CMS carve-out clears clouds over research

Bill Little
Bill Little

“The marketing research community should be very satisfied with the additional guidance on the Sunshine Act from CMS,” said Bill Little, government affairs committee chair for the Pharmaceutical Marketing Research Group (PMRG).

“The plain meaning of the statute's original language remains intact, and CMS's final rule doesn't appear to impact how marketing research can be conducted in the future,” said Little. “Payments to covered recipients should continue to fall outside any reporting requirement because the payments are made through third parties to recipients whose identities are unknown to the manufacturers.

“The exclusion also reinforces that such payments are for fair compensation purposes,” he added. While that was an important victory for PMRG, which worked with lobbying firm Akin Gump on the Sunshine act in Congress, as well as for the MRA and CASRO, it remains to be seen whether the added specificity soothes compliance officers at drug and device companies.

“We won't really know until we hear from our members and researchers around the country about what they're getting back from compliance departments,” said Howard Fienberg, MRA director of government affairs.

Lobbyists are keeping an eye out at the state level, too. “It is our hope that all states will eventually agree with or defer to the Sunshine Act's language and the CMS guideline,” said Little, “but in the end, states can impose more stringent language if they so choose.”