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Efficient Prosecution of False Claims Act Violations May Help Relieve The Current Opioid Crisis

Published online by Cambridge University Press:  06 January 2021

Victor Absil
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American Journal of Law & Medicine , Volume 45 , Issue 2-3 , May 2019 , pp. 253 - 272
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Copyright © American Society of Law, Medicine and Ethics and Boston University 2019

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References

1 See generally Tetrault, Jeanette M & Butner, Jenna L, Non-Medical Prescription Opioid Use and Prescription Opioid Use Disorder: A Review., 88 Yale J. Biol. Med. 227, 227–33 (2015)Google ScholarPubMed.

2 Id.

3 Peterson, Allison et al., State Legislative Responses to the Opioid Crisis: Leading Examples, 11 J. of Health & Life Sci. 1, 2 (2018)Google Scholar.

4 The Executive Office of the President, The Underestimated Costs of the Opioid Crisis, 2–3 (2017), https://www.whitehouse.gov/sites/whitehouse.gov/files/images/ The Underestimated Cost of the Opioid Crisis.pdf.

5 Sarpatwari, Ameet, Sinha, Michael S. & Kesselheim, Aaron S., The Opioid Epidemic: Fixing a Broken Pharmaceutical Market, 11 Harvard L. Pol'y Rev. 463, 463 (2017)Google Scholar.

6 See Davis, Corey S., The Law and Policy of Opioids for Pain Management, Addiction Treatment, and Overdose Reversal, 1 Ind. Heal. L. Rev 1, 1-22 (2017).Google Scholar

7 See George Monbiot, Neoliberalism is Creating Loneliness: That's What's Wrenching Society Apart, The Guardian (Oct. 12. 2016) https://www.theguardian.com/commentisfree/2016/oct/12/neoliberalism-creating-loneliness-wrenching-society-apart. [https://perma.cc/82LG-KT2S].; see also Thaler, Richard and Sunstein, Cass, Libertarian Paternalism Is Not an Oxymoron, 70 U. Chicago L. Rev. 1159,1159-1202 (2003)Google Scholar (authors argue that individuals' opreferences and choices are influenced by default rules, framing effects, and starting points. I posit that these three circumstances are themselves influenced by ontological assumptions).

8 See id.

9 See generally Michel Foucault, History of Madness (Jean Khalfa, 1st ed. 2009).

10 Tullio Giraldi, Unhappiness, sadness and ‘Depression: Antidepressants and the Mental Disorder Epidemic 165–186 (Palgrave Macmillan, 2017)Google Scholar.

11 See id; See also Davis, supra note 6, at 13-15 (discussing how several indications treated with prescriptions, lack evidence of the prescription's effectiveness over alternative treatment methods).

12 See id. (generally discussing the over-prescription of opioids as well as barriers to access treatment).

13 Id.

14 Id. at 15 (citing Open Soc'y Inst., Barriers to Access: Medication-Assisted Treatment and Injection-Driven HIV Epidemics 1 (2009), https://www.opensocietyfoundations.org [https://perma.cc/YF94-88AP] (internal citation omitted).

15 Id.

16 Id.

17 Id.

18 Id.

19 Peterson et al., supra note 3, at 35.

20 Id.

21 Davis, supra note 6.

22 Id.

23 Id.

24 See id.

25 See id.

26 See id.

27 See Peterson et al., supra note 3, at 35.

28 See id.

29 Davis, Corey S. & Carr, Derek, Physician continuing education to reduce opioid misuse, abuse, and overdose: Many opportunities, few requirements, 163 Elsevier 100, 107 (2016)Google ScholarPubMed; Sarpatwari, Sinha, and Kesselheim, supra note 5, at 464.

30 Tetrault, Jeanette M & Butner, Jenna L, Non-Medical Prescription Opioid Use and Prescription Opioid Use Disorder: A Review., 88 Yale J. Biol. Med. 227, 227-233 (2015)Google ScholarPubMed, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4553642/ [https://perma.cc/5Y9S-Z6NQ].

