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The Regulatory Failure to Define Essential Health Benefits
Published online by Cambridge University Press: 06 January 2021
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Basic principles of economics suggest that health insurers should seek to avoid covering sick individuals and attempt to minimize the amount they have to spend if, despite the insurer's best efforts, such individuals enroll in coverage. The drafters of the Affordable Care Act recognized this natural tendency of insurers and put in place multiple provisions aimed at avoiding such behavior. One such tool was the requirement that all health insurers in the individual and small group markets cover an identical, comprehensive set of benefits known as the Essential Health Benefits (“EHBs”). EHBs were designed to ensure that consumers are able to access comprehensive coverage, but also to prevent insurers from trying to avoid high-risk enrollees by designing plans that appeal only to the healthy. Congress did not, however, statutorily define the full package of benefits, instead delegating primary authority for that task to the Department of Health & Human Services (“HHS”). This article argues that HHS has implemented the EHB requirements in a manner that appears structurally incapable of achieving the goals of the statute. By utilizing a vague definition of benefits, allowing benefit substitutions, and failing to limit use of service-level selection tools, HHS has permitted insurers to compete for low-risk insureds, avoid paying for certain high-cost treatments, and prevented consumers from making fully informed purchasing decisions.
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- Copyright © American Society of Law, Medicine and Ethics and Boston University 2018
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I am grateful for the feedback and comments received at faculty workshops at Duke University, Washington University, and the University of Minnesota. My thanks also go to the anonymous peer reviewers for the American Journal of Law & Medicine, whose helpful comments improved this article.
References
1 See generally Robert H. Jerry, II, Risk and Regulation in Private Insurance, in The Oxford Handbook of U.S. Health Law (I. Glenn Cohen et al. eds., 2017). See also Richman, Barak D., The Corrosive Combination of Nonprofit Monopolies and U.S.-Style Health Insurance: Implications for Antitrust and Merger Policy, 69 Law & Contemp. Probs. 139 (2006)Google Scholar (discussing the profit-seeking behavior of nonprofit entities).
2 See Jerry, supra note 1, at 738.
3 See Baker, Tom, Health Insurance, Risk, and Responsibility After the Patient Protection and Affordable Care Act, 159 U. Pa. L. Rev. 1577, 1608-10 (2011)Google Scholar.
4 See Sage, William M., Regulating Through Information: Disclosure Laws and American Health Care, 99 Colum. L. Rev. 1701, 1702-04 (1999)CrossRefGoogle ScholarPubMed. There is, however, considerable disagreement about the optimal form regulation should take. See, e.g., Baker, supra note 3, at 1597-99; Bagley, Nicholas, Federalism and the End of Obamacare, 127 Yale L.J. Forum 1, 16-18 (2017)Google Scholar.
5 Nat'l Fed'n. of Indep. Bus. v. Sebelius, 567 U.S. 519, 547-49 (2012).
6 Premiums can vary based on only four factors: age, geographic area, family size, and tobacco use. 42 U.S.C. § 300gg (2012).
7 Id. § 18022.
8 Id. § 300gg-3. Even if an insurer is able, under these constrained conditions, to somehow attract a healthier-than-average population, it would be required to make a risk-adjustment payment to the government, which would then be distributed to insurers that attract sicker-than-average populations. Id. § 18063.
9 See Mantel, Jessica, Setting National Coverage Standards for Health Plans Under Healthcare Reform, 58 UCLA L. Rev. 221, 224 (2010)Google Scholar (noting that essential health benefits will likely establish both the floor and the ceiling of the care a consumer can receive).
10 Monahan, Amy & Schwarcz, Daniel, Will Employers Undermine Health Care Reform by Dumping Sick Employees?, 97 Va. L. Rev. 125, 133 (2011)Google Scholar.
11 See Haeder, Simon F., Balancing Adequacy and Affordability?: Essential Health Benefits Under the Affordable Care Act, 118 Health Pol'y 285, 288 (2014)Google ScholarPubMed.
12 Chernew, Michael et al., Increasing Health Insurance Costs and the Decline in Insurance Coverage, 40 Health Serv. Res. 1021, 1034 (2005)CrossRefGoogle ScholarPubMed.
13 I.R.C. § 36B (2012).
14 45 C.F.R. § 156.100 (2017).
15 See Clark C. Havighurst, Health Care Choices: Private Contracts as Instruments of Health Reform 117-37 (1995).
16 See id. at 132-37.
17 See id. at 125-32.
18 Benefits are considered actuarially equivalent if, for a standardized plan population, the plan expects the benefits to have the same “value,” which in this context means cost to the insurer. 45 C.F.R. § 156.115(b) (2018).
19 Breyer, Friedrich et al., Health Care Spending Risk, Health Insurance, and Payment to Health Plans, in Handbook of Health Economics 691, 729 (Mark V. Pauly et al. eds., 2011)Google Scholar. See also Ellis, Randall P. et al., Demand Elasticities and Service Selection Incentives Among Competing Private Health Plans, 56 J. Health Econ. 352, 353 (2017)CrossRefGoogle ScholarPubMed; McGuire, Thomas G. et al., Assessing Incentives for Service-Level Selection in Private Health Insurance Exchanges, 35 J. Health Econ. 47, 48 (2014)CrossRefGoogle ScholarPubMed.
20 See, e.g., Abraham, Kenneth S., Efficiency and Fairness in Insurance Risk Classification, 71 Va. L. Rev. 403 (1985) (discussing insurers' risk classification efforts)CrossRefGoogle Scholar; Richman, supra note 1.
21 See, e.g., Dodge, John H., Predictive Medical Information and Underwriting, 35 J. L. Med. & Ethics 36 (2007)CrossRefGoogle ScholarPubMed (describing the underwriting process).
