On November 17, the U.S. Court of Appeals for the Eighth Circuit (Eighth Circuit) issued its decision in Pharmaceutical Care Management Association v. Wehbi, et al., ruling that North Dakota’s…
On Friday, November 5, two federal courts issued decisions in four of the lawsuits that drug manufacturers filed against HHS challenging HHS’ May 17 cease-and-desist letters (“May 17 Letters”) notifying…
On Friday, the U.S. District Court for the Southern District of Indiana (the Court) issued a decision supporting HRSA’s statutory interpretation, as reflected in HRSA’s May 17 determination, that Eli…
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…
The Supreme Court has agreed to review three cases in its next term that have potential impact on 340B covered entities. First, the Supreme Court will review AHA, et al.…
As expected, on June 21, the Secretary of HHS appointed Alternative Dispute Resolution (ADR) Board members. ADR Board members are government representatives (not private stakeholders) from three government agencies: HHS…
The Powers team was informed today that the Secretary of HHS has signed a memorandum appointing members to the 340B Alternative Dispute Resolution Board (ADR Board). Appointment of ADR Board…
Following a favorable May 17 Letter (the “Letter”) issued by HHS requiring six drug companies to restart 340B pricing on drugs shipped to contract pharmacies or risk civil monetary penalties,…
The Court of Appeals for District of Columbia Circuit issued a 2-1 decision today upholding Medicare Part B reimbursement cuts for 340B drugs from ASP+6% to ASP-22.5%. The case is…
The federal appeals court for the District of Columbia Circuit recently ruled in favor of the Humana Medicare Advantage plan in a case by a 340B covered entity contending that…