WHILE THE OFFICE OF INSPECTOR General draft Compliance Program Guidance for Pharmaceutical Manufacturers, as published in early October, is directed specifically to the pharmaceutical industry, CME providers should take notice of several of its components. The Guidance addresses business policies and practices that could be in violation of federal statutes pertaining to kickbacks and false claims. In the mix is the possibility of fraud in industry-funded CME.
The OIG Guidance brings the long-debated issue of “reasonable honoraria” to the fore once again. The section Other Illegal Remuneration and Relationships with Physicians and Other Health Care Professionals makes it clear that the OIG considers fees paid to healthcare professionals by industry to potentially violate fraud and kickback laws.
The draft Guidance states that when pharmaceutical companies engage healthcare professionals as consultants, inclusive of speaking engagements, payment should be at fair market value for services rendered. CME providers and industry supporters must conform to fair value ranges in setting fee structures. Decisions on fees should be reached by using the same value-based analytical process that is used to determine fees for other CME event components.
Reasonable compensation can be measured against commonly accepted ranges or averages for specific services rendered in national, regional, or local settings, and as promulgated by CME providers and industry. Fair market value does and should vary based on the amount of time a consultant or presenter gives to, for example, a speaking engagement, taking into consideration research, preparation, presentation, and coordination, as with activity chairs. Value is also judged on expertise and reputation.
If parties to the fee, that is, the CME provider and the pharmaceutical company, cannot agree because of exaggerated consultant/speaker demands, another healthcare professional with equivalent credentials should be chosen. It is OK to say no when fee requests are out of bounds.
Keep Debate Alive
In a free-market society, payment is in direct proportion to value perceived. As such, it is inappropriate for CME providers or industry to establish set amounts for specific services, for rarely are circumstances identical. Rather, it is important to keep the debate alive. Debate will sensitize the professional recipients and the industry payers to the need for fees in appropriate proportion to services delivered.
The Accreditation Council for CME and Pharmaceutical Research and Manufacturers of America might consider adding a fair market value statement to their guidances in reference to consultant/speaker fees, without setting fixed amounts. This would call attention to the issue, result in more appropriate fee negotiations, and complement the American Medical Association ethical opinions.
Under the OIG Guidance it is important that all parties to the CME process train employees in the existing guidances, require strict compliance, and have a mechanism in place to address violations. Also, employees must be given the tools, opportunities, and encouragement to do it right.
The OIG Guidance is not intended to further regulate CME and will present no threat to “safe harbor” CME when industry, providers, healthcare professionals, and education and communication companies comply fully with in-place guidances. OIG should not and must not reduce the commitment of commercial supporters to CME funding.
Robert F. Orsetti is assistant vice president, continuing education, University of Medicine and Dentistry of New Jersey in Newark. Orsetti, a 24-year CME veteran, is a member of the AMA's National Task Force on CME Provider/Industry Collaboration.