Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013.

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act implements a provision of the Affordable Care Act that requires (1) certain manufacturers to report payments and transfers of value to physicians and teaching hospitals, and (2) certain manufacturers and group purchasing organizations (GPOs) to report ownership or investment interests of physicians and their immediate family members. In turn, the government will make this information publicly available with the stated intention that the transparency will shed light on inappropriate relationships and prevent unnecessary health care costs due to conflicts of interest. The Sunshine Act is strictly a disclosure law and, therefore, does not prohibit payments or ban investment interests. Under the Sunshine Act, applicable manufacturers and GPOs must begin to collect data on August 1, 2013 and electronically submit reports to CMS by March 31, 2014. CMS will publish aggregated data on a public website by September 30, 2014 and will make that data available for download. CMS will not grant reporting extensions and has indicated that late reporting will be deemed a failure to report. Given the fast-approaching deadlines and the significant penalties imposed by the Act for non-compliance, entities should move swiftly to determine their compliance obligations and implement internal systems to capture and synthesize reportable information.

WHO NEEDS TO REPORT?

Two types of entities are required to report under the Sunshine Act: applicable manufacturers and applicable GPOs.