Space Acquisitions: DOD Faces Significant Challenges as it Seeks to Address Threats and Accelerate Space Programs

DOD space systems provide critical capabilities that support military and other government operations. They can also be expensive to acquire and field, costing billions of dollars each year.

As DOD seeks to replenish its satellite constellations, it faces a number of challenges to ensuring funds are used effectively. Because space-based capabilities are fundamental to U.S. national security and civilian activities, it is essential that DOD manage its space system acquisitions carefully and avoid repeating past problems.

This statement provides an update on DOD's space acquisitions, focusing on challenges facing acquisitions of new space systems.

This statement is based on GAO reports issued over the past 10 years on DOD space programs. In addition it draws on recent work performed in support of GAO's 2019 annual reports on the progress of major defense acquisition programs as well as duplication, overlap, and fragmentation across the federal government, among other sources.

DOD is simultaneously undertaking new major acquisitions to replenish its missile warning, protected communications, navigation, and weather satellites. At the same time, it is boosting efforts to increase space situational awareness and protect space assets. Such widespread acquisition acitivites could face a wide range of resource and management challenges that GAO has reported on, including:

Growing threats to satellites. Threats to satellites from both adversaries—such as jamming and cyber attacks—and space debris are increasing. DOD is making changes to how it designs its space systems to increase the resilience and survivability of space capabilities. But it has been challenged in adopting new approaches, such as using commercial satellites to host payloads, and in prioritizing cybersecurity for all of its weapon systems. For hosted payloads, GAO recommended, and DOD concurred, that the department bolster and centralize collection and analysis of cost, technical, and lessons learned data.

Implementing leadership changes . DOD is planning major changes to leadership for space. It recently proposed legislation to establish a United States Space Force—initially to be housed within the Department of the Air Force—that would, according to the President's Space Policy Directive, consolidate existing military space activities and minimize duplicative efforts across DOD. GAO found in July 2016 that changes are needed to reduce fragmentation that has negatively affected space programs for many years. But open questions remain about governance as new programs get underway and whether the changes themselves may result in further fragmentation. For example, it is unclear at this time how the new Space Development Agency will mesh with organizations currently involved in testing and acquiring new space technologies.

Having the right resources and know-how. While there is increased attention on funding for space and building the Space Force, new programs can still face resource challenges. DOD has begun over 9 new space programs at a time when it is also seeking increased investments in ships, aircraft, and the nuclear triad, among other programs. Moreover, it is unclear whether DOD has a sufficient workforce to manage its new programs. GAO issued a report last month that found DOD does not routinely monitor the size, mix, and location of its space acquisition workforce. Further, DOD has difficulty attracting and retaining candidates with the requisite technical expertise. GAO recommended that DOD collect and maintain data on its space acquisition workforce. DOD did not concur, but GAO maintains that DOD should have better information on such personnel, especially in light of its proposal for establishing the Space Force. GAO also found in March 2019 that selected software-intensive space programs often did not effectively engage users to understand requirements and obtain feedback. GAO recommended, and DOD concurred, that the department ensure its guidance addressing software development provides specific, required direction on the timing, frequency, and documentation of user involvement and feedback.

Past GAO reports have recommended that DOD adopt acquisition best practices to help ensure cost and schedule goals are met. DOD has generally agreed and taken some actions to address these recommendations.

I am pleased to have the opportunity to discuss the Department of  Defense’s (DOD) space system acquisitions. DOD’s space systems  provide critical capabilities that support military and other government  operations and can take years to develop, produce, and launch. These  systems can also be expensive to acquire and field, amounting to billions  of dollars each year. Given the time and resource demands of DOD’s  space systems and the need for funds to be used effectively, and  because space-based capabilities are fundamental to U.S. national  security and civilian activities, it is essential that DOD manage space  system acquisitions carefully and avoid repeating past problems.

My statement will focus on (1) the current status and cost of major DOD  space programs and (2) challenges facing acquisitions of new space  systems.

This statement is based on our reports on DOD space programs issued  over the past 10 years and recent work performed in support of our  annual weapon systems assessments to be issued later this year. It is  also based on space-related work in support of our forthcoming 2019  annual report on duplication, overlap, and fragmentation across the  federal government; and our updates on cost increases, investment  trends, and improvements in the last year. More information on our  objectives, scope, and methodology is available in our related products,  which are listed at the end of this statement.

More detailed information on our objectives, scope, and methodology for  our work can be found in the issued reports. We conducted the work on  which this statement is based in accordance with generally accepted  government auditing standards. Those standards require that we plan  and perform the audit to obtain sufficient, appropriate evidence to provide  a reasonable basis for our findings and conclusions based on our audit  objectives. We believe that the evidence obtained provides a reasonable  basis for our findings and conclusions based on our audit objectives.

DOD space systems support and provide a wide range of capabilities to a  large number of users, including the military services, the intelligence  community, civil agencies, and others. These capabilities include  positioning, navigation, and timing; meteorology; missile warning; and  secure communications, among others. Space systems can take a long  time to develop and involve multiple segments, including space, ground  control stations, terminals, user equipment, and launch, as figure 1 below  shows. DOD satellite systems are also expensive to acquire. Unit costs  for current DOD satellites can range from $500 million to over $3 billion.  The associated ground systems can cost over $6 billion to develop and  maintain and the cost to launch a satellite can climb to well over $100  million.

Table 1 provides highlights of the current status of DOD’s major space  programs. As the table shows, DOD is also in the beginning phases of  acquiring several constellations of new satellites and ground processing  capabilities—including for missile warning, protected communications,  space-based environmental monitoring, and space command and control.  We have work underway to assess the Air Force’s space command and  control development efforts and examine DOD’s analysis of alternatives  for wideband communication services. For a more complete description of  these major space programs, see appendix I. In addition, DOD is  exploring alternatives for acquiring wideband satellite communications as  well as funding development of new launch vehicles as it pursues a new  acquisition strategy for procuring launch services.

Our prior work has shown that many major DOD space programs have  experienced significant cost increases and schedule delays. For instance,  the total program cost for the Advanced Extremely High Frequency  (AEHF) satellite program, a protected satellite communications system,  has grown 117 percent since the program’s original cost estimate and its  first satellite was launched more than 3.5 years late. For the Space Based  Infrared System (SBIRS), a missile warning satellite program, the  program cost grew 265 percent from its original estimate and the launch  of the first satellite was delayed roughly 9 years. Both programs moved to  the production phase where fewer problems tend to surface, and where  there is typically less risk of significant cost and schedule growth. A more  recent major satellite program, Global Positioning System (GPS) III, has  seen an almost 4-year delay due to technical issues and program cost  growth of about 32 percent.

Cost and schedule growth has also been a challenge for satellite ground  systems and user equipment. Ground system delays have been so  lengthy, that satellites sometimes spend years in orbit before key  capabilities can be fully exploited. For example,

The command and control system for GPS III satellites, known as the  Next Generation Operational Control System, or OCX, is  approximately 5 years behind schedule. As a result, the Air Force has  had to start two separate back-up efforts to modify the current ground  system to ensure the continuity of GPS capabilities and to make anti- jamming capabilities available via Military Code, or M-code, until OCX  is delivered. Our ongoing review of GPS includes an assessment of  OCX schedule risk and potential impacts on OCX delivery,  acceptance, and operation. We expect to issue our report on GPS in  spring 2019.

Development of GPS user equipment that can utilize the M-Code  signal has lagged behind the fielding of GPS M-code satellites for  more than a decade, due to prolonged development challenges. In  December 2017, we found that while DOD had made some progress  on initial testing of the receiver cards needed to utilize the M-code  signal, additional development was necessary to make M-code work  with the over 700 weapon systems that require it. We also found that  DOD had begun initial planning to transition some weapon systems to  use M-code receivers, but significantly more work remained to  understand the cost and schedule of transitioning to M-code receivers  across DOD. Further, in December 2017, we found that multiple  entities were separately maturing their own receiver cards. We  recommended that DOD assign responsibility to a single organization  to collect test data, lessons learned, and design solutions so that  common design solutions are employed and DOD could avoid  duplication of efforts. DOD concurred with the recommendation, but  has not yet taken action on it.

We have previously reported that over 90 percent of the capabilities to  be provided by Mobile User Objective System communications   satellites—currently, five satellites are in orbit, the first of which  launched in 2012—are being underutilized because of difficulties with  integrating the space, ground, and terminal segments and delays in  fielding compatible user terminals.

Largely because of technical and management challenges, the Joint  Space Operations Center Mission System (JMS) Increment 2  program—intended to replace and improve upon an aging space  situational awareness and command and control system—was almost  3 years behind schedule and 42 percent over budget before the Air  Force stopped development work last year. Last month, we reported  that operational testing in 2018 found that JMS Increment 2 was not  operationally effective or suitable due, in part, to missing software  requirements, urgent deficiencies that affected system performance,  and negative user feedback.

Cost and schedule growth in DOD’s space programs is sometimes driven  by the inherent risks associated with developing complex space  technology; however, over the past 10 years we have identified a number  of other management and oversight problems that have worsened the  situation. These include making overly optimistic cost and schedule  estimates, pushing programs forward without sufficient knowledge about  technology and design, and experiencing problems in overseeing and  managing contractors, among others. We have also noted that some of  DOD’s programs with operational satellites, such as SBIRS, were also  exceedingly ambitious, which in turn increased technology, design, and  engineering risks. While SBIRS and other satellite programs provide  users with important and useful capabilities, their cost growth has  significantly limited the department’s buying power at a time when more  resources may be needed to protect space systems and recapitalize the  space portfolio.

