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February 19, 2013

Physician Payment Sunshine Act Final Rule: ACCME - CMS Validated the Standards for Commercial Support and AAFP Comments

Medical conferences
As we noted earlier this month, the Centers for Medicare & Medicaid Services (CMS) released the final regulations to implement the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act.  Listening to the overwhelming majority of comments with respect to the continuing medical education (CME) industry, CMS exempted payments or other transfers of value provided as compensation for speaking at a continuing education if certain conditions are met—which are consistent with the ACCME’s accreditation standards and standards for commercial support.   

In response to the final rule, the Accreditation Council for Continuing Medical Education (ACCME®) noted in press release that “accredited and certified continuing education systems have received important validation from the Centers for Medicare & Medicaid Services (CMS) in its final rule concerning payments to physicians.” 

“The CMS final rule regarding physician payment transparency is an important recognition of the value of the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities,” said Murray Kopelow, MD, President and CEO, ACCME.  “The final rule creates a special exclusion for payments to speakers at accredited continuing education programs, if certain conditions are met.  These conditions are completely consistent with the ACCME Standards for Commercial Support.  The Standards state that accredited providers must make all decisions regarding CME, including faculty selection, independent of industry influence, and that all commercial support must be paid directly to the CME provider, not to the faculty.   

The Standards are designed to ensure that accredited CME activities are independent, free of commercial bias, based on valid content, and contributing to health care improvement. We appreciate that the CMS recognizes the importance of accredited continuing education and the value of the Standards in safeguarding the independence of accredited continuing education.” 

Dr. Kopelow also provided an audio commentary about the CME rule and CME.  Kopelow noted that “The final rule creates a special exclusion for payments to speakers at accredited continuing education programs, if certain conditions are met.  This exclusion recognizes the value of the safeguards that currently protect the independence of accredited continuing education.”  He also explained that “The conditions for the exclusion are completely consistent with the Standards for Commercial Support.” 

“The ACCME Standards for Commercial Support were reviewed and approved in 2004 by each of the ACCME’s seven member organizations, which represent the profession of medicine.  The Standards demonstrate the ACCME’s leadership in medical education and the medical profession's commitment to effective self-regulation in the field of continuing education,” said James F. Burke, MD, Chair, Board of Directors, ACCME.

“The ACCME Standards for Commercial Support have succeeded in being recognized nationally, by the profession, by the regulators, and by the government as protecting the public from industry influence in continuing medical education. This is a peak moment,” said Norman Kahn, MD, Executive Vice-President and CEO, Council of Medical Specialty Societies (CMSS). CMSS is an ACCME member organization. 

In addition to CMS, a number of government agencies have recognized the value of accredited continuing education.  Federal agencies, including the Office of National Drug Control Policy, Centers for Disease Control and Prevention, National Coordinator for Health Information Technology, and Agency for Healthcare Research and Quality, have incorporated accredited CME as a strategic partner in their public health initiatives. I n July 2012, the Food and Drug Administration released its Risk Evaluation and Mitigation Strategy, or REMS, for extended-release and long-acting opioid analgesics, which includes a prescriber education program that is controlled, designed, and delivered by accredited continuing health care education providers. 

ACCME Rules 

In addition to providing these comments, the ACCME also reminded the public and providers about its various resources and policies regarding the Standards for Commercial Support.  For example, the ACCME explained that accredited CME providers must not ask a “commercial interest” for suggestions related to topics or speakers for CME.  The ACCME emphasized that “There is no reason for the CME provider to request suggestions for speakers or topics from commercial interests -- since it is unacceptable to act upon their suggestions.”  

The ACCME believes that CME can receive commercial support from industry without receiving any advice or guidance, either nuanced or direct, on the content of the activity or on who should deliver that content.  If the provider implements the suggestions of the commercial interest then this creates the situation where the independence of CME from the commercial interest is seriously undermined.  The provider must ensure that the content of the CME remains beyond the control of any commercial interest.  The process to develop the CME must be independent of any commercial interest. Accredited providers must not allow commercial interests to directly (SCS 1.1) or indirectly (SCS 3.2) control the content of CME. 

Next, the ACCME emphasized that commercial support must not be spent directly by the commercial supporter on costs related to the CME activity.  ACCME clarified that “commercial support must go first to the provider or a provider's joint sponsor or a provider's educational partner.” 

In addition, the ACCME explained that a commercial support must not supplement their contributions to the activity by additional direct payments to people involved in the activity.  The ACCME maintains that “All commercial support must be stipulated by a written agreement and must flow through the Provider and/or its educational partner. Only the Provider and/or its educational partner can make payments to people for their role(s) in the activity.” 

Last, but certainly not least, the ACCME explained that under the Standards for Commercial Support, it requires providers to have their own policies and proceures governing honoraria because the CME provide must “be the one to decide how much people are paid for their services as planners, faculty, and authors in CME activities.” 

American Academy of Family Physicians (AAFP) 

The American Academy of Family Physicians (AAFP) also released their comments recently on the finalized Sunshine Regulations.   CMS addressed some, but not all, of the issues raised by the AAFP and other groups.  For example, AAFP noted CMS exempted speaker fees for accredited and certified CME programs from the reporting requirements.  In this way, CMS acknowledged that “CME accrediting and certifying bodies, such as the AAFP, ensure that CME activities adhere to rigorous standards,” said Carly Harrington, M.Ed., manager of CME credit systems and compliance for the AAFP.

“These standards call for transparency, conflict-of-interest mitigation and structural firewalls between commercial entities and educational development,” said Harrington.  “It is important for the public to understand that there is a vast CME community dedicated to providing unbiased CME to physician learners.”

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