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HRSA Considers Additional Delay of 340B Overcharges Rule

The Health Resources and Services Administration (HRSA) announced in a proposed rule that it is considering further delaying until July 1, 2018, implementation of a final rule on ceiling prices and civil monetary penalties in the 340B Drug Pricing Program.

Earlier this year, HRSA issued a final rule that provided additional guidance on the calculation of ceiling prices for 340B drugs supplied to covered entities and imposed civil monetary penalties for manufacturers who knowingly and intentionally charged covered entities more than the ceiling price for covered outpatient drugs. HRSA has delayed implementation of the final rule several times, most recently to Oct. 1.

HRSA now is seeking comments on whether to extend the delay an additional nine months. During the delay period, HRSA intends to continue to examine issues raised by commenters about the implementation of the final rule and to release further rulemaking. Comments on the new proposed rule are due to HRSA 30 days after its publication date, Aug. 21.

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


About the Author

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

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