The CME Coalition (?Coalition?), recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)?also known as the Physician Payment Sunshine Act.? The Coalition estimates that the rule as proposed could cost CME providers almost $170 million over three years.
The CME Coalition represents a collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in our health care system. Their member organizations manage and support development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually.?
Comments on Sunshine?
The Coalition asserted how it ?was never the intent of Congress to expand the public reporting requirements to include transactions related to the provision of continuing medical education when such payments are made from commercial interests to CME providers without allowing for the supporting entity to enjoy any control regarding either the presenters, the curriculum, or the attendees of a given educational program.??
?If left unaddressed, the Sunshine Act reporting requirements will create the erroneous impression that CME instructors have an inappropriate relationship with the commercial organizations that support the programs that include them through grants and other means,? said the Coalition. ?It will also foster the impression that attendees of commercially supported CME programs are inappropriately benefiting from these commercial companies.
?These misimpressions, and the stigma that attaches to them,? said the Coalition, ?will severely chill participation in educational programming among leading practitioners and academics, and will undermine the credibility and integrity of all accredited CME.? Additionally, ?it will be virtually impossible to effectively meet the reporting requirements of the Sunshine Act in the CME context without making it practicably unworkable for the private sector supporters of CME to continue to participate.??
In a very detailed and comprehensive review of the CME industry, CME stakeholders, and CME regulations, standards and rules, the Coalition addressed a number of concerns to CMS.? The Coalition cited the declining amount of commercial support for CME and the impact this has had on both CME providers and CME participants.? The comment also focused on the positive outcomes commercially supported CME has produced by improving patient outcomes in areas such as COPD and hypertension.??
Additionally, the Coalition provided an in depth analysis of the FDA, AMA, PhRMA, AdvaMed, ACCME Standards for Commercial Support, and HHS OIG, rules, standards, guidance, and regulations regarding commercially supported CME.? The Coalition pointed to the important role CME plays in meeting FDA?s required risk evaluation and mitigation strategy (REMS).??
The comment also discussed findings from a 2007 U.S. Senate Finance Committee report on use of educational grants by manufactures.? The Finance Committee report found, amount other things, that ?the pharmaceutical industry is paying increased attention to educational grants and its compliance with fraud and abuse laws,? and that ?major drug companies have limited the direct involvement of field sales representatives and sales and marketing departments in the educational grant-making process.??
The Committee staff found ?some promising trends in pharmaceutical manufacturers? use of educational grants,? such as companies adopting ?corporate policies that, on their face, do not allow educational grants to be awarded for unlawful purposes.? Moreover, the report found that, the overwhelming majority of companies are not ?overtly giving educational grants to provide kickbacks to individual physicians or physician group practices? who attend educational programs and that this practice ?has decreased over time.? The report recognized that, ?major pharmaceutical companies now conduct their educational grants activities in a way that is less likely to involve the direct transfer of remuneration from the company to physicians.??
The Coalition also referenced how compliance with the Sunshine regulations for CME providers would be overly burdensome and contrary to Executive Order 13563, which called on agencies to propose or adopt regulations that ?impose the least burden on society.??
Importantly, the Coalition also recognized the important role FDA plays in its guidance to CME providers and industry.? FDA has not regulated and does not intend to regulate industry-supported scientific and educational activities that are independent of the promotional influence of the supporting company. This distinction is important because in addition to following ACCME SCS, accredited CME providers must also ensure that all programs meet the definitions and factors FDA proscribed for an industry-supported activity to be ?independent.??
If CME providers do not follow FDA?s guidance, there is potential for the CME provider?s activity to be deemed promotional and to fall under FDA?s jurisdiction with risk of penalties for any improper promotional materials or statements. ?Given FDA?s decision not to regulate independent industry-supported activities, the Coalition encouraged CMS to similarly avoid promulgating Sunshine rules that will have the impact of regulating the nature of reporting and payments involving independent CME providers and faculty.?
FDA stated that the provider ensure meaningful disclosure of to the audience, at the time of the program, of: (1) the company?s funding of the program; (2) any significant relationship between the provider (an entity, other than a regulated company, that produces the activity or program), presenters or moderators, and the supporting company (e.g., employee, grant recipient, owner of significant interest or stock); and (3) whether any unapproved uses of products will be discussed. ?FDA defined ?meaningful disclosure? as ?disclosure that is reasonably calculated to reach the relevant audience in a manner that will alert them to potential biases? and to ensure that the audience is in a position to fully evaluate the information presented, in order to avoid being misled, confused, or deceived.??
FDA defined ?significant relationships? as ?relationships that may give rise to actual or perceived conflicts of interest.? Where there is a question as to whether a relationship is significant, FDA recommended that providers, presenters, and supporting companies disclose the existence of the relationship. FDA specifically asserted that, ?the provider should determine how to ensure that disclosure is meaningful.??
The Coalition recommended that CMS? proposed regulations should follow FDA?s preference for allowing the CME providers to ?determine how to ensure that disclosure is meaningful? to the audience, rather than attempting to publish payments on CME faculty and providers.? Furthermore, FDA envisioned that any potential conflict of interest risk could ?be satisfied by disclosing the existence of and characterizing significant relationships, and need not include further detail such as the amount of compensation or funding received.??
Moreover, FDA clearly recognized that ?disclosure should impose only a minimal burden on providers, presenters, and supporting companies.? ?In addition, FDA?s assertion that disclosure ?of any significant relationship between the provider, supporting company, and presenters or moderators would be sufficient,? suggests that further disclosure from CMS would be unnecessary, duplicative and burdensome.?
Accordingly, the Coalition suggested that CMS follow FDA?s recognition that the amount of compensation or funding received is unnecessary for disclosure at CME activities. Moreover, they implored CMS to adopt FDA?s reasoning, which noted that disclosure for CME activities ?should impose only a minimal burden on providers, presenters, and supporting companies.??
Finally, the Coalition also estimated that the regulation could cost hospitals, associations and other CME providers a total of $169,733,813 for three years ($64,151,271 for the first year, and $53,791,271 for years two and three).? The Coalition provided a detailed description and analysis of how it came to this estimate.??
Ultimately, the Coalition asserted that payments made to CME providers for education fall outside of the Sunshine Act?s intentions because CME providers are not covered recipients.? They noted that if CMS believes that CME providers should be treated as covered third parties, then payments to CME providers should be exempted from reporting because of the ACCME?s Standards of Commercial Support or the safeguards, firewalls, and transparency protections already required for certified CME.?
Otherwise, publication of such grants and payments would be detrimental to CME providers in many ways, such as finding sufficient subject-matter expert faculty, planning and budgeting high cost and high quality CME, and soliciting funding.
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