text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Stop Trafficking of Pills Act'' or 
  the ``STOP Act''.
  
  SEC. 2. MEDICAID RESTRICTED RECIPIENT PROGRAM.
  
      (a) In General.--Title XIX of the Social Security Act (42 U.S.C. 
  1396 et seq.) is amended--
              (1) in section 1902(a)--
                      (A) by striking ``and'' at the end of paragraph 
                  (82);
                      (B) by striking the period at the end of paragraph 
                  (83) and inserting ``; and''; and
                      (C) by inserting after paragraph (83) the following 
                  new paragraph:
              ``(84) in accordance with section 1908B, provide for the 
          development and implementation of a restricted recipient 
          program for individuals identified as high-risk prescription 
          drug users.''; and
              (2) by inserting after section 1908A the following new 
          section:
  
    ``restricted recipient program for high-risk prescription drug users
  
      ``Sec. 1908B  (a) Identification of High-Risk Prescription Drug 
  Users.--
              ``(1) In general.--Subject to paragraph (2), the State 
          shall establish and implement a program, subject to approval by 
          the Secretary, to--
                      ``(A) identify any prescription drug that--
                              ``(i) may be dispensed on the prescription 
                          of a physician to an individual eligible to 
                          receive medical assistance under the State 
                          Medicaid program; and
                              ``(ii) presents a high risk of misuse or 
                          overutilization, as determined by the State;
                      ``(B) establish a dosage level for each 
                  prescription drug identified under subparagraph (A) 
                  that would be deemed excessive in the absence of 
                  evidence of medical necessity;
                      ``(C) using a percentile-based method or other such 
                  form of statistical analysis, identify individuals 
                  (referred to in this section as `individuals identified 
                  as high-risk prescription drug users') who are eligible 
                  for medical assistance under the State Medicaid program 
                  and--
                              ``(i) are receiving a prescription drug 
                          that has been identified under subparagraph (A) 
                          at a dosage level that has been determined to 
                          be excessive pursuant to subparagraph (B); or
                              ``(ii) are determined by the State, 
                          pursuant to the procedure established under 
                          paragraph (3), to have been convicted of a 
                          drug-related offense; and
                      ``(D) ensure that individuals identified as high-
                  risk prescription drug users pursuant to subparagraph 
                  (C) are assigned to the restricted recipient program 
                  described in subsection (b).
              ``(2) Case review.--For purposes of paragraph (1), the 
          State shall establish and implement procedures to ensure that 
          an individual who has been identified as a high-risk 
          prescription drug user and is subject to the requirements under 
          the restricted recipient program--
                      ``(A) is provided with reasonable notice regarding 
                  their assignment to the program and a description of 
                  the requirements under such program;
                      ``(B) is permitted to file an appeal with the State 
                  agency and receive a hearing thereon to review whether 
                  the individual has been properly identified as a high-
                  risk prescription drug user;
                      ``(C) for purposes of subsection (b)(1), is 
                  permitted to file a claim with the State agency in 
                  order to seek reassignment to a different physician or 
                  pharmacist; and
                      ``(D) has reasonable access to any prescription 
                  drug that is medically necessary and required to be 
                  dispensed on an emergency basis.
              ``(3) Drug-related offenses.--For purposes of paragraph 
          (1)(C)(ii), the State shall establish and implement procedures 
          to determine whether an individual, at the time of enrollment 
          or re-enrollment in the State Medicaid program, has been 
          convicted (under Federal or State law) of any offense which is 
          classified as a felony by the law of the jurisdiction involved 
          and which has as an element the unlawful possession, 
          manufacture, distribution, or dispensing of a prescription drug 
          (including opioids and similar pain-management prescription 
          drugs).
      ``(b) Restricted Recipient Program.--
              ``(1) Medicaid lock-in program.--
                      ``(A) In general.--Subject to subparagraph (B), the 
                  State shall establish and implement a program (referred 
                  to in this section as the `Medicaid Lock-in Program') 
                  to ensure that any individual identified as a high-risk 
                  prescription drug user is--
                              ``(i) assigned to a single and exclusive 
                          physician (as defined in section 1861(r)) for 
