On May 25, 2016, Sen John Barrasso (R, Wyoming) introduced the Protect Continuing Physician Education and Patient Care Act of 2016, a measure intended to exempt pharmaceutical companies and medical device makers from reporting payments made to physicians for receiving continuing medical education (CME), medical journals, or textbooks. The legislation that this bill is designed to amend, the Physician Payment Sunshine Act, was the brainchild of Sen Charles Grassley (R, Iowa), and was passed as part of the Affordable Care Act (ACA).
The Physician Payment Sunshine Act has broad requirements for manufacturers of federally covered drugs, devices, biologics, or medical supplies to report payments made to physicians and teaching hospitals. The driving rationale for the Barrasso amendment is the logjam created by divergent interpretations of the reporting requirements of the Sunshine Act for CME in particular. Officers of the Centers for Medicare & Medicaid Services (CMS) have espoused a literal interpretation of the Sunshine Act. In a series of regulatory iterations rendered final in 2014, CMS maintained (subject to some exceptions) that the dissemination of educational materials and the underwriting of CME activities are not exempt from reporting. Representatives of organized medicine, however, rejected this interpretation, arguing that the framers of the Sunshine Act never deemed these materials and activities as reportable.
What the Amendment Would Do
If enacted, the Barrasso amendment (currently with the Senate Committee on Finance) would override the CMS reporting requirements. It exempts manufacturers from reporting “certain [financial] transfers [to physicians] used for educational purposes” such as the dissemination of “peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks.” It also exempts manufacturers from reporting “indirect payment or transfer of value” to physicians, such as the underwriting of attendance of or participation in “an educational event…that does not commercially promote a covered drug, device, biological, or medical supply.”
The Barrasso Amendment is but the latest attempt at revising the Physician Payment Sunshine Act and how it is interpreted. On September 18, 2014, Rep Michael Burgess (R, Texas) introduced a bill that was relegated to the House subcommittee on Health, but which nevertheless furnished much of the relevant language incorporated into the Barrasso amendment. Less than a year later, on May 19, 2015, Rep Fred Upton (R, Michigan) introduced a bill called the 21st Century Cures Act containing language identical to that of the amendment that was passed by the House of Representatives on July 10, 2015. It remains under consideration by the Senate Committee on Health, Education, Labor, and Pensions, but its passage into law remains uncertain. The Barrasso amendment, in contrast, appears well positioned to be attached as is to a “must-pass” omnibus spending bill or to other legislation.
Support for the Barrasso Amendment
Much of organized medicine has lined up behind the Barrasso amendment. Signatories to a recent letter to Senator Barrasso included the American Medical Association (AMA), the American College of Cardiology, the American College of Surgeons, and many other specialty societies and other professional associations, as well as virtually all state medical societies. A similar letter of support was furnished by the CME coalition. Advocates of the amendment have a powerful ally in Sen Barrasso, who, in addition to being an orthopedic surgeon, a former member of the AMA Council of Ethics and Judicial Affairs, and an outspoken opponent of the ACA, serves on the Republican leadership team as chairman of the Senate Republican Policy Committee and as chair of the platform committee of the 2016 Republican National Convention and is a member of several Senate committees.
Opponents of the amendment appear to be limited to consumer advocates and to the National Physicians Alliance. Sen Grassley has not publicly disclosed his position on the bill.
The Barrasso amendment is but one link in a long chain of adjustments to the Physician Payment Sunshine Act, which advocates see as a consumer protection measure against potential conflicts of interest. Sen Herb Kohl (D, WI), who cosponsored the Sunshine Act with Sen Grassley, put it this way: “Large corporations do not typically spend these sums unless they think they will get something out of it.”
Are the drug and device industries getting a return on their annual multimillion dollar investment in medical education? Do the programs funded by industry stay true to their mission of providing unbiased education and research, or do they instead market the industry’s latest products? Some advocates of the amendment argue that the Physician Payment Sunshine Act all but ignored or misunderstood the nature and character of the CME universe and that additional transparency measures are unneeded because potential conflicts of interest already are kept effectively at bay. Whatever the outcome of the Barrasso amendment, it is unlikely to satisfy everyone.
About the author: Eli Y. Adashi, MD, MS, is a professor of Medical Science and the former dean of Medicine and Biological Sciences at the Warren Alpert Medical School of Brown University in Providence, Rhode Island.
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