0906-AB26 202010 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS 340B Drug Pricing Program; Administrative Dispute Resolution

This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program.  The final rule sets forth the requirements and procedures for the 340B Program’s administrative dispute resolution process.  This rule will finalize the proposed rule that was issued under 0906-AA90 (81 FR 53381) that was withdrawn from the Spring 2017 Unified Agenda of Regulatory and Deregulatory Actions.

]]> Other Significant First Time Published in The Unified Agenda Final Rule Stage No No Not subject to, not significant 42 CFR 10 42 U.S.C. 256b Yes

The Affordable Care Act added a provision to the 340B statute that requires the Secretary to issue regulations concerning an Administrative Dispute Resolution (ADR) process designed to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after the manufacturer has conducted an audit of a covered entity, that a covered entity has violated the prohibition on diversion or duplicate discounts.

]]> Final Action 12/00/2020 Final Action Effective 12/00/2020 No No None No No No Krista Pedley Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 594-4353 krista.pedley@hrsa.hhs.gov Healthcare Systems Bureau, 5600 Fishers Lane, Rockville MD 20857 Krista Pedley CAPT Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 443-5294 krista.pedley@hrsa.hhs.gov Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03, Rockville MD 20857