Challenges Facing Acquisitions of New Space Systems

DOD faces significant challenges as it replenishes its satellite  constellations. First, DOD is confronted with growing threats in space,  which may require very different satellite architectures and acquisition  strategies. Second, DOD is in the midst of planning major changes to its  leadership for space. While these changes are designed to streamline  decision-making and bring together a dispersed space workforce, they  could cause some disruption to space system acquisition programs.  Third, in fiscal year 2016, Congress required DOD to establish guidance  to speed up acquisition timeframes by streamlining acquisition processes  and oversight for certain acquisitions. GAO is examining DOD’s  application of streamlining to its weapons programs. For space,  challenges with past streamlining efforts may offer some lessons learned.  And fourth, DOD may face resource and capacity challenges in taking on  multiple space acquisitions at one time. For example, our work and other  reports point to potential gaps in the space acquisition workforce and  ongoing difficulties managing software development.

Growing Threats to Satellites Require New Approaches

According to Air Force Space Command and others, U.S. space systems  face intentional and unintentional threats that have increased rapidly over  the past 20 years. These include radio frequency interference (including  jamming), laser attacks, kinetic intercept vehicles, and ground system  attacks. Additionally, the hazards of the already-harsh space environment  (e.g., extreme temperature fluctuations and radiation) have increased,  including numbers of active and inactive satellites, spent rocket bodies,  and other fragments and debris. According to a February 2019 Defense  Intelligence Agency report, China and Russia in particular are developing  a variety of means to exploit perceived U.S. reliance on space-based  systems and challenge the U.S. position in space. The report also states  that Iran and North Korea have demonstrated some counterspace  capabilities that could pose a threat to militaries using space-based  services.

In response, recent governmentwide and DOD strategic and policy  guidance have stressed the need for U.S. space systems to be survivable  or resilient against such threats and DOD has taken steps to be more  resilient in some of its new programs. As we found in October 2014, one  way to do this is to build more disaggregated systems, including  dispersing sensors onto separate satellites; using multiple domains,  including space, air, and ground to provide full mission capabilities;  hosting payloads on other government or commercial spacecraft; or some  combination of these. With capabilities distributed across multiple  platforms, rather than centralized onto just a few satellites, it may be more  difficult for an adversary to target all assets to attack full system  capabilities, and if an attack does take place, the loss of one smaller  satellite or payload could result in less capability loss than damage to, or  loss of, a large multifunctional satellite. In addition to disaggregation,  DOD could make satellites more maneuverable and build in defense  capabilities to protect themselves as a means to increase survivability.

We also found in October 2014 that some of these options could have  beneficial impacts on acquisition. For example, acquiring smaller, less  complex satellites may require less time and effort to develop and  produce. This may be in part due to improved requirements discipline, as  more frequent production rates may allow program managers to delay  new requirements to the next production cycle instead of incorporating  them into ongoing timelines midstream. Building more, less-complex  satellites might also provide DOD the opportunity to use commercial  products and systems that have already been tested in the market. At the  same time, however, addressing the need to make satellites more  resilient could introduce complications. For example, DOD may need to  acquire higher quantities of satellites, which may make it more difficult to  manage acquisition schedules. In addition, potentially more development  and production contracts may result in more complexity for program  offices to manage, requiring increased oversight of contractors. Adding  more satellites and new technologies may also complicate efforts to  synchronize satellite, terminal, and ground system schedules, limiting  delivery of capabilities to end users.

Our work has also found potential barriers to making satellites more  resilient. For example, in October 2014, we found that disaggregation  could require DOD to make significant cultural and process changes in  how it acquires space systems—for instance, by relying on new  contractors, relinquishing control to providers who host government  payloads on commercial satellites, using different contracting methods,  and executing smaller but more numerous and faster-paced acquisition  programs. It will likely require DOD to be more flexible and agile when it comes to satellite acquisitions, especially with regard to coordinating  satellite delivery with interdependent systems, such as user equipment.  Yet, as we have previously found, DOD’s culture has generally been  resistant to changes in space acquisition approaches, and fragmented  responsibilities have made it very difficult to coordinate and deliver  interdependent systems. Senior leaders have recognized the need to  change the space acquisition culture, and as discussed below, changes  are being made to space leadership and acquisition approaches.

More recently, in July 2018, we found that two factors have contributed to  DOD’s limited use of commercially hosted payloads. First, DOD officials  identified logistical challenges to matching government payloads with any  given commercial host satellite. For example, most of the offices we  spoke with cited size, weight, and power constraints, among others, as  barriers to using hosted payloads. Second, while individual DOD offices  have realized cost and schedule benefits from using hosted payloads,  DOD as a whole has limited information on costs and benefits of hosted  payloads. Further, the knowledge DOD obtained is fragmented across the  agency—with multiple offices collecting piecemeal information on the use  of hosted payloads. The limited knowledge and data on hosted payloads  that is fragmented across the agency has contributed to resistance  among space acquisition officials to adopting this approach. We  recommended, and DOD concurred, that the department bolster and  centralize collection and analysis of cost, technical, and lessons learned  data on its use of hosted payloads.

Lastly, in October 2018, we found that DOD faced mounting challenges in  protecting its weapon systems—satellites and their ground systems  included—from increasingly sophisticated cyber threats. We reported  that this was due to the computerized nature of weapon systems, DOD’s  late start in prioritizing weapon system cybersecurity, and DOD’s nascent  understanding of how to develop more secure weapon systems. In  operational testing, DOD routinely found mission-critical cyber  vulnerabilities in systems that were under development, yet program  officials GAO met with believed their systems were secure and even  discounted some test results as unrealistic. Using relatively simple tools  and techniques, testers were able to take control of systems and operate  largely undetected, due in part to basic issues such as poor password  management and unencrypted communications. DOD has recently taken  several steps to improve weapon system cybersecurity, including issuing  and revising policies and guidance to better incorporate cybersecurity  considerations. Further, in response to congressional direction, DOD has  also begun initiatives to better understand and address cyber  vulnerabilities.

Space Leadership Changes Are a Positive Step, But Have Some Risk

We and others have reported for over two decades that fragmentation  and overlap in DOD space acquisition management and oversight have  contributed to program delays and cancellations, cost increases, and  inefficient operations. For example, in February 2012 we found that  fragmented leadership contributed to a 10-year gap between the delivery  of GPS satellites and associated user equipment. The cancellations of  several large programs over the past 2 decades were in part because of  disagreements and conflicts among stakeholders.

In July 2016, in response to a provision of a Senate Report  accompanying a bill for the National Defense Authorization Act for Fiscal  Year 2016, we issued a report that reviewed space leadership in more  depth and concluded that DOD space leadership was fragmented. We  identified approximately 60 stakeholder organizations across DOD, the  Executive Office of the President, the Intelligence Community, and civilian  agencies. Of these, eight organizations had space acquisition  management responsibilities; eleven had oversight responsibilities; and  six were involved in setting requirements for defense space programs. At  the same time, many experts stated that no one seemed to be in charge  of space acquisitions. Our report highlighted the pros and cons of various  options to reorganize space functions recommended in prior  congressionally-chartered studies. The issue has taken on more  importance in recent years, as DOD has realized satellites are highly vulnerable to attacks and needs to make dramatic changes in space  system architectures and operations. We have found that leadership has  not been focused enough to overcome interagency rivalries and  resistance to change, and it has not been able to get concurrence on  future architectures.

The President’s Administration and DOD have taken significant steps to  change space leadership. Most recent is the President’s Space Policy  Directive-4, issued on February 19, 2019, and DOD’s subsequent  legislative proposal submitted on March 1, 2019, to establish a United  States Space Force as a sixth branch of the United States Armed Forces  within the Department of the Air Force. The Policy Directive states that  this is an important step toward a future military department for space and  that the Space Force will (1) consolidate existing forces and authorities  for military space activities, as appropriate, to minimize duplication of  effort and eliminate bureaucratic inefficiencies; and (2) not include the  National Aeronautics and Space Administration, the National Oceanic and  Atmospheric Administration, the National Reconnaissance Office, or other  non-military space organizations or missions of the United States  Government.

According to the Policy Directive, the Space Force would include the  uniformed and civilian personnel conducting and directly supporting  space operations from all DOD Armed Forces, assume responsibilities for  all major military space acquisition programs, and create the appropriate  career tracks for military and civilian space personnel across all relevant  specialties. Pertaining to organization and leadership, the Policy Directive  states that there should be a civilian Under Secretary of the Air Force for  Space, to be known as the Under Secretary for Space, appointed by the  President, and establishes a Chief of Staff of the Space Force, who would  serve as a member of the Joint Chiefs of Staff.

Furthermore, the Policy Directive states that as the Space Force matures,  and as national security requires, it will become necessary to create a  separate military department, to be known as the Department of the  Space Force. This department would take over some or all  responsibilities for the Space Force from the Department of the Air Force.

The Policy Directive requires the Secretary of Defense to conduct  periodic reviews to determine when to recommend that the President  seek legislation to establish such a department.

Our past work has identified fragmentation in space leadership, but  because implementation has not yet occurred, it remains to be seen  whether this policy directive and proposed legislation would resolve these  issues. In implementing these changes there are many complexities to  consider. For example, because space capabilities are acquired and used  across the military services and defense agencies, it will be important to  address many details on how to implement a Space Force among these  equities. Our past work suggests that without close attention to the  consequences of the compromises that will inevitably have to be made to  carve out a new force structure from existing space functions, there is risk  of exacerbating the fragmentation and ineffective management and  oversight the Space Force is intended to address. For instance, in March  2019, DOD established the Space Development Agency to unify and  integrate efforts across DOD to define, develop, and field innovative  solutions. But it is unclear how this new organization will mesh with the  Air Force Space and Missile Systems Center, which acquires satellites,  the Defense Advanced Research Projects Agency, which creates  breakthrough technologies and capabilities, and similar organizations.

