Recommendation: To help the Department of Health and Human Services ensure accuracy in Part B drug payment rates, Congress should consider requiring all manufacturers of Part B drugs paid at ASP, not only those with Medicaid drug rebate agreements, to submit sales price data to CMS, and ensure that CMS has authority to request source documentation to periodically validate all such data.

Agency: Congress
Status: Open

Comments: As of June 2020, no action has been taken on this Matter for Congressional Consideration.

Recommendation: CMS should periodically verify the sales price data submitted by a sample of drug manufacturers by requesting source documentation from manufacturers to corroborate the reported data, either directly or by working with the HHS Office of Inspector General as necessary.

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

Comments: In September 2018, HHS officials reiterated that they believe the agency has addressed our recommendation because CMS works with HHS's Office of Inspector General (OIG) as appropriate to collect source documentation from drug manufacturers and takes action as warranted. HHS stated that CMS has continued to provide information regarding problematic ASP submissions to OIG for evaluation of misreporting and continues to use AMP and other benchmarks as comparisons for pricing determinations. They further stated that they do not believe that additional collection of detailed sales information about ASP, such as invoices, is authorized under Part B drug payment provisions in section 1847A or under section 1927(b). As of June 2020, CMS did not provide any additional updates. While we recognize that CMS conducts routine checks to assess the completeness of ASP data submitted by drug manufacturers, we do not believe these activities are enough to close the recommendation. Specifically, CMS only collects source documentation from manufacturers under very limited circumstances (e.g., when there are obvious inconsistencies in the data submitted by manufacturers). CMS does not periodically verify the accuracy of ASP data for a sample of manufacturers by tracing the data to and from drug manufacturers' source documents, such as sales invoices. Because CMS does not routinely verify the accuracy of the underlying data used to determine Medicare payment rates, the resulting payment rates may be inaccurate if drug manufacturers do not report accurate data. With regards to CMS's authority to collect additional information, such as invoices, we believe the agency could work through OIG to collect such information.

Recommendation: To help ensure the financial sustainability of the Medicare program, protect beneficiaries from unwarranted financial burden, and address potential concerns about the appropriateness of the health care provided to Part B beneficiaries, Congress should consider eliminating the incentive to prescribe more drugs or more expensive drugs than necessary to treat Medicare Part B beneficiaries at 340B hospitals.

Agency: Congress
Status: Open

Comments: As of June 2020, Congress had not acted on this Matter for Congressional Consideration.

Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to finalize new, more specific guidance on the definition of a 340B patient.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2017, HRSA withdrew proposed guidance that included further specificity on the definition of 340B patient in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register. In March 2018, HRSA told GAO that it continues to assess next steps with the Administration on the proposed omnibus guidance, which included the patient definition. In June 2019, HRSA reported that it is still working with the Department to determine next steps for this recommendation. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.

Recommendation: PPACA contained several important program integrity provisions for the 340B program, and additional steps can also ensure appropriate use of the program. Therefore, the Secretary of HHS should instruct the administrator of HRSA to issue guidance to further specify the criteria that hospitals that are not publicly owned or operated must meet to be eligible for the 340B program.

Agency: Department of Health and Human Services
Status: Open

Comments: In January 2017, HRSA withdrew proposed guidance that included additional specificity regarding hospital eligibility in response to the new administration's January 20 memorandum directing agencies to withdraw regulations that were pending before the Office of Management and Budget but had not yet been published in the Federal Register. In March 2018, HRSA reported that it believes it is unable to implement this recommendation without additional legislative authority because the statute does not speak to the issue raised in the recommendation. HRSA also noted that the FY19 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority, and that if this proposal is enacted, it could regulate on hospital eligibility. In June 2019, HRSA reported that it is still unable to implement this recommendation without additional legislative authority, though the President's FY 2020 Budget includes a proposal to provide HRSA with such authority. In July 2020, HRSA reported that it conducted an evaluation of its audit process and other program integrity efforts and determined that guidance does not provide the agency with appropriate enforcement capability. Therefore, HRSA is not pursing new guidance under the Program at this time. The FY 2021 President's Budget includes a proposal to provide HRSA comprehensive regulatory authority.