prompt_front: You are given two reports by the government agency.



Question: Write a one-page summary of the report 1.



Report 2: JWST is envisioned to be a large deployable space telescope, optimized for infrared observations, and the scientific successor to the aging Hubble Space Telescope  JWST is being designed for a 5-year mission to find the first stars, study planets in other solar systems to search for the building blocks of life elsewhere in the universe, and trace the evolution of galaxies from their beginning to their current formation  JWST is intended to operate in an orbit approximately 1 5 million kilometers—or 1 million miles—from the Earth  With a 6 5-meter primary mirror, JWST is expected to operate at about 100 times the sensitivity of the Hubble Space Telescope  JWST’s science instruments are designed to observe very faint infrared sources and therefore are required to operate at extremely cold temperatures  To help keep these instruments cold, a multi-layered tennis court-sized sunshield is being developed to protect the mirrors and instruments from the sun’s heat  The JWST project is divided into three major segments: the observatory segment, the ground segment, and the launch segment  When complete, the observatory segment of JWST is to include several elements (Optical Telescope Element (OTE), Integrated Science Instrument Module (ISIM), and spacecraft) and major subsystems (sunshield and cryocooler)  The hardware configuration referred to as OTIS was created when the Optical Telescope Element and the Integrated Science Instrument Module were integrated  Additionally, JWST is dependent on software to deploy and control various components of the telescope, and to collect and transmit data back to Earth  The elements, major subsystems, and software are being developed through a mixture of NASA, contractor, and international partner efforts  See figure 1 for the elements and major subsystems of JWST and appendix 1 for more details, including a description of the elements, major subsystems, and JWST’s instruments  For the majority of work remaining, the JWST project is relying on two contractors: Northrop Grumman and the Association of Universities for Research in Astronomy’s Space Telescope Science Institute  Northrop Grumman plays the largest role, developing the sunshield, the Optical Telescope Element, the spacecraft, and the Mid-Infrared Instrument’s cryocooler, in addition to integrating and testing the observatory  Space Telescope Science Institute’s role includes soliciting and evaluating research proposals from the scientific community, and receiving and storing the scientific data collected, both of which are services that it currently provides for the Hubble Space Telescope  Additionally, the Institute is developing the ground system that manages and controls the telescope’s observations and will operate the observatory on behalf of NASA  JWST will be launched on an Ariane 5 rocket, provided by the European Space Agency  JWST depends on 22 deployment events—more than a typical science mission—to prepare the observatory for normal operations on orbit  For example, the sunshield and primary mirror are designed to fold and stow for launch and deploy once in space  Due to its large size, it is nearly impossible to perform deployment tests of the fully assembled observatory, so the verification of deployment elements is accomplished by a combination of lower level component tests in flight-simulated environments; ambient deployment tests for assembly, element, and observatory levels; and detailed analysis and simulations at various levels of assembly  We have previously found that complex development efforts like JWST face numerous risks and unforeseen technical challenges, which can often become apparent during integration and testing  To accommodate unanticipated challenges and manage risk, projects reserve extra time in their schedules, which is referred to as schedule reserve, and extra funds in their budgets, which is referred to as cost reserve  Schedule reserve is allocated to specific activities, elements, and major subsystems in the event of delays or to address unforeseen risks  Each JWST element and major subsystem has been allocated schedule reserve  When an element or major subsystem exhausts schedule reserve, it may begin to affect schedule reserve on other elements or major subsystems whose progress is dependent on prior work being finished for its activities to proceed  Cost reserves are additional funds within the project manager’s budget that can be used to address unanticipated issues for any element or major subsystem, and are used to mitigate issues during the development of a project  For example, cost reserves can be used to buy additional materials to replace a component or, if a project needs to preserve schedule reserve, reserves can be used to accelerate work by adding shifts to expedite manufacturing  NASA’s Goddard Space Flight Center— the NASA center with responsibility for managing JWST—has issued procedures that establish the requirements for cost and schedule reserves  In addition to cost reserves held by the project manager, management reserves are funds held by the contractors that allow them to manage program risks and to address unanticipated cost increases throughout development  We have previously found that management reserves should contain 10 percent or more of the cost to complete a project and are generally used to address various issues tied to the contract’s scope  NASA’s cost-plus-award-fee contract with Northrop Grumman has spanned almost two decades, during which there have been significant variances in contractor performance  Cost-reimbursement contracts are suitable when uncertainties in the scope of work or cost of services prevent the use of contract types in which prices are fixed, known as fixed-price contracts  Award fee contracts provide contractors the opportunity to obtain monetary incentives for performance in designated areas identified in the award fee plan  Award fees may be used when key elements of performance cannot be defined objectively, and, as such, require the project officials’ judgment to assess contractor performance  For JWST’s contract with Northrop Grumman, these areas include cost, schedule, technical, and business management and are established in the contracts’ performance evaluation plans  In December 2013, the JWST program and the contractor agreed to replace a $56 million on-orbit incentive—incentives based on successful performance in space—with award fees  The award fees are to incentivize cost and schedule performance during development  This shift increased the available award fee for the entire contract to almost a quarter of a billion dollars  According to officials, restructuring the incentives gave NASA more flexibility to incentivize the contractor to prioritize the cost and schedule performance over exceeding technical requirements  In December 2014, we found that NASA award fee letters of award fee periods from February 2013 to March 2014 indicated that the contractor had been responsive to interim award fee period criteria provided by NASA and that contractor officials confirmed that they pay close attention to this guidance in prioritizing their work  For example, Northrop Grumman officials reported that they had made specific changes to improve communications in direct response to this guidance, which was validated by award fee letters from NASA  The JWST program has a history of significant schedule delays and increases to project costs, which resulted in replans in 2011 and 2018  Before 2011, early technical and management challenges, contractor performance issues, low levels of cost reserves, and poorly phased funding caused the JWST program to delay work  As a result, the program experienced schedule overruns, including launch delays, and cost growth  The JWST program underwent a replan in September 2011, and a rebaseline in November of that same year, and Congress placed an $8 billion cap on the formulation and development costs for the project  On the basis of the replan, NASA rebaselined JWST with a life- cycle cost estimate of $8 835 billion, which included additional money for operations and a planned launch in October 2018  Congress also required that NASA treat any cost increase above the cap according to procedures established for projects that exceed their development cost estimates by at least 30 percent  This process is known as a rebaseline  Congress must authorize continuation of the JWST program if formulation and development costs increase over the $8 billion cost cap  In June 2018, after a series of launch delay announcements due to technical and workmanship issues identified during spacecraft element integration, NASA notified Congress that it had again revised the JWST program’s cost and schedule estimates  NASA estimated that it now required $828 million in additional resources and 29 more months to complete beyond those estimates agreed to in the 2011 rebaseline  As of November 2018, NASA had funding to continue to execute the program and was waiting to see if Congress would authorize the program’s continuation and appropriate funds for the program in fiscal year 2019  Figure 2 shows the project’s history of changes to its cost or schedule and key findings from two external independent review teams and our prior work  As discussed above, various technical and workmanship errors drove some of the more recent delays  Examples of some of the workmanship issues we found in the past include: In October 2015, the project reported that a piece of flight hardware for the sunshield’s mid-boom assembly was irreparably damaged during vacuum sealing in preparation for shipping  The damaged piece had to be remanufactured, which consumed 3 weeks of schedule reserve  In April 2017, a contractor technician applied too much voltage and irreparably damaged the spacecraft’s pressure transducers, components of the propulsion system that help monitor spacecraft fuel levels  The transducers had to be replaced and reattached in a complicated welding process  At the same time, Northrop Grumman also addressed several challenges with integrating sunshield hardware  These issues combined took up another 1 25 months of schedule reserve  In May 2017, some of the valves in the spacecraft propulsion system’s thruster modules were leaking beyond permissible levels  Northrop Grumman determined that the most likely cause was the use of an improper cleaning solution, and the thruster modules were returned to the vendor for investigation and refurbishment  Reattaching the refurbished modules was expected to be complete by February 2018, but was delayed by one month when a technician applied too much voltage to one of the components in a recently refurbished thruster module  NASA and Northrop Grumman reported that resolving the thruster module issue resulted in a 2-month delay to the project’s overall schedule  In October 2017, when conducting folding and deployment exercises on the sunshield, Northrop Grumman discovered several tears in the sunshield membrane layers  According to program officials, a workmanship error contributed to the tears  The tears resulted in another 2-month delay to the project’s overall schedule  In addition, some first-time efforts took longer than planned  For example, in fall 2017, the project determined that it would need to use up to 3 months of schedule reserve based upon lessons learned from the contractor’s initial sunshield folding operation  This first deployment, or unfolding, took 30 days longer than planned  The sunshield has since undergone another deployment, and will be deployed twice more before launch  The IRB took into account these technical and workmanship errors, as well as other considerations, when it analyzed the project’s organizational and technical issues  The board’s