On June 17, 2015, the Health Resources and Services Administration (HRSA) published a proposed rule to clarify how manufacturers should calculate the ceiling price for covered outpatient drugs under the 340B program, and to provide for civil monetary penalties (CMPs) on manufacturers that “knowingly and intentionally” overcharge 340B covered entities.[1] The ceiling price provisions are not expected to significantly change manufacturers’ current practices; however, the possibility of CMPs is a new aspect of the 340B program. Although HRSA speculates that the use of CMPs will “probably be rare,” the proposed rule does not provide significant guidance regarding what constitutes a knowing and intentional violation. The rule would also subject manufacturers to liability for failure to ensure that covered entities receive 340B pricing from wholesalers or other distributors, raising questions about manufacturers’ obligations to oversee these entities.
Continue Reading HRSA Proposes Calculation of 340B Ceiling Prices, Implementation of Manufacturer Civil Monetary Penalties
Orphan Drug
PhRMA Filed Suit Today Seeking to Invalidate the 340B Orphan Drug Exclusion Interpretative Rule
By Jennifer Plitsch & Covington Team on
Posted in Health Care Contracting, Procurement Policy
Today, Pharmaceutical Research and Manufacturers of America (“PhRMA”) filed a suit seeking to invalidate the 340B Orphan Drug Exclusion Interpretative Rule. The same Health Resources and Services Administration (“HRSA”) policy in the “interpretive rule” was previously set forth in substance as a final regulation that was struck down by the U.S. District Court…
Judge Requires PhRMA To Initiate New 340B Orphan Drug Lawsuit to Challenge Interpretive Rule
By Jennifer Plitsch & Covington Team on
Posted in Health Care Contracting
A Washington, D.C., federal judge has declined requests from Pharmaceutical Research and Manufacturers of America(“PhRMA”) to invalidate a new interpretive rule applicable to orphan drugs in the 340B drug discount program, saying the trade group must file a new complaint in order to proceed.
Last week, the D.C. District Court ruled that PhRMA must bring…