22 See Cutler, David M. & Zeckhauser, Richard J., The Anatomy of Health Insurance, in IA Handbook of Health Economics 563, 607 (Anthony J. Culyer & Joseph P. Newhouse eds., 2000)Google Scholar.
23 See id.
24 See, e.g., Dafny, Leemore S. et al., Narrow Networks on the Health Insurance Marketplaces: Prevalence, Pricing, and the Cost of Network Breadth, 36 Health Aff. 1606, 1607 (2017)CrossRefGoogle ScholarPubMed.
25 See Cutler & Zeckhauser, supra note 30, at 607.
26 Id.
27 Id. at 607-08.
28 See Bradley Herring & Mark V. Pauly, The Effect of State Community Rating Regulations on Premiums and Coverage in the Individual Health Insurance Market 19-20 (Nat'l Bureau of Econ. Research, Working Paper No. 12504, 2006), http://www.nber.org/papers/w12504.pdf; Individual Market Rate Restrictions (Not Applicable to HIPAA Eligible Individuals), Kaiser Fam. Found. (2012), https://www.kff.org/other/state-indicator/individual-market-rate-restrictions-not-applicable-to-hipaa-eligible-individuals/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D [https://perma.cc/39ZX-FMEU].
29 See Herring & Pauly, supra note 36, at 19.
30 See id. at 19-21.
31 Monahan, Amy B., Federalism, Federal Regulation, or Free Market? An Examination of Mandated Health Benefit Reform, 2007 U. Ill. L. Rev. 1361, 1363-64 (2007)Google Scholar.
32 For a detailed discussion of the rationales for mandated benefit laws, see generally Monahan, Amy B., Value-Based Mandated Health Benefits, 80 U. Colo. L. Rev. 127 (2009)Google Scholar.
33 See, e.g., Jensen, Gail A. & Morrissey, Michael A., Employer-Sponsored Health Insurance and Mandated Benefit Laws, 77 Milbank Q. 425, 444-45 (1999)CrossRefGoogle ScholarPubMed; Jonathan Gruber, State Mandated Benefits and Employer Provided Health Insurance 5 (Nat'l Bureau of Econ. Research, Working Paper No. 4239, 1992). But see Summers, Lawrence H., Some Simple Economics of Mandated Benefits, 79 Am. Econ. Rev. 177, 178-81 (1989)Google Scholar (arguing that mandated benefit laws may be more efficient than public provision of the same benefits).
34 Chernew et al., supra note 13, at 1036.
35 See, e.g., Richard A. Rettig et al., False Hope: Bone Marrow Transplantation for Breast Cancer 169-74 (2007); Hyman, David A., Drive-Through Deliveries: Is “Consumer Protection” Just What the Doctor Ordered?, 78 N.C. L. Rev. 5, 26 (1999)Google Scholar.
36 See Hyman, supra note 43, at 24-26..
37 See Rettig et al., supra note 43, at 173, 177.
38 U.S. Gen. Accounting Office, GAO/HEHS-96-161, Health Insurance Regulation: Varying State Requirements Affect Cost of Insurance 9 (1996) (“On average, states have enacted laws mandating about 18 specific benefits.”); Monahan, supra note 39, at 1364 (finding a range of two mandates in Idaho to thirty-five mandates in California).
39 42 U.S.C. § 300gg (2012).
40 Id. §§ 300gg-3, 300gg-6.
41 Cutler & Zeckhauser, supra note 30, at 607.
42 I.R.C. § 5000A (2012).
43 Id. § 36B.
44 Baker, supra note 3, at 1611.
45 42 U.S.C. § 18063 (2012).
46 Montz, Ellen et al., Risk-Adjustment Simulation: Plans May Have Incentives to Distort Mental Health and Substance Use Coverage, 35 Health Aff. 1022, 1022 (2016)CrossRefGoogle ScholarPubMed.
47 See id. at 1026-27 (finding that the risk-adjustment mechanism undercompensates insurers for many individuals with mental health or substance abuse disorders, thereby creating a strong incentive for insurers to engage in service-level selection to avoid such individuals).
48 See generally id.
49 See, e.g. Neuman, Patricia et al., Marketing HMOs to Medicare Beneficiaries, 17 Health Aff. 132, 135-36 (1998)CrossRefGoogle ScholarPubMed.
50 Montz, supra note 54, at 1022-23.
51 See id.
52 For example, a silver-level plan is required to have an actuarial value of 70 percent. 42 U.S.C. § 18022(d) (2012). An actuarial value of 70 percent means that, for an average plan population, the plan will pay 70 percent of covered expenses; Larry Levitt & Gary Claxton, What the Actuarial Values in the Affordable Care Act Mean, Kaiser Fam. Found. (April 2011), https://kaiserfamilyfoundation.files.wordpress.com/2013/01/8177.pdf. (The plan remains free to charge vastly different out-of-pocket amounts for various services as long as the average cost sharing remains at 70 percent.)
53 See generally Bernadette Fernandez, Cong. Research Serv., Health Insurance Premium Tax Credits and Cost-Sharing Subsidies (2018).
54 I.R.C. § 36B (2012).
55 42 U.S.C. § 18031(d)(3) (2012).
56 Ctrs. for Medicare & Medicaid Servs., Dep't of Health & Human Servs., Frequently Asked Questions on Essential Health Benefits Bulletin (2011), https://www.cms.gov/CCIIO/Resources/Files/Downloads/ehb-faq-508.pdf.
57 See 42 U.S.C. § 18022(b)(4) (2012). For detailed criticism of the decision to delegate authority in this manner to HHS, see generally Mantel, supra note 10.
58 42 U.S.C. § 18022(b)(1) (2012).
59 See id. § 18022(b).
60 Id. § 18022(b)(2)(A).
61 Id. § 18022(b)(4).
62 42 U.S.C. §18022(b)(2)(A).
