Reform's "Sunshine" Clause Prompts Firms To Review Disclosure Web Sites
Any drug, device or medical supply company that sells products to a government program and provides payments or items worth more than $10 to practicing physicians or teaching hospitals will be required to post those outlays in a publicly-available database starting in 2013
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Some answers to industry questions about ambiguity in sunshine regulations may come through enforcement actions, Sidley Austin’s James Stansel says.
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.
CMS-proposed rule would allow companies to report a single figure for research payments to institutions and attribute it to the principal investigator(s), although the agency will not include it when computing physicians’ total receipts from industry. The agency wants more details on what payments are for, calling on firms to break them down by category when more than one expense type is included in a single payment.