Implementing the New Standards Part One: Disclosure Decisions

ONE OF THE most important aspects of the new Accreditation Council for CME Standards for Commercial Support is the requirement that “providers must have implemented a mechanism to identify and resolve all conflicts of interest prior to the educational activity's delivery.”

This means that providers will have to change the way they collect conflict of interest (COI) information. Today, most of us are using a faculty disclosure form to collect similar information. Now, we will be collecting personal and institutional information from three parties: instructors, planners, and managers, as well as from educational partners whose roles involve the synthesis of information relative to the planning process.

The synthesizer, who may be the course chair, a key staff planner, staff at the educational partner's organization, scientific analyst, etc., is very important when considering conflict of interest issues. This is the person (or persons) who decides on a final list of high priority needs that will form the foundation of the CME activity. This person is the fulcrum around which instructors or others structure their presentation — and therefore has tremendous influence.

Putting a Price Tag on Influence

Your new disclosure form will reflect the criteria you will use to determine conflict of interest. One question to grapple with is the individuality of COI. For example, if person A has revenues of $50,000 and receives $30,000 of that revenue from commercial supporter X, then clearly person A would be very beholden to supporter X and have a high level of incentive to bias information in an activity. However, that same amount of revenue to a person with a total income of $250,000 might not be considered a relevant COI.

When modifying the disclosure declaration forms, providers might consider an enhanced set of questions, such as type of affiliation/financial interest (types include grants/research support, consultancy, stock, honoraria directly from the commercial interest, other financial, material, or agency support); name of commercial interest; category of annual financial remuneration, such as $1 to $25,000, $25,001 to $50,000, etc.; and percent of income received from affiliation/interest. I acknowledge that the fourth point may be problematic because many people will not want to divulge how much money they receive from commercial interests.

Institutional Relationships

In addition, more information may be required to assist the provider in understanding institutional COI. For example, if a provider works with a MECC or other educational partner, you may want to know these additional points: annual funds received from the commercial supporter; percent of total revenue represented by the aforementioned supporter revenue; whether or not there is an “agency of record” relationship between the partner and the supporter; and whether the partner's educational unit has established a real firewall.

In addition, academic institutions that hold patents on products affecting patient care should consider a mechanism to identify the patents held by their institution, and determine if prospective instructors, planners, or managers are in the position to influence product usage.

In upcoming columns, I will discuss how to analyze conflicts of interest and how to begin implementing your new conflict-of-interest process.

Steven M. Passin is president of the CME consulting firm, Steve Passin & Associates in Newtown, Pa. He has also served as deputy health secretary for California. Contact him at [email protected] [2].