Following the passing of last month’s bipartisan doc-fix bill, lawmakers are at it again, working together to advance a popular, bipartisan bill that is speeding its way through the House. The 21st Century Cures Act was introduced with the intention to, “accelerate the discovery, development, and delivery of 21st century cures and for other purposes.” While the Act contains a variety of provisions aimed at research and information sharing, a lesser known aspect of the Act, which proposes to loosen physician gift reporting requirements, may win some praise from speech advocates who have argued that the reporting requirements unduly burden free speech and hamper physician continuing education.
A survey reported by the Journal of the American Medical Association of Internal Medicine conducted in 2009, found that nearly 84 percent of physicians had financial relationships with manufacturers of drugs, biological products, and medical devices and suppliers. The majority of such relationships took the form of meal reimbursements, but also included tickets to events, admissions fees for continuing medical educational events, and consulting fees. While some have maintained that the relationship between physicians and manufacturers can be vital to the development of new drugs, especially in the consulting context, others have argued that such relationships can also create conflicts of interest between a manufacturer’s promotional activities and medical research and practice.
In response to the prevalence of such relationships, the Physician Payment Sunshine Act, (42 U.S.C. Sec. 1320a-7h) was passed as section 6002 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). The Sunshine Act requires drug and medical device manufacturers who participate in federal health programs to report any payments or items of value that they make to doctors or teaching hospitals to CMS, which collects the information and administers the National Physician Payment Transparency Program, also known as the Open Payments Program. The reporting period began in 2013 and the information was compiled into a national, publicly available database.
However, the gift reporting component of the Sunshine Act has many critics arguing that it is an undue burden on the freedom of speech. Additionally, some have criticized the chilling impact the law will have on physician continuing education. The Sunshine Act provided a reporting exception for gifts of “educational materials that directly benefit patients,” but CMS has narrowly defined “educational materials” and determined that gifts of medical journals and textbooks are not excluded from the reporting requirements of the Act. As reported in Forbes such gifts were frequently the most popular way for physicians to stay current on medical information.
However, provisions of the 21st Century Cures Act may soon limit the types of gifts that physicians will be required to report. Specifically, section 3401 of latest version of the bill would exclude peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks from the Sunshine Act reporting requirements. This provision of the proposed law has been strongly supported by the American Medical Association. In a letter to lawmakers supporting the provision, Executive President and CEO James Madara, MD, stated, “regular, unrestricted access to independent, high quality information on the latest clinical innovations that are relevant to improved patient health outcomes is the lifeblood of medical practice for physicians and directly benefits patient outcomes.”
The 21st Century Cures Act’s momentum continues, as it was unanimously approved by the House Energy and Commerce Committee 51-0 vote and is set to head to the House for consideration. After the vote, Full Committee Chairman Fred Upton (R-Mich) expressed enthusiasm for the law and said, “this historic day marks a big bipartisan step forward on our path to cures.” He added that, “in this, the greatest country in the world, Americans deserve a system second to none. We can and must do better. The time for 21st Century Cures is now.”