63 See generally Dep't of Labor, Selected Medical Benefits: A Report from the Department of Labor to the Department of Health and Human Services (2011), http://www.bls.gov/ncs/ebs/sp/selmedbensreport.pdf.
64 Id. at 5.
65 Id. at 7-8.
66 See id. at 10-11.
67 Id. at 18.
68 Id. at 36.
69 Ctr. for Consumer Info. & Ins. Oversight, Dep't of Health & Human Servs., Essential Health Benefits Bulletin 4 (2011), https://www.cms.gov/CCIIO/Resources/Files/Downloads/essential_health_benefits_bulletin.pdf.
70 Id.
71 Id.
72 Id. at 5.
73 Id.
74 The Institute of Medicine is now known as the National Academy of Medicine.
75 See Inst. of Med., Essential Health Benefits: Balancing Coverage and Cost 3 (2012)Google Scholar.
76 Id. at 14.
77 Id. at 1.
78 Id.
79 See id. at 82-90.
80 Id. at 5.
81 Inst. of Med., Essential Health Benefits: Balancing Coverage and Cost, supra note 84, at 87.
82 Id.
83 Id. at 5.
84 Id. at 129.
85 See Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation, 78 Fed. Reg. 12834, 12834, 12840-41 (Fed. 25, 2013) (codified as amended at 45 C.F.R. § 156.100 (2017)) [hereinafter EHB Final Regulations].
86 See Weil, Alan, The Value of Federalism in Defining Essential Health Benefits, 366 New Eng. J. Med. 679, 679-80 (2012)CrossRefGoogle ScholarPubMed.
87 See EHB Final Regulations, supra note 94, at 12844.
88 For example, “habilitative services,” one of the statutorily required categories of coverage, was not a term used by health insurers prior to the ACA, and therefore benchmark plans had to be modified to include this new type of coverage. Similarly, pediatric oral and vision care were not covered by typical health insurance policies and also had to be added to the base benchmark plan. See 45 C.F.R. §§ 110(b)(2), (3); (f) (2017).
89 45 C.F.R. § 156.110 (2017).
90 Id. § 156.115.
91 Id. The “substantially equal” standard was borrowed from the equivalency standard that applies to plans under the Children's Health Insurance Program (“CHIP”). See Ctr. for Consumer Info. & Ins. Oversight, Ctrs. for Medicare & Medicaid Servs., Essential Health Benefits Bulletin 12 (Dec. 16, 2011). The relevant CHIP regulations are set forth at 42 C.F.R. §§ 457.430, 457.431 (2017).
92 45 C.F.R. § 156.115(b) (2017).
93 Id. § 156.115(b)(2).
94 EHB Final Regulations, supra note 95, at 12844.
95 Id.
96 Id.
97 Id.
98 See Am. Acad. of Actuaries, Critical Issues In Health Reform: Actuarial Equivalence 1 (2009) (explaining the concept of “value” in the context of health plan actuarial equivalence).
99 See id. at 2.
100 Id. at 4.
101 Id.
102 EHB Final Regulations, supra note 94, at 12844.
103 45 C.F.R. § 156.122(a)(1) (2017). This approach is similar to that used for Medicare Part D purposes. Under Medicare Part D, insurers must cover at least two drugs in each therapeutic class, as well as every drug in six protected classes: antidepressants, anti-psychotics, immunosuppressants, cancer drugs, and HIV/AIDS drugs. 42 C.F.R. § 423.120(b) (2017). The EHB requirements are therefore less generous than those that apply to Medicare prescription drugs.
104 See 45 C.F.R. § 156.122(a)(1) (2017).
105 Id. §156.122(c).
106 Id.
107 Id. §156.122(a)(3).
108 Id. §156.122(a)(3)(iii)(H).
109 Id. §§156.122(c)(1)-(4).
110 See 42 U.S.C. § 18031(d)(3) (2012).
111 See 45 C.F.R. § 155.170 (2017).
112 EHB Final Regulations, supra note 94, at 12841-42.
113 45 C.F.R. § 156.125(c) (2017).
114 EHB Final Regulations, supra note 95, at 12843.
115 Id.
116 Havighurst, supra note 18, at 117-37.
117 A review by the author of all 2015 state EHB benefit summaries found that 29 of 51 states had to add habilitative services to the benchmark plan in order to comply with EHB requirements.
118 There is likely an interesting explanation of why these three categories were routinely omitted from health insurance contracts, but exploring those underlying rationales is beyond the scope of this article.
119 For example, when searching for plans on healthcare.gov, purchasers see the statement, “All plans offered … cover the same set of essential health benefits.” What Marketplace Health Insurance Plans Cover, HealthCare.gov, https://www.healthcare.gov/coverage/what-marketplace-plans-cover/ [https://perma.cc/59GB-X6QJ]. See, e.g., Coverage Basics, Covered Cal., https://www.coveredca.com/individuals-and-families/getting-covered/coverage-basics/ [https://perma.cc/R9WZ-2JUN] (“All health insurance plans offered in the individual and small-group markets must provide a comprehensive package of items and services, known as essential health benefits.”); 2018 Health Plans, Vt. Health Connect, http://info.healthconnect.vermont.gov/healthplans [https://perma.cc/Q72P-QLZW] (“All Vermont Health Connect plans cover the same set of essential health benefits.”).
120 See, e.g., Robinson, James C., Insurers' Strategies for Managing the Use and Cost of Biopharmaceuticals, 25 Health Aff. 1205, 1206-07 (2006)CrossRefGoogle ScholarPubMed (describing the use of medical management in the administration of biopharmaceuticals).
121 See Hepatitis C Questions and Answers for the Public, Ctr. for Disease Control & Prevention (June, 12 2018), https://www.cdc.gov/hepatitis/hcv/cfaq.htm [https://perma.cc/76JW-4ALX] [hereinafter CDC Hepatitis C FAQs].
