Many physicians recently received a notice from the Centers for Medicare and Medicaid Services (CMS) notifying them of the opportunity to register with the CMS “Open Payments” system and review financial data reported about them by drug and device manufacturers under the federal Physician Payments Sunshine Act (“Sunshine Act”). This had led to some confusion among physicians as to what, if any, obligation they have under the Sunshine Act.
The Sunshine Act requires “applicable manufacturers” of drugs, medical devices and biologicals covered under Medicare, Medicaid and CHIP to report certain payments and items of value given to physicians. This information is collected by CMS and is to be made public on a searchable online database by September 30, 2014. Under the law, an “applicable manufacturer” is limited to an entity operating in the United States that is either: An entity engaged in the production, preparation, propagation, compounding, or conversion of a covered product; or An entity under common ownership with an “applicable manufacturer” that provides assistance or support with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered product. The reporting requirement is the manufacturers’ obligation. Physicians who receive payments from applicable manufacturers have no reporting obligation.
Physicians do have a right, however, to dispute reported payments. Specifically, before CMS posts the collected information to the public website, physicians have 45 days to review and correct the information. The reporting manufacturers will have an additional 15 days to correct the erroneous information before submitting and attesting to the updated information to finalize the data submission. More information on the Sunshine Act can be found on the CMS website here: http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html