                          purposes of receiving any medical assistance 
                          that is related to a prescription drug; and
                              ``(ii) assigned to a single and exclusive 
                          pharmacy for purposes of receiving any 
                          prescription drug that has been prescribed by a 
                          physician described in clause (i).
              ``(2) Medicaid prescription drug restriction program.--
                      ``(A) In general.--Subject to subparagraph (B), the 
                  State, in conjunction with the Secretary, shall 
                  establish and implement a program to ensure that the 
                  claims processing system for the State does not permit 
                  a prescription drug to be dispensed by a provider to an 
                  individual identified as a high-risk prescription drug 
                  user if the same prescription drug has been dispensed 
                  to such individual within the previous 20 days.
                      ``(B) Exceptions.--
                              ``(i) Increased dosage.--For purposes of 
                          subparagraph (A), the restrictions described in 
                          such subparagraph shall not apply to an 
                          individual identified as a high-risk 
                          prescription drug user--
                                      ``(I) if the current prescription 
                                  is for an increased dosage of the 
                                  prescription drug and has been issued 
                                  by the same physician that issued the 
                                  previous prescription; or
                                      ``(II) in such other circumstances 
                                  as determined by the Secretary.
                              ``(ii) Procedural development.--The State, 
                          in conjunction with the Secretary, shall 
                          develop adequate procedures to ensure that 
                          prescriptions described in clause (i) are not 
                          affected by the restrictions described in 
                          subparagraph (A) and are permitted to be 
                          dispensed by a provider to an individual 
                          identified as a high-risk prescription drug 
                          user.
      ``(c) Existing State Programs.--
              ``(1) In general.--Subject to paragraphs (2) and (3), as 
          well as any procedures as are determined appropriate by the 
          Secretary, a restricted recipient program that has been 
          established by a State prior to the date of enactment of the 
          Stop Trafficking of Pills Act may be reviewed and certified by 
          the Secretary as being in accordance with the requirements 
          under this section for purposes of section 1902(a)(84).
              ``(2) Program improvement.--For purposes of paragraph (1), 
          if the Secretary does not certify an existing State restricted 
          recipient program as being in accordance with the requirements 
          under this section, the Secretary shall identify any necessary 
          enhancements or additional developments that are required in 
          order for such program to be deemed in accordance with such 
          requirements.
              ``(3) Drug-related offenses.--For purposes of paragraph 
          (1), an existing State restricted recipient program shall be 
          required to include procedures described in subsection (a)(3) 
          for the identification and inclusion of individuals convicted 
          of a drug-related offense.
      ``(d) Administrative Expenses.--Subject to such requirements as are 
  determined appropriate by the Secretary, for purposes of section 
  1903(a)(7), any amounts expended by the State to develop and implement 
  a restricted recipient program for individuals identified as high-risk 
  prescription drug users under this section, including any necessary 
  enhancements or additional developments identified under subsection 
  (c)(2), shall be considered amounts expended as necessary for the 
  proper and efficient administration of the State Medicaid plan.
      ``(e) Definitions.--For purposes of this section:
              ``(1) State medicaid program.--The term `State Medicaid 
          program' means the State program for medical assistance 
          provided under a State plan under this title, including any 
          waiver approved with respect to such State plan.
              ``(2) Prescription drug.--The term `prescription drug' 
          means a drug subject to section 503(b)(1) of the Federal Food, 
          Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).''.
      (b) Withholding of Payment.--Section 1903(i) of the Social Security 
  Act (42 U.S.C. 1396b(i)), as amended by section 2001(a)(2)(B) of the 
  Patient Protection and Affordable Care Act (Public Law 111-148), is 
  amended--
              (1) in paragraph (25), by striking ``or'' at the end;
              (2) in paragraph (26), by striking the period and inserting 
          ``; or''; and
              (3) by adding at the end the following new paragraph:
              ``(27) with respect to amounts expended for medical 
          assistance for any prescription drug dispensed to an individual 
          identified as a high-risk prescription drug user (as described 
          in section 1908B(a)(1)(C)), unless the requirements under 
          section 1908B are met.''.
  