122 See id.
123 See id.
124 See id. Fifty-eight percent of all intravenous drug users are infected with HCV. Kohli, Anita et al., Treatment of Hepatitis C: A Systemic Review, 312 JAMA 631, 633 (2014)Google Scholar.
125 Kohli et al., supra note 133, at 633. Of those with chronic HCV infection, 60 to 70 percent will develop chronic liver disease, 4 to 20 percent will develop cirrhosis, and 1 to 5 percent will die from cirrhosis or liver cancer. Younossi, Zobair M. et al., Inpatient Resource Utilization, Disease Severity, Mortality and Insurance Coverage for Patients Hospitalized for Hepatitis C Virus in the United States, 22 J. Viral Hepatitis 137, 137 (2015)CrossRefGoogle ScholarPubMed.
126 Van Nuys, Karen et al., Broad Hepatitis C Treatment Scenarios Return Substantial Health Gains, But Capacity is a Concern, 34 Health Aff. 1666, 1666 (2015)CrossRefGoogle ScholarPubMed.
127 More than 80 percent of patients experienced serious adverse effects, with the result that less than 50 percent of patients who began treatment could complete the therapy. Brennan, Troyen & Shrank, William, New Expensive Treatments for Hepatitis C Infection, 312 JAMA 593, 593 (2014)CrossRefGoogle ScholarPubMed. For those who completed treatment, 30 to 80 percent experienced a sustained virological response. Kohli et al., supra note 134, at 1666.
128 See Olysio (Simeprevir Sodium), in U.S. Food & Drug Admin., Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (38th ed. 2018), https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=205123 [https://perma.cc/E9UY-W9D2]; Sovaldi (Sofosbuvir), in U.S. Food & Drug Admin., Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (38th ed. 2018), https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=204671 [https://perma.cc/89TZ-924H].
129 See Harvoni (Ledipasvir; Sofosbuvir), in U.S. Food & Drug Admin., Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (38th ed. 2018), https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=205834 [https://perma.cc/S6NK-6QTA]; Viekira Pak (Copackaged) (Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir), in U.S. Food & Drug Admin., Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (38th ed. 2018), https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=206619 [https://perma.cc/W7LA-AC73].
130 Ward, John W. & Mermin, Jonathan H., Simple, Effective, but Out of Reach? Public Health Implications of HCV Drugs, 373 New Eng. J. Med. 2678, 2678 (2015)CrossRefGoogle ScholarPubMed. Early studies reinforce the breakthrough nature of these new generation treatments. A study of HCV patients within the Veteran Affairs health system found that the proportion of treated patients who achieved a sustained virological response increased from 19.2 percent in 1999 to 90.5 percent by 2015. Moon, Andrew M. et al., Transformation of Hepatitis C Antiviral Treatment in a National Healthcare System Following the Introduction of Direct Antiviral Agents, 45 Alimentary Pharmacology & Therapeutics 1201, 1201 (2017)CrossRefGoogle Scholar.
131 Ward & Mermin, supra note 139, at 2678. In addition to providing enormous benefits for the individual patient being treated, another advantage of the new treatment regimens is that the spread of HCV can be curtailed, providing significant public health benefits. Van Nuys et al., supra note 139, at 1669 (estimating that treating all known HCV infected individuals in the United States with the new oral treatments would reduce the number of individuals with HCV to under 50,000).
132 Troyen Brennan & Shrank, William, New Expensive Treatments for Hepatitis C Infection, 312 JAMA 593, 593 (2014)Google Scholar (noting that a standard 12-week course of sofosbuvir cost $84,000 in 2014); Andrew Pollack, Sales of Sovaldi, New Gilead Hepatitis C Drug, Soar to $10.3 billion, N.Y. Times (Feb. 3, 2015) (prices listed are list prices; significant discounts are often negotiated by payers); Simepriver/Olysio, Hepatitis C Online, https://www.hepatitisc.uw.edu/page/treatment/drugs/simeprevir-drug [https://perma.cc/98FK-57KM].
133 Kuehn, Bridget M., Guideline: New HCV Drugs Should Go to Sickest Patients, 312 JAMA 1084, 1084 (2014)CrossRefGoogle ScholarPubMed. To give an example of the strain the cost of these treatments exert on state Medicaid programs, the State of Washington estimated that if its Medicaid program were to pay for HCV treatment for all currently infected Medicaid recipients, the cost would be three times the current total pharmacy budget. Rubin, Rita, Capitol Health Call: Hepatitis C Drugs Top State Medicaid Pharmaceutical Expenditures, 315 JAMA 549, 549Google Scholar (quoting MaryAnne Lindeblad, Director of Washington State's Medicaid program).
134 Rein, David B. et al., The Cost-Effectiveness, Health Benefits, and Financial Costs of New Antiviral Treatments for Hepatitis C Virus, 61 Clinical Infectious Diseases 157, 162 (2015)CrossRefGoogle ScholarPubMed (estimating increased medical costs of $127.1 billion compared to nontreatment).
135 Id. at 164.
136 The new generation of treatments may achieve a cost-per-quality adjusted life year of $32,000 to $35,000 compared to nontreatment. Id.
137 The ACA provides for an annual open enrollment period during which consumers can freely switch insurance carriers. 42 U.S.C. §18031(c)(6) (2012).
138 See Ctr. for Disease Control & Prevention, Hepatitis C: Why People Born from 1945-1965 Should Get Tested (2016), https://www.cdc.gov/knowmorehepatitis/Media/PDFs/FactSheet-Boomers.pdf.
