US Sunshine Act

Physician Payments Sunshine Act: Organizations Respond to CMS

September 2nd marked the last day for comments on CMS’ proposed rule to eliminate the accredited continuing medical education (CME) exemption from Sunshine Act reporting. In an overwhelming display of support for the exemption, over 800 comments were submitted encouraging the agency to either maintain or expand the current exclusion. -Total comments supporting maintenance or expansion of the CME exemption: 820 -Total comments supporting elimination of the CME exemption: approximately 20 -Percentage of comments supporting the CME exemption: 98% Policy and Medicine have followed this issue closely, and recently analyzed the CME Coalition’s comments and recommendations, as well as the …

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Not Every Conflict of Interest Produces the Same Vote on FDA Panels

For the past decade, the FDA has grappled with competing views about the potential for conflicts of interest among its advisory panel members to unduly influence decisions about which drugs to recommend for regulatory approval. At one point, the agency worried aloud that its own regulations made it difficult to find qualified experts, although that has been less of a problem lately. But as FDA officials continue to monitor the issue, a new study offers some insight into how the agency may want to vet the experts who are asked to serve on advisory committees. As it turns out, panel …

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CMS Extends Window For Sunshine Act Pay Verification

The Centers for Medicare and Medicaid Services on Thursday promised to extend the Physician Payments Sunshine Act’s online system for verifying payments to doctors from drug and device makers by as many days as the tool is offline. The announcement came after CMS took down the verification system over the weekend in response to a complaint from one doctor who said he’d been confused with another physician and been incorrectly associated with certain payments. Upon investigating, CMS confirmed the problem and found additional discrepancies.

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Sunshine Act: Over 100 Medical Associations and Societies Urge CMS To Reconsider CME Exemption and Open Payments Timeline

Medial associations and specialty societies have been understandably frustrated with the way the Physician Payments Sunshine Act has rolled out so far. Yesterday, over 100 medical societies including the American Medical Assocation–49 state medical societies and 64 medical specality societies–sent a letter to Marilyn Tavenner, Administrator of the Centers for Medicare and Medicaid Services (CMS) asking for redress over three problematic issues: the expansion of reporting requirements for educational activities, Open Payments’ condensed timeframe for physician registration, the complicated registration process for dispute, including manufacturer discretion to dismiss disputes. See more at Policy & Medicine

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Docs Complain to CMS About ‘Sunshine’ Data Disclosures

A group of medical societies and pharmaceutical industry trade groups is pushing the government to flesh out data that will be published next month showing how much drug makers pay doctors. They sent a letter to the Centers for Medicare and Medicaid Services to ask the agency to explain what context will be provided to help the public understand the justification for payments, such as speaking fees and grants used to bankroll clinical research. The letter was signed by more than 20 medical societies and organizations, including: – The American Association of Neurological Surgeons; – The American Urological Association; – …

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