Recommendation: To determine the suitability of Medicare's Part B drug payment rate methodology for drugs with coupon programs, Congress should consider (1) granting CMS the authority to collect data from drug manufacturers on coupon discounts for Part B drugs paid based on ASP, and (2) requiring the agency to periodically collect these data and report on the implications that coupon programs may have for this methodology.

Agency: Congress
Status: Open

Comments: As of August 2020, Congress had not passed legislation to address this Matter for Congressional Consideration. We will update the status of this Matter if such action occurs.

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.