Members of Congress Push for CME Sunshine Act Exemption

Several bipartisan Congressional developments last week encouraged Global Education Group and the Washington, DC –based trade group CME Coalition to express cautious optimism for a continued CME grant reporting exemption related to indirect payments from pharmaceutical and medical device companies. The three major developments include a letter to CMS from Congressmen Frank Pallone (D-NJ) and Michael Burgess (R-TX) , the introduction of bill H.R. 5539 by Congressman Burgess and Congresswoman Allyson Schwartz (D-PA), and the results of the comments submitted by CME stakeholders to CMS during their call for comments on the proposed final ruling.

Letter to CMS

Last Thursday, September 18th, Representatives Frank Pallone (D-NJ) and Michael Burgess (R-TX) sent a letter to Marilyn Tavenner, CMS Administrator, urging for CME Sunshine Act exemption. Representatives Burgess and Pallone both sit on the House Energy and Commerce Committee’s Health Subcommittee, with Burgess being the chairman and Pallone the ranking Democrat. The letter summarized the fear that the latest CMS proposal would negatively impact organizations that organize and certify CME activities.

We encourage (CMS) to exempt from its reporting requirements any payments related to the support of certified CME in order to ensure robust physician participation in this important activity without concern for Sunshine Act reporting rules.

This is a positive first step for the entire CME community as a bipartisan effort like this demonstrates how significant and important this exemption is for all parties involved. For a full copy of the letter click here

H.R. 5539 Bill Introduced

The letter sent last Thursday to CMS was followed up by more good news when H.R. 5539 was introduced on Friday, September 19th. Congressman Burgess (R-TX) and Congresswoman Allyson Schwartz (D-PA) sponsored the bill which would amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers for educational purposes. The specific language states that the Social Security act be amended to the following: B. Exclusions. - An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following: 1.Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks 2. "(xiii) A transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician” For a full copy of the bill, please follow this link

Call for Comments submitted to CMS

Earlier this summer CMS accepted comments from the CME community in regards to the proposed rule change to eliminate the CME reporting exemption in The Physician Payment Sunshine Act. The CME coalition reported in a press release earlier this week that CMS received over 900 comments from various stakeholders, of which 98% opposed the final ruling. The unified comment submissions from the CME community to CMS are very encouraging and send a strong message to CMS that there is a significant need for a reporting exemption for CME.

Cautious Optimism for CME Exemption

The month of September, and in particular the last week, has been encouraging for the CME community. The overwhelmingly one-sided results of the comment submissions to CMS, combined with the bipartisan congressional efforts of Congressmen Burgess and Pallone, and Congresswoman Schwartz, have us at Global feeling cautiously optimistic at the possibility of the exemption for CME being included with the final ruling. If you have any questions regarding the Sunshine Act or any of the developments that have been made recently, please contact us here at Global Education Group.