Hostname: page-component-cd9895bd7-jkksz Total loading time: 0 Render date: 2024-12-25T06:58:16.900Z Has data issue: false hasContentIssue false
  • English
  • Français

Paying for Prevention: Challenges to Health Insurance Coverage for Biomedical HIV Prevention in the United States

Published online by Cambridge University Press:  06 January 2021

Kristen Underhill
Kristen Underhill*
Affiliation:
Yale University; Yale Law School, Yale Center for Interdisciplinary Research on AIDS; Yale Law School; Oxford University
Get access Rights & Permissions [Opens in a new window]

Abstract

Reducing the incidence of HIV infection continues to be a crucial public health priority in the United States, especially among populations at elevated risk such as men who have sex with men, transgender women, people who inject drugs, and racial and ethnic minority communities. Although most HIV prevention efforts to date have focused on changing risky behaviors, the past decade yielded efficacious new biomedical technologies designed to prevent infection, such as the prophylactic use of antiretroviral drugs and the first indications of an efficacious vaccine. Access to prevention technologies will be a significant part of the next decade's response to HIV, and advocates are mobilizing to achieve more widespread use of these interventions. These breakthroughs, however, arrive at a time of escalating healthcare costs; health insurance coverage therefore raises pressing new questions about priority-setting and the allocation of responsibility for public health. The goals of this Article are to identify legal challenges and potential solutions for expanding access to biomedical HIV prevention through health insurance coverage. This Article discusses the public policy implications of HIV prevention coverage decisions, assesses possible legal grounds on which insurers may initially deny coverage for these technologies, and evaluates the extent to which these denials may survive external and judicial review. Because several of these legal grounds may be persuasive, particularly denials on the basis of medical necessity, this Article also explores alternative strategies for financing biomedical HIV prevention efforts.

Type
Article
Information
American Journal of Law & Medicine , Volume 38 , Issue 4 , December 2012 , pp. 607 - 666
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 Rotheram-Borus, Mary Jane et al., The Past, Present, and Future of HIV Prevention: Integrating Behavioral, Biomedical, and Structural Intervention Strategies for the Next Generation of HIV Prevention, 5 ANN. REV. CLINICAL PSYCHOL. 143, 143 (2009).CrossRefGoogle ScholarPubMed

2 Padian, Nancy S. et al., Biomedical Interventions to Prevent HIV Infection: Evidence, Challenges, and Way Forward, 372 LANCET 585, 594 (2008).CrossRefGoogle ScholarPubMed

3 Id. at 592.

4 See, e.g., Andreas B. Eisingerich et al., Attitudes and Acceptance of Oral and Parenteral HIV Preexposure Prophylaxis among Potential User Groups: a Multinational Study, PLOS ONE, Jan. 18, 2012, available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0028238 (demonstrating willingness to use PrEP among potential users in a range of countries); Mimiaga, Matthew J. et al., Preexposure Antiretroviral Prophylaxis Attitudes in High-Risk Boston Area Men Who Report Having Sex with Men, 50 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES 77, 80-82 (2009).CrossRefGoogle Scholar

5 Desai, Kamal et al., Modeling the Impact of HIV Chemoprophylaxis Strategies Among Men Who Have Sex with Men in the United States: HIV Infections Prevented and Cost-Effectiveness, 22 AIDS 1829, 1835 (2008)CrossRefGoogle ScholarPubMed; Paltiel, A. David et al., HIV Preexposure Prophylaxis in the United States: Impact on Lifetime Infection Risk, Clinical Outcomes, and Cost-Effectiveness, 48 CLINICAL INFECTIOUS DISEASE 806, 811-12 (2009).CrossRefGoogle ScholarPubMed

6 Long, Elisa F. et al., Potential Population Health Outcomes and Expenditures of HIV Vaccination Strategies in the United States, 27 VACCINE 5402, 5407-08 (2009).CrossRefGoogle ScholarPubMed

7 Pinkerton, Steven D. et al., Cost-Effectiveness of Post-Exposure Prophylaxis Following Sexual Exposure to HIV, 12 AIDS 1067, 1072 (1998).CrossRefGoogle Scholar

8 Cost-effectiveness depends in part on local epidemiology. See Cohen, Deborah A. et al., Comparing the Cost-Effectiveness of HIV Prevention Interventions, 37 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES 1404, 1407-08 (2004).CrossRefGoogle ScholarPubMed

9 See Paxton, Lynn A. et al., Pre-Exposure Prophylaxis for HIV Infection: What If It Works?, 370 LANCET 89, 90-91 (2007).CrossRefGoogle ScholarPubMed

10 Importantly, this Article does not examine obstacles to extending health insurance to uninsured individuals at risk of HIV infection. Although this issue is of key importance for the response to HIV, as acknowledged in Part IV, it is not within the scope of the present inquiry. This Article also does not focus on obstacles to insurance coverage for individuals living with HIV; a recent discussion of this topic may be found in Southerland, Ashley N., Stigmatized Silence: The Exclusion of HIV and AIDS Sufferers from the “Obamacare” Legal Landscape, 20 CORNELL J.L. & PUB. POL’Y 833 (2011).Google ScholarPubMed

11 See infra Part V.A.

12 Corso, Phaedra S. et al., Assessing Preferences for Prevention Versus Treatment Using Willingness to Pay, 22 MED. DECISION MAKING S92, S93 (2002).CrossRefGoogle ScholarPubMed But see Bosworth, Ryan et al., Is an Ounce of Prevention Worth a Pound of Cure? Comparing Demand for Public Prevention and Treatment Policies, 30 MED. DECISION MAKING E40 (2010).CrossRefGoogle Scholar

13 Kates, Jennifer & Levi, Jeffrey, Insurance Coverage and Access to HIV Testing and Treatment: Considerations for Individuals at Risk for Infection and for Those with Undiagnosed Infection, 45 CLINICAL INFECTIOUS DISEASES S255, S256-58 (2007).CrossRefGoogle ScholarPubMed

14 See infra Section III.B.

15 DIV. OF HIV/AIDS PREVENTION, CDC, HIGH-IMPACT HIV PREVENTION 4-5 (2011), available at http://www.cdc.gov/hiv/strategy/hihp/report/pdf/NHPC_Booklet.pdf.

16 Southerland, supra note 10, at 842-44.

17 Pub. L. No. 111-148, 124 Stat. 119 (2010) (to be codified primarily in scattered sections of 42 U.S.C.)

18 Patient Protection and Affordable Care Act § 1201; see also Epstein, Richard A. & Stannard, Paula M., Constitutional Ratemaking and the Affordable Care Act: A New Source of Vulnerability, 38 AM. J.L. & MED. 243, 252 (2012).CrossRefGoogle Scholar

19 Underhill, Kristen et al., Implementation Science of Pre-Exposure Prophylaxis: Preparing for Public Use, 7 CURRENT HIV/AIDS REP. 210, 213 (2010)CrossRefGoogle ScholarPubMed [hereinafter Underhill et al., Implementation Science]; Underhill, Kristen et al., Packaging PrEP to Prevent HIV: An Integrated Framework to Plan for Pre-Exposure Prophylaxis in Clinical Practice, 55 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES 8, 9-10 (2010)CrossRefGoogle ScholarPubMed [hereinafter Underhill et al., Packaging PrEP].

20 Underhill et al., Packaging PrEP, supra note 19, at 10-11.

21 See, e.g., Watson v. Golden Rule Ins. Co., 564 N.E.2d 302, 304-05 (Ind. Ct. App. 1990).

22 See Crepaz, Nicole et al., Do Prevention Interventions Reduce HIV Risk Behaviours Among People Living with HIV? A Meta-Analytic Review of Controlled Trials, 20 AIDS 143, 148-49 (2006)CrossRefGoogle ScholarPubMed; Lyles, Cynthia M. et al., Best-Evidence Interventions: Findings from a Systematic Review of HIV Behavioral Interventions for US Populations at High Risk, 2000-2004, 97 AM. J. PUB. HEALTH 133, 138-39 (2007).CrossRefGoogle Scholar

23 See Silverman, Barbara G. & Gross, Thomas P., Use and Effectiveness of Condoms During Anal Intercourse: A Review, 24 SEXUALLY TRANSMITTED DISEASES 11, 15-16 (1997)CrossRefGoogle ScholarPubMed; S.C. Weller & K. Davis-Beaty, Condom Effectiveness in Reducing Heterosexual HIV Transmission (Review), COCHRANE DATABASE SYSTEMATIC REVS. CD003255 (2002), available at http://apps.who.int/rhl/reviews/langs/CD003255.pdf.

24 See Gallo, Maria F. et al., A Review of the Effectiveness and Acceptability of the Female Condom for Dual Protection, 9 SEXUAL HEALTH 18 (2012)CrossRefGoogle ScholarPubMed; Vijayakumar, Gowri et al., A Review of Female-Condom Effectiveness: Patterns of Use and Impact on Protected Sex Acts and STI Incidence, 17 INT’L J. STDS & AIDS 862 (2008).Google Scholar

25 See Hurley, Susan F. et al., Effectiveness of Needle-Exchange Programmes for Prevention of HIV Infection, 349 LANCET 1797 (1997)CrossRefGoogle ScholarPubMed; Wodak, Alex & Cooney, Annie, Do Needle Syringe Programs Reduce HIV Infection Among Injecting Drug Users: A Comprehensive Review of the International Evidence, 41 SUBSTANCE USE & MISUSE 777, 797 (2006).CrossRefGoogle ScholarPubMed

26 Donald G. McNeil, Jr., Rapid H.I.V. Home Test Wins Federal Approval, N.Y. TIMES, July 3, 2012, http://www.nytimes.com/2012/07/04/health/oraquick-at-home-hiv-test-wins-fda-approval.html.

27 Dworkin, Shari L. & Blankenship, Kim, Microfinance and HIV/AIDS Prevention: Assessing Its Promise and Limitations, 13 AIDS & BEHAVIOR 462, 466 (2009).CrossRefGoogle ScholarPubMed

28 Padian et al., supra note 2, at 585.

29 See Rotheram-Borus et al., supra note 1, at 150-52.

30 Chen, Ray Y. et al., Distribution of Health Care Expenditures for HIV-Infected Patients, 42 CLINICAL INFECTIOUS DISEASES 1003, 1007 (2006)CrossRefGoogle ScholarPubMed; Gebo, Kelly A. et al., Contemporary Costs of HIV Healthcare in the HAART Era, 24 AIDS 2705, 2712 (2010).CrossRefGoogle ScholarPubMed

31 Landovitz, Raphael J. & Currier, Judith S., Postexposure Prophylaxis for HIV Infection, 361 NEW ENG. J. MED. 1768, 1772-73 (2009)CrossRefGoogle ScholarPubMed; Pinkerton, Steven D. et al., Cost-Effectiveness of HIV Postexposure Prophylaxis Following Sexual or Injection Drug Exposure in 96 Metropolitan Areas in the United States, 18 AIDS 2065, 2066 (2004).CrossRefGoogle ScholarPubMed

32 Keller, Samuel B. & Smith, Davey M., The Price of Tenofovir-Emtricitabine Undermines the Cost-Effectiveness and Advancement of Pre-Exposure Prophylaxis, 25 AIDS 2308, 2309 (2011)CrossRefGoogle Scholar; Paltiel, supra note 5, at 809.