Moreover, even if changes are implemented effectively, they are only a  first step toward addressing space acquisition problems. As we discuss  below, programs will still need to embrace acquisition best practices, such  as using demonstrable knowledge to make decisions. Our prior work has  found that they will also need to be open to flexible and innovative  approaches, and work effectively with a very wide range of stakeholders,  including those that will not be part of the Space Force, such as the  intelligence agencies, civilian space agencies, the current military  services, as well as entities within the Office of the Secretary of Defense  who help oversee and manage acquisitions. Senior leaders have  acknowledged that additional changes are needed and have taken steps  to help bring them about, such as the restructuring of the Air Force’s  Space and Missile Systems Center, which is designed to break down  stovepipes and streamline acquisition processes.

Past Streamlining Efforts Offer Lessons Learned

DOD is managing a number of new space acquisition programs using a  new authority, established under Section 804 of the National Defense  Authorization Act for Fiscal Year 2016, which is to provide a streamlined  alternative to the traditional DOD acquisition process. Specifically, the  programs—which include follow-on missile warning and protected  communications satellites, among others—will be exempted from the  acquisition and requirements processes defined by DOD Directive  5000.01 and the Joint Capabilities Integration and Development  System. Instead, program managers are encouraged to use a tailored  approach to documentation and oversight to enable them to demonstrate  new technologies or field new or updated systems within 2 to 5 years. We  have ongoing work looking across the military departments at how  middle-tier acquisition authority is being implemented, including for the Air  Force’s space acquisition programs, and plan to issue a report later this  spring.

GAO and others have highlighted lessons learned from past efforts to  streamline, specifically with an approach adopted for space systems in  the 1990s known as Total System Performance Responsibility  (TSPR). TSPR was intended to facilitate acquisition reform and enable  DOD to streamline its acquisition process and leverage innovation and  management expertise from the private sector. Specifically, TSPR gave a  contractor total responsibility for the integration of an entire weapon  system and for meeting DOD’s requirements. We found in May 2009 that  because this reform made the contractor responsible for day-to-day  program management, DOD did not require formal deliverable  documents—such as earned value management reports—to assess the  status and performance of the contractor. As a result, DOD’s capability  to lead and manage the space acquisition process diminished, which  magnified problems related to unstable requirements and poor contractor  performance. Further, the reduction in DOD oversight and involvement  led to major reductions in various government capabilities, including cost- estimating and systems-engineering staff. This, in turn, led to a lack of  technical data needed to develop sound cost estimates.

Best practices that we identified in the aftermath of TSPR include  retaining strong oversight and insight into programs; using quantifiable  data and demonstrable knowledge to make decisions to proceed, not  allowing development to proceed until certain thresholds are met,  empowering program managers to make decisions on the direction of the  program but also holding them accountable for their choices, and  canceling unsuccessful programs. Similarly, in its study of TSPR  programs, the Defense Science Board/Air Force Scientific Advisory Board  Joint Task Force emphasized the importance of managing requirements,  sufficiently funding programs, participating in trade-off studies, and  assuring that proven engineering practices characterize program  implementation, among other actions. See appendix II for a more  complete list of the best practices we have identified for developing  complex systems.

DOD May Face Resource and Capacity Challenges in Taking on Multiple Programs at One Time

DOD is simultaneously undertaking new major acquisition efforts to  replenish its missile warning, protected communications, GPS, and  weather satellites. At the same time, it is boosting efforts to increase  space situational awareness and protect space assets. It is also helping  to fund the development of new launch vehicles, and it is considering  additional significant acquisitions in wideband satellite communications  and in support of missile defense activities. While there is increased  attention within DOD on funding for space and building the Space Force,  such widespread acquisition activities could still pose resource  challenges. For example:

Funding requests for space system modernization have in the past 10  years represented a small percentage (3.9 to 5 percent) of total  weapon system modernization funding DOD requested. Space is  competing with ships, aircraft, and the nuclear triad, among other  programs for funding. This can be challenging, because over the past  2 years, DOD has begun over 9 new space acquisition programs to  recapitalize current space capabilities and enhance system  resiliency. In the past, we have found that it has been difficult for  DOD to fund multiple new space programs at one time, particularly  when it was concurrently struggling with cost overruns and schedule  delays from its legacy programs. For example, OCX system  development challenges have resulted in a $2.5 billion cost increase  and approximate 5-year delay to the system becoming operational— using more resources for a longer time—at a cost to other programs.

It is unclear whether DOD has a sufficient workforce to manage  multiple new space programs. We issued a report last month that  found DOD did not routinely monitor the size, mix, and location of its  space acquisition workforce. We collected and aggregated data  from multiple DOD space acquisition organizations and found that at  least 8,000 personnel in multiple locations nationwide were working  on space acquisition activities at the end of 2017. Echoing concerns  raised in our prior work, we also found that DOD had difficulty  attracting and retaining candidates with the requisite technical  expertise. Officials from the Air Force’s Space and Missile Systems  Center were concerned that there are not enough experienced mid- level acquisition personnel and also expressed concern that the bulk  of military personnel assigned to program management positions  were more junior in rank than the Center was authorized to obtain. We  recommended that DOD (1) identify the universe of its space  acquisition programs and the organizations that support them, and (2)  collect and maintain data on the workforce supporting these  programs. DOD concurred with our first recommendation but not the  second.

Software is an increasingly important enabler of DOD space systems.

However, DOD has struggled to deliver software-intensive space  programs that meet operational requirements within expected time  frames. Although user involvement is critical to the success of any  software development effort, we found in our report issued last month  on DOD software-intensive space programs that the programs we  reviewed that experienced cost or schedule breaches often did not  effectively engage users to understand requirements and obtain  feedback. Program efforts to involve users and incorporate feedback frequently did not match plans. The lack of user engagement has  contributed to systems that were later found to be operationally  unsuitable. The programs we reviewed also faced challenges in  delivering software in shorter time frames, and in using commercial  software, applying outdated tools and metrics, as well as having  limited knowledge and training in newer software development  techniques. DOD acknowledged these challenges and is taking steps  to address them, including identifying useful software development  metrics and ways to include them in new contracts. We  recommended, and DOD concurred, that the department ensure its  guidance addressing software development provides specific,  required direction on the timing, frequency, and documentation of user  involvement and feedback. Moreover, it should be noted that software  development has been a struggle for other non-space weapons  programs as well. The Defense Innovation Board recently reported  that the department’s current approach to software development is  broken and is a leading source of risk to DOD—it takes too long, is  too expensive, and exposes warfighters to unacceptable risk by  delaying their access to the tools they need to assure mission  success.

Chairman Cooper, Ranking Member Turner, and Members of the  Subcommittee, this concludes my statement. I am happy to answer any  questions that you have.

If you or your staff have any questions about this statement, please  contact me at (202) 512-4841 or chaplainc@gao.gov. Contacts for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this statement. Individuals who made key contributions to  this statement include Rich Horiuchi, Assistant Director; Erin Cohen  (Analyst in Charge); Emily Bond; Claire Buck; Maricela Cherveny; Susan  Ditto; Burns C. Eckert; Laura Hook; and Anne Louise Taylor. Key  contributors for the previous work on which this statement is based are  listed in the products cited.

Appendix I: Status of Major Department of Defense Space Acquisitions

Appendix II: Best Practices GAO Has Identified for Space and Weapons Systems Acquisitions

Our previous work on weapons acquisitions in general, and space  programs in particular, identified best practices for developing complex  systems. We summarize these best practices in table 3, below.

DOD Space Acquisitions: Including Users Early and Often in Software  Development Could Benefit Programs. GAO-19-136. Washington, D.C.:  March 18, 2019.

Defense Space Systems: DOD Should Collect and Maintain Data on Its  Space Acquisition Workforce. GAO-19-240. Washington, D.C.: March 14,  2019.

Weapon Systems Cybersecurity: DOD Just Beginning to Grapple with  Scale of Vulnerabilitie. GAO-19-128. Washington, D.C.: October 9, 2018.

Military Space Systems: DOD’s Use of Commercial Satellites to Host  Defense Payloads Would Benefit from Centralizing Data. GAO-18-493.  Washington, D.C.: July 30, 2018.

Weapon Systems Annual Assessment: Knowledge Gaps Pose Risks to  Sustaining Recent Positive Trends. GAO-18-360SP. Washington, D.C.:  April 25, 2018.

Global Positioning System: Better Planning and Coordination Needed to  Improve Prospects for Fielding Modernized Capability. GAO-18-74.  Washington, D.C.: December 12, 2017.

Space Launch: Coordination Mechanisms Facilitate Interagency  Information Sharing on Acquisitions GAO-17-646R. Washington D.C.:  August 9, 2017  Satellite Acquisitions: Agencies May Recover a Limited Portion of  Contract Value When Satellites Fail. GAO-17-490. Washington, D.C.:  June 9, 2017  Space Acquisitions: DOD Continues to Face Challenges of Delayed  Delivery of Critical Space Capabilities and Fragmented Leadership.  GAO-17-619T. Washington, D.C.: May 17, 2017.

Defense Acquisitions: Assessments of Selected Weapon Programs.  GAO-17-333SP. Washington, D.C.: March 30, 2017.

Global Positioning System: Observations on Quarterly Reports from the  Air Force. GAO-17-162R. Washington, D.C.: October 17, 2016.

Defense Space Acquisitions: Too Early to Determine if Recent Changes  Will Resolve Persistent Fragmentation in Management and Oversight.  GAO-16-592R. Washington, D.C.: July 27, 2016.

