An article in today's Medical Marketing & Media highlights the bizarre policy shift from the Centers for Medicare and Medicaid Services (CMS) to reverse course on the lauded Sunshine Act exemption for CME. The author notes that in "a sudden about face, [CMS] wants to delete the Sunshine rule's exclusion for continuing medical education." The author explains that an exemption was originally carved out for accredited CME to avoid potentially stigmatizing the value of continuing education for medical professionals. However, after a year of stakeholder cooperation that resulted in a Final Rule, CMS has flipped on their original decision.
The author also notes the leadership of the CME Coalition in pushing back against the administration’s surprising reversal. "We are stunned that CMS would reverse course on the common sense reporting exemption for accredited CME that they, themselves, created and finalized last year," said Andrew Rosenberg, Senior Counsel to the CME Coalition. "We are at a loss to explain why CMS would abruptly reverse its own Final Rule which came as a result of significant stakeholder input and participation from all sides."
The Centers for Medicare & Medicaid Services, in what amounts to a sudden about face, wants to delete the Sunshine rule's exclusion for continuing medical education. The elimination of the exemption, a U-turn after earlier granting such payments a carve-out, was among several intended changes to the Open Payments program included in the proposed Physician Fee Schedule for Calendar Year 2015.
While it might seem that this policy change could compel industry to report payments to physicians for CME, the proposal does not appear to affect the statutory exclusion of “indirect” payments, which, according to a note from industry trade group Coalition for Healthcare Communication (CHC), is a provision which excludes payments or other transfers of value where the applicable manufacturer is unaware of the identity of the covered recipient.
The exclusion of indirect payments is one of three conditions outlined in the Sunshine Act to exempt payments to faculty or speakers. The other two are that payments must relate to an accredited event, and that manufacturers cannot select speakers. Payments that meet those three criteria are not now required to be collected by pharma and medical device companies.
The CMS, just prior to the July 4 holiday weekend, explained its rationale for the change as follows: “Eliminating the exemption for payments to speakers at certain accredited or certifying continuing medical education events will create a more consistent reporting requirement, and will also be more consistent for consumers who will ultimately have access to the reported data."
According to the proposal, “CMS' apparent endorsement or support to organizations sponsoring continuing education events was an unintended consequence of the final rule.”
CME's Sunshine carve-out could also have enabled drug and device makers to evade disclosure by shifting their promotional budgets to CME and away from direct promotional programs, asserted Modern Healthcare in a recent piece that quoted Daniel Carlat, of the Prescription Project at Pew Charitable Trusts, as saying that continuing education programs lead physicians “to unduly prescribe products that industry is pushing.”
The proposed rule will be published in the Federal Register on July 11, and CMS will accept comments until Sept. 2. In the meantime, medical communications companies and industry appear to have been taken off guard but are mounting “a sharp and effective defense of the CME exemption,” wrote the CHC.
The CHC called the proposal “a huge step back in reasonable enforcement of the Sunshine Act,” adding that, it's working with industry and lobbying partners, including the CME Coalition and the Alliance for CME in the Health Professions, to develop the response.
"We are stunned that CMS would reverse course on the common sense reporting exemption for accredited CME that they, themselves, created and finalized last year,” wrote Andrew Rosenberg, senior advisor to the CME Coalition.
“If it is allowed to stand,” Rosenberg added, “this policy change will be highly disruptive to every stakeholder in the CME ecosystem—doctors, educators and commercial supporters—who have spent over a year preparing for the implementation of the current rules. We are at a loss to explain why CMS would abruptly reverse its own Final Rule which came as a result of significant stakeholder input and participation from all sides.
“CMS got it right the first time when it recognized that encouraging the practice of accredited CME is vitally important for doctors and patients, and that extending the Sunshine Act's reporting requirements for direct payments between doctors and manufacturers to participants in bona fide, accredited CME would actually discourage physicians from learning new medical science by creating a false stigma of public disclosure. We will fight this proposal alongside patients, doctors and others in order to protect CME from being treated no differently from promotional, marketing or other reportable payment categories under the Sunshine Act."