final report, issued in May 2018, included 31 recommendations that addressed a range of factors  For example, the IRB recommended that the project: Conduct an audit to identify potential embedded design flaws— problems that have not been detected through analysis, inspection, or test activities and pose a significant risk to JWST schedule, cost, and mission success; Establish corrective actions to detect and correct human mistakes during integration and test; Establish a coherent, agreed-upon, and factual narrative on project status and communicate that status regularly across to all relevant stakeholders; and Augment integration and test staff to ensure adequate long-term staffing and improve employee morale  In its response to the IRB’s report, NASA stated that it accepted the report’s recommendations and had already begun implementing action in response to many of them  Further, project officials told us that some of the actions were underway before the IRB completed its review  To develop a new schedule for JWST’s 2018 replan, NASA took into account the remaining integration and test work and added time to the schedule to address threats that were not yet mitigated  This includes 5 5 months to address an anomaly that occurred on the sunshield’s cover in 2018  The project also replenished its schedule reserves—which we found in February 2018 had been consumed—so that they now exceed the recommended levels  Both the project and IRB conducted schedule risk assessments that produced similar launch dates  The project relied on the replan schedule to determine its remaining costs because the workforce necessary to complete the observatory represents most of the remaining cost  Following is additional information on the schedule and cost considerations  Schedule: JWST’s revised launch readiness date of March 2021 reflects a consideration of the hardware integration and test challenges the project has experienced, including adding time to: Add snag guards for the membrane tensioning system—which helps deploy the sunshield and maintain its correct shape—to prevent excess cable from snagging, Repair tears of the sunshield membrane, Deploy, fold, and stow the sunshield, and Mitigate contractor schedule threats  In addition, the project added extra time to the schedule to complete repairs to the membrane cover assembly, which did not perform as expected during acoustics testing in April 2018  The membrane cover assembly shown in figure 3 is used to cover the sunshield membrane when in the stowed position to provide thermal protection during launch  After the anomaly occurred, the project halted spacecraft element testing, investigated the anomaly, and found that the fasteners had come loose due to a design change made to prevent the fasteners from damaging the sunshield membrane  The design change caused the nuts to not lock properly  According to project officials, due to the design of the membrane cover assembly, the project was not able to conduct flight-like, stand- alone testing on the cover prior to spacecraft element testing  As a result, the project did not discover the design issue until the hardware came loose while installed on the spacecraft element  The project determined that the repairs would take approximately 5 5 months  The project’s replan also reflected schedule reserves above the level required by Goddard Space Flight Center policy, which would have been approximately 5 months at that time  The new schedule includes a total of 293 days or 9 6 months of schedule reserves leading up to its committed launch readiness date of March 2021  NASA approved a JWST launch date of March 2021, but the project and the contractor are working toward a launch date in November 2020  Figure 4 shows the project’s new schedule following the 2018 replan, including how the project distributed its schedule reserves through different integration and test activities  As part of its May 2018 study, the IRB reviewed the project’s schedule and recommended a launch date of March 2021, which was subsequently reflected in NASA’s new schedule for the program  In reviewing the project’s schedule, the IRB found that the project had robust scheduling practices for ensuring that the schedule represented a complete and dynamic network of tasks that could respond automatically to changes  This schedule also passed a standard health check with minimal errors indicating that it was well constructed  However, the IRB noted that this schedule does not account for certain types of unknown risks to the program such as integration and test errors which can take many months to resolve, or the potential need to remove a science instrument from the observatory, which can have about a 1 year impact  As a result, the program could experience additional delays if a risk of this magnitude is realized  Cost: The project’s new $9 7 billion life-cycle cost estimate is principally driven by the schedule extension, which requires keeping the contractor’s workforce to complete integration and test longer than expected  Specifically, the project determined that almost all of the hardware had been delivered and the remaining cost was predominantly the cost for the workforce necessary to complete and test the observatory  For the past 3 years, we have reported that Northrop Grumman’s ability to decrease its workforce was central to JWST’s capacity to meet its long- term cost commitments  However, Northrop Grumman’s actual workforce continued to exceed its projections  This was because it needed to maintain higher workforce levels due to technical challenges, including problems with spacecraft and sunshield integration and test  It also needed to keep specialized engineers available when needed during final assembly and test activities  In developing the cost estimate supporting the 2018 replan, the project used a Northrop Grumman workforce profile that is higher than previous projections because Northrop Grumman now plans to maintain personnel longer during integration and test  According to project officials, the planned reduction of Northrop Grumman’s workforce is now more gradual and conservative than the prior plan  For example, the Northrop Grumman workforce will not start to significantly decline until the observatory ships to the launch site, which is expected to occur in August 2020  As shown in Figure 5, the JWST workforce assembling the observatory declines and the government and contractor workforce necessary to manage and operate the observatory remains after the internal launch readiness date of November 2020  As seen in the above figure, the Space Telescope Science Institute workforce, the contractor responsible for operating JWST, will remain generally flat between fiscal years 2021 to 2026 when it operates the observatory  The NASA civil service and support contractor will remain relatively flat through November 2020 launch date and then decline  In addition, the new cost estimate also took into account $61 million for implementing the IRB recommendations and mission success enhancements, funding for project cost reserves, and operations costs  In June 2018, the NASA associate administrator—who is the project’s decision authority—approved the project to proceed with its replan with a March 2021 launch date and $9 7 billion in life-cycle costs based on the Agency Program Management Council review and replan documents  The associate administrator did not require the project to conduct an updated Joint Cost and Schedule Confidence Level (JCL) analysis for this replan
Report 2:  According to officials from the 11 stakeholder organizations we interviewed—which represent authorized collectors and long-term care facilities—several factors may explain why relatively few pharmacies and other eligible entities have chosen to become authorized collectors of unused prescription drugs  These factors include the associated costs of participating, uncertainty over proper implementation, and participation in other, similar efforts for disposing of unused prescription drugs  Costs: Stakeholders said that the costs associated with purchasing, installing, and managing the disposal bins is a factor that explains the relatively low rate of participation  One stakeholder told us that many eligible entities may decide that the benefit of participating does not outweigh the costs associated with doing so  Specifically, stakeholders told us that the major costs associated with participating include the one-time cost of purchasing and installing a disposal bin; the ongoing costs to train personnel to manage the bins; and the cost of contracting with a reverse distributor to periodically dispose of the bin’s inner liner and contents  Stakeholders gave varying examples of the specific costs associated with these investments  For example, one stakeholder estimated the yearly costs of maintaining a disposal bin ranged from $500 to $600 per location; another stakeholder said that the cost is thousands of dollars per location per year, but did not provide a specific estimate  These stakeholders added that costs can increase if the disposal bins fill more quickly and need to be emptied more often than expected  For their part, officials from the reverse distributor stakeholders we interviewed cited incinerating hazardous waste, the availability of incinerators, and the cost of personnel as factors that increase the cost of their services for authorized collectors  One reverse distributor stakeholder told us that there are not many incinerators available, requiring them to travel long distances to incinerate collected waste  The other reverse distributor stakeholder added that DEA’s requirement that a second employee be present during the transportation and disposal increases the cost of their services  While some stakeholders speculated that costs are a reason for low participation, a few stakeholders told us that the benefits are worth the costs  In fact, two stakeholders we spoke with told us that the benefit to the communities was so important that they decided to provide funding to retail pharmacies, alleviating an individual pharmacy’s concern about the cost of installing and maintaining the disposal bins  We found that as of April 2017, over a quarter of the 2,233 authorized collectors using disposal bins received external funding to pay for the costs associated with installing and maintaining the disposal bins  In addition, stakeholders told us that some localities have enacted laws known as extended producer responsibility ordinances, which require that pharmaceutical manufacturers pay for certain costs associated with drug disposal  When asked about the costs associated with operating disposal bins, DEA officials told us that addressing cost issues with eligible participants falls outside of their responsibilities  Uncertainty: Stakeholders also told us that uncertainty regarding how to comply with aspects of DEA’s regulations for prescription drug disposal bins affected their decisions to participate  One stakeholder added that many eligible entities decide not to participate because uncertainties over participation requirements could result in inadvertent non-compliance with DEA’s regulations  As an example of their uncertainty over some of the requirements governing the disposal bins, officials from both of the reverse distributor stakeholders we interviewed cited DEA’s non-retrievable standard for destruction of the inner liners of the bins  DEA requires that the method of destruction be sufficient to render all controlled substances non- retrievable, meaning that the physical and chemical conditions of the controlled substances must be permanently altered and unusable in order to prevent diversion for illicit purposes  Both reverse distributor stakeholders told us that they are uncertain about whether certain disposal methods meet this standard, and they said that the agency has not