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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

AAMC Comments on 340B Drug Pricing Program Proposed Rule

October 14, 2016—The AAMC Oct. 11 submitted a comment letter in response to the Health Resources and Services Administration’s (HRSA) Alternative Dispute Resolution (ADR) proposed rule. As required by the Affordable Care Act (ACA, P.L. 111-148 and P.L. 111-152), HRSA has proposed an ADR process that is limited to the resolution of (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufactures; and (2) claims by manufacturers, after a manufacturer-conducted audit, that a covered entity has violated the prohibition on diversion to eligible patients or duplicate discounts. The proposed rule will provide covered entities with a process to address manufacturer errors, an important improvement to the 340B Drug Pricing Program.

In its comment letter, the AAMC stresses the importance of the 340B Drug Pricing Program to teaching hospitals in expanding access to care. The association is generally supportive of the proposal, but voices several concerns and offers recommendations. The AAMC asks HRSA to require as part of the claim that manufacturers submit a written summary of attempts to work in good faith with covered entities to resolve claims of diversion or duplicate discounts. Additionally, the association believes HRSA should review this summary to ensure the attempts reflect a good faith effort on the part of the manufacturer before a claim can proceed. The AAMC supports uniform timeframes for responses in order to minimize confusion and allow parties ample time to respond to inquiries.

The AAMC supports having a dedicated panel of federal experts to review the claims and recommends that each ADR Panel include a non-voting member from HRSA’s Office of Pharmacy to ensure HRSA expertise is available during the ADR process. The AAMC also recommended the ADR Panel be required to issue a final decision within 20 business days once all parties have responded to the panel’s draft decision letter. The panel’s final decision should also be posted to HRSA’s public website along with responses from the parties involved.  Finally, the AAMC recommends that decisions not be precedential, as each decision by the ADR Panel is specific to the facts of a particular case.

Contact:

Mary Mullaney
Director, Hospital Payment Policies
Telephone: 202-909-2084
Email: mmullaney@aamc.org

Ayeisha Cox, J.D.
Hospital Policy & Regulatory Specialist
Telephone: 202-282-0482
Email: aycox@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org