. According to ABC News, "Baltimore is the heroin capital of the United States," and as a nurse, I have seen the worst of what it can do to people. Living outside of Baltimore, I have seen heroin used in schools, play grounds, homes, and fast food restaurants to name a few. However, nothing is worse than seeing high school students who you graduated with, lose their lives because of this epidemic. Watching mothers, fathers and siblings cry over their lost loved ones is not something I want to remember, but that is what with sticks with you the most. If there was something that could be done to help people get the treatment and help they need, it needs to be done. I believe that if eligible practitioners were to be approved to treat up to 200 patients instead of 100, we would be able to help so many more people. Of course practitioners must comply with all rules and regulations in order to do so, but if we have doctors who are willing to help more individuals with this terrible epidemic we face, I believe they should be allowed to do so. "Buprenorphine is an opioid medication used to treat opioid addiction in the privacy of a physician's office" (NAABT.org). Using this drug through a doctors office allows individuals to stay private with their treatment options but still get the help they need. I am asking to please consider helping double the amount of people with addiction by increasing the number of patient's that doctors can treat to 200.

Yang, C. (2014). Part I: Baltimore is the U.S. heroin capital. ABC News. Retrieved from http://abcnews.go.com/US/story?id=92699&page=1.

The National Alliance of Advocates for Burprenorphine Treatment. What exactly is Buprenorphine? Retrieved from https://www.naabt.org/faq_answers.cfm?ID=2#." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0065,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0065,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Ryan Herrington,1920,"I am an physician in Vermont and I prescribe buprenorphine.

I support the increase to 200 patients because I believe the demand in our community for opioid addiction treatment makes this necessary.

I would like to make three comments.

One, physicians get sick, go on vacation or for other valid reasons are sometimes out of the office and another physician has to cover. I would suggest not counting a buprenorphine prescription that is clearly intended to be short term in nature against that covering physician's buprnorphine limit. This would make things easier.

Two, I understand the Government's concern about not creating buprenorphine "pill mills" hence the limit of 30/100 patients. I suggest that a buprenorphine prescriber not be permitted to make a diagnosis of opioid use disorder or dependency for patients that that provider will be prescribing buprenorphine for. In other words, a system where one party makes the diagnosis of opioid dependency and then refers to another party that prescribes the buprenorphine would be less likely to evolve into a "pill mill."

Three, our state medical board has advised that if a buprenorphine provider goes over his/her numbers by 1, a charge of unprofessional conduct will be made. This seems harsh and forces providers like me to be internally limited to 85 patients to avoid just such a consequence. This of course means there are 15 patients who can't access treatment which is not good for them or our community. Surely, providers who irresponsibly go over their numbers warrant investigation and potentially disciplinary action. It's cumbersome to track patients/prescriptions however and if a good intentioned provider goes over his or number by one or two I would hope the consequence would not be a charge of unprofessional conduct. Just seems too harsh.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0080,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0080,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Angie Giltner,133,This is INCREDIBLY important to our ability to provide adequate treatment to he many people in our community with addiction disease. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0093,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0093,2016-04-19T04:00:00Z,Comment on FR Doc # 2016-07128,William Boyett MD,204,I am encouraged to see the limit raised for those of us treating opiate addiction. We will be able to get more patients into treatment as we have had a waiting list for the past couple of years at least. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0103,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0103,2016-04-25T04:00:00Z,Comment on FR Doc # 2016-07128,"Kathie Watson-Gray, MD",1135,"I am a family practice physician and also board certified in addiction medicine. I am very concerned with DEA limits on pharmacies carrying buprenorphine. I am certified to see 100 patients for MAT. I see many fewer than that, and every month it's a struggle for my patients and I to find medication for them. They try to go to the same pharmacy every time, but every month on several different days the pharmacies will run out of buprenorphine products. There have been several times when I could not find any pharmacy in the town in north eastern Kentucky that I practice in that had any medication at all. The patients then have to go across the river to Ohio, where often their insurance doesn't cover the out of state pharmacy, and often those pharmacies are also out of medication. If docs increase their limits, I only see thIs problem getting worse. This is very frustrating and is just another reason it is hard to attract doctors to the treatment of addiction. I agree that the need for expanded access to treatment is great, but all elements of access need to be addressed to avoid creating more problems." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0110,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0110,2016-04-26T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,616,"Dear Jinhee Lee
We spoke on the phone earlier today as I was concerned that the provisions regarding the necessity of practitioners to accept insurance differs between those who are board certified and those who have a qualified practice setting.
As you stated, the government is attempting to reduce cash only practices to allow more access to treatment for those who have insurance and to avoid problems associated with a cash only model.
I think all practitioners should have to abide by 8.615 (e) which would allow more access to those patients who have insurance.
Thank you for considering this." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0186,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0186,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Barry Glasser,664,"I am the medical director of a non-profit rehabilitation center and have a seven day a week Primary Care office providing Internal Medicine and Addiction Medicine services. I have been doing this for over ten years, going to conventions and taking multiple certification courses and exams. The epidemic of addiction in this country requires qualified medical practitioners to expand their services to better provide their expertise to this underserved and stigmatized population. Please expand services to all physicians with a Board Certification in addiction medicine and remove the arbitrary requirement that physicians hold a subspecialty board certification. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0204,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0204,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Antony Fernandez,4490,"May 11, 2016

The Honorable Lamar AlexanderThe Honorable Fred Upton
455 Dirksen Senate Office Building2183 Rayburn House Office Building
Washington, DC 20510Washington, DC 20515

The Honorable Patty MurrayThe Honorable Frank Pallone
154 Rayburn House Office Building237 Cannon House Office Building
Washington, DC 20510Washington, DC 201515

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Congressional Leaders

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

I urge you to request that SAMHSA (1) raise the patient cap above the proposed 100 patient limit and (2) consider the potential impact that a formulation-based "counting" methodology might have on physician/patient decision-making and patient-driven recovery.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to support SAMHSA to raise the DATA 2000 patient limit to one that meets the needs of our communities, both with respect to the limit and eligible clinicians. Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at drtonyfernandez@hotmail.com

Sincerely,
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0268,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0268,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,George Disney,5002,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

George Disney, MD
16 DeGrandpre Way Ste 300
Plattsburgh, NY 12901

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0507,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0507,2016-07-14T04:00:00Z,Comment on FR Doc # 2016-16069,Anonymous Anonymous,1295,"As a citizen in an area where drug use is quite prevalent, it saddens me to see that there is a proposal that could potentially limit the amount of people who suffer from opioid use disorder that could be treated. The number of people suffering from the opioid epidemic is continuously increasing. Therefore, limiting the amount of people that could potentially be treated is illogical under these circumstances.

The CDC states that the amount of people who are dying from opioid use disorder has quadrupled since 1999. This amounted to 78 Americans per day dying. Aside from death, there are those that are extremely addicted and could potentially suffer more from opioid use disorder. Limiting approved practitioners to only treat 275 patients annually is limiting their ability to help the world. This discourages them to treat those that come for help and may force them to choose between patients in order to satisfy this limit.

Although I do understand that having treatment readily available at their disposal could cause people to believe that they can do whatever they please, the benefits of not limiting treatment is far greater than the risks of limiting it. Placing constraints could kill a lot more people because we can no longer offer everyone help.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0522,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0522,2016-08-03T04:00:00Z,Comment on FR Doc # 2016-16069,Jennifer Smith,2035,"Hello, I am a MAT provider within my Family Practice office in a rural town in Maine. I have some feedback about the proposed monitoring below. I hope that this will be an electronic process and that it is not made so cumbersome that it discourages other providers from providing MAT in our community.

The average monthly caseload of patients receiving buprenorphine-based MAT, per year
b. Percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to:
1. Treatment initiation
2. Change in clinical status

**some of our patients "graduate" from treatment and only use our counselors as needed with a change in status (life stressor, relapse, weaning medication), I don't want them to be reflected in a % of patients "not receiving treatment" if they have successfully completed their treatment plan

c. Percentage of patients who had a prescription drug monitoring program query in the past month (**the state of Maine and our local pharmacies alert me by e-mail or phone if a patient on Suboxone tries to fill any other opiate by any provider. Would this qualify? We do not routinely run PMP data on our Suboxone patients as we require them to be seen to get their Rx, we routinely query PMP data for every controlled substance refilled by phone)

d. Number of patients at the end of the reporting year who:
1. Have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery
**With research supporting substance abuse as a chronic illness, I expect there will by many patients maintained on a low dose of Suboxone long term. I don't feel "completing a course of Suboxone" should be our goal. I would rather measure success by patients being treated with MAT that our successfully in remission

Thanks for allowing my input" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0008,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0008,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Jerry Costley,1251,"As we increase the number of patients a physician can serve with no requirement that therapy or counseling be provided we run the risk of creating "pill mills" where the opioid substance use disorder is only half treated. Opioid Use Disorder is most often a complex, multi-faceted is condition that cannot be adequately treated with medication alone. SAMHSA's working definition of recovery is "A process of change through which individuals
improve their health and wellness, live a self-directed life, and strive to reach their full potential." Again, full recovery, under this definition generally requires counseling and therapy.

If doctors are going to be allowed to increase the number of patients they can see the should be required to clearly document partnerships with therapy provides that their patients can access counseling/therapy as needed. The current regulations regarding physicians providing access to therapy for their patients is so loose as to be meaningless. Physicians should again be required to hire qualified licensed therapists or counselors as part of their practice or have a formalized agreement with outside counselors, therapists or agencies that provide such. This is critical. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0029,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0029,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Christene Amabile,2308,"Although this proposal will undoubtedly be helpful in the treatment of opiate use disorders (OUD), sadly, there is no mention of Nurse Practitioners (NPs) and Physician's Assistance (PAs) gaining legal authority to prescribe buprenorphine (trade names: Suboxone, Zubsolv and Subutex). Buprenorphine is a schedule 111 controlled substance and NPs and PAs in all states except Florida can prescribe schedule 111 narcotics and in most states schedule 11 controlled substances, we cannot prescribe buprenorphine for OUD. Ironically, we can prescribe a buprenorphine patch (Butrans) for pain management, but not the same medication in a different form for OUD. What could possibly be the rationale? If diversion is a concern, consider that there is a market for the illicit sale of buprenorphine because it is not available for those in need. Limiting prescribed medication is in some ways promoting diversion. As an NP certified in Addiction Medicine and working in the field of Substance Use Disorders, each and every day becomes a bit more alarming in terms of the sheer numbers of people (most of them young) who are walking a very fine line between life and death. NPs and PAs have to tell their clients to take a number and get in line for their Suboxone. The wait can be anywhere from weeks to months before a desperate individual can receive a medication that just might save their life. This can be viewed as an ethical responsibility to provide medical care to those in need without an extended waiting period. NPs and PAs are an integral part of the healthcare system. Without them, many would be without medical care especially in rural areas where there is a gross shortage of physicians. How are those areas managing the opiate epidemic without the assistance of NPs and PAs. The answer is clear; it is not managed and continues to grow. The additional education that MDs are required to obtain in order prescribe buprenorphine, is an 8 hour online course that could be required of NPs and PAs as well. Please consider that any epidemic would require an all hands on deck approach in order to help those in need. How is this any different? Please consider supporting federal legislation (TREAT ACT, HR 2536/S.1455) that would allow NPs and PAs to prescribe buprenorphine for OUD. Thank you. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0071,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0071,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Kip Corrington,759,"I have been prescribing buprenorphine to patients for approximately 7 years now. The medication has been a remarkable treatment for my patients. Unfortunately, there are not enough physicians willing to prescribe this medication. I have a waiting list of 50 patients. I have the maximum of 100 patients currently. In my opinion and the opinion of the expert opinions I have read, the lack of access to the medication is the primary reason for the diversion of this medication. It is not because it is used for its euphoric effects. Ideally, more physicians will get their X number and prescribe the medication. An increase in the number of patients for each physician is also another solution to helping to curb this horrible opioid misuse epidemic.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0221,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0221,2016-05-16T04:00:00Z,Comment on FR Doc # 2016-07128,T. Stephen Jones,3322,"T. Stephen Jones, M.D., M.P.H.
123 Black Birch Trail - Florence MA 01062

May 15, 2016

Re: Medication Assisted Treatment for Opioid Use Disorders

I am a public health epidemiologist who has worked on public health issues related to injection drug use since 1987. I retired from the Centers for Disease Control and Prevention in 2003. I continue to work on prevention of deaths from opioid drug overdoses.

In my home state of Massachusetts, the number of confirmed deaths from opioid drug overdoses was about 1,200 in 2014 and is projected to be even higher when the final data for 2015 are available.

One of the clear needs in Massachusetts is for a significant expansion of medication-assisted treatment, particularly methadone and buprenorphine. Because of the limitations on expansion of methadone, expansion of the availability of buprenorphine is our best hope.

At the moment, the main bottleneck for saving lives is the absolute cap of 100 patients for a physician who is entitled to prescribe buprenorphine to treat opioid addiction.

The proposed increase in the maximum number of patients receiving buprenorphine for each physician from 100 to 200 is an important step. I recommend that the maximum number patients for a qualified physician be increased to 300 or more.

In addition, I recommend changes in the qualifications for a higher patient limit. Increasing the number of physicians who qualify for a higher patient limit is a VITAL step in responding to the current epidemics of opioid use and opioid overdose deaths. Addiction specialists with American Board of Addiction Medicine (ABAM) certification will be qualified by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

Thank you for considering these requests and recommendations.

Sincerely yours,

T. Stephen Jones, MD, MPH
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0239,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0239,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Arwen Podesta,5040,"May 17, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Arwen Podesta, MD
Podesta Psychiatry, LLC
podestapsychiatry.com
P: 504-252-0026
F: 504-322-3854

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0014,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0014,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Chad Kingery,919,"This is insane!! As an LAC I am already dealing with many of the facilities here in MT that offer buprenorphine as MAT as laking in any formal plan to titrate the client off the medications. The DR.'s up here will allow the client or patient to run the show in that if they want a higher dose, they get it. These programs are highly manipulated by the client, and I see disaster headed our way. What ever happened to good old therapy and determination? Many more issues are posed with this possible bill. Dr. just dont have the time to make sure clients are also in a program and following through, nor have I seen any set treatment plans with distributers of buprenorphine that states by this date the patient will no longer be taking the meds. So the treatment goes on for years. The other issue is that clients tell me that in itself buprenorphine is highly addictive and it takes for ever to get off the stuff!!" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0031,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0031,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,269,"I support the increase in the number of patients a provider can treat. I also support giving Nurse Practitioners the opportunity to treat opioid addicted patients with Suboxone.
This increases access to treatment, and that is what is needed.

Thank you." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0049,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0049,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Julie Malia,679,"Hello, I work at a hospital that has treatment options for Chemical Dependency patients. We have so many more callers than we have the capacity to help and as you are aware, there is an opioid use crisis at this time. If people are unable to get the help they need, they often then continue to use. Many of these patients could be helped on an out patient basis, but, there are not enough provider "slots" to accommodate them. We have many patients coming to the Emergency rooms and coming inpatient that might not have to use those resources if we had more provider "spots". Please consider expanding a physician's ability to treat pts. Thank You !" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0528,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0528,2016-08-05T04:00:00Z,Comment on FR Doc # 2016-16069,Teresa Baker,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0523,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0523,2016-08-03T04:00:00Z,Comment on FR Doc # 2016-16069,Susan Awad,80,Please see the attached comments from the American Society of Addiction Medicine SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0118,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0118,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Hannah Robertson,859,"I have worked as a registered nurse for the past five years. I have worked with many patients addicted to prescription narcotic drugs and to illegal drugs. According to the National Institute on Drug Abuse, the initial voluntary decision to take drugs changes the chemistry of the brain presenting challenges to the affected individuals self-control and ability to resist impulses. Research shows that the best way to treat these patients is with a combination of addiction treatment medications and behavioral therapy. It is a chronic relapsing disease that can be managed successfully. Contrary to popular belief, we now know scientifically that it takes more than just strong willpower to combat the effects of addiction. This federal rule is a good step towards the right direction in treating drug addiction and promoting treatment over punishment.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0148,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0148,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Karen Drexler,1511,"I strongly support eliminating the word "subspecialty" from the following sentence in section 8.610.
"A practitioner is eligible for a patient limit of 200 if:...

(b) The practitioner:

(1) Holds a subspecialty board certification in addiction psychiatry or addiction medicine; ..."

I believe that it was not the intent to exclude those 3,000+ addiction specialist physicians who are currently certified in Addiction Medicine by the American Board of Addiction Medicine (ABAM). Concern has been raised that the language as written may inadvertently do so.

I am one of over 1000 board certified physicians in the subspecialty of Addiction Psychiatry from the American Board of Psychiatry and Neurology and practice addiction psychiatry within the Veterans Healthcare Administration. I have seen first-hand the extraordinary benefits of this life-saving medication when prescribed as part of a recovery program. I have also personally experienced the difficulty finding qualified physicians to prescribe buprenorphine for Veterans in need both within the VHA and in the community through non-VA purchased-care arrangements (e.g. Veterans Choice Program). I believe that the proposed expansion of the patient limit to 200 for qualified physicians is a thoughtful approach to increase access to care while minimizing the risk of diversion. However, without including ABAM-certified physicians, the expansion would be unnecessarily much more limited." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0184,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0184,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,jack crider,1026,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0195,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0195,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,Britt Borden,1089,"Dear Sir/Madam, I recently reviewed the HHS proposal to increase the patient limit for buprenorphine patients treated by qualified providers from 100 to 200. I urge you to strike the word subspecialty from 8.610(b)(1). This will align the definition of board certified with the definition in 8.2. Specifically I urge SAMHSA to remove the requirement that physicians hold "subspecialty board certification" in 8.610(b)(1) and clarify that all physicians with a "board certification " in Addiction Medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher limit. As you know certification by The American Board of Addiction Medicine is the highest qualification in the field of Addiction Medicine. For 25% of ABAM diplomats this is their primary board certification and they do not have a second board certification. As the HHS proposal is currently worded it would discriminate against these doctors who have devoted their careers to the treatment of addiction and therefore should be modified as I have suggested. Sincerely, Britt Borden MD" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0226,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0226,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,anonymous anonymous,825,Increasing the limit- for board certified physicians only- is a good approach to the opioid abuse epidemic so as not to allow buprenorphine pill mills to develop but there needs to be a mechanism to take care of these patients outside of taking assignment or mandating EMR use. Our group has chosen not to use an EMR yet as patient data safety and compliance with 42 CFR part 2 is a great concern to us; paper charting allows us more flexibilty with the number of counselors and office personnel who have to chart their interactions and it allows us to use specific forms to diagnose and monitor comorbidities and easily place referral letters or testing results in the chart without having to scan and destroy those results. Old fashioned paper chart still works and doesn't result in a big expense with limited utility. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0353,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0353,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,307,"My concern with this expansion is the lack of accountability of everyone involved.the physicians etc. There has to be accountability on the part of the persons prescribing the MAT, patient and counselor (who are a must) to ensure the patient has the supportive services to be successful in their treatment. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0360,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0360,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,927,"Having worked on both sides abstinence based treatment and Medication Maintenance, there are pros and cons to that type of treatment. There needs to be strict monitoring and selection for appropriate clients. There are many that will abuse the medication, there are many that have to go to treatment to get off of the subxone and report the detox is harder than heroine. Funding for abstinence based treatment needs to be increased instead. This increased used of suboxone will lead to many unforeseen problems and years down the road we will have the same problem with this medication we are seeing with opioids. This is a move in the wrong direction. Underlying issues need to be addressed in treatment and will not be by increasing MD caseloads and prescribing more meds to mask the problem. Big pharmacy is pushing this and sees it as a profit opportunity. I strongly feel this is a dangerous move in the wrong direction. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0383,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0383,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Nicholas Gardoni,1617,""Nearly 80 percent of individuals with an opioid use disorder do not receive treatment" according to the Substance Abuse and Mental Health Services Administration (SAMHSA). This is incredible in thinking how large the pharmaceutical industry is now, so by doubling the amount of patients each doctor who has had 100 patients in the past year to 200 patients would substantially help decrease this factor and personally knowing people in my family who suffer from opioid use disorder and by seeing how difficult it can be to get help I believe that this proposed rule would benefit the lives of those who have fallen to opioid use disorder and would be essential to their recovery and will help the recovery of the families that opioid use disorder has caused so many problems to. While one may be skeptical for having a practitioner double his number of patients and may think that the quality of care will decrease, their suspicions should be thwarted because according to USA Today the average visit to the doctors office "only lasts 10-15 minutes" which is not very long but with 100 patients the time can add up. I believe that the passing of the rule from 100 to 200 patients would be a dramatic change in patient limits is unknown territory for doctors. As an alternative, they should gradually expand the limit of patients at a rate of 20-25 people every year for 4-5 years so we can track the effects of this rule affect the quality of care the patients get and the quality of progress they make as the number of patients per practitioner increases." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0382,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0382,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Valdez,2555,"On a cold and rainy night, a man walks alone down the street through harsh winds and thick waves of people into an office where upon entry he makes his way to a seemingly unmoving line only to stand behind one hundred and ninety nine other people moving up a single space every ten minutes. This is the situation opioid addicts would be placed in if the proposed rule were enacted and this is why I am opposed to the rule.
According to addictions.com there is a large amount of time required to monitor an opium addict. Doubling the number of patients to physicians takes the personality of an appointment and creates an issue where a patient with a serious drug addiction is limited to ten minutes with a doctor because there are 199 other people in line behind them. With more patients available the physicians will see each patient as a number and it will be increasingly easy to write a prescription to get the patient out of their office rather than providing proper care.
The 2009 document titled "Prescription Opioid Usage and Abuse Relationships: An Evaluation of State Prescription Drug Monitoring Program Efficacy" details the failed attempt by PDMP to limit opioid abuse. The intended result was to cut down non-prescription drug abuse, the actual result was an increase in prescribed-opioid abuse. Physicians in PDMP states wrote prescriptions to non-qualified patients and even sold opioids online. From personal experience I can say that it is too easy to get prescription medication in the current system. For major depression I was given an opiate as one of my seven prescriptions, without needing it for its intended purpose as a painkiller. If this rule is permitted then people in similar situations to me could potentially be given medication that they don't need, and in a worse case they can form an opiate addiction off of their prescriptions.
A summary of rehab programs in 2016 by drugabuse.gov reminds us that behavioral counseling, evaluation and treatment for co-occurring mental health disorders, and long-term follow-up are essential to successful rehab. De-personalizing the physician and patient relationship and limiting the appointment time dilutes or abolishes some of the practices necessary to proper rehabilitation. This rule should be modified to pass properly. I believe that the maximum patients a physician should be allowed to see should be around 150, this will serve as a compromise to the proposed rule while preserving the respect for a patient-physician relationship. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0386,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0386,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Jorge Botello,862,"I am an Outreach Administrator for a rural health system in south Texas.
I have seen the lack of treatment options for substance use disorders, particularly the opiates prescribed that addict our populations. I have seen the incarceration rate increase amongst young people and the separation of young families through protective service interventions.
I strongly support the increase of prescriber capacity as we have no buprenorphine prescribers in our region. Those that are available are limited by the amount of cases they can carry legally. Expanding the prescription authority to more patients is of benefit to our patient population.
Treatment provides an opportunity for recovery. Incarceration and the separation of families has no positive effect on children and the well being of families.
Therefore, I support the new regulation." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0400,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0400,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Michele Holben,817,"Community Medical Services, an Opiate Treatment Program with multiple locations in Arizona and Montana, supports the proposed rules to increase the number of clients able to be treated by physicians to 200 with the suggested provision of the physicians having ABAM or ASAM certification in order to treat 200 clients, and the review of the 200 patient limit for each individual physician on an annual basis.

Community Medical Services also suggests the proposed rules review increasing access to prescribe buprenorphine products for Nurse Practitioners and Physician Assistants. Additionally, if the proposed patient limit is increased to 200, it is suggested that the additional layer of oversight through CSAT approved accreditation agencies become a requirement for physicians treating 200 clients.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0416,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0416,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Sandra Johnston,646,"The actual population that requires this medication is very low. Using a replacement therapy is in direct contradiction to behavior therapy. Once the drug has left the body's system, a replacement drug is no longer necessary. I view this method as a form of financial gain for pharmaceutical producers. It is an effort to maintain a steady foundation of impaired individuals who believe that they require drugs to "treat" their addiction issues. Any research that seemingly supports this regulation has no basis in reality nor can it be support in a real life setting outside of the study conditions: it cannot be generalized." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0448,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0448,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,"Julie Dravis, LPC, CDCI",1452,"As a mental health provider in a rural community, I understand the need for increased opioid treatment and support medication assisted treatment. I also understand that no other medications are limited in the way MAT is currently. My concern about the increase in number of patients allowable is the disconnection between many physicians and behavioral health providers. The current rule states that physicians have to be able to refer for counseling or substance use treatment but does not say they must refer even for an assessment. No formal relationship with behavioral health care seems required. This concerns me, as I believe that MAT is only one part of treating an opioid use disorder and that integrated care is the highest quality option.

In addition, I am concerned that increasing the total number of people treated by one physician may run the risk of decreasing the quality of treatment and reduce the administrative accountability necessary to protect communities from less ethical physicians. It is a serious concern to me that additional amounts of medications such as buprenorphine may become available "on the street" and used in a disordered way if the clinics are unable to monitor their patients adequately. I hope that a system for carefully monitoring physician practices is developed if a single prescriber will be handling 200 patients.

