Final Rule: 340B Drug Pricing Program; Administrative Dispute Resolution Regulation

The final rule was released on December 14, 2020. It finalized a proposed rule issued in late 2016 to establish an administrative dispute resolution (ADR) process to address disputes between covered entities and drug manufacturers for the 340B drug discount program. Under the 340B program, pharmaceutical manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities (safety net hospitals called 340B hospitals) and other eligible entities at significantly reduced prices. Participation in the 340B Drug Pricing Program is required for Medicare coverage of the medication.

After the administration change on January 20, 2017, the proposed rule was withdrawn . . .