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HHS/HRSA RIN: 0906-AB26 Publication ID: Fall 2020 
Title: ●340B Drug Pricing Program; Administrative Dispute Resolution 
Abstract:

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  This rule will finalize the proposed rule that was issued under 0906-AA90 (81 FR 53381) that was withdrawn from the Spring 2017 Unified Agenda of Regulatory and Deregulatory Actions.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Not subject to, not significant 
CFR Citation: 42 CFR 10   
Legal Authority: 42 U.S.C. 256b   
Legal Deadline:  None

Statement of Need:

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.

Timetable:
Action Date FR Cite
Final Action  12/00/2020 
Final Action Effective  12/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Krista Pedley
Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 594-4353
Email: krista.pedley@hrsa.hhs.gov

CAPT Krista Pedley
Director, Office of Pharmacy Affairs
Department of Health and Human Services
Health Resources and Services Administration
Healthcare Systems Bureau, 5600 Fishers Lane, 10C-03,
Rockville, MD 20857
Phone:301 443-5294
Email: krista.pedley@hrsa.hhs.gov