Sept. 9, 2014 – An overwhelming majority of comments sent to the Centers for Medicare & Medicaid Services (CMS) by last week’s deadline stated that the agency should either retain the continuing medical education (CME) exemption it recently proposed eliminating or revise its proposed reliance on the “indirect payment” provision under the Physician Payment Sunshine Act.

According to the CME Coalition, the total number of comments supporting maintenance or expansion of the CME exemption was 820, with only 20 comments opposing the exemption. Listed below are excerpts of various comments – organized by subject matter – that joined the comment of the Coalition for Healthcare Communication in recommending that CMS change its proposed position (see related article, http://www.cohealthcom.org/?p=2846).

Possible Consequences of Eliminating CME Exemption

• “Absent that specific exemption, attendees may be less willing to participate in those programs – even if the industry support for the program was completely independent and conflict-free – if they believe their identity and attendance may become known to the commercial supporters and the value of the CME may thus be reported against them.” (American Academy of Family Physicians)
• “The proposed rule will link applicable manufacturers and speakers at independent CME in a manner that is antithetical to the notion of ‘independent’ CME and inconsistent with current guidance from FDA and accrediting organizations regarding the conduct of these programs. PhRMA is concerned that this proposal will harm independent CME programs by diminishing speaker and attendee participation at independent CME and by chilling manufacturer funding of these programs.” (Pharmaceutical Research and Manufacturers of America)
• “Pfizer believes that CMS’ proposal will allow reported CME events to be misperceived as subject to industry control, when in fact none existed. … CMS’ alternatives also are not viable options.” (Pfizer)
• “The unintended consequence … may dissuade participation in valuable CME activities and hinder the adoption and spread of important medical education intended to keep the public safe and enable optimal care and outcomes for patients.” (American College of Radiology)
• “Physicians may decline CME faculty positions to avoid the misperception that they are receiving payments or transfers of value from manufacturers for influential purposes, when in fact these funds are determined without knowing the identity of the CME faculty, and without influence on the faculty or content of the program.” (Biotechnology Industry Organization)
• “We are concerned that removing the exemption for CME from the text of the rule itself will create legal ambiguity as to whether such payments continue to be reportable, leaving manufacturers to rely on CMS’s statements in the preamble to the proposed rule, which carry less weight than the regulation itself under the law.” (Medical Device Manufacturers Association)
• “The creation of new products will produce enduring social gains only if physicians are properly trained and educated about these advances. … Patients count on doctors to be up to date with these latest medical breakthroughs, and CME provides doctors with that knowledge.” (CME Coalition)

Redundancy of Provisions

• “The current proposal by CMS to delete 42 CFR 403.904(g) … is seriously flawed. While there may be overlap between the two sections, they are not the same. … Removing Section 403.904(g) in favor of Section 403.904(i)(1) would be replacing the more certain provision with a more problematic and confusing one.” (American College of Radiology)
• “We are concerned, however, that the indirect payment exclusion, as reflected in the regulatory text itself, is not, in fact, redundant with the CME-specific exclusion that CMS proposes to eliminate. Reliance on the indirect payments exclusion could therefore achieve the opposite result from what CMS intends, as it likely would require the reporting of most applicable manufacturer provision of funds to a CME provider.” (Biotechnology Industry Organization)

“Awareness” Standard

• “It would be difficult for funders to claim that they are not ‘willfully ignorant’ about this information during or after the program. Indeed, this information is often freely available well before a CME or CE activity takes place through marketing materials for the activity.” (The Alliance for Continuing Education in the Health Professions)
• “Physician faculty and attendees at accredited CME events are not reportable under the Open Payments program because of the firewall created through their strict adherence to the Standards for Commercial Support (SCS), not by the timing of when an applicable manufacturer may discover their identity.” (American College of Radiology)
• “It is not realistic, nor would it be perceived as transparent, if faculty names were hidden until the day of the program, nor would physicians attend such programs. … Therefore, establishing a policy whereby an arbitrary determination of the presence of a relationship based on the timing of learning of the faculty names is unworkable – the names of faculty at CME programming cannot and should not be hidden.” (American Academy of Pediatrics)
• “AdvaMed member companies have advised that they often come to ‘know’ the identity of a faculty speaker at a program for which they have provided independent support … For example, the manufacturer may have booth space at the same conference, may schedule its own meetings before or after such conferences, or may be part of a presentation panel at the conference. Importantly, in these situations, a company does not know how much – if any – of the grant funding it paid to a third-party conference provider is in turn paid by the third-party conference provider to a physician faculty member.” (AdvaMed)

Recommendation Highlights

• “To avoid the appearance of endorsing particular accrediting organizations, CMS could eliminate the requirement in [403.904(g)(1)(i)] that the accredited CME program be accredited by one of the listed organizations and, instead, require that the CME event be recognized by a state or the federal government as accredited or certified.” (Pharmaceutical Research and Manufacturers of America)
• “We are proposing that CMS maintain an explicit definition in the Final Rule of ‘accredited or certified CME’ in the definition section of the Final Rule. … Second, understanding that the ‘awareness’ standard becomes nearly impossible for accredited CME speakers, faculty and attendees to comply with, instead of removing Section 403.904(g), we would recommend revising it…” (CME Coalition)
• “We urge CME to stay its hand at this early stage in the implementation of Open Payments and to avoid hastily discarding the CME exemption, which was carefully considered before it was enacted and which remains critical to the education of our health care providers and consequently to the health of the public.” (American Academy of Family Physicians)

For additional coverage of comments submitted to CMS regarding the proposed CME exemption elimination, go to Policy and Medicine at http://www.policymed.com/2014/09/physician-payment-sunshine-organizations-respond-to-cms.html?utm_source=feedblitz&utm_medium=FeedBlitzRss&utm_campaign=FeedBlitzRss&utm_content=Physician+Payments+Sunshine+Act%3a+Organizations+Respond+to+CMS