The Physician Payments Sunshine Act requires drug and device manufacturers to report transfers of value to physicians and teaching hospitals publicly. As a result, manufacturers and group purchasing organizations must disclose to the Centers for Medicare & Medicaid Services (CMS) any physician ownership or investment interests.
The law is intended to help reduce potential conflicts of interest that could arise from relationships between physicians or teaching hospitals and manufacturers. The AAFP supports reasonable transparency efforts, but believes physicians should be given the opportunity to preview and appeal data before the information is made publicly available.
While AAFP supports the spirit of transparency promoted by the Sunshine Act, we oppose rules that could result in the publication of misleading information or impose costly and burdensome paperwork requirements on family physicians.
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AAFP News: Physician Organizations Call out CMS for Overreach in Sunshine Act Regulation
CMS Official Website for Open Payments(www.cms.gov)
On July 3, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and rates for services furnished under the Medicare physician fee schedule beginning January 1, 2015. Citing a need to respond to questions and experience administering the program, CMS unexpectedly proposed four changes to the Open Payments program:
• Delete the definition of “covered device” as it is duplicative of the definition of “covered drug, device, biological or medical supply,” which is already defined in regulation.
• Delete the Continuing Education Exclusion in its entirety. CMS asserts that eliminating the exemption for payments to speakers at certain accredited or certifying continuing medical education events will create a more consistent reporting requirement for industry and be more consistent for consumers who access reported data.
• Require the reporting of the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.
• Require applicable manufacturers to report stocks, stock options, or any other ownership interest as distinct categories.
On August 1, the AAFP sent CMS a response letter. The final 2015 Medicare physician fee schedule is expected to be released in November.
Joint Letter to Representative Burgess in Support of H.R. 293 - May 29, 2015(4 page PDF)
Joint Letter to Representative Burgess in Support of H.R. 5339 - October 24, 2014(4 page PDF)
AAFP Letter to CMS in Response to CME Changes in the 2015 Proposed MPFS - August 1, 2014(4 page PDF)
AAFP Executive Summary of Open Payments in the Proposed 2015 MPFS - July 10, 2014(2 page PDF)
Joint Letter to HHS on Potential Impacts to Medical Education and Patient Care - October 28, 2013(3 page PDF)
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Open Payments/Physician Sunshine Act