On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a.
Tuesday, December 15, 2020
The U.S. Health Resources and Services Administration (HRSA) recently released a draft final rule (Final Rule) that establishes a binding administrative dispute resolution (ADR) process concerning drug costs under the Federal 340B Drug Discount Program (340B Program). As per its terms, the Final Rule will be formally published on Dec. 13, 2020 and will take effect on Jan. 13, 2021.
The Final Rule comes after a nearly 10-year wait for HRSA to establish an ADR process as required under 42 U.S.C. § 256b (the 340B Program Statute). However, HRSA’s Final Rule appears mostly motivated by two recent lawsuits filed by groups representing 340B Program-eligible health centers and HIV/AIDS clinics that participate in the 340B Program. In brief, these lawsuits asserted recent actions taken by drug manufacturers to restrict access to 340B Program discounted medications violated the 340B Program Statute and HRSA violated administrative procedure obligation