provided further guidance on how reverse distributors can meet this requirement  DEA officials told us that the agency responds to questions about whether a specific method of destruction meets the non-retrievable standard by telling the registrant to test the remnants after destruction, to see if any components of the controlled substance are still present  In its summary of the regulations implementing the Disposal Act, DEA stated that in order to allow for the development of various methods of destruction, the agency did not require a specific method of destruction as long as the desired result is achieved  However, DEA officials stated that to their knowledge, incineration is the only method known to meet the non-retrievable standard to date, but the officials hoped other methods will be developed in the future  When asked about the guidance they provide to authorized collectors of unused prescription drugs or those eligible to become authorized collectors, DEA officials told us that they post frequently-asked questions on their website, routinely answer questions from participants and others, and give training presentations at conferences that include information on the disposal bins  In our prior work, we found problems with DEA’s communication and guidance to stakeholders  In 2015, we recommended that DEA identify and implement cost-effective means for communicating regularly with pharmacies and other entities authorized to handle controlled substances  DEA agreed with the recommendation, and officials told us that, starting in August 2017, these entities can subscribe to DEA’s website to receive notifications when it is updated with new guidance  Stakeholders also noted that some DEA requirements related to disposal bins may conflict with other state and federal requirements governing the transportation and disposal of hazardous waste, which includes some controlled substances  For example, the two reverse distributor stakeholders told us that some incinerator permits issued by states require that hazardous waste be examined before incineration; however, DEA requirements do not allow the contents of the liners to be examined, even at the time of incineration  To address the incinerator permit requirements, one reverse distributor told us that they use the Environmental Protection Agency’s hazardous waste household exemption, which treats the liners as household waste and thereby allows incinerator facilities to destroy the liners without examining the contents or violating their state permit  In addition, some stakeholders raised concerns that DEA’s regulations may conflict with other federal regulations  For instance, one stakeholder noted that they recently learned that transporting the disposal bin’s inner liners could violate Department of Transportation regulations  DEA officials told us that they were aware of this, explaining that the conflict was between DEA’s requirement that controlled substances be transported in liners and the Department of Transportation’s requirement that this type of waste be transported in sturdy containers  According to DEA officials, this conflict has been resolved by the Department of Transportation allowing reverse distributors to place the liners inside sturdy containers kept on trucks  Participation in or Availability of Similar Efforts: Stakeholders said that some pharmacies and other eligible entities were already participating in other, similar efforts that allow for the safe disposal of controlled substances, and therefore they did not want to invest additional resources into participating as authorized collectors using disposal bins  For example, the Centers for Medicare & Medicaid Services has an established process that long-term care facilities use to dispose of their unused controlled substances  As a result, all of the long-term care stakeholders told us that long-term care facilities may choose not to partner with pharmacies interested in placing disposal bins within their facilities because it adds significant cost and effort without any additional benefit  Furthermore, pharmacy stakeholders noted that because of the availability of other prescription drug collection efforts in their communities, they did not think that maintaining a disposal bin at their locations was needed  For example, two of the stakeholders explained that local law enforcement precincts already had a similar type of disposal bin in place to collect unused prescription drugs  DEA officials told us that they were aware of other options for the public and entities such as long-term care facilities that are not registered as authorized collectors to dispose of controlled substances  The officials also indicated that the availability of disposal options at law enforcement agencies contributes to the low participation rates among pharmacies as authorized collectors of unused prescription drugs  We provided a draft of this report to the Department of Justice for comment  DEA, part of the Department of Justice, provided technical comments, which we incorporated as appropriate  As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date  At that time, we will send copies to the Attorney General of the United States and the Administrator of DEA  In addition, the report will be 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 draperd@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  In addition to the contact name above, Elizabeth H  Curda (Director), Will Simerl (Assistant Director), Kathryn Richter (Analyst-In-Charge), Nick Bartine, Giselle Hicks, Jessica Lin, and Emily Wilson made key contributions to this report  Also contributing were Muriel Brown and Krister Friday 

ground_truth: The misuse of prescription opioid pain relievers and illicit opioids, such as heroin, has contributed to increases in overdose deaths. According to the most recent Centers for Disease Control and Prevention data, in 2015 over 52,000 people died of drug overdose deaths, and about 63 percent of them involved an opioid. For those who are addicted to or misuse opioids, MAT has been shown to be an effective treatment. GAO was asked to review HHS and other efforts related to MAT for opioid use disorders. This report (1) describes HHS's key efforts to expand access to MAT, (2) examines HHS's evaluation, if any, of its efforts to expand access to MAT, and (3) describes efforts by selected stakeholders (states, private health insurers, and national associations) to expand access to MAT. GAO gathered information from HHS officials as well as a non-generalizable selection of 15 stakeholders selected based on their MAT expansion activities, among other factors. GAO also assessed HHS's evaluation plans using internal control standards for defining objectives and evaluating results. In an effort to reduce the prevalence of opioid misuse and the fatalities associated with it, the Department of Health and Human Services (HHS) established a goal to expand access to medication-assisted treatment (MAT). MAT is an approach that combines behavioral therapy and the use of certain medications, such as methadone and buprenorphine. HHS has implemented five key efforts since 2015 that focus on expanding access to MAT for opioid use disorders—four grant programs that focus on expanding access to MAT in various settings (including rural primary care practices and health centers) and regulatory changes that expand treatment capacity by increasing patient limits for buprenorphine prescribers and allowing nurse practitioners and physician assistants to prescribe buprenorphine. Some of the grant awards were made in 2015, while others were made as recently as May 2017. (See figure.) As of August 2017, efforts under all the grant programs were ongoing. Grant recipients can use funding to undertake a range of activities, such as hiring and training providers and supporting treatments involving MAT. In addition, certain providers and grant recipients are required to develop plans for preventing MAT medications from being diverted for nonmedical purposes. HHS officials told GAO that as of August 2017, the department was in the process of finalizing its plans to evaluate its efforts to address the opioid epidemic. In September 2016, HHS awarded a contract to conduct the evaluation. HHS officials told GAO that they are still working with the contractor to finalize the evaluation approach and that it will focus on whether HHS's efforts to address the opioid epidemic have been implemented as intended. HHS officials said that in the future, HHS may also evaluate whether, or to what extent, its efforts have been effective in expanding access to MAT, in addition to evaluating implementation. While HHS has some of the information that could be used in a future evaluation of the effectiveness of its efforts to expand access to MAT, it has not adopted specific performance measures with targets specifying the magnitude of the increases HHS hopes to achieve through its efforts to expand access to MAT, and by when. For example, HHS has not established a long-term target specifying the percentage increase in the number of prescriptions for buprenorphine HHS would like to achieve, which would help to show whether efforts by HHS and others are resulting in a sufficient number of prescriptions for MAT medications. HHS has also not chosen a specific method of measuring treatment capacity or established targets associated with it, which would help determine whether a sufficient number of providers are becoming available to evaluate and treat patients who may benefit from MAT. Without specifying these performance measures and associated targets, HHS will not have an effective means to determine whether its efforts are helping to expand access to MAT or whether new approaches are needed. Gauging this progress is particularly important given the large gap identified nationwide between the total number of individuals who could benefit from MAT and the limited number who can currently access it based on provider availability. In addition, GAO also found that as of August 2017, HHS had not finalized its approach for its planned evaluation activities, including timeframes. Without timeframes for the evaluation's activities, HHS increases the risk that the evaluation will not be completed as expeditiously as possible. In addition to HHS efforts to expand access to MAT, officials from selected states, private health insurers, and national associations reported using several efforts to expand patients' access to MAT for opioid use disorders. For example, several stakeholders provided GAO with the following examples of their efforts: States. State health officials from all five selected states have implemented or are planning approaches that focus on integrating the use of MAT into primary care, such as by providing services for centralized intake and initial management of patients or through telehealth that connects patients in rural areas with addiction specialists in a different location. Private health insurers. Three private health insurers reported removing prior authorization requirements for MAT medications so patients can avoid a waiting period before receiving the medications. National associations. Officials told GAO that they are conducting outreach and training for their members and developing tools and resource guides. For example, one association developed a road map with strategies that state policymakers can use to address the opioid epidemic, including strategies for reducing the stigma associated with MAT through educating the public and potential providers. GAO recommends that HHS take two actions: (1) establish performance measures with targets related to expanding access to MAT, and (2) establish timeframes for its evaluation of its efforts to expand access to MAT. HHS concurred with both recommendations.

prompt_front: You are given two reports by the government agency.