Thank you for you time in considering these comments." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0063,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0063,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Sabrina Trocchi,1497,"Wheeler Clinic welcomes the opportunity to provide comments to SAMHSA on the proposed rule to expand access to medication-assisted treatment (MAT) by allowing eligible practitioners to request approval to treat up to 200 patients under section 303(g)(2) of the Controlled Substances Act (CSA).
Wheeler Clinic, founded in 1968, is an independent, not-for-profit, community-based organization providing a comprehensive continuum of substance abuse and mental health treatment and recovery services, including Medication Assisted Treatment options to the individuals we serve. Although we fully welcome the proposed changes to increase patients that can be served by an eligible practitioner, we urge you to also consider designating mid-level practitioners, including physician assistants and advanced practice registered nurses, under the supervision of an MD, as eligible practitioners in prescribing buprenorphine. Although we are fully committed to the delivery of MAT, including buprenorphine, the current restrictions in eligible practitioners is a significant barrier in increasing access and availability of high-quality MAT services to the individuals desperately needing these services. Including mid-level practitioners as eligible providers, particularly with workforce healthcare shortages we are experiencing, would significantly increase access to MAT services.

Thank you,
Sabrina Trocchi, Ph.D. Candidate, MPA
Chief Strategy Officer
Wheeler Clinic
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0054,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0054,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Samuel Lee,1131,"This proposed rule has the potential to save lives. Medically assisted treatment for opioid addiction is the most sensible way for the government to approach the increasing number of people effected by opioid abuse. Increasing the number of patients that a doctor may treat at any one time will increase access to treatment for those that need it most. Increasing the number of patients a doctor may treat at any one time may also decrease the costs to the patient or whomever is paying for the treatment through economies of scale. However, doctors are not producing a widget, they are trying to make their patient as healthy as possible. My main concern with this increase in patients is how will the quality of treatment remain at the level it was at before when the doctor may effectively double their work load if this rule is finalized. SAMHSA writes that doctors will have to report certain things in order to make sure that they are providing high quality care to their patients, but will SAMHSA make periodic and random inspections of the doctors' offices in order to make sure that these doctors are being compliant? " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0055,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0055,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Steven Powell,2054,"I believe the restrictions placed in the definition of qualified practice setting are too narrow. They make it difficult for rural physicians or physicians in an underserved setting. Also, accepting third party payment should not be a criterion for a qualified practice setting, since many patients do not have insurance. And if they do have insurance, many insurance programs will not pay for the appropriate medication or place unreasonable restrictions on coverage. Appropriately trained practitioners should be able to treat patients in whatever reimbursement setting they choose.
The limit on number of patients has for years served as an impediment to treatment of the population. It is not enough to serve as an incentive for practitioners to seek out specialty board certification. Requirement of board certification in addiction medicine will severely limit the number of available practitioners. Also the continued limits serve as an impediment to the development of a large community of practitioners who have a great deal of experience in treating this condition. Familiarity and comfort level in treating addiction will not develop among office based practitioners who are only allowed to see 100 or even 200 patients. This serves as an impediment to the development of expertise, availability of mentoring, and long term care.
Also the increase from 100 to 200 is not adequate to address the pressing need in most communities for medication assisted therapy. While it is a doubling of the available slots, the shortage of available practitioners willing and able to provide medication assisted therapy will still fall far short. While this is definitely a step in the right direction, the small increase in slots coupled with the above restrictions, will do very little to increase overall access to medication assisted therapy to anywhere near the level needed in the population.
These limits and the restrictions continue to be a restraint of practice that is unjustified in the face of the problem facing our population.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0069,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0069,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Owen Murray,4877,"I am a licensed behavioral health clinician working full time supporting 6 MD prescribers of buprenorphine in 4 OBOT settings under the State of Vermont's Hub (OTP) and Spoke (OBOT) initiative. Information about Hub and Spoke can be found here: http://www.healthvermont.gov/adap/documents/HUBSPOKEBriefingDocV122112.pdf

The Fact Sheet-MAT for Opioid Use Disorders-Increasing the Buprenorphine Patient Limit states: "Existing evidence shows that evidence-based MAT is under-utilized." This is indeed the case. The proposed rule change should help many more people with opioid use disorders access the medication but it does not substantially address access to the therapy. The Fact Sheet states: MAT is the use of medications in combination with counseling and behavioral therapies to provide a whole patient approach to the treatment of substance use disorders. Behavioral therapy is also important in addressing issues of medication diversion and abuse, as well as whole person recovery. Therefore, if the cap is raised without required parameters for the behavioral health component of treatment, treatment outcomes as well as buprenorphine abuse and diversion may worsen significantly. Requiring prescribers to comply with "a request for information regarding: ... Percentage of active buprenorphine patients that received psychosocial or case management services (either by direct provision or by referral) in the past year" as the proposed rule text states does not ensure the level of behavioral care and oversight which I presume is the intent of the 100 patient cap.

I conduct initial assessments for opioid dependent patients seeking MAT. In my substance use history interviews, I find approximately one in five patients endorse lifetime history of nasal abuse of generic buprenorphine and/or IV abuse of Suboxone film. Virtually every patient endorses lifetime history of buying buprenorphine to self-medicate when not in treatment. These opioid dependent patient self-reports suggest that many patients abuse and/or divert buprenorphine. Urine drug tests of my patient panels demonstrate that approximately one in four patients drink alcohol or use benzodiazepines along with their prescribed buprenorphine, chemical combinations that are potentially fatal. Behavioral interventions including education about the dangers of these behaviors, reviewing results of urine drug tests with patients, individual and group psychotherapy, and case management are all essential in delivering safe and effective MAT. Raising the cap on medication provided by one person without mandating an equivalent increase in the behavioral aspects of the treatment will serve to increase access to medication but also increase the risks of the treatment. Many patients only engage in the behavioral health aspects of treatment if their buprenorphine prescription depends on it. I know this because my group and individual sessions were poorly attended until prescribers linked buprenorphine prescriptions with therapy attendance. This experience with opioid dependent patients leads me to conclude that if the rule expands access to buprenorphine but only mandates a minimum of "connection" to behavioral health services, the very patients most likely to abuse or divert buprenorphine will be even less likely to engage in the behavioral aspects of MAT.

The State of Vermont's Hub and Spoke initiative provides one full-time equivalent licensed behavioral health clinician and one full-time equivalent Registered Nurse to support each prescriber per 100 buprenorphine patients treated, paid through Vermont Medicaid. I propose that a similar requirement be added to the rule change: raise the cap from 100 to 200 buprenorphine patients per prescriber but require a FTE behavioral health provider be dedicated to the care of each 100 buprenorphine patients.

Finally, I would add that the pharmacology of buprenorphine is not more complex than opioid pain medications, and pain medications are more prone to abuse. The HHS press release: 'HHS takes steps to increase access to the opioid use disorder treatment medication buprenorphine' supports the idea that pain medications are more prone to abuse by stating: "Buprenorphine -- because of its lower potential for abuse -- is permitted to be prescribed or dispensed in physician offices..." Given the nature of the pharmacology, I would also suggest expanding access to treatment by allowing other professionals to become opioids prescribers, such as nurse practitioners and physician's assistants, to prescribe buprenorphine in conjunction with a required FTE behavioral health clinician. This would also greatly expand access while improving the safety and effectiveness of MAT.

Sincerely,

Owen Murray, LMFT " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0121,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0121,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,475,"Support the increase to 200 MAT Patients. Tremendous lack of waivered providers in the rural areas, the list of providers that are waivered is not accurate because a significant number of them do not participate in MAT.
The opioid epidemic and lack of Patient access to resources for MAT is outstanding. How can this epidemic be positively impact if providers are not given the opportunity to treat more Opioid Use Disorder Patients?
RN,MSN-MAT Program Director in TN" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0299,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0299,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Joseph Ranieri,4574,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Joseph N Ranieri DO ABAM -Diplomate
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0315,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0315,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,John Barringer,885,"I currently am a doctor that has a waiver to treat 100 patients but have over 100 hours of continuing medical education credits in treating addiction. However, I am not board certified or have a subspecialty in addiction medicine or addiction psychiatry. Also, I don't know of any private practice outpatient office setting that could qualify as a qualified treatment setting that has 24 hour emergency coverage. I would recommend that all physicians that have a waiver, except those that meet the board subspecialty requirements and those that are ASAM-certified, take 40 hours of classes in Buprenorphine treatment so that we could go up to 200 patients. I have had to turn many patients away because of the 100 patient cap so this law is necessary to create more access to treatment as well as continuing to provide high quality treatment. Thank you for your consideration." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0325,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0325,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Norman Wetterau,498,Physicians who are certified by the recent American Board of Addiction Medicine should be able to have their limit increased.I practice in rural upstate NY. There is a large demand and most patients cannot find a doctor to prescribe unless they drive 100 or 200 miles. There are no addiction psychiatrists in the area but several ASAM addiction specialists including me. It is important for those in rural areas to be able to see us and that our limits be raised.

Norman Wetterau MD DFASAM SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0397,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0397,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Ann Cotton,329,"Please allow ARNPs to prescribe buprenorphine for treatment of Opiate Use Disorder!!! They already have the legal authority to prescribe opioids for pain. This would SAFELY expand our ability to treat opiate use disorders in rural areas and in sorely underserved areas. This only makes good sense.

Thank you,

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0412,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0412,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Richard Levine,1305,"I support the proposed rule, section 303 (g)(2) increasing the prescriber patient load from 100 to 200 in prescribing buprenorphine especially when one is credentialed in addiction medicine by the American Board of Addiction Medicine and the American Psychiatric Assn.

I am a pharmacist clinician working in New Mexico, am classified as a mid level clinician, similar in scope to a physician's assistant (PA) or nurse practitioner (NP). My specialty is in addiction and pain medicine. I perform patient assessments and adjust methadone dosing. New Mexico and the Drug Enforcement Agency permit me to write orders for methadone and other controlled substances. I like many physicians working in addiction medicine am a member of the American Society of Addiction Medicine.

There are only a few states that allow such credentialing. Our numbers are small.
As a result most federal agencies are not aware that we exist. For this reason pharmacist clinicians were not included in the language of HR 4981 but PAs ad NPs were in allowing prescribing of buprenorphine irrespective of their training and competency in addiction medicine.

I urge SAMHSA to change the language of HR 4981 so as to include pharmacists clinicians.

Richard Levine, Pharm.D., M.P.H.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0457,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0457,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anne Jackson,369,"It is ironic in the face of the current epidemic of opioid addiction and overdose deaths, that essentially all physicians can have unlimited numbers of patients treated with opiates, but addiction specialists have a limit on the number we can treat with opiate replacement therapy.

PLEASE LIFT THE CAP ON TREATMENT OF ADDICTED PATIENTS WITH BUPRENORPHINE.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0541,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0541,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Anonymous Anonymous,73,The American Medical Association's comments are attached. Thank you. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0114,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0114,2016-04-28T04:00:00Z,Comment on FR Doc # 2016-07128,J. Neal Felber,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0361,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0361,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,jason kletter,48,Please see attached comments from BAART Programs SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0338,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0338,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Gautam Datta,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0477,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0477,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Arlene Gonzalez-Sanchez,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0493,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0493,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Kolodny,94,Please see uploaded comment on behalf of Physicians for Responsible Opioid Prescribing (PROP). SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0476,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0476,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Deborah Trautman,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0228,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0228,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Jose R. Sanchez MD,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0280,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0280,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,67,"Please see comments from the American Nurses Association, attached." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0287,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0287,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Mark Covall,107,
Attached is a comment letter from the National Association of Psychiatric Health Systems (NAPHS).
SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0319,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0319,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0199,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0199,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Jeff Unger MD,4958,"

May 10, 2016

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Congressional Leaders

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA (1) raise the patient cap above the proposed 200 patient limit and (2) consider the potential impact that a formulation-based "counting" methodology might have on physician/patient decision-making and patient-driven recovery.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.



I urge you to support SAMHSA to raise the DATA 2000 patient limit to one that meets the needs of our communities, both with respect to the limit and eligible clinicians. It is worth noting that the clinician time required during induction is far greater, and the risks potentially higher, than what is required during maintenance and tapering. SAMHSA should consider a "counting" methodology that captures the realities of patient care and associated time requirements, dosing, and risks throughout the stages of recovery. This type of approach may offer greater precision and increase overall capacity without increased diversion risk. Clinicians who have reached their patient capacity, and are primarily managing a patient population through maintenance and tapering could "count" these lower-dose maintenance patients at a specified fraction and would be able to offer treatment to new patients.

.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Congress whether this program would be a success or a catastrophic failure. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should NEVER be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the address noted below.

Sincerely,



Jeff Unger, MD, ABFM, FACE
Director, Unger Primary Care Concierge Medical Group
9220 Haven Ave. Suite 230
Rancho Cucamonga, CA. 91730
909-484-2105
jungermd@aol.com

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0328,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0328,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Bennett,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0445,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0445,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Bill Burman,454,"Dear Jinhee Lee,

On behalf of Dr. Bill Burman, CEO of Denver Health -- Attached please find our organization's comments on the proposed
Opioid Rule from CMS. Should you have any questions please contact Dr. Burman at

777 Bannock Street, Mail Code 0278
Denver CO 80204

by phone at 303-602-4918 or
by email at: bill.burman@dhha.org

Thank you, Leticia Gonzalez, Assistant to CEO, Denver Health
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0454,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0454,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Dan Rabbitt,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0450,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0450,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Richard Hamburg,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0458,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0458,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Carlos del Rio,67,Please see the attached comments from the HIV Medicine Association. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0393,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0393,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,"Alberto Avendano, MD",149,Indivior respectfully submits the attached comment in response to the SAMHSA Proposed Rule on Medication Assisted Treatment for Opioid Use Disorders. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0396,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0396,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Jerry Morris,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0390,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0390,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Laurie Sylla,4461,"May 27, 2016

The full comments and rationale for the recommendations of the King County and Seattle Heroin and Opioid Addiction Task Force are attached. Our recommendations include:
Removing the prescribing cap for waivered/addiction-trained physicians
Creating a faster pathway to 200 patients if the cap is kept
Keeping the proposed rule change of not counting temporary cross covered patients toward the cap, if a cap is kept
Expanding buprenorphine prescribing authority to addiction-trained mid-level providers
Allowing all practitioners who meet the training requirement for a waiver to treat patients at the higher cap level, not only those who are certified addiction specialists
Encouraging your partners at CMS to increase Medicaid reimbursement rates so more waivered practitioners will be willing to provide publicly-funded treatment
Respectfully submitted:
King County and Seattle Heroin and Opioid Addiction Task Force
Members:
Scott Lindsay, Assistant on Police Reform and Public Safety, City of Seattle Mayor's Office
Jim Pugel, Chief Deputy Sheriff, King County Sheriff's Office
Robert Merner, Assistant Chief for Investigations, Seattle Police Department
Brad Finegood, Assistant Division Director, BHRD, King County Department of Community and Human Services
Jeff Duchin, MD, Health Officer of Public Health, Public Health-Seattle & King County
Frank Chafee, Manager, HIV/STD Program, Public Health- Seattle & King County
Reba Gonzales, Deputy Chief for Medical Services Administration, Seattle Fire Department
Dr. Tom Rea, Medical Director, King County Emergency Medical Services
Catherine Lester, Director, Seattle Human Services Department
Jeff Sakuma, Health Integration Strategic Advisor, Seattle Human Services Department
Darcy Jaffe, Chief Nursing Officer and Senior Associate Administrator, Harborview Medical Center
Mark Larson, Chief Criminal Deputy, King County Prosecuting Attorneys Office
Mark Cooke, Policy Advocate, American Civil Liberties Union of Washington
Steve Stocker, Commander, Auburn Police Department
Kevin Milosevich, Chief, Renton Police Department
Caleb Banta-Green, Senior Research Scientist, University of Washington Alcohol and Drug Abuse Institute
Susan Kingston, Continuing Education Coordinator, University of Washington Alcohol and Drug Abuse Institute
Tim Bondurant, MD, Medical Director, Opioid Treatment Program, U.S. Veteran's Administration
Sara Chaudry, U.S. Veteran's Administration
Jim Walsh, MD, Swedish Hospital, Medical Director, Addiction Recovery Service
Annette Hayes, U.S. Attorney, Western District of Washington, U.S. Attorney's Office
Charissa Fotinos, Deputy Chief Medical Officer, Washington State Health Care Authority
Lisa Daugaard, Director, Public Defender Association
Patricia Sully, Attorney, Public Defender Association
Penny Legate, Family Member of Person Who Experienced Addiction
Thea Oliphant-Wells, Social Worker, Public Health - Seattle & King County Needle Exchange
Mark Putnam, Director, All Home of King County
Dan Cable, Chemical Dependency Manager, Muckleshoot Tribe
Molly Carney, Executive Director, Evergreen Treatment Services
Norm Johnson, Executive Director, Therapeutic Health Services
Michael Ninburg, Executive Director, Hepatitis Education Project
Andy Adolfson, EMS Commander, City of Bellevue
Pegi McEvoy, Assistant Superintendent for Operations, Seattle Public Schools
Shilo Murphy, Director, People's Harm Reduction Alliance
David Dickinson, Regional Administrator, U.S. Substance Abuse and Mental Health Services Administration, Regional Office
Roger Dowdy, Director of Operations, NeighborCare
Annie Hetzel, Puget Sound Educational Service District
Mary Taylor, Manager, King County Drug Court
Daniel Malone, Executive Director, Downtown Emergency Service Center
Ryan Oftebro, Chief Executive Officer, Kelley Ross Pharmacy
Suzan Mazor, Emergency Medicine, Toxicology, Children's Hospital and Medical Center

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0379,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0379,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Marvin Lindsey,474,"The Community Behavioral Healthcare Association of Illinois (CBHA) is pleased to submit the attached comments on the
proposed rule to increase access to opioid use disorder treatment while reducing the opportunity for medication diversion,
entitled Medication Assisted Treatment for Opioid Use Disorders ("Proposed Rule") and published by the Substance Abuse
and Mental Health Services Administration ("SAMHSA") on March 30, 2016.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0388,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0388,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Pamela Greenberg,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0275,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0275,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Darren Lehrfeld,194,"On behalf of CARF International, thank you for this opportunity to submit comments on the proposed rule, Medication Assisted Treatment for Opioid Use Disorders. CARF's comments are attached." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0276,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0276,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Randy Runyon,5090,"The Ohio Association of Community Health Centers (OACHC) represents all of Ohio's 45 Federally Qualified Health Centers (FQHC) which deliver accessible, affordable, high-quality care to over 572,000 Ohioans resulting in over two million patient visits annually-regardless of patient insurance status or ability to pay. Ohio's FQHCs offer an innovative model of care that removes barriers and health disparities, lowers health system costs & allows communities to lead in the direction of their own care.

According to the Ohio Opiate Action Team, "Prescription opioids account for more fatal overdoses than any other prescription or illegal drug, including cocaine, heroin & hallucinogens combined. The number of Ohio lives lost to unintentional drug overdose has risen from 369 lives in 1999 to 1,765 in 2011, a 440% increase! Prescription drugs are involved in most of the unintentional drug overdoses & have largely driven the rise in deaths. Prescription pain medications (opioids) & multiple drug use are the largest contributors to the epidemic."

Substance abuse, including opioid addiction, has become a top public health concern in the U.S., & Ohio's FQHCs are seeing the consequences first hand. To combat this, Ohio received more than $5M to 15 health centers to help improve & expand the delivery of substance abuse services, with a specific focus on Medication-Assisted Treatment of opioid use disorders in underserved populations.
Ohio FQHCs are ready to serve patients who are struggling with substance abuse & addiction, but there is a clear need for additional support & policy change to enable them to do so more effectively.

:: OACHC supports increasing the maximum number of patients an eligible practitioner can treat with buprenorphine to at least 200 individuals ::

As SAMHSA notes in the preamble to the proposed rule, the opioid epidemic has reached an all-time high. Many Ohio FQHCs have decades of experience working in communities that have been struggling with opioid addiction long before the unfortunate surge. To maximize their ability to provide high-quality, comprehensive primary & behavioral health care, health centers should be permitted to use every evidence-based method available to treat their patients, without facing arbitrary barriers. One such barrier is the current cap on the maximum number of patients that eligible practitioners may treat at one time with certain types of FDA-approved narcotic drugs (buprenorphine). Research clearly points to the effectiveness of these drugs when prescribed by qualified providers & used appropriately as part of a MAT program. However, the current limit on how many patients eligible providers may treat at one time creates unnecessary delays and access barriers for patients-many of whom already face a variety of other access barriers that leave providers with limited opportunities to engage them in appropriate treatment.

For these reasons, OACHC & its member health centers support SAMHSA's proposal to increase the maximum number of patients that eligible practitioners may treat with buprenorphine to at least 200. This will permit eligible FQHC providers to rely on their own judgment and experience to establish their own limits for effective patient management based on their unique capacity, community needs, & available resources.

:: OACHC encourages SAMHSA to pursue additional administrative & regulatory policies to help address the opioid addiction crisis ::

Increasing the maximum number of patients that an eligible practitioner can treat with buprenorphine is a valuable step, however it is far from adequate to address the current epidemic of opioid addiction. To this end, a multi-pronged approach is needed which addresses prevention, monitoring, accessibility of care, & treatment. Therefore, within the constraints imposed by statutory language & funding levels, we encourage SAMHSA to pursue additional administrative and regulatory changes that will contribute to this multi-pronged approach.
For example, OACHC requests that SAMHSA continue to support efforts to:
improve integration of behavioral health into primary care;
increase the number of patients screened for substance use disorders & connected to treatment via Screening, Brief Intervention, and Referral to Treatment (SBIRT);
more appropriately reimburse for coordination of care between primary care & behavioral health providers;
provide training & education to help providers make informed prescribing decisions;
improve the distribution of opioid antagonists such as naloxone in preventing opioid overdose; and
assist states in developing and improving prescription drug monitoring programs (PDMPs).

Thank you for this opportunity to comment on this important proposed rule. OACHC would be happy to provide SAMSHA with any further information that would be beneficial to help finalize this rule." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0033,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0033,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Lucas Lund,4898,"I am a physician with a DATA 2000 waiver to prescribe buprenorphine products for the treatment of opioid use disorder, and currently treat 98-100 patients. The proposed legislation mentions a wish to not burden physicians with reporting requirements for managing 200 patients. I have several concerns with the legislation as written.

First, as you must know, legislation to raise the number of patients that one physician may treat is overdue, so I hope you will act swiftly and well.

I'd like to give you some sense of what practicing is like. Time is crucial to a physician managing 100 patients if s/he is doing it well in a meaningful manner. My patients receive addiction counseling onsite for at least an hour every week, more if they need it. Though I have a consultant to file prior authorization requests with insurance companies for coverage of medication costs, the companies balk at doing so. They sometimes approve coverage for only one month, or three. They request a taper schedule though the patient is relatively new to treatment, and they set dose limits, coming dangerously near to practicing medicine without a license.

8.635 (b) (4) "Number of patients at the end of the reporting year who: (i) Have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery" smacks of the same...oversimplification or unfairness that insurance companies increasingly show. One year of treatment is not enough time for the majority of patients to recover enough to leave treatment. Additionally, a number reported at the end of a year won't reflect how long the patients who "graduate" were in treatment, yet taken out of context it will be used to restrict length of treatment to one year, as more insurers have already begun to do. Given that many patients live in neighborhoods and towns riddled with dealers and users, how can anyone predict their chances of continued sobriety after they leave treatment? Those are the conditions to which many patients in detox or rehab must return, and that is in large part why the success rate of detox and rehab are so low. Patients are safer in treatment, and they know that. They tell me they don't want to die "out there". Not knowing how long a patient may need to stay in treatment, it seems to me that even an implication from a governmental department that patients should leave treatment will have deadly repercussions. They are dying out there and in proportionally greater numbers here in NH. I also have found it impossible to follow up with the majority of patients who leave the program. Phone numbers fall out of service, a bad sign, and even patients who do "graduate" seem reluctant to return calls. Some I find out eventually, relapsed. I have no ability to know what number of patients "sustain recovery"as the reporting requirement calls for as currently written.

One of my favorite mentors taught me decades ago during my internship not to order tests if I couldn't use the data it supplied. How will CSAT use this data? As my staff and I get better at treating addiction, it has become evident to me that the improvement comes from our building a better recovery community, and as that happens, our drop-out rate falls and our "graduation" rate also stays low, yet I have no doubt that the patients who do "graduate" this year will do better than those who managed it last year. Though always a happy moment for patient and staff, what use is this number that does not correlate with quality of the program?

Regarding 8.635 (b)(3) "Percentage of patients who had a prescription drug monitoring program query in the past month" Not all states have an operational PDMP. Ours in NH is very clunky and incomplete, with some pharmacies weeks behind in reporting. Though touted as an excellent diversion prevention tool, I have it on good authority that all three of the patients I found to be simultaneously receiving buprenorphine prescriptions from two different physicians continued to use and deal after I stopped prescribing for them. Does a PDMP help patients, or place them at greater risk by driving them deeper into the drug world? What will CSAT do with the information? As with (b)(4) is a cut off planned wherein a physician who reports less than some required number will be denied permission to treat 200 patients?

It seems to me that there are better words, better ways and better questions with which to measure the quality of a treatment program, but as I stated near the beginning of this comment, it is far more important to expand access to treatment then it is to quibble about anything less catastrophic than this deadly epidemic. Please pass the legislation swiftly." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0161,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0161,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Bradley Levin,1659,"To Whom It May Concern:
It is vitally important that those individuals who have taken the time and necessary preparation to become ABAM board certified be recognized for their achievements. Those of us who practice Addiction Medicine full time recognize the epidemic proportions of substance abuse and addiction patients that our society currently has to deal with. This translates into a grossly underserved populace that can neither find adequate numbers of facilities and or practitioners. Limiting a board certified physician to a specific number of patients with addiction issues would be similar to limiting a physician to a specific number of patients with diabetes or high blood pressure. Clearly that does not even begin to make sense.
I do not believe that general practitioners per se have the necessary environment, or training to adequately treat these patients unless they have access to appropriate counseling and group services and the appropriate background education. Those of us working in clinics that have the necessary support services can more than adequately address these patient's needs and vastly increase our admissions unless hampered by unnecessary and restrictive regulations and requirements.
Let's work together to help control this raging epidemic by fostering and encouraging those with board certification to practice to the full extent of their capabilities without the unnecessary shackles of regulation limits.

