0906-AB28 202310 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 revise the Administrative Dispute Resolution (ADR) final rule currently in effect and apply to all drug manufacturers and covered entities that participate in the 340B Drug Pricing Program (340B Program). It will establish new requirements and procedures for the 340B Program’s ADR process. This administrative process will allow covered entities and manufacturers to file claims for specific compliance areas outlined in the statute after good faith efforts have been exhausted by the parties.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 42 CFR 10 Not Yet Determined Yes

This final rule will revise the December 2020 340B Administrative Dispute Resolution (ADR) final rule, which became effective January 13, 2021. The final rule will implement new requirements and procedures for the 340B Program’s ADR process. The final rule applies to drug manufacturers and covered entities participating in the 340B Drug Pricing Program (340B Program) by allowing these entities to file claims for specific compliance areas outlined in the 340B statute after good faith efforts have been exhausted by the parties. It aligns with the President’s priorities on drug pricing, better reflects the current state of the 340B Program, and seeks to correct procedural deficiencies in the current 340B ADR process.

]]>

Section 340B(d)(3) of the Public Health Service Act (PHS Act) requires the Secretary to promulgate regulations establishing and implementing an ADR process for certain disputes arising under the 340B Program. Under the 340B statute, the purpose of the ADR process is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the PHS Act, that a covered entity has violated the prohibition on diversion or duplicate discounts.

]]>

The 2020 340B ADR final rule would remain in effect. This final rule is designed to be more accessible to stakeholders and will use fewer stakeholder and government resources to resolve disputes as opposed to the 2020 340B ADR final rule.

]]>

The ADR process will not have a significant financial impact on stakeholders nor result in significant costs.  The final rule will enable stakeholders to resolve disputes in a fair, efficient, and expeditious manner in accordance with section 340B(d)(3) of the Public Health Service Act.

]]>

None

]]> NPRM 11/30/2022 87 FR 73516 NPRM Comment Period End 01/30/2023 Final Action 12/00/2023 No No None No No No No Michelle Herzog Deputy Director, Office of Pharmacy Affairs 0906 Health Resources and Services Administration HRSA 301 443-4353 mherzog@hrsa.gov 5600 Fishers Lane, 08W12, Rockville MD 20857