Question: Write a one-page summary of the report 2.

Report 1: Health care practitioners prescribe opioid medications to treat pain and sometimes for other health problems, such as severe coughing  Opioid medications are available as immediate or extended release and in different forms, such as a pill, liquid, or a patch worn on the skin  Opioids slow down some processes of the body, such as breathing and heartbeat, by binding with certain receptors in the body  Over time, the body becomes tolerant to opioids, which means that larger doses of opioid medications are needed to achieve the same effect  People may use opioids in a manner other than as prescribed—that is, they can be misused  Because opioids are highly addictive substances, they can pose serious risks when they are misused, which can lead to addiction and death  Symptoms of an opioid use disorder include a strong desire for opioids, the inability to control or reduce use, and continued use despite interference with major obligations or social functioning  Another concern associated with prescribed opioids is the potential for diversion for illegal purposes, such as nonmedical use or financial gain  Research has shown that MAT—which combines behavioral therapy and the use of certain medications (methadone, buprenorphine, and naltrexone)—can be more effective in reducing opioid use and increasing retention (i e , reducing dropouts) compared to abstinence based treatment—that is when patients are treated without medication  Three medications are currently approved by FDA for use in MAT for opioid use disorders—methadone, buprenorphine, and naltrexone  Methadone: Methadone is a full opioid agonist, meaning it binds to and activates opioid receptors to help prevent withdrawal symptoms and reduce drug cravings  It has a long history of use for the treatment of opioid dependence in adults  Methadone suppresses withdrawal symptoms during detoxification therapy, which involves stabilizing patients who are addicted to opioids by withdrawing them in a controlled manner  Methadone also controls the craving for opioids during maintenance therapy, which is ongoing therapy meant to prevent relapse and increase treatment retention  Methadone can be administered to patients as an oral solution or in tablet form  Buprenorphine: Buprenorphine is a partial opioid agonist, meaning it binds to opioid receptors and activates them, but not to the same degree as full opioid agonists  It reduces or eliminates opioid withdrawal symptoms, including drug cravings  It can be used for detoxification treatment and maintenance therapy  It is available for MAT for opioid use disorder in tablet form for sublingual (under the tongue) administration, in film form for sublingual or buccal (inside the cheek) administration, and as a subdermal (under the skin) implant  Naltrexone: Naltrexone is an opioid antagonist, meaning it binds to opioid receptors but does not activate them  It is used for relapse prevention following complete detoxification from opioids  Naltrexone prevents opioid drugs from binding to and activating opioid receptors, thus blocking the euphoria the user would normally feel  It also results in withdrawal symptoms if recent opioid use has occurred  It can be taken daily in an oral tablet form or as a once-monthly injection given in a doctor’s office  Two of the three medications used to treat opioid use disorders— methadone and buprenorphine—are drugs that carry a potential for misuse  Under the Controlled Substances Act (CSA), treatment involving these medications can take place in certain authorized settings: as part of federally regulated OTPs or in other settings, such as a physician’s office, within certain restrictions  OTPs  OTPs provide MAT, including methadone and buprenorphine, for people diagnosed with an opioid use disorder  Methadone may generally only be administered or dispensed within an OTP, as prescriptions for methadone cannot be issued when used for opioid use disorder treatment  Buprenorphine may be administered or dispensed within an OTP, or may also be prescribed by a qualifying practitioner who has received a waiver from SAMHSA  Naltrexone is not a controlled substance and can be used in OTPs and other settings  Office-Based and Other Settings  Under a Drug Addiction Treatment Act of 2000 (DATA 2000) waiver, practitioners may prescribe buprenorphine to up to 30 patients in the first year of their waiver, 100 patients in the second year, and up to 275 patients in the third year  Practitioners at the 275-patient level must meet additional qualifications and requirements  Naltrexone does not have similar restrictions  HHS has implemented five key efforts from 2015 through August 2017 that focus on expanding access to MAT for opioid use disorders  Four of these are grant programs, including programs focused on health centers or primary care practices in rural areas  Targeted Capacity Expansion: Medication Assisted Treatment – Prescription Drug and Opioid Addiction (MAT-PDOA)  This grant program is administered by SAMHSA and provides funding to states to increase their capacity to provide MAT and recovery support services to individuals with opioid use disorders  Grant recipients are expected to identify a minimum of two high-risk communities within the state and partner with local government or community- based organizations to address the MAT-related treatment needs in these communities  Among other things, recipients are to use outreach and other engagement activities to increase participation in and access to MAT for diverse populations at risk for opioid use disorders  In August 2015, SAMHSA awarded 3-year grants to 11 states, under which each of the states will receive up to $1 million in each grant year  In September 2016, SAMHSA awarded 11 additional 3-year grants to other states  Total funding is expected to be up to $66 million for all 22 grants  SAMHSA announced the availability of up to 5 additional 3-year grants for fiscal year 2017  Applications for these grants of up to $2 million per year were due in July 2017 and as of August 2017 they had not been awarded  Substance Abuse Service Expansion Supplement to Health Centers  This grant program is administered by HRSA and provides funds for existing health centers to improve and expand their delivery of substance abuse services, including services with a specific focus on MAT for opioid use disorders in underserved populations  Health centers that receive these grants are required to increase the number of patients with health center-funded access to MAT for opioid use or for other substance abuse disorders treatment by adding at least one full-time substance abuse provider and supporting new or enhanced existing substance abuse services  HRSA awarded 2-year grants in March 2016 to 271 health centers  According to HRSA documents, total funding could be up to $200 million for all grants over 2 years  HRSA announced the availability of another set of grants to health centers for fiscal year 2017  Applications for these grants were due in July 2017, and as of August 2017 they had not been awarded  Increasing Access to Medication-Assisted Treatment in Rural Primary Care Practices  This grant program is administered by AHRQ and funds demonstration research projects that aim to expand access to MAT for opioid use disorders in primary care practices in rural areas of the United States  Grant recipients are expected to recruit and engage primary care providers and their practices, provide training, and support physicians and their practices in initiating treatment  The program also identifies and tests strategies for overcoming the challenges associated with implementing MAT in primary care settings and creates training and other resources for implementing MAT  AHRQ awarded these 3-year grants of up to $1 million per year to four recipients—the recipients are teams of state health departments, academic health centers, local community organizations, physicians, and others—with project start dates of September 30, 2016  According to AHRQ documents, total funding is expected to be up to $12 million for the four grants over 3 years  State Targeted Response to the Opioid Crisis Grants (Opioid STR)  This grant program is administered by SAMHSA and provides funding to states and others to increase access to treatment services for opioid use disorders, including MAT; reduce unmet treatment needs; and reduce opioid overdose deaths  Grant recipients are expected to implement or expand access to evidence-based practices, particularly the use of MAT, and to report on the number of people who receive opioid use disorder treatment, the number of providers implementing MAT, and the number of providers trained to use MAT  SAMHSA awarded 2-year grants starting in May 2017 to 50 states, the District of Columbia, four U S  territories and the free associated states of Micronesia and Palau  According to SAMHSA documents, total funding could be up to $970 million for all grants over 2 years  Figure 1 displays the implementation timeframes, the number of grants, and funding levels for the four HHS grant programs related to MAT  As the figure shows, some of these awards were made in fiscal year 2015, while others were made as recently as May 2017  As of August 2017, these efforts were ongoing  In addition to these four grant programs, HHS’s fifth key effort increases treatment capacity by expanding the waivers that practitioners may receive to prescribe buprenorphine  Specifically, SAMHSA issued a regulation that became effective August 8, 2016 increasing the number of patients that eligible practitioners can treat with buprenorphine outside of an OTP (e g , in an office-based setting)  Previously, qualified practitioners could request approval to treat up to 30 patients at a time, and after 1 year the limit could increase to 100 patients at a time upon SAMHSA approval  The new regulation expanded access to MAT by allowing eligible practitioners who have had waivers to prescribe buprenorphine to 100 patients for at least 1 year to request approval to treat up to 275 patients thereafter  Similarly, SAMHSA has implemented provisions of the Comprehensive Addiction and Recovery Act of 2016 (CARA) that expanded the types of practitioners who can receive a waiver to prescribe buprenorphine in an office-based setting to include qualifying nurse practitioners and physician assistants  CARA generally requires that these nurse practitioners and physician assistants complete 24 hours of training to be eligible for a waiver  According to HHS documents, as of early 2017, nurse practitioners and physician assistants who have completed this training could request a waiver from SAMHSA to treat up to 30 patients at a time  In addition to its five key efforts focused specifically on expanding access to MAT for opioid use disorders, HHS has other efforts with broader focuses, such as treating multiple types of substance abuse  While these efforts are not specifically focused on expanding access to MAT for opioid use disorders, they may result in expanded access to MAT  For example, CMS has approved section 1115 Medicaid demonstration projects to allow states to undertake comprehensive reforms of their delivery of substance abuse services, including provisions to enhance the use of MAT for opioid use disorders  In July 2015, CMS issued a state Medicaid Director letter informing states that they may seek approval of section 1115 demonstrations to undertake comprehensive substance use service reforms  According to CMS, all participating states are using the demonstration authority to develop a full continuum of care for individuals with substance abuse disorders, including coverage of short-term residential treatment services not otherwise covered