Bradley H. Levin, M.D., FACC, FACS, FASAM, DABAM, CMRO

Medical Director

Elkton/Pine Heights Treatment Centers

ARS of Lancaster, Aberdeen, and Camp Hill" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0165,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0165,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Michael T,1349,"I am a physician trained and certified through the American Board of Addiction Medicine (ABAM). I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term "subspecialty" from 8.610(b)(1). This change would align the eligibility requirement with the concept of "board certification" as defined in 8.2, which includes board certification in addiction medicine from ABAM.
I have been in practice since 2007 and since the very beginning I have been at the 30 then100 patient limit with a waiting list This proposal is an excellent start to address this continuing serious problem of Opioid Use disorder in the US. As a board certified specialist in Addiction Medicine, I feel that the practices of those of us that have undergone the training, testing, and continued rigorous maintenance of certification should not be restricted at all however. No such restrictions exist for Cardiologists or Neurologists for example. The limits as they exist now restrict me to seeing (5 patients per day x 20 day work month). As most other medical specialties see 20 or more patients per day that would equate to a 400 patient limit as being more reasonable. This increase to 200 is a great beginning." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0175,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0175,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,"Bryan Van Doren, M.D.",1481,"The proposed HHS rule change for higher buprenorphine patient limits is desperately needed in the State of Oklahoma. As currently written the rule appears to exclude those physicians practicing full time Addiction Medicine who are board certified by the American Board of Addiction Medicine. We have 5 physicians at the Oklahoma University School of Community Medicine (3 Internists & 2 Psychiatrists) who have been certified by the ABAM within the past 5 years and two of us completed our fellowship training at OU. We have a comprehensive ADM treatment program, are all waivered at the 100 patient limit, and have a current waiting list of over 250 patients in desperate need of medication assisted therapy. Based on the current language in the rule change none of us would qualify for the increased limit until the American Board of Preventive Medicine can formally ratify us as ADM Board Certified which is going to take several years.

I strongly urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Sincerely,

Bryan A. Van Doren, M.D., FASAM, MRO
Assistant Professor of Internal Medicine & Addiction Medicine
Oklahoma University School of Community Medicine
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0216,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0216,2016-05-12T04:00:00Z,Comment on FR Doc # 2016-07128,Thomas KLINNER,970,"THOSE OF US THAT ARE MEMBERS OF THE AMERICAN ACADEMY OF ADDICTION MEDICINE WANT TO HELP THOSE THAT HAVE ADDICTIONS. WE SPENT THE TIME AND SPENT THE MONEY NECESSARY TO LEARN HOW TO TREAT THEM.

THE VAST MAJORITY OF MY BUPRENORPHINE/NALOXONE PATIENTS SINCERELY WANT TO BE FREE FROM THEIR HABITS. THEY ARE TIRED OF THE WAY THE DRUGS MAKE THEM FEEL. THEY ARE TIRED OF SPENDING ALL THEIR MONEY ON DRUGS AND BEING UNABLE TO TAKE CARE OF THEIR FAMILIES.THEY WANT AND NEED HELP.

AS PHYSICIANS, WE KNOW WHEN WE HAVE REACHED OUR CAPACITY TO PROVIDE ADAQUATE CARE FOR OUR PATIENTS. WE HAVE DONE SO FOR YEARS. ONLY THOSE PHYSICIANS WHO FEEL CAPABLE TO TREAT MORE PATIENTS WILL APPLY FOR THE HIGHER LIMIT. AND THERE WILL BE THOSE WHOSE CAPACITY IS BETWEEN 100 AND 200 AND THEY WILL STOP TAKING NEW PATIENTS WHEN THEY HAVE REACHED THAT
LIMIT.

THE FASTEST WAY TO INCREASE ACCESS WOULD SEEM TO BE TO LET THOSE OF USTHAT ARE TRAINED AND WANT TO HELP DO SO." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0318,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0318,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Brent Boyett,2984,"RE:RIN 0930-AA22
ATTN:Jinnhee Lee, Pharm D.

5/25/2016

Dear Secretary Burwell,

I am happy to hear that your administration is considering increasing the limit on the number of patients that DATA 2000 waivered doctors can treat. Understanding the pharmacology of mu receptor agonists, it seems counter intuitive to limit partial agonists and yet continue to place no restrictions on full mu agonists. I personally continue to see doctors throughout our region use chronic pain codes and documentation to treat what is actually surreptitious substance use disorders. Chronic pain is far less regulated, and full opioid agonists do not suffer the bureaucratic scrutiny applied to the long acting partial agonist of buprenorphine. When naloxone is added to buprenorphine, the abuse potential is reduced even further and yet the double standard driven by stigma remains.

While buprenorphine and naloxone have revolutionized medical assisted treatment for opioid dependence, diversion remains a serious concern. I believe that it is critical that all prescribers of controlled substances have a formal (written) diversion mitigation strategy in place utilizing policies like the following:
1.Wrapper counts - patients must bring in their opened and unopened film wrappers. This will reduce hoarding and diversion.
2.Random wrapper/ film counts and random drug testing.
3.Insurance companies should be compelled to allow for increased drug testing instead of placing caps on the number of times that a person can be tested in a year. Now is the time for increased testing until our current epidemic is reversed.
4.The Parity Law should be enforced allowing for treatment, counseling and early intervention into behavioral disorders.
5.The use of more efficient and lower dose, dual therapy (with naloxone) preparations like Bunavail should be favored over older buprenorphine products especially monotherapy, to reduce street value and the amount of buprenorphine milligrams on the street.
The potential of future products like implants and injections hold great promise to mitigate the harmful impact of diversion. Doctors must be educated that the controlled medication they prescribe are commonly sold, shared, or traded. They should be trained to reduce this risk.

I am grateful for your efforts in dealing with this complex but important public health issue. As a doctor from a small town in Alabama, I must sadly report that this epidemic has had a devastating effect on our entire region. Thank you for working to remove the barriers to treatment and to reverse this trend that has damaged our society over the past 20 years.

Sincerely,

Brent Boyett D.M.D., D.O.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0362,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0362,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Luke Nasta,2540,"My name is Luke Nasta I have been the executive director of Camelot Counseling Services of Staten Island for 4 decades and am a survivor of the last Heroin Epidemic.
I support a harm reduction approach to save lives, prevent overdoses, and the spread of disease. I have the benefit of history, professionally and personally.
In the haste to come up with an emergency action plan, having doctors write yet more prescriptions without an intensive counseling treatment mandate is a prescription only for diversion and failure. Addicts will use the drugs to stem the effects of withdrawal until they can sell the prescription medication and buy heroin. This is not theory; ask any heroin addict. The attempt to stem the rising tide of addiction through private practice physicians failed in the 1960s and 1970s as untrained MDs were charged with treating complex patients. Todays health management system wherein doctors have even less time per patient is how the addict will manipulate, coerce, and dupe the healer while continuing heroin use and spreading the contagious plague of opiate dependence. Methadone clinics were offered as the alternative solution for treatment expansion and access. I do not consider Methadone a best practices choice for an initial attempt at treatment for those in their late teens or early twenties. Intensive counseling in a government funded 6 month residential setting or intensive outpatient program is the indicated treatment plan. The proposed instinctive response to the escalating number of deaths is a public policy of overdose prevention without rehabilitation.
I strongly advise Treatment Assisted by Medication (TAM) or we will sacrifice a generation that began with the prescription pill epidemic 15 years ago. I shudder to think that the current users are to be forsaken as lost souls in the misguided attempt to reduce the threat of overdose deaths. The New York City Department of Health Statistics indicates 1 in 10 overdoses results in death. What of the others? Treatment providers warned government of the psychological dependence of cocaine(1980s), of the oncoming prescription pill problem(1990s), and the inevitable conversion to heroin use(5 years ago). Government needs to do more for monitored counseling treatment and not (our current prediction) spread the nations number 1 health problem.
Respectfully submitted for your consideration.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0375,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0375,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Margaret Kinney,691,"I understand that the proposal is to increase the number of patients a medical provider can treat with the medication buprenorphine. I agree that changes need to made to be able to serve more patient with opiate use disorders. However, I do not think the proposed change is sufficient. As I understand it, there are no limits on the number of medical providers who can prescribe opiates. As number of individuals struggling with opiate use disorders continue to rise, why limit the number of individual who want to recovery to access to a useful treatment? I think that there should be no limits on providers who wish to aid their patients by providing a prescription for buprenorphine. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0376,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0376,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Marie Coyle,296,I agree with this proposal because there are so many addicted who are simply afraid of treatment because they are afraid of the withdrawal symptoms. To be able to withdraw without those symptoms would hopefully push more people to seek help. The addiction in this country is destroying families. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0404,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0404,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Steve Weaver,1080,"I agree with Neal Lakritz M.D. FASAM in his earlier comment and Joseph Koeningsmark comments also. The requirement that physicians use an EMR or that they accept third party payment is simply a thinly veiled attempt to concentrate MAT in the hands of large practices that have the resources to comply with these requirements. Small practices like mine will be forced to stop seeing these patients because the requirements will be too expensive while third party reimbursements are too low. Let's be clear, none of these requirements have anything to do with increasing access to MAT. These requirements are an attempt to force smaller practices to shut down so that these large clinics can increase their business. This goes against the original intent of DATA 2000. Patients in rural areas will be forced to travel to larger cities because small town doctors like myself will be unable to comply. What a shame!! Patients in my rural area have been greatly helped by MAT but now they will no longer have local access to this life saving treatment.

Steven G Weaver, MD" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0417,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0417,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Luke Nasta,2567,"My name is Luke Nasta I have been the executive director of Camelot Counseling Services of Staten Island for 4 decades and am a survivor of the last Heroin Epidemic.
I support a harm reduction approach to save lives, prevent overdoses, and the spread of disease. I have the benefit of history, professionally and personally.
In the haste to come up with an emergency action plan, having doctors write yet more prescriptions without an intensive counseling treatment mandate is a prescription only for diversion and failure. Addicts will use the drugs to stem the effects of withdrawal until they can sell the prescription medication and buy heroin. This is not theory; ask any heroin addict. The attempt to stem the rising tide of addiction through private practice physicians failed in the 1960s and 1970s as untrained MDs were charged with treating complex patients. Today's health management system wherein doctors have even less time per patient is how the addict will manipulate, coerce, and dupe the healer while continuing heroin use and spreading the contagious plague of opiate dependence. Methadone clinics were offered as the alternative solution for treatment expansion and access. I do not consider Methadone a best practices choice for an initial attempt at treatment for those in their late teens or early twenties. Intensive counseling in a government funded 6 month residential setting or intensive outpatient program is the indicated treatment plan. The proposed instinctive response to the escalating number of deaths is a public policy of overdose prevention without rehabilitation.
I strongly advise Treatment Assisted by Medication (TAM) or we will sacrifice a generation that began with the prescription pill epidemic 15 years ago. I shudder to think that the current users are to be forsaken as lost souls in the misguided attempt to reduce the threat of overdose deaths. The New York City Department of Health Statistics indicates 1 in 10 overdoses results in death. What of the others? Treatment providers warned government of the psychological dependence of cocaine(1980s), of the oncoming prescription pill problem(1990s), and the inevitable conversion to heroin use(5 years ago). Government needs to do more for monitored counseling treatment and not (our current prediction) spread the nation's number 1 health problem.
Respectfully submitted for your consideration.
Luke J. Nasta
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0423,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0423,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Schlafly,3669,"The following objections to the proposed rule entitled Medication Assisted Treatment for Opioid Use Disorders (the "Proposed Rule"), are submitted on behalf of the Association of American Physicians & Surgeons ("AAPS"). The Regulatory Information Number (RIN) is 0930-AA22.

Founded in 1943, AAPS is a non-profit, national group of thousands of physicians and surgeons. AAPS has filed amicus curiae briefs in many cases before the United States Supreme Court and appellate courts, and AAPS's submissions have been cited favorably in multiple opinions. See, e.g., Valfer v. Evanston Northwestern Healthcare, 2016 IL 119220 (Illinois Sup. Ct. May 19, 2016); District of Columbia v. Heller, 554 U.S. 570, 704 (U.S. Sup. Ct. 2008) (Breyer, Stevens, Souter and Ginsburg, JJ., dissenting); Springer v. Henry, 435 F.3d 268, 271 (3d Cir. 2006) (citing and relying on an AAPS argument); United States v. Rutgard, 116 F.3d 1270, 1275 (9th Cir. 1997) (mentioning AAPS as amicus curiae).

AAPS members and their patients would be adversely affected by this Proposed Rule in at least three ways.

First, the Proposed Rule attempts to require physicians to accept third-party payment. Proposed Rule 8.615(e). AAPS has many members who intentionally do not participate in third-party payment systems because of the interference with the patient-physician relationship that results. There should be no restriction on the ability of a physician to accept payments directly from patients without participating in third-party payment schemes. This is a violation of basic freedoms of both patients and physicians in requiring physicians to participate with third-party payors in connection with medical care.

Second, the Proposed Rule improperly coerces physicians to use Electronic Health Records ("EHR"). Proposed Rule 8.615(c). Often paper medical records are less expensive, more accurate, and more protective of patient privacy than EHR. There is no justification for the Proposed Rule to push EHR on physicians and patients. In small practices commonly used by AAPS members, EHR is often not cost-effective or productive, and physicians should not be told by federal regulation to use EHR.

Third, Agency Questions for Comment #3 ("Practitioner Training for 200 Patient Limit") and #4 ("Alternate pathways to qualify for 200-patient prescribing limit") propose that physicians should be board certified in addiction psychiatry or addiction medicine in order to qualify for the higher 200-patient prescribing limit outside of a qualified practice setting. But this board certification condition simply enriches a private entity that controls board certification without any political accountability or transparency. There is no proven correlation between board certification or re-certification and the quality of medical services rendered by a physician. The Proposed Rule imposes a money-making scheme for the benefit of a private entity and its officers, and takes the already scarce time of physicians away from treating patients. Burdening physicians with time-consuming, costly requirements that have no demonstrable benefit should not be part of a federal regulation.

AAPS specifically requests that the final rule contain no requirement of accepting third-party payments or participating in EHR. In addition, AAPS asks that any condition of board certification or re-certification be removed.

Thank you for your attention to these comments.

Andrew Schlafly
General Counsel, Association of American Physicians & Surgeons
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0456,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0456,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Judy Rummler,2398,"The FED UP! Coalition to End the Opioid Epidemic is a coalition of organizations on the front line of the North American prescription opioid and heroin crisis. We have joined forces to advocate together for a more forceful federal response to the opioid addiction epidemic. We are pleased that HHS is seeking to improve access to buprenorphine treatment and we appreciate the opportunity to comment on the proposed rule change. We believe that buprenorphine is a first-line treatment for the life-threatening condition of opioid addiction and that better access to this medication could save thousands of lives.

We believe that lifting the cap from 100 patients to only 200 patients will not adequately expand access in communities with high rates of opioid use disorders and few waivered physicians. Furthermore, we believe that a low patient cap is a disincentive for the development of specialty centers capable of treating large numbers of patients. If there is to be any cap, we favor a significantly higher limit of perhaps 2300 patients, which is the number of patients a primary care physician typically treats.

We note that patient caps do not exist for treatment of chronic pain with schedule II opioids such as oxycodone, even though schedule II opioids are by definition more dangerous and their use for chronic pain may not be safe or effective. If HHS believes that there should be a cap on the number opioid-addicted patients treated with buprenorphine we wonder why it is not also seeking a cap on the number of patients prescribed schedule II opioids for chronic pain.

The FED UP! Coalition is also opposed to new reporting requirements for prescribers eligible to treat up to 200 patients. We believe that the additional administrative burden will be a disincentive for physicians to treat more than 100 patients. Again, we note that there are no similar reporting requirements for treatment of pain with schedule II opioids and wonder why HHS is not seeking these requirements for a treatment that is more dangerous and is not evidence-based.

In summary, (1) we urge HHS to raise the cap to a significantly higher level than 200 patients, and (2) we oppose new reporting requirements for prescribers treating more than 100 patients.

Submitted by: The FED UP! Coalition to End the Opioid Epidemic
www.fedupcoalition.org

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0474,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0474,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,jonathan connell,2191,"Dear Secretary Burwell,

I am writing on behalf of the Opioid Treatment Providers of Georgia (OTPG) which represents over 65 treatment programs which serves over 12,500 Opioid Addicted patients in our state. I am writing in response to the Federal Register Notice of March 30, 2016.

OTPG its board and members are not in favor of raising the patient limit on DATA 2000 physician's.

There are some core beliefs as a providers group that we believe which we are convinced are not being taken into considerations:

1. opioid use disorder is a disease. A part of this disease is that patient's can not take opioids medication as prescribed even medications that could help them. In fact we are in a public health crisis with people overdosing from taking opioid on our streets. Thus opioid addicted patient should be required to take these mediations in front of a nurse because Supervised Treatment works. Patients that take medications daily in front of a nurse are stabilized are more apt to comply with treatment and have been shown to make huge changes in their addictive behavior. The evince that we have today to support Medication Assisted Treatment have come from this model. Therefore we know Supervised Treatment Works.

Also Supervised treatment ensures these patients are taking the mediation and not selling these drugs on the street. we all know that we have seen a huge growth in Buprenorphine sales on the street.

2. Treatment Works not just medication: we believe that patient's do not need just medication but also need counseling both individual and groups, treatment planning and other social services provided at accredited opioid treatment programs.

3. Access to care: We agree that we need more access but we believe that the Federal Government should be putting pressure on the states to open access to care through Opioid Treatment Programs in states that are more prohibit Opioid treatment Programs from operating. We want greater access to quality treatment that is going to offer real hope to a people who need it.

Thank you Secretary for taking the matters into account.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0021,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0021,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Raymond Gorman,295,These rule changes are essential to meet the growing demand for services and to help combat the opioid epidemic in this country.
As the Pres/CEO of a Joint Commission Behavioral Health Home serving seriously mentally ill and substance abusers we see the need for these changes in regulation. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0234,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0234,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,"William Scott, III",6117,"May 17, 2016

The Honorable Lamar AlexanderThe Honorable Fred Upton
455 Dirksen Senate Office Building2183 Rayburn House Office Building
Washington, DC 20510Washington, DC 20515

The Honorable Patty MurrayThe Honorable Frank Pallone
154 Rayburn House Office Building237 Cannon House Office Building
Washington, SC 20510Washington, DC 20515

Re:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Congressional Leaders

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap above the proposed 200 patient limit. It is my experience that patients should be monitored monthly and prescribed buprenorphine in a supply limiting its use to monthly amounts with no refills available. This is done as a preventative measure against diversion. It is imperative that a clinic treating addiction have counselors on staff capable of monitoring each patient as to their use and compliance with program guidelines.

When DATA 2000 was enacted, few clinicians likely thought at 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this public health crisis, it is difficult to identify an interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. This statement is indeed the truth unless proper monitoring of patients takes place. As an ASAM board certified addiction specialist since 2009, I personally own both methadone and suboxone clinics and see no real difference in the management of patients with this chronic relapsing disease. Our practice has been highly successful in the detoxification process which we have developed through years of practice and study. We believe that this in itself is a deterrent to diversion as more people are detoxed successfully from the use of these medications.

MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care and adequately staffed to properly treat and monitor patient progress and compliance is undoubtedly ideal. Without the staff and program guidelines to properly maintain accountability of patients, MAT cannot be successful. Addiction medicine professionals are an invaluable resource in reversing this growing epidemic. As I indicated, our practice emphasizes total detoxification from Buprenorphine as the drug itself has its own side effects in renal disease and pregnancy to name a few.

There are fifty (50) certified addiction providers in the State of South Carolina. If each of these providers was full with a patient population of 300 patients, it would largely cover the need of the people without opening up the ability to providers not properly trained in addiction medicine and the use of Buprenorphine products.

Adequate access and diversion control should not be viewed a mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and
to the DATA 2000 program generally. Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless the treatment capacity of certified providers grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly and limit the increase to those providers properly trained and certified to maintain a successful MAT program.

If you have any questions or interest in discussing my comments, please feel free to contact me at the number listed below.

Sincerely yours,

William M. Scott, III, MD
206 Wall Street
Piedmont, SC 29673
864.269.7950

cc: Jinhee Lee, Substance Abuse and Mental Health Services Administration, Department of Health and Human Services, 5600 Fishers Lane, Room 13E21C, Rockville, MD 20857
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0111,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0111,2016-04-27T04:00:00Z,Comment on FR Doc # 2016-07128,George Testmand,61,Homicidal and suicidal thoughts feel like people that get me SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0508,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0508,2016-07-26T04:00:00Z,Comment on FR Doc # 2016-16069,Julie Perez,822,"DHHS - SAMHSA - Medication Assisted Treatment for Opioid Use Disorders
RIN 0930-AA22
Docket: SAMHSA - 2016 - 0001

Reference: Federal Register Vol. 81, No. 61 / Wednesday, March 30, 2016 / Proposed Rules - page 17642

From: III. Background B: Medication-Assisted Treatment (MAT) - column 3:

"Under 21 U.S.C. 823 (g)(2), qualified practitioners can prescribe, administer, or dispense medicines containing buprenorphine for treatment of opioid use disorder in various settings, including in an office, community hospital, health department, or correctional facility."

Question: Does this rule apply to providers who are hospitalists only in an acute inpatient psychiatric facility? Providers will not follow patients as outpatient post-discharge provider.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0056,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0056,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Elworth,192,I applaud the proposed rule change which will allow physicians possessing the required qualifications to increase the limit to 200 patients from 100. I believe you made the correct threshold. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0077,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0077,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Anna Engley,668,"This is a bad idea. These mediations need supervision in order to be effective. There is no magic pill. A combination of services are necessary. I have worked as a recovery counselor in a recovery house. Many individuals were on Suboxone. It has an unlimited potential to be abused. Without medical, psychological, and peer support, recovery is not advanced. MAT abuse adds to the cycle of addiction. It does not interrupt it. Most of the individuals that overdose in my area have tried MAT. Lets spend our time and money on something that really works. My observations are mainly experiential,
coming from my 29 years of recovery through the 12 steps. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0102,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0102,2016-04-25T04:00:00Z,Comment on FR Doc # 2016-07128,Frank Mongillo,1319,"I have been prescribing buprenorphine in my internal medicine practice in New Haven, CT for the past 9 years. This drug has changed the lives of many of my patients. When a patient is motivated and ready for treatment, buprenorphine can be an extremely effective tool to help overcome addiction. This has been an extremely gratifying part of my practice.
The 100 patient limit is a challenge. Every week we turn away patients who are seeking help because of the limit. Increasing the limit has the potential to make life saving treatment available to more people. The problem with the proposed rule change is that it is limited to addiction medicine specialists and "qualified practice settings." I am board certified in Internal Medicine, but not addiction. I do however have 9 years of experience. I am not sure if my practice would be considered a "qualified setting" based on the information given so far. I am also concerned about the possible reporting requirements associated with the higher number of patients. This added burden will likely discourage many doctors from seeking the additional waiver.
The best way to help a greater number of people fight addiction is to allow the doctors who have experience and are willing to see these patients treat more of them. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0135,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0135,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Richard Levine,536,"Allowing mid level practitioners trained in MAT working under the jurisdiction of supervising physicians to prescribe buprenorphine would expand access.
I am a pharmacist clinician-mid level practitioner-trained in addiction medicine (In New Mexico). I work in methadone maintenance performing patient assessments, adjusting methadone doses and counseling in behavioral health interventions. With more than 10 years of experience in MAT it is incredulous that I cannot prescribe buprenorphine similarly as I prescribe methadone." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0146,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0146,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Miriam Komaromy,432,I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit. This will include the large number of physicians who are boarded through the American Board of Internal Medicine. Thank you for your consideration. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0237,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0237,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Peter Rao,5211,"May 17, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Peter A. Rao, MD
Peter Alan Rao, M.D., PLLC
Diplomate, American Board of Psychiatry and Neurology
Diplomate, American Board of Addiction Medicine
5544 S. Lewis Avenue, Suite 600
Tulsa, OK 74105
(918) 747-4900 (o)
(918) 747-4903 (f)
(918) 640-6445 (c)

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0246,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0246,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Keisling,5017,"May 17, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Robert Keisling, MD
Unity Healthcare
3020 14th St NW #4
Washington, DC 20009

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0269,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0269,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Jeff Unger,5166,"May 23, 2016

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Congressional Leaders

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA (1) raise the patient cap above the proposed 200 patient limit and (2) consider the potential impact that a formulation-based "counting" methodology might have on physician/patient decision-making and patient-driven recovery.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.


I urge you to support SAMHSA to raise the DATA 2000 patient limit to one that meets the needs of our communities, both with respect to the limit and eligible clinicians. It is worth noting that the clinician time required during induction is far greater, and the risks potentially higher, than what is required during maintenance and tapering. SAMHSA should consider a "counting" methodology that captures the realities of patient care and associated time requirements, dosing, and risks throughout the stages of recovery. This type of approach may offer greater precision and increase overall capacity without increased diversion risk. Clinicians who have reached their patient capacity, and are primarily managing a patient population through maintenance and tapering could "count" these lower-dose maintenance patients at a specified fraction and would be able to offer treatment to new patients.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Congress whether this program would be a success or a catastrophic failure. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should NEVER be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.


The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the address noted below.