Evolved Expendable Launch Vehicle: DOD Is Assessing Data on  Worldwide Launch Market to Inform New Acquisition Strategy.  GAO-16-661R. Washington, D.C.: July 22, 2016  Defense Weather Satellites: DOD Faces Acquisition Challenges for  Addressing Capability Needs. GAO-16-769T, Washington, D.C.: July 7,  2016.

Defense Weather Satellites: Analysis of Alternatives is Useful for Certain  Capabilities, but Ineffective Coordination Limited Assessment of Two  Critical Capabilities. GAO-16-252R. Washington, D.C.: March 10, 2016.

Space Acquisitions: Challenges Facing DOD as it Changes Approaches  to Space Acquisitions. GAO-16-471T. Washington, D.C.: March 9, 2016.

Space Acquisitions: GAO Assessment of DOD Responsive Launch  Report. GAO-16-156R. Washington, D.C.: October 29, 2015.

Space Situational Awareness: Status of Efforts and Planned Budgets.  GAO-16-6R. Washington, D.C.: October 8, 2015.

GPS: Actions Needed to Address Ground System Development Problems  and User Equipment Production Readiness. GAO-15-657. Washington,  D.C.: September 9, 2015.

Evolved Expendable Launch Vehicle: The Air Force Needs to Adopt an  Incremental Approach to Future Acquisition Planning to Enable  Incorporation of Lessons Learned. GAO-15-623. Washington, D.C.:  August 11, 2015.

Defense Satellite Communications: DOD Needs Additional Information to  Improve Procurements. GAO-15-459. Washington, D.C.: July 17, 2015.

Space Acquisitions: Some Programs Have Overcome Past Problems, but  Challenges and Uncertainty Remain for the Future. GAO-15-492T.  Washington, D.C.: April 29, 2015.

Space Acquisitions: Space Based Infrared System Could Benefit from  Technology Insertion Planning. GAO-15-366. Washington, D.C.: April 2,  2015.

Defense Acquisitions: Assessments of Selected Weapon Programs.  GAO-15-342SP. Washington, D.C.: March 12, 2015.

Defense Major Automated Information Systems: Cost and Schedule  Commitments Need to Be Established Earlier. GAO-15-282. Washington,  D.C.: February 26, 2015.

DOD Space Systems: Additional Knowledge Would Better Support  Decisions about Disaggregating Large Satellites. GAO-15-7. Washington,  D.C.: October 30, 2014.

U.S. Launch Enterprise: Acquisition Best Practices Can Benefit Future  Efforts. GAO-14-776T. Washington, D.C.: July 16, 2014.  2014 Annual Report: Additional Opportunities to Reduce Fragmentation,  Overlap, and Duplication and Achieve Other Financial Benefits.  GAO-14-343SP. Washington, D.C.: April 8, 2014.

Defense Acquisitions: Assessments of Selected Weapon Programs.  GAO-14-340SP. Washington, D.C.: March 31, 2014.

Space Acquisitions: Acquisition Management Continues to Improve but  Challenges Persist for Current and Future Programs. GAO-14-382T.  Washington, D.C.: March 12, 2014.

Evolved Expendable Launch Vehicle: Introducing Competition into  National Security Space Launch Acquisitions. GAO-14-259T.  Washington, D.C.: March 5, 2014.

The Air Force’s Evolved Expendable Launch Vehicle Competitive  Procurement. GAO-14-377R. Washington, D.C.: March 4, 2014.

Space Acquisitions: Assessment of Overhead Persistent Infrared  Technology Report. GAO-14-287R. Washington, D.C.: January 13, 2014.

Space: Defense and Civilian Agencies Request Significant Funding for  Launch-Related Activities. GAO-13-802R. Washington, D.C.: September  9, 2013.

Global Positioning System: A Comprehensive Assessment of Potential  Options and Related Costs is Needed. GAO-13-729, Washington, D.C.:  September 9, 2013.

Space Acquisitions: DOD Is Overcoming Long-Standing Problems, but  Faces Challenges to Ensuring Its Investments are Optimized.  GAO-13-508T. Washington, D.C.: April 24, 2013.

Satellite Control: Long-Term Planning and Adoption of Commercial  Practices Could Improve DOD’s Operations. GAO-13-315. Washington,  D.C.: April 18, 2013.

Defense Acquisitions: Assessments of Selected Weapon Programs.  GAO-13-294SP. Washington, D.C.: March 28, 2013.

Launch Services New Entrant Certification Guide. GAO-13-317R.  Washington, D.C.: February 7, 2013.

Evolved Expendable Launch Vehicle: DOD Is Addressing Knowledge  Gaps in Its New Acquisition Strategy. GAO-12-822. Washington, D.C.:  July 26, 2012.

Space Acquisitions: DOD Faces Challenges in Fully Realizing Benefits of  Satellite Acquisition Improvements. GAO-12-563T. Washington, D.C.:  March 21, 2012.

Space and Missile Defense Acquisitions: Periodic Assessment Needed to  Correct Parts Quality Problems in Major Programs. GAO-11-404.  Washington, D.C.: June 24, 2011.

Space Acquisitions: Development and Oversight Challenges in Delivering  Improved Space Situational Awareness Capabilities. GAO-11-545.  Washington, D.C.: May 27, 2011.

Space Acquisitions: DOD Delivering New Generations of Satellites, but  Space System Acquisition Challenges Remain. GAO-11-590T.  Washington, D.C.: May 11, 2011.

Global Positioning System: Challenges in Sustaining and Upgrading  Capabilities Persis., GAO-10-636. Washington, D.C.: September 15,  2010.

Defense Acquisitions: Challenges in Aligning Space System  Components. GAO-10-55. Washington D.C.: October 29, 2009.

This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.

This testimony updates the House on DOD space system acquisitions, such as satellites and ground equipment.

Our work has found many major DOD space programs exceed their budgets and are late. For instance, the cost of a satellite communications system has grown 117% and its first launch was delayed more than 3.5 years.

Today, as DOD is simultaneously undertaking major acquisitions to replenish missile warning, communications, navigation, and weather satellites, it faces:

Growing threats to satellites including cyber attacks and space debris

Funding and acquisition workforce challenges


Opioid Use Disorder: Barriers to Medicaid Beneficiaries' Access to Treatment Medications

Almost 70,000 people died from drug overdoses in 2018, an estimated 69 percent of which involved opioids. Medicaid, a joint federal-state health care program for low-income and medically needy individuals, is one of the largest sources of coverage for individuals undergoing treatment for opioid use disorder.

Congress included a provision in statute for GAO to review access barriers to MAT medications, including the distribution methods. This report describes policies that can restrict Medicaid beneficiaries' access to MAT medications, including any related to the distribution methods.

To do this work, GAO reviewed relevant laws, policies, and documents, as well as studies describing access barriers and the benefits and challenges of the distribution methods. GAO also interviewed federal officials; stakeholders representing state Medicaid directors, health care providers, patients, and pharmacies; and state officials and health care providers from Minnesota, North Carolina, and Ohio, as well as the District of Columbia. GAO selected these three states and the District of Columbia based on their Medicaid programs' coverage of the MAT medications, their programs' spending for the treatment of opioid use disorder, and other criteria.

Medication-assisted treatment (MAT)—which combines behavioral therapy and the use of certain medications, such as buprenorphine—has been shown to be effective at reducing the misuse of or addiction to opioids and increasing treatment retention. The federal government has identified expanding access to MAT as important for reducing opioid use disorders and overdoses, and has taken action to increase access. However, GAO found that some state and federal policies can restrict Medicaid beneficiaries' access to MAT medications. Some of these policies, and three selected states' and the District of Columbia's efforts to address potential access barriers, include the following:

MAT medication coverage. A 2018 study found that about 40 percent of states may not provide Medicaid coverage for some formats of MAT medications, such as injectable and implantable formats, as required by federal law; however, the Centers for Medicare & Medicaid Services (CMS), which oversees Medicaid, has not determined the extent to which states are in compliance with the federal requirements to cover MAT medications.

Prior authorization requirements. Some MAT medications and formats are subject to prior authorization, which requires these medications to be pre-approved before being covered by Medicaid. While these requirements are generally used to reduce expenditures, unnecessary utilization, and improper payments, stakeholders told GAO the requirements may cause life-threatening delays in the case of MAT medications. Some states, including three states and the District of Columbia that GAO reviewed, have taken steps to remove prior authorization requirements for MAT medications.

Distribution methods. States may mandate the ways MAT medications can be distributed. For example, Minnesota's fee-for-service plan requires the use of the buy-and-bill distribution method for all injectable and implantable medications. This method requires providers, such as physicians, to purchase and store these medications until administered to the patient, allowing immediate access to the MAT medication for Medicaid beneficiaries. However, for expensive injectable medications, which can cost $1,200 per treatment, this method places providers at financial risk if the medication is not used or the reimbursement is less than the providers' costs, requiring resources some providers may lack, according to providers in the selected states and District of Columbia. As a result, some states have removed such restrictions to maximize beneficiary access.

Federal waiver for prescribing buprenorphine. According to stakeholders GAO interviewed, some providers are unwilling to obtain the federal waiver necessary to prescribe or administer buprenorphine for opioid use disorder—due to reasons such as the hours of training associated with the waiver—which can restrict beneficiary access to this MAT medication. In addition, while nurse practitioners and physician assistants are eligible for these waivers, some state laws require them to be supervised by a physician. Stakeholders told GAO that some nurse practitioners may find it difficult to identify a qualified physician, which may affect patient access to MAT.

GAO recommends that CMS determine the extent to which states are in compliance with federal requirements to cover MAT medications, and take action as appropriate. HHS concurred with this recommendation.

