Today, Inside Health Policy reported on the state-of-play regarding the Sunshine Act exemption for Continuing Medical Education (CME) - along with the Burgess-DeFazio provision - that was included in yesterday’s ‘21st Century Cures’ draft legislation. Senior Advisor for the CME Coalition, Andy Rosenberg, was quoted in the article: "CME is such a vital part and plays a vital role in bringing innovation to the patient's bedside, and 21st Century Cures recognizes that."
The draft legislation released by Energy and Commerce Chairman Fred Upton (R–MI) has been a major initiative for the Committee for multiple months. There have been regular hearings with stakeholders and several White Papers written on various topic that the initiative hopes to affect. The focus has generally been on streamlining the process at the FDA and other government agencies to and get patient-centered treatments to market faster. CME fits well into these goals, as the "cures" are most helpful when doctors can discuss them with patients.
Continuing medical education (CME) stakeholders are buoyed by inclusion of a bipartisan CME exemption from reporting under the Open Payments Program (Sunshine Law) in the House 21st Century Cures draft legislation released Tuesday (Jan. 27). Stakeholders have been confused as to whether payments from drug and device manufacturers to support CME events now need to be reported following CMS' move to ax the CME exclusion in its 2015 final Physician Pay Rule. One CME stakeholder said his group appreciates the "Cures" draft provision put forward by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR) that would codify the CME exemption.
Andrew Rosenberg, senior adviser for the CME Coalition, told Inside Health Policy that stakeholders realize that the "Cures" draft legislation is still very fluid and up for discussion but they are very supportive of the "bipartisan effort" to protect CME from reporting requirements.
"CME is such a vital part and plays a vital role in bringing innovation to the patient's bedside, and 21st Century Cures recognizes that," Rosenberg said.
Under the original CME exemption, funding for CME did not have to be reported if companies didn't set the agenda, choose speakers, or pay speakers directly, but CMS proposed over the summer to include indirect payments when it issued the Proposed 2015 Physician Pay Rule in July.
In the proposed rule, CMS said the CME exclusion was redundant because of another provision that excludes indirect payments or transfers to medical professionals providing CME lectures as long as manufacturers are "unaware" of the lecturers' identities for up to a year and a half after the indirect payment has been made.
Burgess even got into the act before CMS released the final rule, sending a letter along with Rep. Frank Pallone (D-NJ) to CMS Administrator Marilyn Tavenner in September asking that the CME exemption remain intact.
Burgess and Pallone said in their letter that the importance of CME "in our healthcare system by improving patient outcomes, facilitating medical innovations, and keeping our nation's medical professionals up-to-date with the rapid pace of scientific discovery" is why CMS excluded indirect payments from drug and device manufacturers to CME providers from having to report under the Open Payments program.
"(I)f an applicable manufacturer or applicable GPO provides funding to support a continuing education event but does not require, instruct, direct, or otherwise cause the continuing education event provider to provide the payment or other transfer or value in whole or in part to a covered recipient, the applicable manufacturer or applicable GPO is not required to report the payment or other transfer of value. The payment is not reportable regardless if the applicable manufacturer or applicable GPO learns the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year because the payment or other transfer of value did not meet the definition of an indirect payment," CMS said in the final rule.
Stakeholders have said CMS' language on whether the exclusion now just exists in a separate form, and they are still unsure exactly what is and isn't reportable under the Sunshine Law.
Rosenberg said this is why stakeholders are very supportive of efforts to codify the exemption in law.