Final Sunshine Act Rule Released

Was Delayed 15 Months

Final Sunshine Act Rule ReleasedAfter a 15-month delay, the Centers for Medicare and Medicaid Services (CMS) has released final guidance that implements the Physician Payments Sunshine Act – a much-discussed component of the Affordable Care Act. The goal of the regulations is to expose payments and gifts provided to doctors by pharmaceutical and medical device companies. Under the law, pharmaceutical companies must report these payments to CMS, which will then post the disclosures on a public, online database.

"You should know when your doctor has a financial relationship with the companies that manufacture or supply the medicines or medical devices you may need," said Peter Budetti, a CMS deputy administrator, in a statement. "Disclosure of these relationships allows patients to have more informed discussions with their doctors."

Although by strict definition of the law, promotional products given to doctors are considered payments, the legislation does allow exceptions that benefit ad specialty firms. Specifically, reporting exceptions include anything of value that's less than $10, unless the total value over a one-year period exceeds $100. Additionally, "small incidental items that are under $10" given out at large events, like conferences, are also exempted. Finally, products deemed to have educational value – like anatomical models or nutrition journals – do not fall under the reporting requirements either.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is among several trade groups that have released statements about the Sunshine Act guidance. "PhRMA is currently reviewing the final regulation of the Physician Payments Sunshine Act and looks forward to seeing how CMS addressed key concerns that were previously raised," the group said. "PhRMA remains committed to the principles of the Sunshine Act and continues to believe that careful implementation is essential to ensuring that Sunshine fulfills its objective of usable, transparent, and understandable sharing of information."

The final rule, which is outlined in a 287-page document, mandates that pharmaceutical companies and impacted purchasing organizations must begin collecting applicable data on August 1 of this year and report it to CMS by March 31, 2014. The rule also provides a 45-day review and correction period for doctors to make sure disclosures are accurate.

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