31 Dineen, Kelly K. & DuBois, James M., Between a rock and a hard place: Can physicians prescribe opioids to treat pain adequately while avoiding legal sanction?, 42 Am. J. Law Med. 7, 8-10 (2016)CrossRefGoogle Scholar.

32 Davis and Carr, supra note 29, at 100.

33 Id.

34 Sarpatwari, Sinha, and Kesselheim, supra note 5, at 465-466.

35 Id. at 468.

36 Davis and Carr, supra note 29, at 104.

37 Id. at 101.

38 Dineen and DuBois, supra note 31, at 92-100.

39 U.S. Dep. Of Health and Human Services Office of Inspector General, State False Claims Act Reviews, https://oig.hhs.gov/fraud/state-false-claims-act-reviews/ [https://perma.cc/DJY5-NMXH].

40 Gilson, Aaron M. & Kreis, Paul G., The burden of the nonmedical use of prescription opioid analgesics, 10 Pain Med. S89, S95 (2009)CrossRefGoogle ScholarPubMed.

41 The Council of Economic Advisers, supra note 4 at 1.

42 Monty Wilkinson et al., Healthcare Fraud 2016, United States Atty. Bull., 7, 7-8 (2016).

43 Id. at 72.

44 Prohibited acts, 21 U.S.C. §331 (2011).

45 See U.S. Food and Drug Administration, How Did The Federal Food, Drug and Cosmetic Act Come About? (2017), https://www.fda.gov/AboutFDA/Transparency/Basics/ucm214416.htm (Congress enacted the FDCA in response to an untested pharmaceutical killing patients and children).

46 Press Release, Department of Justice, Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing, (Apr. 27, 2010).

47 Jr.Helmer, James and Neff, Robert Clark, War Stories: A History of the Qui Tam Provisions of the False Claims Act, The 1986 Amendments to the False Claims Act, and Their Application, 18 Ohio North. Univ. Law Rev. 35, 35 (1991)Google Scholar.

48 See id.

49 See id.

50 Id. at 36.

51 See id. at 35-36.

52 Rose, , Appreciating the Impact of Universal Health Servs. Inc. v. United States ex rel. Escobar in False Claims Act Actions, 63 Fed. Lawyer 43, 43–45 (2016)Google Scholar.

53 See Helmer, James and Robert Clark Neff, supra note 47.

54 See id. at 38.

55 Rice, , False Claims Act Puts Health Care Providers at Risk, 32 State J. 1, 1–3 (2016)Google Scholar.

56 Rose, supra note 52.

57 Thomas Sullivan (Policy and Medicine), CMS-FDA Breast Cancer and Avastin: FDA Pulls Approval While CMS Pays, Policy Med. (2011), http://www.policymed.com/2011/12/cms-fda-breast-cancer-and-avastinfda-pulls-approval-while-cms-pays.html [https://perma.cc/6JU2-DA8X].

58 See generally AstraZeneca, supra note 46.

59 Id.

60 Rice, supra note 55.

61 False claims, 31 U.S.C. 3729(a)(1)(A)-(B)(2009).

62 False claims, 31 U.S.C. 3729(a)(1)(G)(2009).

63 False claims, 31 U.S.C. 3729(b)(1)((2009).

64 See Universal Health Services v. U.S. ex rel. Escobar, 579 US 1, 14 (2016)Google Scholar.

65 See id. at 11.

66 See id. at 11.

67 See id. at 12.

68 John W. Nisbett, The Three-Headed Monster of Healthcare Fraud Enforcement: The False Claims Act, Stark Law, and the Anti-Kickback Statute, American Bar Association (Aug. 1, 2015), https://www.americanbar.org/groups/young_lawyers/publications/tyl/topics/health-law/three-headed-monster-healthcare-fraud-enforcement-false-claims-act-stark-law-anti-kickback-statute.html [https://perma.cc/9VAB-NPBE].

