Kalderos Sues HHS Over Contract Pharmacy Policy
On October 7, technology company Kalderos Inc. filed a lawsuit in the U.S. District Court for the District of Columbia against HHS alleging that HRSA’s contract pharmacy policy is unlawful. …
United Therapeutics Seeks Records from HRSA Regarding Covered Entity Compliance with Duplicate Discount and Diversion Prohibitions
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…
Sanofi Files Emergency Motion to Halt ADR Proceedings
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…
North Carolina PBM Reform Law Protects Certain 340B Covered Entity Types
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…
PhRMA Sues in Federal Court to Stop Enforcement of Arkansas Law
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…
Senator Braun (R-IN) Introduces Legislation to Authorize HHS to Audit 340B Income
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…
HRSA Refers Six Pharmaceutical Manufacturers to HHS-Office of the Inspector General for Imposition of Civil Monetary Penalties
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 Notifies Pharmacies of Its New PAP/MAP Policy
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…
Arkansas Law Suspended at PhRMA’s Request
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…
Merck Restricts Purchases of 340B Drugs for 340B Hospitals Effective September 1
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…