The law firm representing United Therapeutics (UT), Latham & Watkins, has filed a request with HRSA to obtain a wide range of records related to HRSA’s enforcement of the 340B…
On October 7, Sanofi filed a request to the D.C. District Court to temporarily halt any 340B ADR proceedings filed against it. Sanofi filed the request in its lawsuit challenging…
On September 20, North Carolina enacted a PBM reform law, Session Law 2021-161, that includes provisions protecting certain categories of 340B covered entities against discriminatory practices. The law protects federally…
On September 29, PhRMA brought a case in the U.S. District Court for the Eastern District of Arkansas to stay enforcement of the Arkansas law (Act 1103) that makes it…
On September 23, U.S. Senator Mike Braun (R-IN) introduced a bill to amend the 340B statute to allow HHS to audit 340B covered entities to determine how they use “net…
Earlier today, HRSA sent letters to Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi, and United Therapeutics alerting them that the agency has notified the HHS-Office of the Inspector General (OIG),…
Gilead recently notified pharmacies that beginning January 1, 2022, they must enter into a participation agreement in order to submit claims and receive reimbursement under Gilead’s Patient Assistance Program and…
On July 29, the Arkansas Insurance Department (“AID”) issued an order suspending for 90 days (until October 27) the enforcement of certain provisions of a recently enacted Arkansas law that…
On August 11, Merck issued a letter announcing its policy to stop “voluntarily” providing 340B discounts to hospital covered entities on drugs dispensed at contract pharmacies unless the hospital provides…
On July 19, HHS and the Departments of Labor and Treasury took an important step to remove insurance copayment requirements as a barrier to access to HIV preexposure prophylaxis (“PrEP”)…