33 AIDS 2010: Study Finds Microbicide Containing HIV Drug Lowers Infection Risk in Women by 39 Percent, KAISER FAMILY FOUND. (July 20, 2010), http://globalhealth.kff.org/Daily-Reports/2010/July/20/GH-072010-AIDS-2010-Gel-Study.aspx; see also Wilson, David P. & Coplan, Paul M., Mathematical Models and Health Economic Aspects of Microbicides, 3 CURRENT OPINION HIV & AIDS 587, 590 (2008).CrossRefGoogle ScholarPubMed

34 Stephanie L. Sansom et al., Cost-Effectiveness of Newborn Circumcision in Reducing Lifetime HIV Risk Among U.S. Males, PLOS ONE, Jan. 18, 2010, at 3, available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008723.

35 Schoen, Edgar J. et al., Cost Analysis of Neonatal Circumcision in a Large Health Maintenance Organization, 175 J. UROLOGY 1111, 1113 (2006).CrossRefGoogle Scholar

36 Models contain, show, and/or predict varied costs of the vaccine from $2000 to $10,000. See, e.g., Walensky, Rochelle P. et al., A Therapeutic HIV Vaccine: How Good Is Good Enough?, 22 VACCINE 4044, 4047 (2004).CrossRefGoogle ScholarPubMed

37 Chesson, Harrell W., Collins, Dayne & Koski, Kathryn, Formulas for Estimating the Costs Averted by Sexually Transmitted Infection (STI) Prevention Programs in the United States, 6 COST EFFECTIVENESS & RESOURCE ALLOCATION 10 (2008).CrossRefGoogle ScholarPubMed These costs include sequelae such as pelvic inflammatory disease in women, epididymitis in men, and neurosyphilis or cardiovascular syphilis for untreated syphilis cases. DISEASE CONTROL PRIORITIES PROJECT, SEXUALLY TRANSMITTED INFECTIONS ARE PREVENTABLE AND TREATABLE, BUT THE FULL BENEFIT DEPENDS ON THE LOCAL CONTEXT 1 (2007), available at http://www.dcp2.org/file/144/DCPP-STI.pdf. The cost of STI treatment is lower in low-income countries. See id. at 5 tbl.2 (estimating the average cost of treatment or cure at $39.49).

38 French, Michael T. et al., The Economic Costs of Substance Abuse Treatment: Updated Estimates and Cost Bands for Program Assessment and Reimbursement, 35 J. SUBSTANCE ABUSE TREATMENT 462, 466 (2008).CrossRefGoogle ScholarPubMed

39 Meng, Ying-Ying et al., Financial Impact of California's New Law to Increase HIV Screening by Mandating Insurance Coverage, 23 AIDS CARE 206, 209 (2011)CrossRefGoogle ScholarPubMed; Cohen, Deborah A. et al., Cost-Effective Allocation of Government Funds to Prevent HIV Infection, 24 HEALTH AFF. 915, 921 (2005).CrossRefGoogle ScholarPubMed

40 Cohen, Myron S. & Gay, Cynthia L., Treatment to Prevent Transmission of HIV-1, 50 CLINICAL INFECTIOUS DISEASES S85, S86 (2010).CrossRefGoogle ScholarPubMed

41 Id. at S85.

42 Id.

43 Maggiolo, Franco & Leone, Sebastiano, Comment, Is HAART Modifying the HIV Epidemic?, 376 LANCET 492, 492-93 (2010)CrossRefGoogle ScholarPubMed; see also Weber, Jonathan et al., Postexposure Prophylaxis, Preexposure Prophylaxis or Universal Test and Treat: The Strategic Use of Antiretroviral Drugs to Prevent HIV Acquisition and Transmission, 24 AIDS S27, S30 (2010).CrossRefGoogle ScholarPubMed

44 Cohen & Gay, supra note 40, at S86; Montaner, Julio S.G. et al., Association of Highly Active Antiretroviral Therapy Coverage, Population Viral Load, and Yearly New HIV Diagnoses in British Columbia, Canada: A Population-Based Study, 376 LANCET 532, 532 (2010).CrossRefGoogle ScholarPubMed

45 See Nandi Siegfried et al., Antiretrovirals for Reducing the Risk of Mother-to-Child Transmission of HIV Infection, COCHRANE DATABASE SYSTEMATIC REVS. CD003510 (2011).

46 Cohen, Myron S. et al., Prevention of HIV-1 Infection with Early Antiretroviral Therapy, 365 NEW ENG. J. MED. 493 (2011)CrossRefGoogle ScholarPubMed; see also Attia, Suzanna et al., Sexual Transmission of HIV According to Viral Load and Antiretroviral Therapy: Systematic Review and Meta-Analysis, 23 AIDS 1397, 1397 (2009)CrossRefGoogle ScholarPubMed; Donnell, Deborah et al., Heterosexual HIV-1 Transmission After Initiation of Antiretroviral Therapy: A Prospective Cohort Analysis, 375 LANCET 2092, 2092 (2010)CrossRefGoogle ScholarPubMed; Montaner et al., supra note 44.

47 Granich, Reuben M. et al., Universal Voluntary HIV Testing with Immediate Antiretroviral Therapy as a Strategy for Elimination of HIV Transmission: A Mathematical Model, 373 LANCET 48, 55 (2009).CrossRefGoogle ScholarPubMed

48 Id. at 54.

49 See, e.g., Buchanan, Robert J., State Medicaid Coverage of AZT and AIDS-Related Policies, 78 AM. J. PUB. HEALTH 432 (1988)CrossRefGoogle ScholarPubMed (describing state Medicaid policies regarding coverage of AZT, the only existing drug for treating HIV infection).

50 Tokars, Jerome I. et al., Surveillance of HIV Infection and Zidovudine Use Among Health Care Workers After Occupational Exposure to HIV-Infected Blood, 118 ANNALS INTERNAL MED. 913, 913 (1993).CrossRefGoogle ScholarPubMed

51 Cardo, Denise M. et al., A Case-Control Study of HIV Seroconversion in Health Care Workers After Percutaneous Exposure, 337 NEW ENG. J. MED. 1485, 1488 (1997)CrossRefGoogle ScholarPubMed (95% confidence interval: 48–94%); see also Weber et al., supra note 43; Taryn Young et al., Antiretroviral Post-Exposure Prophylaxis (PEP) for Occupational HIV Exposure, COCHRANE DATABASE SYSTEMATIC REVS. CD002835 (2007).

52 See, e.g., Hamlyn, Elizabeth & Easterbrook, Philippa, Occupational Exposure to HIV and the Use of Post-Exposure Prophylaxis, 57 OCCUPATIONAL MED. 329, 332-33 (2007).CrossRefGoogle ScholarPubMed

53 See Panlilio, Adelisa L. et al., Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis, 54 MORBIDITY & MORTALITY WKLY. REP. (RECOMMENDATIONS & REP. NO. RR-9) 1, 1, 4 (2005).Google ScholarPubMed

54 See generally Smith, Dawn K. et al., Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States, 54 MORBIDITY & MORTALITY WKLY. REP. (RECOMMENDATIONS & REP. NO. RR-2) 1, 1 (2005).Google ScholarPubMed

55 Id. at 8.

56 See Draughon, Jessica E. & Sheridan, Daniel J., Nonoccupational Postexposure Prophylaxis Following Sexual Assaults in Industrialized Low-HIV-Prevalence Countries: A Review, 17 PSYCHOL. HEALTH & MED. 235, 241-48 (2012).CrossRefGoogle Scholar

57 Ongoing PrEP Trials, AVAC, http://www.avac.org/ht/d/sp/i/3507/pid/3507 (last visited Sept. 15, 2012).

58 See van der Straten, Ariane et al., How Well Does PrEP Work? Unraveling the Divergent Results of PrEP Trials for HIV Prevention, 26 AIDS F13 (2012)CrossRefGoogle Scholar (summarizing results to date).

59 See id. at F15 tbl.1.

60 FDA, TRUVADA FOR PREP FACT SHEET: ENSURING SAFE AND PROPER USE (2012), available at http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM312279.pdf; Andrew Pollack, F.D.A. Approves Once-a-Day Pill for H.I.V., N.Y. TIMES, Aug. 27, 2012, http://www.nytimes.com/2012/08/28/business/fda-approves-once-a-day-pill-for-hiv.html.

61 See WORLD HEALTH ORG., GUIDANCE ON PRE-EXPOSURE ORAL PROPHYLAXIS (PREP) FOR SERODISCORDANT COUPLES, MEN AND TRANSGENDER WOMEN WHO HAVE SEX WITH MEN AT HIGH RISK OF HIV: RECOMMENDATIONS FOR USE IN THE CONTEXT OF DEMONSTRATION PROJECTS (2012), available at http://apps.who.int/iris/bitstream/10665/75188/1/9789241503884_eng.pdf; CDC, Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men, 60 MORBIDITY & MORTALITY WKLY. REP. 65, 67 (2011)Google Scholar; Smith, Dawn K. et al., Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults, 61 MORBIDITY & MORTALITY WKLY. REP. 586, 587-88 (2012)Google Scholar. This drug is patented by the pharmaceutical firm Gilead Sciences, Inc. See TRUVADA, www.truvada.com (last visited Oct. 27, 2012).

62 See Desai et al., supra note 5; Paltiel et al., supra note 5.

63 See Underhill et al., Implementation Science, supra note 19, at 215 (citing studies).

64 Cf. id. (citing studies).

65 Kevin Fisher et al., Does PrEP Need a Pipeline? Criteria for Identifying the Next PrEP Candidates, AVAC, http://www.avac.org/ht/display/EventDetails/i/5884/a/GetDocumentAction/i/28794 (last visited Aug. 9, 2012).

66 Padian et al., supra note 2, at 590-91.

67 Abdool Karim, Quarraisha et al., Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women , 329 SCIENCE 1168, 1168 (2010).CrossRefGoogle ScholarPubMed

68 Microbicide Clinical Trials, AVAC, http://www.avac.org/ht/d/sp/i/178/pid/178/d/sp/i/325/pid/325 (last visited Oct. 27, 2012).

69 See Woodsong, Cynthia, Covert Use of Topical Microbicides: Implications for Acceptability and Use, 30 INT’L FAM. PLAN. PERSP. 94, 96 (2004).CrossRefGoogle ScholarPubMed

70 See generally CDC, MALE CIRCUMCISION AND RISK FOR HIV TRANSMISSION AND OTHER HEALTH CONDITIONS: IMPLICATIONS FOR THE UNITED STATES (2008), available at http://www.cdc.gov/hiv/resources/factsheets/PDF/circumcision.pdf.

