CONTINUING MEDICAL EDUCATION
After issuing the proposed regulations under the Sunshine Act, CMS
received many comments criticizing the requirement that CME providers
report “indirect payments” to physicians who attend CME programs
partially or fully sponsored by Industry.145 Many commenters argued that
the reporting requirements were overly burdensome and would deter
funding for essential CME programming.146 They opined that the reporting
requirements of the Sunshine Act would be duplicative of the requirements
of the ACCME Standards and would deter financial support from
industry.147 Further, they urged that requiring disclosure of payments to
CME providers would result in higher admission costs for CME and fewer
CME activities.148 CMS agreed with these arguments in its final rules,
which excluded payments to third-party CME providers from the definition
of “indirect payment,” if the drug or device companies do not select the
speakers or provide a list of potential speakers.149 Accordingly, drug and
device manufacturers need not disclose payments to accredited third-party
CME providers as long as the manufacturer does not condition its payment
on use of any particular content or speakers.150 In other words, drug and
device companies are not required to report most payments routed through
accredited CME providers.151
The exception for indirect payments contradicts the purpose of the
Sunshine Act, which is to provide for transparency and accountability in the
relationships between physicians and industry.152 The regulatory loophole
allows industry to conceal payments to physicians that would otherwise be
disclosed under the PPSA when the payments pass through third-party
accredited CME providers.153 Instead of encouraging transparency in
industry sponsorship of CME, the industry will essentially be able to avoid
disclosure by “laundering” money through third party CME providers. The
exception for indirect payments makes sense only if CME providers are
truly independent and resistant to commercial influence.154 Current federal
144. Id. § 1320a-7h(b)( 2).
145. See Transparency Reports and Reporting of Physician Ownership or Investment
Interests, 78 Fed. Reg. 9458, 9479-80 (Feb. 8, 2013) (codified at 42 C.F.R. pts. 402, 403).
147. See id.
148. See id.
149. See id.
150. See id. at 9524.
151. See id.
152. See id.
153. See id.
154. See id.