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HRSA Proposes Earlier Implementation Date for Ceiling Price and Civil Monetary Penalty Final Rule

November 2, 2018—The Health Resources and Services Administration Oct. 31 released a notice of proposed rulemaking (NPRM) that changes the implementation and compliance date for the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties (CMP) final rule to Jan. 1, 2019. The current implementation date is July 1, 2019 [see Washington Highlights, June 8].  

The AAMC, along with the American Hospital Association, America’s Essential Hospitals, and 340B Health, filed a Sept. 2018 lawsuit in U.S. District Court challenging the years-long delay to implement the final rule [see Washington Highlights, Sept. 14]. 

The final rule, initially published in on Jan. 2, 2017 (82 Fed. Reg. 1210), establishes the process for calculating the ceiling price for drugs acquired under the 340B Program and the application of CMPs for manufacturers not in compliance with program requirements. This process will allow 340B covered entities to verify the ceiling price of 340B drugs to ensure they have been charged the correct prices. 

The AAMC will submit comments to the NPRM, which are due Nov. 24.


Mary Mullaney
Director, Hospital Payment Policies
Telephone: 202-909-2084


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Senior Legislative Analyst, Govt. Relations
Telephone: 202-903-0806