69 See Universal Health Services v. U.S. ex rel. Escobar, 579 US 1, 14 (2016)Google Scholar.

70 Id.

71 See 31 U.S.C. §3729(b)(4)(2009).

72 See Universal Health Services v. U.S. ex rel. Escobar, 579 US 1, 16 (2016)Google Scholar.

73 Id.

74 Id.

75 See 42 U.S.C.A. 1396r-8(k)(3)(2019).

76 See generally supra note 42 (describing how proof of materialtiy hinges on CMS's payment decision).

77 False claims, 31 U.S.C. 3729(a)(1)(A), (B)(2009); Prohibited acts, supra note 44.

78 42 U.S.C.A. 1396r-8(k)(3)(2019).

79 42 U.S.C.A. 1396r-8(k)(6)(2019); see also 42 U.S.C.A. 1396r-8(g)(1)(B) (Medical researchers and other professionals submit data on drug use to statutorily designated compendia which is assessed using predetermined standards).

80 See id.

81 See Lammers, Austin et al., Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals, 7 Blood Cancer J. 637 (2017)CrossRefGoogle ScholarPubMed; see also, U.S. Food & Drug Administration, Development & Approval Process, https://www.fda.gov/drugs/developmentapprovalprocess/ (last visited April 12, 2018) [https://perma.cc/9LVX-ANDE].

82 See Elizabeth Richardson, Off-Label Drug Promotion, Health Affairs (June 30, 2016), https://www.healthaffairs.org/do/10.1377/hpb20160630.920075/full/ [https://perma.cc/KQJ5-AVK3]; see also Press Release, U.S. Dep't of Justice, Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations (Nov. 4, 2013), https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations [https://perma.cc/EHR9-C9PS].

83 See 42 U.S.C.A. 1396r-8(k)(6)(2019).

84 Id.

85 See 42 U.S.C.A. 1396r-8(k)(3)(2019).

86 See Youtt, M., Thomas, V., Robison, A., False Claims Act Actions—The Developing Case Law Regarding If And When Opinions Of Medical Necesssity Can Be Fraudulent, 27 Health Law 36, 36-43 (2015)Google Scholar (FCA liability is not limited to promoting off label uses. Physicians may be liable for a FCA violation if they submit a claim for a medically unnecessary prescription, when the physician knew the drug was not medically indicated. However, when physicians may reasonably disagree on a good faith medical opinion regarding medical necessity, the resulting prescription typically will not give rise to liability. Fraudulent conduct under the FCA requires that the physician meet the minimum mens rea of deliberate ignorance or reckless disregard).

87 See Tetrault and Butner, supra note 1 at 228-229.

88 See Monty Wilkinson et al., Healthcare Fraud 2016, United States Atty. Bull., 7, 7-16 (2016).

89 See Prohibited acts, supra note 44.

90 See id; see also, Tetrault and Butner, supra note 1 at 228-229.; see also, Gilson and Kreis, supra note 40 at S89.

91 See Amity Doolittle, Tragedy of the Commons, Oxford Bibliographies, (June 6, 2017), https://www.oxfordbibliographies.com/view/document/obo-9780199830060/obo-9780199830060-0116.xml [https://perma.cc/Z4U9-JATC].

92 DiClemente, Salazar, Crosby, Health Behavior Theory for Public Health 232-242 (Jones & Bartlett Learning) (2013).

93 See id.

94 See Sismondo, Sergio, Key Opinion Leaders and the Corruption of Medical Knowledge: What the Sunshine Act Will nd Won't Cast Light On, 41 J. L. Med. & Ethics 635, 640 (2013)CrossRefGoogle Scholar.; see also How Did The Federal Food, Drug and Cosmetic Act Come About? supra note 45 (describing the purpose of FDA approval).