71 Id.; see Lance B. Price et al., The Effects of Circumcision on the Penis Microbiome, PLoS ONE, Jan. 6, 2010, at 2, available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008422.

72 Nandi Siegfried et al., Male Circumcision for Prevention of Heterosexual Acquisition of HIV in Men, COCHRANE DATABASE SYSTEMATIC REVS. CD003362 (2009) (citing sources).

73 Wawer, Maria J. et al., Circumcision in HIV-Infected Men and Its Effects on HIV Transmission to Female Partners in Rakai, Uganda: A Randomised Controlled Trial, 374 LANCET 229, 235 (2009).CrossRefGoogle ScholarPubMed

74 See CDC, supra note 70.

75 Warner, Lee et al., Male Circumcision and Risk of HIV Infection Among Heterosexual African American Men Attending Baltimore Sexually Transmitted Disease Clinics, 199 J. INFECTIOUS DISEASES 59, 64 (2009).CrossRefGoogle ScholarPubMed

76 Xu, Fujie et al., Prevalence of Circumcision and Herpes Simplex Virus Type 2 Infection in Men in the United States: The National Health and Nutrition Examination Survey (NHANES), 1999-2004, 34 SEXUALLY TRANSMITTED DISEASES 479, 480, 482 (2007)Google ScholarPubMed, cited in CDC, supra note 70.

77 Leibowitz, Arleen A. et al., Determinants and Policy Implications of Male Circumcision in the United States, 99 AM. J. PUB. HEALTH 138, 138, 141 (2009)CrossRefGoogle ScholarPubMed; see also Morris, Brian J. et al., Letter, Medicaid Coverage of Newborn Circumcision: A Health Parity Right of the Poor, 99 AM. J. PUB. HEALTH 969 (2009).CrossRefGoogle Scholar

78 See Vaccine Clinical Trials, AVAC, http://www.avac.org/ht/d/sp/i/177/pid/177/d/sp/i/324/pid/324 (last visited Feb. 28, 2012); Dolin, Raphael, Editorial, HIV Vaccine Trial Results—An Opening for Further Research, 361 NEW ENG. J. MED. 2279 (2009).CrossRefGoogle ScholarPubMed

79 Rerks-Ngarm, Supachai et al., Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand, 361 NEW ENG. J. MED. 2209, 2209, 2214-15 (2009).CrossRefGoogle ScholarPubMed

80 Vaccine Clinical Trials, supra note 78.

81 Padian et al., supra note 2, at 588 (citing studies).

82 Id.

83 Padian et al., supra note 2, at 586; Rotheram-Borus, et al., supra note 1, at 151.

84 St. Louis, Michael E. et al., HIV Prevention Through Early Detection and Treatment of Other Sexually Transmitted Diseases—United States: Recommendations of the Advisory Committee for HIV and STD Prevention, 47 MORBIDITY & MORTALITY WKLY. REP. (RECOMMENDATIONS & REP. NO. RR-12) 1, 1, 7 (1998).Google Scholar

85 See generally Metzger, David S. et al., Drug Treatment as HIV Prevention: A Research Update, 55 J. ACQUIRED IMMUNE DEFICIENCY SYNDROME S32 (2010)CrossRefGoogle ScholarPubMed; see also Linda Gowing et al., Substitution Treatment of Injecting Opioid Users for Prevention of HIV Infection, COCHRANE DATABASE SYSTEMATIC REVS. CD004145 (2008); Sullivan, Lynn E. et al., Decreasing International HIV Transmission: The Role of Expanding Access to Opiod Agonist Therapies for Injection Drug Users, 100 ADDICTION 150 (2005).CrossRefGoogle Scholar

86 See Metzger et al., supra note 85; Gowing et al., supra note 85.

87 Weinhardt, Lance S. et al., Effects of HIV Counseling and Testing on Sexual Risk Behavior: A Meta-Analytic Review of Published Research, 1985-1997, 89 AM. J. PUB. HEALTH 1397, 1402 (1999).CrossRefGoogle Scholar

88 Although this mechanism of intervention is behavioral, testing is included in this Article because it is purchased through the healthcare system.

89 Holtgrave, David R., Costs and Consequences of the US Centers for Disease Control and Prevention's Recommendations for Opt-Out HIV Testing, 4 PLOS MED. 1011, 1011, 1013 (2007).CrossRefGoogle ScholarPubMed

90 Id. at 1014.

91 Branson, Bernard M. et al., CDC, Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, 55 MORBIDITY & MORTALITY WKLY. REP. (RECOMMENDATIONS & REP. NO. RR-14) 1, 1 (2006).Google ScholarPubMed

92 See Holtgrave, supra note 89, at 1015.

93 See, e.g., Rotheram-Borus et al., supra note 1, at 145.

94 The National Institutes of Health (NIH) has dedicated funds to test these combination approaches. See Methods for Prevention Packages Program (MPIII) (R01), NAT’L INSTS. OF TECH., http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-10-005.html (last visited Mar. 14, 2012).

95 Liu, Albert Y. et al., Commentary, Preexposure Prophylaxis for HIV: Unproven Promise and Potential Pitfalls, 296 JAMA 863, 864 (2006).CrossRefGoogle ScholarPubMed

96 See Underhill et al., Implementation Science, supra note 19, at 11.

97 Eaton, Lisa A. & Kalichman, Seth C., Risk Compensation in HIV Prevention: Implications for Vaccines, Microbicides, and Other Biomedical HIV Prevention Technologies, 4 CURRENT HIV/AIDS REP. 165, 165 (2007).CrossRefGoogle ScholarPubMed

98 See Desai et al., supra note 5, at 1833-34; Debby C.J. Vissers et al., The Impact of Pre-Exposure Prophylaxis (PrEP) on HIV Epidemics in Africa and India: A Simulation Study, PLOS ONE, May 7, 2008, at 2, available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0002077. Risk compensation has also been suggested as an effect of HIV testing, circumcision, vaccines, and microbicide use. See Holtgrave, supra note 89, at 1014; Eaton & Kalichman, supra note 97.

99 See Kaiser Comm’n on Key Facts, The Uninsured and the Difference Health Insurance Makes, KAISER FAMILY FOUND. (Sept. 2012), http://www.kff.org/uninsured/upload/1420-14.pdf.

100 See DIV. OF HIV/AIDS PREVENTION, supra note 15; see also Who Are Vulnerable and Most-at-Risk Populations?, INT’L HIV/AIDS ALLIANCE (July 2010), http://www.aidsalliance.org/includes/Document/Prevention%20campaign/Campaign-Policy-Briefing-1.pdf.

101 The focus in this Part is on exclusively preventive technologies, rather than on those that serve dual purposes.

102 U.S. Dep't of Health & Human Servs., 2020 Topics and Objectives: HIV, HEALTHYPEOPLE.GOV, http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=22 (last updated Sept. 6, 2012).

103 U.S. Dep't of Health & Human Servs., National HIV/AIDS Strategy: Overview, AIDS.GOV, http://www.aids.gov/federal-resources/policies/national-hiv-aids-strategy/ (last visited Mar. 2, 2012).

104 CDC Responds to HIV/AIDS, CDC, http://www.cdc.gov/hiv/aboutDHAP.htm (last updated Nov. 2, 2011).

105 Singh, Jerome A. & Mills, Edward J., The Abandoned Trials of Pre-Exposure Prophylaxis for HIV: What Went Wrong?, 2 PLOS MED. 0824, 0824-25 (2005)CrossRefGoogle ScholarPubMed; Deena Beasley, Analysis: Use of Pill to Prevent HIV May Be Limited in U.S., REUTERS, Sept. 7, 2012, available at http://uk.reuters.com/article/2012/09/07/us-usa-health-aids-prevention-idUKBRE88611M20120907.

106 Danzon, Patricia M. & Towse, Adrian, Differential Pricing for Pharmaceuticals: Reconciling Access, R&D and Patents, 3 INT’L J. HEALTH CARE FIN. & ECON. 183, 186 (2003).CrossRefGoogle Scholar

107 This has led to a lack of research and development for diseases affecting primarily people in low-income countries, spurring responses such as the Drugs for Neglected Diseases Initiative. See DRUGS FOR NEGLECTED DISEASES INITIATIVE, http://www.dndi.org/ (last visited Oct. 27, 2012).

108 Michael Smith, HIV Life Expectancy Approaching Normal, MEDPAGE TODAY (June 27, 2008), http://www.medpagetoday.com/HIVAIDS/HIVAIDS/9930 (noting that the median age for beginning care was thirty-nine in one study, leading to a median life expectancy of sixty-three, nearing the age of Medicare eligibility).

109 See, e.g., Bassett, Ingrid V. et al., AIDS Drug Assistance Programs in the Era of Routine HIV Testing, 47 CLINICAL INFECTIOUS DISEASES 695, 696-97 (2008).CrossRefGoogle ScholarPubMed

110 See Timothy Jost, Implementing Health Reform: Preventive Services, HEALTH AFF. BLOG (July 15, 2010), http://healthaffairs.org/blog/2010/07/15/implementing-health-reform-preventive-services/.

111 See Dobson, Allen et al., The Cost-Shift Payment ‘Hydraulic’: Foundation, History, and Implications, 25 HEALTH AFF. 22, 24 (2006).CrossRefGoogle ScholarPubMed

112 See Frakt, Austin B., How Much Do Hospitals Cost Shift? A Review of the Evidence, 89 MILBANK Q. 90, 123 (2011).CrossRefGoogle Scholar

113 Id. at 122.

114 See GUIDO CALABRESI, THE COSTS OF ACCIDENTS 55-64 (1970).

115 See Kinney, Eleanor D., Recognition of the Human Right to Health and Health Care in the United States, 60 RUTGERS L. REV. 335, 353-54 (2008).Google Scholar

116 Id. at 355.

117 LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 8 (2008).

118 Id. at 8-9.

119 KENNETH S. ABRAHAM, INSURANCE LAW AND REGULATION 377 (5th ed. 2010).

120 Kinney, supra note 115, at 337 fig.1.

121 Id. at 354-55.

122 See infra notes 373-74 and accompanying text.

123 Oberlander, Jonathan, Under Siege – The Individual Mandate for Health Insurance and Its Alternatives, 364 NEW ENG. J. MED. 1085 (2011).CrossRefGoogle ScholarPubMed

124 Koh, Howard K. & Sebelius, Kathleen G., Promoting Prevention Through the Affordable Care Act, 363 NEW ENG. J. MED. 1296 (2010).CrossRefGoogle ScholarPubMed

125 See, e.g., Kinney, Eleanor D., Realizing the International Human Right to Health: The Challenge of For-Profit Health Care, 113 W. VA. L. REV. 49, 64 (2010).Google Scholar

126 See Patient Protection and Affordable Care Act, § 1201, 42 U.S.C.A. § 300gg (West 2012).

127 See Tom Myers, HIV Prevention Pill Will Do More Harm Than Good, U.S. NEWS & WORLD REP. (Aug. 3, 2012), http://www.usnews.com/opinion/articles/2012/08/03/hiv-prevention-pill-will-do-more-harm-than-good-hiv-pill-will-give-a-false-sense-of-security; Action Alert: AHF's DHHS AIDS Protest Targets Approval of Gilead's Prevention Pill, AIDS HEALTHCARE FOUND. (Jan. 23, 2012), http://www.aidshealth.org/archives/6687/.