Sincerely,

Jeff Unger, MD, ABFM, FACE
Director, Unger Primary Care Concierge Medical Group
9220 Haven Ave. Suite 230
Rancho Cucamonga, CA. 91730
909-484-2105
jungermd@aol.com

Cc: Jinhee Lee, Substance Abuse and Mental Health Services Administration, Department of Health and Human Services, 5600 Fishers Lane, Room 13E21C, Rockville, MD 20857" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0277,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0277,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,D James,928,"While this rule is a step in the right direction it does little for rural areas with limited resources. I live in a small town of 10,000 people. If only one provider is willing to run a qualified OTP that means even under the more "generous" allowance of 200 people that practitioner can only treat .2% of the local population while the state addiction rate hovers close to 10%. I like many others do not understand why the restriction on these 3 drugs prescriptions exists but any practitioner can write as many oxycodone prescriptions as they have pages in their prescription pad to do so. The restrictions make absolutely no sense and increasing from 100 to 200 is a very small drop in the bucket of need this country has right now for these services. I support the calls of many others here to increase that upper limit for practitioners that have proven they comply with the regulations to 500 or 1000 instead. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0302,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0302,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Brad Bachman,4524,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM: ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.

Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0519,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0519,2016-08-01T04:00:00Z,Comment on FR Doc # 2016-16069,Sara Carver,314,"As the Director of an Opioid Treatment Program, we see first-hand the value of counseling services along with MAT.
It would be interesting to collect data on the percentage of DATA Waiver patients who had one hour of counseling
in the past month. Counseling seems critical to recovery from this disease." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0006,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0006,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,"Benjamin Nordstrom, MD, PhD",906,"I strongly support this proposed action. Having worked in rural New England and in Long Island, New York, I have seen first hand the suffering caused by poor access to MAT. While there may be plenty of physicians with waivers to provide buprenorphine, few physicians are willing to take on the challenges of providing Office Based Opioid Therapy (OBOT). This means that the few doctors who do provide OBOT hit their patient caps very quickly. This is especially true as long periods of maintenance are proving to be more effective than short periods of maintenance.

This proposed action substantially improves the current situation, but it could go further. I urge the leadership of CSAT, SAMHSA, and DHHS to strongly consider allowing mid-level providers to obtain waivers as well. I believe that the TREAT Act would be a more comprehensive solution and I hope it continues to progress." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0429,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0429,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Lucinda Grovenburg,1059,"As board certified in both Family Practice and Addiction Medicine, I applaud the Federal Government's decision to increase the number of buprenorphine patients a provider may care for from 100 to 200. However, I must take issue with the requirements for the "practice setting".
My husband (also double-boarded) and I work in rural upstate New York where the waiting list to see a "suboxone doctor" is probably averaging about 6 months. The concept of "case management" really refers to us and us alone -- we provide the behavioral health services and even attempt to steer the patients towards adequate housing and decent employment. we would love to be able to offer the resources you describe to our patients but they do not exist in a rural setting. The buck starts and stops with us.
My husband also works as the deputy Medical Examiner for our county. Unfortunately, it is not uncommon for him to attend three overdoses in a week. We would much rather be prescribing Suboxone than signing death certificates!" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0490,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0490,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,"Susan Cary, M.D.",2282,"My comment is in regards to a physician determining if the requirements in increasing the proposed cap limit to 200 patients is reasonable for the physician.
This comment is directly related to the withdrawal of the ABAM board certification which allowed physicians working in addictions to take the board exam without doing a fellowship in Addiction Medicine or Addiction Psychiatry.
I am a child psychiatrist by training, with a board certification expiring in 2017. In 2013, I began working fulltime in addictions. It was my plan to take the board exam in 2016 in order to obtain Addiction board certification before my child psych certification expired. That is no longer possible due to the abandonment of the ABAM boards, leaving those of us who believed we had another year before it was likely that the opportunity would end.

In 2013, a friend and I bought an addiction treatment program, with my intention to become Addiction certified. This was somewhat ambitious as I was 63 at the time. I am now at the point where I had planned to work until age 72, God willing, and I am concerned that I will now be unable to become board-certified in Addictions, despite working fulltime in the area. As the owner of the practice, I feel it is unreasonable for a 65+ year old to leave the practice for a year to do an addiction fellowship. Doing both simultaneously is not an option for me, given that the closest program is an hour away. I've never NOT been board-certified since 1995 and I am afraid I see my options narrowing.

It is my request that there be a grandfathering clause for those who are currently working full-time in addiction who have missed the option to become board-certified without doing a fellowship by the precipitous change in the availability of the ABAM exam. Credentialing by insurance companies is often based on board certification and need for the specialty. In this case, there may be a need greater than the availability.

So, I feel the other requirements will need extra administrative attention, but they are not overbearing.

Thank you very much for considering this.
Sincerely,
Susan Cary, M.D.
Experience Wellness Centers, 80 Congress St., Springfield MA Phone 413-732-0040
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0061,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0061,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,130,"As a practicing addiction MD, this would be a great start in increasing patient access to treatment.

MMcDanielMD
Ohio" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0078,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0078,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Joyce Senter,1386,"I live in Columbus Ohio and work for a Psychiatrist. The drug addiction problem in central Ohio and surrounding counties is out of control. There are so many people asking for help that can't get it! The Drs. need to be able to take in more patients without more Government regulations put upon them. It is a horrible problem and the patients we have helped have turned their lives around and are working, functioning adults now, buying homes and healthy again.

Please consider changing all the number controls for the Drs. We get 10 or more calls a day asking for help or to be seen and we are limited by Government controls so we can't help them. It is a huge problem in this country and needs to be addressed immediately!

There are so many people begging to be helped and this country needs to change its ways to start somewhere to help more addicts.

It can happen to you or I at any given moment just from an accident or surgery that requires pain medication. So many have become addicted just from those situations, it is not just street drugs and the down trodden.

Please help to get the restrictions and government regulations off of this and the help to the people that need it. It is so rewarding to see a person turn their life and the lives of their family members around when they are treated.

Thanks
Joyce Senter" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0083,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0083,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,stanley harrell,708,If you increase patients to Any 1 facility you are stopping there actual medical treatment cause the patient normally has to attend clinics like gynocologist. Eye care specialist. And chiropractors. And the medicine should have less effect on the patients when they do not have them . They are uncontrollable and will care less if you only give increase in medicine to be destributed at any facility. What about actual departments such as mental health care providers and will allowing more mental cases in future. Are we ready or can we maintain the amount of patients properly needs to be distributed only by south Carolina departments and no outside agency's. Cause then we keep it under control SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0125,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0125,2016-05-04T04:00:00Z,Comment on FR Doc # 2016-07128,William Boyett MD,203,I support increasing the patient limit to 200 for those physicians qualified as stated. This will be a step in the right direction in helping treat addicts and overcome our nation's opioid epidemic. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0188,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0188,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,John Grizzle M D,608,"Dear Sir,

I have been treating opioid addiction with suboxone for > 8 years and have long been discouraged by the limitations of 100 patients. Increasing this to 200 patients is inadequate. There is no other medical condition that a physician is limited on treating. We have a PANDEMIC in opioid addiction and it will continue to worsen with your current limited options. I'm confident if treatment with suboxone and vivitrol was not limited that Hepatitis, HIV, Aides and syringe and needle exchange would be markedly decreased saving money, lives, and morbidly. Sincerely, John Grizzle M D" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0211,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0211,2016-05-12T04:00:00Z,Comment on FR Doc # 2016-07128,Stuart Gitlow,3942,"No physician in any other branch of medicine is limited from a regulatory standpoint with respect to the number of patients he or she can treat. Further, physicians are not limited from a regulatory standpoint with respect to the number of prescriptions they can write for either potentially dangerous or highly complicated medication regimens. Limiting the number of patients whom one can treat utilizing a safe medication such as buprenorphine, which has a ceiling effect and which is risky only in combination with sedative agents, therefore is illogical and inconsistent with other regulations.

Looking at an increased cap as being a potential financial opportunity also defies logic. There are only a few thousand addiction certified physicians in the US. We are largely overwhelmed with patients. In my private practice, I regularly treat well over 700 patients, seeing them with a frequency that ranges from weekly to annually. My practice is full, as are the practices of all the other addiction specialist physicians with whom I'm familiar (and as Past President of ASAM, I'm familiar with a great many). Of my 700+ patients, 100 are treated with buprenorphine. The remaining patients either need buprenorphine but cannot find a legal resource, or do not have opioid-related difficulties. Eliminating the cap would simply mean that I can finally treat ALL my patients appropriately, with indicated medication as well as with the therapy that I routinely provide. It wouldn't increase my revenue at all because my caseload is already full.

For many years, I had a DEA certificate to prescribe controlled drugs and never prescribed any controlled drugs. Many physicians obtained a DATA 2000 certification so that they could 1) meet the requirements of a residency or fellowship program, 2) obtain 8 free hours of CME, 3) provide coverage for other physicians on an occasional basis, 4) provide prescriptions for buprenorphine while working in an ER. The majority of those with such certification did NOT obtain it so that they could have an addiction medicine practice, nor do they by and large have any intent of providing such care to a large group of patients.

Imagine if I had an epidemic of plumbing difficulties in my community, and all plumbers were told that they could repair pipes of only 10 houses per month. The number of basements flooded would keep rising and the community would cry out to their legislators for aid. Would the legislators say, "There aren't enough plumbers so we will allow mail carriers to repair pipes as well. That will quickly solve the problem," or would they say, "We will eliminate the absurd restriction which we had previously placed on plumbers despite there being no science or evidence to support the need for such a restriction." Unfortunately, it seems that government is moving toward the mail carrier solution, which will only worsen the overall situation, in my analogy with botched pipe repair, and in our reality with botched addiction treatment from individuals with highly limited training.

We, the addiction medicine and addiction psychiatry physician community, are flooded with calls from patients whom we are not allowed to help because of the absurd ties around our hands in the form of regulations. The cap must be eliminated so that we can address the epidemic in the same manner that we treat ALL other disease states in this country. The cap should be eliminated for those of us who have completed our specialization in the field of addiction, generally through a one year fellowship, and who have ABPN, ABAM, or ASAM certification. Failing to eliminate the cap, or addressing the problem through an almost insignificant alteration (e.g. 100 to 200 plus increased regulatory burden) is unlikely to accomplish our goal, which is to provide treatment from those most qualified to those in need.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0297,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0297,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,James Follette,1726,"I strongly advocate for the right of physicians certified by the Board of Addiction Medicine to increase the number of patients for which they can prescribe buprenorphine products from 100 to 200 individuals!
I am board certified in Anesthesiology and provide pain management for patients in my practice and in 2010 I became certified by the American Board of Addiction Medicine and have been dealing with patients addicted to opioids for the past 6 1/2 years. Currently I have 100 patients on buprenorphine for opioid use disorders and receive calls almost daily to take on more patients. I am dedicated to the task of helping these individuals achieve lifetime sobriety and, in my hands, buprenorphine is an extremely valuable tool to begin that journey.
As you know the opportunity to prescribe buprenorphine to patients for opioid use disorders has been available to all physicians for almost 15 years, and yet how many physicians have taken advantage of this opportunity? Dealing with patients with this disease requires, in my mind, a certain predisposition: quite honestly some of these patients are the most difficult patients I have dealt with in my 36 years of practice. I think, therefore, since I have this predisposition and have obtained all necessary education (and continue to do so) to become certified by a specialty dedicated to the care of these individuals, as has every other physician certified by the Board of Addiction Medicine, I and my colleagues should be allowed at this time to increase our patient loads to help accommodate the number patients who will benefit from our care.
I appreciate your consideration on this matter.
Sincerely,
James W Follette, MD, D-ABA, D-ABAM " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0320,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0320,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Raymond Edison,2518,"To Whom It May Concern:
I am a practicing addiction specialist who has been in this field since 1991. I am a diplomate of the American Board of Addiction Medicine by examination in 2010. ABAM is the certifying body that has the most addiction specialist and we need to be included in those eligible for the patient limit increase. Without the efforts of ABAM there would not be an impending subspecialty of addiction medicine from the ABPM. I hope this was just an oversight and can be corrected so this rule can have some impact on the opiate addiction problem. I do also hope that we don't have to be mired in more paperwork that only takes time from patient care. In my opinion, the only physicians that should be limited are those that are not certified in this field. There are many misconceptions and myths about addiction still held by unlearned physicians and the lay public as you well know. I hear this every day from my patients. While I fully understand the concerns about prescription mills, diversion and the like; I fear that there is too much concern about this rule becoming a financial bonanza to the physicians involved instead of how much good will be done and how many lives will be saved. Also it should be noted that in the long run less money will be spent as affected persons return to productive activities. This problem will not be solved without spending money in some way so it might as well unlimited the hands of those who are certified in the field to do what we do. Most physicians do not like addiction medicine and it will be decades before there are enough addiction specialist to address the need we have right now. It would be grossly counterproductive to shackle those few who have demonstrated an interest and willingness to work in this field. Therefore my suggestion and comment to this proposed rule is to
1. include those certified by ABAM
2. have no limits on these ABAM certified physicians
3. insure that reporting requirements are not onerous and overly burdensome

In closing, I must say that I graciously applaud this proposed rule by HHS as a great step in the right direction. It is however so disturbingly ironic that my chosen specialty of addiction medicine is the only one in all of medicine where I am restricted by how many persons I can help in the face of such an enormous need; and with the potential to save as many or more lives as any other specialty in medicine.

Raymond C. Edison, M.D.
ABAM Diplomate" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0333,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0333,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Jackie Anonymous,648,"Not only should this be expanded but the limits should be removed entirely. The patient number restrictions for physicians has created an undue burden on communities that are experiencing record high fatal overdoses and inadequate capacity to provide drug treatment to people in such desperate need. Drug diversion activities should be focused on the prescribers who have created this epidemic. Instead of limiting the number of physicians who treat someone with and an opioid use disorder, limits should be placed on unregulated pain clinics. Please change this rule to expand the number of patients to whom a physician can prescribe suboxone." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0356,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0356,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,duncan mcewen,571,I strongly endorse allowing the increase in patient load. Physicians who have invested in seriously providing addiction treatment are less likely to be involved in mishaps that encourage diversion. Lower patient limits only encourages the sprouting of more doctors with less training and committment.

Quality of treatment is something that should and can be monitored. Setting arbitrary limits on physicians who have devoted themselves to developing expertise in addiction treatment is a blunt instrument that is not serving the purpose it was designed for. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0384,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0384,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Charles Luke,2123,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term "subspecialty" from 8.610(b)(1).
Those qualified ABAM certified physicians, should have their patient limit increased to at least 500.

There are many physicians, who have taken an eight hour course to get a waiver to prescribe buprenorphine containing drugs to opiate addicts. This is the good news. We do need more prescribers. However, if these physicians are not Board Certified in Addiction Medicine, I would argue they aren't fully prepared to treat all types of opiate addicts. Unfortunately, opiate addiction has become epidemic problem in the US destroying the lives of millions of Americans.
This disease should be treated in same manner we treat Diabetes Mellitus (DM). We would expect to have DM specialist, endocrinologist treating more diabetic patients than a general practitioner. Likewise, an addiction medicine specialist should be able to see more patients than those simply with a waiver and prescribing experience. Our goal as addiction medicine specialists is to properly manage, treat and decrease the number afflicted by this devastating disease.

PLEASE allow qualified physicians that are Board Certified in Addiction Medicine (entails those of us that have met academic and clinical training requirements of ASAM) to treat more opiate addicts than those with buprenorphine waiver with less than five years of prescribing experience. Patients are dying each day because they are without access to proper treatment modalities particularly buprenorphine products and qualified treatment providers. Please help to improve the treatment for these forgotten group of patients.

Thank you,

Charles Luke, MD, MBA, FASAM
Senior Medical Director of Accessible Recovery Services
Associate Director of Silvermist Recovery, LLC
President Tri-State Anesthesia Consultants, LLC
Addiction Medicine and Anesthesia Consultant
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0394,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0394,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Steve Weaver,519,The provision of medication assisted treatment (MAT) should be limited to physicians. NP's DO NOT have the requisite training or experience to provide this service. I simply ask you to consider that the majority of NP's in private practice are little more than opioid prescribing factories. They are not well trained for primary care and are abysmal when it comes to opioid prescribing. Giving them the ability to provide MAT will destroy this very effective method of helping patients with opioid use disorder. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0403,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0403,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Rachel McLean,4590,"May 27, 2016

Via Internet

Jinhee Lee, PharmD
Public Health Advisor, Center for Substance Abuse Treatment
The Substance Abuse and Mental Health Services Administration (SAMHSA)
U.S. Department of Health and Human Services
5600 Fishers Lane, Room 13E21C
Rockville, MD 20857

Re: Regulatory Information Number (RIN) 0930-AA22 Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

I am writing on behalf of the California Department of Public Health (CDPH), Office of Viral Hepatitis Prevention, to comment on the proposed SAMHSA rule on medication assisted treatment (MAT) for opioid use disorders (OUD). While CDPH does not have a position on the specific number of patients to whom a given clinician should be able to prescribe medicated assisted treatment, CDPH wishes to support increasing overall access to medication assisted treatment (specifically, buprenorphine) among persons with OUD, due to the evidence supporting the role of medication assisted treatment in preventing hepatitis C virus (HCV) transmission among young persons who use injection drugs.

Hepatitis C is a leading cause of liver disease, liver cancer, liver transplantation, and now causes more deaths each year than HIV. Persons who inject opioids and other drugs account for sixty percent of acute hepatitis C infections nationwide.[1] Recent acute HCV rate increases seen in Appalachia have raised concerns nationally about the potential costs and complications of increased injection drug use among young rural and suburban populations.[2] While the rates of newly reported chronic hepatitis C infections among young people in California remain stable, preliminary data indicate a 26% increase in the rate of newly reported chronic hepatitis C cases among males aged 18-24 in California state prisons between 2009 and 2013, a possible harbinger for future trends in non-incarcerated populations.[3]

The costs and complications of hepatitis C infection among injection drug users can be prevented or mitigated by medication assisted treatment for OUD. A ten-year cohort study of young injection drug users in San Francisco found that medication assisted treatmentspecifically methadone maintenance treatment or buprenorphinereduced the incidence of new HCV infections among young IDUs by 60%.[4] A meta-analysis of studies evaluating interventions to prevent HCV among injection drug users also found that hepatitis C infection can be effectively prevented among IDUs through a combination of medication assisted drug treatment, syringe access programs, and health education.[5]

However of Californias approximately 3,000 providers currently waivered to prescribe buprenorphine, 1,200 (40%) have never written a prescription.[6] The reasons for this gap are not well understood, but may include a reluctance to prescribe in the event that backup DATA waived prescribers are not available. Increased prescribing capacity for new and experienced buprenorphine providers is of the utmost importance in enhancing Californias ability to effectively prevent hepatitis C infections among opioid injectors.

Thank you for your consideration of these comments and for SAMHSAs ongoing efforts to support a comprehensive response to the opioid epidemic and associated health consequences.

Sincerely,

Rachel McLean, MPH
Viral Hepatitis Prevention Coordinator

Citations:

[1] U.S. Centers for Disease Control and Prevention. Viral hepatitis surveillance, 2012. http://www.cdc.gov/hepatitis/Statistics/2012Surveillance/PDFs/2012HepSurveillanceRpt.pdf
[2] U.S. Centers for Disease Control and Prevention. Increases in Hepatitis C Virus Infection Related to Injection Drug Use Among Persons Aged 30 Years Kentucky, Tennessee, Virginia, and West Virginia, 20062012. MMWR. May 8, 2015 / 64(17);453-458. http://www.cdc.gov/MMWr/preview/mmwrhtml/mm6417a2.htm
[3] CDPH; unpublished data.
[4] Tsui JI; et al. Association of opioid agonist therapy with lower incidence of hepatitis C virus infection in young adult injection drug users. JAMA Intern Med. 2014 Dec;174(12):1974-81. http://www.ncbi.nlm.nih.gov/pubmed/25347412
[5] Hagan H, Pouget ER, Des Jarlais DC. A systematic review and meta-analysis of interventions to prevent hepatitis C virus infection in people who inject drugs. JID. 2011 Jul 1;204(1):74-83. http://www.ncbi.nlm.nih.gov/pubmed/21628661
[6] California Department of Health Care Services; unpublished data.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0402,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0402,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Dr. Nelson Alba,382,"The rule itself does not appear to have major problems. The key observation is "When taken as prescribed, buprenorphine is safe and effective." I have experienced cases where persons have been prescribed for Buprenorphine and obviously have abused it. The results are devastating and dangerous. The observation is how to prevent multiple prescriptions to the same person. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0419,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0419,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,"George Halstead, M.D.",1640,"While the proposed rule change is a step in the right direction, I have several concerns. It appears that different standards apply for board certified versus facility approval requirements for an increase to the 200 patient limit. The requirement that third party payers and EHR be in use for facility approval may in fact decrease access for many patients. There are still many uninsured and under insured patients seeking treatment. Many practices offer a wide variety of recovery services to their patients including
cognitive behavioral therapy, cognitive processing therapy, yoga, meditation, in house 12 step meetings, group therapy sessions, social services, and others, all of which increase the overhead of the practice. If we are forced to accept Medicaid and Medicare reimbursements that do not cover our costs we have no other choice but to eliminate these needed services. Recovery does not occur by treating the substance use disorder alone. We must have the tools in place and the ability to treat the entire patient and all of their associated problems. I am seriously concerned that instead of allowing us to treat more patients with the best standard of care, we will have to undertreat the problems facing the patients.
Getting more patients into medicated assistant treatment only makes sense if we
can provide the level of care needed to allow full recovery. Lets provide the necessary treatment and address the entire problem instead of just the tip of the iceberg.

I am concerned enough about these issues that I am willing to travel to Washington, D.D. at my expenses to discuss these concerns." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0422,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0422,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Jane Orient,2525,"Regulatory Information Number (RIN) 0930-AA22

Re: SAMHSA proposed rule entitled Medication Assisted Treatment for Opioid Use Disorders

Physicians and their patients would be adversely affected by this Proposed Rule in several ways.

First, the Proposed Rule attempts to require physicians to accept third-party payment. Proposed Rule 8.615(e). Many physicians, in increasing numbers, decline to accept third-party payment because of its destructive effect on the patient-physician relationship, as well as the unsupportable administrative costs. Despite or because of the Affordable Care Act (ACA), many patients do not have insurance coverage. It is a violation of basic rights to deny medical care to patients because they cannot afford or choose to forgo third-party payment.

Second, the Proposed Rule improperly coerces physicians to use Electronic Health Records ("EHR"). Proposed Rule 8.615(c). Often paper medical records are less expensive, more accurate, and more protective of patient privacy than EHRs. There is no justification for the Proposed Rule to force EHRs on physicians and patients.

Third, Agency Questions for Comment #3 ("Practitioner Training for 200 Patient Limit") and #4 ("Alternate pathways to qualify for 200-patient prescribing limit") propose that physicians should be board certified in addiction psychiatry or addiction medicine in order to qualify for the higher 200-patient prescribing limit outside of a qualified practice setting. "[T]his means that only practitioners with subspecialty board certifications will be eligible to apply for a patient waiver of 200 and practitioners satisfying training requirements via the other pathways for the 30 and 100 patients will not be eligible " But this board certification condition simply enriches a private entity that controls board certification without any political accountability or transparency. There is no evidence that it improves care, but it does make it more costly. Such care needs to be more available as the number of patients who need it is increasing.

Unless the above three points are addressed and revised accordingly in the Proposed Rule, it will hinder medical care for patients. Please acknowledge these defects in the Proposed Rule and correct them accordingly before issuing a final rule.

Jane M. Orient, M.D.
Executive Director, of the Association of American Physicians & Surgeons ("AAPS").
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0042,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0042,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,1713,"I am the mother of an adult who was addicted to heroin, now he is addicted to methadone which is legal. We have been on this journey for over 15 years and a lot has changed but a lot still needs to change. The one most important thing that has changed is that the stigma of addiction is slowly slipping away. The one most important thing that has not changed is treatment. Finding a doctor, a recovery treatment center, or medication that truly helps and is affordable is close to impossible to find. I don't know what the government is thinking. We need more services. Going from 30 to 100 is a step in the right direction. But what we also need are more doctors. There is one methadone clinic in the city we live in. ONE. The next closest methadone clinic is 19 miles away. I am grateful that my son has his life back with the help of methadone. It is affordable but it is just one step to recovery. Those who suffer from addiction need options. We need GOOD doctors, GOOD counselors and GOOD medications. What we don't need are road blocks, there are enough of those fighting the disease. I know that without methadone, my son might by now be in jail or dead. And that still could happen because of government regulations and medications that are financially out of reach. I am grateful for each day that I can spend with my son. I used to worry about the details, about trying to change things, to look for answers but I know that that is out of my reach. I don't look forward to tomorrow because I don't know what it will bring but I am grateful for this moment. I hope that those who do have the power to make change will continue to listen to those who feel powerless. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0105,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0105,2016-04-25T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,1716,I know there's a problem with opioid pain relief with kids put it really put s a damper on people who do need them. The United States goverment has all the doctors scared to give a prescription instead they give prescriptions like Gabapentin and from what I have read on those it doesn't sound good they're for people with seizures and have a lot of side effects a person even has to be weened off of them. There's even people out there saying they have lawsuit s on the drug and doctors that prescribe them.I have been suffering with pain for a 1 1/2 cause the government has the doctors running scared hell my doctor told me he won't prescribe them cause a buddy of his medical license taking away so he doesn't prescribe them anymore. I believe the parents are the problem cause they are not paying attention to their kids lifes.I'm just trying to understand why I have to suffer. Gabapentin causes people to commit suicide so how are they any different. Just because parents are out there throwing fits about opioid pain relief when it's their fault for not paying attention to their kids. I can't even do anything with my grandkids because of the pain. My life has been laying in bed basically 24/7. What kind of life is that I might as well be de ad cause I don't want to live the rest of my life in this pain. I'm 52 and I feel my life is over. I just want to be able to enjoy doing things with my grandkids and not have to depend on people to do things for me when I'm still able to if I could get the right pain relief. I could go get them on any corner if I wanted to pay for them.please don't take it out on the people that need them look at the parents SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0117,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0117,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,477,"Physicians who are boarded in Addiction medicine and Psychiatry will help more patients if the limit is increased to 200.
In fact, they should have no restrictions and not be burdened by reporting or renewal. They have chosen a specialty to treat Addictions, and this is their career and mission. We don't ask Infectious disease specialists to renew every 2 or 3 years a permit to treat certain number of patients for HIV or Hepatitis C (one day medication cost $1000)" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0367,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0367,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,"Richard Poppy, MA LISAC",2680,"This is my concerns:
Unfortunately the treatment options discussed are primarily limited to Medication assisted replacement therapies. More traditional treatment options of detox followed by inpatient or outpatient drug alcohol treatment programs seem to be excluded, which is unfortunate. My suspicion is that this is probably due to the lobbying power of the pharmaceutical companies and the cost of traditional drug alcohol programs. Having worked, owned and run both OTP's( Methadone and Buprenorphine clinics and traditional drug alcohol programs( residential and outpatient), it is my experience that medical detox followed by inpatient / outpatient treatment is often the preferred mode of treatment for many patients and should be considered the first option. If done right, this mode of treatment is very successful. For if successful, our patients are drug /medication dependent free! Remember that both Buprenorphine and methadone are opiate replacement therapies. The patients using these medications are still chemically dependent / addicted to those drugs.

