Here Comes the Sun: Medical Professionalism and the Implications of the Sunshine Act for Gastroenterology Practice

Abstract

The Affordable Care Act, passed in 2010, contained a number of regulations that directly affect physician practices, behavior, and relationships with others in the health care industry. One such provision is the “Physician Payment Sunshine Act,” which is the subject of this month's Practice Management: The Road Ahead column. The authors have provided us with a detailed and enlightening review of how our relationships with pharmaceutical and medical device companies have become transparent and public. It will be important for you to understand this law and take the time to review your own data through CMS's Enterprise Portal (http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Physicians.html).John I. Allen, MD, MBA, AGAFSpecial Section Editor Professionalism has long been a cornerstone of the practice of medicine, dating back to at least the fifth century BC and the origins of the Hippocratic Oath. The modern concept of medical professionalism has been traced back to the work of late 18th century English physician Thomas Percival, who is credited with having developed the first modern code of medical ethics. The American Medical Association’s (AMA) Code of Medical Ethics, first issued in 1847 and recognized as the first national code of ethics propagated for any profession, borrowed extensively from Percival’s Medical Ethics.1Wynia M.K. The short history and tenuous future of medical professionalism: the erosion of medicine’s social contract.Perspect Biol Med. 2008; 51: 565-578Google Scholar In recent years, the concept of medical professionalism has continued to evolve. Although a single comprehensive and universally accepted definition of the term has been elusive, for many, medical professionalism has grown to be seen as something “[m]ore than the adherence to a set of medical ethics.”2ABIM Foundation. What is medical professionalism? Available at: http://www.abimfoundation.org/Professionalism/ Medical-Professionalism.aspx. Accessed June 13, 2014.Google Scholar Rather, it is the “heart and soul of medicine,” the daily expression of the “desire to help people and to help society as a whole by providing quality health care.”2ABIM Foundation. What is medical professionalism? Available at: http://www.abimfoundation.org/Professionalism/ Medical-Professionalism.aspx. Accessed June 13, 2014.Google Scholar Thus, some attempts to develop a normative definition of professionalism in medicine focus on core physician behaviors, with the belief that “the concept of medical professionalism…must be grounded in what physicians actually do and how they act, individually and collectively.”3Swick H.M. Toward a normative definition of medical professionalism.Acad Med. 2000; 75: 612-616Google Scholar Whether defined in terms of a code of medical ethics, a set of core behaviors, or some loftier philosophical precepts, central to the idea of medical professionalism is the belief that the practice of medicine is a quintessentially public service. As noted in the Preamble to the Charter on Medical Professionalism, “[p]rofessionalism is the basis of medicine’s contract with society” and “[e]ssential to this contract is public trust in physicians, which depends on the integrity of both individual physicians and the whole profession.”4ABIM FoundationPreamble to medical professionalism in the new millennium: a physician charter.Ann Intern Med. 2002; 136: 243-246Google Scholar Although the practice of medicine may be considered by many to be a fundamentally public service profession, modern medicine is also undeniably big business. In the United States alone, health care expenditures in 2011 were estimated to have reached $2.7 trillion, or 17.9% of the total US gross domestic product, and currently are projected to reach $4.8 trillion by 2021.5Centers for Medicare and Medicaid Services, Office of the Actuary. National health expenditure projections 2011-2021. Available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/Proj2011PDF.pdf. Accessed June 13, 2014.Google Scholar The potentially corrupting influence of commercial interests on the integrity of the medical profession has long been recognized in the law. For example, the corporate practice of medicine doctrine generally prohibits business corporations in many states from practicing medicine or even employing a physician to provide professional medical services under the rationale that such relationships tend “to the commercialization and debasement of [the medical] profession,”6Barton v Codington Country, 2 NW2d 337, 343 (SD 1942).Google Scholar and is based on the premise that corporate involvement in medical practice undermines the physician–patient relationship and the physician’s exercise of independent medical judgment in the sole interest of the patient.7Garcia v Texas State Board of Medical Examiners, 348 FSupp 435, 437 (WD Tex. 1974).Google Scholar Most attempts to codify standard principles of medical professionalism include provisions addressing the conflicts of interest that are inherent in the financial interactions between physicians and companies involved in the medical industry, such as medical device and pharmaceutical manufacturers. For example, the AMA Code of Medical Ethics explicitly declares, “Under no circumstances may physicians place their own financial interests above the welfare of their patients” and contains a specific provision with a laundry list of rules governing gifts to physicians from industry.8American Medical Association. AMA Code of Medical Ethics, opinions 8.03 and 8.061. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page. Accessed June 13, 2014.Google Scholar Additional provisions specifically govern conflicts of interest in biomedical research and clinical trials, conflicts of interest for physicians who hold financial interests in imaging facilities, and financial incentives and the practice of medicine.9American Medical Association. AMA Code of Medical Ethics, opinions 8.031, 8.0315, 8.045 and 8.054. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page. Accessed June 13, 2014.Google Scholar Similarly, the Charter on Medical Professionalism, jointly developed by American and European internal medicine associations, establishes the “[c]ommitment to maintaining trust by managing conflicts of interest” as one of its 10 core professional responsibilities of physicians, stating the following: “Medical professionals and their organizations have many opportunities to compromise their professional responsibilities by pursuing private gain or personal advantage. Such compromises are especially threatening in the pursuit of personal or organizational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. Physicians have an obligation to recognize, disclose to the general public, and deal with conflicts of interest that arise in the course of their professional duties and activities.”10ABIM FoundationMedical professionalism in the new millennium: a physician charter.Ann Intern Med. 2002; 136: 243-246Google Scholar Physician professional organizations, medical educators, medical student groups, health care providers, and even major health care industry groups and individual companies all have issued guidelines intended to govern the financial interactions between physicians and the health care industry. Clearly, there is recognition of the need to reconcile the often-competing demands of medical professionalism with the enormous financial interests of health care providers and the health care industry. Despite the clear recognition of the importance of health care without financial conflicts of interest, with the exception of a handful of statutes that prohibit certain egregious practices, such as the Anti-Kickback Statute, the False Claims Act, and the Stark law, compliance with the vast majority of existing regulations governing the disclosure and reconciliation of financial conflicts of interest arising from industry payments to physicians are voluntary in nature and carry little or no real penalty. For instance, although the AMA Code of Medical Ethics provides detailed guidelines for a broad array of financial practices, violation of the Code can result in, at worst, expulsion from the AMA. Compliance with voluntary disclosure rules has been shown to be far less than universal. In 2009, researchers that analyzed physician payments reported (as part of a legal settlement) by “five companies that account for nearly 95% of the market for total hip and knee prostheses”11Okike K. Kocher M.S. Wei E. et al.Accuracy of conflict-of-interest disclosures reported by physicians.N Engl J Med. 2009; 361: 1466-1474Google Scholar concluded that a total of 20.7% of directly related payments and 50.0% of indirectly related payments reported by the device manufacturers during the 2007 calendar year were not disclosed by physicians who were subject to conflict-of-interest disclosure regulations as authors of presentations, or as board members or committee members at the 2008 annual meeting of the American Academy of Orthopedic Surgeons. These payments were not insignificant: the 43 directly related payments that were not disclosed totaled $4,320,563, and the 16 indirectly related payments that were not disclosed totaled $7,772,105. However, the consequences of the failure to reconcile financial conflicts of interest can potentially be severe for both patient safety and public trust. For example, in March 2001, the Seattle Times published a lengthy 5-part series examining 2 failed clinical trials at the Fred Hutchinson Cancer Research Center (FHC) in Seattle that occurred from the mid-1980s to the late 1990s and may have led to the deaths of a number of the patients enrolled in these trials.12Wilson D, Heath D. Uninformed consent: what patients at “The Hutch” weren’t told about the experiments in which they died. The Seattle Times. March 11-15, 2001. Available at: