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    Subject Term: "Medicare Part B"

    1 publication with a total of 2 open recommendations
    Director: James Cosgrove
    Phone: (202) 512-7114

    2 open recommendations
    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 August 2017, 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 its comments on a draft of this report, HHS concurred with this recommendation. HHS stated that it will continue to work with the Office of Inspector General (OIG) as appropriate to collect source documentation from drug manufacturers and take action as may be warranted. HHS also stated that OIG reviews and compares the submitted average sales price (ASP) to the average manufacturer price (AMP) for Medicare Part B drugs and CMS has the authority to adjust ASP-based payment amounts when the difference between the two rates reaches a certain threshold. We do not consider this recommendation closed because 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 request source documentation, such as sales invoices, from a sample of drug manufacturers to verify that the reported data reflect actual sales prices. As of August 17, 2017, CMS has not provided any additional information about actions to address this recommendation.