Health Resources and Services Administration

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

Earlier this month, HRSA set forth steps that providers should follow to make a “self-disclosure” when a “material breach” of 340B compliance has occurred.  HRSA noted that it is “working to standardize the self-disclosure process, and highlight best practices to assist covered entities in this effort.”

During the annual covered entity recertification process, the 

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