The misuse of and addiction to prescription opioid pain relievers (such as  oxycodone) and illicit opioids (such as heroin) has become a significant  public health problem in the United States. In 2018, an estimated 2 million  Americans age 12 or older had an opioid use disorder (OUD)—the  misuse of or addiction to opioids—according to the Substance Abuse and  Mental Health Services Administration (SAMHSA). According to the  latest, preliminary data from the Centers for Disease Control and  Prevention, in 2018, almost 70,000 Americans died of a drug overdose,  with an estimated 69 percent of those deaths involving an opioid. For  those with OUD, research shows that medication-assisted treatment  (MAT), which combines behavioral therapy and the use of certain  medications, can be effective at reducing opioid use and increasing  treatment retention, in comparison to other treatments. However, we have  previously reported on barriers—such as federal laws, provider  availability, perception, and cost—that can restrict patient access to the  medications used in MAT.

The Department of Health and Human Services (HHS) has identified  expanding access to MAT as an important strategy for reducing opioid  use disorders and opioid overdoses. HHS’s Medicaid program—which  provided health coverage to an estimated 75 million low-income and  medically needy individuals in fiscal year 2018—is one of the largest  sources of federal funding of health care services for individuals with  OUD, including MAT. According to an analysis of SAMHSA’s National  Survey on Drug Use and Health by the Kaiser Family Foundation,  Medicaid provided health care coverage in 2017 to 38 percent of  nonelderly adults with OUD. States’ Medicaid programs have flexibility in  how they design their programs and can therefore vary in how MAT  medications are covered and distributed, such as through retail  pharmacies. However, little information exists on how different distribution  methods may affect beneficiaries’ access to the medications.

The Substance Use-Disorder Prevention that Promotes Opioid Recovery  and Treatment for Patients and Communities Act (SUPPORT Act)  included a provision for GAO to study the effect of states’ Medicaid  programs and policies related to the distribution methods of MAT  medications in terms of beneficiary access, cost, and provider willingness  to provide these medications. In this report, we describe policies that  may restrict such access to MAT medications for Medicaid beneficiaries,  including any related to the distribution methods.

For our report, we focused our work on three of the medications used for  MAT: buprenorphine, buprenorphine-naloxone, and naltrexone. We  reviewed scientific studies and literature describing policies that could  create potential access barriers, as well as the benefits and challenges of  the distribution methods, identified through searching bibliographic  databases, including Medline and Scopus, for articles published from  2009 to 2019. We also reviewed relevant laws and regulations related to  MAT medications. We also interviewed federal officials and officials from  14 stakeholder organizations representing state Medicaid directors,  general health care providers, providers that specialize in treating OUD,  patients with OUD, and pharmacies, distributors, certain manufacturers of  MAT medications, as well as a policy research organization. We  identified these organizations through our background research on the  topic and through our interviews.

In addition, we selected three states—Minnesota, North Carolina, and  Ohio—and the District of Columbia, based on their Medicaid programs’  coverage of all of the MAT medications, as well as variation in terms of  program spending on MAT medications; expansion of Medicaid to  uninsured, low-income adults; the number of opioid overdose deaths per  state; and the number of MAT prescriptions for Medicaid beneficiaries.  We also used information gathered from our stakeholders pertaining to  access barriers to MAT medications or initiatives by the states to expand  access to MAT medications. In these states, we reviewed relevant state  documents and policies, and interviewed state Medicaid officials, officials  from the managed care organizations (MCO)—private organizations that  contract with the state to provide health care services to Medicaid  beneficiaries—that served the largest number of Medicaid beneficiaries in  those states, and providers who specialize in addiction medicine identified  by the state chapters of the American Society of Addiction Medicine. Of  our four selected states, North Carolina was the only state that did not  contract with MCOs at the time of our review.

We conducted this performance audit from February 2019 to January  2020 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that that evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.

Medicaid is a joint federal-state health care program that provides health  care coverage to low-income and medically needy individuals. At the  federal level, the Centers for Medicare & Medicaid Services (CMS), within  HHS, is responsible for overseeing Medicaid, while states administer their  respective Medicaid programs’ day-to-day operations. Each state’s  Medicaid program, by law, must cover certain categories of individuals  and provide a broad array of benefits. Within these requirements,  however, states have significant flexibility to design and implement their  programs, resulting in more than 50 distinct state-based programs. The  federal government requires coverage for certain mandatory services  under Medicaid, but states may decide to include other optional services  as well. Some of the largest and most commonly included services  include prescription drugs, nursing facilities, home and community-based  care, and hospital inpatient care.

Although pharmacy coverage is an optional service under Medicaid, all 50  states and the District of Columbia provide coverage for prescription  drugs. State Medicaid programs that opt to cover prescription drugs are  generally required to cover all of the outpatient drugs of any drug  manufacturer participating in the Medicaid Drug Rebate Program,  including all of the drugs’ formats. State Medicaid programs do not  directly purchase prescription drugs, but instead reimburse pharmacies  for covered prescription drugs dispensed to Medicaid beneficiaries.  Providers (including physicians, nurse practitioners, and physician  assistants) and pharmacies provide health care services, seek payment,  and are reimbursed for services by state Medicaid agencies. States may  directly pay health care providers for services rendered using a fee-for- service system or may delegate these responsibilities to MCOs. Under  managed care, the state contracts with MCOs to provide comprehensive  health care services through its network of providers.

Buprenorphine, buprenorphine-naloxone, and naltrexone may be  prescribed, administered, or dispensed for use in MAT. These  medications come in a variety of formats, including oral, implantable, and  injectable.

Buprenorphine. Buprenorphine is a partial opioid agonist, meaning it  binds to opioid receptors and activates them. It reduces or eliminates  opioid withdrawal symptoms, including drug cravings, and blunts the  euphoria or dangerous side effects of other opioids, such as heroin. It can  be used for detoxification treatment and maintenance therapy.  Buprenorphine is available as a MAT medication in two oral formats—(1)  tablets for sublingual (under the tongue) administration, and (2) film for  sublingual or buccal (inside the cheek) administration; as a subdermal  (under the skin) implant; and in an injectable format. Oral formats are  often used for beneficiaries that are in the beginning stages of treatment.  The implantable format is generally used for beneficiaries who are  already stable on a low or moderate dosage of oral buprenorphine. The  oral formats are taken daily, while the injectable format is administered  monthly, and the implantable format is administered every 6 months. The  medication carries a risk of abuse, particularly in oral formats where it can  be used inappropriately or illegally re-sold. The injectable and implantable  formats of buprenorphine are intended to minimize this risk and to  increase beneficiary compliance, because the medication is administered  by a provider.

Buprenorphine-naloxone. Naloxone is a medication added to some oral  formats of buprenorphine to reduce the chances of misuse or abuse.  Buprenorphine-naloxone is available in an oral format as either a film or a  tablet. It discourages people from inappropriately injecting a crushed and  dissolved tablet of buprenorphine by inducing symptoms of opioid  withdrawal when injected by individuals physically dependent on opioids.

Naltrexone. Naltrexone is an opioid antagonist, meaning it binds to opioid  receptors, but does not activate them, thereby blocking the euphoria the  user would normally feel from opioids. It also may result in withdrawal  symptoms if recent opioid use has occurred. Therefore, it is used for  relapse prevention following complete detoxification from opioids. It can  be taken daily in an oral format or as a once-monthly injection; though  due to low patient compliance, SAMHSA does not recommend using oral  naltrexone for OUD treatment. Naltrexone carries no known risk of abuse.  For the injectable format of naltrexone, beneficiaries have to be free from  opioids for at least a week before they can begin the medication.

Prior Authorization and Preferred Drug Lists

Subject to certain requirements, state Medicaid agencies may use  different strategies, such as prior authorization and preferred drug lists  (PDL), to manage the cost of prescription medications and ensure that  patients are taking medications that are clinically appropriate. Prior  authorization requires that certain conditions are met before services can  be provided to patients, in part, to control utilization and prevent improper  payments. PDLs reflect state Medicaid agencies’ determinations on  whether medications, including those used for MAT, will be covered and  whether these medications will be categorized as preferred or non- preferred. A PDL indicates the first-choice or preferred medication for a  beneficiary’s particular medical condition. PDLs are utilized by state  Medicaid agencies to incentivize providers to prescribe certain types of  medications. In addition, the preferred or non-preferred categorization of  medication can vary between fee-for-service and managed care plans  within a state. If a medication is not listed on a PDL, prior authorization  may be required. However, medications listed on a PDL may still have  prior authorization requirements, such as requirements to ensure patient  safety.

There are three distribution methods by which beneficiaries can obtain  MAT medications. (See fig. 1.)  1.  Retail pharmacy. After receiving a prescription from a health care  provider, pharmacists at a retail pharmacy, such as CVS or  Walgreens, prepare and dispense (or deliver) the medication directly  to a beneficiary. The pharmacist is reimbursed for the cost of the  medication by a payer, such as Medicaid or private insurance, and by  any co-payment from the beneficiary.  2.  External delivery from a specialty pharmacy. After receiving a  prescription from a physician or other health care provider, a specialty  pharmacy delivers the medication directly to the provider so the  medication can be administered (injected or implanted by the  provider) to the beneficiary for whom it was prescribed. The specialty  pharmacy ensures that any specific requirements for a medication are  maintained; for example, injectable naltrexone requires the use of  refrigerated warehouses, insulated shipping containers, and  temperature monitoring equipment. The specialty pharmacy is  reimbursed by Medicaid or another payer.  3.  Buy-and-bill. A health care provider purchases the medication from a  manufacturer or distributor and stores the medication until it is  dispensed or administered to the appropriate patient. After the  medication is dispensed or administered, the provider bills Medicaid  or another payer for the cost of the medication.

