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During the past 50 years, we have seen an unprecedented extension in life expectancy, from age 68 in 1950 to age 78 today. Many of our health improvements are due to new therapies and treatments created by collaborations between physicians and industry.
Along with these breakthroughs come enduring concerns that physician-industry collaboration can raise ethical issues, such as potential conflicts of interest. To allay these concerns, Congress passed the Physician Payments Sunshine Act, section 6002 of the Affordable Care Act, in 2009.
In addition to the guidelines and legal memorandum, the CME Coalition has been active in getting clarification of the final regulations on the issues noted above and several other areas. The recent FAQs posted by CMS have provided needed clarification to CME providers and stakeholders to ensure that physician speakers and, physician-attendees, and manufacturers can live in harmony with the Sunshine Act, without chilling physician-industry participation in the CME enterprise.
Despite this additional clarity, many nuanced questions around Sunshine reporting remain. To address these uncertainties, the www.cmecoalition.org CME Coalition has an area on its Web site dedicated to answering questions around CME and the Sunshine Act.
Ultimately, the goal of the Sunshine Act is to bring transparency to payments between physicians and manufacturers, not to regulate the way manufacturers do business. Given the tremendous impact accredited CME has on improving patient outcomes and ensuring physicians are up-to-date on new clinical and scientific data, it will be incumbent on CMS to ensure that its final regulations do not overly burden CME providers and stakeholders.
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