The CME Coalition has submitted comments to CMS regarding Open Payment’s impact on CME, including the impact on the distribution of journal reprints and medical texts. As the letter explains, “upon publication of the rule in 2016 there was a significant pause in funding for accredited CME as commercial supporters tried to assess the interaction of the rule and its sub-regulatory guidance.” The letter goes on to note that while a majority of stakeholders have interpreted the FAQs to exclude most independent, accredited CME activities from the definition of “payment,” the Coalition remains concerned that “if CMS were to ever make changes to the rule or FAQs to require reporting for independent CME, we would see significant reductions in both funding of and participation in accredited CME programs.” Further, the letter details the extensive barriers preventing the slightest industry influence from entering the accredited educational content that our members support, provide and rely upon — specifically citing the Accreditation Council for Continuing Medical Education’s (ACCME) Standards for Commercial Support (SCS) that have been adopted by many accrediting organizations.
At the 16th annual CBI summit on independent medical education and grants, the CME Coalition's Andy Rosenberg outlined the major legislative and regulatory issues that the Coalition has been engaged in throughout 2018.
In a letter to Centers for Medicare and Medicaid (CMS) Administrator Seema Verma, the CME Coalition urged the agency to provide an exemption for CME and certain educational materials from the reporting requirements of the Physician Payments Sunshine Act. “We strongly believe that commercial support payments for CME that do not meet the Sunshine Act’s definition of payments should be definitively exempted from reporting,” writes CME Executive Director Chris Lamond. “As a nation, we should be encouraging and facilitating accredited physician continuing education, not stigmatizing it by requiring the collection and reporting of payments that underwrite it.” The letter also notes that while the current FAQ #8165 provides CME stakeholders with solid guidance regarding independent commercial support for CME activities, the numerous updates to the policy via these FAQ updates leaves stakeholders with a need for certainty that only a definitive Final Rule can deliver.
The letter in its entirety can be read below.
CMS POSTS REVISED FAQ TO CLARIFY THAT SUPPORT FOR INDEPENDENT CME IS NOT TO BE REPORTED UNDER SUNSHINE ACT
Yesterday, the Centers for Medicare and Medicaid Services (CMS) posted a revised FAQ on its Open Payments website regarding the reporting of CME-related payments. The revised FAQ 8165, which is provided below, replaces an earlier FAQ on the same subject by providing greater specificity with regard to the exclusion of certain CME-related payments from Sunshine Act reporting that meet the standards outlined by CMS. We believe that while this FAQ is fully consistent with our earlier interpretation of the status of independent CME-related payments when CMS revised the regulations in 2014, as well as the interpretation of other leading stakeholders like the American Medical Association, the revised FAQ now provides even greater clarity to stakeholders.
As it does not represent a shift in policy, this FAQ applies to all CME-related transfers of value that have taken place since January 1, 2016.
We are hopeful that this guidance from CMS creates a consensus understanding among CME stakeholders that information related to independent CME payments to physician faculty or speakers are not intended to be collected or reported to CMS.
NEW FAQ LANGUAGEQ: “If an applicable manufacturer or group purchasing organization (GPO) provides a payment or transfer of value to a continuing education provider to support a continuing education program, but did not require, instruct, direct or otherwise cause (including, but not limited to, ‘encouraging’ or ‘suggesting’) the continuing education provider to provide payments or transfers of value to a specific or particular physician speaker or faculty, would the contribution be considered a reportable payment?
A: No. A payment or transfer of value as described above would not be subject to reporting under Open Payments for any covered recipient physician speakers or faculty. As explained in the Calendar Year 2015 Physician Fee Schedule Final Rule, when an applicable manufacturer or GPO provides funding to a continuing education provider, but does not: (1) select or pay the covered recipient speaker directly, or (2) provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program, CMS will consider those payments to be excluded from reporting under § 403.904(i)(1) [revised as § 403.904(h)(i)]. This approach is consistent with our discussion in the preamble to the final rule, where we explained that if an applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments are outside the scope of the rule (79 Fed. Reg. 67759). We continued by saying ‘[t]his is the case even 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.’ (79 Fed. Reg. 67760).”
The FAQ is posted here: https://questions.cms.gov/faq.php?id=5005&faqId=8165.
In a letter to Sen. John Barrasso (R-WY), the American Medical Association and dozens of specialty groups and state medical societies offered their support to legislation sponsored by the Wyoming senator that would exempt continuing medical education (CME) activities from Sunshine Act reporting requirements. The groups urge prompt passage of the legislation, citing confusion around Centers for Medicare and Medicaid Services (CMS) rules and the effect those rules have on the publication of medical textbooks and peer-reviewed journals.
"Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by the Centers for Medicare and Medicaid Services (CMS) that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent certified and/or accredited continuing medical education (CME)," reads the medical groups' letter." This legislation would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive."
The letter can be found in full below.