Each of the distribution methods used for MAT medications has  characteristics with implications for beneficiaries, providers, pharmacies,  and payers. (See table 1.)

Laws and Regulations for Prescribing Buprenorphine and Buprenorphine- Naloxone

Medications containing buprenorphine, including buprenorphine- naloxone, are considered controlled substances, which are governed at  the federal level by the Controlled Substances Act (CSA), and may be  subject to state laws as well. The CSA assigns controlled substances— including narcotics, stimulants, depressants, hallucinogens, and anabolic  steroids—to one of five schedules based on the substance’s medical use,  potential for abuse, and risk of dependence.

In addition to the laws and regulations that apply to controlled substances  generally, buprenorphine—when used in the treatment of OUD—is  subject to additional requirements under the CSA and implementing  regulations issued by the Drug Enforcement Administration (DEA) and  SAMHSA. Buprenorphine can be administered or dispensed in a  SAMHSA-certified and DEA-registered opioid treatment program when  used for OUD treatment. In addition, eligible providers may obtain a Drug  Addiction Treatment Act of 2000 (DATA 2000) waiver from SAMHSA in  order to dispense or prescribe buprenorphine, including buprenorphine- naloxone, to a limited number of patients for OUD treatment in an office- based setting, such as a doctor’s office. Until 2016, only physicians  were eligible to receive a DATA 2000 waiver. However, the  Comprehensive Addiction and Recovery Act of 2016 amended the CSA  to allow nurse practitioners and physician assistants to receive a DATA  2000 waiver through October 1, 2021. In 2018, the SUPPORT Act  eliminated the time limit, thereby permanently allowing nurse practitioners  and physician assistants to obtain DATA 2000 waivers.

To qualify for a waiver, providers must be appropriately licensed under  state law and meet applicable certification, training, or experience  requirements. Providers who prescribe, dispense, or administer  buprenorphine under a DATA 2000 waiver are also subject to the CSA’s  inventory and recordkeeping requirement. The waiver requirements  include the following:

Physicians must complete an 8-hour training course or have certain  certifications or experiences, while nurse practitioners and physician  assistants must complete a 24-hour training course.

Physicians that receive a DATA 2000 waiver can generally treat 30  patients in their first year and may apply to increase to 100 patients  after a year.

Physicians that meet certain criteria can treat 100 patients in the first  year and up to 275 patients after one year of prescribing at the 100- patient limit.

Nurse practitioners and physician assistants may treat 30 patients in  their first year with the waiver and 100 patients thereafter.

State and Federal Policies, Including Some Related to Distribution Methods, Can Restrict Medicaid Beneficiaries’ Access to MAT Medications

State Medicaid programs have policies related to the coverage and  distribution of prescription drugs that can restrict beneficiary access to  MAT medications. CMS has undertaken various coordination efforts  aimed generally at addressing OUD. Federal requirements and state laws  can also restrict beneficiaries’ access to the treatment medications.

State Medicaid Policies on Coverage for MAT Medications, Prior Authorization Requirements, Preferred Drug Lists, and Distribution Methods May Restrict Beneficiary Access

Our review of research and interviews with stakeholders found that  several state Medicaid program policies related to prescription drug  coverage and distribution can restrict beneficiaries’ access to MAT  medications. These are policies governing coverage of MAT medications,  prior authorization requirements, preferred drug lists, and limits placed on  distribution methods. While some of these policies are generally used to  manage utilization and costs related to a wide range of medications, the  research we reviewed and stakeholders we interviewed said that these  policies can also restrict beneficiaries’ access to the medications used in  MAT. In what follows, we describe these policies, including selected  states’ and CMS efforts to address the potential access barriers related to  these policies.

Recent research suggests that several state Medicaid programs may not  cover all MAT medications in all formats. Specifically, in 2018, SAMHSA  reported that while all 50 states’ and the District of Columbia’s Medicaid  programs covered oral formats of MAT medications and extended-release  injectable naltrexone, it found no indication that 21 states (41 percent)  covered either implantable buprenorphine, extended-release injectable  buprenorphine, or both. CMS officials said that evidence of coverage  may be difficult to find if the medications are billed as part of a medical  procedure rather than separately as a medication. However, according to  the study’s methodology, SAMHSA took steps to check whether the MAT  medications were covered as a medical procedure, and did not find any  evidence of such coverage. According to CMS officials, all the  manufacturers of MAT medications in our review participate in the  Medicaid Drug Rebate Program, and as a result, state Medicaid programs  are required to cover these medications and all their formats. CMS  officials stated that the agency generally investigates complaints about  lack of drug coverage, but had not received any complaints regarding  MAT medications. In addition, the officials said they were unaware of the  SAMHSA report and had not taken action based on the report’s findings.  Therefore, CMS lacks the information to confirm whether or to what  extent gaps may exist in state Medicaid programs’ coverage of MAT  medications in all formats, as SAMHSA’s report indicates. As such, Medicaid beneficiaries undergoing medication-assisted treatment may not  have access to the medications they need for treatment and that are  required by law to be covered.

In addition, the SUPPORT Act includes a new requirement for state  Medicaid programs to cover medication-assisted treatment, including all  Food and Drug Administration-approved MAT medications, from October  2020 through September 2025. CMS officials stated that the agency is  drafting guidance related to this requirement and plans to communicate  the guidance to state Medicaid programs through a State Medicaid  Director Letter prior to October 2020. The officials told us that they have  not determined when the guidance will be issued.

When state Medicaid agencies cover a MAT medication, they may  impose certain constraints, including requiring prior authorization from the  MCO or the state Medicaid agency, before a beneficiary can receive the  medication. However, these requirements can have unintended  consequences, such as preventing timely access to MAT. According to  SAMHSA’s 2018 report, several states use prior authorizations to ensure  that patients receive behavioral therapy in addition to their MAT  medications or to ensure that patients have abstained from opioids for a  certain period of time, which is necessary before receiving a naltrexone  injection. Further, when a patient switches from one medication to  another (or another format of the same medication), prior authorization  may be required for a variety of reasons, such as to ensure patient safety.

Officials from a stakeholder organization representing providers and  officials from a manufacturer said that prior authorization for injectable  buprenorphine was particularly burdensome and that decisions on  whether the state Medicaid agency will allow a prescription to be  dispensed can take up to 14 days. Providers in our selected states and  literature we reviewed noted that these delays could be life threatening,  because patients may return to drug use and possibly overdose before receiving their medication. We were also told by officials from one  manufacturer that small providers may not have the office staff to  promptly process the prior authorization paperwork, creating additional  delays.

Potential Consequences of OUD Patients  Missing Treatment  A health care provider told us that patients  receiving treatment for opioid use disorder  (OUD) need consistent access to medication- assisted treatment (MAT) medications, just as  diabetic patients need consistent access to  insulin. According to a survey of providers,  patients with OUD who experience delays in  their MAT medications could lose motivation  for their treatment, which could be life  threatening.

Literature we reviewed and stakeholders we interviewed described other  ways that prior authorization requirements can delay access to MAT  medications for Medicaid beneficiaries and other patients. The examples  described include the following:

Talking to patients before authorizing medications. According to  literature we reviewed and officials we spoke with from a  manufacturer and an organization representing providers, some  insurance companies require that their staff or the pharmacist talk to  the patient before approving a MAT medication when using external  delivery from a specialty pharmacy. This is to affirm that the patient  wants the medication and agrees that the pharmacy can bill the state  Medicaid program. However, speaking directly to patients can be  particularly challenging for this population. Officials representing a  manufacturer of a MAT medication and officials representing a health  care provider organization noted that patients undergoing residential  treatment may not have access to a phone, and patients in outpatient  treatment are often encouraged to change their phone numbers to  reduce contact with people involved in their past drug use. Also,  patients may not answer phone calls from unrecognized numbers.

Medication reauthorization. Providers from the District of Columbia  told us that they need to reauthorize MAT medication prescriptions  every 6 months, but patients may not realize the authorization is about  to expire so they run out of the medication, causing them to wait hours  or days to get the new prescription filled.

Transportation. Prior authorization requirements for MAT  medications can result in multiple trips to the pharmacy, which is  problematic for patients and beneficiaries without adequate  transportation. Providers from the District of Columbia noted that  sometimes prescriptions for MAT medications are not ready for  patients when they arrive at the pharmacy, and repeated trips to the  pharmacy can be problematic for those who lack adequate  transportation. Nevertheless, the patient may need multiple trips to go  back to the provider and then the pharmacy again, which can be  especially challenging.

Fail-first requirements. Literature we reviewed, officials we  interviewed representing a provider organization, and state Medicaid  officials and providers noted that some prior authorizations require  that a provider cannot begin treatment with certain MAT medications  until treatment with other MAT medications has failed. This literature  indicated that this treatment failure can increase the risk of drug use,  overdose, and death.

Some states have taken steps to reduce these access barriers by  removing prior authorizations through changes in state policies or laws.  Officials from a nonprofit organization specializing in addressing addiction  told us that, as of September 1, 2019, at least 12 states had laws that  prohibited prior authorizations for substance use disorder medications,  including MAT medications. States may also address prior authorizations  through other means, such as policies or guidance. Among our selected  states, all four have taken steps to remove prior authorization  requirements.

The District of Columbia began to generally allow providers to  prescribe and dispense MAT medications without prior authorization  in April 2019.

Minnesota Medicaid officials told us that in August 2018 they  removed prior authorization requirements for all MAT medications on  their PDL.

