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Deciphering the Sunshine Act

Transparency Regulation and Financial Conflicts in Health Care

Published online by Cambridge University Press:  06 January 2021

Richard S. Saver*
Arch T. Allen Distinguished Professor, UNC School of Law; Professor (Secondary Appointment), UNC School of Medicine; Adjunct Professor, UNC Gillings School of Global Public Health.


The Physician Payments Sunshine Act (“Sunshine Act”), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients.

Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.

Copyright © American Society of Law, Medicine and Ethics and Boston University 2017

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This article benefited from helpful comments received by participants at the UNC School of Law Faculty Workshop and a conference at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Special thanks also to MacKenzie Dickerman and Kerry Dutra for excellent research assistance.


1 This Article uses the terms “financial conflicts” and “conflicts of interest” as defined by the Institute of Medicine. A health care provider's primary interests include rendering professional care to patients, engaging in credible, ethical research, and supporting quality medical education. Inst. of Med. of the Nat'l Acads., Conflict of Interest in Medical Research, Education, And Practice 6 (Bernard Lo & Marilyn J. Field, eds., 2009) [hereinafter IOM Conflict of Interest Report]. A “conflict of interest” involves “circumstances that create a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest,” such as financial gain. Id.

2 Chad Terhune, University of California OKs $8.5 Million in Spine Surgery Cases, Kaiser Health News (Aug. 1, 2016), [].

3 Press Release, Manhattan U.S. Attorney Announces $54 Million Settlement Against Salix Pharmaceuticals for Using “Speaker Programs” as Mechanism to Pay Illegal Kickbacks to Doctors to Induce Them to Prescribe Salix Products, U.S. Dep't Just., (June 9, 2016), [].

4 Ctrs. for Medicare & Medicaid Servs., The Facts About Open Payments Data: 2015 & 2016 Totals, [] (detailing about $2.80 billion in general payments and $4.36 billion in research payments for 2016 and $2.68 billion in general payments and $4.45 billion in research payments for 2015). These estimates refer to payment transfers and do not include ownership and investment interests held by physicians and teaching hospitals.

5 See, e.g., Howard Brody, Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry 5 (2007) (“In one sense, medicine's relation to the pharmaceutical industry, and the gifts and rewards that it dispenses, has been likened to an addiction…. [M]edicine has for many decades now been betraying [] public trust in the way that it has accepted various benefits from the pharmaceutical industry.”); Rodwin, Marc A., Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform, 40 J.L. Med. & Ethics 511, 511 (2012)CrossRefGoogle ScholarPubMed (“Physician [economic] relations with pharmaceutical firms are a source of conflicts of interest that can bias their prescriptions and advice.”).

6 IOM Conflict of Interest Report, supra note 1, at 23, 27.

7 See Rosenbaum, Lisa, Understanding Bias—The Case for Careful Study, New Eng. J. Med. 1959, 1959-60 (2015).CrossRefGoogle Scholar

8 See, e g., Fleischman, William et al., Association Between Payments from Manufacturers of Pharmaceuticals to Physicians and Regional Prescribing: Cross Sectional Ecological Study, 354 Brit. Med. J. 1, 4-5, 7 (2016).Google ScholarPubMed

9 See, e.g., Ahn, Rosa et al., Financial Ties of Principal Investigators and Randomized Controlled Trial Outcomes: Cross Sectional Study, 356 Brit. Med. J. 1, 6 (2017).Google Scholar Publication bias refers to the greater likelihood in industry-funded trials that positive outcomes will be published and shared with the medical community, and the lower likelihood that negative trial results will be publicly reported. Id.

10 42 U.S.C. § 1320a-7h (2012).

11 See infra notes 19-20 and accompanying text.

12 See, e.g., Home Mortgage Disclosure (Regulation C), 80 Fed. Reg. 66127 (Oct. 28, 2015) (codified at 12 C.F.R. pt. 1003); The Mixed Blessings of Financial Transparency, 31 Yale J. on Reg. 809 (2014)Google Scholar; Open Internet Transparency Rule, Fed. Comm. Commission, (last updated Sept. 8, 2017) [].

13 See, e.g., Archon Fung et al., Full Disclosure: The Perils and Promises of Transparency 5-7 (2007); Schauer, Frederick, Transparency in Three Dimensions, 2011 U. Ill. L. Rev. 1339, 1347-53 (2011).Google Scholar

14 See, e.g., Hospital Compare,, []; see generally Madison, Kristin, The Law and Policy of Health Care Quality Reporting, 31 Campbell L. Rev. 215 (2009).Google Scholar

15 See, e.g., 10A N.C. Admin. Code 41A.0106 (2016); see also Halpin, Helen A. et al., Mandatory Reporting of Hospital-Acquired Infection Rates: A Report from California, 30 Health Aff. 723, 723 (2011)CrossRefGoogle ScholarPubMed (noting that, in 2011 “thirty-eight states [had] enacted legislation requiring reports of hospital-acquired infection rates.”).

