On December 21, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing significant manufacturer price reporting changes under the Medicaid Drug Rebate Program. This final rule is another in a series of drug pricing-related rules issued by the Trump Administration in the past several weeks (which we described here, here, and here).
Among other provisions, the rule affects manufacturer-sponsored patient assistance programs subject to pharmacy benefit manager (PBM) accumulator programs, Best Price (BP) reporting related to certain value-based purchasing (VBP) arrangements, line extensions, and Average Manufacturer Price (AMP) reporting for authorized generics. The regulations affecting the potential reporting of multiple BPs in connection with certain VBP arrangements and related to key definitions for the determination of line extensions become effective January 1, 2022, and the regulations affecting manufacturer-sponsored patient assistance programs subject to PBM accumulator programs are scheduled to take effect January 1, 2023. Other provisions are scheduled to take effect 60 days after publication in the Federal Register.
The remainder of this Update summarizes key provisions of the final rule and certain changes compared to the proposed rule, which we described here. In summarizing the final rule, we are not endorsing the positions or interpretations CMS has taken. The final rule, or portions of it, may be subject to legal challenges and/or regulatory action by the incoming Administration.
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