http://seattletimes.com/uninformed_consent. Accessed June 13, 2014.Google Scholar Although there were potentially more serious issues involving informed consent and the appropriate disclosure of risks to patients, the articles suggested that the financial interests of the physicians at the FHC who ran the clinical trials—which were not disclosed to patients enrolled in the trials—might have compromised the integrity of the trials and called into question whether the physicians had been motivated to stubbornly continue failed trials at least in part because of the potential financial rewards that the physicians may have reaped had the trials been successful.12Wilson D, Heath D. Uninformed consent: what patients at “The Hutch” weren’t told about the experiments in which they died. The Seattle Times. March 11-15, 2001. Available at: http://seattletimes.com/uninformed_consent. Accessed June 13, 2014.Google Scholar Only the physicians involved can truly say whether or not the undisclosed financial interests played any part in the decisions that led to the deaths of any of the patients in the FHC trials, but the publicity surrounding the failure to disclose those potential financial conflicts of interest certainly makes the story more likely to engender significant harm to the public trust in the health care system. Although a jury eventually found in favor of FHC and the physicians on the issue of informed consent in a lawsuit arising from the clinical trials, comments attributed to the jury foreman were telling and were as follows: “the most compelling argument made by the [patients’] families was that the doctors owned shares of stock in a company whose antibodies they were testing in Protocol 126.”13Heath D, Timmerman L. Jury finds Hutch not negligent in 4 deaths. The Seattle Times. April 9, 2004. Available at: http://seattletimes.com/html/localnews/2001899403_hutchverdict09m.html. Accessed June 13, 2014.Google Scholar The inability of voluntary disclosure mechanisms to properly address issues surrounding financial conflicts of interest is exacerbated by the fact that physicians and patients appear to have very different perceptions as to what kinds of financial considerations have the potential for affecting physician behavior. Studies have shown that physicians and patients consistently rank the acceptability and potential influence of medical industry gifts differently, with patients tending to find gifts of any type or level less appropriate and more influential than physicians.14Gibbons R.V. Landry F.J. Blouch D.L. et al.A comparison of physicians' and patients' attitudes toward pharmaceutical industry gifts.J Gen Intern Med. 1998; 13: 151-154Google Scholar Complicating the issue still further is the fact that financial relationships between industry and physicians are not necessarily ill-intended and often serve important goals, particularly in terms of industry sponsorship and funding of innovative research. Industry–physician partnerships are important generators of medical innovation that should not necessarily be prohibited or even discouraged.15Lewin J. Arend T.E. Industry and the profession of medicine: balancing appropriate relationships with the need for innovation.J Vasc Surg. 2011; 54: 47S-49SGoogle Scholar Recognizing the inadequacy of the voluntary disclosure paradigm, and balancing that concern against the importance of health industry investment in innovation and research, a number of states have introduced laws in recent years mandating disclosure of industry payments to physicians and enacting various marketing limitations to address real and perceived conflicts of interest. Colloquially termed sunshine laws, these regulations largely do not prohibit financial relationships that may give rise to conflicts of interest; rather, they seek to reign in abuses by shining the light of public scrutiny on such transactions. At the federal level, the Physician Payment Sunshine Act (Sunshine Act) was enacted in 2010 as part of the Patient Protection and Affordable Care Act.16Physician Payment Sunshine Act, 42 USC §1320a-7h, et seq.Google Scholar Effective August 1, 2013, the Sunshine Act covers drug and device manufacturers that manufacture at least one product covered by Medicare, Medicaid, or Children's Health Insurance Program, and group purchasing organizations and physician-owned distributors (collectively known as reporting entities). Through the Centers for Medicare and Medicaid Services (CMS) Open Payments program, the Sunshine Act requires these reporting entities to track and report to the CMS “transfers of value” of $10 or more (or transfers of less than $10 if they add up to more than $100 in a calendar year) that the reporting entities provide to all licensed physicians and teaching hospitals. The term transfers of value is used to underscore the idea that payments are reportable even if not in cash or cash equivalents. The range of items that must be reported includes the following: in-kind items or services, stock, consulting