16 I.R.C. § 501(r)(3)(B) (2012).

17 Madison, Kristin, Regulating Health Care Quality in an Information Age, 40 U.C. Davis L. Rev. 1577, 1582-85, 1589-92 (2007)Google Scholar; Sage, William M., Regulating Through Information: Disclosure Laws and American Health Care, 99 Colum. L. Rev. 1701, 1704-07, 1710-11 (1999).CrossRefGoogle ScholarPubMed

18 Rosenthal, Meredith B. & Mello, Michelle M., Sunlight as Disinfectant—New Rules on Disclosure of Industry Payments to Physicians, 368 New Eng. J. Med. 2052, 2053 (2013).CrossRefGoogle Scholar

19 Alison Hwong et al., Putting the Patient at the Center of the Physician Payment Sunshine Act, Health Aff. Blog (June 13, 2012), [].

20 Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458, 9458-59 (Feb. 8, 2013) (codified at 42 C.F.R. pts. 402-03).

21 See generally Nathan Cortez, Regulation by Database, 89 Colo. L. Rev. (forthcoming) (discussing the goals and burdens of “regulation by database” as well as proposing ideas for how policymakers can optimize database disclosures).

22 42 U.S.C. § 1320a-7h(a)(2), (e)(1), (e)(2), (e)(4), (e)(5) (2012).

23 42 U.S.C. § 1320a-7h(a)(1).

24 See Open Payments Data, Ctrs. for Medicare & Medicaid Servs., [].

25 Id.

26 42 U.S.C. § 1320a-7h(e)(10); 42 C.F.R. § 403.904(h) (2015).

27 42 U.S.C. § 1320a-7h(a)(1)(A)(vi); 42 C.F.R. § 403.904(e)(2). The possible general payment categories are consulting fees, compensation for non-consulting services such as speaker fees, honoraria, gifts, entertainment, food and beverage, travel and lodging, education, charitable contributions, royalties and license fees, payments related to ownership and investment interests, speaker/faculty fees for non-accredited educational events, speaker/faculty fees for accredited continuing education programs, grants, and space rental or facility fees. Id.

28 42 U.S.C. § 1320a-7h(b)(1).

29 42 U.S.C. § 1320a-7h(b)(2).

30 42 U.S.C. § 1320a-7i(a)(1).

31 42 U.S.C. § 1320a-7h(e)(10)(B).

32 See, e.g., Form for Disclosure of Potential Conflicts of Interest, Int'l Committee Med. J. Editors,

33 See, e.g., Conflict of Interest (COI), Research Ethics & Compliance U. Mich. (2017), []; Conflict of Commitment and Conflict of Interest Policy, Wake Forest Baptist Med. Ctr., Section IV (2015),

34 See Mass. Gen. Laws ch. 111N, § 6 (2012); Minn. Stat. § 151.47(f) (2011); Vt. Stat. tit. 18, § 4632; see also Chimonas, Susan et al., Show Us the Money: Lessons in Transparency from State Pharmaceutical Marketing Disclosure Laws, 45 Health Servs. Res. 98, 100 (2010)CrossRefGoogle ScholarPubMed; Kesselheim, Aaron et al., Distribution of Industry Payments to Massachusetts Physicians, 368 New Eng. J. Med. 2049, 2049 (2013).CrossRefGoogle Scholar

35 Press Release, Dep't of Justice, Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-Label Promotion of Zyprexa (Jan. 15, 2009), []; Securities and Exchange Commission, Corporate Integrity Agreement between the Office of Inspector General of the Department of Health and Human Services and Eli Lilly and Company (2009) [].

36 42 C.F.R. §§ 50.601-.605 (2011); 45 C.F.R. §§ 94.1-.5 (2011).

37 21 C.F.R. pt. 54.

38 42 U.S.C. § 1320a-7h(a)(1)(A)(vi).

39 For example, Minnesota's sunshine law initially provided only public access to the data on paper, with no aggregate reports made available to the public, while West Virginia's law required disclosure of payments to state regulators but not that this information, in turn, be made readily available to the public. See Chimonas, supra note 34, at 100.

40 See supra notes 12-18 and accompanying text.

41 Cortez, supra note 21, at 55.

42 See Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458, 9466 (codified at 42 C.F.R. pts. 402-03).

43 Id. at 9467.

44 Charles Orenstein, Transparency Program Obscures Pharma Payment to Nurses, Physician Assistants, ProPublica (July 6, 2015), [].

45 Grundy, Quinn et al., Marketing and the Most Trusted Profession: The Invisible Interactions Between Registered Nurses and Industry, 164 Annals Internal Med. 733, 735 (2016).CrossRefGoogle ScholarPubMed

46 Id. at 733.

47 See Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458, 9461-62 (Feb. 8, 2013) (codified at 42 C.F.R. pts. 402-03).

48 Note that manufacturers that try to “pass through” payments to physicians by first paying a distributor, which, in turn, relays the funds to the physician, would still likely have to report such payments as the Sunshine Act does require reporting of indirect payments. See 42 C.F.R. § 403.902 (defining “indirect payments or other transfers of value”). But more sophisticated business models where the cooperating distributor is arguably making the physician payment independently, and not under the control or direction of the manufacturer, would likely not trigger reporting as indirect payments.