by Medicaid  In addition, FDA has programs to help expedite development and to provide for faster review of marketing applications for certain drugs  According to FDA, it has conducted expedited reviews of Suboxone (buprenorphine and naloxone sublingual film), Vivitrol (extended release naltrexone injection) and Probuphine (buprenorphine subdermal implant)  According to some federal officials and other stakeholders that we interviewed, as part of efforts to expand access to MAT for opioid use disorder, steps are being taken to prevent the possibility that the MAT medications could, in some cases, be diverted for illicit use, misuse, or for purposes not intended by a prescriber  For example, OTPs and practitioners who request and receive a waiver to prescribe buprenorphine to treat up to 275 patients outside of an OTP setting are required under federal regulations to maintain a diversion control plan  In addition, the MAT-PDOA grant program explicitly requires grant recipients to implement a diversion control plan, though the other grant programs do not have similar additional requirements  (See appendix I for an overview of the diversion control plan requirements for OTPs and the practitioners who prescribe buprenorphine outside of an OTP ) The 2016 Surgeon General’s report on Alcohol, Drugs, and Health noted that decades of research have shown that the benefits of MAT greatly outweigh the risks associated with diversion, and that withholding these medications greatly increases the risk of relapse to illicit opioid use and overdose death  HHS officials told us that as of August 2017, the department is in the process of finalizing its approach for evaluating the implementation of its agencies’ collective efforts to address the opioid epidemic that were undertaken as part of the HHS Opioid Initiative and will continue under the new administration’s Opioid Strategy  HHS officials provided a draft of the evaluation’s schedule  According to the officials, the evaluation will include, but not be limited to, efforts to expand access to MAT  In September 2016, HHS awarded a 2-year contract to Research Triangle Institute International (RTI) to evaluate HHS agencies’ collective efforts  HHS officials told us that they are still working with RTI to finalize the evaluation approach given new leadership priorities  Specifically, in April 2017, the new Secretary of HHS announced a revised strategy for addressing the opioid epidemic that will continue to address access to MAT for opioid use disorders but also include additional priority areas  According to HHS officials, to be responsive to the new priorities, the evaluation will focus initially on whether HHS’s efforts have been implemented as intended, and officials expect the evaluation to also provide information on any challenges HHS has faced in implementing these efforts  According to HHS officials, while the evaluation of MAT expansion efforts will use information from several sources, they have not yet determined exactly which information will be used or how it will be used  This information may include, for example, results from a separate, planned evaluation of one of the grant programs, Opioid STR, as well as other information HHS agencies collect as part of their ongoing monitoring efforts for each of their individual MAT grant programs  While the reporting requirements vary across the four MAT grant programs, the grantees provide HHS with information related to expanding access to MAT  Specifically, Targeted Capacity Expansion: Medication Assisted Treatment – Prescription Drug and Opioid Addiction (MAT-PDOA): Every 6 months, grant recipients are expected to submit progress reports to SAMHSA on the planned and actual number of patients treated, as well as information on other performance measures  Increasing Access to Medication-Assisted Treatment in Rural Primary Care Practices: Grant recipients are expected to submit quarterly progress reports to AHRQ with various information, such as information on the number of physicians who have been certified to prescribe buprenorphine and the number of primary care practices successfully initiating the delivery of MAT services as a result of the grant project  Substance Abuse Service Expansion Supplement to Health Centers: Health centers that received these grants were expected to submit quarterly progress reports to HRSA through the second quarter of 2017 on the number of physicians who have obtained a DATA 2000 waiver and the number of patients who received MAT from these physicians  Health centers must now report these data elements in their annual performance reporting along with information on the number of certified nurse practitioners and physician assistants who have received a DATA 2000 waiver  State Targeted Response to the Opioid Crisis Grants (Opioid STR): Every 6 months, grant recipients are expected to submit progress reports to SAMHSA on the number of individuals who receive opioid use disorder treatment, the number who receive opioid use disorder recovery services, and the number of providers implementing MAT, among other measures  While HHS’s evaluation will focus on whether HHS’s efforts have been implemented as intended, officials told us that in the future an evaluation may also focus on the effectiveness of these efforts, including the effectiveness of efforts to expand access to MAT  Doing so would be consistent with federal standards for internal control, which call for agencies to evaluate results  HHS has some of the information that could be used in a future evaluation of the effectiveness of its efforts to expand access to MAT  In particular, an HHS document describing the department’s fiscal year 2016 – 2017 goals identifies expanding MAT access as an important strategy for the success of HHS’s longer-term goal of reducing opioid use disorders and opioid overdoses  In addition, HHS has identified three potential ways to measure access to MAT: the number of prescriptions for MAT medications, the treatment capacity of practitioners who are authorized to prescribe buprenorphine for opioid use disorders through a DATA 2000 waiver, and the treatment capacity of OTPs certified to administer methadone and other medications  In addition, HHS has data that could be useful for tracking progress in these areas (see table 1)  However, HHS has not adopted specific performance measures with targets specifying the magnitude of the increases HHS hopes to achieve through its efforts to expand access to MAT, and by when  For example, HHS has not established a long-term target specifying the percentage increase in the number of prescriptions for buprenorphine HHS would like to achieve, which would help to show whether efforts by HHS and others are resulting in sufficient progress in increasing prescriptions for this MAT medication  HHS has also not chosen a specific method of measuring treatment capacity or established targets associated with it, which would help to show whether a sufficient number of providers are becoming available to evaluate and treat patients who may benefit from MAT  Without specifying these performance measures and associated targets, HHS will not have an effective means to determine whether its efforts are helping to expand access to MAT  The lack of such performance measures with associated targets is inconsistent with federal internal control standards that specify that management should define objectives and evaluate results  According to these standards, using performance information such as performance measures can help agencies monitor results and determine progress in meeting program goals  In the context of HHS’s efforts to expand access to MAT, establishing appropriate performance measures with associated targets would allow HHS to determine whether its efforts are making sufficient progress or whether they need to be improved  Gauging this progress is particularly important, given the large nationwide MAT treatment gap identified in 2015 between the total number of individuals who could benefit from MAT and the limited number who can access it based on provider availability  This gap was estimated at nearly 1 million people as of 2012, and according to HHS officials and other stakeholders, lack of providers continues to be a challenge  Until HHS establishes performance measures with associated targets for the factors related to access to MAT, the department will be unable to evaluate its progress expanding access to MAT for opioid use disorders  In addition, as of August 2017, HHS has not finalized its approach for the planned evaluation activities, including timeframes  ASPE officials said that timeframes for a finalized evaluation approach had not been established because they were still working with RTI to finalize the evaluation approach given the new leadership priorities  When we spoke with the officials, they provided us with a draft evaluation schedule that covered the contract period ending September 2018  As of October 2017, HHS had not provided a finalized evaluation approach or schedule  Federal internal controls call for management to establish and operate monitoring activities and evaluate results  Without an implementation timeframe for the evaluation’s activities, HHS increases the risk that its evaluation of its agencies’ efforts will not be completed as expeditiously as possible, including an evaluation of HHS’s efforts to expand access to MAT  Officials from selected state health departments and behavioral health agencies, private health insurers, and national associations reported using several different efforts to help expand patients’ access to MAT for opioid use disorders  All of the stakeholders we interviewed reported conducting outreach efforts to communicate information about the importance of MAT and how to access it, or providing training to educate providers on prescribing MAT medications  Efforts by states  State health officials we spoke to described several planned or ongoing efforts to expand access to MAT, some of which are supported by federal funding, including federal grant programs  Officials from all five selected states told us that they are offering outreach to and training for providers to help expand access to MAT  For example, several state officials told us that they are promoting training to (1) encourage physicians to obtain authorization (DATA 2000 waivers) to prescribe buprenorphine and (2) encourage physicians with waivers to treat patients up to their patient limit or to request a higher patient limit  According to the stakeholders, all five selected states have implemented or are planning to implement a health care delivery model or approach that will expand access to MAT  Specifically, these models or approaches focus on integrating the use of MAT into primary care settings  For example, health officials from three states described use of a hub-and-spoke model  This model generally involves centralized intake and initial management of patients at a “hub” (e g , an OTP) and then connecting these patients to community providers at “spokes” (e g , primary care clinics) for ongoing care, with ongoing support provided by the hub as needed  Additionally, officials from two states described offering remote MAT-related consultations through telehealth that connects patients in rural areas with addiction specialists  According to a 2017 Healthcare Fraud Prevention and Partnership whitepaper, telehealth expands the reach of the addiction professional workforce and the existing pool of MAT providers, and it supports remote forms of behavioral therapy to make trained professionals more accessible to those in underserved or isolated communities  Officials from three states described focusing their MAT expansion efforts in various settings, such