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.
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.
