On February 1, 2013, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited final regulations with a lengthy preamble (collectively referred to herein as “Final Regulations”) relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the “Physician Payment Sunshine Act.”[1] The Final Regulations are available online.
Generally, the Physician Payment Sunshine Act requires “applicable manufacturers” of a “covered drug, device, biological, or medical supply” to report annually certain information to CMS regarding “payments and other transfers of value” provided to “covered recipients.” The Physician Payment Sunshine Act also requires applicable manufacturers and “applicable group purchasing organizations (‘GPOs’)” to report annually certain information to CMS regarding “ownership or investment interests” held by physicians and their immediate family members. For an overview of the Physician Payment Sunshine Act generally, see the Epstein Becker Green health reform alert titled “Federal Transparency Is Now a Reality: Challenges and Opportunities for Pharma, Devices and PBMs.” Additionally, see the Epstein Becker Green health reform alert titled “CMS Issues Proposed Rules on Federal Sunshine Law for Manufacturers and GPOs” for an overview of the CMS proposed regulations issued December 14, 2011 (“Proposed Regulations”).