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November 1, 2017

HRSA Delays Rule on Determination of 340B Ceiling Prices and Manufacturer Penalties for Overcharging Providers

HRSA furthered delayed implementation of a final rule codifying the calculation of the 340B ceiling price, and implementing civil monetary penalties for manufacturers that knowingly and intentionally overcharge 340B providers.  The final rule had been published on January 5th under the Obama Administration, and then delayed as part of the Trump Administration’s regulatory review. HRSA has now further delayed the rule’s effective date until May 22nd, and is inviting comments on whether a longer delay until October 1 would be appropriate. The requirement to issue the rule was part of the Affordable Care Act, prompting concerns about further delay from 340B provider groups.