49 See Charles Ornstein et al., Data on Payments from Drugmakers to Doctors is Marred by Error, N.Y. Times (Jan. 22, 2015),

50 42 C.F.R. §403.904(c)(8).

51 See Charles Ornstein, 5 Things We Learned from New Database of Payments to Doctors, NPR (Oct. 1, 2014), [] (noting drug Acthar was mentioned in the Open Payments Database under at least eight different name variations).

52 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, 79 Fed. Reg. 67,548, 67,758 (Nov. 13, 2014) (revising the reporting requirements under 42 C.F.R. § 403.904(c)(8)).

53 See, e.g., Charles Ornstein & Ryann Gronchowski Jones, Vying for Market Share, Companies Heavily Promote ‘Me Too’ Drugs, ProPublica (Jan. 7, 2015, 3:00 PM), [].

54 42 C.F.R. § 403.908(g).

55 Santhakumar, Sachin et al., The Physician Payment Sunshine Act: Testing the Value of Transparency, 313 JAMA 23, 23 (2015)CrossRefGoogle ScholarPubMed (noting that only 4.8% of physicians and 29.8% of teaching hospitals engaged in the vetting process for the 2013 Open Payments data).

56 Ed Silverman, What Money? Many Docs Haven't Visited the Open Payments Database, Wall St. J. (Feb. 20, 2015),

57 Elizabeth Richardson, Health Policy Brief: The Physician Payments Sunshine Act, Health Aff. 1, 4 (Oct. 2, 2014), [].

58 Charles Ornstein, Government Will Withhold One-Third of the Records from Database of Physician Payments, ProPublica (Aug. 15, 2014), [].

59 Id.

60 Chimonas, Susan et al., Bringing Transparency to Medicine: Exploring Physicians' Views and Experiences of the Sunshine Act, 17 Am. J. Bioethics 4, 5-7 (2017).CrossRefGoogle ScholarPubMed

61 Richardson, supra note 57, at 6; Julie Treumann, The Sunshine Act: 7 Things You Need to Know, Med. Econ. (Mar. 25, 2013) [].

62 Robert Gatter, Communicating Loyalty: Advocacy and Disclosure of Conflicts in Treatment and Research Relationships, in The Oxford Handbook of U.S. Health Law 261 (2017).

63 See, e.g., Armour, Brian et al., The Effect of Explicit Financial Incentives on Physician Behavior, 161 Archives Internal Med. 1261, 1265-66 (2001)CrossRefGoogle ScholarPubMed; Saver, Richard S., Squandering the Gain: Gainsharing and the Continuing Dilemma of Physician Financial Incentives, 98 Nw. U. L. Rev. 145, 207-10 (2003)Google ScholarPubMed; Taylor, Patrick L., Innovation Incentives or Corrupt Conflicts of Interest? Moving Beyond Jekyll and Hyde in Regulating Biomedical Academic-Industry Relationships, 13 Yale J. Health Pol'y L. & Ethics 135, 154-63 (2013).Google ScholarPubMed

64 42 U.S.C. § 1320a-7h (2010).

65 Sara Reardon, Disclosing Conflicts of Interest Has Unintended Effects, Nature (Oct. 3, 2014), [].

66 See, e.g., Brennan, Troyen A. et al., Health Industry Practices That Create Conflicts of Interest, 295 JAMA 429, 430-32 (2006)CrossRefGoogle ScholarPubMed; Katz, Dana et al., All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving, 10 Am. J. Bioethics 11, 11-14 (2010)CrossRefGoogle ScholarPubMed (“[W]hile it might seem both logical and practicable to distinguish small gifts from larger, seemingly more problematic gifts, a large body of evidence from the social sciences shows that behavior can be influenced by gifts of negligible value.”).

67 See generally Jason Dana, How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine, in IOM Conflict of Interest Report, supra note 1, at app. D 358-74.

68 Perry, Joshua E. et al., Trust and Transparency: Patient Perceptions of Physicians' Financial Relationships with Pharmaceutical Companies, 42 J.L. Med. & Ethics 475, 484-85 (2014).CrossRefGoogle ScholarPubMed

69 Id. at 487.

70 Id.

71 Id.

72 See, e.g., Licurse, Adam et al., The Impact of Disclosing Financial Ties in Research and Clinical Care, 170 Archives Internal Med. 675, 678 tbl.2, 680 (2010)CrossRefGoogle Scholar (presenting data that “suggest[s] that patients find gifts to physicians to be less acceptable when the gifts are large and when they are of a personal, rather than professional, nature.”).

73 See, e.g., Settlement Agreement at ¶ 6, United States v. Reinstein (N.D. Ill. 2015) (No. 15-CR-044); Ctrs. for Medicare & Medicaid Servs., Avoiding Medicare Fraud and Abuse: A Roadmap for Physicians 8 (Aug. 2016),; Press Release, Dept't of Justice, Drug Maker Forest Pleads Guilty to Pay More Than $313 Million to Resolve Criminal Charges and False Claims Act Allegations (Sept. 15, 2010), [].