fees, compensation for services other than consulting, honoraria, gifts, entertainment, food, travel (including the destination), education, research, charitable contributions, royalties or licenses, current or prospective ownership or investment interest, speaker compensation for continuing medical education events, and grants. Ownership and investment interests in reporting entities held by physicians and members of their immediate family also must be reported. Categories of payments exempted from the reporting requirements include the following: product samples, educational materials, temporarily loaned devices or supplies, discounts, distributions from a publicly traded security or mutual fund, indirect payments (such as travel expenses for speakers) associated with continuing education programs that meet certain accreditation or certification requirements and are not paid directly to the physician, and other types of personal, non–business-related payments. Compliance with data collection and reporting requirements under the Open Payments program is the responsibility of reporting entities. Recipients are not legally required to track or report payments received. However, it may be advisable for physician recipients to maintain at least some record of payments received because they are permitted to review and dispute payment data provided to CMS if they believe the data are inaccurate or miscategorized. Registration for the CMS Open Payments system, which allows physicians to review information submitted about them by reporting entities, began in early June 2014. Penalties for failure to comply with the Sunshine Act can be severe. Reporting entities can be fined $10,000 for each transfer of value that inadvertently is not reported, up to a maximum of $150,000 annually. Knowingly failing to report can result in fines of up to $100,000 per infraction, capped at $1 million annually. Perhaps more importantly, noncompliance also could result in the imposition of a Corporate Integrity Agreement by the Office of the Inspector General and even exclusion from participation in Medicare, Medicaid, or other federal health care programs. Implementation of the Sunshine Act is still in its infancy and its implications, particularly with respect to physician behavior, remain unclear. Although significant reductions in pharmaceutical industry payments to physicians already have been documented in recent years, whether such reductions are a result of industry anticipation of Sunshine Act implementation, or other coincidental factors such as the loss of patent protection for several blockbuster drugs, is not certain.17Sagara E. Doctor payments on the decline. ProPublica. March 11, 2014. Available at: http://projects.propublica.org/graphics/d4d-slopegraph. Accessed June 13, 2014.Google Scholar The Sunshine Act does not newly prohibit any particular payments or financial relationships—it merely requires their disclosure. Moreover, the disclosure burden falls on industry and not on physicians, who are encouraged to review and challenge industry disclosures but are not required to do so. Thus, simple inertia or ignorance of the Sunshine Act possibly could limit its effects on physician behavior. Interestingly, research studies have identified some unintended adverse consequences in the physician–patient context that arise from the disclosure of conflicts of interest. In one study, experiments suggested that physicians required to disclose conflicts of interest may compensate by engaging in either “strategic exaggeration”—providing even more biased advice to counteract an anticipated discounting of such advice by patients to whom a conflict of interest has been disclosed—as well as “strategic restraint”—unjustifiably reining in advice to avoid the perception of bias.18Cain DM, Loewenstein G, Moore DA. When sunlight fails to disinfect: understanding the perverse effects of disclosing conflicts of interest. J Consumer Res. July 7, 2010. Available at: http://www.cmu.edu/dietrich/sds/docs/loewenstein/WhenSunLightFails.pdf. Accessed June 13, 2014.Google Scholar In another study, researchers found that disclosure can serve to increase biased advice owing to moral licensing. By reducing the moral implications of biased advice—the patient, after all, has been warned of the potential for bias—disclosure of a conflict of interest may cause the disclosing physician to provide even more biased advice by assuaging the guilty conscience that might otherwise serve to restrain bias if the conflict were left undisclosed.18Cain DM, Loewenstein G, Moore DA. When sunlight fails to disinfect: understanding the perverse effects of disclosing conflicts of interest. J Consumer Res. July 7, 2010. Available at: http://www.cmu.edu/dietrich/sds/docs/loewenstein/WhenSunLightFails.pdf. Accessed June 13, 2014.Google Scholar Other research conducted in states that already have implemented sunshine laws has suggested that the effect on physician behavior may be minimal. A study of physician