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Physician Sunshine Act Final Rules Issues

CMS Issues Final Rules Under Physician Sunshine Act 

physician sunshine actThe Physician Sunshine Act was enacted as part of the Affordable Care Act.  The Physician Sunshine Act requires drug, device, biological and medical supply manufacturers to make annual reports to the Department of Health and Human Services regarding payments or transfers of value to physicians and teaching hospitals and certain ownership interests that are held by physicians.  Manufacturers are subject to civil monetary penalties if they fail to comply with the reporting requirements.

 Data that is reported by manufacturers is required to be published on a public website.  An annual report must also be made to Congress and each state. 

CMS published proposed rules in 2011 which defined more precise obligations that manufacturers need to meet in order to comply with the requirements of the Physician Sunshine Act.  Just last week, CMS issued final regulations on the Physician Sunshine Act Law.  The Physician Sunshine Law as interpreted by the final regulations require applicable manufacturers to begin collecting required data by August 1, 2013 and to make their first data report to CMS by March 31, 2014.

The Final Rule provides further definition of terms that are necessary to determine compliance.  For example, the Final Regulations provide more complete definitions of applicable manufacturers and the types of drugs, devices, biological and medical supplies that are covered.  The Final Rules also provide clarification on the procedures and forms that manufacturers must use to report data.  The character of payments to be reported is also defined further.

The reporting requirements fall on the manufacturer.  However, physicians may be interested to know more details on the types of payments and activities that relate to them that would need to be reported by manufacturers.  Physicians are in the front lines of interactions with pharmaceutical and other sales representatives.  The Physician Sunshine Act has not changed the types of interactions that are permissible or prohibited.  However, even permissible arrangements with physicians will need to be reported by manufacturers and will be made publically available.

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John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
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