Open Payments Program (aka the Sunshine Act) makes public debut.

نویسنده

  • Charlie Schmidt
چکیده

W ith government funding for bio-medical research stagnant or declining, scientists rely more than ever on industry support. Yet although that support is indispensible, it poses delicate challenges: Scientists and doctors are sometimes tempted to decide what's best for a sponsoring company rather than for patients. These conflicts of interest have sparked growing calls for transparency into industry's financial ties to the biomedical community. A federal website, managed by the Centers for Medicare and Medicaid Services (CMS), will soon reveal virtually all transactions between the drug industry and its collaborators. Set to launch Sept. 30, the website represents the public face of the Open Payments Program (OPP)—a provision of the Affordable Care Act created to avert conflicts of interest in biomedical research and physician prescribing practices. OPP is better known by its former name, the Sunshine Act, and it requires drug and medical device companies to report all payments of at least $10 to doctors and teaching hospitals, ranging from meals and gifts to long-term support for clinical trials. Even as stakeholders applaud OPP's intentions , many worry that it could fuel misper-ceptions about industry's role in bringing new treatments to market. " The data have to be accurate and must provide the right context; otherwise, they're meaningless, " said chief medical officer of the American Society of Clinical Oncology. " The public must be able to distinguish legitimate research support from a company flying me to the Caribbean for a nice dinner and a marketing spiel. " A July 28 letter from more than 20 medical organizations to CMS echoed Schilsky's views, opining that financial data disclosed as " names and numbers with no context " would result in public " confusion and misinterpretation. " Hospitals, universities, journals, professional organizations, and states have implemented disclosure programs for years. But to some federal legislators—notably Sen. Charles Grassley (R-Iowa), who pioneered the Sunshine Act and its addition to the Affordable Care Act—this ad hoc system lacks consistency. OPP therefore imposes the same requirements on all companies that sell drugs or medical devices in the United States. To comply with the law, companies tracked and reported transactions during August–December 2013. CMS urged doctors and hospitals to register with OPP, so they could check transactions for accuracy during a 45-day " review and dispute " period that began this year July 17 and ended Aug. 24. In addition to providing dates, recipients , …

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عنوان ژورنال:
  • Journal of the National Cancer Institute

دوره 106 9  شماره 

صفحات  -

تاریخ انتشار 2014