as in the criminal justice setting and emergency room departments  State health officials from four of the five states told us that programs in their states are using peer specialists (individuals who have successfully recovered from substance abuse disorders) in emergency rooms and other settings to engage with addicted patients and refer them to addiction specialists or behavioral health counselors  Officials from the selected states said that some of these and other efforts are funded through federal sources, such as MAT expansion grants awarded by SAMHSA, or with state funds to the extent they are available  Efforts by private health insurers  Officials from private health insurers reported that they are expanding access to MAT through outreach or training for providers and through the following three efforts: Eliminating the need for prior authorization to prescribe MAT medications  Officials from three insurers reported removing prior authorization requirements for MAT medications, thereby making it easier for patients to access needed MAT medications more readily, rather than undergoing a waiting period for approval to receive the medications  Other private health insurers told us that they continue to require prior authorization, intended for safety reasons and to reduce drug misuse, and officials from one insurer told us that they will allow a patient to access a limited amount of MAT medications for a period of 24 to 72 hours while making a determination about the appropriate treatment services for the patient  Modifying health benefit coverage  Officials from one private health insurance plan told us that the company is redesigning the benefit coverage for methadone and has removed member copays  This effort is intended to make MAT medications more affordable and allow members who are not able to use buprenorphine to have an alternative, such as methadone, that is not cost-prohibitive  Incentivizing providers and health insurance plan members to use MAT  Officials from four private health insurance plans described plans to offer incentives to providers or patients to use MAT  For example, officials from three health plans stated that they are offering alternative payment models or paying higher rates to providers that offer MAT, and another private health insurer is offering incentives to its members who are enrolled in behavioral health programs that provide access to MAT  Efforts by national associations  Officials we interviewed from the national associations—including the American Society of Addiction Medicine, the National Governors Association, and the Association of State and Territorial Health Officials—told us that they are helping to expand access to MAT through outreach and training for their members and by developing tools and resource guides for their members  An official from one association told us that it shares federal grant announcements, including those that are focused on expanding access to MAT, with its members  Officials from another association said it provides training to providers on how to appropriately prescribe MAT medications  In addition, officials from one association told us that they developed an opioid-related road map that identifies examples of strategies—including MAT—that state policymakers can use in their ongoing efforts to address the opioid epidemic  Examples of strategies include reducing the stigma associated with MAT through educating the public and potential providers  Another strategy in the road map is changing payment policies to expand access to MAT services, such as ensuring that Medicaid and other state health programs adequately cover all MAT medications and behavioral interventions and encouraging or requiring commercial health plans to adopt similar policies  HHS funds grant programs and has taken other steps to expand access to MAT, which has been shown to be effective in reducing the prevalence of opioid use disorders and with them, the likelihood of drug overdoses  HHS’s Opioid Initiative began in 2015, and the grants that support it are ongoing, so it is likely too early to determine how effective HHS’s efforts have been in expanding access to MAT and in meeting HHS’s other priorities related to addressing the opioid epidemic  According to HHS, access to MAT can be measured in terms of the number of prescriptions for MAT and by the treatment capacities of OTPs and practitioners who are authorized to prescribe buprenorphine  Our review suggests, however, that HHS may not be ready to perform this evaluation  While HHS told us that it may evaluate the effectiveness of its efforts in the future, the department has not established performance measures with targets that would specify the results that HHS hopes to achieve through its efforts, and by when  Furthermore, HHS has not established timeframes for the activities that will make up its planned evaluation of whether HHS’s efforts have been implemented as intended  Without performance measures with targets and evaluation timeframes, HHS increases the risk that the evaluation will not be completed in a timely manner or that HHS will not know whether its MAT- related efforts are successful or whether new approaches are needed  The evaluation is particularly important, given the hundreds of millions of dollars HHS has invested in its MAT-related grant programs  We are making the following two recommendations to HHS  The Assistant Secretary for Planning and Evaluation should establish performance measures with targets related to expanding access to MAT for opioid use disorders  (Recommendation 1) The Assistant Secretary for Planning and Evaluation should establish timeframes in its evaluation approach that specify when its evaluation of efforts to expand access to MAT will be implemented and completed  (Recommendation 2) We provided a draft of this report to HHS for review, and HHS provided written comments, which are reprinted in appendix II  HHS also provided technical comments, which we incorporated as appropriate  In its written comments, HHS concurred with both of our recommendations  Specifically, for our first recommendation to establish performance measures with targets related to expanding access to MAT for opioid use disorders, HHS stated that developing such measures is appropriate and that the department will continue to work to develop robust performance measures, including measures related to MAT, as part of its overall Opioid Strategy, which includes the department’s most recent efforts to address the opioid epidemic  For our second recommendation to establish timeframes in its evaluation approach that specify when its evaluation of efforts to expand access to MAT will be implemented and completed, HHS agreed that timeframes are important to any evaluation  HHS noted that its evaluation is being conducted under a 2-year contract that is scheduled to end in September 2018  HHS has also provided us with a draft evaluation schedule  We clarified in our report, however, that HHS has not yet provided a finalized approach for the planned evaluation or a finalized schedule establishing timeframes for the activities that will make up the evaluation  Until it finalizes its evaluation approach and establishes related timeframes, HHS increases the risk that it will not complete its planned evaluation by September 2018  We are sending copies of this report to the HHS, and appropriate congressional committees  In addition, the report will be available at no charge on the GAO website at http://www gao gov  If you or your staff have questions about this report, please contact me at (202) 512-7114 or curdae@gao gov  Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report  Major contributors to this report are listed in appendix III  According to the Department of Health and Human Services, a diversion control plan is a set of documented procedures intended to reduce the possibility that controlled substances will be transferred or used illicitly  Opioid treatment programs (OTPs) and practitioners who prescribe buprenorphine at the highest patient level through a Drug Addiction Treatment Act of 2000 (DATA 2000) waiver are required to have these plans  OTPs are programs that may administer or dispense medication- assisted treatment (MAT) for people diagnosed with an opioid use disorder, including the use of methadone and buprenorphine  In addition, under a DATA 2000 waiver, practitioners may prescribe buprenorphine for patients, up to a 30-, 100-, or 275 patient limit  An OTP must maintain a current diversion control plan that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use  Per federal guidelines, the goal of the diversion control plan is to reduce the scope and significance of diversion and its impact on communities  The guidelines state that each OTP’s diversion control plan should make every effort to balance diversion control against the therapeutic needs of the individual patient  They also state that diversion control plans should address at least four general areas of concern: program environment, dosing and take-home medication, prevention of multiple program enrollment, and prescription medication misuse  The guidelines include details about each of these areas: Program environment: Diversion in the program environment can be deterred and detected by regular surveillance and the monitoring of areas in and around the program, where opportunities for diversion may exist  A visible human presence at a program’s location gives community members the opportunity to approach staff with concerns and communicates the program’s commitment to assuring a safe environment and a positive impact on the surrounding community  Dosing and take-home medication: In the area of dosing and take- home medication, diversion control encompasses careful control of inventory, attentive patient dosing, and close supervision of take- home medication  Observing a patient take his or her dose and having each of them drink and speak after dosing are fundamental components of diversion control  Take-home dosing should be provided with careful attention to regulatory compliance and the therapeutic benefit and safety these regulations are meant to promote  Prevention of multiple program enrollment: Reasonable measures should be taken to prevent patients from enrolling in treatment provided by more than one clinic or individual practitioner  An OTP, after obtaining patient consent, may contact other OTPs within a reasonable geographic distance (100 miles) to verify that a patient is not enrolled in another OTP  Misuse of prescription medication: The misuse of prescription medication has become an area of great concern nationally and impacts diversion control planning at OTPs  All OTP physicians and other healthcare providers, as permitted, should register to use their respective state’s prescription drug monitoring program (PDMP) and query it for each newly admitted patient prior to initiating dosing  The PDMP should be checked periodically (for example, quarterly) through the course of each individual’s treatment and, in particular, before ordering take-home doses as well as at other important clinical decision points  SAMHSA’s best-practice guidelines for using buprenorphine for treating opioid use disorders include multiple references to diversion, including monitoring for diversion, storage of this medication to minimize diversion, and use of formulations that may be less likely to be diverted  Specifically, the best practices state that, when possible, practitioners should use the combination buprenorphine/naloxone product, which increases safety and decreases the likelihood of diversion and misuse  Further, physicians who request and receive a waiver to prescribe buprenorphine to treat up to 275 patients outside of an OTP are required to have a diversion control plan  According to an HHS official, as of July 13, 2017, roughly 3,330 of the over 39,000 practitioners with a waiver had a 275-patient limit waiver  The majority of these practitioners, just over 27,000, have a 30-patient limit  According to SAMHSA guidance, the diversion plan should contain specific measures to reduce the possibility of diversion of buprenorphine from legitimate treatment use and should assign specific responsibilities of the medical and administrative staff of the practice setting for carrying out these measures  Further, the guidance states that the plan should address how: the environment at the practice setting can prevent onsite diversion; to prevent diversion with regard to dosing and take-home medication; and to prevent patients from receiving a prescription from more than one practitioner and later diverting some of the prescribed medication  Elizabeth H  Curda, Director, (202) 512-7114 or curdae@gao gov  In addition to the contact name above, Will Simerl, Assistant Director; Natalie Herzog, Analyst-in-Charge; La Sherri Bush; and Emily Wilson made key contributions to this report  Also contributing were Muriel Brown, Krister Friday, Sandra George, and Christina Ritchie 


