CONTINUING MEDICAL EDUCATION
(CMS) recently promulgated rules under the Physician Payments Sunshine
Act that require full disclosure of any industry payments to physicians
through CME activities. 12 However, the regulations exempt indirect
payments made by industry players to accredited CME providers from the
reporting requirements, creating a means for industry to avoid disclosure of
payments made. 13 This has reignited the debate about Industry influence
over CME delivery.
This article highlights the various flaws in the way CME is conducted,
financed, regulated, and evaluated. Part II discusses the regulatory
framework for CME activities, including the accreditation process and the
history of the roles of the FDA and the HHS Office of Inspector General’s
(OIG’s) roles in ensuring independence and reliability in CME content.
Part III focuses on the various shortcomings of the current regulatory
schemes that seek to protect against undue industry influence in CME
activity. Finally, Part IV provides recommendations for improving the
CME programming framework to ensure accountability and independence
for CME providers.
II. HISTORY AND SHORTCOMINGS OF THE CURRENT
CME REGULATION REGIME
While HHS has largely left CME regulation to ACCME, a regulatory
framework does exist - made up of various federal laws, regulations, and
industry codes. The federal government has a hand in preventing off-label
marketing that occurs during CME activities, though courts have largely
restricted it from directly regulating CME content because of First
Amendment concerns. 14 Instead, the ACCME’s accreditation standards and
its Standards for Commercial Support are the primary means of regulation
for CME activities. 15 The ACCME enforces its guidelines through the
threat of revoking a CME provider’s accreditation. 16 Other voluntary
guidelines, such as the OIG’s Compliance Program Guidance for
Pharmaceutical Manufacturers and the Pharmaceutical Research
BLOG (July 30, 2009), http://pharmamkting.blogspot.com/2009/07/nissen-puts-stake-through
12. Physician Payments Sunshine Act, 42 U.S. C. A. § 1320a-7h(a)( 1)( A) (West,
WestlawNext through P.L 113-31).
13. See 42 C.F.R. § 403.904(g)( 1) (West, WestlawNext through Dec. 26, 2013; 78 Fed
Reg 78,691); see also Larry Husten, No Sunshine for Continuing Medical Education,
FORBES (Feb. 1, 2013), http://www.forbes.com/sites/larryhusten/2013/02/01/no-sunshine-for-
14. See, e.g., Wash. Legal Found. v. Henney, 202 F.3d 331 ( D. C. Cir. 2000).
15. See ACCME STANDARDS FOR COMMERCIAL SUPPORT, supra note 10, at 1.
16. See id.