July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be published July 11, the Centers for Medicare & Medicaid Services (CMS) proposed the elimination of the exemption from Sunshine Act reporting for continuing medical education (CME) supported by industry.

“When so many other issues need to be addressed – especially the needed exemption from Sunshine Act reporting for reference texts and journal reprints – it’s startling and disappointing that the CMS would chose to reopen the CME exemption,” said Coalition for Healthcare Communication Executive Director John Kamp. “It’s high time that CMS limit and simplify these rules, not extend and complicate them.”

Specifically, CMS proposes deleting the CME Sunshine Act exemption in its entirety. “Eliminating the exemption for payments to speakers at certain accredited or certifying [CME] events will create a more consistent reporting requirement,” CMS states in a July 3 fact sheet about the proposed changes.

CMS explains in the proposed rule that the changes are in response to stakeholder comments raising concerns “that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not.”

Moreover, the proposal would further complicate the enforcement of the statutory exclusion of “indirect” payments that appears unaffected by the new proposal.  According to CMS, the indirect payment “ provision excludes indirect payments or other transfers of value where the applicable manufacturer is ‘unaware’ of, that is, ‘does not know,’ the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.”

Under this provision, if an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure.

In addition to eliminating the CME exemption, CMS also is proposing three related changes:

• Deleting the definition of “covered device” as it is duplicative of the definition of “covered drug, device, biological or medical supply” which is already defined in regulation.
• Requiring the reporting of the marketed name of the related covered and non-covered drugs, devices, biologicals, or medical supplies, unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply.
• Requiring applicable manufacturers to report stocks, stock options or any other ownership interest as distinct categories, to enable CMS to collect more specific data regarding the forms of payment made by applicable manufacturers.

CMS will be accepting comments on its July 11 proposed rule until Sept. 2

The Coalition for Healthcare Communication is working with industry and lobbying partners, including the CME Coalition and the Alliance for CME in the Health Professions, to develop a sharp and effective defense of the CME exemption. All members interested in being part of these discussions should contact John Kamp at: jkamp@cohealthcom.org