Report 2:  A JCL is an integrated analysis of a project’s cost, schedule, risk, and uncertainty whose result indicates the probability of a project’s success of meeting cost and schedule targets  NASA policy states that a JCL should be recalculated and approved as a part of the rebaselining approval process, but it is not required  In its replan decision memo, NASA’s associate administrator explained that he did not require the project to update the JCL because project costs are almost entirely related to the workforce and most of the remaining planned activities will be performed generally in sequence  Therefore, according to NASA’s associate administrator, the total cost would be driven almost entirely by the schedule because the workforce levels will remain the same through delivery of the observatory  Both the project and independent estimators used multiple schedule estimating methods to analyze the schedule for the remaining work, and NASA’s associate administrator said these analyses returned consistent, high confidence launch dates  The project’s ability to execute to its new schedule will be tested as it progresses through the remainder of challenging integration and test work  The project has yet to complete three of five integration and test phases  The remaining phases include integration and test of OTIS, the spacecraft element, and the observatory  Our prior work has shown that integration and testing is the phase in which problems are most likely to be found and schedules tend to slip  For a uniquely complex project such as JWST, this risk is magnified as events start to become more sequential in nature  As a result, it will continue to become more difficult for the project to avoid schedule delays by mitigating issues in parallel  As of November 2018, the project is about a week behind its replanned schedule because repairs on the membrane cover assembly took longer than planned  Completing the membrane cover assembly repairs and returning the spacecraft to vibration testing was a key event for the project to demonstrate that it could execute to its new schedule  When the project developed its 2018 replanned schedule, it had planned to complete the membrane cover assembly repairs and reinstall the assembly onto the sunshield and restart spacecraft element integration and test activities by November 6, 2018  The project allocated 4 weeks of schedule reserves specifically for these repairs  However, the membrane cover repairs proved more difficult than anticipated  For example, the program had to address unanticipated technical challenges on the membrane cover assemblies, including repairing tears and pin holes in the covers discovered after the covers were removed  The project also had to allot time to install bumpers, which are kapton tubes, to the assembly to protect the composite material on a sunshield structure during launch  The project identified the need to add the bumpers during subassembly vibration testing  As a result, as of November 2018, the project had used about 4 5 weeks of schedule reserves to cover delays associated with these activities  The use of reserves beyond what the project had planned for the repairs pushed the restart of spacecraft element integration and test activities out about a week to November 14, 2018  Figure 6 compares the project’s initial membrane cover assembly schedule in June 2018 to the actual schedule in November 2018  While the project repaired the membrane cover assembly, it also used this time to conduct risk mitigation activities on OTIS  For example, the project worked to mitigate a design issue on the frill connections  The frill is composed of a single layer of blankets placed around the outside of the primary mirror used to block stray light (see figure 7)  A combination of modeling and inspections revealed that most of the frill sections did not have as much slack as expected at the near-absolute zero cryogenic temperatures of space  This caused shrinkage that put stress on the edges of the outer ring of mirrors, which could affect the stability of the optical mirror and image quality  The project loosened these outer connections by adding a ring to the connecting points  As of November 2018, project officials said they were in the process of verifying the fix through inspections  Examples of technical issues and risks that the project continues to face during the remaining phases of integration and test include: The project is working to mitigate a design issue on the sunshield membrane tensioning system—which helps deploy the sunshield and maintain its correct shape  In our February 2018 report, we found that Northrop Grumman was planning to modify the design of the membrane tensioning system after one of the sunshield’s six membrane tensioning systems experienced a snag when conducting folding and deployment exercises on the sunshield in October 2017  The project and Northrop Grumman determined that a design modification was necessary to fully mitigate the issue, which includes modifying clips used to progressively release the cable tension and adding guards to control the excess cable  The project identified a concern that the depressurization of trapped air in the folded sunshield membrane when the fairing separates to release the JWST observatory may overly stress the membrane material  The project is working with Arianespace—the company responsible for operating JWST’s launch vehicle—and experts at the Kennedy Space Center to resolve this concern  Officials estimated that a design solution would be in place in mid-2019  However, if the project determines that it needs to reinforce the membrane covers to survive excessive residual pressure as it works on this design solution, a multi-month schedule delay could occur  As of November 2018, the project has mitigated 21 of its 47 hardware and software risks to acceptable levels, and reviews these risks monthly for any changes that might affect the continued acceptability of the risk  Five of these 21 risks are related to the project’s more than 300 potential single point failures—several of which are related to the deployment of the sunshield  The project is actively working to mitigate the remaining 26 risks to acceptable levels or closure prior to launching  The project also has several first-time and challenging integration and test activities remaining  For example, the project must integrate OTIS and the completed spacecraft element and test the full observatory in the final integration phase, which includes another set of challenging environmental tests  See figure 8 for an image of OTIS and the spacecraft element prior to being integrated  As previously discussed, the project also has two remaining deployments of the sunshield, and prior deployments have taken longer than planned  To help mitigate the risks associated with the deployments, the project added additional time for deployments in the 2018 replanned schedule based on lessons learned from prior deployments  The two remaining deployments are to occur after spacecraft element integration and test and again after observatory integration and test  The JWST project office is required to evaluate whether the project can complete development within its revised cost and schedule commitments at its next major review—the system integration review—planned for August 2019  This review is to occur after the project has completed two major tasks—OTIS and spacecraft element integration and test  The review is to evaluate whether the project (1) is ready to enter observatory integration and test, and (2) can complete remaining project development with acceptable risk and within its cost and schedule constraints  NASA guidance does not require projects to conduct a JCL at this review  However, project officials said that they plan to conduct another schedule risk analysis in the future  They do not intend to complete a new JCL for the same reasons they did not complete one for the 2018 replan— because costs are almost entirely related to the workforce and can be derived from a schedule that takes into account known risk  While not required, conducting a JCL prior to the system integration review would inform NASA about the probability of meeting both its cost and schedule commitments  If the project proceeds with its plan to conduct only a schedule risk analysis, NASA would be provided only with an updated probability of meeting its schedule commitments  Our cost estimating best practices recommend that cost estimates should be updated to reflect changes to a program or kept current as it moves through milestones and as new risks emerge  In addition, government and industry cost and schedule experts we spoke with noted that integration and testing is a critical time for a project when problems can develop  These experts told us that completing a JCL is a best practice for analyzing major risks at the most uncertain part of project execution  Conducting a JCL at system integration review—a review that occurs during the riskiest phase of development, the integration and test phase— would allow the project to update its assumptions of risk and uncertainty based on its experiences in OTIS and spacecraft element integration and test  The project could then determine how those updated assumptions affect overall cost and schedule for the JWST project  As noted above, the project has many risks to mitigate, technical challenges to overcome, and challenging test events to complete, which could affect the project’s schedule and risk posture  Further, the project has an established history of significant cost growth and schedule delays  In its June 2018 letter notifying an appropriate congressional committee of its updated cost and schedule commitments, NASA acknowledged that recent cost growth for the project will likely impact other science missions  Conducting a JCL at system integration review would provide NASA and Congress with critical information for making informed resource decisions on the JWST project and its affordability within NASA’s portfolio of projects more broadly  NASA has taken steps to augment oversight of the contractor and project following the discovery of the embedded design flaws and workmanship errors that contributed to the project’s most recent schedule delays and cost increases  See table 1 for examples of changes NASA has made to contractor and project oversight—some of which NASA self-identified and others that were in response to IRB recommendations  The IRB made 31 recommendations that