In an article for the American Bar Association's Health eSource, Shook Associate Tim Moore discusses proposed federal legislation that would amend the Sunshine Act, which requires the public disclosure of certain payments to physicians.
The Centers for Medicare & Medicaid Services (CMS) has interpreted the existing Sunshine Act as requiring companies to report financial contributions to programs that train physicians, with exceptions for materials that directly benefit patients and for payments to speakers at continuing education events, Moore writes. CMS has been limiting the situations in which these education-related exclusions apply, resulting in stricter reporting standards.
Moore details two pieces of federal legislation that have been introduced in response to CMS's changing standards. H.R. 293 would specifically bring peer-reviewed journals, conference reports and medical textbooks within the education-related exception, while the 21st Century Cures Act would create similar exclusions but specifies that it would apply to medical conference reports and clarifies which speaking engagement payments would fall under the exception.
"Applicable manufacturers should pay particularly close attention to the 21st Century Cures Act," Moore advises. The act has gained more momentum, he says, so "applicable manufacturers may well see the 21 Century Cures Act become law—and with it, relief from CMS’s curtailment of their efforts to promote patient health by educating physicians."