  SEC. 3. MEDICARE RESTRICTED RECIPIENT PROGRAM.
  
      Part D of title XVIII of the Social Security Act (U.S.C. 1395w-101 
  et seq.) is amended by adding at the end the following new section:
  
    ``restricted recipient program for high-risk prescription drug users
  
      ``Sec. 1860D-44  (a) Identification of High-Risk Prescription Drug 
  Users.--
              ``(1) In general.--Subject to paragraph (2), the Secretary 
          shall establish and implement a program to--
                      ``(A) identify any prescription drug that--
                              ``(i) may be dispensed on the prescription 
                          of a physician to an individual enrolled in a 
                          prescription drug plan under this part; and
                              ``(ii) presents a high risk of misuse or 
                          overutilization, as determined by the 
                          Secretary;
                      ``(B) establish a dosage level for each 
                  prescription drug identified under subparagraph (A) 
                  that would be deemed excessive in the absence of 
                  evidence of medical necessity;
                      ``(C) using a percentile-based method or other such 
                  form of statistical analysis, identify individuals 
                  (referred to in this section as `individuals identified 
                  as high-risk prescription drug users') who are enrolled 
                  in a prescription drug plan under this part; and
                              ``(i) are receiving a prescription drug 
                          that has been identified under subparagraph (A) 
                          at a dosage level that has been determined to 
                          be excessive pursuant to subparagraph (B); or
                              ``(ii) are determined by the Secretary, 
                          pursuant to the procedure established under 
                          paragraph (3), to have been convicted of a 
                          drug-related offense; and
                      ``(D) ensure that individuals identified as high-
                  risk prescription drug users pursuant to subparagraph 
                  (C) are assigned to the restricted recipient program 
                  described in subsection (b).
              ``(2) Case review.--For purposes of paragraph (1), the 
          Secretary shall establish and implement procedures to ensure 
          that an individual who has been identified as a high-risk 
          prescription drug user and is subject to the requirements under 
          the restricted recipient program--
                      ``(A) is provided with reasonable notice regarding 
                  their assignment to the program and a description of 
                  the requirements under such program;
                      ``(B) is permitted to file an appeal and receive a 
                  hearing thereon to review whether the individual has 
                  been properly identified as a high-risk prescription 
                  drug user; and
                      ``(C) has reasonable access to any prescription 
                  drug that is medically necessary and required to be 
                  dispensed on an emergency basis.
              ``(3) Drug-related offense.--For purposes of paragraph 
          (1)(C)(ii), the Secretary shall establish and implement 
          procedures to determine whether an individual, at the time of 
          enrollment or re-enrollment in a prescription drug plan under 
          this part, has been convicted (under Federal or State law) of 
          any offense which is classified as a felony by the law of the 
          jurisdiction involved and which has as an element the unlawful 
          possession, manufacture, distribution, or dispensing of a 
          prescription drug (including opioids and similar prescription 
          pain-management drugs).
      ``(b) Prescription Drug Restriction Program.--The Secretary shall 
  establish policies and procedures to ensure that the provisions 
  described in section 1908B(b)(3) are applied to any individual 
  identified, pursuant to subsection (a)(1), as a high-risk prescription 
  drug user in a similar manner as such provisions are applied to such 
  individuals for purposes of title XIX.''.
  
  SEC. 4. EFFECTIVE DATE.
  
      (a) In General.--Except as provided in subsection (b), the 
  amendments made by this section shall take effect 120 days after the 
  date of enactment of this Act.
      (b) Extension of Effective Date for State Law Amendment.--In the 
  case of a State plan under title XIX of the Social Security Act (42 
  U.S.C. 1396 et seq.) which the Secretary determines requires State 
  legislation in order for the plan to meet the additional requirements 
  imposed by the amendments made by this section, the State plan shall 
  not be regarded as failing to comply with the requirements of the 
  amendments made by this section solely on the basis of its failure to 
  meet such additional requirements before the first day of the first 
  calendar quarter beginning after the close of the first regular session 
  of the State legislature that begins after the date of the enactment of 
  this Act. For purposes of the previous sentence, in the case of a State 
  that has a 2-year legislative session, each year of the session is 
  considered to be a separate regular session of the State legislature.
target: Stop Trafficking of Pills Act or STOP Act - Amends title XIX (Medicaid) of the Social Security Act (SSA) to require state Medicaid plans to: (1) identify prescription drugs that present a high-risk of misuse or overutilization, (2) establish a dosage level for each such drug that would be deemed excessive in the absence of evidence of medical necessity, (3) identify Medicaid-eligible individuals who are either receiving a prescription drug at excessive dosage levels or who have been convicted of a drug-related offense, and (4) ensure that they are assigned to a state-established restricted recipient program.
  
  Requires a state to establish a Medicaid Lock-in Program to ensure that a high-risk prescription drug user is assigned to: (1) a single and exclusive physician for purposes of receiving any medical assistance related to a prescription drug, and (2) a single and exclusive pharmacy to receive any physician-prescribed drug.
  
  Requires a state to establish a Medicaid prescription drug restriction program to ensure that the state claims processing system does not permit a prescription drug to be dispensed to a high-risk prescription drug user more than once every 20 days.
  
  Amends part D (Miscellaneous) of SSA title XXVIII (Medicare) to direct the Secretary of Health and Human Services (HHS) to establish a similar restricted recipient program for high-risk prescription drug users under the Medicare program.
feat_title: A bill to prevent misuse, overutilization, and trafficking of prescription drugs by limiting access to such drugs for Medicare and Medicaid beneficiaries who have been identified as high-risk prescription drug users.