prescribing behavior in 2 states with sunshine laws, Maine and West Virginia, found only “negligible to small effects” of disclosure laws on prescription rates for highly substitutable, branded medications within 2 therapeutic classes.19Pham-Kanter G. Alexander G. Nair K. Effect of physician payment disclosure laws on prescribing.Arch Intern Med. 2012; 172: 819-821Google Scholar However, the applicability of this study to the Sunshine Act may be limited because the Maine and West Virginia sunshine laws require only reporting to government agencies and not to the public at large in readily accessible ways. In the end, perhaps the greatest impact of the Sunshine Act may be in its arming of third parties, such as investigative journalists, government agencies, professional societies, and watchdog groups, with comprehensive data to enhance informal oversight and consumer reporting. A preview of the potential for such third-party scrutiny of disclosure data already has played out in recent years because 15 of the largest pharmaceutical companies in the world—representing approximately 43% of prescription drug sales in the US market in 2012—have been disclosing physician payment data since 2009 pursuant to Corporate Integrity Agreements with the federal government resulting from lawsuits for unlawful marketing. In October 2010, the website ProPublica painstakingly combined these individual disclosures and assembled them into a “single, comprehensive database that allows patients to search for their physician or medical center and receive a listing of all payments matching that name.”20Sagara E, Ornstein C, Weber T, et al. Dollars for docs, how industry dollars reach your doctors. ProPublica. March 3, 2014. Available at: http://projects.propublica.org/docdollars. Accessed June 13, 2014.Google Scholar The Association for Medical Ethics has developed a similar database of disclosures of payments to physicians by 4 major medical device manufacturers that were required to make such disclosures as part of a settlement with the Department of Justice to avoid criminal prosecution over financial inducements paid to surgeons.21Association for Medical Ethics. Doctor search database. Available at: http://www.ethicaldoctor.org/doctor-search. Accessed June 13, 2014.Google Scholar Since the introduction of the ProPublica and Association for Medical Ethics databases, numerous news outlets have used the data for articles and exposés on medical industry payments to doctors. For example, on March 25, 2014, an article on the front page of the Boston Globe presented ProPublica’s analysis of payments to a physician and researcher at Tufts Medical Center under the banner title “Doctors Draw Critics for Aid from Drug Firms.”22Ornstein C, Jones R. Doctors draw critics for aid from drug firms. Boston Globe. March 25, 2014. Available at: http://www.bostonglobe.com/metro/2014/03/24/drug-companies-extra-payments-researchers-raise-conflict-interest-concerns/N2xZV00WnLGhaHGH3c07OK/story.html. Accessed June 13, 2014.Google Scholar Although no actual wrongdoing was alleged, it is unimaginable that Tufts Medical Center desired this kind of publicity, which included numerous references to policies of other medical institutions that would prohibit the payments accepted by the Tufts physician. Furthermore, even absent any proof of wrongdoing, the article indicated that the physician still had been placed under a “rigorous management plan to ensure the research is done in a transparent and ethical manner, including meetings…every six months to review his research and any changes in his relationship with industry.”22Ornstein C, Jones R. Doctors draw critics for aid from drug firms. Boston Globe. March 25, 2014. Available at: http://www.bostonglobe.com/metro/2014/03/24/drug-companies-extra-payments-researchers-raise-conflict-interest-concerns/N2xZV00WnLGhaHGH3c07OK/story.html. Accessed June 13, 2014.Google Scholar The Sunshine Act is ushering in a new era of open disclosure of financial transactions between physicians and the medical industry. Ultimately, this kind of public scrutiny (or the fear of such scrutiny) and not express prohibitions, underpins the deterrent effect of sunshine laws. By requiring companies to disclose even modest transfers of value, the Sunshine Act eliminates the discretion previously afforded to physicians under the sometimes hazy concepts of medical professionalism, to decide which financial arrangements with industry might influence their decision making and present a conflict of interest requiring disclosure under existing voluntary guidelines. Whether such mandatory disclosure leads to more open and honest dialogue regarding the influence of corporate largesse on physician behavior or whether it merely leads to unfair prejudice or unwarranted suspicion against physicians that innocently accept payments remains to be seen. One thing, however, is certain: physicians who ignore the implications of the new Sunshine Act requirements do so at their own peril.