Article preview from "The Gray Sheet" - February 11, 2013
CMS has finalized several sunshine rule provisions: the definition of “applicable manufacturer” has been narrowed; many payments to speakers at continuing medical education programs and events need not be reported; and the agency will allow manufacturers to supply contextual information on the public database.
Companies Dig Into Sunshine Rule Details In Preparation For Aug. 1 Go-Live Date
Article preview from "The Gray Sheet" - February 11, 2013
Device firms may have until Aug. 1 to start complying with CMS’ recently finalized Physician Payment Sunshine Act regulations, but until that time there will be many details to sift through.
The final rule, released by CMS Feb. 1 after substantial delay, sets ground rules for a legal requirement that device and drug makers track and report payments and other transfers of value made to physicians and teaching hospitals to CMS for posting on a public website. It also addresses requirements for manufacturers and group purchasing organizations to report physician ownership and investment interests.
Precisely what transactions need to be reported, and which don’t, who needs to report and how the information will be presented in public, among other issues, are detailed in the 280-page-plus rule, which includes some adjustments from a proposed version issued in December 2011. “Overall, we are pleased,” said Christopher White, general counsel and senior executive VP of AdvaMed, in an interview. “The agency seemed to carefully consider our comments” on the proposed version of the rule, he said.
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