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 This rule will finalize the proposed rule that was issued under 0906-AA90 (81 FR 53381) that was withdrawn from the Spring 2017 Unified Agenda of Regulatory and Deregulatory Actions.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