Health Law & Policy Matters published a follow up to their posting in July about the Centers for Medicare and Medicaid Services' (CMS) proposed rule to eliminate the reporting exemption for accredited continuing medical education within the Physician Payments Sunshine Act. Author Brian P. Dunphy explains how the redefinition of indirect payments lays the ground work for CME events to remain exempt from PPSA reporting. They also site the CME Coalition's press release.
The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed several of these changes in July, my colleague discussed them in detail in an earlier post. The changes will become effective for the 2016 reporting year (pharmaceutical and medical device manufacturers (“Manufacturers”) will submit reports to CMS covering 2016 in 2017).
The Final Rule includes four changes. First, CMS eliminated a separate reporting exclusion for payments to physicians for speaking at accredited or certified continuing medical education (“CME”) programs. Even though CMS eliminated this CME-specific exclusion, most of these CME payments will still not have to be reported. CMS decided that, where a Manufacturer provides funding to a third-party CME provider for physicians to attend or to speak at a CME program, these payments are not reportable “indirect payments” if the Manufacturer does not “require, instruct, direct, or otherwise cause” the CME provider to direct the payment to a specific physician. CMS further explained that a CME payment does not become reportable if the Manufacturer later learns the physician’s identity “because the payment or other transfer of value did not meet the definition of an indirect payment.” With respect to tuition fees for physician attendees, CMS will issue “sub-regulatory guidance specifying [that] tuition fees provided to physician attendees that have been generally subsidized at continuing education events by manufacturers are not expected to be reported.”
Although most of these four changes are not contentious, the proposed elimination of the reporting exclusion for certain CME payments proved controversial when the proposed Sunshine Act changes were announced in July 2014. But with the interpretation that CMS adopted in the Final Rule, which will keep many CME payments from being reported, CME coalitions largely applauded the change.