128 See, e.g., JOHN ADAMS, RISK 14-16 (1995); GERALD J.S. WILDE, TARGET RISK 2 (2001); Hedlund, James, Risky Business: Safety Regulations, Risk Compensation, and Individual Behavior, 6 INJ. PREVENTION 82 (2000).CrossRefGoogle ScholarPubMed

129 Golub, Sarit A. et al., Preexposure Prophylaxis and Predicted Condom Use Among High-Risk Men Who Have Sex with Men, 54 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES 548, 549 (2010)CrossRefGoogle ScholarPubMed; Helen Shen, Gay and Bisexual Men in Providence Interested in Taking HIV-Prevention Drug, Survey Finds, BOSTON.COM (July 25, 2012, 5:41 PM), http://www.boston.com/dailydose/2012/07/25/gay-and-bisexual-men-providence-interested-taking-hiv-prevention-drug-survey-finds/UJXpkJZNZ2PwPTDz8RpS2K/story.html.

130 GILEAD SCIENCES, INC., TRUVADA® RISK EVALUATION AND MITIGATION STRATEGY (REMS) 1 (2012), available at http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM312304.pdf.

131 Underhill, Kristen, Risk-Taking and Rulemaking: Addressing Risk Compensation Behavior Through FDA Regulation of Prescription Drugs, 30 YALE J. ON REG. (forthcoming 2013).Google Scholar

132 This is not the first time questions about the use of unproven technologies have arisen in the history of the U.S. response to HIV/AIDS. See, e.g., George J. Annas, At Law: FDA's Compassion for Desperate Drug Companies, HASTINGS CENTER REP., Jan./Feb. 1990, at 35.

133 Chronic Diseases and Health Promotion, CDC, http://www.cdc.gov/chronicdisease/overview/index.htm (last updated Aug. 13, 2012).

134 For a discussion of behavior change interventions, see Underhill, Kristen, Transferring Behavioral Interventions for Global Health: Intellectual Property Barriers, Information Constraints, and Possible Solutions, 10 YALE J. HEALTH POL’Y L. & ETHICS 357 (2010).Google ScholarPubMed

135 Cargill, Victoria A. & Stone, Valerie E., HIV/AIDS: A Minority Health Issue, 89 MED. CLINICS N. AM. 895, 895 (2005).CrossRefGoogle ScholarPubMed

136 See, e.g., Burris, Scott, Public Health, “AIDS Exceptionalism” and the Law, 27 J. MARSHALL L. REV. 251 (1994)Google ScholarPubMed; Casarett, David J. & Lantos, John D., Have We Treated AIDS Too Well? Rationing and the Future of AIDS Exceptionalism, 128 ANNALS INTERNAL MED. 756, 758 (1998).CrossRefGoogle ScholarPubMed

137 Cohen, Joshua T. et al., Does Preventive Care Save Money? Health Economics and the Presidential Candidates, 358 NEW ENG. J. MED. 661, 662 (2008)CrossRefGoogle ScholarPubMed

138 See Galárraga, Omar et al., HIV Prevention Cost-Effectiveness: A Systematic Review, 9 BMC PUB. HEALTH (SUPP. I) S5 (2009).CrossRefGoogle ScholarPubMed

139 Underhill et al., Implementation Science, supra note 19, at 213.

140 Desai et al., supra note 5, at 1834.

141 Id.; Johnston, Margaret I. & Fauci, Anthony S., An HIV Vaccine—Challenges and Prospects, 359 NEW ENG. J. MED. 888, 889 (2008).CrossRefGoogle ScholarPubMed

142 See, e.g., David M. Cutler, A Guide to Healthcare Reform, J. ECON. PERSP., Summer 1994, at 13, 20. See generally Moncrieff, Abigail R., Cost-Benefit Federalism: Reconciling Collective Action Federalism and Libertarian Federalism in the Obamacare Litigation and Beyond, 38 AM. J.L. & MED. 288 (2012)CrossRefGoogle ScholarPubMed (discussing collective action federalism and externalities); Purdy, Jedediah & Siegel, Neil S., The Liberty of Free Riders: The Minimum Coverage Provision, Mill's “Harm Principle,” and the American Social Morality, 38 AM. J.L. & MED. 374 (2012)Google ScholarPubMed (discussing collective action and free-rider issues related to the ACA).

143 ABRAHAM, supra note 119, at 4-5.

144 See, e.g., Finley, Kim H., Life, Liberty, and the Pursuit of Viagra? Demand for “Lifestyle” Drugs Raises Legal and Public Policy Issues, 28 CAP. U. L. REV. 837, 867-68 (2000)Google Scholar; Hayden, Lisa A., Gender Discrimination Within the Reproductive Health Care System: Viagra v. Birth Control, 13 J.L. & HEALTH 171, 183-84 (1999)Google Scholar; Korland, Lee, Sex Discrimination or a Hard Pill for Employers to Swallow: Examining the Denial of Contraceptive Benefits in the Wake of Erikson v. Bartell Drug Co., 53 CASE W. RES. L. REV. 531, 559-61 (2002)Google ScholarPubMed; Kindell, Kathryn, Comment, Prescription for Fairness: Health Insurance Reimbursement for Viagra and Contraceptives, 35 TULSA L.J. 399, 399-400 (2000)Google ScholarPubMed. The practice of charging women higher premiums to cover the possibility of maternity care has been characterized as discriminatory. See NAT’L WOMEN's LAW CTR., STILL NOWHERE TO TURN: INSURANCE COMPANIES TREAT WOMEN LIKE A PRE-EXISTING CONDITION (2009), available at http://www.nwlc.org/sites/default/files/pdfs/stillnowheretoturn.pdf.

145 Hayden, supra note 144, at 181.

146 Id. at 184.

147 See, e.g., BRIAN MOULTON & LIZ SEATON, HUMAN RIGHTS CAMPAIGN FOUND., TRANSGENDER AMERICANS: A HANDBOOK FOR UNDERSTANDING 25, available at http://www.hrc.org/files/assets/resources/hrcTGguide.pdf; Hong, Kari E., Categorical Exclusions: Exploring Legal Responses to Health Care Discrimination Against Transsexuals, 11 COLUM. J. GENDER & L. 88, 96-97 (2002)Google Scholar; Cox, Travis, Comment, Medically Necessary Treatments for Transgender Prisoners and the Misguided Law in Wisconsin, 24 WIS. J.L. GENDER & SOC’Y 341, 363 (2009).Google Scholar

148 See, e.g., Mario v. P & C Food Markets, Inc., 313 F.3d 758, 765-66 (2002).

149 Hong, supra note 147, at 96.

150 Underhill et al., Implementation Science, supra note 19, at 214.

151 See ABRAHAM, supra note 119, at 4-5.

152 Id.

153 Garber, Alan M., Evidence-Based Coverage Policy, 20 HEALTH AFF. 62 (2001) [hereinafter Garber, Evidence-Based].CrossRefGoogle ScholarPubMed

154 See infra Section V.A.3.

155 National coverage determinations that result in a “continuing evidence development” determination extend coverage only to beneficiaries who enroll in clinical trials. See infra Section V.A.3.

156 Priest, George L., The Government, the Market, and the Problem of Catastrophic Loss, 12 J. RISK & UNCERTAINTY 219, 221-22 (1996)CrossRefGoogle Scholar [hereinafter Priest, Government]; George L. Priest, How Insurance Reduces Risks 1 (1996) (unpublished manuscript) (on file with author) [hereinafter Priest, Manuscript].

157 Priest, Manuscript, supra note 156, at 6.

158 Priest, Government, supra note 156, at 221-25.

159 Id. at 221.

160 Priest, Manuscript, supra note 156, at 1-2.

161 Id. at 2.

162 See id. at 3.

163 Priest, Government, supra note 156, at 221. This has been described as the law of large numbers. Id.

164 This may differ for PEP, since the exposure to HIV that triggers PEP use may have been unpredictable.

165 Priest, Manuscript, supra note 156, at 1. Coverage may even temporarily decrease predictive accuracy, given uncertainty about demand and downstream effects.

166 Johnston & Fauci, supra note 141, at 889.

167 Priest, Manuscript, supra note 156, at 4-11.

168 Id. at 8-9; see also Priest, Government, supra note 156, at 223.

169 Patient Protection and Affordable Care Act § 1201. 42 U.S.C.A. § 300gg (West 2012); see Epstein & Stannard, supra note 18, at 252.

170 For example, Vermont and Washington both prohibit insurance discrimination based on sexual orientation, which would forbid any effort to segregate men who have sex with men into a pool based on a higher likelihood of using HIV prevention technology. See INST. OF REAL ESTATE MGMT. LEGISLATIVE STAFF, LAWS PROHIBITING DISCRIMINATION BASED ON SEXUAL ORIENTATION AND GENDER IDENTITY 4, 7 (2007).

171 See Priest, Government, supra note 156, at 223; Priest, Manuscript, supra note 156, at 10-11.

172 Priest, Manuscript, supra note 156, at 11.

173 See id. at 9 n.19. This conversion generally makes risks uninsurable. See id. They may nevertheless be covered if it is cost-effective for the insurer.

174 See id.

175 See ABRAHAM, supra note 119, at 533-46.

176 Smith et al., supra note 61, at 589.

177 See, e.g., Padian et al., supra note 2, at 591-92; Rotheram-Borus et al., supra note 1, at 150-51; van der Straten et al., supra note 58.

178 Cf. Underhill et al., Implementation Science, supra note 19, at 214.

179 Jost, supra note 110.

180 See Rotheram-Borus et al., supra note 1, at 150.

181 This may inadvertently increase the incentives for ex ante moral hazard among policyholders seeking to qualify for coverage.

182 See Andrew Pollack, Coupons for Patients, but Higher Bills for Insurers, N.Y. TIMES, Jan. 1, 2011, http://www.nytimes.com/2011/01/02/business/02coupon.html?_r=1.

183 Massachusetts has prohibited this practice. Id. In Colorado, it is a criminal offense for healthcare providers to finance or waive patients’ deductibles for purposes other than charity. COLO. REV. STAT. § 18-13-119 (2011). These practices “increas[e] [healthcare] costs by removing the incentive that copayments and deductibles create in making the consumer a cost conscious purchaser of [healthcare].” Id.

