Final Rule on Physician Sunshine Act Released

Manufacturers, GPOs Required to Report Certain Payments, Gifts to Physicians

February 15, 2013 03:25 pm News Staff

CMS has issued a final rule( that implements a provision in the health care reform law requiring drug and device manufacturers and group purchasing organizations (GPOs) to report payments or gifts of $10 or more made to physicians, hospitals and other providers on a yearly basis.

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The provision, known as the Physician Payments Sunshine Act, also requires manufacturers of these products and GPOs to report ownership and investment interests held by physicians or their immediate family members in the entities.

CMS is requiring manufacturers and GPOs to start collecting data on Aug. 1. These groups must submit data collected between Aug. 1 and the end of 2013 to CMS by March 31, 2014.

The agency plans to publish the initial data on a public website by Sept. 30, 2014. In subsequent years, the agency will post the information annually on June 30. CMS is required by law to give physicians at least 45 days to review, dispute and correct reported information before posting it on the website, according to an AAFP summary of the rule.

"You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need," said Peter Budetti, M.D., CMS deputy administrator for program integrity in a prepared statement( "Disclosure of these relationships allows patients to have more informed discussions with their doctors."

CMS expected to issue the final rule by the end of 2012, but the agency delayed its release after receiving more than 300 responses during the comment period on the proposed rule. These included comments from the AAFP and other organizations, who warned that the reporting requirements would create "significant complexities."

CMS addressed some, but not all, of the issues raised by the AAFP and other groups. For example, at the request of the AAFP and other organizations, CMS exempted speaker fees for accredited and certified CME programs from the reporting requirements. In this way, CMS acknowledged that "CME accrediting and certifying bodies, such as the AAFP, ensure that CME activities adhere to rigorous standards," said Carly Harrington, M.Ed., manager of CME credit systems and compliance for the AAFP.

"These standards call for transparency, conflict-of-interest mitigation and structural firewalls between commercial entities and educational development," said Harrington. "It is important for the public to understand that there is a vast CME community dedicated to providing unbiased CME to physician learners."

The final rule exempts other items from the Sunshine Act, as well, including

  • OTC drugs and class I and II medical devices, such as elastic bandages and suture materials;
  • gifts or payments valued at less than $10 -- unless the aggregate amount paid to the physician exceeds $100 annually;
  • incidental items worth less than $10 (e.g., pens and note pads) as well as general food and drinks offered to all participants at conferences or large-scale events;
  • educational materials and items intended for use by or with patients;
  • discounts and rebates from a manufacturer;
  • samples intended for patient use, including coupons and vouchers for obtaining samples;
  • certain indirect payments transferred by a third party if the manufacturer does not know the identity of the recipient; and
  • payments or other transfers of value to residents.