Chapter 8.D.2: Determining What Is Medically Appropriate
To insert after Ch. 8.D.2 (p. 819):
For discussions of medical necessity (note 1), see Timothy P. Blanchard, “Medical Necessity” Determinations: A Continuing Healthcare Policy Problem, 37 J. Health L. 599 (2004); Muriel R. Gillick, Medicare Coverage for Technological Innovations: Time for New Criteria?, 350 New Eng. J. Med. 2199 (2004); Janet L. Dolgin, Unhealthy Determinations: Controlling “Medical Necessity,” 22 Va. J. Soc. Pol’y & L. 435 (2015). For a discussion of how judgments about medical necessity intersect with health care for trans people, see Anna Kirkland, Shauhin Talesh, & Angela K. Perone, Health Insurance Rights and Access to Health Care for Trans People: The Social Construction of Medical Necessity, 55 Law & Soc’y Rev. 539 (2021).
For those who are interested in appeals procedures (note 2), a fairly detailed overview can be found on the Web site for this book, www.health-law.org. There is also substantial scholarly commentary. The most prolific author on these topics is Professor Eleanor Kinney. See Eleanor Kinney, The Accidental Administrative Law of the Medicare Program, 15 Yale J. Health Pol’y L. & Ethics 111 (2015); Eleanor Kinney ed., Guide to Medicare Coverage Decision-Making and Appeals (2002); Eleanor D. Kinney, Medicare Coverage Decision-Making and Appeal Procedures, 60 Wash. & Lee L. Rev. 1461 (2003); Eleanor Kinney, Rule and Policy Making Under the Medicaid Program: A Challenge to Federalism, 51 Ohio St. L. J. 855 (1991). For general and comprehensive overviews, see also Diane Hoffmann & Virginia Rowthorn, Achieving Quality and Responding to Consumers: The Medicare Beneficiary Complaint Process, 5 Ind. Health L. Rev. 9 (2008); Maxwell Mehlman & Karen Visocan, Medicare and Medicaid: Are They Just Health Care Systems?, 29 Hous. L. Rev. 835 (1992).
For in-depth commentary and analysis, with both theoretical and philosophical analyses and numerous suggestions for improvement on the full range of these procedural issues, see Eleanor D. Kinney, Protecting American Health Care Consumers (2002); Aaron Kesselheim, What’s the Appeal? Trying to Control Managed Care Medical Necessity Decisionmaking Through a System of External Appeals, 149 U. Pa. L. Rev. 873 (2001); Nan D. Hunter, Risk Governance and Deliberative Democracy in Health Care, 97 Geo. L. J. 1 (2008); Meir Katz, Towards a New Moral Paradigm in Health Care Delivery, 36 Am. J. L. & Med. 78 (2010); Won Bok Lee, Recalibrating “Experimental Treatment Exclusion”: An Empirical Analysis, 83 U. Cin. L. Rev. 171 (2014).
For commentary generally supportive of the Bechtold point of view (note 4), see Mark Hall & Gerard Anderson, Health Insurers’ Assessment of Medical Necessity, 140 U. Pa. L. Rev. 1637 (1992); Richard Saver, Reimbursing New Technologies: Why Are the Courts Judging Experimental Medicine?, 44 Stan. L. Rev. 1095 (1992). For contrasting commentary, supportive of Zorek, see David Frankford, Food Allergy and the Health Care Financing Administration: A Story of Rage, 1 Widener L. Symp. J. 159 (1996); Sara Rosenbaum et al., Who Should Determine When Health Care Is Medically Necessary?, 340 New Eng. J. Med. 229 (1999). For an international perspective, see Timothy Jost, Health Care Coverage Determinations: An International Comparative Study (2004). For thorough analysis of medical, legal, and health policy issues relating to bone marrow transplants, see Richard A. Rettig, False Hope vs. Evidence-Based Medicine: Bone Marrow Transplantation and Breast Cancer (2005); Peter Jacobson et al., Litigating the Science of Breast Cancer Treatment, 32 J. Health Pol. Pol’y & L. 785 (2007). Considering the facts of Zorek, it is interesting to note that “stomach-stapling” surgeries for obesity constitute a growing area of dispute and litigation. See Mark A. Hall, State Regulation of Medical Necessity: The Case of Weight-Reduction Surgery, 53 Duke L. J. 653 (2004); Manny v. Central States, Southeast and Southwest Areas Pension and Health Welfare Funds, 388 F.3d 247 (7th Cir. 2004) (Posner, J.).
For discussions of how ERISA shapes the interpretation of insurance contracts (notes 6 and 7), see John H. Langbein, Trust Law as Regulatory Law: The UNUM/Provident Scandal and Judicial Review of Benefit Denials Under ERISA, 101 Nw. U. L. Rev. 1315 (2007); Timothy Jost, “MetLife v. Glenn”: The Court Addresses a Conflict over Conflicts in ERISA Benefit Administration, 27 Health Aff. w430 (2008); Roy Harmon & A. G. Harmon, Weighing Medical Judgments, 13 Mich. St. U. J. Med. & L. 157 (2009); Maria Hylton, Post-Firestone Skirmishes: “Obama Care,” Discretionary Clauses and Judicial Review of ERISA Plan Administrator Decisions, 10 Wm. & Mary Pol’y Rev. 1 (2010); Mark Hall et al., Judicial Protection of Managed Care Consumers: An Empirical Study of Insurance Coverage Disputes, 26 Seton Hall L. J. 1055 (1996).
