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Implementing Average Sales Price Reporting Requirements for Skin Substitutes

Before 2022, average sales price (ASP) reporting requirements applied only to Part B drugs subject to Medicaid rebate agreements. However, manufacturers of skin substitutes-used in the treatment of wounds-generally did not participate in the Medicaid drug rebate program and thus were not required to report ASPs. Congress addressed this reporting gap through the Consolidated Appropriations Act, 2021, with an implementation date of January 1, 2022. Preliminary analysis indicates that: (1) several manufacturers of skin substitutes did not report ASPs as required and (2) CMS has not uniformly set payment amounts using ASPs for cases in which manufacturers reported such data. Given that Medicare Part B spends more than $1 billion per year on skin substitutes, this Early Alert will seek to quickly identify and address reporting and implementation issues.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
October 2022 Centers for Medicare and Medicaid Services Implementing Average Sales Price Reporting Requirements for Skin Substitutes Office of Evaluation and Inspections OEI-BL-23-00010 2023