First, some self-declarations. Since 1992 I have benefited financially from in-office sales of dietary supplements via the integrative medical practice of my spouse. On multiple occasions over 30 years, I have helped mount or been associated with medical conferences in which the business model relied on exhibits from dietary supplements companies. I have in multiple instances secured grants from natural products companies to support initiatives of various professional organizations, research projects, and for The Integrator Blog. Such relationship are often the rule across the functional, naturopathic, integrative, chiropractic and traditional Chinese medicine communities. What’s new now is that those involved in integrative and functional medicine continuing medical education are increasingly in the spotlight of the Accreditation Council for Continuing Medical Education (ACCME) via new application of old rules, and new ACCME rules under consideration. These may – for better and for worse – shake-up the way integrative CME is offered, and potentially not only for medical doctors.

Comments due February 21 on ACCME’s on proposed changes: click here.

The emerging issues from ACCME regarding “content validity” for integrative CME were covered in Part 1 of this series. I explored them further via interviews with ACCME president and CEO Graham McMahon, MD, MMSc and with Rick Hecht, MD, chair of the Academic Consortium for Integrative Medicine and Health (The Consortium). The other core concern that provoked ACCME to issue new proposed standards is medicine’s historic problem of conflicts of interest (COI). ACCME is re-framing COI under McMahon’s leadership as “Integrity and Independence”. This area has its own challenges for the status quo in integrative CME.

Perhaps the most startling change relates to the widespread business model of integrative practices to profit from in-office sales of supplements. Will this exclude a presenter ho makes such sales as a speaker for accredited CME if the topic should touch on nutritional supplementation?

ACCME has not yet announced a position. Yet recent actions have alerted some integrative CME providers that these can potentially influence the ACCME-recognition for presentations from many top clinician presenters in whose practices sales of supplements figures. While the field does not yet know how the ACCME will rule, it is clear that “ineligible entities” are proposed to be “growers and sellers of dietary supplements.” From this would flow a multitude of required changes:

• For speakers, financial relationships “of any dollar amount” must be disclosed to the CME provider (thus apparently including in-office sales) They must also specifically “disclose the known financial relationships [with such entities] of their spouse or partner.”
• Owners and employees of supplement companies are excluded from serving as planners or as faculty. The language is not clear regarding those who are consultants or speakers. A recent query to McMahon, below, did not clarify this.

For the constituency that ACCME accredits – the providers of CME rather than the speakers themselves – the list of requirements to “identify, mitigate and disclose” any such conflicts is even longer. Among these:

• The CME provider [the company or association or institution] must make all such relationships of speakers known in detail and in advance to attendees.
• Prior approvals from attendees must be followed before exhibitors can be given lists of attendees.
• Conference handouts cannot include corporate logos or similar corporate branding.
• Marketing and exhibits cannot be in the same physical space as educational programs.

Additional perspectives from ACCME’s McMahon

All of these are good requirements for anyone who believes in clarity about a presenter’s related financial interests. The ACCME has expressed an intention to apply these rules across the board to the entire medical industry, and not just relative to supplements.  Many are already adhered to by multiple integrative CME providers, though perhaps less stringently enforced than optimal. For others the new focus and potential rules may be a wake up call.

I put together a list of specific questions to McMahon on areas where I had gathered that the field needed clarification. Some are my own issues with my relationship to a for-profit publishing company, and my spouse’s practice. These are attached at the bottom of this article. This was McMahon’s response, as e-mailed on February 17:

As an overall answer, remember that all accredited providers in the ACCME system are held to the same rules. There are no different rules for organizations or individuals offering education about integrative and functional education. Some of these questions are related to the proposed, revised Standards. Since these are still in the proposal stage, it would be premature to answer questions about compliance. When we release the final Standards, we will prepare educational resources, such as FAQ and examples of compliance and noncompliance.

In the meantime, accredited providers can access our current FAQ and examples of compliance on our website, under the resources tab. For example, here is the link to FAQ about commercial support. Here is the link to compliance and noncompliance examples related to exhibits. If providers need more information, they are also welcome to contact us with their specific questions at info@accme.org. Since each circumstance is different, we answer those questions on an individual basis.

I replied to McMahon by sharing that I would report his response (as I am doing here) and that I understood the intention to hold all to the same rules. I shared my appreciation that since some areas lacking clarity are not yet policy, providing a next level of interpretation could thus be considered not yet in order. (It would be akin to lawmakers crafting regulations prior to passage of a law to which the regulations would apply.)  Yet the integrative field’s distinct practices of making a portion of their living off selling natural products and in come cases, sales of laboratory tests, clearly means the ACCME’s impact could have an especially challenging impact.

