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340B Program Dispute Resolution Process Proposed Rule

The Health Resources and Services Administration (HRSA) has released a proposed rule that would establish an administrative dispute resolution process for the 340B Drug Pricing Program.

The proposed rule implements a provision of the Affordable Care Act that requires a binding administrative dispute process for program participants. This includes covered entities that claim to have been overcharged for drugs purchased through the program. HRSA is proposing that a decision-making body within the Department of Health and Human Services be responsible for reviewing claims and resolving deputes.

America’s Essential Hospitals is analyzing the proposed rule. HRSA is accepting comments on it through Oct. 11.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Erin O' Malley is the senior director of policy at America's Essential Hospitals.

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