North Carolina Medicaid officials told us that in November 2017 they  eliminated their prior authorization requirement for providers to submit  a treatment plan before treating patients with any MAT medication.  After the requirement was removed, the officials observed an increase  in beneficiaries receiving MAT medications and an increase in the  number of providers writing prescriptions for buprenorphine. The  officials said North Carolina has never required prior authorization for  injectable buprenorphine, but that the state does have some prior  authorization requirements for certain forms of oral buprenorphine or  buprenorphine-naloxone. Specifically, in order to prescribe an  alternative oral medication, the provider needs to demonstrate the  patient tried and failed with or is medically unable to use the  buprenorphine-naloxone film.

Ohio Medicaid officials told us they have no prior authorization  requirements for injectable naltrexone, and they removed prior  authorization requirements for oral buprenorphine in January 2019.  According to the officials, the state has prior authorization  requirements for implantable and injectable buprenorphine to ensure  patients are initially stable on oral buprenorphine before beginning  these other formats.

According to stakeholders we interviewed, having multiple PDLs within a  state or changing PDLs can create confusion for health care providers,  because they need to keep track of and follow different requirements for  the same MAT medication. Such confusion can result in reduced  beneficiary access to MAT medications. For example, in the District of  Columbia, four MCOs and the fee-for-service program have separate  PDLs. Health care providers in the District of Columbia told us that the  four MCOs have different dosage restrictions for the same MAT  medications. A stakeholder group representing pharmacies told us that  having a uniform PDL for the state makes it easier for pharmacists to  comply with the relevant restrictions and minimize delays in accessing  MAT medications. In addition, a PDL may change multiple times within a  short time frame, which can create further problems for patients who had  become comfortable with the medication they had been taking, according  to officials from a provider organization.

To address any possible confusion due to the use of multiple PDLs, some  states have a uniform PDL for their Medicaid programs, which means that  all PDLs used in the state cover the same MAT medications in the same  way. Uniform PDLs can simplify the process for prescribers and eliminate  some confusion for beneficiaries when they switch health plans. For  example, Minnesota implemented a uniform PDL in July 2019 to ensure  more consistent access for Medicaid beneficiaries and minimize  disruptions if a beneficiary changes health plans. In addition, North  Carolina plans to institute a uniform PDL when its Medicaid program  moves to a managed care model in November 2019. Ohio also plans to  institute a uniform PDL across the state in January 2020. Ohio Medicaid  officials told us the uniform PDL will have both brand name and generic  oral buprenorphine as preferred medications.

States’ Distribution Method Policies for MAT Medications

According to stakeholders we interviewed, the characteristics of each  distribution method, as well as states’ policies on distribution methods,  have implications for beneficiary access to MAT medications. The  following describe the different ways in which the distribution methods  may restrict beneficiaries’ access to MAT medications.

Retail pharmacies generally offer access to oral formulations of  medications. However, retail pharmacies do not typically administer  injectable or implantable buprenorphine, and some retail pharmacies  may choose not to offer any MAT medications. One survey of  physicians found that some pharmacies may either treat individuals  prescribed buprenorphine poorly or refuse to carry the MAT  medications.

External delivery from specialty pharmacies is often used by  providers for the injectable or implantable MAT medications, because  the specialty pharmacy deals with the administrative responsibilities of  the prescription; however, processing delays can impede access to  MAT medications through this method, according to literature we  reviewed and stakeholders we interviewed. These specialty  pharmacies handle the administrative responsibilities of acquiring the  medication, including purchasing the medication and sending it to the  provider for administration, and receiving reimbursement from the  payer, such as Medicaid. Health care providers who administer these  medications may still encounter logistical challenges in their  acquisition and storage. Other challenges identified by literature and  stakeholders include the following:

The patient must return to the provider for a follow-up appointment  to receive the medication, because the medication is delivered to  the provider. However, if the patient does not return,  stakeholders—including those representing specialty  pharmacies—told us that the unused medication must be  disposed of.

Providers may face challenges ensuring staff are available to  receive medication deliveries—particularly in rural locations or in  small practices with multiple office locations that are not always  staffed, according to stakeholders representing specialty  pharmacies and providers.

Prescriptions are not always filled by the specialty pharmacy until  they have confirmed that they will be reimbursed by the payer,  according to officials from one manufacturer we interviewed. The  officials stated that when the claim is processed manually, it can  take over 20 days to fill the prescription. In contrast, the officials  said that if a claim can be processed electronically, payment and  delivery of the medication can be almost immediate.

Buy-and-bill distribution allows patients to have immediate access  to MAT medications, because their provider has the medications in  stock; however, some providers prefer not to use this method,  because it places them at financial risk. In particular, smaller health  care practices may not have the infrastructure or resources to deal  with the administrative responsibilities associated with buy-and-bill,  and they may not have the financial ability to pay for medications up  front and then wait for reimbursement, according to stakeholders we  interviewed. For example, one stakeholder we interviewed said that  the cost for just 2 to 3 doses of injectable medication obtained through  buy-and-bill could take up a significant portion of the profit margin for  a smaller medical practice.

Furthermore, if patients do not use these medications before they  expire or if the reimbursement from the payer does not equal the cost  of the medication, the provider may face a financial loss. According to  providers we interviewed in our four selected states, the high cost of  some medications—as much as $1,200 per dose for injectable  medications—makes the financial risk of buy-and-bill too high.  Providers also told us that some providers choose not to store  buprenorphine, because they are concerned that they could be  subject to a DEA inspection. Surveys of health care providers have  found provider concerns related to these inspections. And as with  specialty pharmacies, the provider must have someone available to  receive deliveries, which can be difficult for smaller practices,  according to providers in our selected states.

How Access Barriers Can Affect Opioid  Use Disorder Treatment  A health care provider we interviewed  described how access barriers affected a  Medicaid beneficiary’s opioid use disorder  treatment. This beneficiary was initially  prescribed oral buprenorphine, but the  medication was repeatedly stolen by the  patient’s partner. The provider and  beneficiary agreed that injectable  buprenorphine would allow treatment to  continue without the risk of theft. Initially, the  provider was not able to find a specialty  pharmacy with an electronic prescription  system compatible with the provider’s  system, which was necessary to receive the  prescriptions. The provider told us that after a  compatible specialty pharmacy was identified  and the order was completed, the delivery  was further delayed, because two staff  members—as required—were not available  to sign for the delivery when it arrived. Three  months after the decision was made to switch  medications, the delivery was completed and  the provider administered the medication.

Furthermore, state Medicaid policies that require or prevent the use of  certain distribution methods for MAT medications can restrict providers  from using methods that may be best suited for their patients or practice,  which may in turn affect beneficiaries’ access to the medications,  according to stakeholders. Medicaid officials and providers we  interviewed told us that some states require the use of certain distribution  methods when a provider prescribes a MAT medication. For example,  Minnesota’s fee-for-service plan (which covers about 25 percent of the  state’s Medicaid population) requires that health care providers use buy- and-bill for all physician administered medications, including those that  are injected or implanted. Minnesota providers we interviewed told us  that they are reluctant to prescribe either the injectable or implantable  versions of MAT medications, due to payment delays or other problems  they experienced when they attempted to use buy-and-bill.

Stakeholders told us that access to MAT medications would be  maximized if providers and beneficiaries are not restricted when choosing  among the three distribution methods—and some states have removed  such restrictions. Officials from one manufacturer told us that since 2016,  nine states that required use of buy-and-bill for their medication have  eliminated those requirements. Medicaid officials in North Carolina told us  that because smaller medical practices do not want the inventory costs  associated with buy-and-bill, the state has moved to allow providers to  obtain the injectable buprenorphine through either buy-and-bill or a  specialty pharmacy. According to the officials, this has resulted in the  increased use of the medication. Similarly, Medicaid officials in the District  of Columbia told us that prior to 2017, injectable MAT medications were only available through buy-and-bill—despite Medicaid reimbursements  being lower than providers’ costs. In 2017, these medications became  available from specialty pharmacies.

CMS Has Undertaken Opioid Coordination Efforts

CMS has undertaken various coordination efforts aimed generally at  addressing OUD. These efforts include the following:

Opioid Steering Committee—composed of CMS senior leadership  and staff, according to agency officials—helps coordinate opioid policy  across the agency. CMS officials told us that the bi-weekly committee  meetings have included discussions about reducing barriers related to  prior authorization, other utilization management practices, and  implementation of the SUPPORT Act, among other opioid related  topics.

Action Plan to Prevent Opioid Addiction and Enhance Access to  MAT—an effort by an interagency task force—is intended to address  OUD barriers in Medicaid, among other things, as required by the  SUPPORT Act. In September 2019, CMS held a public meeting and  requested public input to develop this action plan, which it plans to  issue by January 2020, as mandated by the act.

State Opioid Workshop, organized by CMS, brought together state  officials to share innovative practices and discuss efforts to decrease  barriers to accessing treatment for OUD, according to CMS officials.  The second of such workshops was held in September 2018, and  CMS documentation shows that the workshop included sessions  focused on MAT, including a session on states’ approaches to  improving the availability and use of MAT through benefit, payment,  and system design.

Informational bulletins have been used by CMS to communicate  information states need to manage their Medicaid programs, including  recommended actions. For example, in July 2014, CMS issued a  bulletin to states providing background information on MAT, examples  of state-based initiatives to increase access to MAT, and resources to  help ensure proper delivery of MAT services. In January 2016, CMS  issued another bulletin that focused on best practices for addressing  prescription opioid overdoses, misuse, and addiction, and urged  states to take action to reduce the potentially dangerous usage of  opioids used for pain. While this bulletin was not focused on MAT, it  suggested generally that states consider reviewing benefits coverage  and service utilization to ensure beneficiaries have sufficient access to  MAT services, and indicated that some benefit requirements, such as  prior authorizations, can reduce the use of and access to MAT.

Drug Utilization Review Survey, conducted annually by CMS,  contains information that the agency publishes on states’ activities  related to all prescription drugs in the Medicaid program, including  some limited information about MAT medications.

