On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.” The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (GPOs) to report all ownership and investment interests held by physicians or members of their families. As set forth in the final regulations, applicable manufacturers and GPOs must begin data collection on August 1, 2013, and must file their first reports on March 31, 2014.  

In addition to the final regulations, CMS also released the following proposed templates for data collection and submission of reports required by the Sunshine Act:

  • Non-research Payment Template;
  • Physician Ownership Template; and
  • Research Payment Template.

CMS is currently accepting comments on the proposed templates. Interested parties may submit their comments electronically to:

http://www.regulations.gov/#!documentDetail;D=CMS-2013-0052-0001

Comments may also be submitted via regular mail to the following address:

CMS, Office of Strategic Operations and Regulatory Affairs Division of Regulations Development Attention: Document Identifier/OMB Control Number CMS – 10419 Room C4–26–05 7500 Security Boulevard Baltimore, Maryland 21244–1850

Comments must be submitted by April 9, 2013, to assure consideration.