139 Van Nuys, supra note 139, at 1667 (“Infection through injection drug use poses the greatest risk of hepatitis C virus transmission in the United States today”). See also Cummings, Janet R. et al., Health Insurance Coverage and the Receipt of Specialty Treatment for Substance Use Disorders Among U.S. Adults, 65 Psychiatric Servs. 1070, 1070, 1072 tbl. 1 (2014)Google ScholarPubMed (finding increased use of treatment for substance use disorder among adults with private insurance).
140 For example, a single carrier, such as Blue Cross Blue Shield, might offer ten different silver-level plans in a given market. In that situation, a single one of those ten plans was randomly selected for inclusion in the study.
141 For states that utilize the healthcare.gov platform, this initial search was straightforward, as there is a search function that lets users select which drugs they are interested in, so that a plan search returns results that indicate which of the available plans includes the designated drugs on their formulary. For other states, that information often had to be obtained through each plan's website. A plan's formulary is simply the list of drugs covered by the plan, typically determined by the plan's pharmacy benefit manager. While some health plans perform prescription drug management and administration in house, many outsource this function to third party pharmacy benefit managers who administer the prescription drug benefits and process drug claims on behalf of the health insurer. See David H. Kreling, U.S. Dep't of Health & Human Servs., Cost Control for Prescription Drug Programs: Pharmacy Benefit Manager (PBM) Efforts, Effects, and Implications (2009), https://aspe.hhs.gov/cost-control-prescription-drug-programs-pharmacy-benefit-manager-pbm-efforts-effects-and-implications [https://perma.cc/2F9Y-2TQN].
142 Specialty drugs are commonly subject to prior authorization. See Lotvin, Alan M. et al., Specialty Medications: Traditional and Novel Tools Can Address Rising Spending on These Costly Drugs, 33 Health Aff. 1736, 1740 (2014)CrossRefGoogle ScholarPubMed.
143 Kreling, supra note 150, at 7 (noting studies finding that copayments can reduce drug utilization, as well as studies showing that utilization decrease is more common for discretionary drugs than essential drugs).
144 But see Goldman, Dana P. et al., Benefit Design and Specialty Drug Use, 25 Health Aff. 1319 (2006)CrossRefGoogle ScholarPubMed.
145 Lotvin et al, supra note 138, at 1741.
146 The actual costs of treatment may be lower for individuals with income at or below 250 percent of federal poverty because of ACA cost-sharing reductions that reduce the applicable out-of-pocket maximum for such individuals and increase the actuarial value of the plan. See 42 U.S.C. § 18071.
147 Full results are presented in Appendix A.
148 A patient's doctor might be able to access the prior authorization criteria, but individuals would not be able to obtain the information prior to purchasing coverage or starting treatment without making a direct inquiry to the insurance company.
149 Health Partners, Hepatitis C Treatment Criteria 4 (2017), https://www.healthpartners.com/ucm/groups/public/@hp/@public/documents/documents/entry_143032.pdf.
150 Id.
151 Kaiser Permanente, Ledipasvir/Sofosbuvir Prior Authorization Guidelines 2 (2016), https://healthy.kaiserpermanente.org/static/health/en-us/pdfs/nw/nw_Harvoni_Guidelines.pdf; Anthem Blue Cross Blue Shield, Harvoni (Ledipasvir/Sofosbuvir) Prior Authorization Guidelines 3 (2016), https://www11.anthem.com/provider/noapplication/f0/s0/t0/pw_e225444.pdf?na=pharminfo.
152 Anthem Blue Cross Blue Shield, supra note 160.
153 While there is not specific evidence of a shortage of infectious disease or other specialists who treat HCV, the shortage of health care professionals in rural areas is well documented. See, e.g., Dalen, James E., Generalists and Specialists: Achieving the Balance, 156 Archives of Internal Med. 21, 22 (1996)CrossRefGoogle ScholarPubMed (stating that 29 percent of rural residents live in areas with a shortage of health professionals). See also Abdus, Salam & Hill, Steven C., Growing Insurance Coverage Did Not Reduce Access to Care for the Continuously Insured, 36 Health Aff. 791, 796 (2017)CrossRefGoogle Scholar (finding that 5.4 percent of insured individuals reported a problem seeing a specialist).
154 See Sen, Aditi P. et al., Most Marketplace Plans Included at Least 25 Percent of Local-Area Physicians, But Enrollment Disparities Remained, 36 Health Aff. 1615, 1619 (2017)CrossRefGoogle ScholarPubMed (finding that, in 2016, 40 percent of marketplace plans offered networks that were either “small” or “extra-small”).
155 See, e.g., Anand, Bhupinder S. et al. Alcohol Use and Treatment of Hepatitis C Virus: Results of a National Multicenter Study, 130 Gastroenterology 1607, 1611 (2006)CrossRefGoogle ScholarPubMed; Mauss, Stefan et al., A Prospective Controlled Study of Interferon-Based Therapy of Chronic Hepatitis C in Patients on Methadone Maintenance, 40 Hepatology 120, 122 (2004)CrossRefGoogle ScholarPubMed.
156 Eugene R. Schiff & Nuri Ozden, Hepatitis C and Alcohol, Nat'l Inst. on Alcohol Abuse & Alcoholism (2004) (documenting increased liver damage in Hepatitis C infected individuals who consume alcohol), https://pubs.niaaa.nih.gov/publications/arh27-3/232-239.htm [https://perma.cc/4TDG-J3NS].
157 For example, state Medicaid programs instituted similar criteria with the explicit goal of rationing care and therefore avoiding an untenable increase in costs. See Viohl & Assoc. for Medicaid Health Plans of America, The Sovaldi® Squeeze: High Costs Force Tough State Decisions 3 (2014), http://www.medicaidplans.org/_docs/SovaldiSqueeze-Oct2014.pdf.
158 The ACA explicitly provides that the Secretary, in defining the EHBs, shall not “make coverage decisions…in ways that discriminate against individuals because of their…expected length of life.” 42 U.S.C. § 18022(b)(4)(B).
