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 have begun data collection on August 1, 2013, and must file their first reports on March 31, 2014.
In addition to the final regulations, CMS maintains a list of Frequently Asked Questions (FAQs) on its National Physician Payment Transparency Program: Open Payments website. The FAQs, which include questions posed by interested parties and responses by CMS, were most recently updated on October 30, 2013. Among others, CMS added an FAQ clarifying whether a meeting is a reportable event if an applicable manufacturer located in the United States conducts the meeting in a foreign country. CMS states that the event is reportable and that “[a]ny payments or other transfers of value provided by an applicable manufacturer to covered recipients (or physician owners or investors), wherever made, are required to be reported.”
In another FAQ, CMS clarifies that a loan of a covered device by an applicable manufacturer for training purposes at a CME or non-CME event is not considered a payment or other transfer of value, so long as the device was loaned to the CME vendor for training covered recipients at a CME event and the covered recipient did not take possession of the covered device.