For general analysis of which institutional actor should make coverage decisions (note 8), see Mark A. Hall, Making Medical Spending Decisions ch.3 (1997); David Hsia, Benefits Determination Under Health Care Reform: Who Should Decide Coverage Policy?, 15 J. Leg. Med. 533 (1994).
For articles taking a therapeutic jurisprudence or a legal process approach to analyzing coverage disputes (note 9), see Kathy Cerminara, Dealing with Dying: How Insurers Can Help Patients Seeking Last-Chance Therapies (Even When the Answer Is “No”), 15 Health Matrix 285 (2005); Nan D. Hunter, Managed Process, Due Care: Structures of Accountability in Health Care, 6 Yale J. Health Pol’y L. & Ethics 93 (2006); Charity Scott, Therapeutic Approaches to Conflict Resolution in Health Care Settings, 21 Ga. St. U. L. Rev. 797 (2005).
For discussions of paying for clinical medical research (note 11), see Sandra J. Carnahan, Medicare’s Coverage with Study Participation Policy: Clinical Trials or Tribulations?, 7 Yale J. Health Pol’y L. & Ethics 229 (2007); Mark Barnes & Jerald Korn, Medicare Reimbursement for Clinical Trial Services, 38 J. Health L. 609 (2005); Dina Berlyn, Routine Patient Care in Clinical Trials: Whose Cost Is It Anyway?, 16 J. L. & Health 78 (2003); Earl Steinberg et al., Insurance Coverage for Experimental Technologies, 14(4) Health Aff. 143 (Nov. 1995); Mark B. McClellan & Sean R. Tunis, Medicare Coverage of ICDs, 352 New Eng. J. Med. 222 (2005).
To insert after Note on Peer Review Organizations and Utilization Review (p. 821):
Problem: Choosing Health Insurance
From what you have learned so far, which of the following insurance plans do you personally prefer, assuming each one costs the same? Defend your choice (both your selection and rejections) with reasons drawn from these readings:
- Plan A: Covers the full range of medical care, subject to standard medical necessity or experimental exclusions, without any deductibles or co-payments, but you must receive all care at an HMO clinic where doctors are paid a bonus for saving money.
- Plan B: Excludes mental health services, but covers the rest of the normal range of medical care, subject to a $250 deductible and 20 percent co-payment up to a maximum of $2,000 per year. Your choice of doctor, but all expensive treatments must be submitted for prior approval by the insurer to determine medical appropriateness.
- Plan C: Covers the full range of medical care, with no major exclusions and your choice of doctor, and no prior authorization requirement, but subject to a $4,000 deductible.
- Plan D: Coverage is defined in an approach similar to the Oregon plan, but using 5,000 specific categories of inclusion and exclusion taken from the latest practice guidelines based on medical research, as selected by a national panel of politically appointed experts. No other restrictions or financial limitations.
For narrative accounts of the maddening logic and personal impact of medical necessity determinations, see Andrew Batavia, Of Wheelchairs and Managed Care, 18(6) Health Aff. 171 (Nov. 1999); Lisa Iezzoni, Boundaries, 18(6) Health Aff. 171 (Nov. 1999); Margaret Gilhooley, Broken Back: A Patient’s Reflections on the Process of Medical Necessity Determinations, 40 Vill. L. Rev. 153 (1995) (a law professor’s personal account of an insurer that “evicted” her from the hospital); Gerald Grumet, Health Care Rationing Through Inconvenience, 31 New Eng. J. Med. 607 (1989) (railing against the “managerial-review process in which armies of claims clerks, administrators, auditors, form processors, peer reviewers, functionaries, and technocrats of every description insinuate themselves into a complex system that authorizes, pays for and delivers medical care”). For a more neutral and academic account of how health insurance medical directors go about their work, see Thomas Bodenheimer & Lawrence Casalino, Executives with White Coats — The Work and World View of Managed-Care Medical Directors, 341 New Eng. J. Med. 1945 (1999). For the view from an actual medical director, see S. D. Boren, I Had a Tough Day Today, Hillary, 330 New Eng. J. Med. 500 (1994).
On the legal oversight of utilization review (note 3), see Gail Agrawal, Resuscitating Professionalism: Self-Regulation in the Medical Marketplace, 66 Mo. L. Rev. 341 (2001); Edward P. Richards, The Police Power and the Regulation of Medical Practice: A Historical Review and Guide for Medical Licensing Board Regulation of Physicians in ERISA-Qualified Managed Care Organizations, 8 Ann. Health L. 201 (1999); David L. Treuman, The Liability of Medical Directors for Utilization Review Decisions, 35 J. Health L. 105 (2002).