We previously reported that CMS issued its final rule on the PPSA with comment period at the end of October 2014, and that there is still major confusion with the final rule. For example, CMS stated that payments NOT meeting the CMS definition of “indirect payment” both needed to be reported and at the same time were not reportable, according to CMS. However, the rule was clear in several areas, including the preamble:

If an applicable manufacturer conveys “full discretion” to the CME provider, those payments were outside the scope of the rule

However, an FAQ document released last week by CMS further muddied the water. In that document, CMS stated that

When an applicable manufacturer provides a payment to a CME organization for a CME event for physicians, and the manufacturer knows the identity of some physicians within a time period, that would be reportable

Now, we have work to do in two main areas which are both addressable and solvable by us in the CME comunity. The two main areas being that we need to require consistency at CMS, and we need to help clarify the confusion with the final rule.

Require Consistency at CMS

The CMS final rule stated that payments associated with accredited CME meeting the current ACCME guidelines would not be reportable, and we should hold CMS to that same standard. In the court this is called Stare decisis, and in the regulatory arena it’s simply called precedent. We need to hold CMS to the precedent they set in the final rule.

Help Clarify the Confusion

We also need to help clarify the confusion for CMS. CMS does not understand the big difference between accredited CME and other forms of education and information out there, which is not surprising. Just a few years ago The AMA (American Medical Association) confused CME with marketing and free lunches. As recent as last year, JAMA (The Journal of the American Medical Association) equated advertising agencies with accredited CME providers that only work in science-based accredited CME. It’s obvious that this is confusing, and the landscape can get more confusing when you mix in advertising, promotional education, and the recent advent of MSL or medical science liaisons, which are all typically promotional in nature. Another example are society conferences, where we often have a mix of all the above mentioned promotional education with accredited CME held in separate rooms, so it's easy to see where this confusion comes from. We as a community need to distinguish accredited CME from all other education, and we can work with The ACCME, CMS, The CME Coalition, and other stakeholders to simply educate on these differences. It’s our job every day, and it’s our job now more than ever to educate CMS about what makes accredited CME different. If you have any questions please feel free to contact us here at any time.