74 C.f. Perry, supra note 68, at 488 (“Equipped with this finding from our study, industry would have an incentive to lump payment data into the more favorably-viewed ‘consulting’ category.”).

75 42 U.S.C. § 1320a-7h(a)(1)(A)(vi) (2012); 42 C.F.R. § 403.904(e)(2).

76 Swann, James & Alexander, Madi, Drug, Device Co. Payments to Docs Are Transparent, But Do They Explain the Whole Story?, 25 Bloomberg BNA (Aug. 26, 2016), [].Google Scholar

77 Cortez, supra note 21, at 65-66.

78 Shaw, Gina, Open Payments: How is the Information About Industry Payments to Physicians Being Used?, 16 Neurology Today 33, 33 (2016).Google Scholar

79 See Open Payments Data, Ctrs. for Medicare & Medicaid Servs., [].

80 See supra notes 12-18 and accompanying text.

81 Omri Ben-Shahar & Carl E. Schneider, More Than You Wanted to Know: The Failure of Mandated Disclosure 3 (2014).

82 Id. at 175, 178-79.

83 Id. at 145-47.

84 Cain, Daylian M. et al., The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest, 34 J. Legal Stud. 1, 5-6 (2005)CrossRefGoogle Scholar; Ben-Shahar, supra note 81, at 173.

85 See Medicare, Medicaid, Children's Health Insurance Program; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458, 9517 (Feb. 8, 2013) (codified at 42 C.F.R. pts. 402-03).

86 See infra notes 98-100 and accompanying text.

87 Daniel L. Chen et al., Mandatory Disclosure: Theory and Evidence from Industry-Physician Relationships 8 (J. Legal Stud. Working Paper No. 16-716),

88 Id. at 36 (“First, mandatory disclosure increases the average payoff to the paid physicians, because for a given physician effort, the payment to physician increases. Second, the marginally effective physicians drop out and we should observe a drop in small payments.”).

89 IOM Conflict of Interest Report, supra note 1, at 216.

90 Id. at 52-56.

91 Open Payments Data in Context, Ctrs. for Medicare & Medicaid Servs., [] (last modified Nov. 28, 2016).

92 See, e.g., Victor Fiorillo, These 10 Philly Docs Received $12.8 Million From Medical Device and Pharmaceutical Companies Last Year, ProPublica (July 9, 2015), []; Jane Porter, Ten Triangle Doctors Received $8.3 Million From Pharmaceutical and Medical Device Companies Last Year, Indy Week (July 10, 2015), [].

93 Rosenbaum, Lisa, Beyond Moral Outrage—Weighing the Trade-Offs of COI Regulation, 372 New Eng. J. Med. 2064, 2066 (2015).CrossRefGoogle ScholarPubMed

94 Cortez, supra note 21, at 64-72 (“Thoughtful designs will evaluate the optimal format, size, and scope of the database, as well as the target audiences and their potential uses.”).

95 Nathaniel Weixel, Data Collection Starts in August Under Final Physician Payment Sunshine Rule, Bloomberg BNA (Feb. 6, 2013), [].

96 See Ctrs. for Medicare & Medicaid Servs., Annual Report to Congress on the Open Payments Program 2 (2016) (“This public website is designed to increase access to, and knowledge about, healthcare industry financial relationships and provide the public with information to enable them to make informed decisions about their healthcare”); Open Payments Data in Context, supra note 91 (“Open Payments means different things to different people and audiences. For patients, consumers, and the public, Open Payments can be used to learn about the relationships between physicians and applicable manufacturers and GPOs…. For physicians and teaching hospital representatives, reviewing the data reported about you in the Open Payments system can ensure that this information is accurate. You can also[] use the information reported about you to plan for questions from patients.”).

97 According to CMS in its rulemaking commentary, the transparency program “will permit patients to make better informed decisions when choosing health care professionals and making treatment decisions.” Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458, 9520 (Feb. 8, 2013) (to be codified at 42 C.F.R. pts. 402-03).

98 Ctrs. for Medicare & Medicaid Servs., Annual Report to Congress on the Open Payments Program 20 (2016).

99 Id.

101 Pham-Kanter, Genevieve et al., Public Awareness of and Contact with Physicians Who Receive Industry Payments: A National Survey, 32 J. Gen. Internal Med. 767, 770-71 (2017).CrossRefGoogle ScholarPubMed

102 Id. at 770.

103 Id.

104 See Brennan supra note 66; Perry, supra note 68.

105 Sah, Sunita et al., Effect of Physician Disclosure of Specialty Bias on Patient Trust and Treatment Choice, 113 Proc. Nat'l Acad. Sci. 7465, 7468 (2016).CrossRefGoogle ScholarPubMed

106 Loewenstein, George et al., The Unintended Consequences of Conflict of Interest Disclosure, 307 JAMA 669, 670 (2012).CrossRefGoogle ScholarPubMed

107 In one representative study, mailing compensation disclosure letters did not change patient trust in primary care physicians overall, but patients receiving the disclosure had more confidence in their ability to judge the possible influence of financial incentives on their health care. Pearson, Steven D. et al., A Trial of Disclosing Physicians' Financial Incentives to Patients, 166 Archives Internal Med. 623, 623 (2006)CrossRefGoogle ScholarPubMed. Among patients remembering receiving the letters, 21-24% reported that the disclosure increased trust, and less than 5% reported that it decreased trust. Id. Further, loyalty to their physician group was higher among the disclosure patients. Id.