95 See Universal Health Services v. U.S. ex rel. Escobar, 579 US 1, 14 (2016)Google Scholar.; see also, False claims, 31 U.S.C. 3729. (the FCA imposes liability for causing a false claim to submitted).

96 See U.S. Food & Drug Administration, Development & Approval Process, https://www.fda.gov/drugs/developmentapprovalprocess/ (last visited Aug. 1. 2019) [https://perma.cc/MKH5-N5DL].

97 See False claims, supra note 61.

98 42 U.S.C.A. 1396r-8(k)(6)(2019).

99 42 U.S.C.A. 1396r-8(e)(4)(C)(2019).

100 See Brown, , Gain a solid understanding of compendia and its impact on patient access., 47 Formulary 1, 1–8 (2012)Google Scholar; see also U.S. Food & Drug Administration, Development & Approval Process (Drugs), https://www.fda.gov/drugs/developmentapprovalprocess/ (last visited April 13, 2018) [https://perma.cc/V8RR-R8PJ].

101 See John E. Osborn, Can I Tell You the Tuth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, Yale J. Health Pol. L. & Ethics 299, 356 (2010) (Describing the uncertainty facing manufacturers in promoting off-label uses and how it leads to increased settlements).

102 42 U.S.C.A. 1396r-8(g)(1)(B)(ii)

103 AstraZeneca, supra note 46.

104 See generally Lammers, Austin et al., Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals, 7 Blood Cancer J. 637 (2017)CrossRefGoogle ScholarPubMed; see also Off-Label Drug Promotion, supra note 82.

105 Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices, Food and Drug Admin. 1, 2-3 (2014), https://www.fda.gov/downloads/drugs/%20guidancecomplianceregulatoryinformation/guidances/ucm387652.pdf.

106 Id. at 7.

107 Id. at 7-10.

108 Id. at 8.

109 See generally Austin Lammers et. al. supra note 104; see also, Miller, Francis, Trusting Doctors: Tricky Business When It Comes to Clinical Research, 81 B.U. L. Rev. 423, 432-37 (2001)Google Scholar; see also United States v. Caronia, 703 F.3d 149, 168-169 (2nd Cir. 2012) (the second circuit held that the first amendment protects manufacturer's truthful, non-misleading speech. Thus, promoting the lawful, off-label use of drugs is not prohibited in the second circuit. The protection however, “is limited to FDA-approved drugs for which off-label use is not prohibited…” Thus, speech remains unlawful when false or when promoting a use that is not medically indicated).

110 See id. at 639.

111 See id. at 636-39.

112 See generally id.

113 See id. at 640.

114 Dineen and DuBois, supra note 31 at 10-12.

115 42 U.S.C.A. 1396r-8(k)(6)(2019); see also 42 U.S.C.A. 1396r-8(g)(1)(B)(Medical researchers and other professionals submit data on drug use to statutorily designated compendia which is assessed using predetermined standards).

116 See supra note 109 at 433-35 (2001).

117 See generally U.S. v. Joseph, 709 F.3d 1082 (2013).

118 See press release, U.S. Dep't of Justice, Two Mobile Pain Doctors Convicted After Seven-Week Trial (Mar. 8, 2017); see also Susan Zalkind, Death Pill: Fentanyl Disguised As Other Drugs Linked to Spike in US Overdoses, The Guardian (May 10, 2016), https://www.theguardian.com/society/2016/may/10/fentanyl-drug-overdoses-xanax-painkillers [https://perma.cc/HR5L-TDCY] (“fentanyl is 50 to 100 times as powerful as morphine.”).

119 See id.

120 42 U.S.C.A. 1396r-8(g)(1)(B)(2019).

121 See generally Youtt supra note 86 (describing the developing standard for physician liability in FCA violations).

122 See supra note 42 at 7-8.

123 See Nicole Huberfeld, Elizabeth Weeks & Kevin Outterson, The Law of American Health Care 1, 14 (2017).

124 See Obtaining a Medical License, https://www.ama-assn.org/education/obtaining-medical-license (last visited February 3, 2018).