159 See, e.g., Alexander M. Capron, The Ethics of Rationing Healthcare, in The Oxford Handbook of U.S. Health Law 892-893 (I. Glenn Cohen et al. eds., 2017); Weeks Leonard, Elizabeth, Death Panels and the Rhetoric of Rationing, 13 Nev. L. J. 872, 876 (2013)Google Scholar; but see Richard A. Epstein, Mortal Peril 47 (1997) (“Health care may well be ‘special’ to some, but even if it is not rationed by price, it still must be rationed in some other way”).
160 The ACA imposes a maximum amount that insurers can charge patients for covered services in a given year. 42 U.S.C. § 18022(c)(1). The amount is indexed for inflation, and in 2018 is $7,350 for individual coverage and $14,700 for family coverage. Out-of-Pocket Maximum/Limit, U.S. Ctrs. for Medicare & Medicaid Servs., https://www.healthcare.gov/glossary/out-of-pocket-maximum-limit/ [https://perma.cc/7SUR-NV8W] (last visited Sept. 10, 2018).
161 See Cal. Gov't Code §100504(c) (granting authority to the executive board of the California Health Benefit Exchange to standardize products offered through the exchange).
162 See, e.g., Himmelstein, David U. et al., Medical Bankruptcy in the United States, 2007 – Results of a National Study, 122 Am. J. Med. 741 (2009)CrossRefGoogle ScholarPubMed; Sugden, Ryan, Sick and (Still) Broke: Why the Affordable Care Act Won't End Medical Bankruptcy, 38 Wash. U. J. L. & Pol'y 441 (2012)Google Scholar.
163 Differences among the carriers might, however, effect re-enrollment decisions. If an individual seeking HCV treatment has coverage for a particular drug denied by an insurer, he or she might very well choose a plan from a different insurer during the next enrollment period.
164 The ability to use prior authorization to ration drug coverage may be effectively curtailed by the 2017 amendments to the EHB regulations, which require plans to follow specific procedures and criteria in establishing formulary coverage, and provides specific appeals procedures for enrollees to gain access to clinically appropriate drugs. See 45 C.F.R. § 156.122 (2017).
165 See, e.g., Dep't Ins. Fin. Inst. & Prof'l Registration, Annual Report to the Missouri Legislature, Insurance Coverage for Autism Treatment and Applied Behavior Analysis 4 (2014) (noting that ABA is often excluded from health insurance coverage due to its experimental nature). See also Maglione et al., supra note 173, at S170 (noting the goals for primary treatment of autism are to address behavioral, social, and cognitive deficits in children, which insurers sometimes use to deny coverage for ABA on the basis that it is not a medical intervention); Hansel, Kendra, Rethinking Insurance Coverage of “Experimental” Applied Behavior Analysis Therapy and Its Usefulness in Combating Autism Spectrum Disorder, 34 J. Legal Med. 215, 228 (2013)CrossRefGoogle Scholar (noting that ABA is often provided by individuals who are not licensed health professionals, another basis on which insurers deny coverage).
166 See Inst. of Med., Essential Health Benefits: Balancing Coverage and Cost, supra note 84, at 61.
167 Barbaresi, William J. et al., Autism: A Review of the State of the Science for Pediatric Primary Health Care Clinicians, 160 Archives of Pediatric & Adolescent Med. 1167, 1167 (2006)CrossRefGoogle ScholarPubMed; Maglione, Margaret A. et al., Nonmedical Interventions for Children with ASD: Recommended Guidelines and Further Research Needs, 130 Pediatrics S169, S170 (2012)CrossRefGoogle ScholarPubMed.
168 Maglione et al., supra note 173, at S170.
169 Silverman, Chloe & Brosco, Jeffrey P., Understanding Autism: Parents and Pediatricians in Historical Perspective, 161 Archives Pediatrics & Adolescent Med. 392, 394 (2007)CrossRefGoogle ScholarPubMed.
170 Bowman, Rachel A. & Baker, Jeffrey P., Screams, Slaps, and Love: The Strange Birth of Applied Behavior Analysis, 133 Pediatrics 364, 364 (2014)CrossRefGoogle ScholarPubMed.
171 Id. at 365.
172 Id.; see Barbaresi et al., supra note 173, at 1171 (stating that “[d]ecades-worth of scientific research provide clear and convincing support for … Applied Behavior Analysis”)..
173 Barbaresi, supra note 173, at 1171.
174 Id.
175 See Marc Lambright, Oliver Wyman, Actuarial Cost Estimate: Utah House Bill 69: at 15 (2012), https://www.autismspeaks.org/images/advocacy/UT_Wyman.2012.pdf
176 See Papatola, Kathleen J. & Lustig, Stuart L., Navigating a Managed Care Peer Review: Guidance for Clinicians Using Applied Behavior Analysis in the Treatment of Children on the Autism Spectrum, 9 Behav. Analysis Prac. 135, 137 (2016)Google ScholarPubMed.
177 Hansel, supra note 183, at 227.
178 Mazza, Marissa, Comment, Are You Covered? The Need for Improvement in Insurance Coverage for Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291, 314 (2010)Google Scholar.
179 Maglione et al., supra note 172, at S173, S176.
180 See infra. app. B. (detailing full results). While none of the states have an individual market ABA mandate, Missouri selected a benchmark plan from the group market that is subject to a state law requiring coverage of ABA.
181 See id. (referring to Missouri benchmark plan).
182 See id. (referring to North Carolina benchmark plan).
183 See id. (referring to CareSource (Indiana); Cigna (Missouri), and Oscar (Tennessee)).
184 See id. (referring to SelectHealth (Idaho) and Blue Cross Blue Shield (Oklahoma)).
185 See id. (referring to Cigna (North Carolina)).
186 See id. (referring to Mountain Health Co-op (Idaho), Ambetter (Indiana), Ambetter (Missouri), Blue Cross Blue Shield (North Carolina), Cigna (Tennessee)).