108 Loewenstein, George et al., The Limits of Transparency: Pitfalls and Potential of Disclosing Conflicts of Interest, 101 Am. Econ. Rev. 423, 424 (2011).CrossRefGoogle Scholar

109 Khan, Mustafa H. et al., The Surgeon as Consultant for Medical Device Manufacturers: What Do Our Patients Think? 32 Spine 2616, 2616 (2007)CrossRefGoogle Scholar (finding that 72.7% of patients wanted to know if the device being recommended by their physician was actually designed by him or her).

110 Id.; see also Lieberman, Jay R. et al., Disclosure of Financial Conflicts of Interest: An Evaluation of Orthopaedic Surgery Patients' Understanding, 471 Clinical Orthopaedics & Related Research 472, 472 (2013)CrossRefGoogle ScholarPubMed (only 15% of patients reported that disclosure of the surgeon's financial conflicts would make them less likely to have the surgeon operate on them).

111 Hampson, Lindsay A. et al., Patients' Views on Financial Conflicts of Interest in Clinical Trials, 355 New Eng. J. Med. 2330, 2330 (2006).CrossRefGoogle Scholar

112 Grady, Christine et al., The Limits of Disclosure: What Research Subjects Want to Know About Investigator Financial Interests, 34 J.L. Med. & Ethics 592, 592 (2006)CrossRefGoogle ScholarPubMed; Weinfurt, Kevin P. et al., Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research, 23 J. Gen. Internal Med. 860, 860 (2008).CrossRefGoogle ScholarPubMed

113 Licurse, supra note 72, at 680.

114 See, e.g., Weinfurt, Kevin P. et al., Effects of Disclosing Financial Interests on Participation in Medical Research: A Randomized Vignette Trial, 154 Am. Heart J. 689, 689 (2008)CrossRefGoogle Scholar; see also Spece, Roy et al., An Empirical Method for Materiality: Would Conflict of Interest Disclosures Change Patient Decisions?, 40 Am. J.L. & Med. 253 (2014).Google ScholarPubMed

115 See Pham-Kanter et al., supra notes 102-03 and accompanying text.

116 See generally Hall, Mark, Trust, Law, and Medicine, 55 Stan. L. Rev. 463 (2002)CrossRefGoogle Scholar (suggesting that “[p]atients' faith in their doctors is based not only on a patients' knowledge of their doctors' personal characteristics, but also on patients' preexisting concepts of the archetypal physician.”).

117 Pham-Kanter, Genevieve, Act II of the Sunshine Act, 11 PLOS Med. 1, 2 (Nov. 2014).CrossRefGoogle ScholarPubMed

118 Oaks, Michael et al., How Should Doctors Disclose Conflicts of Interest to Patients? A Focus Group investigation, 98 Minn. Med. 38, 40-41 (Jan. 2015).Google Scholar

119 See infra notes 129-31 and accompanying text.

120 Silverman, supra note 56, at 1.

121 Chimonas, supra note 60, at 7-9.

122 Pham-Kanter, Genevieve, Effect of Physician Payment Disclosure Laws on Prescribing, 172 Archives Internal Med. 819, 819-20 (2012).CrossRefGoogle ScholarPubMed

123 Id.

124 Rosenthal, supra note 18, at 2053.

125 Tong Guo et al., Let the Sun Shine in: The Impact of Industry Payment Disclosure on Physician Prescription Behavior, Soc. Sci. Res, Network 1, 1-2 (April 18, 2017), [].

126 Id. at 1

127 Id. at 2-3.

128 Id. at 22.

129 Loewenstein, supra note 106, at 669.

130 Id.

131 Id.; Sah, Sunita, Conflicts of Interest and Your Physician: Psychological Processes That Cause Unexpected Changes in Behavior, 40 J.L. Med. & Ethics 482, 485 (2012).CrossRefGoogle ScholarPubMed

132 See generally Sah, Sunita & Loewenstein, George, Nothing to Declare: Mandatory and Voluntary Disclosure Leads Advisors to Avoid Conflicts of Interest, 25 Psychol. Sci. 575 (2014).CrossRefGoogle ScholarPubMed

133 Sah & Lowenstein, supra note 132, at 582.

134 Cortez, supra note 21, at 69.

135 See Sage, supra note 17, at 1736-37.

136 Rosenthal, supra note 18, at 2054.

137 C.f. Rosenthal, supra note 18, at 2053 (“Overall, it seems unlikely that the mere existence of a payment-information repository will lead many patients or physicians to alter their behavior. Active use of the payment data by one or more expert intermediaries, however, could make a big difference, doing what patients cannot (or will not) do and raising the stakes for physicians.”).

