Recommendation: The Commissioner of FDA should take additional steps to address inconsistency in its written comments to generic drug applicants—including the clarity of writing and the content of comments—among reviewers, such as requiring additional training for reviewers. (Recommendation 1)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA stated that it is evaluating methods to improve the clarity and content of primary reviewer comments by developing and providing training and work aids on written communication to ensure that FDA conveys deficiency comments in a clear and consistent manner to applicants. FDA noted that best practices on ensuring consistency in deficiency comments will be shared with primary reviewers. In addition, FDA stated that the agency is reviewing current training and providing coaching for secondary reviewers to exchange, compare, discuss, and improve the content and consistency of common deficiencies communicated in primary reviewer comments.

Recommendation: The Commissioner of FDA should assess the extent to which the timing of brand-name drug companies' drug labeling changes affect the approval of generic drug applications in the first review cycle, and take steps, as appropriate, to limit the effect of brand-name drug labeling changes on pending generic drug applications. (Recommendation 2)

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA reported that it is identifying and assessing examples of applications in which the brand-name drug company submitted a supplemental application for a labeling change that impacted the timeline of the generic drug approval. After gathering data, FDA officials stated that they will assess what particular actions could address this issue, including whether FDA has the authority to take any such identified actions.

Recommendation: The Administrator of CMS should evaluate the possible costs and savings of using disposable devices that could potentially substitute for DME, including options for benefit categories and payment methodologies that could be used to cover these substitutes, and, if appropriate, seek legislative authority to cover these devices.

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: In March 2019, HHS included in its fiscal year 2020 budget a legislative proposal to extend Medicare coverage to disposable devices that could potentially substitute for DME in treating and managing diabetes. As of March 2020, CMS has not provided documentation of the evaluation of possible costs and savings that we recommended and that we believe underpins the legislative proposal. We will review this documentation once provided.

Recommendation: To better understand the available opportunities for collecting inmate health care utilization data, BOP should conduct a cost-effectiveness analysis of potential solutions, and take steps toward implementation of the most effective solution.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to improve organizational alignment and strengthen data analytics capabilities. This firm is also examining data analytics solutions and by late March 2020 is expected to make recommendations to BOP to support a request for purchase (RFP) for the most cost-effective one. BOP anticipates the RFP will then follow within the subsequent three months. This contracting work is a positive step that should help BOP identify the most cost-effective solution to collect health care utilization data. BOP is still in the early stages of implementing this action, therefore it is too soon to assess whether its efforts will fully address GAO's recommendation. However, once these actions are completed, BOP could be better positioned to find a solution for collecting the needed data.

Recommendation: To better understand the available opportunities for controlling health care costs, BOP should implement its guidance to conduct "spend analyses" of BOP's health care spending, using data sources already available

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to identify opportunities to improve organizational alignment and strengthen data analytics capabilities. As part of this effort, BOP also contracted with a health care finance expert, who began working with BOP Health Services Division in June 2019. The expert has met with subject matter experts across disciplines to identify reliable sources for medical cost data, including medical activities data, staffing data, and medical cost data to support conducting spend analyses. BOP expects this effort to be completed by late spring 2020. This contracting work is a positive step toward implementing BOP's spend analysis guidance; however, since BOP has not yet completed this effort, it is too soon to assess whether BOP's efforts will fully address GAO's recommendation. Once BOP has completed this effort, it could be better positioned to identify opportunities for controlling health care costs.

Recommendation: To determine the actual or likely effectiveness of its ongoing or planned health care cost control initiatives, BOP should evaluate the extent to which its initiatives achieve their cost control aim.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In 2018, BOP contracted with a management consulting firm to identify opportunities to improve organizational alignment and strengthen data analytics capabilities. As part of this effort, BOP also contracted with a health care finance expert, who began working with BOP Health Services Division in June 2019. BOP is working with this expert to validate existing financial data sources and apply a standardized cost accounting model to evaluate the cost effectiveness of key health care cost control initiatives. According to BOP, the model is being developed in phases with the initial phase expected to be completed by late March 2020. The second phase of the model is scheduled to launch in October 2020. This is a positive step that will better position BOP to evaluate its health care cost control initiations. Since BOP has not yet completed this effort, it is therefore too soon to assess whether its efforts will fully address GAO's recommendation. However, once BOP has completed this effort, it could help BOP evaluate the effectiveness of its health care cost control initiatives.

Recommendation: To enhance its strategic planning for and implementation of health care cost control efforts, BOP should incorporate elements of a sound planning approach and (1) establish a means of measuring progress toward and effectiveness of its activities for its current strategic objectives and goals related to controlling health care costs; and (2) identify the resources and investments necessary for implementation of its planned health care cost control initiatives.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: BOP agreed with GAO's June 2017 recommendation and has begun to take steps to address it. In October 2018, BOP initiated a contract with an external group of public administration experts to examine BOP's organizational structure and its lines of authority. The group completed its study and issued a report in October 2019, which included recommendations for BOP. According to BOP, the Health Services Division is in the process of creating a Strategic Plan Advisory Group, which will implement recommendations in the October 2019 report, and will establish a 2020-2025 Strategic Plan. The Strategic Plan Advisory Group will also evaluate metrics, including those related to financial performance that will, according to BOP, enable it to identify the resources and investments to help control health care costs. This action is a positive step that could help BOP enhance its strategic planning for and implementation of health care cost control efforts. However, BOP is in the early stages of implementing this recommendation; thus it is too soon to assess if BOP will find the most effective method for enhancing its strategic planning.

Recommendation: To improve the reliability and utility of its Federal Medical Center mission analyses, BOP should document the analyses and findings that underlie its recommendations.

