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AAMC Submits Comment Letter on “Sunshine” Act Proposed Dispute Resolution Process

June 6, 2014—The AAMC June 2 submitted a comment letter  to the Centers for Medicare and Medicaid Services (CMS) and the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) regarding a proposed process for tracking the initiation and resolution of disputes in the CMS Open Payments program database.  CMS requested comments through a notice of Agency Information Collection Activities published in the May 5 Federal Register.

Open Payments is the program initiated under the Sunshine provisions of the Affordable Care Act (ACA, P.L. 111-148 and P.L. 111-152).  The final rule, “Transparency Reports and Reporting of Physician Ownership or Investment Interests,” requires manufacturers of drugs, devices, biologicals and medical supplies to report annually to CMS any payments or transfers of value made to physicians and teaching hospitals [see Washington Highlights, Feb. 8, 2013].

Physicians and teaching hospital delegates will have access to records about them for a 45 day review window.  Disputed records need to be resolved within those 45 days or a 15 day resolution period in order for any changes to be made to the information.

The AAMC expresses concern that supporting materials seem to give a manufacturer or group purchasing organization (GPO) the option to unilaterally dismiss a dispute about a payment when no actual resolution has been reached. The association urges CMS to make some changes to the proposed system to ensure that those payments disputed by physicians and teaching hospitals were either resolved to the satisfaction of both parties or marked in the public database as disputed and unresolved.

“Congress, individuals and institutions who will be listed in the database, and the American public,” the letter concludes, “need to know that the information ultimately presented has been reviewed by those who are the subjects of the reports and that CMS has taken every opportunity to confirm that the database more faithfully represents transparency into the relationships between manufacturers and health care providers.”


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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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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Jason Kleinman
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Telephone: 202-903-0806