184 Pollack, supra note 182.

185 See CALABRESI, supra note 114, at 39, 42.

186 See id. at 42, 47-48.

187 See Priest, Government, supra note 156, at 225-28.

188 Rosenbaum, Sara & Rousseau, David, Medicaid at Thirty-Five, 45 ST. LOUIS U. L.J. 7, 11-14 (2001)Google Scholar (“Because it is not concerned with ‘risk,’ Medicaid does not restrict coverage to persons with insurable risks … . The result is an ability to respond to national health policy priorities whose resolution extends beyond the limits of conventional insurance.”).

189 Poundstone, K.E. et al., The Social Epidemiology of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome, 26 EPIDEMIOLOGIC REVS. 22 (2004).CrossRefGoogle ScholarPubMed

190 Cf. id. at 24 fig.1; Rotheram-Borus et al., supra note 1, at 144-47.

191 Operario, Don & Underhill, Kristen, Community-Embedded Approach to Understanding HIV Risk Behaviour: Examples from Transgender Women in San Francisco, 28 CURARE 281 (2005).Google Scholar

192 Id.

193 Id.

194 See infra Section V.A.

195 See Berenson, Robert A. & Dowd, Bryan E., Medicare Advantage Plans at a Crossroads—Yet Again, 28 HEALTH AFF. (WEB EXCLUSIVE) w29, w35 (2008)CrossRefGoogle Scholar, available at http://content.healthaffairs.org/content/28/1/w29.full.pdf+html (“Commercial insurers also look to Medicare to make initial technology approval decisions and to initiate more-aggressive payment denials … .”), cited in JACOB S. HACKER, THE CASE FOR PUBLIC PLAN CHOICE IN NATIONAL HEALTH REFORM: KEY TO COST CONTROL AND QUALITY COVERAGE 14 (2008), available at http://institute.ourfuture.org/files/Jacob_Hacker_Public_Plan_Choice.pdf.

196 HACKER, supra note 195, at 14.

197 See, e.g., Hall, H. Irene et al., Estimation of HIV Incidence in the United States, 300 JAMA 520, 524 (2008)CrossRefGoogle ScholarPubMed; Div. of HIV/AIDS Prevention, Epidemiology of HIV Infection Through 2010, CDC, http://www.cdc.gov/hiv/topics/surveillance/resources/slides/general/slides/general.pdf (last visited Mar. 2, 2012).

198 See generally Kellogg, Timothy A. et al., Incidence of Human Immunodeficiency Virus Among Male-to-Female Transgendered Persons in San Francisco, 28 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES 380 (2001).CrossRefGoogle ScholarPubMed

199 Kates & Levi, supra note 13, at S255.

200 PAUL FRONSTIN, EMP. BENEFIT RESEARCH INST., ISSUE BRIEF: SOURCES OF HEALTH INSURANCE AND CHARACTERISTICS OF THE UNINSURED: ANALYSIS OF THE MARCH 2011 CURRENT POPULATION SURVEY 5 fig.1 (2011), available at http://www.ebri.org/pdf/briefspdf/EBRI_IB_09-2011_No362_Uninsured1.pdf.

201 Sanchez, Travis et al., Human Immunodeficiency Virus (HIV) Risk, Prevention, and Testing Behaviors–United States, National HIV Behavioral Surveillance System: Men Who Have Sex with Men, November 2003—April 2005, 55 MORBIDITY & MORTALITY WKLY. REP. (SURVEILLANCE SUMMARIES NO. SS-6) 1, 5 tbl.1 (2006).Google ScholarPubMed

202 Bernstein, Kyle T. et al., Same-Sex Attraction Disclosure to Health Care Providers Among New York City Men Who Have Sex with Men, 168 ARCHIVES INTERNAL MED. 1458, 1460 tbl.1 (2008).CrossRefGoogle ScholarPubMed

203 See, e.g., Cronquist, Alicia et al., Health Care Utilization Among Young Adult Injection Drug Users in Harlem, New York, 13 J. SUBSTANCE ABUSE 17, 20 tbl.1 (2001)CrossRefGoogle ScholarPubMed; Risser, Jan et al., Gender Differences in Social Support and Depression Among Injection Drug Users in Houston, Texas, 36 AM. J. DRUG & ALCOHOL ABUSE 18, 20 (2010).CrossRefGoogle ScholarPubMed

204 Cronquist et al., supra note 203, at 21 (finding that 52% of participants surveyed had Medicaid or Medicare, while the remainder were uninsured); Mehta, Shruti H. et al., Limited Uptake of Hepatitis C Treatment Among Injection Drug Users, 33 J. COMMUNITY HEALTH 126, 128 (2008)CrossRefGoogle ScholarPubMed (finding that 36% of participants had Medicaid, and 37% were uninsured).

205 See, e.g., Kootenai Hosp. Dist. v. Bonner Cnty. Bd. of Comm’rs, 233 P.3d 1212, 1213 (Idaho 2010) (describing rescission of a private insurance policy because the applicant had received prior treatment for substance use); Watson v. Golden Rule Ins. Co., 564 N.E.2d 302, 305 (Ind. App. Ct. 1990).

206 Clements-Nolle, Kristen et al., HIV Prevalence, Risk Behaviors, Health Care Use, and Mental Health Status of Transgender Persons: Implications for Public Health Intervention, 91 AM. J. PUB. HEALTH 915, 919 tbl.4 (2001).Google ScholarPubMed

207 Sanchez, Nelson F. et al., Health Care Utilization, Barriers to Care, and Hormone Usage Among Male-to-Female Transgender Persons in New York City, 99 AM. J. PUB. HEALTH 713, 715 tbl.1 (2009).CrossRefGoogle ScholarPubMed

208 FRONSTIN, supra note 200, at 17 fig.16.

209 Ayanian, John Z. et al., Unmet Health Needs of Uninsured Adults in the United States, 284 JAMA 2061, 2063 tbl.1 (2000).CrossRefGoogle ScholarPubMed

210 Wu, Li-Tzy et al., Substance Use, Dependence, and Service Utilization Among the US Uninsured Nonelderly Population, 93 AM. J. PUB. HEALTH 2079, 2081 (2003).CrossRefGoogle ScholarPubMed

211 Wingood, Gina M. & DiClemente, Ralph J., Application of the Theory of Gender and Power to Examine HIV-Related Exposures, Risk Factors, and Effective Interventions for Women, 27 HEALTH EDUC. BEHAV. 539, 547, 556 (2000).Google ScholarPubMed

212 FRONSTIN, supra note 200, at 14.

213 Div. of HIV/AIDS Prevention, supra note 197, at 29.

214 FRONSTIN, supra note 200, at 16 fig.15.

215 Poundstone et al., supra note 189, at 26.

216 See Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566 (2012).

217 Patient Protection and Affordable Care Act § 1501, 26 U.S.C.A. § 5000A (West 2012). Much of the ACA debate focused on the individual mandate. See, e.g., Kapp, Marshall B., If We Can Force People to Purchase Health Insurance, Then Let's Force Them to Be Treated Too, 38 AM. J.L. & MED. 397 (2012)CrossRefGoogle ScholarPubMed; Lawson, Gary & Kopel, David B., The PPACA in Wonderland, 38 AM. J.L. & MED. 269, 277-87 (2012)CrossRefGoogle Scholar (discussing the unconstitutionality of the individual mandate).

218 Patient Protection and Affordable Care Act § 1501(f).

219 Id. § 1501(d).

220 Id. § 1501(a).

221 Id. § 1201.

222 Id. § 2001.

223 Id.

224 Letter from the Cong. Budget Office to Nancy Pelosi, Speaker, House of Representatives, at 9 (Mar. 20, 2010), available at http://www.cbo.gov/ftpdocs/113xx/doc11379/AmendReconProp.pdf; see also Summary of Coverage Provisions in the Affordable Care Act, KAISER FAMILY FOUND. http://www.kff.org/healthreform/upload/8023-R.pdf (last updated July 27, 2012).

225 Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, 2607 (2012).

226 Id.

227 See, e.g., Michael Cooper, Many Governors Are Still Unsure About Medicaid Expansion, N.Y. TIMES, July 14, 2012, http://www.nytimes.com/2012/07/15/us/governors-face-hard-choices-over-medicaid-expansion.html; Abby Goodnough, Lines Are Drawn over Opting out of Medicaid Plan, N.Y. TIMES, July 12, 2012, http://www.nytimes.com/2012/07/13/health/policy/in-florida-a-fight-brews-over-governors-vow-to-opt-out-of-medicaid-expansion.html?pagewanted=all.

228 Mimiaga et al., supra note 4, at 80.

229 Barash, Elizabeth Anne & Golden, Matthew, Awareness and Use of HIV Pre-Exposure Prophylaxis Among Attendees of a Seattle Gay Pride Event and Sexually Transmitted Disease Clinic, 24 AIDS PATIENT CARE & STDS 689, 690 (2010).CrossRefGoogle ScholarPubMed

230 See, e.g., Eisingerich et al., supra note 4; Mimiaga et al., supra note 4, at 80.

231 See, e.g., Newman, Peter A. et al., Preventive HIV Vaccine Acceptability and Behavioral Risk Compensation Among a Random Sample of High-Risk Adults in Los Angeles, 44 HEALTH SERVICES RES. 2167 (2010).CrossRefGoogle Scholar

232 Hammett, Theodore M. et al., Acceptability of Formulations and Application Methods for Vaginal Microbicides Among Drug-Involved Women: Results of Product Trials in Three Cities, 27 SEXUALLY TRANSMITTED DISEASES 119, 124 (2000).CrossRefGoogle ScholarPubMed

233 Corso et al., supra note 12, at 97-98.

234 See FRONSTIN, supra note 200, at 5 fig.1.

235 STEVEN PLITT ET AL., COUCH ON INSURANCE § 144:32-:34 (West 3d ed. 2010).

236 See Employee Retirement Income Security Act, 29 U.S.C. § 1181-91 (2006); Patient Protection and Affordable Care Act, Pub L. No. 111-148, 124 Stat. 119 (2010) (to be codified as amended primarily in scattered sections of 42 U.S.C.).

237 See Metro. Life Ins. v. Massachusetts, 471 U.S. 724 (1985).

238 Patient Protection and Affordable Care Act § 1302.

239 PLITT ET AL., supra note 235, § 144:2.

240 Id. § 144.3. Debate still occurs over how to define what constitutes a “medical necessity” and similar terms. See also Jessie Hill, B., What Is the Meaning of Health? Constitutional Implications of Defining “Medical Necessity” and “Essential Health Benefits” Under the Affordable Care Act, 38 AM. J.L. & MED. 445 (2012).CrossRefGoogle Scholar

241 PLITT ET AL., supra note 235, § 144:32, .34.

242 Id. § 144.34.

243 See Blanchard, Timothy P., “Medical Necessity” Determinations—A Continuing Healthcare Policy Problem, 37 J. HEALTH L. 599 (2004)Google ScholarPubMed; Hall, Mark A. & Anderson, Gerard F., Health Insurers’ Assessment of Medical Necessity, 140 U. PA. L. REV. 1637, 1645 (1992)CrossRefGoogle Scholar; Sage, William M., Managed Care's Crimea: Medical Necessity, Therapeutic Benefit, and the Goals of Administrative Process in Health Insurance, 53 DUKE L.J. 597 (2003).Google ScholarPubMed

244 See, e.g., Succession of Coddington v. Time Ins. Co., 26,992 (La. App. 2 Cir. 5/10/95); 658 So.2d 1326.

245 E.g., Price v. State Capital Life Ins. Co., 134 S.E.2d 171, 173 (N.C. 1964) (“‘[S]ickness’ is a condition interfering with one's usual activities, whereas disease may exist without such result.”).

