HRSA Issues Interpretive Rule On 340b Orphan Drug in Response to Court Vacating Final Rule

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”).[1] 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 (the “Final Rule”).[2]

Hospital Lab Services May Not Constitute Unrelated Trade or Business: IRS Technical Advice Memorandum

Hospital Lab Services May Not Constitute Unrelated Trade or Business: IRS Technical Advice Memorandum

On July 11, 2014, the Internal Revenue Service (“IRS”) released a Technical Advice Memorandum (“TAM”) dated March 7, 2008, which concluded that, contrary to the general rule set forth in Revenue Ruling 85-110 (“Rev. Ruling 85-110”), a tax-exempt hospital’s income from laboratory testing services to patients of private physicians is not subject to the unrelated business income tax.

Charting the Future of Premium Subsidies Under the Affordable Care Act: Halbig V. Burwell and King V. Burwell

On July 22, 2014, two federal appellate courts issued conflicting decisions, within hours of each other, regarding the IRS final rule published on May 23, 2012 (the “IRS Rule”), intended to implement the exchange-related tax credit provisions of the Affordable Care Act (“ACA” or the “Act”).