View Rule

This proposed rule would replace 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 would establish new requirements and procedures for the 340B Program’s ADR process.  This administrative process would 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.

Statement of Need:

This NPRM proposes to replace the 340B Administrative Dispute Resolution (ADR) final rule, which was published in December 2020 and became effective January 13, 2021. This new rule will propose new requirements and procedures for the 340B Program’s ADR process. The proposed 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. This NPRM better 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 340B ADR process.

Summary of the Legal Basis:

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.

Alternatives:

N/A

Anticipated Costs and Benefits:

N/A

Risks:

None