Recent Blog Posts
- U.S. District Court Vacates HRSA’s Interpretative Rule on Orphan Drugs On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the “Court”), Judge Rudolph Contreras, vacated the Health Resources and Services Administration’s (“HRSA”) interpretive rule on Orphan Drugs (“the Interpretative Rule”) as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” As a result of the ruling, pharmaceutical manufacturers are not required to provide 340B discounts to certain types of covered entities for Orphan Drugs, even when the drugs are prescribed for... More
- HRSA Issues Proposed “Omnibus Guidance” The Health Resources and Services Administration (“HRSA”) issued a notice proposing guidance under the 340B Drug Pricing Program. The proposed Omnibus Guidance was issued in pre-publication format and is available online at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-21246.pdf. The notice is scheduled to be published in the Federal Register on August 28, 2015 and will be available at https://www.federalregister.gov/articles/2015/08/28/2015-21246/guidance-340b-drug-pricing-program-omnibus.
HRSA intends to finalize the proposed guidance after consideration of public comments. The notice is open for a 60-day public comment period, with comments due on or... More
- House Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady
The House of Representatives Energy and Commerce Committee (“the Committee”) circulated draft language to include in its 21st Century Cures legislation earlier this week to reform the 340B drug discount program (the “340B Program”). Although the draft 340B language was pulled from the legislation yesterday, the language proposed provides insight into what future legislative reform may include. The draft language, if adopted, would have a substantial impact on all 340B... More
- Members of House Subcommittee Express Support for the 340B Program, but Need for Clarity, Oversight and Transparency On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee (the “Subcommittee”) held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration (“HRSA”), the Director of the Office of Pharmacy Affairs (“OPA”) of HRSA, the Director of Health Care of the Government Accountability Office (“GAO”), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General... More
- HRSA Withdraws 340B “Mega-Reg;” Plans to Issue Guidance in 2015 On November 13, 2014, the Health Resources and Services Administration (“HRSA”) announced its plans to abandon the much anticipated “mega-reg” amid questions concerning HRSA’s rule-making authority. The “mega-reg” was expected to provide much needed clarity to the 340B drug discount program (the “340B Program”) by addressing, among other things, the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility, and criteria for hospital off-site facilities.
HRSA submitted draft regulations to OMB in April 2014, and the proposed “mega-reg”... More
- HRSA Issues Interpretive Rule on 340b Orphan Drug in Response to Court Vacating Final Rule 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 Drugs for Certain Covered Entities under the 340B Program” (the “Interpretive Rule”). The Interpretive Rule follows the ruling by the U.S. District Court for the District of Columbia on May 23, 2014, that vacated the final rule previously released by HRSA on the treatment of orphan drugs under the 340B program... More
- 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 (“HRSA”) of the United States Department of Health and Human Services (“HHS”), the Office of Inspector General (“OIG”) of HHS, and industry stakeholders (including Epstein Becker Green) presented on current developments with the 340B drug discount program (the “340B Program”). A brief summary of the 340B Program, including contract pharmacy arrangements,... More
- OIG Issues Report on 340B Contract Pharmacy Arrangements Supporting Need for Tighter Rules By Constance Wilkinson, Alan Arville, and David Gibbons
The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a Report  on February 5th based on in-depth interviews with a sample of thirty 340B Covered Entities – half were disproportionate share hospitals (“DSH”) and half were community health centers (“CH”) – and eight contract pharmacy administrators to gain a better understanding of how contract pharmacy arrangements operate under the 340B Drug Discount Program, codified as Section... More