On September 22, 2016, 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 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. CMS believes that while this new FAQ is fully consistent with its earlier interpretation of the status of independent CME-related payments, 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. CMS is 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.
The new FAQ notes that if an applicable manufacturer or group purchasing organization (GPO) program provides a payment or transfer of value to a CME provider to support a CME program, but did not require, instruct, direct, or otherwise cause (including, but not limited to “encouraging” or “suggesting”) the CME provider to provide payments or transfers of value to a specific or particular physician speaker or faculty, the contribution is not considered a reportable payment.
When an applicable manufacturer or GPO provides funding to a CME provider, but does not either (1) select or pay the covered recipient speaker directly or (2) provide the CME provider with a distinct, identifiable set of covered recipients to be considered as speakers for the CME program, CMS will consider those payments to be excluded from reporting under the Sunshine Act.
In the preamble to the final rule, CMS noted that if an applicable manufacturer conveys “full discretion” to the CME provider, those payments are outside the scope of the rule, “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.”
As we have noted time and again, CME is a crucial part of ensuring physicians and others (i.e., nurses and pharmacists) in the medical field are up to date on their technical knowledge and practice skills. Graduation from medical school and residency training are just the first steps in a career-long educational process for physicians and others, of which CME is a large component.
In practice, this guidance once again confirms that applicable manufacturers may continue to exclude from Sunshine Act reporting grants made to ACCME-accredited CME providers because the ACCME mandates that commercial supporters convey full discretion to the CME provider regarding physician speakers, faculty, and attendees. Applicable manufacturers likely will need to address whether other accrediting bodies impose similar requirements on a case-by-case basis to exclude such interactions from Sunshine Act reporting. Manufacturers that make CME-related payments directly to teaching hospitals likely must continue to report such payments as direct payments.