CME publishes Annual Report to Congress Regarding Open Payments Program
In August of 2021, the Centers for Medicare and Medicaid Services came out with their annual Congressional report on open payments, including new guidelines and requirements for CME. The announcement specifically consolidates guidelines for compensation for faculty or speakers for both unaccredited and accredited CME programs after recommendations from various stakeholders.
'Open Payments' Reporting for CME
In September 2016, the Centers for Medicare and Medicaid Services (CMS) posted an FAQ on its Open Payments website providing specificity with regard to the exclusion of certain CME-related payments from Sunshine Act reporting. 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.
In the FAQ, CMS says that payments are not reportable "[i]f 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."
The revised FAQ 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. 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. Click here for additional details on the FAQ.
AmA Legal Advisory
A legal advisory from the American Medical Association (AMA) presents the Open Payments reporting requirements for CME, and concludes that AMA certified and ACCME accredited programs "are exempt from reporting by commercial supporters." Consistent with the October 2014 guidance issued by CMS, AMA concludes that when an “applicable manufacturer conveys ‘full discretion’ to the continuing education provider, those payments are outside the scope of the rule” and thus, not subject to reporting.
Template Grant Language for CME Providers
In response to questions about the Open Payments 'reportability' for transfers of value related to the provision of accredited CME events, the CME Coalition has developed ‘template’ grant language for use in CME agreements between commercial supporters and providers. The template, drafted with expert legal counsel from Arnold and Porter, includes language that tracks directly with CMS’ guidance indicating that supporters have not “directed, instructed or caused” the CME provider to pay specific covered recipients.
Letters of Support
In support of the Open Payments reporting exemption for CME, hundreds of medical associations and individual practitioners have reached out to CMS to voice their concerns regarding the a previous proposed that would have jeopardized the reporting status of CME. Indeed, CME providers and medical specialists from around the country overwhelming agreed that public reporting for payments related to accredited medical education events would have had a chilling effect on CME, and could negatively impact patient care.