If we are going to increase access to these medications, which I am not opposed to, as long as other treat options are explored and discussed. I would recommend mandating more therapy into the Buprenorphine treatment, along with titration schedules built into the prescribing protocols. The desired end result of this treatment, should be to get patients to a place of being medication / chemical free within a reasonable time frame and stable in their recovery. For most patients, that is attainable within one year, if they have the therapeutic support.

In my opinion raising, the Buprenorphine prescribing limit to 200, is a bad idea without stricter treatment guidelines with desired outcome measures. For most likely, those patients will not receive the individualized treatment and the therapy they need to move forward, thus becoming dependent on the medication to manage their addiction. Consequently, they may never experience the benefit of being medically / chemically free. Patients that become medication / chemically free report much higher levels of personal satisfaction and feel a real sense of freedom from addiction.

I believe in a multi-pronged treatment approach: Using medication as an adjunct to therapy and the therapeutic process,addressing co-occurring psychiatric issues, developing stricter national guidelines on the prescribing of opiate medications and include stepped upped prevention efforts, in grades school through college, along with the public in general. Especially those being prescribed opiates.

Thank you,

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0371,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0371,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Dave Emeritz,162,"I'm all for the change. There is an epidemic afoot; suboxone helps opioid addicts overcome their addiction.

Dave Emeritz, LCSW. CASAC
Long Island" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0369,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0369,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Pam Anonymous,183,"Please allow doctors to treat addicts with lifesaving medication and grant greater access to buprenorphine, this lifesaving and necessary medication that can prevent people from dying" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0407,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0407,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Ronald Rager,663,"I have been treating 100 patients at any one time with "Suboxone...etc.
I have seen great progress in my patients.
Our practice does not require formal counseling.
Many patients state that going to NA meetings are counter-productive because at meetings there are patients who are mandated by the justice system who have no interest in what the meeting is trying to address. Just by being there it increases their (my patient's) desire to use.

The rate of relapse is hardly any lower after being counseled than in those without, I believe.

I'm in favor of increaing the limit without a requirement for formal counseling." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0420,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0420,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Douglas Bovee,1055,"I am an adult and addiction medicine physician on the front lines of the opioid addiction epidemic. I have a buprenorphine waver and have been stuck at caring for 100 patients for a few years now. Meanwhile I get calls every day from patients looking for my help. At present, I am unable to effectively serve them.
My experience supports the data on the incredible efficacy of buprenorphine to assist people suffering from opioid dependency. I find the work incredibly satisfying as the vast majority of my patients are dramatically better with this medicine and regularly express their gratitude to me for helping them.
One of the reasons for the opioid overdose epidemic, is inadequate access to effective opioid dependency treatment. This rule change will significantly improve access to an extremely effective treatment immediately. I look forward to serving more of the callers looking for my help. The sooner this rule can go into effect, the better.
With appreciation for your consideration,
Douglas L. Bovee, MD, FASAM, FACP" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0025,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0025,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Belluso,150,"As an Addiction Medicine specialist, I can tell you that raising the limit to 200 is not going to be enough for the 2.2 million people who need help. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0038,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0038,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,William Yarborough,978,"My concerns about this issue, is that it is not enough. Having been in the medication assisted treatment field, for over 10 years, I very much realize that people are dying daily, due to lack of access to treatment. I am not for sure why those physicians that are addiction certified, need a specific cap.

The other issue I have, is a concern that the reporting requirements will be a major barrier for doctors, particularly in rule areas, and practices that cannot afford a compliant EHR. I do think that collecting this information would be important and useful, but I fell that in the short term, we just need to get this treatment to the most people possible, and not do things that continue to discourage doctors participating in this. The DEA audits deter enough doctors, and we don't need more right now. I realize that the PCMH, and CPC initiatives need data, and all treatment should move along these lines, but this issue is a bit of an emergency. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0039,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0039,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,"T Riordan, MD",3756,"Dear Secretary of Health and Humans Services and leadership at SAMHSA:

I write in response to comments solicited regarding the proposed rule change to the Medication Assisted Treatment patient cap for practitioners. I am a board certified addiction psychiatrist who has held a DEA DATA Waiver (X number)since 2003. I serve on my State Methadone Death and Incident Review Team. I also work with a county Psychiatry Advisory Panel and a newly formed County Drug Overdose Task Force. I have been a mentor in the SAMHSA sponsored PCSS-B program since inception.

I have had tremendous professional success at treating patients with the Schedule III drugs approved by the FDA and authorized under DATA 2000 legislation. I believe I practice with skill and caution when prescribing and treating patients in this population. I know many of my colleagues do as well.

Unfortunately, it has become apparent the vast majority of practitioners who have applied for and received DATA Waivers to prescribe under the regulations do not exercise such caution or judgment. There are many who practice in an errant fashion, causing problems with diversion and misuse of these drugs. This I have experience when family members bring their loved ones to me after having a horrible experience at the hand of another provider. This includes behaviors such as prescribing excessive doses, combinations with other addicting and deadly drugs such as benzodiazepines, lack of appropriate supervision of administration of the drugs, and missing necessary psycho-therapeutic interventions. Believe it or not, far less of this patient population may be appropriate for the lowest level of care in Office Based Opioid Treatment than who are receiving it.

I am sure my comments will disagree with many of my peers in positions of influence at ASAM and AAAP. I challenge whether others are making actual patient care related considerations, or one of financial gain. It is very difficult for one physician to care well for 100 opiate abusing patients - how would one practitioner do so for even more? I myself have a policy of tapering most patients over time and therefore have never needed to exceed the 100 cap limit, since someone is always transitioning off the drug when another patient looks to go on.

We have communities throughout my state where prescription buprenorphine drugs are as much of a problem or more so than illicit drugs. For patients, family, and the recovery community at large the stigma of these drugs being more problem than good is a challenge to overcome when trying to help patients in a completely appropriate setting. There is inadequate policing and regulation of the DEA X-program, and from my experience too few ever seems to have their DEA X License rescinded unless prosecuted for some other offense. In the meantime much harm can be inflicted on this vulnerable patient population. In fact, there are many indicators that some physicians should have a cap reduction. There are practitioners who readily admit they do not have adequate "capacity" to refer for counseling services, and so are therefore out of compliance with the testamentary statement on the DEA Waiver they have signed.

Regardless of community drug use crisis and media attention to this current problem, unless significant modifications in the oversight and practice of physicians using this treatment modality occurs, I must implore the Secretary of HHS to NOT increase the treatment cap.

Lack of extreme caution to changes in policies on political 'hot-topic' items are ill fated. Thank you for your attention to my comments. Please feel free to contact me if I can be of any additional assistance." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0134,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0134,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,"Ayaz Khan, MD",888,"This rule is extremely discriminatory and biased.Thousands of physicians who are Board Certified by American Board of Addiction Medicine are not being allowed to take upto 200 patients for
Buprenorphine maintenance treatment,to be able treat patients who suffer the chronic disease of opioid dependence.These physicians have months long waiting lists to treat such patients.There is a huge shortage of trained physicians with Addiction Medicine specialty training who can treat heroin,opioid and other addictions.Physicians with Board Certification in Addiction Medicine are no less qualified than the physicians who have Addiction Psychiatry training.The rule should allow these highly qualified Board Certified Addiction Medicine specialists to take up to 200 patients in their practice.

Ayaz Mahmood Khan
MD,MBA,DABAM,ADAAPM,MS,DAAPM,
Dip.Adult Psychology,LSSBB" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0151,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0151,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Harry Haus,579,The proposed rule should be specific that physicians board certified in Addiction Medicine be allowed to have a panel of 200 patients. There is no limit on the number of patients treated in Canada and most nations in the world. Also CDC 2016 guidelines says this is a physician driven epidemic from providers writing for to many opioids. The limit should be on all providers not to write for more than 200 opioid prescriptions per month.

Harry L. Haus MD JD
Board Certified Family Medicine
Board Certified Addiction Medicine
Certified Medical Review Officer SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0153,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0153,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,John Harris,736,Tell HHS that ABAM-certified physicians should be eligible for the higher patient limit based on their extensive and rigorous education and training in addiction medicine. I am a formally addiction certified physician currently with a suboxone clinic. My practice cares for the underserved patient base. These patients need an increase in the DATA 2000 limit to care for more patients in my under served area in NC. ABAM-certified physicians should be approved for the higher patient limit. Board certified by the American Board of Addiction Medicine are the best qualified of all doctors to provide this care. Please inclued ABAM certified physicians for the increase in patient limits for this very important work.

Thank you. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0170,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0170,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,1906,"Very strongly support that the highest credentialed physicians ( ABAM Certified, Addiction Psychiatry Certified) be allowed to increase to 200 patient limit proposal. As an ABAM certified physician with a 10 year OBOT practice, I follow the guidelines & highest standard of care including bio-psychosocial counseling at each visit, urine drug screening, group sessions at a monthly minimum, and a revisable treatment plan for each patient based on progress. There are 4 potential concerns however based on 10 years of OBOT......These can all be largely avoided by utilizing the training and clinical oversight by Boarded Addiction Medicine Physicians in any increase in numbers. ( Except # 1 )
1) Pharmacies where either there is not enough medication to support patient demand, or Pharmacists that choose to practice medicine at the pharmacy cash register by discriminating and denying patients prescriptions because they "have been in treatment too long", or "Do not agree with dosage", et al.........
2) in the state where I practice, opioid prescribing skyrocketed when mid level practitioners started opening their own pain management clinics. PA & NP prescribing of buprenorphine "off label" has already caused issues. I see no benefit and only danger in any consideration for mid level prescribing of buprenorphine
3) Data X waivered but Non Board certified physicians that only issue prescriptions with no accountability, no support services, no treatment plan..( Increased potential for diversion).
4) Clinics owned and operated by Non Physicians, employing part time newly data waivered physicians, with no full time Addiction Medicine Physician oversight and supervision..Greatly Increased potential for diversion).........

Thank- you for the opportunity to comment..
A rural based Addiction Medicine Physician, DABAM, FASAM" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0177,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0177,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,james mcginnis,616,"We have reviewed your current proposed rule change.
We would suggest that the limit for those providers who are board certified
in Addiction Medicine be
increased to 500.
This would allow those with documented experience, knowledge, and passion
to pursue Addiction Medicine as a full time career.
This would decrease governmental costs by congealing a fragmented industry.
This would be a move in the right direction as the current Suboxone limit is not adequately addressing the opioid addiction problems we are experiencing.
Thank you for your consideration.

James McGinnis" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0180,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0180,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Taufik Kassis,238,I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1

SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0203,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0203,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,karl hafner,957,"While it seems logical that increasing the patient limit would increase the ability to get people into the system, it does have some very serious downsides. 1/3 of suboxone providers have a criminal past. Several of these providers (at least in our area) are what most would consider pill mills. This only puts more medication on the street for abuse. If you increase the numbers you will force most providers to go this model if we are to keep our patients. Those who are serious require a treatment program and some form of self help. Why do this when they can go down the street get all the suboxone they could ever dream of, continue using all their other drugs and not have to get into a treatment program. By increasing the limit you will move physicians from doing this as part of a practice to just doing suboxone and they will become pill mills. Do not increase the cap unless it is tied to treatment programs. There are plenty of providers. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0219,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0219,2016-05-13T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,350,"I believe increasing limit to 200 patients for not board certified in addiction medicine or addiction psychiatry would not be a great idea.
This can be taken as a pilot project, review the outcome and can be revisited in three years later.

ABAM certified physician should be included clearly in the writing of increasing to 200 patients." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0230,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0230,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Richard Whitney,4939,"I have been practicing Addiction Medicine for 26 years, since beginning an Addiction Medicine fellowship January 15, 1990. I was certified by examination by the American Society of Addiction Medicine in 1993, and became a Diplomate of the American Board of Addiction Medicine in 2009. I currently practice this specialty full-time in a hospital-owned treatment setting.

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
Richard N. Whitney, MD, FASAM" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0279,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0279,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,John Machata,1069,"I prescribe buprenorphine for opioid dependence and may therefore be biased. That said, I spend my time treating opioid dependence and all conditions as a family doctor. I am busy and my practice is effectively closed to new patients.
It is time to raise the patient limit for buprenorphine providers from 100 to 200. Buprenorphine is among the safest medications on the market today. If 'high' on opioids and a person takes buprenorphine, they will enter a partial withdrawal. If taking buprenorphine and a person takes an opioid intending to get 'high', the opioid is unlikely to have an effect given the strong affinity by buprenorphine for the mu receptor sites.
Can buprenorphine be diverted and abused? Yes, but this diversion rarely translates into deaths. Buprenorphine saves lives even when purchased on the street. Lives will be saved if more people get access to this life-saving medication!
I am dumbfounded that it has taken so long to increase access to this medication if the face of thousands dying from opioid overdose!
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0304,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0304,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Eric Troyer,741," The revisions that are being made are little more than media hype and lip service to the problem of addiction. The number of physicians actually permitted to increase the number of patients they are treating with Buprenorphine is absurdly small. I have been at 100 patients for some time now and receive calls every day from people who just want to help but, at present, I am having to put on a waiting list. The increase to 200 patient should be expanded to all physicians currently prescribing buprenorphine products for substance abuse treatment who have been doing so for two or more years. Again, anything else is a simply playing to the media, but not a true attempt to help the unfortunate individuals who are battling addiction. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0501,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0501,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,363,"Speaking of OHIO, HHS and State of Ohio would look for all these state employed doctors in north coast, taking all state funded money not working there full time, taking public funded money and working in other hospitals and scamming medicaid to take state money. They are running around and taking every body's money and not providing good service anywhere. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0483,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0483,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Fred Brason II,2250,"Project Lazarus applauds U.S. DHHS and SAMHSA' desire to increase buprenorphine patient limits as a piece of addiction care and treatment. MAT is most successful when wrap around/field support services are combined and it is noted in Appalachian areas that some providers simply provide the prescription with little else. Guidelines of treatment and care from SAMHSA, NIDA, ASAM. AATOD and others clearly indicate the need to address the psycho/social/cultural and environmental aspects (the social determinants) of an individuals life and not just the biology of addiction. Efforts within communities and building coalitions that do engage all treatment modalities, medical providers, ED's, LE, and others, provides for referring responsibly and ultimately caring collaboratively which further reduces the stigma of addiction. This assists substance use disorder treatment to move into mainstream medical care, but only if the care includes more then just the dispensing of medication.

Experience has found many do not accept insurance reimbursement leaving the added "weight" of "cash only" upon those most needing as much support as possible. In our NC alone with 50 OTP's, only 18 accept Medicaid. Experience has also revealed the practice of beginning buprenorphine treatment and setting discharge dates in advance in order to allow for others to be inducted, creating more "cash" through enrollment fees. Perhaps the limit raised will deter such a practice, if only for a limited timeframe.

I do not agree with the subspecialty board certification requirement and that all physicians board certified in addiction medicine or addiction psychiatry should also be permitted the 200 patient limit. The requirement, as suggested, would further hinder available buprenorphine addiction treatment, that is lacking in rural American communities.

The "number" of patients alone is not the answer, but with already established guidelines that become policy and practice, more will find and succeed in care, treatment and recovery. Increasing the number sets the stage, please insure all the acts are in place so as not to "harm" the person within our communities." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0495,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0495,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Timothy Smyth,607,"Please allow HHS Secretary's proposed increase in the number of patients a physician can treat take effect. There is a desperate need for increased access to addiction treatment, Nationwide, and particularly in my area, Northeast Tennessee.

Please specify that individuals Board Certified in Addiction Medicine by the American Board of Addiction Medicine be allowed to increase the number of patients they may treat to the limit of 200.

This is a first step in advocating for increased access to addiction treatment and concomitant efforts to de-stigmatize the disease of addiction." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0533,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0533,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Britt Borden,1943," The appropriate approach to minimizing diversion is to ask what percentage of patients: 1) received a random urine drug test in the past month and 2) had the PDMP checked. Random testing deters drug use. Checking for buprenorphine in the urine identifies patients who are diverting. Finding opioids in the urine identifies patients who may require a dose adjustment which improves treatment. Checking the PDMP identifies patients receiving multiple buprenorphine prescriptions for diversion and those obtaining opioids for abuse or diversion. These should be incorporated.
The proposed reporting requirements d. 1,2,3 and 4 are impractical. Furthermore these would waste time,effort and resources. Since the information would be collected over the phone from patients who are no longer interested in treatment it would be of poor quality and not useful. The estimated burden of 3 hrs per year is completely inaccurate as requirement d.1,2,3 and 4 would require 3 hrs per day to achieve. Nearly all of my patients have medicaid which is poorly reimbursed. I cannot afford to hire someone to call patients who choose to miss their appointments. While individual patients will enter and leave treatment, if the overall number of patients remains 275 the overall benefit will remain the same. Requirements d. 1,2,3 and 4 should be removed.
The proposed reporting requirement for doctors to keep track of which counseling services a patient is using is irrelevant. Since the 12 step group is the foundation of addiction treatment a better question is what percentage of patients reported attendance at 12 step groups over the past month. I always ask my patients how many 12 step meetings they attended since I last saw them or how many they attend per week. The reporting requirement regarding counseling services should be removed.
I hope my suggestions are helpful. Please feel free to contact me. Britt M Borden MD FASAM
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0023,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0023,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Mary McMasters,411,"I strongly support any requirement which specifies that prescribers "possess subspecialty board certification in addiction medicine or addiction psychiatry". There is an enormous amount of damage being done to patients with the disease of addiction by prescribers who are not qualified to treat them. Also, "adher[ance] to evidence-based treatment guidelines" should be strictly enforced. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0542,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0542,2016-08-09T04:00:00Z,Comment on FR Doc # 2016-16069,Saira Sultan,13,See Attached. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0529,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0529,2016-08-05T04:00:00Z,Comment on FR Doc # 2016-16069,Mark Parrino,184,"I am attaching AATOD's response to the Supplemental Rulemaking Notice in addition to providing comments with regard to the Final Rule.

Sincerely yours,
Mark Parrino " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0112,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0112,2016-04-27T04:00:00Z,Comment on FR Doc # 2016-07128,Allyson Pinkhover,1246,"I am writing today to advocate for the approval of the patient-limit increase from 100 to 200 patients per physician. Increasing accessing to MAT, particularly buprenorphine-based treatment is important during this period of increasing opioid overdose deaths. MAT has been shown over and over again to improve outcomes for individuals suffering from a substance use disorder, including reducing overall risk of overdose mortality, and increasing chances of maintaining a prolonged period of sobriety. Additionally, MAT reduces potential exposure to HIV/HCV and other bloodborne pathogens by reducing or eliminating injection drug use.

Access to buprenorphine treatment also helps relieve the vast disparities in methadone clinic accessibility. Often methadone clinics are restricted to urban areas, leaving rural populations without services. Physician offices that can provide buprenorphine MAT offer expanded access to rural areas, which have experienced extreme increases in overdose deaths in recent years, yet remain underserved.

It is obvious that this is a critical time for overdose prevention and substance use disorder treatment in the United States, and expanding access to buprenorphine is a key component of this. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0128,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0128,2016-05-06T04:00:00Z,Comment on FR Doc # 2016-07128,Ronda Steinhour,2458,"I am currently trying to find a Suboxone provider for my husband and it is an extremely frustrating process! M husband developed a severe opioid addiction after his second back surgery in 18 months. Once I finally got he to admit he had a problem and that he wanted help we had a heck of a time getting him admitted. After 10 days and two rounds of self detoxing at home he became suicidal. Once he was suicidal we were able to get him admitted. He was inpatient for six days. During his inpatient stay he was started on Suboxone. When he was discharged he was given a 30 day prescription for Suboxone and a list of Suboxone providers. There was no mention of how difficult the search for an outpatient provider would be.
His 30 day prescription runs out today and we have not been able to find a certified Suboxone provider who is accepting new patients and is a network provider with our insurance in a 100 mile radius of our home. Actually that is false we did find one provider who was accepting new patients and was a network provider with our insurance. However, he does not accept insurance for Suboxone patients. He charges $500 for the initial appointment which requires a $100 deposit and $300 each month for follow up. We are both frustrated to no end.
He is currently experiencing anxiety about the possible withdrawal symptoms he is about to experience and we believe our only choice now is for him to be admitted again so we get another 30 days to find a provider.

With all that said, I 100% agree with increasing the number of patients a Suboxone provider can see will help address the issue, but will not entirely take care of the problem. I think to address the real problem something needs to be done about these providers refusing to accept insurance! My insurance company is mandated by state law to provide substance abuse treatment, but the providers are not even encouraged to accept insurance. If we increase the number of patient who can be seen and address the issue of not accepting insurance we will be much better off.

Please continue to try and improve access issues related to substance abuse issues. A person who wants help should be able to get it without having to fight these bureaucratic battles and focus on their recovery program an treatment. If we had a better system maybe more people would be successful in sobriety!

Thanks for reading!" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0129,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0129,2016-05-06T04:00:00Z,Comment on FR Doc # 2016-07128,Alan Johnson,2098,"While the 200 patient limit is an improvement, it still limits treating patients with a safe partial-agonist narcotic, which is far safer than "all" other approved narcotic medications on the market that have no limits. Adding more restrictions doesn't lesson stigma, it could encourage it.
Since some diversion protocols seem to be advocated, we recommend that a compromise would be to at least have no limits for physicians operating in nationally accredited or state licensed substance use disorder treatment centers, which have the experience to administrate responsibly.
As another alternative to such low limits, we would recommend that counseling and drug testing be included in the treatment, which would ensure a more interactive medical experience with this population. Medication-Assisted Treatment means that medications must be supported conjointly with behavioral health support, which at a minimum includes individual therapies. We recommend that "behavioral health support" be better defined.
We agree with the stipulation that the patient cap could be changed when considering buprenorphine implants with sub-regulatory guidance. Another recommendation is to allow APRNs to prescribe, especially for rural communities. We recommend that policies be implemented to reduce stigma because it is still a looming concern such that this population is still undesirable to many physicians.
We would advocate that part of our objectives is to promote systemic changes with ACOs, CHCs, MCOs, HMOs and CMHCs to mobilize their doctors to provide medications in an integrated setting. We want to promote that the physiological component is important too for substance use disorders when providing the psychological component. The U.S. has a public health crisis with drug overdoses, which warrants more assertive action with improving the administration of buprenorphine. More work needs to be done to improve future rules so that physicians are encouraged to use buprenorphine because excessive restrictions may lead to continued diversions.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0139,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0139,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Shearer,2039,"I have received an email from ASAM that suggests that board certification through ABAM would not entitle a provider to be eligible for the increase. I don't read the rule this way but I want to stress that physicians with ABAM certification most definitely should be eligible for any increase. I am an obstetrician with 35 years of a women's health care practice in a rural town in Tennessee. The increase in neonatal abstinence in 2012 jolted me and to be able to participate in solving the problem I reviewed the literature and determined that best evidence supported that I attain a waiver to use buprenorphine. I originally thought my practice would be limited to a few pregnant patients but soon discovered the real need. Within 1 week of getting my waiver I had 30 patients who had been seen by me for ob gyn care over the years who requested that I allow them to transfer to my practice. They all knew I would accept their Medicaid or Medicare as payment and reported that they were paying 3-4 hundred dollars cash per month to get a prescription and then often had to pay for their Meds if insurance didn't cover.
At 1 year I increased my limit to 100 and have been maxed out since 2014. I felt a calling to become board certified and began the process of collecting the 2000 hrs of hands on care and began the CMES. IN 2015 I passed the ABAM test and directed my practice to be addiction based focused on women pregnant and not who receive either Medicaid, Medicare or 3rd party insurance. We have 1-2 cash slots only. 95 % governmental and 2-3 3rd party. Patients come from a 100 mile radius around my clinic.
I have a licensed master social worker and soon will integrate with a mental health group.
Certainly I am qualified to manage any number of individuals allowed by law and actually believe a cap of 200 to be too low to solve problems. As an obstetrician I delivered 300-400 babies yearly in addition to gyn care and surgery so 200 is not really a big number. Thank you for allowing my comments." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0140,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0140,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Daniel Strickland,838,"I was issued my DATA 2000 waiver almost 3 years ago, and have had my D/W 100 for over a year.

I have been treating patients in OBOTs (and OTPs), and only one of these programs accepted insurance, and that was only Medicaid, in a large, multi-clinic, corporate program.