246 PLITT ET AL., supra note 235, § 144:32.

247 Id. § 144.33 (citing McGregor v. Gen. Acc. Fire & Life Assur. Corp., 198 S.E. 641 (N.C. 1938)); see also Aetna Life Ins. Co. v. Hays, 510 So. 2d 829, 830 (Ala. Civ. App. 1987) (“‘Disease’ … is a serious illness, which has impaired the constitution or left in its wake some organic or chronic effect undermining general health.”)

248 Hall & Anderson, supra note 243, at 1646 n.27.

249 PLITT ET AL., supra note 235, § 22:14.

250 Id. § 144.4.

251 Id.; see Hall & Anderson, supra note 243, at 1648-49; see also ABRAHAM, supra note 119, at 37.

252 Hall & Anderson, supra note 243, at 1648.

253 See, e.g., Maxa v. John Alden Life Ins. Co., 972 F.2d 980 (8th Cir. 1992); Brewer v. Lincoln Nat’l Life Ins. Co., 921 F.2d 150 (8th Cir. 1990), cited in PLITT ET AL., supra note 235, § 144:4.

254 Smith v. Hartford Ins. Grp., 6 F.3d 131, 140 n.9 (3d Cir. 1993); see also Barnes v. Indep. Auto. Dealers Ass’n of Cal. Health & Welfare Benefit Plan, 64 F.3d 1389 (9th Cir. 1995); Phillips v. Lincoln Nat’l Life Ins. Co., 978 F.2d 302 (7th Cir. 1992). But see Winters v. Costco Wholesale Corp., 49 F.3d 550, 554 (9th Cir. 1995) (holding contra proferentum does not apply when self-funded ERISA plan grants administrator explicit discretion to determine eligibility).

255 Hunter v. N. Am. Co. for Life & Health Ins., 671 F. Supp. 2d 1182, 1186, 1188 (S.D. Cal. 2009); see also Citizens Ins. Co. of Am. v. MidMichigan Health ConnectCare Network Plan, 449 F.3d 688, 692 (6th Cir. 2006); Peterson v. Am. Life & Health Ins. Co., 48 F.3d 404, 411 (9th Cir. 1995).

256 SARA ROSENBAUM ET AL., U.S. DEP't OF HEALTH & HUMAN SERVS., MEDICAL NECESSITY IN PRIVATE HEALTH PLANS: IMPLICATIONS FOR BEHAVIORAL HEALTHCARE, 64 tbl.5 (2003), available at http://sphhs.gwu.edu/departments/healthpolicy/dhp_publications/pub_uploads/dhpPublication_3A45C497-5056-9D20-3DAA24F165B5678A.pdf.

257 Employee Retirement Income Security Act § 503, 29 U.S.C. § 1133 (2006).

258 See 29 C.F.R. § 2560.503-1(b) (2011).

259 Patient Protection and Affordable Care Act § 1001, 42 U.S.C.A. § 300gg-19 (West 2012).

260 Employee Retirement Income Security Act § 502; see also ABRAHAM, supra note 119, at 385.

261 Interim Final Rules for Group Health Plans and Health Insurance Issuers, 75 Fed. Reg. 43,329, 43,334 (July 23, 2010) (to be codified at 26 C.F.R. pts. 54, 602; 29 C.F.R. pt. 2590; 45 C.F.R. pt. 147).

262 ABRAHAM, supra note 119, at 385.

263 Id.

264 ROSENBAUM ET AL., supra note 256, at 20.

265 KAREN POLITZ ET AL., KAISER FAMILY FOUND., ASSESSING STATE EXTERNAL REVIEW PROGRAMS AND THE EFFECTS OF PENDING FEDERAL PATIENTS’ RIGHTS LEGISLATION 3 (2002), cited in Sage, supra note 243, at 625.

266 For more information, see HEALTH CARE COVERAGE DETERMINATIONS: AN INTERNATIONAL COMPARATIVE STUDY (Timothy Stoltzfus Jost ed., 2005); RICHARD A. RETTIG, HEALTH CARE IN TRANSITION: TECHNOLOGY ASSESSMENT IN THE PRIVATE SECTOR (1997); Garber, Alan M., Cost-Effectiveness and Evidence Evaluation as Criteria for Health Policy, 23 HEALTH AFF. (WEB EXCLUSIVE) W4-284 (2004)Google Scholar [hereinafter Garber, Cost-Effectiveness], available at http://content.healthaffairs.org/content/early/2004/05/19/hlthaff.w4.284.full.pdf+html; Garber, Evidence-Based, supra note 153; Parisi, Thomas J., How Much Did You Pay for Your Heart: Is a Centralized Entity Performing Health Technology Assessment with Cost-Effectiveness Analysis the Answer to the Rising Costs of Health Care? , 49 JURIMETRICS 285 (2009).Google Scholar

267 RETTIG, supra note 266, at 3 (quoting COMM. FOR EVALUATING MED. TECHS. IN CLINICAL USE, INST. OF MED., ASSESSING MEDICAL TECHNOLOGIES 2 (Frederick Mosteller et al. eds., 1985)); see also Parisi, supra note 266.

268 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 4-5.

269 Id. at 208.

270 Id.

271 Linda Bergthold et al., Using Evidence and Cost in Managed Care Decision-Making 9 (Aug. 23, 2002) (unpublished manuscript), available at http://content.healthaffairs.org/content/suppl/2009/11/25/hlthaff.w4.284v1.DC2/garber_supp.pdf.

272 Trosman, Julia R. et al., Health Technology Assessments and Private Payers’ Coverage of Personalized Medicine, 7 J. ONCOLOGY PRAC., no. 3S, 2011 at 18s, 19s.Google Scholar

273 Parisi, supra note 266, at 292-93.

274 Id. at 292.

275 Id.

276 See Garber, Evidence-Based, supra note 153, at 69.

277 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 208.

278 Garber, Evidence-Based, supra note 153, at 75.

279 Parisi, supra note 266, at 293.

280 Garber, Cost-Effectiveness, supra note 266, at W4-290.

281 Id.

282 See HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 8-9 (citing NORMAN DANIELS & JAMES E. SABIN, SETTING LIMITS FAIRLY: LEARNING TO SHARE RESOURCES FOR HEALTH (2002)).

283 See ROSENBAUM ET AL., supra note 256, at 11.

284 See HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 8-9.

285 See, e.g., Interim Final Rules for Group Health Plans and Health Insurance Issuers, 75 Fed. Reg. 43,329, 43,344 (July 23, 2010) (to be codified at 26 C.F.R. pts. 54, 602; 29 C.F.R. pt. 2590; 45 C.F.R. pt. 147).

286 MARK A. HALL ET AL., THE LAW OF HEALTH CARE FINANCE AND REGULATION 270 (2d ed. 2008); Blanchard, supra note 243, at 600.

287 Blanchard, supra note 243, at 600.

288 42 C.F.R. § 440.230(d) (2011).

289 Garber, Cost-Effectiveness, supra note 266, at W4-293.

290 42 U.S.C.A. § 1395y(a)(1)(A) (West 2012).

291 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 209-19.

292 42 C.F.R. § 431.205(a)-(b) (2011); 42 U.S.C.A. § 1396a(a)(3).

293 42 C.F.R. § 431.233(a) (2011).

294 Kinney, Eleanor D., Procedural Protections for Patients in Capitated Health Plans, 22 AM. J.L. & MED. 301, 318 (1996).Google ScholarPubMed

295 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 220.

296 42 C.F.R. § 405.1000 (2011).

297 Id. § 405.1100.

298 Id. § 405.1136.

299 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 219.

300 Id. at 214-16.

301 Id. at 230.

302 Garber, Cost-Effectiveness, supra note 266, at W4-293.

303 Parisi, supra note 266, at 301.

304 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266266, at 229.

305 Garber, Cost-Effectiveness, supra note 266, at W4-293.

306 See Parisi, supra note 266, at 299, 301; PETER J. NEUMANN, USING COST-EFFECTIVENESS TO IMPROVE HEALTH CARE 19 (2005); HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 217-18; Garber, Evidence-Based, supra note 153, at 71.

307 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 218.

308 Parisi, supra note 266, at 302. Oregon's famous experiment with cost-effectiveness based on quality-adjusted life-year gains was heavily criticized. Id.

309 Sullivan, Sean D. et al., Health Technology Assessment in Health-Care Decisions in the United States, 12 VALUE IN HEALTH (SUPP. 2) S39, S40 (2009).CrossRefGoogle ScholarPubMed

310 Id.

311 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 212; see also Parisi, supra note 266, at 301.

312 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 213.

313 Id.

314 Id.

315 Parisi, supra note 266, at 301.

316 HEALTH CARE COVERAGE DETERMINATIONS, supra note 266, at 215.

317 Parisi, supra note 266, at 301.

318 Id.

319 Id.

320 See generally Hill, supra note 240 (explaining the difficulty in defining medical necessity).

321 Jost, supra note 110, at 3; PLITT ET AL., supra note 235, § 181:1.

322 Jost, supra note 110, at 1.

323 Hall & Anderson, supra note 243, at 1646; Sage, supra note 243, at 605.

324 Jost, supra note 110, at 1-2.

325 Id.

326 Kesselheim, Aaron Seth, What's the Appeal? Trying to Control Managed Care Medical Necessity Decisionmaking Through a System of External Appeals, 149 U. PA. L. REV. 873, 874-75 (2001).CrossRefGoogle Scholar

327 See supra note 259 and accompanying text.

328 Blanchard, supra note 243, at 600.

329 See Schroeder by Swanson v. Blue Cross & Blue Shield, United of Wisconsin, 450 N.W.2d 470, 475 (Wis. Ct. App. 1989).

330 Sage, supra note 243, at 605; see also PLITT ET AL., supra note 235, § 181:1.

331 For a fuller discussion, see ROSENBAUM ET AL., supra note 256; Blanchard, supra note 243; Glazier, Alexandra K., Genetic Predispositions, Prophylactic Treatments and Private Health Insurance: Nothing Is Better than a Good Pair of Genes, 23 AM. J.L. & MED. 45 (1997)Google ScholarPubMed; Kesselheim, supra note 326; Sage, supra note 243; Singer, Sara J. & Bergthold, Linda A., Prospects for Improved Decision Making About Medical Necessity, 20 HEALTH AFF. 200 (2007).CrossRefGoogle Scholar

332 ROSENBAUM ET AL., supra note 256, at 45-63 tbls.1, 2, 3 & 4 (gathering medical necessity definitions from published literature, managed care documents, judicial decisions, and state statutes).

