Under Proposal, CME Speakers No Longer Exempt from Sunshine Act

August 20, 2014
Ericka L. Adler, JD
Ericka L. Adler, JD

Shareholder at Roetzel & Andress

CMS is proposing to withdraw the Sunshine Act exemption for payments made to healthcare providers who serve as speakers for accredited CME programs.

As most physicians are aware, CMS released the final rule of the Physician Payments Sunshine Act in 2013. The act was created to provide transparency for payments and gifts made to physicians and teaching hospitals by applicable manufactures of covered drugs, devices, biological products, and medical supplies.

Under the act, this data is required to be reported annually to CMS and then is made publicly available on a searchable federal database.  Upon release of the act, dozens of national and state medical societies expressed concern that payment disclosures could be misinterpreted without any contextual information.

However, despite these initial complaints, CMS declined to amend the requirements for data capture, and the first federal reports were due to CMS on March 31, 2014.

In the Medicare Physician Fee Schedule for Calendar Year 2015, released July 3, 2014, CMS buried a proposal that would withdraw one of the Sunshine Act’s exemptions related to CME. Under the act, there is a specific exemption for direct or indirect payments made to healthcare providers who serve as speakers for accredited CME programs. CMS’s proposal to withdraw this exemption has drawn a flurry of comments from physicians and organizations alike.

The basis for the proposed change stems from concern over the final rule’s exemption of five named organizations as approved accreditors of CME. The specificity of the rule was intended to differentiate programs that are unaccredited or non-certified CMEs, from those that are accredited. Nevertheless, an unintended consequence of naming certain organizations was an apparent endorsement of a select few CME providers in the healthcare industry.

CMS has proposed two alternative approaches to rectify this issue: (1) expanding the list of accredited organizations by name; or (2) establishing accreditation or certification standards. Each alternative comes with its own set of problems, from implying endorsement of an organization to requiring enforcement of any promulgated standards.

Those who agree that the CME exemption in the final rule should be amended argue that manufacturers of drugs and medical devices could potentially take advantage of the CME exemption, leading to biased CME programs. This is because manufacturers fund both for-profit and not-for-profit organizations that educate physicians about new treatment options and, since other types of payments are now reportable under the act, manufacturers will avoid public disclosure by indirectly funneling money into the exempted CME providers, thus shaping content and prescribing habits.

On the other side of the argument is a concern that if the exemption is eliminated completely, funding for the CME industry will be subsequently decreased, and the spread of medical information could be significantly stymied. Some have even argued that CME attendees will be less willing to speak at educational sessions if the value of the CME is being reported under the act.

Although there are valuable arguments on both sides, CMS should look to the original purpose behind the Sunshine Act, which was passed to provide transparency on financial relationships between physicians and manufacturers. If the CME exemption were to remain, true transparency and accountability would likely not occur and could permit those manufacturers with the most money and power to drive education in the medical field.

Elimination of the CME exemption is unlikely to forestall manufacturers from marketing their wares at CME programming events as well as other efforts to educate and collaborate with physicians.  The only result hopefully will be that financial relationships between the parties will be out in the open.  Whether the current reporting mechanisms are fair, accurate and will meet their stated purpose is yet to be seen, and is an entirely different issue on which we are sure to hear much discussion going forward.