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340B Implementation Date Delayed

March 19, 2017—The Department of Health and Human Services (HHS) May 18 released an update to the final rule that revises the implementation date for the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs) that will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Drug Pricing Program. The policy changes were initially postponed to May 22 in accordance with the Jan. 20 memorandum from the administration. The policies will now begin on Oct. 1, 2017. 

The rule finalized the:

  • requirement that a manufacturer calculate the 340B ceiling price on a quarterly basis;

  • new “penny pricing” policy for certain drugs that requires manufacturers to charge $0.01 per unit measure for a drug whose calculated ceiling price is less than $0.01;

  • new methodology manufacturers must use when estimating the ceiling price for a covered outpatient drug; and

  • explanation of how a CMP would be imposed on a manufacturer that knowingly and intentionally overcharges a covered entity.


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
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806