As  previously reported on Pharmaspective, the Centers for Medicare and Medicaid Services (CMS)  recently posted on its website revised templates for data collection and submission of reports required by 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.

CMS is currently accepting comments on the following revised templates:

  • General Payments (Non-Research) Template;
  • Physician Ownership Template; and
  • Research Payment Template.

To be assured consideration, comments and recommendations must be received no later than 5 p.m. on June 3, 2013, at the following electronic address:

Office of Management and Budget

Office of Information and Regulatory Affairs

Attention: CMS Desk Officer

Fax Number: (202) 395-6974

Email: OIRA_submission@omb.eop.gov.