Agency: Department of Justice: Bureau of Prisons
Status: Open

Comments: In June 2017, BOP agreed with GAO's recommendation. However, BOP decided to end the Federal Medical Center mission analyses process. Instead, in September 2018 BOP established a Medical Referral Center (MRC) Executive Advisory Board, made up of BOP's Health Services Division leadership and wardens from all seven MRCs. According to BOP, the Board plans to develop and implement dashboard metrics by the end of calendar year 2020 to monitor essential functions at the centers, which it hopes will improve management of the inmate health care system. In the meantime, BOP reports that the Board has already developed and implemented the MRC pipeline patient dashboard, which permits the MRC wardens to monitor incoming patients in advance of arrival and to maximize the best patient care and housing until treatment is complete. In addition, the Board has developed and implemented the Memory Disorder Unit at one if its MRCs. This resulted in BOP making more efficient use its inpatient beds, as inmates that were housed in community hospitals could return to a BOP inpatient setting. While these steps might not fulfill the recommendation as worded, they have already resulted in some improvements to the utility of the MRCs, and therefore the intent of the recommendation. We will continue to monitor progress on this effort to ensure BOP develops and implements the metrics as planned.

Recommendation: To improve consistency in CMS oversight of federal spending under section 1115 demonstrations, the Secretary of Health and Human Services should require the Administrator of CMS to develop and document standard operating procedures for monitoring spending under demonstrations that (1) require setting reporting requirements for states that provide CMS the data elements needed for CMS to assess compliance with demonstration spending limits; (2) require consistent enforcement of states' compliance with financial reporting requirements; and (3) require consistent tracking of the amount of unspent funds under demonstration spending limits.

Agency: Department of Health and Human Services
Status: Open

Comments: The Department of Health and Human Services (HHS) has taken steps to improve the consistency of oversight of federal spending under section 1115 demonstrations. In November 2018, HHS officials reported that they have developed draft guidance, including a standard reporting tool for states, to better ensure consistent reporting of the elements needed to assess compliance with demonstration spending limits and was in the process of testing the tool with two states. In addition, the agency is developing standard operating procedures for agency staff to require consistent tracking of unspent funds under the spending limit. As of November 2019, HHS has not provided any updates. GAO will continue to monitor HHS's actions and once procedures are in place, GAO will assess whether they address our recommendation.

Recommendation: In order to prevent the shift of services from physician offices to HOPDs from increasing costs for the Medicare program and beneficiaries, Congress should consider directing the Secretary of HHS to equalize payment rates between settings for E/M office visits--and other services that the Secretary deems appropriate--and to return the associated savings to the Medicare program.

Agency: Congress
Status: Open

Comments: The Bipartisan Budget Act of 2015, enacted in November 2015, partially addressed our recommendation as it limits certain providers from billing at higher hospital outpatient department payment rates. Specifically, the legislation excludes services furnished by off-campus hospital outpatient departments from reimbursement under Medicare's hospital outpatient prospective payment system, effective January 1, 2017. According to the Congressional Budget Office, this action saves the Medicare program $9.3 billion over 10 years. However, the Act does not apply to services furnished by providers billing as hospital outpatient departments prior to enactment of the legislation-which includes providers billing as hospital outpatient departments during the study period in our report-as well as hospital outpatient departments located on hospital campuses. This means that, even in 2017 and beyond, many providers will not be affected by the Act, and Medicare will continue to pay more than necessary for certain services. In November 2018, CMS issued a final rule adopting payment changes-that have since been partially overturned under a decision by a federal district court, which CMS has appealed-capping payment rates for certain services furnished by the off-campus hospital outpatient departments that existed or were under construction in 2015 at the physician fee schedule rate. Since these services furnished by these off-campus hospital outpatient departments were paid under a higher rate, the payment cap, which was to be implemented over 2 years, was intended to equalize payment rates for certain clinical visits between settings. In 2019, CMS applied 50 percent of the payment reduction and in 2020 and subsequent years planned to apply 100 percent of the payment reduction. The rule applied to specific clinical visits; and other services would continue to be paid at the higher rate. However, a federal district court overturned the payment cap in September 2019. CMS has appealed that ruling and adopted a final rule in November 2019 that will implement the payment reduction in 2020. A lawsuit challenging the November 2019 final rule has been filed.

Recommendation: Congress may wish to consider requiring increased attention to fiscal responsibility in the approval of section 1115 Medicaid demonstrations by requiring the Secretary of HHS to improve the demonstration review process through steps such as (1) clarifying criteria for reviewing and approving states' proposed spending limits, (2) better ensuring that valid methods are used to demonstrate budget neutrality, and (3) documenting and making public material explaining the basis for any approvals.

Agency: Congress
Status: Open

Comments: As of April 2020, there had been no legislation introduced to require HHS to improve the Medicaid demonstration review process. However, HHS has taken some action to address some aspects of GAO's recommendation. CMS established new policies that addressed certain problems GAO had identified and issued written guidance on the process and criteria used to approved states' proposed spending limits. Not all problems identified by GAO were addressed by the new CMS policy, thus legislation to require HHS to improve the Medicaid demonstration review process, as GAO recommended in January 2008, continues to be a viable matter for consideration.

Recommendation: Congress may wish to consider addressing whether demonstrations that allow states to operate public managed care organizations and retain excess revenue to support programs previously funded by the state--including the Vermont demonstration--are within the scope of the Secretary of HHS's authority under section 1115 of the Social Security Act.

Agency: Congress
Status: Open

Comments: As of April 2020, Congress had not passed legislation in response to our matter for congressional consideration.