Topic
340B
257 published works
Inside Government Contracts
HRSA Updates the Self-Disclosure Process for 340B Noncompliance
By Jennifer Plitsch, Covington Team
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…
Inside Government Contracts
Judge Requires PhRMA To Initiate New 340B Orphan Drug Lawsuit to Challenge Interpretive Rule
By Jennifer Plitsch, Covington Team
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…
Triage Health Law
HRSA issues 340B Interpretive Rule
The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) recently announced the availability of an interpretive rule (the “Interpretive Rule”) regarding section…
Health Care and Life Sciences
HRSA Issues Interpretive Rule on 340b Orphan Drug in Response to Court Vacating Final Rule
By Constance A. Wilkinson, Alan J. Arville
By Constance Wilkinson, Alan Arville, and Jonathan Hoerner On July 23, 2014, the Health Resources and Services Administration ("HRSA") issued an "interpretive rule" entitled "Implementation of the Exclusion of Orphan…
Health Industry Washington Watch
HRSA Issues Interpretive Rule on 340B Orphan Drug Exclusion
On July 21, 2014, the Health Resources and Services Administration (HRSA) released an “interpretive rule” reiterating that 340B-covered entities affected by the orphan drug exclusion may purchase orphan drugs at…
Health Law Update
The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA
By Lee H. Rosebush, Susan Feigin Harris
On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to…
Focus on Regulation
340B Program: U.S. District Court for the District of Columbia Vacates HRSA’s Final Rule on the 340B Orphan Drug Exclusion
By Alice Valder Curran, Christopher Schott, Natalie Morris
On Friday, May 23, 2014, the U.S. District Court for the District of Columbia "vacated," or invalidated, the Health Resources and Services Administration's (HRSA) final rule on the treatment of…
Health Industry Washington Watch
HRSA Releases 340B Audit Results
On May 9, 2014, the Health Resources and Services Administration (HRSA) released the results of its FY 2012 audits of covered entity compliance with 340B drug discount program rules. Based…
Health Industry Washington Watch
OIG Examines 340B Program Contract Pharmacy Arrangements in Advance of HRSA Rules
A recent OIG report examined potential problems associated with the growing use of contract pharmacies under the 340B discount drug program. The OIG describes these arrangements as when a 340B…
Health Care and Life Sciences
Major Themes at 340B Coalition Winter Conference Include Contract Pharmacy Oversight, Medicaid Managed Care, and Anticipated 340B “Mega-Reg”
By Alan J. Arville Last week, the 2014 340B Coalition Winter Conference was held in San Diego, California (the "Winter Conference"), where representatives from the Health Resources and Services Administration…