In a notable demonstration of bipartisanship, Representatives Michael Burgess (R-TX) and Frank Pallone (D-NJ) came together to encourage the Centers for Medicare and Medicaid Services (CMS) to exempt from Sunshine Act reporting requirements payments related to the support of certified continuing medical education (CME). The lawmakers stated that this would “ensure robust physician participation in this important activity without concern for Sunshine Act reporting rules.”
View the letter here: Download Reps Burgess and Pallone CMS Letter
The Sunshine Act requires pharmaceutical and device manufacturers to report to CMS their direct and indirect payments or other transfers of value made to healthcare providers and teaching hospitals. In February 2013, CMS released the Final Rule of the Sunshine Act. As we have detailed on Policy and Medicine, the Final Rule contains an exemption for payments to healthcare providers who serve as speakers for accredited continuing education programs, as well as for the educational value of programs for attendees.
On July 3, CMS stated it wanted to remove the CME exclusion in the Sunshine Act because it was redundant with another provision of the law. Stakeholders, however, are concerned that CMS' plan will have a negative impact on both speakers and attendees at CME events despite CMS' assurances that doing away with the CME exclusion will not require reporting of indirect payments from drug and device manufacturers to CME lectures and conferences.
Reps. Burgess and Pallone, who sit on the House Energy and Commerce Committee’s Health Subcommittee, join an overwhelming number of CME stakeholders urging CMS to rethink its proposal. More than 800 comments—98 percent—favored keeping the explicit exclusion in place.
The legislators note that the current Final Rule’s “unambiguously defined exemption sent a clear message to physician participants that they could present at, and attend, CME programs without finding themselves publicly reported in the Open Payments system as receivers of commercial support.”
CME is vital to “improving patient outcomes, facilitating medical innovation, and keeping our nation’s medical professionals up-to-date with the rapid pace of scientific,” note the representatives. “Because of CME’s important role in health care delivery, CME is recognized by medical practitioners as an essential part of continued professional development and a key resource in ensuring both the quality and effectiveness of care delivery.”
“As you consider public comment and finalize your proposal in the coming weeks we ask that you take into account our concerns for the proposed policy's potential negative impact on CME and the medical community,” Reps. Burgess and Pallone wrote to CMS. We will follow CMS' response in the weeks ahead.