If you require programs to accept insurance, few, if any, of the small clinics will be able to comply. Billing insurance for these services would be too costly for small clinics, involving expensive billing software and dedicated personnel to submit and track payments.

I have no problem with the other requirements.

In summary I don't think that requiring insurance payment is a good idea and if that is required the goals of the increase (improved access) will be largely unmet.

Daniel M. Strickland, MD
XS4393954" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0150,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0150,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Donald Taylor,2123,"Buprenorphine saves lives. The governments limiting the ability of addiction medicine specialists to use this medication to some arbitrary number of patients is senseless: As a physician I can write an unlimited amount of oxycodone for pain but I am limited as to how much buprenorphine I can use to treat addiction! As one of my colleagues from the UK said: That is bloody insane.

As a ABAM certified Fellow in Addiction Medicine, I can only make sense of limiting the number of patients I can treat with buprenorphine if I assume that the government is intentionally trying to kill addicts. Limiting the use of buprenorphine by pain specialists is no different than murder. You can say you are protecting the public from "the buprenorphine menace" (whatever that is) but speaking from the trenches, I can tell you this is murder by legislation.

Addiction is a brain disease yet the government refuses to accept this and refuses to allow doctors to treat the sick with one of the most effective medications we have at our disposal. You do not need multimillion dollar studies to know if this drug works, if this drug saves lives. Just come to my office and meet my patients and see people who have regained control of their lives and are living as productive members of society. These men and women are college students, lawyers, nurses, factory workers, auto mechanics, food servers; they come from every walk of life and they have all been saved from destitution and death by buprenorphine. Come talk to these patients and tell me which one you would let die. Limiting my ability as an Addiction Medicine physician to prescribe this life saving drug will kill people.

An artificially set limit on how many patients Addiction Medicine physicians can treat with buprenorphine serves no purpose other than to harm addicts, their families and the society in which they live (untreated addiction is expensive and harmful to society).

Stop this madness and less us care for our patients. Eliminate any restrictions on Addiction Medicine specialists prescribing buprenorphine." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0145,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0145,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Fox,1413,"please do something to break,reduce the barriers to treatment by reducing the limits so patients may see QUALIFIED PRACTITIONERS,MOST QUALIFIED for continued care.Have you know idea how perversive this problem is.Many do not take advantage of the ability to provide this service but those who are certified by ASAM,especially diplomates of ABAM ,are and have a passion to treat and not uncommonly are committed to treat as it is their main interest. A passion if you will.We do this because we love to,have a passion to,and prefer this as a specialty and the demands are too high especially with all the complications associated with the " pain management " ongoing in this country. The demand is even greater and reimbursement much smaller with the demands of Obama care. Who do you think are the docs that are going to work the trenches with all the bullshit we have to do with government requirements and authorizations with even medicare ,not to mention all the other insurers? Now we have to worry what happens when we turn people away or fear of going above are number with the DEA. The pain docs can what they want and we clean up their mess, and have to manage their failures on top of the rest of the population. Between drug courts and MAT how do you expect us to manage this and who do you think even wants to?CERTIFIED GUYS!!!FIX this and while your at it,feel free to make it for 300 limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0154,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0154,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Howard Wetsman,4523,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0196,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0196,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,Verna Bain,459,I really hope this is an error that doctors board certified by ABAM would not be included.I have been practicing addictiion medicine since 2009. I have been on the 100 limit since 2011. I have constant calls every day and have to turn patients away. ABAM certified doctors are extensively trained. We have a rigorous maintenance of certification path that we must maintain . Please replace subspeciality with board certification to include ABAM certification. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0232,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0232,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Raymond Garcia,4528,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0278,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0278,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,1208,"I am writing to you because I am disabled due to a chronic illness with chronic pain. It took me a long time to get on a regiment that would allow me to function on a daily basis. For me functioning just means being able to do minor daily tasks. This regiment includes opioids. I still suffer in pain but my pain medication does help. I know the risks and will not increase my dosage because of them.

It is so difficult to get to doctors, pharmacies, etc... Making it any more difficult to get pain medication could be detrimental to many. (Try hitting yourself with a baseball bat and doing anything that requires concentration right after. Think about it. It would be almost impossible.)We have to continue to be our own advocate. This takes effort, concentration and organization. Some days or moments are better than others. When we feel okay we scramble to get everything done.

Dealing with doctors, pre-authorizations, appeals, pharmacies, cost assistance programs to help us afford our expensive drugs, etc.. can be very hard for people in constant pain. Please do not make it any more difficult to get the medications we need to function or sometimes barely function." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0337,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0337,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Peter Friedmann,1215,"1. The title "Medication Assisted Treatment"(MAT) implies that the medication is only an adjunct to treatment. The term MAT sustains the stigmatization of effective medication treatment of opioid use disorders, and it implies that remission resulting from medication treatment is not true recovery. We don't refer to medication treatment this way for any other disease -- no one considers insulin treatment of diabetes to be an adjunct to diet. They are all effective treatment. I strongly recommend that we retire the rubric of "Medication Assisted Treatment" in favor of "medication treatment" or "pharmacotherapy". For opioid use disorders, numerous studies have demonstrated that the medication is a primary treatment, not just an adjunct to counseling.

2. I support raising the limit, but continue to protest the idea that legitimate and credentialed addiction medicine physicians are limited as to the number of patients they can treat with an effective medication. Patients are dying from overdose because they cannot access effective medication treatment. The limit should be eliminated for certified addiction medicine and psychiatry specialists. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0342,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0342,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,"Hilding Ohrstrom, LCPC",1668,"I want to express concern that Section F. What Constitutes a Qualified Practice Setting? (8.615) does not include a mandate to either have trained substance use disorder counseling staff on site or available by an affiliation agreement. I strongly recommend that medical practices wishing to treat up to 200 patients have one full time counselor to 30 MAT patients either in their practice location or available by agreement at another location. I would also recommend that physicians be required to participate in regular clinical staffing of cases as a part of a multidisciplinary team. Private practice and primary physicians rarely do as there is no compensation for the time, yet other clinicians do as a part of god clinical practice. I have worked within the substance use disorders field for 37 years and wish to make it clear that medication is only one small aspect of treatment for opioid disorders in my clinical opinion. I further recommend that people seeking MAT be required to link with some sort of counseling services for bio-psycho-social assessment preliminary treatment planning prior to receiving a prescription for either methadone or Suboxone/Subutex. It is because that process is not followed that interferes with successful treatment. It is also noted in the research that there s a high rate of relapse following discontinuation of buprenorphine. That could be reduced by the rules mandating increased counseling or case management support services be put in place for a 3-9 month period after cessation of the medication. It is ore often the case that people's counseling supports have been reduced when they are stopping Suboxone. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0350,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0350,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,542,I disagree. Many private doctors are not obtaining regular urine or oral toxicologys. Patient's also are not being required to attend groups or individual counseling on a regular basis. Private doctors do not registered patient's with Lighthouse which may lead to double dipping. They are not governed by OASAS or other agencies except DEA. I Stop is not being checked by all doctors. I Stop is only for certain states NY Conn and NJ. Many private doctors do not involve family members and do not provide any regular teaching. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0359,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0359,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Matthew Tessena,1676,"I have significant concerns about a single physician being able to have a caseload of 200 buprenorphine patients. Even if this was a physician's full time practice, I do not think that one physician could safely and effectively manage this patient load. My current clinic practice in buprenorphine is 20 hrs. a week and I cannot manage any more then 80 patients.

I do not think increasing the number of allowable patient will help access. I have yet to meet a provider who has a full panel of 100 patients. It is more a matter of physicians willing to prescribe buprenorphine rather than panel limits that is causing problems with availability. Managing a buprenorphine panel is difficult and requires a lot of time and expertise to manage appropriately. These patients provide many challenges and frequently have slips to opioids and other drugs even while on buprenorphine. The average primary care physician does not have the expertise in this field to manage more then a handful of stable patients.

Expanding the limit would likely lead to increased diversion and abuse of the medication. I would recommend that the current limit of 100 patients be continued.

I believe that the state of the art treatment for opioid use disorder will be naltrexone injectable in the near future. It will take time, but I believe the research will demonstrate this. It greatly reduces opioid use and prevents overdose. It also stops the cycle of withdrawals followed by drug use to alleviate symptoms. With the availability of this safe and easy to use medication, almost any general practitioner can safely manage an opioid addicted patient. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0372,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0372,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Terry Schleder,166,"Please pass this rule because it will save lives in New Mexico, where we have an opioid abuse epidemic. The current cap is insufficient, so please act now.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0365,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0365,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Alistair James Reid Finlayson,2262,"Although in support of medically Assisted TREATMENT (emphasis deliberate) for opioid use disorders, I'm writing to express caution and concern about simply making buprenorphine products more available as a solitary strategy. Although these products are, like methadone, effective in reducing many harmful and costly behaviors associated with addiction, they are palliative in nature. The treatment model employed by drug courts and physician health programs achieve significantly better outcomes by mandating ongoing monitoring with random drug testing, plus attendance at treatment and support groups (DuPont et al).

There is no question that Buprenorphine is often superior to methadone in many respects but making it more widely available, absent adequate monitoring and treatment, risks more abuse, more diversion, and also risks another (iatrogenic - like heroin, oxycodone) epidemic of opioid (buprenorphine) dependence in our communities.

Where is the provision for the chain of custody random urine testing used by physician health programs and drug courts that would provide reliable outcome data (and improve safety) while patients are followed on buprenorphine?

Where is the push for better training of specialists in addictions, pain management and psychiatry to provide oversight and consultation to difficult complex patients and help reduce opportunistic buprenorphine prescription-mills?

Where is the data system for monitoring attendance at treatment sessions and support groups that would enable outcome research to guide those patients who may wish to discontinue treatment with buprenorphine once their lives are reliably stable?

Where is the social and educational planning needed to reduce the increasing incidence of opioid use?

In the 19th century some believed that heroin would cure the epidemic of morphine dependence. Now we are just reacting, rebounding to avoid fallout from the unsubstantiated pharmaceutical assertion that addiction doesn't occur in the presence of real pain!

This is a plea, not to reduce the appropriate use of buprenorphine, but to employ more scientific wisdom in monitoring the safety and outcome of this pharmaceutical strategy." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0366,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0366,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Randolph Holmes MD,131,I strongly support increasing the limit on buprenorphine from 100 to 200 patients. This will improve patient access and save lives. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0368,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0368,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,Teresa Kassick,911,"I agree with the proposed increase of Doctors ability to prescribe for 200 patients. I have worked in the field of recovery for 14 years, 2 years of that was at the Here to Help Program sponsored by Reckitt Benckiser. I worked as a recovery coach to discuss with patients the medical and psychological benefits buprenorphine as a treatment for opioid dependence. Of the client database I worked with 90% were dependent on prescribed pain medications. I had comprehensive training of how buprenorphine works and the statistics of the use in Europe for success of this treatment. I currently work at Psychiatric Rehabilitation Program as a Wellness Specialist. I have observed the benefit of treatment for mental health and substance abuse at the same time as crucial in long term stability in a persons life. The opportunity for people to have increased acess to a potentially lifesaving treatment is essential." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0415,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0415,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Denise Boehner,762,"Its my understanding that this drug has a 99% rate of preventing opioid over doses. It is my opinion that if this drug were more widely available to the addicted and those who are self medicating because of mental illness, we would have a much more productive society. On a more personal note, this drug being more widely available would have allowed our son to be a good father to his children. And he wouldn't be looking down the barrel of a six to seven year prison sentence for drug abuse, drug sales and several other charges. Our prisons are the largest mentle health service in the U.S. These people should not be forced into a life of crime to get treated for mental health issues, especially when there is a family history of mental illness history." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0449,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0449,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,d w,2430,"Section VII. Questions for comment:

Question 1.
- How was the 200 patient limit selected? Is there evidence to support that limit? Limiting the number of patients with opioid use disorder a provider with an addictions board certification can manage with buprenorphine seems like an unethical restriction preventing the care of patients with an opioid use disorder by providers willing and able to manage their chronic illness.

- Please provide the justification and/or evidence for why it is appropriate to restrict the number of patients who can receive buprenorphine for treatment of opioid use disorder yet there are no restrictions on how many patients any prescriber (MD, NP, PA) can prescribe an opioid medication. It appears that patients with opioid use disorder are being unfairly limited in how they can receive treatment while prescribers have unlimited ability to prescribe addicting substances.

Question 3.
-While I do not agree with the 200 patient limit, I am wondering why the decision was made to only allow those with addiction medicine or addiction psychiatry board certifications to increase their limit to 200? A majority of the patient with opioid use disorder are seen in primary care and general mental health settings. Why would any provider with the required waiver training not be able to increase their prescribing limit if they are willing and able to manage more patients?

Question 7.
- Why does the waiver for 200 patient limit need to be renewed every 3 years? Only board certified addictions physicians are allow to increase to that limit according to your proposal. I do not feel that there is evidence to support limiting the number of patients a physician with an addictions specialty can manage let alone to ask them to have to renew the waiver every 3 years. This is setting unnecessary limitations and barriers to care for providers trying to manage patients with opioid use disorder.

Section 8.635
- Please provide justification for your proposal on reporting requirements. The proposed reporting requirements are cumbersome and will prevent providers from wanting to manage patients with opioid use disorder. Until a rule is proposed to require similar reporting requirements for providers who prescribe opioids, it does not seem that these reporting requirements are justified or supported by evidence.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0470,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0470,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Ted Parran Jr. MD FACP,2190,"This is a needed change to the rule, but ONLY if the new rule somehow BARS the individual clinician AND chain-type buprenorphine CASH CLINICS from requiring cash payments for services that patient's insurance will pay for.

With the current 100 patient limit, these cash prescribers and cash clinics typically charge any where from $175 - $400 PER visit per patient (a typical 99212-99213 outpatient clinic follow-up reimbursed by Medicare Part B at 40-60$). If multiplied by 100 patients, and 12 visits per year, this can generate easily $200,000 to $300,000 dollars per year in cash money, taken from - some say extorted from - addicted patients who are desperate. This "easy" income has proven irresistible to many physicians who otherwise appear to be ethical and reasonable clinicians. If the cap is increased to #200, then there can be an expected doubling of this "cash flow" that is ethically troubling at best.

Any change in the # of patients / waivered prescriber, must include language barring charging cash for ANY clinical services that are covered by insurance (if the client has insurance). This is the only way to truly make OBOT with buprenorphine the kind of clinical tool originally envisioned in DATA 2000.

Our survey indicates that 48% of current prescribers in Ohio require cash for all visits, EVEN WHEN PATIENTS HAVE PRIVATE INSURANCE. Requiring the above cited cash payments from low-income patients with Medicaid is even more ethically concerning! Preliminary information from a blinded PMP-OARRS check indicates that cash prescribers in Ohio tend to prescribe significantly higher doses of buprenorphine, and tend to have all or nearly all patients on the same dose (i.e. no individualization of patient care).

It is unclear to me that there is any attention to this "unintended consequence" of DATA 2000 in the proposed rule changes, but I implore you to carefully review the implications outlined above and see if they can be addressed. The moral and ethical basis of the treatment of addictive disease is actually threatened by the emergence of these unanticipated practice behaviors. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0520,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0520,2016-08-02T04:00:00Z,Comment on FR Doc # 2016-16069,Richard Levine,1075,"The Comprehensive Addiction and Recovery Act (CARA), the compromise legislation to the Medication Assisted Treatment for Opioid Use Disorders allows advanced practice clinicians-nurse practitioners (NP) and physician assistants (PA)-to prescribe buprenorphine. Another class of advanced practice clinicians-pharmacist clinicians was omitted from CARA.

Pharmacist clinicians as advanced practice clinicians work similar in scope to NPs and PAs due to their advanced education and training. I am a pharmacist clinician working in addiction medicine. I work in a methadone maintenance program in New Mexico where I perform patient withdrawal assessments and prescribe methadone and other medications.

Being that we are small in number with only a few states licensing us, unknown to most in the health care community and lacking a national advocacy organization our profession was not included in the legislation.

Pharmacist clinicians as NPs and Pas can greatly expand accessibility for those seeking treatment for opioid addiction.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0532,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0532,2016-08-08T04:00:00Z,Comment on FR Doc # 2016-16069,Meg Chaplin,311,"I have one additional comment- since retention has been clearly linked to treatment success, why not collect 90 day retention data? that would be relatively easy, and would encourage clinicians to keep clients in treatment. NOT continuing treatment with buprenorphine, just continuing in any kind of treatment. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0019,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0019,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Debra Young,32,This is great and really needed. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0043,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0043,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Mitchell,2433,"I am a DATA 2000 SAMHSA certified Osteopathic Physician holding a DEA 100 Patient Waiver, and I have worked in an Office-Based Opioid Treatment (OBOT) program providing buprenorphine medication management services to opioid dependent patients for the past 8 years. Yet, even with a DEA 100 Patient Waiver, I constantly turn away people who need my help because of the 100 patient limit. I commend this increase in the treatment limit, however, I would ask you to consider providing some waiver increase for all certified OBOT physicians.

There is still an whelming number of individuals needing treatment for opioid dependence, with many of these individuals being financially destroyed and without healthcare insurance. Healthcare providers like myself offer our OBOT services at rates these people can afford even without third party payment. For example, I only charge $40 per week for people to be in my OBOT, and they buy medication at a pharmacy of their choice. However, because I'm not board certified in addiction medicine, and I don't work in a qualified practice setting (I don't take insurance), I cannot apply for a waiver to treat more than 100 people at a time.

Given what happened during the past decade in the state where I live, Florida, where doctors ran high-volume pain medication pill mills, I fully understand your concern in restricting patient volume so that unscrupulous physicians do not take advantage of patients. However, some increase for all physicians in good standing is warranted. I would suggest that all physicians currently holding a DEA 100 waiver who have been in good standing for the past year be allowed increases as follows:

1. NOT board certified and NOT working in a qualified practice setting - additional 50 patients (a 150 patient total waiver).

2. NOT board certified but ARE working in a qualified practice setting - additional 100 patients (a 200 patient total waiver).

3. ARE board certified but NOT working in a qualified practice setting - additional 150 patients (a 250 patient total waiver).

4. ARE board certified and ARE working in a qualified practice setting - additional 200 patients (a 300 patient total waiver).

Please note that I would only qualify for the 150 patient total waiver, however, I would greatly appreciate the ability to offer my services to more needy people in my area." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0047,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0047,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,328,I work in behavioral for inpatient and outpatient clients and see on a daily basis the need for more physicians needed for Suboxone maintanance. It would be an incredible benefit if the few providers licensed to be able to take on more patients. It would be a great benefit to the patients and communities we serve.

SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0067,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0067,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,3231,"Enacting this rule would save many lives in Arizona and all throughout the United States. Arizona holds the fifth largest opioid prescription rate in the country. About one Arizonan dies every day from overdose and in 2014, 372 people died from prescription opioid deaths, and 180 dies from heroin-caused deaths. By passing this rule, Arizona would have more treatment options available for individuals who want to get clean and stay clean and help patients avoid relapse and overdose. This rule is also important to Arizona because of the high rate of drug trafficking across from Mexico. A 2013 survey by the Drug Enforcement Administration's National Drug Threat Assessment found that the amount of heroin seized at the southwest border of US and Mexico has grown by 232% since 2008. Between 2009 and 2013, Pima County saw an overdose rate about twice as high as other Arizona counties, with Tucson having the most overdoses in the county. Illegal drugs are more likely to be trafficked into Tucson because it is the closest large city in Arizona from the US-Mexico border. By enacting this proposed rule, Arizona will be better prepared to address the aftermath of the increase in drugs in Arizona and in Tucson. The drug epidemic in Arizona is not only hurting adults, but it is also effecting children and youth. Arizona is ranked eighth highest in drug overdose deaths with a rating of 10.2 per every 100,000 youth age 12 to 25. Compare this to the national rate of 7.3 per every 100,000 youth, and it is obvious that Arizona needs an increase in accesses to treatment to help the youth get in recovery and stay in recovery.

By passing this rule, Arizona would be able to expand the treatment availability of qualified physicians who treat opioid use disorder through MAT by having eligible practitioners treat more patients. Arizona ranks as one of the highest in opioid prescriptions and in overdoses for both youth and adults. This rule will help save the lives of the hundreds of people who die every year from opioid and heroin related deaths in Arizona, including youth. In addition, this rule would help prevent the switch from prescription opioids to illegal substances such as heroin. For people receiving MAT, they will have services available to them to help them fight relapse, such as diversion programs, and case management programs. If this rule is not passed, more and more Arizona youth run the risk of becoming addicted to opioids and eventually heroin, which may lead to a potential overdose and dying. In addition, the monetary benefits of this rule heavily outweigh the monetary costs. By enacting this rule, Arizona will ensure that people who are struggling with opioid and heroin addiction get the treatment they need to be productive and healthy citizens.

December 16, 2015, Arizona at Front Line of Nation's Drug Addiction Epidemic Arizona Public Media
March 2, 2016, Arizona heroin, prescription drug overdoses escalate, Azcentral
January 11, 2015, Proximity to border helps make Tucson an epicenter of Arizona's heroin epidemic, Cronkite News
November 2015, Reducing Teen Substance Misuse: What Really Works, Trust for America's Health

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0073,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0073,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Israel Stein,1973,"I am a licensed physician in Massachusetts with a primary practice in treating narcotic addiction with buprenorphine assisted therapy. In my experience, the results achievable with this medication, combined with psychosocial support, are far superior to alternative means of treatment of addiction.
In view of the opioid epidemic, the availability of buprenorphine assisted treatment is critical. The 100 patient limitation under the present SAMSHA/DEA program, has limited access to this medical therapy. My office, in fact, has a waiting list of 14 patients, a number of patients that could be easily accommodated.

In addition, this quota system for services requires patients in under served areas to travel long distances for treatment. I have patients coming three hours by car from Vermont, because of the lack of licensed providers.

There is one other issue that bears noting and requires attention. Even if the patient limitation is lifted, the number of patients to be treated may not increase. There is continued resistance on the part of the insurers and their pharmacy review panels in providing coverage. The increasingly burdensome prior approval ("PA") process for buprenorphine therapy; the lack of standardization of such PA request forms; and the arbitrariness of the PA review process, raises questions about desire of the insurers to provide services. These obstacles also increase the likelihood that providers will not increase the number of patients they will treat. We should also note that patients have difficulty in procuring their medications, as some pharmacies will also not carry these pharmaceuticals.

In light of the national addiction problem, the elimination of the restriction of buprenorphine therapy to 100 patients is unquestionably justified with a means of addiction therapy that has had proven success. At the same time, the impediments to providing services have to be addressed.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0100,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0100,2016-04-25T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,3204,"All is good, with only a few provisos. One, nurse practitioners and physician's assistants should never be allowed to prescribe this medication. They just don't have enough pharmacology and pathophysiology under their belt to prescribe it responsibly. Two, physicians should be able to prescribe this medication even in states where they do not carry a medical license as long as they carry a medical license in at least one state and have an X number. This will expose much more of the country to this medication. Once exposure occurs, other physicians will follow.

Above all, though, and I repeat, nurse practitioners and physician's assistants, even those that closely care for patients under the umbrella of a specific physician, should never be allowed to prescribe this medication in any form on their own or under an MD ever under any circumstances. They just don't understand the complicated pharmacology and intricate implications of short or long term use of this long half life but super strong receptor affinity opiate. Without that ability, they cannot correctly prescribe it, they cannot correctly educate others about it, they cannot correctly realize its dangers. It's correct prescribing is also heavily dependent on a masterful knowledge of non-opiate prescribing for medical and psychiatric comorbidity. They lack that, too, as evidenced by their current over-prescribing of traditional opiates.

Only physicians that have an X number that has always been in good standing and a regular DEA number that has always been in good standing should be allowed to prescribe this medication. This brings up many points. I know physicians that have X numbers, but their previous DEA number was restricted because of quantity violations. Those physicians should no longer be able to have an X number. Period. They have shown their lack of restraint in prescribing opiates. Such a similar lack of restraint in prescribing buprenorphine preparations as if they were dramatically safer is extremely likely out of complacency. Such excess prescribing is dangerous, regardless of the reason.

Again, for the purpose of summary, nurse practitioners and physician's assistants should not be allowed to prescribe buprenorphine prescriptions in any capacity, in any sector, regardless of supervision. And, again in summary, physicians with an X number in good standing with no history of DEA number problems should be able to prescribe buprenorphine preparations in any state as long as they have a medical license in good standing in at least one state. And if that can't be done in states where this drug is needed but where licensing is difficult (e.g., California), there should be a special fast track or waiver for qualified MDs applying for licensure in those states. With the nation's current opioid epidemic, either of these two scenarios should be easily accepted (note: a national license to practice medicine would facilitate care in high need states; anything else including our current situation should be deemed restriction to trade blocking access to such necessary care in our current great time of need).

Kind regards." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0122,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0122,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,665,There is a high potential of relapse and failure while on Bupernorphine treatment. The relapse is often more dangerous as the tolerance to Opioids is lowered after period of treatment. Expanding the number to 200 patient limit for physicians who have had few hours of online training may address quantity and could undermine quality. I suggest to have an advanced training (step 2) for interested physicians to learn more about Opioid addiction and other drugs addiction and their management. They will be acting as busy addiction specialist and having a full time caseload of addiction patients. The only way to have good quality care is higher level of training. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0160,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0160,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Daniel Logan,4848,".

I am currently board certified in Emergency Medicine through ABEM and Addiction Medicine through ABAM.I am actively practicing Addiction Medicine with a large Suboxone population. An increase in the number of patients I can treat would be very beneficial to me and the community in which I practice.

