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21st Century Cures Act: Sunshine Provisions at Risk in Last Minute Maneuvering

William Sacks

Vice President, COI Product Management

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On December 7th the Senate passed the 21st Century Cures Act, which passed in the House of Representatives one week earlier. It then moved to President Obama and received his signature. The bill promotes biomedical research and innovation and is designed to help bring drugs and devices to market faster and at reduced cost.

When the bill was first presented it contained provisions which would have weakened the Physician Payment Sunshine Act, which was passed as part of the Affordable Care Act in 2010. That law requires drug and device companies to publicly report virtually all payments to doctors, including meals, gifts, travel, and royalties, as well as speaking and consulting fees. The proposed provisions would have eliminated the requirement to report the value of textbooks and medical journal reprints given to doctors. They also wouldn’t have had to disclose payments for continuing medical education courses, essentially training programs funded by companies about subjects that they care about and run by third-parties. 

These provisions met stiff resistance from both sides of the political spectrum. Public Citizen, a consumer rights organization, faulted a number of provisions in the Cures Act, saying they would endanger public health. The group said the disclosure provisions “would allow for secret influence from pharmaceutical and medical device companies on the practice of medicine and medical education.”

The proposed provisions were also opposed by Republican Senator Charles Grassley of Iowa, one of the original authors of the Sunshine legislation. “The Sunshine Act brings transparency to a big part of the health care system for public benefit,” said Sen. Grassley, in a statement. “Transparency brings accountability wherever it’s applied. With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever.” Before the House voted on the bill on December 1st, Grassley, chairman of the Senate Judiciary Committee, threatened a parliamentary maneuver that could stretch out discussion of the bill.

Apparently, the pressure from opponents of the proposed provisions to weaken disclosure requirements was successful, as the provisions were removed on November 29th, the night before the House, and a week later the Senate, overwhelmingly passed the legislation. This leaves the Sunshine regulations intact for the moment, at least until the Trump administration begins to follow through on its plans to “repeal and replace” the Affordable Care Act itself.

Learn more about HCCS Conflicts of Interest management solutions.

Source: Ornstein, Charles, “Medical Innovation Bill Would Water Down Disclosure of Industry Payments to Doctors,” ProPublica, Nov. 29, 2016, 8 a.m., accessed at https://www.propublica.org/article/medical-innovation-bill-water-down-disclosure-industry-payments-doctors.