187 Cigna Health & Life Ins. Company, Tenn. Cigna Connect 4750 Plan 40 (2017) (effective for 2018 plan year).
188 Id. at 48.
189 See infra. app. B (referring to Indiana, Missouri, and Tennessee).
190 See Dep't of Labor, supra note 72, at 7-8; Kirsten Beronio et al., ASPE Research Brief: Affordable Care Act Will Expand Mental Health and Substance Use Disorder Benefits and Parity Protections for 62 Million Americans 1 (2013), available at https://aspe.hhs.gov/system/files/pdf/76591/rb_mental.pdf.
191 42 U.S.C. § 18022(b)(E) (2012).
192 26 C.F.R. § 54.9812-1 (2018).
193 Am. Psychiatric Ass'n, Diagnostic and Statistical Manual of Mental Disorders (5th ed. 2013).
194 See, e.g., Knickman, James et al., Improving Access to Effective Care for People with Mental Health and Substance Use Disorders, 316 JAMA 1647, 1647 (2016)CrossRefGoogle ScholarPubMed (stating that 8 percent of U.S. adults had a substance use disorder in 2014); Schuckit, Marc A., Treatment of Opioid-Use Disorders, 375 New Eng. J. Med. 357, 357 (2016)CrossRefGoogle ScholarPubMed (stating that 4 million Americans have reported nonmedical use of prescription pain relievers, and that some estimate almost 17,000 deaths from opioids per year).
195 Rapoport, Alison B. & Rowley, Christopher F., Stretching the Scope – Becoming Frontline Addiction-Medicine Providers, 377 New Eng. J. Med. 705, 706 (2017)CrossRefGoogle ScholarPubMed.
196 Friedmann, Peter D., Alcohol Use in Adults, 368 New Eng. J. Med. 365, 365 (2013)CrossRefGoogle ScholarPubMed.
197 See generally Gerstein, Dean R. & Lewin, Lawrence S., Special Report: Treating Drug Problems, 323 New Eng. J. Med. 844 (1990)CrossRefGoogle Scholar.
198 See Friedmann, supra note 205, at 366 (noting that only a quarter of those with alcohol dependence ever receive treatment).
199 Gerstein & Lewin, supra note 206, at 846.
200 See, e.g., id.; Friedmann, supra note 205, at 366.
201 See, e.g., Friedmann, supra note 205, at 368-69.
202 See, e.g., Dunlap, Beth & Cifu, Adam S., Clinical Management of Opioid Use Disorder, 316 JAMA 338, 339 (2016)CrossRefGoogle ScholarPubMed (noting that the effectiveness of residential treatment for opioid use disorder is uncertain because of a lack of empirical studies).
203 See e.g., Friedmann, supra note 190, at 365-366.
204 See 21 USC § 801 (2012) (Under the Drug Addiction Treatment Act of 2000, a physician must register with the Drug Enforcement Administration to receive the waiver necessary to prescribe Suboxone (buprenorphine)).
205 Dunlap & Cifu, supra note 211 at 338 (2016) (noting that medication-assisted treatment has been found to be superior to unmedicated withdrawal with respect to overdose death, rates of communicable disease, retention in treatment, and relapse); Volkow, Nora V. et al., Medication-Assisted Therapies – Tackling the Opioid-Overdose Epidemic, 370 New Eng. J. Med. 2063 (2014)CrossRefGoogle ScholarPubMed; Sigmon, Stacey C., The Untapped Potential of Office-Based Buprenorphine Treatment, 72 JAMA Psychiatry 395, 395 (2015)CrossRefGoogle ScholarPubMed (referring to medication-assisted therapy as “the most efficacious treatments for opioid dependence).
206 Dunlap & Cifu, supra note 211, at 338 (2016) (noting that fewer than half of all individuals in the US with opioid addiction are able to access medication-assisted treatment); Lembke, Anna & Chen, Jonathan H., Use of Opioid Agonist Therapy for Medicare Patients in 2013, 73 JAMA Psychiatry 990 (2016)CrossRefGoogle ScholarPubMed (concluding that Suboxone therapy is underused by Medicare prescribers); See, e.g., Rapoport & Rowley, supra note 204, at 706 (noting that only 4 percent of all active U.S. physicians are able to prescribe Suboxone); Sigmon, supra note 214, at 395 (referring to Suboxone and methadone as “severely underused”).
207 See infra. app. C.
208 See id. (referring to benchmark plans in Alabama, Iowa, Mississippi, South Carolina (excluding “long-term” residential care), and West Virginia).
209 See id. (referring to benchmark plan in Alabama).
210 See id. (referring to benchmark plan in Ohio).
211 See id. (referring to Ambetter (Mississippi), Med Mutual (Ohio), Blue Cross Blue Shield (South Carolina), Blue Cross Blue Shield (West Virginia)).
212 See infra. app. C (referring to Blue Cross Blue Shield (Alabama), which excludes residential treatment and methadone maintenance).
213 There was at least one notable exception. The CareSource Silver plan, offered in Ohio and West Virginia, covers outpatient substance abuse treatment with a $10 copay per visit, without having to first satisfy the deductible.
214 These summaries are available on the Centers for Medicare & Medicaid Services Essential Health Benefits website, https://www.cms.gov/cciio/resources/data-resources/ehb.html.
215 It is also possible that this study fails to capture strategic behavior because it looks only at three types of treatment, a small sampling of the possible areas for such behavior.
216 For example, a healthy individual might purchase coverage from an insurance company with incredibly strict medical management policies.