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0167,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0167,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Clifton Frederick Lord,4727,"To the Honorable Secretary of Health and Human Services
I urge you, in the strongest terms possible, to amend the language in proposed rule such that the opportunity to qualify for a higher patient limit may be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.
There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.
This particularly true in the geographic area in which I practice, a rural area on the border of Vermont and New Hampshire. There is currently one psychiatrist who holds sub-specialization in addiction psychiatry in active practice. There are a small number of physicians who hold American Board of Addiction Medicine certification and are otherwise qualified to prescribe at a full complement of 100 patients. The need for treatment for these individuals is greater, not less, and the current resources are unable to meet demand.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), realize that it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:
ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates or physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them.
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.
Respectfully,

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0222,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0222,2016-05-16T04:00:00Z,Comment on FR Doc # 2016-07128,Julie Chicks,1443,"Every week an average of 12 persons seeking treatment for opiate use disorder are turned away from this office based opiate treatment clinic. Desperate inquires from persons willing to travel hundred's of miles to obtain treatment, including women who are pregnant. If we, as a nation, believe there is societal benefit in treating OUD, access to medication assisted treatment must be increased.

Therefore, I beseech SAMHSA to modify the definition of qualified practitioners to specifically include practitioners who are American Board of Addiction Medicine diplomats. It seems irrational and irresponsible to exclude ABAM diplomats. They are physicians who have already been determined to be knowledgable and adequately experienced to treat addiction. Excluding ABAM diplomats from the 200 patient limit will unreasonably deny patients with OUD access to treatment by many qualified and experienced physicians who have, for years, dedicated a significant portion of their practice to treating patients with OUD. Physicians, like myself, who have found addiction medicine to be worth the bulk of their professional attention, over and above their original field of training.

Of note, the necessary elements of a qualified practice setting (8.615) includes items numbered (1), (3), (4), (5), and (6). Item (2) is absent. Whether a misnumbering or an accidental omission is not clear, but should be rectified.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0242,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0242,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Lucy Clauter RN,921,"I am writing to express my support of FR Doc # 2016-07128. I am a registered nurse with a MS in Rehabilitation Counseling specializing is substance abuse. I have 26 years experience in this field and it is my hope that the limit for providers of Suboxone therapy will be raised given the current opiate / opioid epidemic. I have personally witnessed the stability this medication offers while helping addicts recover and begin to lead normal lives. With the help of this medication, persons suffering from this addiction return to work, avoid legal consequences and decrease the likelihood of health problems associated with addiction. In addition their family lives are improved avoiding intervention with DCFS. These costs are borne by the tax payers and can be avoided if addicts are able to receive the treatment they need in conjunction with medication assistance. Thank you for consideration in this matter. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0387,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0387,2016-05-27T04:00:00Z,Comment on FR Doc # 2016-07128,joanne poje,1159,"I have practiced addiction medicine since 2007. Since that time I have taken many courses as well as attended most of the ASAM meetings .

I had studied and prepared to take the ABAM exam in 2010 and passed and have been active in the ASAM in Ohio.
I have had people scheduled for appointments not make it because of the waiting list in that I was filled up.
I am aware that there are prescribing practitioners who are not compliant but for those who are certified by ABAM and are practicing according to the guidelines and have counseling as part of the program I believe that increasing the quota can save lives .
I currently work in a practice that takes most of the insurances including the state plans ,one who also has weekly counseling and group counseling. We have in place systems to deter divergence through using the pharmacy reports as well as doing counts .
I would hope that this will be TAKEN INTO CONSIDERATION IN THE ABAM certified although not considered specialty boarded yet are qualified to meet the standards to have an increased caseload that can only save lives
Sincerely
Joanne Poje FASAM " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0016,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0016,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Roland Lavallee,1317,"I agree with the proposal and hope that it does not go the route of H.R.2536 - TREAT Act that has been floundering in congress since it was introduced 05/21/2015.

Concerns about the proposal:

1) It continues to focus primarily on the provider limits, not comprehensive treatment.

2) It does not allow physician extenders(nurse practitioners, physician assistants) the opportunity to obtain the same training and provide treatment (in accordance with the individual state guidelines)even though they are allowed to prescribe other controlled substances that are of greater risk.

3) It does not address the insurance issues that greatly limit access to treatment with buprenorphine. These include widely varying and sometimes very restrictive formats for requesting approval for treatment services and prescription coverage. Some insurance providers restrict physician enrollment to only a few subspecialties effectively eliminating most of the providers certified to provide treatment with Suboxone, and the low reimbursement rate may further limit the providers who participate with the plan. Some also have time limits on coverage for buprenorphine treatment. These restrictions will continue to significantly limit access to treatment even if the provider limits are raised. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0041,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0041,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Steve Weaver,487,I do not believe the rule should be changed. This is simply going to consolidate the use of this medication in the very large centers which are already monopolizing the field. I believe this goes against the original idea of buprenorphine. It was to be used by regular physicians in their practices. Now buprenorphine will only be written by physicians in large MAT programs. This will lead to increased prices for patients as competition will be thwarted. Please reconsider this please. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0088,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0088,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Amber Adams,1360,"I am very happy to see the patient limit has finally come up for review. I am not sure about other states, but I am aware that here in West Virginia many of our treatment facilities and private doctor offices have a minimum of a 6 month waiting list. I am a recovering drug addict and I have been without treatment myself for months because I cannot get in to see a doctor anywhere, I am on waiting lists at many facilities. Increasing the patient limit from 100 to 200 would certainly help these facilities clear out their waiting lists and make room for new patients as well. There simply are not enough treatment facilities to treat all of the individuals that need help with the limit of 100 patients per doctor. With addiction receiving so much attention lately, many people have started coming forward, admitting their addictions and trying to seek help only to find they cannot receive help for an extended period of time. I personally do not want to have to wait an extended period of time to be treated for my disease and I am sure others that seriously want help do not want to wait that amount of time either. I think the patient limit increase from 100 to 200 is a very good idea and is a great starting point for being able to more readily offer addiction treatment services to those who need them. I would like to see the patient limit increased." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0115,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0115,2016-04-28T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Crausman,206," Prescribers who get the increased waiver to 200 should be required to accept medicaid and Medicare. Specifically, they should be prohibited from charging Medicaid and Medicare patients cash for services. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0187,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0187,2016-05-10T04:00:00Z,Comment on FR Doc # 2016-07128,ROBERT CERRATO,4544,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0250,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0250,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Ellie Grossman,3786,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term "subspecialty" from 8.610(b)(1). This change would align the eligibility requirement with the concept of "board certification" as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; "subspecialty board certification" is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim "subspecialty" board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM.

Given that it will be at least one year until any physician can claim "subspecialty" board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim "subspecialty" board certification, and that a large fraction of the addiction specialist workforce will never be able to claim "subspecialty" board certification, I urge SAMHSA to remove the requirement that physicians hold "subspecialty board certification" in 8.610(b)(1) and clarify that all physicians with a "board certification" in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Further, to expand the addiction treatment workforce, I strongly suggest that the ability to prescribe buprenorphine for treatment of opioid use disorder be expanded to include nurse practitioners and/or physician assistants - so that buprenorphine prescribing ability matches prescribing ability for other opioids -- assuming the NP or PA in question has obtained a DEA buprenorphine waiver in the usual process. These 'midlevel' providers are critical, skilled elements in our health-care system, they have trusted relationships with patients, and they should be allowed to fully participate in care of treatment of patients with addiction disorders." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0253,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0253,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Kittay,4755,"

Dear Mr. Secretary,

I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1).

This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA.

As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients.

ABAM physicians are eminently qualified to treat opioid addicted patients through advanced training and clinical experience. They have:
Demonstrated advanced expertise in addiction medicine through a rigorous board examination;
Participate in a Maintenance of Certification Program involving multiple live and didactic educational activities;
Are recertified by examination on a regular basis.

ABAM physicians have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM.

Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.

Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification,

I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit.

Respectfully,

Michael J. Kittay, MD

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0257,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0257,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Liz K,376,"In rural areas where poverty is much more prevalent than urban health centers - patients have a difficult time finding suboxone doctors and not all doctors want to help opiod addicts. The ones who take the time to get certified should have flexibility in expanding their practice to meet the community's need. For this reason, I support ending the 30/100 rule.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0263,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0263,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Joseph Cassady,5008,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Joseph Cassady, MD
6000 Lindhurst Avenue Suite 700
Marysville, CA 95901

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0316,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0316,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,"Joseph A. Cabaret, MD",2722,"I recommend the following changes be incorporated into the final rule:

Include ABAM-certified physicians among those who would qualify for the higher limit based on their medical education and training by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients and thus would have a very limited impact on access to specialist care.

Expand the training pathways to allow non-specialists to qualify for the higher limit by taking additional and ongoing training in addiction medicine. The addiction treatment gap is so large and the urgency to expand access so great in the face of our current epidemic that it is imperative we leverage the full strength of our primary care workforce. Specialists and those who work in qualified practice settings will not be able to close the treatment gap on their own, and patients are dying as they wait for care. Non-specialists with additional training (as described below) should be able to treat additional patients regardless of their practice setting.

Raise the patient cap to 500 for board-certified physicians and those who have completed additional and ongoing training. To make a meaningful impact on the current epidemic, the proposed rule needs to go further in expanding access to treatment.

Clarify the requirements to be a qualified practice setting. Additional detail is needed for physicians to understand if their practice meets the requirements of the rule.

Convene an expert panel to revise the data collection form. The template reporting requirement form requests information that is either clinically meaningless, uninformative to determining whether the care being provided is of high quality, difficult to extract from an electronic medical record (EMR), or all of the above. ASAM offers some specific comments below, but recommends SAMHSA convene an expert panel of addiction specialists to revise the form before it is instituted as a reporting requirement.

Joseph A. Cabaret, MD
President, California Society of Interventional Pain Physicians
Board Certified in Anesthesiology, Pain Medicine, and Addiction Medicine
Founder/Partner, Regenerative Medicine Specialists
Founder/Partner, Paradigm Recovery Group
Chief Medical Officer, A Healing Place
1100 Paseo Camarillo
Camarillo, CA 93010
805-484-8558
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0032,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0032,2016-04-17T04:00:00Z,Comment on FR Doc # 2016-07128,Elizabeth Ross,437,"Yes, I think it's a great idea!! I'm hoping it passes! I know alot of people who need this and want it but doctors have no more openings for patient's!! This is a life saving drug that does not get you high or give a buzz of any kind! It keeps you from feeling the pain of with drawl and cravings and makes you feel normal to where you can function like a normal human being!! I'm praying and hoping this goes through!!! " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0091,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0091,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Shawn Waldron,5082,"I am a Licensed Clinical Mental Health Counselor and Licensed Drug and Alcohol Counselor in the state of Vermont, currently working in a Primary Care Office with six (6) Providers,( three MD's and three NP's). One of the MD's prescribes Suboxone/Buprenorphine as part of the state's Office Based Opioid Treatment (OBOT) Program.
I am detailed from the local designated mental health agency. Prior to being the full time mental health and substance abuse counselor for this practice, I worked as one of the MAT Clinical Care Coordinators mentioned in this proposal. I am intimately familiar with the MAT process in Vermont, managed by the Blueprint for Care, and the barriers to treatment and successful recovery. While in the role of the MAT Care Coordinator, I worked directly with six physicians in a widely scattered geographic area in rural Vermont. The Blueprint has several outstanding initiatives to foster training, support and collaboration among MAT Teams and providers throughout the state.
I am not sure if you are familiar with Vermont's Hub and Spoke Treatment Model, this is a way of determining level of care based on severity of addiction, availability of recovery supports, and motivation for treatment. The HUBs consist of Methadone treatment programs, as well as Buprenorphine/Suboxone programs for individuals starting treatment, having difficulty maintaining treatment, or who have been unable to maintain compliance with treatment at the OBOT level. The OBOT level is the focus of this rule change, and is geared towards those individuals who have been stabilized on their Suboxone dose, have strong support systems in place, and have shown themselves to be compliant with treatment protocols. HUBs generally have stricter administration guidelines, starting with daily dosage at the facility, and working towards take home doses, but usually not more than a week's worth at a time. At the OBOT level, an individual usually demonstrates motivation, stability and compliance that allows them to progress quicker to longer based prescriptions, sometimes up to 30 days between formal check ins; interspersed with those are random drug screens and pill counts to minimize diversion or other substance use.
While I do not object in principle to Provider's being able to see more patients, I believe there is a better way, which would deliver better patient care. Rather than increase the burden on already taxed doctors, I believe it would be more effective to leave the cap at 100, but expand the authorization to include Nurse Practitioners. It makes no clinical sense that NP's who can prescribe the opiates that many of these patients are abusing, cannot prescribe the medication to help them break free of their addiction.
I also believe that a recently added change to MAT program guidance at the state and local levels needs to be rescinded as soon as possible. While not all addictions are the result of underlying emotional or behavioral problems (we all acknowledge an increase in addiction to pain killers following medical procedures)--the vast majority are. As such, any hope we have of stemming and reversing this trend, must be based on providing those suffering with addiction the cognitive and emotional tools to deal with the stresses and temptations of abstinence -- without relapse. Medication alone cannot do that. If all we do is increase the number of patients we can get into MAT, without a sensible and effective strategy for them to transition off MAT, then we fail them again. Methadone and Buprenorphine are not miracle drugs, they are opioids themselves and under the current guidelines we are just making a trade off - we are getting people to give up their uncertain street habit in exchange for the certainty of regular dosages and no withdrawals. We convince ourselves because they have a prescription that they "have their lives back" and are fully functional. They are still consuming daily doses of opiates that have physiological and cognitive effects. They are still bound to a treatment protocol, with travel restrictions based on their "take home" doses. The only mention of counseling in the Vermont guidelines is that Medical providers must ensure they know of qualified counselors to refer their patients to.
And in Para 6.2.2.4 of the final rule it specifically states that doctors MAY NOT withhold or discontinue MAT from/for a patient who declines refuses to seek or attend counseling. (tried to attch rules) This leverage is often the only motivation some patients have to do the emotional work necessary to eventually taper off MAT completely. So all this rule does is increase the number of patients transitioning from illegal drugs to prescribed drugs. If you want to do the most good, put the emphasis back on the "Treatment" in the term Medication ASSISTED Treatment, and mandate counseling for all MAT recipients. What happens when 200 is not enough? Just keep adding? Please think long term success
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0107,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0107,2016-04-26T04:00:00Z,Comment on FR Doc # 2016-07128,THOMAS BERTSCH,3387,".
Dear Sirs,

I take pen in hand today because I am overwhelmed by the apparent lack of recognition of the U.S. Constitution by the administrative staff of the Federal Drug Enforcement Agency and the Food and Drug Administration.
As I am returning from today's doctors appointment, I was totally overwhelmed by emotion and shock, as I tried to understand how a Federal Agency, of my government can overstep it's authority and implement rules and regulations which directly infringe upon the Constitutional rights guaranteed me by the founders and forefathers of this great democracy.

Background: I am a disability retired Fire Captain from one of the Nations largest Fire Departments, Cal-Fire. Formerly known as The California Department of Forestry and Fire Protection. I am a third generation, professional firefighter. My Grandfather, Father, two older Brothers, numerous Cousins and Uncles, and now, my Son, all professional full time firefighters. Cal- Fire responds to over 355,000 calls per year. And after eight years with various fire departments, and another decade of service with Cal-Fire, I was forced to accept a "Disability" retirement due to several on-the-job injuries and illnesses.

Since 1988, I have been prescribed Xanax and Hydrocodone to combat my chronic and debilitating pain. I have had 1/2 of my Thyroid removed, surgery on my Rt knee twice, several lymph nodes surgically removed. Several years ago, I had my left testicle removed because of an overwhelming and unbearable pain in this region. Doctors have had no help for curing my pain, just an attempt to manage the pain by medication. Which is the best I can hope for at this point in time. On occasion, when this medication is not enough, I take a ride to the emergency room for an injection of Demerol, which completely overwhelms me.

Today, at the end of my Doctor visit, I was handed a urine sample cup, And informed that the "D.E.A. and the F.D.A. now required a "Drug Test" before my prescription will be filled. The test in this case, scans for many, various types of drugs. Both prescription and illegal drugs.

IT WAS AT THIS POINT I FELT I WAS BEING BLACKMAILED BY MY OWN GOVERNMENT . I WAS TOLD THAT MY PAIN PILLS WOULD NOT BE GIVEN TO ME, UNLESS I SURRENDERED MY CONSTITUTIONAL RIGHT TO BE FREE FROM UNREASONABLE SEARCH AND SEIZURE ! BY SUBMITTING TO A DRUG TEST WHICH WAS REQUIRED WITHOUT ANY REASONABLE SUSPICION OF DRUG MISUSE OR ABUSE.

The Fourth Amendment protects all of us from government-mandated searches unless there is cause or justification. The mandatory drug testing simply goes too far.

I am caught between enjoying the freedoms given to me by the Constitution, or receiving my pain medication. I am perplexed.

I urge you and all elected officials, to concentrate your efforts to end this abuse by the current administration of the D.E.A. and F.D.A. I will be contacting any and all my representatives in government, and requesting they do the same.

I spent my life in the service of others. I worked, non stop, year round, away from my own family, protecting and helping the public and now I ask your assistance in this troublesome dilema, and consider my opinion.

Sincerely,
Thomas M. Bertsch
Fire Captain
Cal-Fire
Retired" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0123,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0123,2016-05-02T04:00:00Z,Comment on FR Doc # 2016-07128,Lisa Wilson,390,"There should be a cap on the patient cost also. Doctors that arent accepting insurance and are charging $1,000 a month to thier pateints are as bad as drug dealers. Hold them accountable and protect us.
There is such a shortage on doctors that out of pure desperation people are being forced to break the law in order to afford paying their cash only doctor for their service. Not Fair!" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0163,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0163,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,John Barbuto,2851,"The goal medical care is to improve the lives of the ill. It is not the goal to build industries that benefit from providing services to the ill. Flying under the banner "pain is under-treated" we have built an American pain industry that far outsizes pain as a biological condition. Thus we have the often-quoted statistic that the U.S. has less than 5% of the world's population but consumes over 80% of the world's prescribed opioids. And as consequence of other factors, we find ourselves in an opioid-use and opioid-death epidemic.

Thankfully, the pendulum of sentiment is now shifting away from the "pain is under-treated" mantra that has heavily contributed to creating industry at the expense of lives. In this shift we do not want it simply re-directed to creating another set of industries that benefit illness propagation.

As a doctor with boards in neurology and also addiction I believe buprenorphine is a good drug - when used for the right circumstances. There is no question there are patients who abuse it. There is no question there are patients who use it to tide them by until they can reconnect with a source of full-agonists (pain pills or heroin). And, subjectively, patients report that it can be harder to get off of buprenorphine than even methadone. To be sure, this is subjective reports - with all of the inherent limitations of such information. However, it is not a rare report.

In our current epidemic it is probably a good idea to raise the limits to 200 patients - as long as this is coupled with solid information that use is producing improved OBJECTIVE FUNCTION. We do not want to simply produce a new epidemic of buprenorphine excess and buprenorphine games (as has occurred in the "chronic pain" games that have over-built our pain industry).

We need to build personal strength and capability in this country, not pander to symptoms that propagate or encourage dysfunction. Addiction is a serious illness with very far-reaching consequences (even to the next generation via epigenetics). We need to understand the illness and treat it in ways that build people into solid life function. Excessive or inappropriate use of buprenorphine will not serve these goals. Appropriate use - that supports positive trends of life function - will serve these goals in appropriate patients.

As the chronic pain industry seeks new ways to propagate itself in the era of greater treatment conservativism, we must be sure that our actions serve building health rather than just building industry. I support raising the limits of buprenorphine prescribing to 200 as long as this is solidly coupled with documented, objective efforts to ensure that treatment moves the patient toward objective improvement in function. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0173,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0173,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,David Beck,4523,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment.

There are currently 3,644 U.S. physicians certified by ABAM, but only 1,088 physicians with an addiction psychiatry subspecialty certification from ABPN, and 7 physicians with a subspecialty board certification in addiction medicine from AOA. As currently written, the proposed rule appears to categorically exclude the vast majority of the addiction specialist physician workforce from the opportunity to treat additional patients. These are physicians who have demonstrated advanced expertise in addiction medicine through a rigorous board examination and have dedicated their medical careers to treating patients with the disease of addiction. Excluding these physicians would surely and severely limit the impact of the proposed rule and perpetuate the current addiction treatment gap.

While addiction medicine was recently recognized as a multi-specialty subspecialty by the American Board of Medical Specialties (ABMS) under the American Board of Preventive Medicine (ABPM), it will still be several years before any physician will be able to claim subspecialty board certification in addiction medicine under ABPM, and many ABAM-certified physicians will never be eligible for subspecialty board certification under ABPM:

ABPM has yet to announce when it will offer the first ABMS-level addiction medicine exam for subspecialty certification. It will be no sooner than 2017. If no exam is offered in 2017, it will not be until 2019 that some current ABAM diplomates and other physicians who have completed an addiction medicine fellowship could claim ABMS certification.
Physicians who passed the 2015 ABAM exam will not be required to recertify under ABPM to claim ABMS board subspecialty certification. However, only 392 of the 539 who passed the exam will be eligible for the ABMS-level certificate and it is unknown when it will be awarded to them (although its been indicated that it will not be until the first cohort of successful ABMS examinees are awarded their certificates).
Current ABAM-certified physicians with a primary ABMS board certification who are younger than 65 on July 1, 2016 will have until at least until 2022 to sit for the ABMS addiction medicine exam. (Physicians with a primary ABMS board certification who are 65 or older on July 1, 2016 will not be required to take the ABMS exam and will receive a time-unlimited certificate from ABAM when the transition period ends.)
Current ABAM-certified physicians without a primary ABMS board certification (940 total physicians including 328 osteopathic physicians) are ineligible for ABMS subspecialty certification in addiction medicine. These physicians will also receive a time-unlimited certificate from ABAM when the transition period ends.
Given that it will be at least one year until any physician can claim subspecialty board certification in allopathic addiction medicine, and that it may be five years or more until the majority of the ABAM-certified addiction specialists are able to complete the ABMS exam and claim subspecialty board certification, and that a large fraction of the addiction specialist workforce will never be able to claim subspecialty board certification, I urge SAMHSA to remove the requirement that physicians hold subspecialty board certification in 8.610(b)(1) and clarify that all physicians with a board certification in addiction medicine or addiction psychiatry as defined in 8.2 be eligible to apply for the higher patient limit." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0208,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0208,2016-05-11T04:00:00Z,Comment on FR Doc # 2016-07128,James Eelkema,967,"I am the director of the non-profit HeroinProjectLTD. As a former prescriber of Suboxone, I have seen the miracles it can work. For the last two years, I have attempted to increase the number of Suboxone credentialed primary care physicians in the state of Minnesota. I have not had a lot of success.
I applaud the HHS and the proposed rule change lifting the patient limit to 200 from 100. This is an excellent move.
However, I cannot for the life of me figure out why HHS would EXCLUDE doctors Board Certified in Addiction Medicine (ASAM) from making full use of this change. Do you not want more heroin addicts and narcotic abusers/diverters to have access to this powerful and magic medicine? Please change your minds and allow ALL Suboxone credentialed doctors to manage up to 200 patients. Thank you. James Eelkema, MD, Email address is <doctor at heroinprojectLTD.com" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0264,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0264,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Parr,5044,"May 23, 2016

The Substance Abuse and Mental Health Services Administration
Department of Health and Human Services
Attn: Jinhee Lee, SAMHSA
5600 Fishers Lane
Room 13E21C
Rockville, MD 20857

RE:RIN 0930-AA22
Proposed Rule, Medication Assisted Treatment for Opioid Use Disorders

Dear Ms. Lee:

As a clinician specializing in addiction medicine, I am pleased that the Substance Abuse and Mental Health Services Administration's (SAMHSA) took the important step of issuing the above-referenced proposed rule. I hope SAMHSA will continue to seek input from the expert provider community and finalize a rule that puts evidence-based treatment and recovery within reach of those who seek it. I urge you to request that SAMHSA raise the patient cap well above the proposed 200 patient limit.

When DATA 2000 was enacted, few clinicians likely thought that 16 years later we would be facing a therapy supply and demand crisis and an opioid use disorder epidemic extending to every community across the country. As a specialist with the precise training, expertise, and experience to respond to this pubic health crisis, it is difficult to identify any interest served by limiting the number of patients I can treat. I am unaware of similar policies for any other specialty or set of medications.

SAMHSA has expressed a sense of caution in expanding access to MAT due to concerns that increased use will mean increased diversion. The patient cap reflected the stigma that persists with respect to addiction, and a sense of trepidation that office-based treatment and take-home medication would open the floodgates to poor quality addiction treatment and rampant diversion into the illicit drug market. Our experience over the past 16 years has revealed that the overwhelming majority of buprenorphine diversion may be due to therapy "sharing" and related to the patient cap. From 2000 to 2014, nearly half a million Americans died from opioid overdose. The number of U.S. deaths related to buprenorphine from 2003-2013 was 420, with the majority attributable to concurrent drug use and only 2 deaths due to intravenous buprenorphine use. A newly-established patient cap that falls short of demand to accommodate diversion concerns ignores what we have learned and is difficult to accept in light of what we know - patients will die, and they don't have to.

Similarly, while MAT through a board-certified specialist or within an office capable of offering the full range of services comprising evidence-based care is undoubtedly ideal, DATA 2000 was enacted to expand access beyond addiction specialists and into "mainstream" healthcare. Addiction medicine professional are an invaluable resource in reversing this growing epidemic. Given the current statistics on opioid use disorder, however, it is unlikely that each impacted community has adequate access to addiction medicine specialists or addiction psychiatrists.

I urge you to finalize the proposed rule with a MUCH higher patient limit, one that meets the needs of our communities, both with respect to the limit and eligible clinicians.

