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HRSA Proposes Further Delay of 340B Rule

A new Health Resources and Services Administration (HRSA) proposed rule would further delay implementation of a final rule on ceiling prices and manufacturer civil monetary penalties in the 340B Drug Pricing Program.

The final rule, issued in 2017, provides guidance on the calculation of ceiling prices for 340B drugs supplied to covered entities. The rule also imposes civil monetary penalties for manufacturers who knowingly and intentionally charge covered entities more than the ceiling price for covered outpatient drugs.

HRSA has repeatedly delayed implementation of the rule; the agency now proposes to push back the effective date one year, from July 1, 2018, to July 1, 2019. HRSA notes that the proposed delay comes as the Department of Health and Human Services plans other policy changes on drug prices, including through Medicare Parts B and D, Medicaid, and the 340B program.

America’s Essential Hospitals issued a statement on the latest proposal to delay implementation.

HRSA is accepting comments on the proposed rule through May 22.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Rachel Schwartz is a former policy associate at America's Essential Hospitals.

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