HHS enforcing full manufacturer participation in 340B
Lilly, AZ and other pharmas could be fined for alleged non-compliance
Seven pharmas are defying the threat of $5,000 per violation in fines and revocation of their ability to participate in Medicare and Medicaid, betting that a federal court will uphold their view that pharmacies that contract with 340B entities are not eligible for 340B pricing.
Six of the companies — AstraZeneca plc (LSE:AZN; NASDAQ:AZN), Eli Lilly and Co. (NYSE:LLY), Novartis AG (SIX:NOVN; NYSE:NVS), Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO), Sanofi (Euronext:SAN; NASDAQ:SNY) and United Therapeutics Corp. (NASDAQ:UTHR) — have been referred to the Office of the Inspector General (OIG) by the Health Resources & Services Administration (HRSA), setting the stage for a showdown that will play out in federal court. HRSA requested the seventh, Boehringer Ingelheim GmbH, provide updates regarding its alleged non-compliance no later than Oct. 18. ...