Promoting books, programs and courses

Another area where the heightened attention to conflict of interests will come into play is speaker reference to their own work products that provide them income. This can be books, tapes, courses, and other such programs. The language is straight-forward:

“Accredited education must be free of sales of products or services. Professionals may not promote or sell products or services that promote their professional or financial interests during accredited education.”

Again, the standards here are not integrative specific. They apply across the board and respond to decades-long concerns inside regular medicine. Will ACCME press as closely on dermatologists, cosmetic surgeons, dentists and other specialties that gain more than an “administrative fee” for sales of products in their office? That is left to be seen – or not – depending on the diligence of the integrative field.

Concluding comments

Two of McMahon’s responses in his prior interview seem to affirm that, while application of rules across fields may be even-handed, that integrative and functional medicine CME are in fact very much in ACCME’s sights. First, McMahon provided no evidence of safety concerns that prompted the recent actions against CME providers and new rules. Second, he did not provide, without prodding, any “content validity” concerns in medical specialties or practices that are not coat-tail relatives of integrative and functional practices. All he mentioned was medical marijuana and stem cell injections in orthopedics. Each in relatively close to integrative practices.

One way to view the ACCME’s intensified scrutiny on integrative CME is as a mark of arrival. The integrative and functional medicine fields are not going away. Internally, this new position reasonably means more diligent self-regulation. It means questioning the unspoken belief in these fields that because supplements have fewer adverse effects than regular pharma that the conflicts are not as important. Montana clinician and naturopathic leader  Margaret Beeson, ND has made the honest case that for these fields that rely on lengthy integrative visits that are under compensated in their time-intensity, supplements are effectively the procedures that float the economic boats of other specialists. What surgeon will ACCME hold off the accredited podium for recommending practices that are with little doubt grossly over performed in a medical industry in which a third of what is done is waste?

Then again, perhaps heightened awareness in the integrative, naturopathic, and functional medicine fields will provide a course correction. There is no denying that profiting off sales provides an incentive to sell more, and that bags-of-supplements is a disagreeable part of integrative patient experience. Denying self-interest is a holier than thou position that can’t withstand a look in the mirror. Might limiting benefits from supplement sales lead to deeper engagement in other forms of change behavior, to increased use of groups and other models?

Then again – as I shared with McMahon – there is the truism that graced the wall of the office of the activist Washington State Senator King Lysen for whom I worked from 1979-1981: “Just because I’m feeling paranoid doesn’t mean they are not out to get me.”

Prior articles in this series:

Is Integrative Medicine Continuing Education Threatened by Proposed ACCME Guidelines? Part 1 “Content Validity”

Reflections from Rick Hecht, MD on Academic Consortium Meeting with ACCME President Graham McMahon, MD, MMSc

Is Integrative Medicine Being Targeted? Interview with ACCME CEO Graham McMahon on New CME Proposals

02/14/20 JW e-letter to ACCME/Graham McMahon requesting clarifications

“Thank you for your time last week. As you may recall, my first article and the interviews focused on “content validity.” I promised readers a follow-up relative to COI/”Integrity and Independence.” I am writing such an article for publication February 23 – though also to report out at a conference on February 21. I would appreciate your answers to these additional questions. Most are pretty simple and straight forward.

Many integrative and functional practitioners sell supplements in their practice with a wholesale-to-retail mark-up.

• Does doing so make them “ineligible providers”?
• Would referring to such herbs-vitamins-minerals generically be considered “marketing or sales of products or services”?
• Would such physician clinicians be prohibited from providing ACCME approved CME on any content that may generically reference natural agents that they may sell?
• Would they be prohibited from serving as advisers to conferences on program in which such products might be referenced?

The draft notes exclusions for “owners and employees.”  

• Does this also extend to individuals who from time to time serve as consultants or speakers for a fee from a supplement company?
• Does it include individuals who may be on a retainer with such a company?

Does the CME provider have responsibility for the messaging of exhibitors? (What regulation of exhibitors is expected?)

• Must the provider guarantee that exhibitor materials meet “generally accepted” evidence standards?
• Must the provider police to see that exhibitor verbal messaging meets such a standard?

Specific questions for me. I am paid a retainer by a private business, Mary Ann Liebert, Co, publisher of the peer-reviewed and indexed (25 years in the field) Journal of Alternative and Complementary Medicine (JACM), for service as Editor in Chief.

• Must I disclose this?
• Am I prohibited from mentioning the work of JACM in presentations, and using a visual representation of an issue of the journal ? (I like to call attention to special issues.)

Finally, my spouse is a licensed, primary care integrative physician in Washington State (ND, MPH) who sells supplements for a profit as part of her business.

• Must I disclose this?