138 See infra Part V. E.

139 One important caveat is that it is not possible to make apples to apples comparisons of what earlier disclosure programs, such as the few state sunshine laws, identified and the data accrued under the Sunshine Act because of the Sunshine Act's broader scope and differences in the way payments are categorized.

140 Campbell, Eric G. et al., A National Survey of Physician-Industry Relationships, 356 New Eng. J. Med. 1742, 1742 (2007).CrossRefGoogle ScholarPubMed

141 See Kesselheim, supra note 34, at 2049 (citing surveys that indicate about 83% of physicians received industry gifts in 2004 and about 71% in 2009).

142 See, e.g., Rothman, David J. et al., Professional Medical Associations and Their Relationships with Industry: A Proposal for Controlling Conflicts of Interest, 301 JAMA 1367, 1367-68 (2009).CrossRefGoogle Scholar

143 See Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458, 9515 (Feb. 8, 2013) (to be codified at 42 C.F.R. pts. 402-03).

144 Pham-Kanter, supra note 101, at 767.

145 Tringale, Kathryn R. et al., Types and Distributions of Payments from Industry to Physicians in 2015, 317 JAMA 1774, 1780 (2017).CrossRefGoogle Scholar

146 The Open Payments Database contains only five months of reported data for 2013. As for full year comparisons, for 2014 the Open Payments Database shows $2.68 billion in general payments, $4.07 billion in research payments, with a combined total of $6.75 billion. For 2015, there were $2.68 billion in general payments, $4.45 billion in research payments, with a combined total of $7.13 billion. For 2016, there were $2.80 billion in general payments, $4.36 billion in research payments, with a combined total of $7.16 billion. These estimates refer to payment transfers and do not include ownership or investment interests held by the physicians and teaching hospitals. See The Facts on Open Payments, Summary Data, Ctrs. for Medicare & Medicaid Servs., [].

147 Sinha, Michael S. & Kesselheim, Aaron S., The Effects of the Sunshine Act: What Can and Should We Expect?, 17 Am. J. Bioethics 22, 22 (2017).CrossRefGoogle ScholarPubMed

148 Pham-Kanter, supra note 101, at 768.

149 Id.

150 Id. at 767.

151 Tringale, supra note 145, at 1779 tbl.4.

152 Id.

153 Id.

154 Marshall, Deborah C. et al., Disclosure of Industry Payments to Physicians: An Epidemiologic Analysis of Early Data from the Open Payments Program, 91 Mayo Clinic Proc. 84, 88 tbl.2 (2016).CrossRefGoogle ScholarPubMed

155 See, e.g., Heidi Ledford, Industry Ties Remain Rife on Panels for Psychiatry Manual, Nature (Mar. 13, 2012), [].

156 Tringale, supra note 145, at1780.

157 See Gardiner Harris, Top Psychiatrist Didn't Report Drug Makers' Pay, N.Y. Times (Oct. 3, 2008),

158 Marshall, supra note 154, at 88.

159 Id.; Samuel, Andre M. et al., Orthopaedic Surgeons Receive the Most Industry Payments to Physicians but Large Disparities Are Seen in Sunshine Act Data, 473 Clinical Orthopaedics & Related Res. 3297, 3300 (2015)CrossRefGoogle ScholarPubMed (royalty and license fees account for 69% of all industry payments to orthopedic surgeons according to 2013 Sunshine Act data).

160 Marshall, supra note 154, at 88.

161 Id.

162 Id.

163 Id.

164 Tringale, supra note 145, at 1780.

165 Samuel, supra note 159, at 3301.

166 Marshall, supra note 154, at 88.

167 Id.

168 See generally Brody, supra note 5.

169 Kesselheim, supra note 34, at 2051.

170 See, e.g., Iyer, Sravisht et al., Orthopaedics and the Physician Payments Sunshine Act, 98 J. Bone & Joint Surgery e18(1), e18(8) (2016)CrossRefGoogle Scholar (noting the “unique interaction between orthopedic surgery and industry” with regard to the degree of surgeon involvement in new device development compared to other clinical fields).

171 See, e.g., Surgeons for Sale, Conflicts and Consultant Payment in the Medical Device Industry: Hearing Before the S. Spec. Comm. Aging, 10th Cong., 2d Sess., (Feb. 27, 2008); Gelberman, Richard H., Orthopedic Surgeons and the Medical Device Industry: The Threat to Scientific Integrity and the Public Trust, 92 J. Bone & Joint Surgery 765 (2010).CrossRefGoogle Scholar

172 Marshall, supra note 154, at 88 tbl.2, 92. One exception to this trend, for example, is plastic surgery, a high interventionist field where the prevalence rate (37%) of physicians having any form of reported financial ties is relatively low. Id. at 88 tbl.2; see also Tringale, supra note 145, at 1777 (analyzing 2015 Sunshine Act data and finding that interventionalist physicians received the highest median number and value of payments per physician among all physician groups).

