Physician Sunshine Rule Needs Longer Lead Time Before Implementation, PhRMA Says; Scope Challenged By CROs
The Pharmaceutical Research and Manufacturers of America seeks at least a six-month lead time before implementation in comments to CMS. The Association for Clinical Research Organizations takes issue with including payments for “legitimate” research in the rulemaking at all.
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Final CMS reg on reporting industry payments to physicians include limiting coverage to companies operating in the U.S. and a definition of third-party payments; despite wins in the revisions from the proposed rule, industry may need a widespread education campaign in order to preserve the value of its physician relationships.
Drug makers get three more months to comply than the proposed rule offered; firms must send the data by March 31, 2014, to CMS, which plans to make the information available on a public website by Sept. 30, 2014.
CMS is still unable to provide certainty regarding the timeline for releasing a final rule implementing the Sunshine Act, Policy and Data Analysis Group Director Niall Brennan told a congressional roundtable on the issue Sept. 12.