Adequate access and diversion control should not be viewed as mutually exclusive. Addiction professionals recognize that effective diversion control is essential to each individual's recovery and to the DATA 2000 program generally.

DATA 2000 was enacted by Congress as an "experimental program" designed to assist patients who are opioid dependent. Fortunately, for millions of Americans, this program has saved lives, restored social viability and family stability. Unfortunately, there is so much work to be done by those of us who are working tirelessly to save more lives. Physicians should never be chastised and reprimanded for what they do best...provide compassionate medical care to those in need.

Diversion control strategies should ideally focus on education, clear guidelines, and actionable protocols developed in concert with ASAM and similar organizations.

The opioid use disorder crisis has grown and unless our treatment capacity grows quickly and sufficiently, people will continue to die unnecessarily. I appreciate SAMHSA's efforts to address the inadequate upper limits on the DATA 2000 patient cap, and the opportunity to comment on the proposed rule. However, we need your support to address SAMHSA directly. If you have any questions or interest in discussing my comments, please feel free to contact me at the number noted below.

Sincerely,

Michael S Parr MD
Chemical Dependency Treatment Associates
455 University Ave #320
Sacramento, CA 95825

cc:The Honorable Lamar Alexander
The Honorable Fred Upton
The Honorable Patty Murray
The Honorable Frank Pallone" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0291,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0291,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Scott Steiger,1719,"I am board certified in both Internal Medicine and Addiction Medicine, and I've maintained between 25-40 patients on buprenorphine for treatment of opioid use disorder for the past several years. While I welcome the proposed increase on the limit of patients any one prescriber can see, I would recommend that the Federal Government expand access to treatment in other ways as well.
The most obvious example would be to allow mid-level providers (i.e., nurse practitioners and physician assistants) to prescribe buprenorphine for the treatment of opioid use disorder. The point of the DATA 2000 law is to expand access to treatment in a primary care setting, and these folks provide a large and growing percentage of primary care in this country. Furthermore, these providers can already prescribe the more lethal substances to which patients are addicted! I have been referred several patients from nurse practitioners who astutely picked up that patients on oxycodone had problems controlling their use of the drug. Under the current rules, they could continue to prescribe oxycodone, but not buprenorphine! Preventing mid-level providers from treating addiction makes no sense.
Another important consideration would be the adoption of rules for Medicare and Medicaid which would require managed care plans to cover visits for treatment of opioid use disorder with buprenorphine and prescription drug coverage associated with these plans to cover buprenorphine indefinitely. Extant evidence suggests that taper off of the medication results in relapse within one year's time in nearly 100% of patients. Putting time limits on the treatment of this chronic disease puts our patients at risk." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0311,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0311,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Trupti Patel,2162,"as a board certified addiction medicine (as well as board certified in adult psychiatry and geriatric psychiatry) specialist, it is nice to hear we are moving forward in providing further access to treatment. my practice is 100% addiction (90% employed and 10% small private practice).

we must also consider the problem on the streets with illicit buprenorphine, and i can't help but to think this is a doctor driven problem, as there are many physicians with the DATA 2000 waiver, who operate 'suboxone clinic' on the side, and that these side practices have contributed to this epidemic.

is there any consideration to keeping the limit on those whose practice is less than 75% addiction, while allowing those whose practice is 75% or more addiction to have a higher limit? this ensures that those who truly practice/ understand addiction are the ones that are writing scripts, and not those that only know addiction as their 'side business.'

my worries are that if all MD's with data 2000 waivers are allowed to increase, what will the illicit buprenorphine epidemic become?????

while i am in agreement with the need to increase limits, i think there should be some consideration as to who to allow increases in, and not make it a generic increase for all. i see lots of clinics, where radiologists/ OB-gyns (taking male patients!?!?!)/ ER docs/ anesthesiologists/ .... open side businesses with their data 2000 waivers, but when those patients come to see me, i hear that they asked for doses to be tapered.... and MD's were not willing to work with them, so they decided to leave those offices..... i had a patient come see me, same situation, only for the first several months, i didn't even write her a Rx, instead, we used her 100+ remaining suboxone 8 mg strips to work down on her dose- she reported she had only been using about 4 mg daily, but MD kept writing for 16 mg daily, despite her telling MD about her dose..... it was good that this pt. kept the strips, as I'm sure there are some that sell these extras, hence the illicit buprenorphine epidemic....

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0313,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0313,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Andrew Topliff,509,"The American Board of Addiction Medicine as a specialty is the most skilled at treating addiction . We have the skill set and have studied all forms of addiction. If legislation does not increase suboxone limits for ABAM members lives will be lost. We are the specialty that makes the most sense for treating addiction and hope that these comments will be carefully thought through.

Sincerely,

Andrew Ross Topliff MD

Boarded in Addiction Medicine, Toxicology and Emergency Medicine." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0332,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0332,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Donna Poole,720,"The best way to increase the number of buprenorphine prescribers, would be to allow advanced practice nurses the opportunity to practice to their full scope. I have a fair amount of experience and training in substance use disorders but have not yet taken the buprenorphine training because I would not be allowed to use the knowledge gained. I am an independent practitioner who prescribes medications with equal or more serious side effects that buprenorphine. My state would allow me to prescribe if there were not federal regulations that impede my ability to contribute to my community. Please consider allowing advance practice nurses to be part of the solution.
Donna L Poole, MSN, ARNP, PMHCNS-BC
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0347,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0347,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Heather Muxworthy,800,"Please consider allowing Nurse PRactitioners and Physician Assistants to prescribe suboxone. There is no reason why NPs and PA's, especially those practicing in behavioral health and addiction treatment. I work in an FQHC in an area that is short of practicing psychiatrists and suboxone providers. It would help our agency, that currently only has 75 MAAT patients, but a wait list of 385 due to shortage of providers. I am a Psych NP who has been practicing in psychiatry since 1990. I am quite competent in treating addictions and Suboxone is pretty straight forward in terms of its prescribing practice. If NP's and PA's went through the same credentialing as the doctors that would help with access to so many patients out there that are falling through the cracks. Please consider. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0408,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0408,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,3178,"Thank you for the opportunity to provide comment.

Certainly the need for better access to medication assisted therapy for opioid use disorder is unquestioned. Having ANY limit on the number of patients a physician can treat seems to relate to two major factors, diversion risk and quality of care. Diversion seems to be controllable only to a point since we cannot control what an individual does outside of our offices. We also do not have a good way of measuring it. In my opinion, after nearly 5 years of treating opioid use disorder with buprenophine containing medication, patient limits will not have a significant effect on diversion.

But, since expansion of the current limit is the issue at hand, I think that adequate provider education is most important and I think ASAM's comment on additional training for non-board certified physicians makes a lot of sense. They have proposed a CME based approach to qualify for an increased patient limit. It also would be far less onerous and expensive than full board certification. Trying to get enough physicians board certified will take a considerable amount of time, time some patients don't have.

I am certainly in favor of using the controlled substance database which we already do in our practice.

In terms of quality of care, again, I think physician education is the most important factor. I think it is reasonable for an office to ensure that the patient has access to counseling and report on that. However, I would like to point out that even if a patient is simply treated with medication and refuses counseling, for instance, they are likely to be safer, have a better quality of life, and function better than if they are not treated at all. This would be an example of a harm reduction strategy.

Regarding a Qualified practice setting...

Specifically regarding access to "case management" services. I do not think I could ensure that in our area due to lack of availability.

I stongly oppose the suggestion that EHR be required whether or not the practice setting is already using it. EHR has been a disaster for physicians. It creates inefficiency, frustration, and adds nothing to patient care. It also takes the focus and eye contact away from the patient. A requirement to use it in the addiction treatment setting will not be an incentive for physicians to take on more patients. If reporting of data is the issue, that can easily be accomplished using other methods.

I strongly oppose any requirement to accept third-party payment. Unfortunately, due to increasingly poorer reimbursement, it is not practical to expect physicians to expand their patient numbers under these conditions. I believe this would limit the expansion of access which is what the patient limit increase is trying to achieve. It will discourage new physicians from becoming interested in treating opioid use disorder. It is also not practical to expect physicians to provide more extensive services like in house/mandatory counseling at the time of their visit with the physician if they can't afford to do it.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0411,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0411,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Michael Dunn,1208,"Kana Enomoto
Acting Director
Substance Abuse and Mental Health Services Administration 5600 Fishers Lane
Rockville, MD 20857
RE: Regulatory Information Number (RIN) 0930-AA22

Dear Ms. Enomoto,
I welcome the proposed rule to increase patient access to opioid addiction treatment with buprenorphine. I live and work in a community where only my partner and I actively practice addiction medicine and prescribe buprenorphine for opioid dependency. Most of the time we are at the 100 patient limit and must turn patients away causing them to return to using heroin or other opioids to prevent themselves from falling into the throes of withdrawal. We are both certified by the American Board of Addiction Medicine and the American Board of Internal Medicine.

In order that our practice be able treat the many people in our community afflicted with opioid addiction and who do not currently have access to care II would ask the the rule be clarified and that office based practitioners that are certified by the American Board of Addiction Medicine be allowed to treat greater numbers of patients.

Thank you for your consideration

Michael J Dunn, MD
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0409,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0409,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,George Kolodner,1227,"Question 1. Optimal Patient Prescribing Limit: Although I have reservations about buprenorphine for addictions being the only medication for which physician limits exist, I believe that 200 patients is a reasonable compromise. I am concerned that a higher number would be an incentive to investor-owned commercial interests to set up high volume operations of lower quality.

As the Medical Director of a free-standing outpatient addiction treatment center (www.kolmac.com), I and my medical staff have , since 2003, prescribed buprenorphine to several thousand opioid addicted patients -- all of whom have participated in our rehabilitation and continuing care program. Based on this experience, I think that 200 patients can be adequately treated by a single physician.
Question 3. Practitioner Training: Based on this same experience, I believe that the elements of a "qualified practice setting" are well described. I think, however, that even the waivered physicians in this setting should have addiction certification, especially if there is only a single physician. This again is intended to discourage the establishment of high volume, lower quality treatment centers by investor-driven entities." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0471,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0471,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,397,This rule is good except ABAM certified doctors should be incorporated so that they can see 200 patients.
More rehab needs to be opened to fight this Epidemic which is killing many people everyday.

I am glad American Medical Association also has agreed that new rule should incorporate ABAM certified docs to see 200 patients along with other highly qualified board certified by ABPN. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0166,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0166,2016-05-09T04:00:00Z,Comment on FR Doc # 2016-07128,Richard Ries,1026,"I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). This change would align the eligibility requirement with the concept of board certification as defined in 8.2, which includes board certification in addiction medicine from ABAM. As written, the eligibility requirement is unclear; subspecialty board certification is not defined anywhere in the proposed rule but implies that only physicians with subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology (ABPN) or subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) would qualify for the higher patient limit based on their medical education and training. If that is indeed the case, the proposed rule is forfeiting a valuable opportunity to expand access to high-quality addiction treatment." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0217,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0217,2016-05-13T04:00:00Z,Comment on FR Doc # 2016-07128,Brent Boyett,231,I recommend in the strongest terms possible that the opportunity to qualify for a higher patient limit be broadened to include those addiction specialists with ABAM certification by striking the term subspecialty from 8.610(b)(1). SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0241,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0241,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,136,"Please include ABAM certified physician as they took extra mile, time and dedication to get certified. ABMS is recognizing them as well." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0288,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0288,2016-05-24T04:00:00Z,Comment on FR Doc # 2016-07128,Diana Duenne-Sonnega,454,"

Please tell HHS to Expand Access to Specialty Addiction Treatment!
American Society of Addiction Medicine
HHS's proposed rule on Medication Assisted Treatment for Opioid Use Disorders would raise the buprenorphine patient limit for qualified physicians from 100 to 200 patients, but ABAM-certified physicians do not qualify! Please tell HHS that ABAM-certified physicians should be eligible for the higher patient limit.

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0506,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0506,2016-07-11T04:00:00Z,Comment on FR Doc # 2016-16069,"David Shreiner, MD",1188,"The proposed rule limiting patients to 275 makes no sense when the CDC recognizes the USA is in the midst of a growing epidemic of opiate drug addiction that shows no signs of declining. The proposed rule increases the burden of reporting on the inadequate number of physicians able to provide therapy.

Why does HHS control treatment of addiction more severely than the prescription of opiates for pain that lead in many cases to more addicted patients? This simply makes no sense. The proposed limit on numbers of addicted patients who may be treated prevents an adequate response to the increasing problem of addiction. Furthermore, the added reporting requirements for physicians also limits the numbers of patients who can be treated.

The objective of providing adequate treatment without diversion or misuse of drugs is an impossible goal. A more inclusive and tolerant view would allow for some diversion in order to treat the greater number of addicted patients. Buprenorphine is a very safe drug and preferable to any other opiate in treating addiction. Failure to allow more people access to this treatment is the antithesis of stopping the epidemic." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0310,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0310,2016-05-25T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Lambert,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0438,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0438,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Sara Koziel,813,"Summary of Comments from the Michigan Primary Care Association (MPCA)

1.MPCA supports increasing the maximum number of patients an eligible practitioner can treat with buprenorphine to at least 200 individuals.
2.MPCA encourages SAMHSA to promulgate additional requirements for linking MAT services to clinical supports to ensure continuity of care.
3.MPCA encourages SAMHSA to pursue additional administrative and regulatory policies to help address the opioid addiction crisis, including investigating its authority to grant non-physician practitioners a waiver to provide buprenorphine.

**Please refer to attached file for full description of attached comments" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0436,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0436,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Jonas Coatsworth,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0479,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0479,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,David Hebert,85,Please find the attached comments of the American Association of Nurse Practitioners. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0475,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0475,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Emily Feinstein,173,"Thank you for this opportunity to submit comments on the proposed rule, Medication Assisted Treatment for Opioid Use Disorders. Please see our comments in the attached PDF." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0473,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0473,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Dr. Steve Bentsen,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0488,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0488,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Ethan Jorgensen-Earp,223,"Please find attached comments from the President of the American Academy of Pediatrics, Benard Dreyer, MD, FAAP, regarding docket no. SAMHSA-2016-0001 (RIN 0930-AA22). Thank you.

Sincerely,
Ethan Jorgensen-Earp" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0410,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0410,2016-05-28T04:00:00Z,Comment on FR Doc # 2016-07128,Janet Pelmore,149,"I am in favor of increasing the provider patient limit. I am especially in support of the ASAM comments and proposal.

Janet C. Pelmore, MD" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0330,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0330,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Dennis Malmer,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0431,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0431,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,William Conway,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0435,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0435,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,71,See attached file(s)from the American Association of Nurse Anesthetists SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0343,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0343,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Jeffery Pevnick,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0460,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0460,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Ellie Garrett,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0255,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0255,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Mark Parrino,275,This correspondence represents AATOD's response to the Federal Register Notice concerning Medication Assisted Treatment for Opioid Use Disorders. This communication has been reviewed and approved by the AATOD Board of Directors and our Association's member chapters. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0260,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0260,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Susan Awad,17,See attached file SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0254,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0254,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Deborah Hersman,34,Comment of National Safety Council SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0525,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0525,2016-08-05T04:00:00Z,Comment on FR Doc # 2016-16069,Charles Atkins,669,"Buprenorphine providers with the DATA waiver are already visited by the DEA on a regular basis. We are required to keep lists of our patients and provide documentation that we're following the rules. Additional reporting requirements run the risk of discouraging practitioners from providing bup.

That said, one way to collect tons of data without inconveniencing the prescriber is by mining each state's prescription monitoring program. Much of the data you're looking for will be there.

As for the specific piece related to psychosocial treatment that could easily be tacked on to the questions pursued by the DEA when they come to call." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0108,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0108,2016-04-26T04:00:00Z,Comment on FR Doc # 2016-07128,Hyunhye Seo,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0518,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0518,2016-08-01T04:00:00Z,Comment on FR Doc # 2016-16069,James Walsh,993,"The requirement to report "Percentage .. that received psychosocial or case management service" implies that providing these services is required or normative. This does not match the published evidence base.

The use of the word "completed" in the requirement to report how many "have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery" suggests that buprenorphine is a temporary treatment (as though we would treat diabetes with insulin for only one year) and that patients on buprenorphine are not actually in recovery.

The range of options for "Number of patients at the end of the reporting year who:" does not seem to include patients who are lost to follow up or relapse.

Jim Walsh, MD
Medical Director
Addiction Recovery Service
Swedish Medical Center
Seattle, Washington
jim.walsh@swedish.org
pager 206 540-6573

" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0097,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0097,2016-04-22T04:00:00Z,Comment on FR Doc # 2016-07128,Timothy OConnell,725,"This is a wonderful idea and long overdue. We need to stop as many tragic overdose deaths as possible and work harder to get the opioid epidemic under control. I am Board Certified in Addiction Medicine. I own and operate a methadone clinic and I have a private Suboxone practice. I see both sides. I see patients that need a combination of intense counseling and MAT and I see patients that have been clean for years that need low dose Suboxone, possibly for life. I know of many families that have undergone tragedies because the methadone clinic had a waiting list and the Suboxone provider was capped at 100. We need to open up all doors to allow those addicted obtain treatment. This has to be our priority now. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0349,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0349,2016-05-26T04:00:00Z,Comment on FR Doc # 2016-07128,Azfar Malik,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0482,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0482,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Vicky Bass,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0491,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0491,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Bill Piper,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0480,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0480,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Lisha Barre,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0243,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0243,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Barbara DiPietro,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0249,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0249,2016-05-23T04:00:00Z,Comment on FR Doc # 2016-07128,Tiffany McCaslin,13,See attached. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0082,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0082,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,stanley harrell,532,The care for the clinic should not let it override the actual doctors offices . Cause the amount increaseing will take away from other care professionals . Counselors work load will not allow for this. Unless more certifications and more documents . To be filed Cause then you will take away from actual health care providers who provide medical care on a regular basis. And the doctors will have less care for the patient. This drug should be in its own schedule for punishment increase for possession. Or transferring to others SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0090,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0090,2016-04-18T04:00:00Z,Comment on FR Doc # 2016-07128,Brandi Whitley,3663,"Supporting this rule will have a significant economic impact on communities. The facts that support this rule are:
Each day 44 people die from prescription drugs overdose
In 2014, 28,647 or 61% opioids related deaths, which has tripled since 2000
Estimated 1 million people out of 2.3 million in the United States with opioid abuse or misuse going untreated.
Currently 1,400 Opioids Treatment Programs (OTP) & 31,857 practitioners waived to prescribe buprenorphine
57% of patients are currently being treated for buprenorphine assuming practitioners treating at maximum capacity
At state level 3 patients per 1,000 in the United States has an unmet need for treatment
Need for Office based Medication Assisted Treatment (MAT) setting w/ buprenorphine products
Need for more Specialty addiction treatment programs OTP
According to results from the 2010 National Survey on Drug Use and Health (NSDUH), an estimated 2.4 million Americans used prescription drugs non-medically for the first time within the past year, which averages to approximately 6,600 initiates per day.
The facts from the bill S.636 support the nominal amount of deaths from opioid use, the lack of users going untreated due to the need of an increase of office based MAT settings and OTP.
The lack of treatment main stream is having a significant impact on our youth starting from the age of 12 years old and the community, this is a public health emergency.
The affect that tragedy's have on families and friends is tremendous. These tragedy's come in two forms; loss to untreated overdose or misuse without regulation. 7,000 people a day are treated in emergency rooms for misuse because regulations aren't firm enough
or there isn't enough access practitioners. Practitioners limitations to serve up to100 patients are a disservice to the community. Increasing practitioners limits to 200 will allow addicts to receive the help needed in mainstream settings without being turned away because
the practitioner cannot accept anymore patient because there is a cap due to regulations. In the event of an emergency physicians have additional options that will enable them respond and cross treat. As a citizen, mother and friend that has been personally affected by the misuse of opioids I recognize the benefit offered to patients through advanced training and maintenance of knowledge and skill associated with the acquisition of subspecialty board certification; and the higher level of direct service provision and care coordination envisioned in the qualified practice setting
This bill is addressing the shortage and training issue we currently have which complicates and impairs the ability to effectively address the opioid epidemic in rural and underserved areas of the nation. This bill has analyzed the impact on the community, small businesses, public health, safety effects, environmentally, and financially.
The proposed rule has taken into account all necessary precautions that can possibly hinder the progress of this bill and rule. The rule demonstrates that the increase will be effective and adequate measures have been taken to ensure public safety and successful recovery for patients; in turn this proposed rule has my full support to pass into legislation. ." SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0421,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0421,2016-05-30T04:00:00Z,Comment on FR Doc # 2016-07128,Barbara Cimaglio,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0446,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0446,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,52,See attached comment from Braeburn Pharmaceuticals. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0440,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0440,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Ronald Foster,94,Please see attached Pennsylvania Department of Human Services' comments for consideration. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0439,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0439,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Deb Beck,116,Please see the attached comments submitted by the Drug & Alcohol Service Providers Organization of Pennsylvania. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0434,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0434,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Joycelyn Woods,30,See attached file(s)

SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0465,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0465,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Jenna Ventresca,158,"Please see attached for comments from the American Pharmacists Association, Academy of Managed Care Pharmacy and National Community Pharmacists Association. " SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0453,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0453,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,colleen meiman,99,Please find comments from the National Association of Community Health Centers (NACHC) attached. SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0455,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0455,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Forman,20,See attached file(s) SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0451,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0451,2016-05-31T04:00:00Z,Comment on FR Doc # 2016-07128,Anonymous Anonymous,14,See attachment SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0095,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0095,2016-04-21T04:00:00Z,Comment on FR Doc # 2016-07128,Robert Perry,5068,"First and foremost I am a proponent of MAT, however I have concerns about increasing the patient load for MAT providers from 100-200 patients. In my area of the country, Region 1 of Tennessee, we have a huge issue with MAT medication diversion and abuse. Before we increase the number of patients that a provider can see, I think we must first address the way treatment is delivered and the level of accountability that these providers have. Working in and with the judicial system, DCS, and privately in the mental health and substance disorders field, I have a lot of exposure to individuals being treated with MAT. MAT is an extremely powerful tool in the treatment of opioid addiction when used properly (in conjunction with cognitive behavioral therapy, appropriate psycho-social support, and well defined and adhered to protocols for diversion and abuse (SAMSHA Guidelines); this has not been what I've found here. I have found that there is not a big push to be more comprehensive in MAT. I personally can only think of four reasons for this: 1) A lack of knowledge regarding best practice treatment protocols and/or what specific protocols entail. 2) Unwillingness to collaborate with the other "helping professions" in delivering the other aspects of best practices treatment with MAT. 3) Unwillingness to differ to other treatment professionals in their specific areas of expertize from either a lack of respect for those professions, a lack of understanding as to what those professionals do (scope of practice), or a lack of knowledge as to what best practices are for MAT. 4) Capitalism without consideration for their client with intent, or through ignorance, or through professional arrogance. I personally believe that it is mostly number 1. A lot of doctors I have spoken to want to help these clients, they have seen them come through the medical system and have felt frustrated at the lack of options to help these individuals; they see MAT as being a very positive and helpful practice they can engage in which also happens to bring in a fairly good income. I think that most of these doctors have very little experience or knowledge about the treatment of addiction other than from a medical perspective which mostly entails treating the medical consequences of addiction, not the addiction itself and though great strides have been made in addiction in regards to medical neurosciences, these advances do not negate cognitive behavioral nor the psychosocial treatment needs, however; that Medication Assisted Treatment by its very name infers that the medication assists treatment not that it is the treatment. When whole aspects of treatment are left out or minimalized to pseudo NA meetings and job resource handouts then you see the kind of things that I find here:
1) I can honestly say that I have spoken to upwards of 200 MAT clients and I have not met a single one that takes their medication as prescribed, not one. However, probably 80% of them say that being addicted to MAT meds is much better than other opioids; that there is less wreckage, but that the withdrawals are worse.
2) Of those 200 or so MAT clients I have spoken to, at least 60% say they "shoot" and "snort" their meds,39% say they snort it only, and about 1% say that they put it under their tongue.
3) If you would have asked me 6 years ago what "drugs of choice" they would find in a typical treatment group here, I would have told them that about 70% of the addicts around here in treatment would say opiates, like Roxicodone, and benzo's; 20% would say "meth"; 9% would be alcoholics, and there would be an odd crack addict or two. Today if you asked me the same question the only thing that would change is the type of opiate that people prefer as their drug of choice which is now buprenorphine and what they tend to use with it which varies from the prescribed Klonopin, or Neurontin, or "meth".
4. Neonatal Abstinence Syndrome is on the rise on my region due to MAT meds. In Northeast Tennessee approximately 3500 babies are born each year, about 500 suffer from NAS; thats about 15% percent of births in our area, about 45 babies a month. Of those 45 babies a month between 23 and 35 of those will require morphine or methadone to manage symptoms and their NICU stay will be about 3 weeks. NICU costs are at the minimum $3000 dollars a day, about $60000 a baby or about 1.8 million a month for our region of Tennessee. This does not include the cost of DCS involvement with the family, cost of treatment, services, etc Approximately 61% our NAS babies are a result of MAT meds.
5. We have the highest concentration of top ten MAT prescribers in the country in N.E. Tennessee, 3 of the top 10 in fact. In one community, a community of around 60,000 people, we have 59 MAT prescribing doctors.

I think that having a consistent standard of care across the board is more important right now than giving doctors in my area an extra 100 pts each.
" SAMHSA,Medication Assisted Treatment for Opioid Use Disorders,2020-12-09T01:15:23Z,SAMHSA-2016-0001-0094,https://api.regulations.gov/v4/comments/SAMHSA-2016-0001-0094,2016-04-21T04:00:00Z,Comment on FR Doc # 2016-07128,Lewis Bratton,64,see att file(s) I Lewis Bratton you can call me at 479-747-0873