The Centers for Medicare and Medicaid Services (CMS) is continuing its efforts to quickly implement 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.
On February 1, 2013, CMS announced the release of the final regulations implementing Sunshine Act. CMS also released proposed templates for data collection and submission of reports required by the Sunshine Act. Interested parties were permitted to submit comments on the proposed templates by April 9, 2013. CMS recently posted on its website the following revised templates for data collection and submission of reports required by the Sunshine Act:
- General Payments (Non-Research) Template;
- Physician Ownership Template; and
- Research Payment Template.
In addition to the revised templates, CMS also posted a “Revisions Crosswalk” document, which outlines the changes and additions that were made to the proposed templates and the reason for such changes and additions. Although the revised templates are currently undergoing final clearance, CMS has indicated that it intends to use the revised templates for 2013 data collection. 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.