The Sunshine Act, now called Open Payments, does not directly change or prohibit relationships between manufacturers, physicians, teaching hospitals, or continuing medical education providers. Rather, the legislation and regulations require applicable pharmaceutical, biological, and device manufacturers, and group purchasing organizations, to report certain payments they make to physicians or teaching hospitals. Manufacturers were required to begin tracking their payments to physicians and teaching hospitals on August 1, 2013. They will collect data through December 31, 2013 (with the first report due March 31, 2014). Reporting is required annually thereafter. A manufacturer or GPO that fails to report or reports inaccurately may face annual fines up to $1.15 million.

Once manufacturers collect, record, and report the required information, the Center for Program Integrity at the Centers for Medicare & Medicaid Services, which issued the final regulations and is responsible for oversight and implementation of them, will aggregate payments to all physicians and teaching hospitals and post them on a searchable, public Web site after September 30, 2014.

The act’s definition of “physician” includes all licensed medical and osteopathic doctors, dentists, dental surgeons, podiatrists, optometrists, and chiropractors, regardless of whether they are currently practicing or whether they are enrolled with CMS. Non-U.S. physicians are excluded, but several countries have enacted similar legislation (e.g., France, U.K., Slovakia, Russia, and the Netherlands). It does not apply to medical residents, pharmacists, physician’s assistants, nurses, or nurse practitioners. However, CMS recently clarified in its Frequently Asked Questions page that “fellows” are not considered residents, and therefore, payments to fellows are reportable.