333 Id. at 25. A variety of synonyms have been used in contracts to specify this concept. See PLITT ET AL., supra note 235, § 181:1.

334 See, e.g., Weiss v. CIGNA Healthcare, Inc., 972 F. Supp. 748, 755 (S.D.N.Y. 1997); see also Hughes v. Blue Cross of N. Cal., 263 Cal. Rptr. 850 (Ct. App. 1989).

335 ROSENBAUM ET AL., supra note 256, at 20.

336 Id.

337 See, e.g., COUNCIL ON MED. SERV., AM. MED. ASS’N, CMS REPORT 13 – I-99, REPORT OF THE COUNCIL ON MEDICAL SERVICE 1 (1999).

338 Medical Necessity Definition: Model Medicaid Managed Care Contract Provisions, NAT’L HEALTH LAW PROGRAM, http://www.healthlaw.org/index.php?option=com_content&view=article&id=281:medical-necessity-definition-model-medicaid-managed-care-contract-provisions&catid=42 (last visited Oct. 27, 2012). The insurance industry trade group, America's Health Insurance Plans, also encourages insurers to consult preventive care guidelines when issuing coverage determinations. See Public Health and Prevention Statements of Support, AM.'s HEALTH INS. PLANS, http://216.52.120.13/content/default.aspx?bc=38|65|20356|285 (last updated July 18, 2007).

339 31 JOHN ALAN APPLEMAN, APPLEMAN ON INSURANCE 2D § 186.03 (2007).

340 Harrison v. Aetna Life Ins. Co., 925 F. Supp. 744, 748 (M.D. Fla. 1996).

341 Abernathy v. Prudential Ins. Co. of Am., 264 S.E.2d 836, 838 (S.C. 1980).

342 See 46 C.J.S. Insurance § 1337 (2007).

343 See, e.g., Carmouche v. CNA Ins. Cos., 535 So.2d 1279 (La. Ct. App. 1988) (finding that the trial court may afford greater weight and probative value to testimony of the treating physician); Shumake v. Travelers Ins. Co., 383 N.W.2d 259, 264 (Mich. Ct. App. 1985).

344 1 EMPLOYMENT COORDINATOR BENEFITS § 5:10 (2011) (citing Donaho v. FMC Corp., 74 F.3d 894 (8th Cir. 1996)).

345 31 APPLEMAN, supra note 339, § 186.03; PLITT ET AL., supra note 235, § 181:2; see, e.g., Sheppard & Enoch Pratt Hosp., Inc. v. Travelers Ins. Co., 32 F.3d 120 (4th Cir. 1994).

346 Tillery v. Hoffman Enclosures, Inc., 280 F.3d 1192, 1199 (8th Cir. 2002); Franks v. La. Health Servs. & Indem. Co., 382 So. 2d 1064, 1068 (La. Ct. App. 1980).

347 See supra Section IV.B.1.

348 See, e.g., Wait v. Metro. Life Ins. Co., 564 N.Y.S.2d 535 (App. Div. 1990) (“[Plaintiffs’ affidavit] does not argue that any medical diagnosis exists … .”).

349 See supra notes 144-147 and accompanying text.

350 See PLITT ET AL., supra note 235, at § 181:3 (“The high cost of prophylactic treatments has led insurers to resist coverage on the grounds that prophylactic measures are not medically necessary because they do not treat an actual disease.”).

351 Div. of HIV/AIDS Prevention, supra note 197.

352 See generally AM. PSYCHOLOGICAL ASSOC., APA POLICY STATEMENTS ON LESBIAN, GAY, BISEXUAL, & TRANSGENDER CONCERNS 3 (2011), available at http://www.apa.org/about/policy/booklet.pdf (describing the American Psychiatric Association's decision to remove homosexuality from the official list of mental disorders, emphasizing that “the American Psychological Association urges all mental health professionals to take the lead in removing the stigma of mental illness that has long been associated with homosexual orientations”); see also id. at 29 (describing how efforts to promote homosexuality as “symptomatic” often appear “embedded within the larger context of conservative religious political movements that have supported the stigmatization of homosexuality on political or religious grounds”).

353 See Div. of HIV/AIDS Prevention, supra note 197.

354 ROSENBAUM ET AL., supra note 256, at 19.

355 See, e.g., Underhill et al., Implementation Science, supra note 19, at 214 (discussing the potential reluctance of policymakers to finance PrEP when behavioral prevention strategies could be used instead).

356 Garber, Cost-Effectiveness, supra note 266, at W4-290.

357 Mount Sinai Hosp. v. Zorek, 271 N.Y.S.2d 1012 (Civ. Ct. 1966), cited in 31 APPLEMAN, supra note 339, § 186.03.

358 These claims would likely also fail on the grounds that the HIV-infected partner is not the policyholder; providing this care would require the insurer to incur the costs of treating an HIV infection, in the hopes that the policyholder would not also become infected.

359 See Leibowitz et al., supra note 77, at 143; Morris et al., supra note 77.

360 See Landovitz & Currier, supra note 31; Jill Cadman, PEP Talk, THE BODY (July/Aug. 1999), http://www.thebody.com/content/art13461.html (noting that insurers may refuse to cover all the costs of PEP).

361 Cadman, supra note 360.

362 See supra note 56 and accompanying text.

363 Shen, supra note 129.

364 See supra Section V.A.2.

365 Substance abuse treatment has been denied on grounds of medical necessity, but these cases either lack a final decision on the merits or were factually unique. Jones v. Kodak Med. Assistance Plan, 169 F.3d 1287, 1290 (10th Cir. 1999) (ERISA plan granted administrator “full discretion to determine eligibility for benefits,” and external medical examiner found that the policyholder did not meet the policy's medical criteria for inpatient care); Koenig v. Metro. Life Ins. Co., No. 92 C 5588, 1993 WL 45944, at *1 (N.D. Ill. Feb. 17, 1993) (insurer cited policyholder's “numerous past treatment opportunities” and “lack of personal responsibility”). Both cases were also cited by ROSENBAUM ET AL., supra note 256, at 21.

366 See Mental Health Benefits: State Laws Mandating or Regulating Mental Health Benefits, NATIONAL CONFERENCE OF STATE LEGISLATURES, http://www.ncsl.org/issues-research/health/mental-health-benefits-state-laws-mandating-or-re.aspx (last updated Dec. 2011).

367 See 42 U.S.C.A. § 300gg-26 (West 2011).

368 See Patient Protection and Affordable Care Act § 1302, 42 U.S.C.A. § 18022 (West 2012) (defining “[m]ental health and substance use disorder services” as part of an “essential health benefits package”).

369 See Tudor v. Metro. Life Ins. Co. 539 N.Y.S.2d 690, 691-92 (Dist. Ct. 1989).

370 See, e.g., CAL. HEALTH BENEFITS REVIEW PROGRAM, EXECUTIVE SUMMARY: ANALYSIS OF ASSEMBLY BILL 1894: HIV TESTING (2008), available at http://www.chbrp.org/docs/index.php?action=read&bill_id=45&doc_type=2.

371 Koh & Sebelius, supra note 124, at 1297; see also Patient Protection and Affordable Care Act § 2713.

372 Patient Protection and Affordable Care Act § 4106; Jost, supra note 110.

373 USPSTF A and B Recommendations, U.S. PREVENTIVE SERVS. TASK FORCE, http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm (last updated Aug. 2010).

374 U.S. Preventive Servs. Task Force, Screening for HIV: Recommendation Statement, 143 ANNALS INTERNAL MED. 32, 33 (2005) (emphasis added).CrossRefGoogle Scholar

375 See, e.g., Thompson, Melanie A. et al., Antiretroviral Treatment of Adult HIV Infection: 2010 Recommendations of the International AIDS Society—USA Panel, 304 JAMA 321, 322-23 (2010)CrossRefGoogle ScholarPubMed (recommending expanding highly active antiretroviral therapy, also known as HAART, eligibility to asymptomatic patients with a CD4 cell count of 500 per μL, which is less severe than prior recommendations indicate, as well as to patients when there is “a heightened risk of HIV transmission,” such as serodiscordant couples).

376 See, e.g., Kitahata, Mari M. et al., Effect of Early Versus Deferred Antiretroviral Therapy for HIV on Survival, 360 NEW ENG. J. MED. 1815 (2009)CrossRefGoogle ScholarPubMed; Severe, Patrice et al., Early Versus Standard Antiretroviral Therapy for HIV-Infected Adults in Haiti, 363 NEW ENG. J. MED. 257 (2010).CrossRefGoogle ScholarPubMed

377 Weaver v. Reagan, 886 F.2d 194, 198 (8th Cir. 1989), cited in HALL ET AL., supra note 286, at 271.

378 ME. REV. STAT. ANN. tit. 24, § 2320-G (West 2012); ME. REV. STAT. ANN. tit. 24-A, §§ 2745-F, 2837-G, 4234-E (West 2012); MASS. GEN. LAWS ANN. ch. 175, §§ 47O, 47P (West 2012); MASS. GEN. LAWS ANN. ch. 176A, § 8Q (West 2012); MASS. GEN. LAWS ANN. ch. 176B, § 4P (West 2012); MASS. GEN. LAWS ANN. ch. 176G, § 4G (West 2012).

379 For more information, see Ader, Mary, Investigational Treatments: Coverage, Controversy, and Consensus, 5 ANNALS HEALTH L. 45 (1997)Google Scholar; Francis, Leslie Pickering, Legitimate Expectations, Unreasonable Beliefs, and Legally Mandated Coverage of Experimental Therapy, 1 IND. HEALTH L. REV. 213 (2004)CrossRefGoogle Scholar; Hoffman, Sharona, A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments, 78 OR. L. REV. 203 (1999)Google Scholar; Lahr, J. Gregory, Commentary, What is the Method to their “Madness?”: Experimental Treatment Exclusions in Health Insurance Policies, 13 J. CONTEMP. HEALTH L. & POL’Y 613 (1997).Google ScholarPubMed

380 See PLITT ET AL., supra note 235, § 181:4 (specifying these two types of denials).

381 See supra Sections II.B, II.D.

382 Although the preventive effects of dual-purpose technologies such as substance use treatment and STI treatment were also discovered recently, these likely will not receive experimental treatment denials. Policyholders seeking these technologies can instead claim that they are seeking the dual-purpose care for its treatment or diagnostic effect, instead of its more recently discovered preventive purpose.

383 PLITT ET AL., supra note 235, §181:4 (citing Lahr, supra note 379).

384 Hoffman, supra note 379, at 208-09 (citing references). See also ROSENBAUM ET AL., supra note 256 (collecting definitions of medical necessity in several dozen cases, which included twenty-two denials of experimental care).

385 PLITT ET AL., supra note 235, § 181:5 (citing cases including Dahl-Eimers v. Mut. of Omaha Life Ins. Co., 986 F.2d 1379 (11th Cir. 1993); Lubeznik v. HealthChicago, Inc., 644 N.E.2d 777 (Ill. App. Ct. 1994)).

