News and Insights

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The final rule regarding the “Sunshine Act” was published by the Centers for Medicare and Medicaid Services (“CMS”) on February 1, 2013. This rule interprets the provisions of the physician payment provisions for the Affordable Care Act, and finalizes the creation of a database of the financial relationship between physicians and covered drug and device manufacturers.

This long-awaited rule is intended to increase transparency and “to reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers,” according to the statement released by CMS.

The Sunshine Act establishes guidelines and requirements for certain entities referred to as “applicable manufacturers” to report their financial relationships with physicians. Specifically, manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program must report to CMS payments or other transfers of value they make to physicians and teaching hospitals. Group purchasing organizations and applicable manufacturers must also disclose physician ownership or investment interests held on or after August 1, 2013.

The Sunshine Act excepts certain types of transfers of value from the reporting requirement, such as incidental items valued at less than $10 and educational materials intended for use with patients. Physicians will be provided an opportunity to review and, if necessary, dispute information reported to CMS.

The final rule implements reporting timelines, and also creates a venue for the public to view the information. Data collection is to begin on August 1, 2013; the first reports to CMS must be filed by March 31, 2014. The data is slated to be released to the public via a CMS website by September 30, 2014.

For information regarding reporting and reviewing information, see the CMS Open Payments website here. See the final rule here.