Other CMS efforts also addressed Medicaid beneficiaries’ access to  MAT. In November 2017, CMS announced a new policy to increase  flexibility for states seeking a section 1115 demonstration to improve  access to and quality of OUD treatment for Medicaid beneficiaries.  CMS has approved section 1115 demonstrations that included OUD- related provisions for 26 states and the District of Columbia between  August 2015 and November 2019. States implementing these  demonstrations are expected to take action to ensure access to MAT  for Medicaid beneficiaries, including by establishing a requirement  that inpatient and residential settings provide access to MAT. CMS  has also examined access to OUD treatment through its Innovation  Accelerator Program, which provides resources to states to introduce  delivery system and payment reforms in a variety of areas, including  OUD.

Requirements for Federal Waivers and State Laws Limit Who Can Administer the Medications Waiver Requirements for Buprenorphine

Our review of literature and interviews with stakeholders show that in  addition to Medicaid policies, other federal and state policies can limit  Medicaid beneficiaries’ access to MAT medications.

According to stakeholders we interviewed and literature we reviewed,  requirements associated with DATA 2000 waivers may limit the number  of providers willing to prescribe or administer buprenorphine for MAT.  Stakeholders and the literature note that providers may be reluctant to  obtain the DATA 2000 waiver, due to the hours of training associated with  the waiver and the cost of registering with the DEA after obtaining the  waiver, among other things.

According to officials from a stakeholder organization representing  providers and providers in one of our selected states, the  requirements to obtain a DATA 2000 waiver, including the associated  hours of required training—ranging from 8 hours for physicians to 24  hours for nurse practitioners and physician assistants—contributes to  perceptions that prescribing buprenorphine for the treatment of OUD  is dangerous, particularly since waivers are not required to prescribe  buprenorphine for pain management. A 2019 National Academy of  Sciences report also notes that treatment with buprenorphine is less  risky than many other OUD treatments that do not require special  training. Another study suggested that other opioids not used in the  treatment of OUD—and not requiring special training—are more  commonly misused, diverted, or responsible for overdoses, compared  with buprenorphine.

All providers who prescribe controlled substances are required to  register with DEA. For providers with a DATA waiver who wish to  administer injectable or implantable buprenorphine in multiple office  locations, the requirement that each office location be registered with  DEA may be an additional burden, as these fees are $731 for 3 years,  according to DEA. DEA requires that the provider pay the registration  fee for each location where controlled substances are stored,  administered, or dispensed, which might not be recouped if only a  small number of patients are treated at the various locations.

Stakeholders we interviewed and literature we reviewed also noted a  concern among some health care providers that having a waiver  would subject them to increased oversight from DEA and other law  enforcement agencies. Specifically, officials from an organization  representing addiction providers and providers in our selected states  told us that the possibility of interaction with law enforcement can  intimidate some providers and can be anxiety-provoking and  disruptive. Literature we reviewed reported that this can lead to  providers not pursuing a waiver or ceasing to prescribe  buprenorphine. Surveys of health care providers have found similar  concerns.

These factors can create a potential treatment barrier for patients and  beneficiaries by limiting the number of available providers, according to  officials from an organization representing addiction providers we  interviewed and literature we reviewed. The waivers also limit how many  patients, including Medicaid beneficiaries, providers may treat with MAT  medications. These limits may create an additional barrier to OUD  treatment, particularly for providers who specialize in addiction medicine.  Studies have consistently found that providers who have waivers treat  fewer OUD patients than their waiver allows—and some may not accept  new patients. For example:

A 2016 study of rural physicians found that more than half of providers  with waivers were not accepting new patients; those with a 30-patient  waiver limit were treating an average of fewer than nine patients; and  more than half of the providers with waivers were not treating any  patients. Providers with a 100-patient waiver limit treated an average  of 57 patients, although more than one-quarter were at or  approaching their patient limit.

A survey of physicians, nurse practitioners, and physician assistants  who obtained a waiver or increased their patient waiver limit in 2017  found that these providers were treating about one-third of their  patient limit.

Literature we reviewed noted that providers might not treat the maximum  number of patients allowed by their waiver limit, because they are not  specialists in addiction medicine, or they do not want to treat a larger  number of patients with OUD. These providers may have obtained a  waiver to respond to the needs of their existing patients who have OUD,  rather than to add new patients. In contrast, one of these studies and  officials from one organization representing health care providers in  addiction medicine we interviewed noted that there are providers who are  addiction medicine specialists that cannot work a full-time schedule if they  are only allowed to treat 275 patients, which is the maximum allowed  under the waiver rules. The study projected that a capacity range of 378  to 524 patients would be necessary for providers to practice addiction  medicine full time.

CMS officials told us they have taken some steps to increase the number  of providers with DATA 2000 waivers through funding new planning  grants in 15 states, as authorized by the SUPPORT Act. According to  CMS officials, the grants cover training expenses to help providers obtain  the waiver, among other things.

State Laws That Prevent Certain Providers from Prescribing MAT Medications

Federal laws allow certain non-physicians—such as nurse practitioners  and physician assistants—to obtain a DATA 2000 waiver to prescribe and  administer buprenorphine to treat OUD; however, some states’ laws may  restrict their ability to do so. These laws determine the type of health care  services that can be provided by different types of providers. According to  literature we reviewed and stakeholders we interviewed representing  physician assistants and nurse practitioners, some state laws do not allow  non-physicians to write prescriptions for any controlled substances and  some specifically limit their ability to write prescriptions for buprenorphine  for the treatment of OUD, while others may impose no restrictions for  non-physicians beyond the federal training and patient limit requirement  associated with the DATA 2000 waiver. For example, officials from an  organization representing providers reported that physician assistants in  some states, such as Kentucky and Tennessee, cannot prescribe  buprenorphine for the treatment of OUD. Further, according to officials from another organization representing providers, most states require  nurse practitioners to be supervised by or have a collaborative agreement  with a physician. Thus, to prescribe buprenorphine for MAT, the nurse  practitioners in these states must obtain a DATA 2000 waiver and have  supervision from or a collaborative agreement with a physician. North  Carolina Medicaid officials told us that physician assistants and nurse  practitioners in the state that have a DATA 2000 waiver must consult with  a physician, but do not need to have direct affiliation with a supervising  physician.

The supervision requirements can affect patients’ access to MAT,  including for Medicaid beneficiaries, according to stakeholders. For  example, officials from an organization representing providers told us that  some nurse practitioners may find it difficult to identify a qualified  physician with whom they can have a collaborative agreement. In the  states where nurse practitioners are not required to collaborate with a  physician, these officials also told us that they see higher percentages of  nurse practitioners prescribing MAT medications.

HHS has identified expanding access to medication-assisted treatment as  a key component of its efforts to reduce opioid use disorder and opioid  overdoses. Through our work, we identified state Medicaid policies and  federal and state laws that may create barriers to treatment for Medicaid  beneficiaries and other patients with OUD by restricting access to MAT  medications. We also identified efforts by states and CMS to address  these barriers. Under federal law, state Medicaid programs are required  to cover all formats of MAT medications reviewed in our study, because  all manufacturers of those medications participate in the Medicaid Drug  Rebate Program. In addition, the SUPPORT Act will mandate broader  coverage of MAT beginning in October 2020. However, a study by  SAMHSA found that nearly half of all state Medicaid programs do not  cover all formats of MAT medications in our review. Yet, CMS has not  taken steps to determine whether state Medicaid programs do cover all of  these MAT medications and their formats, as required. Until CMS  determines the extent to which state Medicaid programs cover all MAT  medications, as required—and address coverage gaps when found— Medicaid beneficiaries may not be able to obtain the most effective  medications to treat their opioid use disorder.

We are making the following recommendation to CMS:  The Administrator of CMS should determine the extent to which state  Medicaid programs are in compliance with federal requirements to cover  MAT medications in all formats and take actions to ensure compliance, as  appropriate. (Recommendation 1)

We provided a draft of this report to HHS for review. HHS provided written  comments which are reprinted in appendix I. HHS also provided technical  comments, which we incorporated as appropriate. In its written  comments, HHS concurred with our recommendation. Specifically, HHS  stated that it will examine the extent to which state Medicaid programs  are in compliance with the requirements of the Medicaid Drug Rebate  Program as it relates to the coverage of MAT medications and take  actions to ensure compliance, as appropriate. HHS also reiterated its  plans to develop guidance for states on the SUPPORT Act’s new  requirement for states to cover MAT medications.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of the Health and Human Services, and other  interested parties. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or DeniganMacauleyM@gao.gov. Contact points  for our Offices of Congressional Relations and Public Affairs may be  found on the last page of this report. GAO staff who made key  contributions to this report are listed in appendix II.

Appendix I: Comments from the Department of Health and Human Services

Appendix II: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Will Simerl (Assistant Director),  Carolyn Feis Korman (Analyst-in-Charge), Rebecca Hendrickson, Shirin  Hormozi, Virginia Lefever, Drew Long, Leslie McNamara, and Carla Miller  made key contributions to this report. Also contributing were Leia  Dickerson, Carolyn Garvey, Ethiene Salgado-Rodriguez, and Emily  Wilson Schwark.

Nearly 2 million Americans misused or were addicted to opioids in 2018. Medication-assisted treatment—which combines medications such as buprenorphine with behavioral therapy—can effectively treat opioid use disorders and overdoses.

Medicaid is one of the largest sources of coverage for individuals undergoing medication-assisted treatment. The Department of Health and Human Services has worked to increase access to the treatment.

We identified state policies that can restrict Medicaid beneficiaries’ access to medication-assisted treatments, and recommended that HHS ensure states comply with federal requirements to cover them.