125 See supra note 109 at 427-28.

126 See id.

127 See id.

128 See id. at 439-440.

129 42 U.S.C. 1395(a).

130 Milgate, Karen & Hackbarth, Glenn, Quality in Medicare: from measurement to payment and provider to patient., 27 Health Care Fin. Rev. 91, 91-92 (2006)Google Scholar.

131 Id.

132 Petrovich v. Share Health Plan of Illinois, Inc., 188 Ill.2d 17, 47-48 (1999).

133 Id.

134 Dineen and DuBois, supra note 31 at 10-12.

135 See id.

136 Id.

137 See Manoj Jain, More rules are needed to curb drug firms' attempts to influence physicians, The Washington Post, 2010, at 11–15.

138 Id.; see generally Milgate and Hackbarth, supra note 130(Manufacturer's make the drugs and conduct studies on their effectiveness. Further incentives for investment in quality care, and innovative drug development, entails policies that establish payment methods such as “pay-for-performance”.

139 See Dineen and DuBois, supra note 31, at 21.

140 42 U.S.C.A. 1396r-8(k)(3)(2019).

141 42 U.S.C.A. 1396r-8(k)(6)(2019).

142 42 U.S.C.A. 1396r-8(k)(3)(2019).

143 42 U.S.C.A. 1396r-8(e)(4)(C)(2019).

144 Id.

145 Id.

146 42 U.S.C.A. 1396r-8(g)(2)(A)(i)(2019).

147 See id.

148 Id.

149 Id.

150 42 U.S.C.A. 1396r-8(k)(6)(2019).

151 42 U.S.C. §1395w-102(e)(4)(B(2018)); 1395x(t)(2)(B)(ii)(I)(2018).

152 Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 937 (1984)Google Scholar.

153 See id.

154 See 42 U.S.C. §1395w-102(e)(4)(B)(2018).

155 42 U.S.C.A. 1396r-8(k)(3)(2019).

156 See 42 U.S.C. §§ 1395x(t)(2)(B)(ii)(I)(2018); MEDICARE BENEFIT POLICY MANUAL Ch. 15, § 50.4.5(A) (Rev. 222, May 13, 2016) (this means that so called failed studies hold great significance and may inform physicians and the public just as much as successful studies.).

157 See Gilson and Kreis, supra note 40 at S93.

158 Centers For Medicare & Medicaid Services, U.S. Dept. of Health and Human Services, Medicare Appeals, 41-52 (2015).

159 See 42 U.S.C. §§ 1395x(t)(2)(B)(ii)(II)(2018); MEDICARE BENEFIT POLICY MANUAL Ch. 15, §50.4.5(A) (Rev. 222, May 13, 2016)(appeals of anticancer drugs allow patients to submit peer reviewed literature).

160 Tetrault, Jeanette M & Butner, Jenna L, Non-Medical Prescription Opioid Use and Prescription Opioid Use Disorder: A Review., 88 Yale J. Biology & Med. 227, 227–33 (2015)Google ScholarPubMed (suggesting substance abuse assessments for patients who are prescribed opiates).

161 Ana Swanson, Big Pharmaceutical Companies Are Spending Far More on Marketing than Research, The Wash. Post, Feb. 11, 2015, https://www.washingtonpost.com/news/wonk/wp/2015/02/11/bigpharmaceutical-companies-are-spending-far-more-on-marketing-than-research/?utm_term=.6f89aef975ec [https://perma.cc/3PGA-SE2W].

162 See Huberfeld, supra note 123.

163 See id.

164 Gilson and Kreis, supra note 40 at S89.

165 See generally Sismondo, supra note 94.

166 See generally How Did The Federal Food, Drug and Cosmetic Act Come About?, supra note 44 (describing the purpose of FDA approval as evaluating the safety and efficacy of drugs for particular uses).