ranged from improving employee morale to improving security during transporting JWST to its launch site  NASA has also used award fees to try to incentivize Northrop Grumman to improve its performance  In a July 2018 hearing on the JWST program before the House Science, Space, and Technology Committee, Administrator Bridenstine stated that NASA had reduced the available award fee through commissioning by $28 million out of a total of about $60 million  Northrop Grumman also did not earn its full award fee in the two most recent periods of performance that NASA assessed  For the performance period of April 1, 2017 to September 30, 2017, Northrop Grumman earned approximately 56 percent of the available award fee  Reasons that NASA cited for its evaluation of award fees in this period included workmanship errors on the propulsion system, schedule delays, as well as issues with schedule execution, management, and quality control  For the period of October 1, 2017 to March 31, 2018, Northrop Grumman earned none of the available award fee  Northrop Grumman’s overall score was driven by an “unacceptable” rating in schedule and cost due to delays and in anticipation of exceeding the project’s $8 billion cost cap  Northrop Grumman received an “excellent” rating under the technical category, but the evaluation noted ongoing issues with quality controls, which resulted in delays  For example, the process steps for applying voltage to the spacecraft’s pressure transducers were not clear enough, which resulted in technician error and irreparable damage to the hardware  According to Northrop Grumman officials, the contractor has started to take action to try to improve its quality assurance processes  Officials described actions that ranged from rewriting hardware integration and test procedures to starting efforts to change aspects of the company’s culture that contributed to quality control issues  For example, in July 2018, Northrop Grumman initiated a JWST mission assurance culture change campaign to increase focus on product quality and process compliance  This effort includes having inspectors affirm by signature that they have personally inspected, verified, and confirmed that all aspects of an activity meet quality standards  According to the form instructions, if the inspector is uncertain on compliance or if instructions are unclear, workers are to halt work, investigate and assess the situation, and request help to resolve the situation  Project and Northrop Grumman officials provided an example of these changes working  During a manual deployment of a radiator panel, a Northrop Grumman employee discovered that a flap used as thermal protection for a radiator was installed incorrectly and reported the error  Northrop Grumman technicians found that this flap had been swapped with another flap in the process of moving them to be installed and corrected the problem before work proceeded  Further, NASA and Northrop Grumman are conducting audits to try to minimize the risk of failures during the remaining phases of integration and test  These audits are conducted on items that have not been fully tested, are in workmanship-sensitive areas, or have had a late design change  The first phase of the audit was completed in September 2018 and found no major design issues or hardware rework required  The project plans to audit other areas through at least spring 2019, but will add audits if needed  The JWST oversight structure includes a number of positions that could be responsible for ensuring that the recent augmentations to contractor and project oversight are sustained through launch (see table 2)  In response to our review, NASA officials clarified that the project manager has sole responsibility for ensuring that these improvements are sustained through launch  Further, these officials stated that the project office is responsible for monitoring these changes at the project level and at Northrop Grumman  The project manager’s continued focus on these efforts will be important because: The project is implementing a wide span of improvement efforts, ranging from more on-site coverage at the contractor facility to cultural improvements, which will now need to be sustained for an additional 29 months  The project has had recurring issues with effective internal and external communication as well as defining key management and oversight responsibilities, both of which are important to sustaining oversight  For example, the Independent Comprehensive Review Panel identified communication problems—between the JWST project and Science Mission Directorate management as well as between NASA and Northrop Grumman—and that the project’s governance structure lacked clear lines of authority and accountability  In December 2012, we found the JWST project had taken several steps to improve communication—such as instituting meetings that include various levels of NASA, contractor, and subcontractor management— but the IRB’s findings in 2018 indicate that communication and governance issues have resurfaced in some areas  For example, the IRB found that communication with key stakeholders including the science community, Congress, and NASA leadership, has been variable and at times inconsistent  The project may encounter new schedule pressures as it proceeds through integration and test  A senior NASA official with expertise in workmanship issues told us that schedule pressure is a key reason for increased quality problems on projects  For example, this official said that companies tend to give experts leniency to operate without the burden of quality assurance paperwork when schedule pressures arise, which can lead to workmanship errors  While JWST project officials told us they do not view this as applicable to their project, the perspective regarding potential schedule pressures and workmanship is important to keep focus on given the magnitude of technical challenges and delays the project has faced  We will continue to monitor the project’s efforts at maintaining these oversight augmentations in future reviews, given that less than a year has passed since the project began implementing many of them  Moreover, the project may find that some actions will be required of officials outside the project, particularly since the communication problems identified by the IRB may well extend to headquarters’ interaction with stakeholders from the science community, industry, and the Congress  JWST is one of NASA’s most expensive and complex science projects, and NASA has invested considerable time and resources on it  The project first established its cost and schedule baseline in 2009  Since then, the project made progress by completing two of five phases of integration and test, but has also experienced significant cost growth and schedule delays  However, the project did not complete a JCL analysis as part of its second replan  Between now and its system integration review planned for August 2019, the JWST program will have to continue to address technical challenges and mitigate risks  Conducting a JCL would better inform decision makers on the status of the project as they determine whether the project can complete remaining project development with acceptable risk and within its cost and schedule constraints  Given the project is now on its third iteration of cost and schedule commitments, conducting a JCL is a small step that NASA can take to demonstrate it is on track to meet these new commitments  We are making the following recommendation to NASA: The NASA Administrator should direct the JWST project office to conduct a JCL prior to its system integration review  (Recommendation 1) We provided a draft of this report to NASA for comment  In written comments, NASA agreed with our recommendation  NASA expects to complete the JCL by September 2019, prior to the system integration review  The comments are reprinted in appendix II  NASA also provided technical comments, which have been addressed in the report, as appropriate  We are sending copies of this report to the appropriate congressional committees, the NASA Administrator, 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 on matters discussed in this report, please contact me at (202) 512-4841 or chaplainc@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 III  In addition to the contact named above, Molly Traci (Assistant Director), Karen Richey (Assistant Director), Jay Tallon (Assistant Director), Brian Bothwell, Daniel Emirkhanian, Laura Greifner, Erin Kennedy, Jose Ramos, Sylvia Schatz, Roxanna Sun, and Alyssa Weir made key contributions to this report 

ground_truth: JWST, a large, deployable telescope, is one of NASA's most complex projects and top priorities. The project has delayed its planned launch three times since September 2017 due to problems discovered in testing. In June 2018, NASA approved new cost and schedule estimates for JWST. Since the project established its cost and schedule baselines in 2009, the project's costs have increased by 95 percent and the launch date has been moved back by 81 months. Conference Report No. 112-284, accompanying the Consolidated and Further Continuing Appropriations Act, 2012, included a provision for GAO to assess the project annually and report on its progress. This is the seventh report. This report assesses (1) the considerations NASA took into account when updating the project's cost and schedule commitments and (2) the extent to which NASA has taken steps to improve oversight and performance of JWST, among other issues. GAO reviewed relevant NASA policies, analyzed NASA and contractor data, and interviewed NASA and contractor officials. In June 2018, the National Aeronautics and Space Administration (NASA) revised the cost and schedule commitments for the James Webb Space Telescope (JWST) to reflect known technical challenges, as well as provide additional time to address unanticipated challenges. For example, the revised launch readiness date of March 2021 included 5.5 months to address a design issue for the cover of the sunshield (see image). The purpose of the sunshield is to protect the telescope's mirrors and instruments from the sun's heat. NASA found that hardware on the cover came loose during testing in April 2018. The new cost estimate of $9.7 billion is driven by the schedule extension, which requires keeping the contractor's workforce on board longer than expected. Before the project enters its final phase of integration and test, it must conduct a review to determine if it can launch within its cost and schedule commitments. As part of this review, the project is not required to update its joint cost and schedule confidence level analysis—an analysis that provides the probability the project can meet its cost and schedule commitments—but government and industry cost and schedule experts have found it is a best practice to do so. Such analysis would provide NASA officials with better information to support decisions on allocating resources, especially in light of the project's recent cost and schedule growth. NASA has taken steps to improve oversight and performance of JWST, and identified the JWST project manager as responsible for monitoring the continued implementation of these changes. Examples of recent changes include increasing on-site presence at the contractor facility and conducting comprehensive audits of design processes. Sustaining focus on these changes through launch will be important if schedule pressures arise later and because of past challenges with communications. GAO will follow up on the project's monitoring of these improvements in future reviews. GAO recommends NASA update the project's joint cost and schedule confidence level analysis. NASA concurred with the recommendation made in this report.