173 Tringale, supra note 145, at 1779.

174 Id.

175 Id.

176 Charles Ornstein, Men Dominate List of Doctors Receiving Largest Payments from Drug Companies, N.Y. Times (Oct. 8, 2014),

177 Deborah C. Marshall et al., Distribution and Patterns of Industry-Related Payments to Oncologists in 2014, J. Nat'l Cancer Inst., Dec. 2016, at 1, 4, 9.

178 Susannah Rose, Gender Differences in Physicians' Financial Ties to Industry: A Study of National Disclosure, PLOS One, June 11, 2015, at 1, 8.

179 Tringale, supra note 145, at 1781.

180 Catherine Saint Louis, Dr. Paid-Less: An Old Title Still Fits Female Physicians, N.Y. Times (July 11, 2016.),

181 Rose, supra note 178, at 8.

182 Id.

183 Cvetanovich, Gregory et al., Industry Financial Relationships in Orthopaedic Surgery, 97 J. Bone & Joint Surgery 1288, 1293-94 (2015).CrossRefGoogle ScholarPubMed

184 Id.

185 Rathi, Vinay K. et al., Industry Ties in Otolaryngology: Initial Insights from the Physician Payments Sunshine Act, 152 Otolaryngology—Head & Neck Surgery 993, 993 (2015).CrossRefGoogle Scholar

186 Tierney, Nicole M. et al., Industry Payments to Obstetrician-Gynecologists, 127 Obstetrics & Gynecology 376, 379 (2016).CrossRefGoogle ScholarPubMed

187 Samuel, Andre M. et al., Orthopedic Surgeons Receive the Most Industry Payments to Physicians but Large Disparities Are Seen in Sunshine Act Data, 47 Clinical Orthopaedics & Related Res. 3297, 3301 fig.3 (2015).CrossRefGoogle Scholar

188 Id.

189 C.f. Gelberman, supra note 171, at 773.

190 See, e.g., Madison, Kristin, Health Care Quality Reporting: A Failed Form of Mandated Disclosure?, 13 Ind. Health L. Rev. 310, 330-33 (2016).CrossRefGoogle Scholar

191 Rosenthal, supra note 18, at 2054.

192 Me. Stat. tit. 32, § 13759.

193 Id.

194 Katie Lannan, More Doctors Log on to Prescription Monitoring Program, (Nov. 27, 2016), [].

195 Joe Lawlor, Speakers at Hearing Support Limiting Drug Company Gifts to Maine Doctors, Portland Press Herald (April 11, 2017), [].

196 Joe Lawlor, Even Amid Crisis, Opioid Doctors Plied Doctors with Perks, Maine Sunday Telegram (December 25, 2016), [].

197 C.f. Gelberman, supra note 171, at 773.

198 See Lo, Bernard & Grady, Deborah, Payments to Physicians: Does the Amount of Money Make a Difference?, 317 JAMA 1719, 1719 (2017).CrossRefGoogle Scholar

199 See infra notes 209-16 and accompanying text.

200 Medicare Provider Utilization and Payment Data: Physician and Other Supplier, Ctrs. for Medicare & Medicaid Servs., [].

201 Medicare Provider and Utilization and Payment Data: Part D Prescriber, Ctrs. For Medicare & Medicaid Servs., [].

202 Marshall, supra note 154, at 93.

203 See, e g., DeJong, Colette et al., Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries, 176 JAMA Internal Med. 1114, 1114 (2016)CrossRefGoogle Scholar; Fleischman, supra note 8, at 1; Taylor, Stanford C. et al., Physician-Industry Interactions and Anti-Vascular Endothelial Growth Factor Use Among US Ophthalmologists, 134 JAMA Ophthalmology 897, 897 (2016).CrossRefGoogle ScholarPubMed

204 Roy H. Perlis & Clifford S. Perlis, Physician Payments from Industry Are Associated with Greater Medicare Part D Prescribing Costs, PLoS One, May 16, 2016, at 1, 4-5.

205 Id. at 6.

206 Id. at 7.

207 42 U.S.C. § 1320a-7h(a)(1)(A)(vii) (2010).

208 Ornstein & Jones, supra note 53.

209 42 U.S.C. § 1320a-7b (2015).

210 31 U.S.C. §§ 3729-33 (2009).

211 42 U.S.C. § 1395nn (2010).

212 See generally Brian A. Dahl, Mining Open Payments Spend Data: Managing the Risk of Transparency, Corp. Compliance Insights (Mar. 15, 2016), [] (“One company in particular – Insys Therapeutics, Inc. – has already witnessed the mining of its Open Payments data firsthand.”).

213 Subsys Highlights of Prescribing Information, FDA (2016),

214 Katie Thomas, Former Insys Officials Charged in Scheme to Push its Painkiller, N.Y. Times (Dec. 8, 2016),

215 Liz Szabo, Drug Salesmen Arrested for Paying Doctors to Prescribe Fentanyl, USA Today (June 15, 2016, 9:45 AM), [].

216 Roddy Boyd, The Black World of Insys Therapeutics, S. Investigative Reporting Found. (July 14, 2015), []; Katie Thomas, Using Doctors with a Troubled Past to Market a Painkiller, N.Y. Times (Nov. 27, 2014)

217 Press Release, Or. Dep't of Justice, AG Rosenblum Settles with Pharmaceutical Company Insys over Unlawful Promotion of the Powerful Opioid Subsys (Aug. 5, 2015), [].

