The Centers for Medicare & Medicaid Services (CMS) posted additional frequently asked questions (FAQs) on its website for Open Payments (Physician Payment Sunshine Act), including a long-awaited clarification on the new rules regarding accredited or certified continuing medical education (CME). Below is a summary of the CME questions and several others, along with a bit of analysis.
Are payments provided as compensation to speakers at CME events run by CME providers that that are accredited or certified by accreditation or certification bodies other than those enumerated in 42 CFR § 403.904(g)(1)(i) eligible for the exclusion from reporting (assuming they also meet the other requirements for exclusion in § 403.904(g)(1))?
No, the list of accrediting or certifying bodies in the final rule at 42 CFR § 403.904(g)(1)(i) is exhaustive; in order to qualify for the exclusion in § 403.904(g)(1),
CME events must be run by CME providers that are accredited or certified by one of the accreditation or certification entities in § 403.904(g)(1)(i) and, accordingly, meet the accreditation or certification requirements and standards of any of those specific entities. Payments to speakers at CME events that are not run by CME providers accredited or certified by one of the entities in § 403.904(g)(1) -- or that don't meet either or both of the other two requirements for exclusion in § 403.904(g)(1) -- are reportable payments or other transfers of value for Open Payments. We will consider modifications to this provision in possible future rulemaking.
Reminder: the five accrediting/certifying bodies include: the Accreditation Council for Continuing Medical Education ("ACCME"), the American Academy of Family Physicians ("AAFP"), the American Dental Association's Continuing Education Recognition Program ("ADA CERP"), the American Medical Association ("AMA"), or the American Osteopathic Association ("AOA").
Analysis: In comments submitted to CMS, the CME Coalition noted that at least eleven (11) other accrediting or certifying bodies and several international entities, which use physicians as speakers or faculty, have either formally adopted the ACCME Standards for Commercial Support or substantially identical standards. In other words, CME stakeholders asked CMS whether it would recognize other accrediting groups that "meet the accreditation or certification requirements and standards" of one of the five entities enumerated by CMS.
CMS at this time declined to extend this exemption to any other accreditation or certification bodies. Thus, payments to physicians for speaking or serving as faculty at a CME program not accredited or certified by one of these five must reported as required, likely as "speaking at a non accredited continuing medical education program" or "compensation for services other than consulting." Manufacturers could also report such payments as "honorarium," "grant," or "education," depending on the nature of the arrangement.
In addition, payments provided to speakers, faculty, and physician attendees for travel, lodging and meals at CME programs that are not accredited by one of the five enumerated bodies are also reportable, and must be reported separately. Educational value and materials provided to physician-attendees, such as a journal reprint, would also be reportable for programs not accredited by the five bodies. CMS recommended in a separate FAQ that "[t]he value of a journal reprint should reflect the cost that an applicable manufacturer … paid to acquire the reprint from the publisher or other distributor."
This strict interpretation by CMS of their own rule may limit the participation of "physicians" in allied health educational programs supported by manufacturers. It also ignores the accreditation systems which have adopted similar standards as the ACCME for optometrists, podiatrists and chiropractors. These doctors will have all their faculty payments for accredited education listed as "payments for serving in a non-accredited medical education program"; "honorarium", "services other than consulting", "grant" or "charitable donation" (if applicable).
Compliance with Open Payments reporting requirements does not exempt applicable manufacturers, applicable group purchasing organizations, covered recipients, physician owners or investors, immediate family members, other entities, and other persons from any potential liability associated with payments or other transfers of value, or ownership or investment interests under the Federal Anti-Kickback statute, False Claims Act or similar laws. As noted in the preamble of the rule, however, the inclusion of a payment or other transfer of value or ownership or investment interest in Open Payments is not, by itself, an indicator of wrongdoing or illegal conduct.
To determine if an applicable manufacture (or applicable group purchasing organization) has met the $100 aggregate threshold for reporting small payments to a covered recipient or physician owner/investor, is it required to aggregate small payments or other transfers of value different across different nature of payment categories?
Yes. To determine if payments or other transfers of value exceed the $100 threshold and must be reported, applicable manufacturers and applicable group purchasing organizations must aggregate payments of less than $10 across multiple nature of payment categories. For example, if the applicable manufacturer provides a physician with multiple separate payments valued under $10 each and the cumulative amount of those separate payments exceeds $100 during the year (e.g. 6 hot dogs - $9 per hot dog, 3 sporting tickets - $9 per ticket, and 3 cab fares - $9 per cab), the threshold will have been met and these payments must be reported.
Which nature of payment category should applicable manufacturers report payments to physician covered recipients for promotional speaking?
Applicable manufacturers and applicable group purchasing organizations should consider the purpose and manner of the payment or other transfer of value and make a reasonable determination. A payment for promotional speaking may be included in the "compensation for services other than consulting" or "honorarium" nature of payment category depending on the specific facts. Applicable manufacturers and applicable group purchasing organizations may submit an assumptions document clarifying any assumptions made to determine the nature of payment category.