386 Id.

387 See Fuja v. Benefit Trust Life Ins. Co., 18 F.3d 1405, 1412 (7th Cir. 1994) (suggesting that some experimental treatments “are so cost prohibitive that requiring insurers to cover them might result in the collapse of the healthcare industry”).

388 PLITT ET AL., supra note 235, § 181:5; see, e.g., Fuja, 18 F.3d at 1411.

389 Rollo by Rollo v. Blue Cross/Blue Shield of N.J., Civ. A. No. 90-597, 1990 WL 312647, at *7 (D.N.J. Mar. 22, 1990), cited in 2 J. PETER RICH & SUSAN M. NASH, AM. HEALTH LAWYERS ASSOC., HEALTH LAW PRACTICE GUIDE § 18:11 (2012).

390 See, e.g., Steinberg, Earl P. et al., Insurance Coverage for Experimental Technologies, 14 HEALTH AFF. 143, 149-150 (1995).CrossRefGoogle ScholarPubMed

391 Id. at 150.

392 Am. Soc’y of Cataract & Refractive Surgery v. Sullivan, 772 F. Supp. 666, 672-73 (D.D.C. 1991), vacated, 986 F.2d 546 (D.C. Cir. 1993).

393 Dresser, Rebecca & Frader, Joel, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 J.L. MED. & ETHICS 476, 476 (2009)CrossRefGoogle Scholar; Ratner, Mark & Gura, Trisha, Off-Label or Off-Limits?, 26 NATURE BIOTECHNOLOGY 867, 867 (2008).CrossRefGoogle ScholarPubMed

394 See supra Section II.A.3.

395 See Dresser & Frader, supra note 393, at 478, 482-83.

396 Cohen, Joshua et al., Off-Label Use Reimbursement, 64 FOOD & DRUG L.J. 391, 392 (2009)Google ScholarPubMed; Fugh-Berman, Adriane & Melnick, Douglas, Off-Label Promotion, On-Target Sales, 5 PLOS MED. 1432, 1432 (2008).CrossRefGoogle ScholarPubMed

397 See, e.g., Cassanese v. United Healthcare Ins. Co., No. 8:08-cv-373-T-26MAP, 2008 WL 4642292 (M.D. Fla. Oct. 20, 2008).

398 See I.V. Servs. of Am., Inc. v. Trustees of the Am. Consulting Engineers Council Ins. Trust Fund, 136 F.3d 114, 119-20 (2d Cir. 1998).

399 See Cohen et al., supra note 396, at 396-97.

400 See id. at 396 (also noting that Medicare has recently added three compendia to its list of approved uses); see also 42 U.S.C.A. § 1396r-8(g)(1)(B)(i) (West 2012) (noting that the drug use review program will examine covered drugs against standards consistent with three compendia and peer-reviewed medical literature).

401 Pearson, Steven D. et al., Medicare's Requirement for Research Participation as a Condition of Coverage: Is It Ethical?, 296 JAMA 988, 988 (2006).CrossRefGoogle Scholar

402 See Wang, Sally, Recent Case Development, False Claims Act: The Right Treatment for Off-Label Marketing?, 38 J.L. MED. & ETHICS 708 (2010).CrossRefGoogle ScholarPubMed

403 See Cohen et al., supra note 396, at 396-97.

404 See id. at 396 (“Generally, whether an off-label use is reimbursable depends on its inclusion in one or more recognized pharmaceutical compendia … . If a compendium … is not at hand, off-label use reimbursement may depend on publication of supportive clinical evidence for the particular indication in peer-reviewed medical literature or clinical practice guidelines established by medical professional societies.”).

405 For an example of one such policy provision, see Haw. Med. Serv. Ass’n v. Adams, 209 P.3d 1260, 1263 n.5 (Haw. Ct. App. 2009).

406 See Francis, supra note 379, at 235.

407 Id.

408 See, e.g., MASS. GEN. LAWS ANN. ch. 175, § 47O (West 2012); see also Francis, supra note 382, at 235 (collecting statutes).

409 See Francis, supra note 379, at 235 (collecting statutes).

410 These mandates do not necessarily require that the empirical evidence be of rigorous methodological quality. See, e.g., id. at 236.

411 See, e.g., CAL. HEALTH & SAFETY CODE § 1370.4 (West 2010).

412 Francis, supra note 379, at 238 (collecting statutes); 2 RICH & NASH, supra note 389, § 18:11.

413 See, e.g., Francis, supra note 379, at 232.

414 See Panlilio et al., supra note 53.

415 Id. at 1.

416 See supra Section II.A.3 and accompanying notes.

417 See, e.g., PATRICK HAZELTON, PROJECT INFORM, FINANCING AND DELIVERY MECHANISMS TO INCREASE PRE-EXPOSURE PROPHYLAXIS (PREP) ACCESS IN POPULATIONS AT HIGH-RISK OF HIV INFECTION 26 (2011), available at http://www.projectinform.org/pdf/prep_finance_0611.pdf; Shen, supra note 129.

418 See supra note 62.

419 See, e.g., C. Preston Neff et al., Oral Pre-Exposure Prophylaxis by Anti-Retrovirals Raltegravir and Maraviroc Protects Against HIV-1 Vaginal Transmission in a Humanized Mouse Model, PLOS ONE, Jan. 21, 2010, available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015257.

420 Francis, supra note 379, at 233.

421 See ME. REV. STAT. ANN. tit. 24, § 2320-G (West 2012); ME. REV. STAT. ANN. tit. 24-A, §§ 2745-F, 2837-G, 4234-E (West 2012).

422 See MASS. GEN. LAWS ANN. ch. 175, §§ 47O, 47P (West 2012); MASS. GEN. LAWS ANN. ch. 176A, § 8Q (West 2012); MASS. GEN. LAWS ANN. ch. 176B, § 4P (West 2012); MASS. GEN. LAWS ANN. ch. 176G, § 4G (West 2012).

423 See supra note 421.

424 See supra notes 421-422.

425 Garber, Evidence-Based, supra note 153, at 67.

426 CDC, supra note 70, at 5.

427 See Roni Caryn Rabin, Benefits of Circumcision Are Said to Outweigh Risks, THE N.Y. TIMES, Aug. 27, 2012, at A3; Task Force on Circumcision, Am. Acad. of Pediatrics, Circumcision Policy Statement, 130 PEDIATRICS 585 (2012).CrossRefGoogle Scholar

428 Siegfried et al., supra note 72, at 2 (citing sources).

429 See supra note 77.

430 See generally Glazier, supra note 331, at 60-62.

431 Epstein & Stannard, supra note 18, at 265.

432 Id. at 254.

433 Priest, Manuscript, supra note 156, at 8-9.

434 See Glazier, supra note 331, at 59-61.

435 See, e.g., Farley v. Ark. Blue Cross & Blue Shield, 147 F.3d 774 (8th Cir. 1998); Salvaggio v. Time Ins. Co., 553 F. Supp. 2d 577 (D.S.C. 2008); Leddy v. Miss. State Med. Ass’n, 7 F. Supp. 2d 819 (S.D. Miss. 1998).

436 Glazier, supra note 331, at 60.

437 See Lawson v. Fortis Ins. Co., 301 F.3d 159, 160 (3d Cir. 2002).

438 See PLITT ET AL., supra note 235, § 144:88-:92 (discussing standards for determining whether conditions are preexisting).

439 Id.

440 Id. § 144:39.

441 Id. (citing cases).

442 McLellan, A. Thomas et al., Drug Dependence, a Chronic Medical Illness, 284 JAMA 1689 (2000).CrossRefGoogle ScholarPubMed

443 PLITT ET AL., supra note 235, § 144:39.

444 Id.

445 See Pendo, Elizabeth, Working Sick: Lessons of Chronic Illness for Health Care Reform, 9 YALE J. HEALTH POL’Y L. & ETHICS 453, 461 n.46 (2009)Google ScholarPubMed (citing CLAUDIA H. WILLIAMS & BETH C. FUCHS, ROBERT WOOD JOHNSON FOUND., POLICY BRIEF NO. 4, EXPANDING THE INDIVIDUAL HEALTH INSURANCE MARKET: LESSONS FROM THE STATE REFORMS OF THE 1990S, at 3 fig.3 (2004), available at http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2004/rwjf18005).

446 See 42 U.S.C.A. § 300gg (West 2012); ABRAHAM, supra note 119, at 377-78.

447 Public Health Service Act § 2705(a), 42 U.S.C.A. § 300gg-4 (West 2012), amended by Patient Protection and Affordable Care Act, Pub L. No. 111-148, § 1201, 124 Stat. 119, 156 (2010).

448 Id.

449 Reed Ableson, U.S. Turns to Waivers to Address Talk of Dropping Health Coverage, N.Y. TIMES, Oct. 6, 2010, at B1; Emily Berry, Insurers Drop Child-Only Coverage on Eve of Health Reform Mandates, AM. MED. NEWS, Oct. 4, 2010, http://www.ama-assn.org/amednews/2010/10/04/bil11004.htm.

450 Rosenbaum & Rousseau, supra note 188, at 12-13.

451 See, e.g., Haw. Med. Serv. Ass’n v. Adams, 209 P.3d 1260, 1268 (Haw. Ct. App. 2009).

452 PLITT ET AL., supra note 235, § 144:56-:57.

453 See supra notes 216-221 and accompanying text.

454 These exclusions appear frequently in litigation after drunk driving accidents. See, e.g., Tourdot v. Rockford Health Plans, Inc., 439 F.3d 351 (7th Cir. 2006); Carter v. ENSCO Inc., 438 F. Supp. 2d 669 (W.D. La. 2006); Bekos v. Providence Health Plan, 334 F. Supp. 2d 1248 (D. Or. 2004).

455 ABRAHAM, supra note 119, at 401.

456 31 APPLEMAN, supra note 339, § 186.03.

457 Patient Protection and Affordable Care Act § 1311(d)(3)(B), 42 U.S.C.A. § 18031(d)(3)(B) (West 2012); CTR. FOR CONSUMER INFO. & INS. OVERSIGHT, DEP't OF HEALTH & HUMAN SERVS., ESSENTIAL HEALTH BENEFITS BULLETIN 9 (2011).

458 See Koh & Sebelius, supra note 124, at 1296.

459 Under most market conditions these increased premiums would constrict access to insurance.

460 See CALABRESI, supra note 114, at 39.

461 See supra Section III.E.3.

462 See supra Section III.E.2.

463 Rigorous privacy protections would be necessary to ensure that these data would be kept confidential.

464 See, e.g., PENNY E. MOHR ET AL., PROJECT HOPE CTR. FOR HEALTH AFFAIRS, PAYING FOR NEW MEDICAL TECHNOLOGIES: LESSONS FOR THE MEDICARE PROGRAM FROM OTHER LARGE HEALTH CARE PURCHASERS 9-12 (2003).