218 Jennifer Chambers, Oakland Co. Doc with Rare Coin Collection Pleads Guilty, Detroit News, (Nov. 17, 2016, 4:50 PM), []; see also Lindsay Knake, Michigan Neurologist Under Federal Medicare Fraud Investigation, MLive (May 8, 2014), [].

219 Thomas, supra note 214.

220 Investor Alert: Class Action Lawsuit Against Insys Therapeutics, Bus. Wire (May 20, 2014, 10:32 AM), [].

221 See Amended Class Action Complaint at ¶ 58-59, Larson v. Insys Therapeutics, Inc., No 2:14-cv-01043-GMS (D. Ariz. Oct. 27, 2014), ECF No. 41.

222 Claims Administrator Angeion Group Announces Proposed Settlement in Insys Therapeutics Class Action, PR Newswire (July 8, 2015, 8:00 PM), [].

223 Consolidated Verified Derivative Complaint at ¶ 106-111, In re Insys Therapeutics Inc. Derivative Litigation, No. 12696-VCMR, (Del. Ch. Ct. 2016.), 2017 WL 1807183.

224 Id. at ¶ 133.

225 Amended Consolidated Class Action Complaint, Schaffer v. Horizon Pharma PLC, No. 1:16-cv-01763 (S.D.N.Y. 2016), ECF No. 103.

226 Id. at 2-3.

227 Andrew Pollack, Drug Makers Sidestep Barriers on Pricing, N.Y. Times (Oct. 19, 2015),

228 Id.

229 Amended Complaint, supra note 225, at ¶ 104-110.

230 Id. at ¶ 106, 107, 368.

231 Id. at ¶ 106.

232 Sears v. Bristol-Myers Squibb Co., No. 1:16-cv-00065-LJO-BAM (E.D. Cal. 2016).

233 Id.

234 Complaint at ¶ 76, Sears v. Bristol-Myers Squibb Co., No. 1:16-cv-00065-CJO-BAM (E.D. Cal. 2016). This information comes from ProPublica's Dollars for Docs database, which in turn is based on information from the Open Payments Database. See infra notes 242-44 and accompanying text.

235 In re Abilify (Aripiprazole) Prods. Liab. Litig., 232 F. Supp. 3d 1342 (U.S. Jud. Pan. Mult. Lit. 2016).

236 Roberge v. Janssen Pharmaceuticals, No. 3:17-cv-01619 (D. N.J. 2017).

237 Complaint, Roberge v. Janssen Pharmaceuticals, No. 3:17-CV01619 (D. N.J. 2017).

238 Id. at ¶ 30(c). The complaint specifically references information from ProPublica's Dollars for Docs database, a database which includes information obtained from the Open Payments database. See infra notes 242-44 and accompanying text.

239 31 U.S.C. § 3729-33 (2009).

240 First Amended Complaint at ¶ 136, United States v. Medtronic, No. 2:15-cv-01212 (C.D. Cal. 2015).

241 Class Action Complaint at ¶ 406, Third Amended Class Action Complaint at ¶ 747, 999, 1036, Medical Mutual of Ohio v. AbbVie Inc., No. 1;14CV08857 (N.D. Ill. 2014) (relying upon both Dollars for Docs and Open Payments Database information).

242 See Charles Ornstein et al., Dollars for Docs: How Industry Dollars Reach Your Doctors, ProPublica (Dec. 13, 2016), [].

243 Charles Ornstein et al., Now There's Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds, ProPublica (Mar. 17, 2016), [].

244 Id.

245 See Scott, James G. & Avots-Avotins, Andrejs E., Aligning Your Health System's Conflict of Interest Policies with the Physician Payment Sunshine Act, 28 J. Contemp. Health L. & Pol'y 39, 40-41 (2011).Google ScholarPubMed

246 See id.

247 See id.

248 Mitchell, Aaron P. et al., Financial Relationships with Industry Among National Comprehensive Cancer Network Guideline Authors, 2 JAMA Oncology 1628, 1628 (2016).CrossRefGoogle ScholarPubMed NCCN officials responded that the Open Payments Database contains inaccuracies. They also claimed that their conflict rules were not meant to count research payments as conflicting interests. Adjusting for these factors, they argued that only less than 1% of guideline panelists had financial relationships in excess of NCCN's conflict of interest rules. See Carlson, Robert W. & McClure, Joan S., Comment & Response: Financial Relationships with Industry Among National Comprehensive Cancer Network Guideline Authors, 2 JAMA Oncology 1660, 1660 (2016).CrossRefGoogle Scholar

249 Thompson, Jennifer C. et al., Sunshine Act: Shedding Light on Inaccurate Disclosures at a Gynecological Annual Meeting, 215 Am. J. Obstetrics & Gynecology 661.e1, 661.e1 (2016).CrossRefGoogle Scholar

250 Id. at 661.e4-661.e5.

251 Id. at 661.e1.

252 Cortez, supra note 21, at 69.