Physician Payment Sunshine: CME Leaders Requests Clarification ...

Echoing the comments and concerns of many other health care stakeholders, particularly those in the continuing medical education (CME) community, a number of leaders in the CME world submitted comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)?also known as the Physician Payment Sunshine Act.? ?The comment was submitted on behalf of:

• Murray Kopelow, MD, MS(Comm), FRCPC, Chief Executive and Secretary, Accreditation Council for Continuing Medical Education (ACCME)
• Andrew T. Filak, Jr., MD, President Association for Hospital Medical Education (AHME)
• Martin S. Levine, DO, President American Osteopathic Association (AOA)
• Norman Kahn, MD, Executive Vice President and CEO, Council of Medical Specialty Societies (CMSS)
• Humayun J. Chaudhry, DO, FACP, President and Chief Executive Officer Federation of State Medical Boards (FSMB)
• Gabrielle Kane, MB, EdD, FRCPC, President, Society for Academic Continuing Medical Education (SACME)
• James L. Madara, MD, Executive Vice President, CEO, American Medical Association (AMA)
• Roland A. Goertz, MD Chair, Board of Directors, American Academy of Family Physicians (AAFP); and
• Damon K. Marquis, MA, MS, FACME, President, Alliance for Continuing Education in the Health Professions (ACEHP)

This group of leaders noted that language of the PPSA as adopted appropriately addressed a few specific issues, which appear in the proposed rule to need clarification and modification, to avoid unintended consequences. These issues include:

1. Distinguishing between Accredited and Certified CME offered by CME providers, and promotional education offered by pharmaceutical and medical device manufacturers;
2. Recognizing the roles and relationships that faculty in Accredited and Certified CME programs have with CME Providers and not with companies which may provide grants to CME Providers; and
3. Recognizing that attendees at or participants in Accredited and Certified CME programs have no relationships with companies which may provide grants to CME Providers.

The CME leaders noted that ?Accredited CME? refers to those activities in Continuing Medical Education that have been deemed to meet the requirements and standards of a CME accrediting body (ex., the Accreditation Council for Continuing Medical Education (ACCME); the America Osteopathic Association, the American Academy of Family Physicians). ?Certified CME? refers to those activities in Continuing Medical Education that carry CME credit offered by one of the three grantors of CME credit in the US: the American Academy of Family Physicians (since 1948), the American Medical Association (since 1968), and the American Osteopathic Association (since 1972).

They noted how all organizations involved in Accredited and Certified CME in the US have adopted and operate under the strict firewalls which are promulgated, monitored and enforced through the ?Standards for Commercial Support (SCS): Standards to Ensure the independence of CME Activities? of the Accreditation Council for Continuing Medical Education (ACCME), to which the entire profession of medicine adheres.

They explained how the SCS (most recently revised in 2004) set standards for relationships between Accredited and Certified CME Providers and the companies which may provide grants to CME Providers. Faculty of certified Continuing Medical Education (CME) programs are selected, directed, reviewed, evaluated and paid by the Accredited CME providers, and have no relationship with the manufacturers. Indeed, not only is this a requirement of SCS, but also of the ?Code on Interactions with Health Professionals? of the Pharmaceutical Research and Manufacturers of America (PhRMA Code).

The CME Leaders maintained that, ?Faculty who have no relationships with companies supporting certified CME programs will not be pleased to be put in a position of being assumed and reported to have a relationship with a manufacturer, by virtue of their accepting an invitation to present at the CME program.? Indeed, many if not most speakers who have no relationships with manufacturers will refuse to serve as faculty, in order to avoid being assumed and reported to have such relationships.

The comment also recognized how, in the context of Accredited and Certified CME, direct payments to physicians (either in the role of faculty or attendees) by companies are prohibited, cannot occur, and therefore would be irrelevant when it comes to disclosure under the PPSA.? Manufacturers will therefore not be in a position to comply with this provision of the Act, as they have no relationships with CME faculty, either directly or indirectly.

They also noted how a speaker?s participation in the context of Accredited and Certified CME, does not qualify as a reportable activity under Sec. 6002, as the manufacturers cannot have any role in speaker selection for the Accredited and certified CME activity. Furthermore, manufacturers cannot, and do not, under all rules governing faculty of CME programs, provide ?direct compensation for serving as faculty or as a speaker for a continuing medical education program.?

The CME leaders also expressed to CMS that speakers for promotional programs should not be described as ?faculty or speakers in a CME program? since promotional educational programs, offered directly by manufacturers, are not Accredited and Certified CME programs.

Ultimately, the CME leaders asserted that the final rule needs to distinguish between direct compensation for serving as a speaker in a promotional educational program offered by an applicable manufacturer, which should be reportable under the Act; in contrast to faculty serving as speakers in Accredited and Certified CME programs, in which the faculty are selected and paid by the CME Provider and have no relationship with any applicable manufacturer which might be supporting the CME activity through an educational grant to the CME Provider.

In addition, they maintained that the final rule needs to clarify that grants from applicable manufacturers to CME Providers for Accredited and Certified CME activities do not constitute an indirect transfer of value, either to faculty independently selected and paid by the CME Provider, or to participants in the Accredited and Certified CME activity, nor are there in such cases payments made at the request of or on behalf of the faculty.

Source: http://www.policymed.com/2012/02/cme-leaders-requests-clarification-in-sunshine-rules.html

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