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HRSA Moves Up Effective Date for 340B Ceiling Price, CMP Rule

In an Oct. 31 proposed rule, the Health Resources and Services Administration (HRSA) moved up to Jan. 1, 2019, the effective and implementation date for a final rule providing guidance on the calculation of ceiling prices for drugs administered through the 340B Drug Pricing Program.

The rule also will impose civil monetary penalties (CMPs) for manufacturers who knowingly and intentionally charge covered entities more than the ceiling price for covered outpatient drugs.

Following several delays, the rule most recently was scheduled for implementation on July 1, 2019.

America’s Essential Hospitals released a statement praising the new effective date and encouraging the Department of Health and Human Services (HHS) to launch a website providing price information to 340B participating hospitals as soon as possible after Jan. 1, 2019.

Comments on the proposed rule are due to HRSA by Nov. 23.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

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