217 See Haeyoun Park & Margot Sanger-Katz, The Parts of the Affordable Care Act That the Republican Bill Will Keep or Discard, N.Y. Times (Mar. 24, 2018); See, e.g., Robert Pear, Trump to Issue Rule That Weakens Affordable Care Act, N.Y. Times (June 18, 2018).
218 See Jayne O'Donnell, What the GOP Bill Could Mean for ‘Essential Health Benefits, USA Today (March 23, 2017); See, e.g., Peter Sullivan, What the GOP's Plan to Kill Essential Health Benefits Means, The Hill (Mar. 23, 2017).
219 Cutler & Zeckhauser, supra note 30, at 607-08.
220 See, e.g., Ian Spatz & Michael Kolber, The Future of Essential Health Benefits, Health Aff (Feb. 14, 2017), https://www.healthaffairs.org/do/10.1377/hblog20170214.058765/full/ [https://perma.cc/58GA-TV9S] (citing arguments that repealing the EHBs will give “more liberty and more flexibility”).
221 See Ctr. for Consumer Info. & Ins. Oversight, Ctrs. for Medicare & Medicaid Servs., supra note 81, at 12.
222 Whether the resulting choice is meaningful consumer choice (i.e., would a consumer ever learn of this distinction and choose a health plan on this basis) is an issue beyond the scope of this article.
223 45 C.F.R. §§156.122(a)(3) & (c).
224 See generally Fox, Daniel M. & Leichter, Howard M., The Ups and Downs of Oregon's Rationing Plan, 12 Health Aff. 66 (1993)CrossRefGoogle ScholarPubMed (detailing Oregon's attempt to “establish a comprehensive list of conditions and treatments and for the legislature to fund as many of those as professional judgment, community sentiment, and state resources would allow.”).
225 See Croley, Steven P., Theories of Regulation: Incorporating the Administrative Process, 98 Colum. L. Rev. 1, 119-35 (1998)CrossRefGoogle Scholar.
226 See generally Ginsburg, Marjorie et al, (De)constructing ‘Basic’ Benefits: Citizens Define the Limits of Coverage, 25 Health Aff. 1648 (2006)CrossRefGoogle ScholarPubMed (emphasizing the importance of community input to policymakers).
227 For an overview of independent agencies, see Datla, Kirti & Revesz, Richard L., Deconstructing Independent Agencies (and Executive Agencies), 98 Cornell L. Rev. 769 (2013)Google Scholar.
228 See Bagley, supra note 6, at 16-19 (discussing the possible role of states in health reform). If states were tasked with defining EHBs, they would face the same institutional design issues as the federal government, but the delegation would presumably result in a multitude of approaches and experimentation that could illustrate best practices.
229 For the ACA's external review provisions, see 45 C.F.R. §147.136(d).
230 See RAND Health, The Health Insurance Experiment: A Classic RAND Study Speaks to the Current Health Care Reform Debate 2-4 (2006), http://www.rand.org/content/dam/rand/pubs/research_briefs/2006/RAND_RB9174.pdf.
231 See, e.g., Chernew, Michael E. et al., Value-Based Insurance Design, 26 Health Aff. w195 (2007)CrossRefGoogle ScholarPubMed.
232 These clinical guidelines are for Harvoni approval, which is this insurer's preferred treatment for most HCV patients. Preapproval criteria for the other drugs are substantially similar.
233 The maximum out-of-pocket cost for specialty drugs drops to $150 per prescription for those with income of 150% of federal poverty or less. Covered California, 2017 Standard Benefit Plan Designs 7, https://board.coveredca.com/meetings/2016/6-16/2017%20Standard%20Benefit%20Plan%20Designs_REVISED%20HDHP_2016%2006%2016.pdf.
234 I was able to locate the clinical criteria for these drugs for other products offered by CCHP, but not for exchange-based plans.
235 These clinical guidelines are for Harvoni approval, which is this insurer's preferred treatment for most HCV patients. Preapproval criteria for the other drugs are substantially similar.
236 Plan will also cover Olysio and Viekira Pak, but only if the patient's physician determines that they are medically necessary.
237 In 2016, Harvard Pilgrim Health Care announced on its website that it would no longer deny coverage for HCV drugs based on a patient's fibrosis score. Harvard Pilgrim Health Care, Updated Coverage Criteria for Hepatitis C Drugs (August 2016), https://www.harvardpilgrim.org/portal/page?_pageid=253,9330051&_dad=portal&_schema=PORTAL. However, at the time this study was conducted, the accessible clinical criteria still indicated that a minimum fibrosis score was required.
238 Either compensated liver disease with or without cirrhosis, or decompensated liver disease with cirrhosis.
239 Between 2016 and 2017, Health Partners dropped the requirement that patients have evidence of liver disease in order to receive HCV treatment. Compare Health Partners, Hepatitis C Treatment Criteria (June 15, 2016) with Health Partners, Hepatitis C Treatment Criteria (January 1, 2017).
240 Interestingly, the Medica plan has an out-of-pocket maximum of $5,750, well below the maximum allowed under law.
241 Olysio, Sovaldi, and Viekira Pak are available if treatment with Harvoni fails.
242 MVP Health Care entered into an agreement with the Attorney General of New York to no longer condition coverage for HCV drugs on a minimum fibrosis score. New York Attorney General Press Office, A.G. Schneiderman Announces Major Agreement With Seven Insurers To Expand Coverage Of Chronic Hepatitis C Treatment For Nearly All Commercial Health Insurance Plans Across New York State, April 26, 2016, https://ag.ny.gov/press-release/ag-schneiderman-announces-major-agreement-seven-insurers-expand-coverage-chronic. It is not clear, however, whether MVP Health Care dropped that requirement for plans offered outside of New York, as its coverage criteria are not publicly available.
243 While I was able to locate the form that must be completed in order to request prior authorization of HCV drugs, those forms did not explicitly state the criteria that were necessary to establish for coverage.