Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted its long-held position on its website, this time calling it an “interpretative …
HHS POISED FOR ROUND TWO OF ORPHAN DRUG FIGHT
June 16, 2014 Leave a Comment
HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that struck down a regulation issued by the Health Resources & Services …
FEDERAL COURT INVALIDATES 340B ORPHAN DRUG REGULATION
May 27, 2014 Leave a Comment
Last Friday a federal district court invalidated a regulation that had authorized the 340B discount for critical access hospitals, sole community hospitals, rural referral centers and free-standing cancer hospitals when they purchase orphan drugs for off-label purposes. Two concepts are necessary for …