February 08, 2013
Area(s) of Interest: Health Care Reform Licensing & Regulatory Issues
On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) issued the final regulations implementing the Physician Payments Sunshine Act (Sunshine Act) provisions of the Affordable Care Act (ACA). The intention of the law is to increase transparency and reduce the potential for conflicts of interest that can influence research, education and clinical decision making.
Beginning Aug. 1, 2013, manufacturers of drugs, medical devices and biologics that participate in federal health care programs must begin tracking and reporting certain payments and items of value—including consulting fees, travel reimbursements, research grants and other gifts—given to physicians and teaching hospitals. The Sunshine Act also requires manufacturers and group purchasing organizations (GPOs) to report certain ownership interests held by physicians and their close family members. While the first reporting period will only be five months from Aug. 1 to Dec. 31, 2013, thereafter the reporting period will be a full calendar year. The majority of the information contained in the reports will be made available on a public, searchable website beginning in September 2014. Physicians have the right to review their reports and to challenge any information that is false, inaccurate or misleading. By statute, physicians are provided, at a minimum, 45 days to review the transparency reports and make corrections before they are made public.
The final regulation contained important changes to address concerns raised by the California Medical Association (CMA), the American Medical Association (AMA) and others in organized medicine. Most significant, the final regulation excludes from reporting certified and accredited continuing medical education and expands the time afforded physicians to challenge inaccurate, false and misleading reports.
However, the final regulation contains provisions that continue to raise concerns, including: (1) the agency’s decision to not require manufacturers to provide ongoing notice to physicians of transfers or payments that the manufacturer intends to report; and (2) the agency’s broad interpretation of reportable indirect transfers. The latter may have implications that require careful consideration of financial interactions between manufacturers and organizations or businesses that employ or provide services to physicians.
The Sunshine Act covers all physicians who have an active state license, even if they do not participate in federal health care programs, but excludes residents and medical students. AMA has established a webpage with detailed information on the types of payments, transfers of value and ownership interests covered by this reporting requirement as well as the exceptions.