The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting provisions but includes new limitations; exempts certain continuing medical education (CME) payments from disclosure; and includes additional reporting guidance.

The Sunshine Act requires applicable manufacturers of drugs, devices, biologics, or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (Manufacturers) to collect and report payments and other transfers of value to physicians and teaching hospitals. These requirements apply if a Manufacturer sells or distributes at least one covered drug, device, biologic, or medical supply (Covered Product). The Sunshine Act also requires Manufacturers and Group Purchasing Organizations (GPOs) to disclose ownership or investment interests held by physicians or their immediate family members.