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
PhRMA
HRSA Updates the Self-Disclosure Process for 340B Noncompliance
By Jennifer Plitsch & Covington Team on
Posted in Health Care Contracting
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 …
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…