Quality of Life: Erosions and Opportunities under Managed Care

Morreim E.H. , “The Impossibility and the Necessity of Quality of Life Research,” Bioethics, 6 (1992): 218–232 (hereinafter, “Impossibility”); Leplege A. and Hunt S. , “The Problem of Quality of Life in Medicine,” JAMA, 278 (1997): 47–50; Morreim E.H. , “Quality of Life in Health Care Allocation,” in Reich W.T. , ed. Encyclopedia of Bioethics (New York: Simon and Schuster, 1995): at 1358–1361; Morreim E.H. , “Computing the Quality of Life,” in Agich G. and Begley C. , eds., The Price of Health: Cost Benefit Analysis in Medicine (Dordrecht: D. Reidel Pub. Co, 1986): at 45–69; Testa M.A. and Simonson D.C. , “Assessment of Quality-of-Life Outcomes,” N. Engl. J. Med., 334 (1996): 835–40; Coates A. , “Improving the Quality of Life During Chemotherapy for Advanced Breast Cancer,” N. Engl. J. Med., 317 (1987): 1490–95; Gill T.M. and Feinstein A.R. , “A Critical Appraisal of the Quality of Quality-of-Life Measurements,” JAMA, 272 (1994): 619–26; Lehman A.F. , “Measuring Quality of Life in a Reformed Health System,” Health Affairs, 14, no. 3 (1995): 90–101; Smith A. , “Qualms About QALYs,” Lancet, May 16 (1987): 1134–36; Guyatt G.H. Feeny D.H. and Patrick D.L. , “Measuring Health-Related Quality of Life,” Annals of Internal Medicine, 118 (1993): 622–29; LaPuma J. and Lawlor E.F. , “Quality-Adjusted Life-Years: Ethical Implications for Physicians and Policymakers,” JAMA, 263 (1990): 2917–21.

McNeil B.J. , “Tradeoffs Between Quality and Quantity of Life in Laryngeal Cancer,” N. Engl. J. Med., 305 (1981): 982–987; Evans R.W. , “The Quality of Life of Patients with End-Stage Renal Disease,” N. Engl. J. Med., 312 (1985): 553–559; Tannock I.F. , “Treating the Patient, Not Just the Cancer,” N. Engl. J. Med., 317 (1987): 1534–35; Morreim , Impossibility, supra note 1.

See detailed discussions of the numerous methodological and theoretical problems inherent in measuring QL, supra note 1.

Hadorn D.C. , “The Problem of Discrimination in Health Care Priority Setting,” JAMA, 268 (1992): 1454–1459; Smith A. , “Qualms about QALYs,” Lancet, May 16 (1987): 1134–1136.

GUSTO Investigators, “An International Randomized Trial Comparing Four Thrombolytic Strategies for Acute Myocardial Infarction,” N. Engl. J. Med., 329 (1993): 673–682; The GUSTO Investigators, “The Effects of Tissue-Plasminogen Activator, Streptokinase, or Both on Coronary-Artery Patency, Ventricular Function, and Survival after Acute Myocardial Infarction,” N. Engl. J. Med., 329 (1993): 1615–1622; Farkouh M.E. Land J.D. and Sackett D.L. , “Thrombolytic Agents: The Science of the Art of Choosing the Better Treatment,” Annals of Internal Medicine, 120 (1994): 886–888; Lee K.L. , “Holding GUSTO up to the Light,” Annals of Internal Medicine, 120 (1994): 87–881.

Woolf S.H. and Lawrence R.S. , “Preserving Scientific Debate and Patient Choice: Lessons from the Consensus Panel on Mammography Screening,” JAMA, 278 (1997): 2105–2108; Davis D.L. and Love S.M. , “Mammographic Screening,” JAMA, 271 (1994): 152–153; Kerlikowske K. , “Efficacy of Screening Mammography,” JAMA, 273 (1995): 149–154; Lindfors K.K. and Rosenquist J. , “The Cost-Effectiveness of Mammographic Screening Strategies,” JAMA, 274 (1995): 881–884; Ransohoff D.R. and Harris R.P. , “Lessons from the Mammography Screening Controversy: Can We Improve the Debate?,” Annals of Internal Medicine, 127 (1997): 1029–34; Salzmann P. Kerlikowske K. and Phillips K. , “Cost-Effectiveness of Extending Screening Mammography Guidelines to Include Women 40 to 49 Years of Age,” Annals of Internal Medicine, 127 (1997): 955–65; Eddy D.M. , “Breast Cancer Screening in Women Younger than 50 Years of Age: What's Next?,” Annals of Internal Medicine, 127 (1997): 1035–36.

Emanuel E.J. and Emanuel L.L. , “The Economics of Dying,” N. Engl. J. Med, 330 (1994): 540–544; Schneiderman L. J. , “Effects of Offering Advance Directives on Medical Treatments and Costs,” Annals of Internal Medicine, 117 (1992): 599–606.

“Managed care” can refer to widely varying arrangements in the financing and delivery of health care. However, a common description, articulated by Marc Rodwin, will be used here.

Managed care refers to health insurance combined with … controls over the delivery of health services. Managed care organizations (MCOs) exercise control over the kind, volume, and manner in which services are provided by choosing providers, or by controlling their behavior through financial incentives, rules, and organizational controls. Under traditional indemnity insurance and fee-for-service medical practices, the insurers enter into a contract with the insured party and reimburse the individual for certain medical expenses that are incurred. The individual receives medical services from any provider he or she chooses and usually pays a fee for each service rendered, with the insurer having no control over the choice of provider or provision of services. Managed care changes this relationship either (1) by directly providing the contracted-for services; or (2) by exercising control over the services provided. Many indemnity insurers now provide managed care in that they exercise control over their beneficiaries' use of medical services. They require preauthorization for … expensive referrals or procedures. They do not reimburse claims from medical providers for services rendered if the organization decides they were not necessary. Rodwin M.A. , “Managed Care and Consumer Protection: What are the Issues?,” Seton Hall Law Review, 26 (1996): 1007–54, at 1009.

Morreim E.H. , “Redefining Quality by Reassigning Responsibility,” American Journal of Law and Medicine, 20, (1994): 79–104, at 80.

Mold J.W. and Stein H.F. , “The Cascade Effect in the Clinical Care of Patients,” N. Engl. J. Med., 314 (1986): 512–514; Fisher E.S. and Welch H.G. , “Avoiding the Unintended Consequences of Growth in Medical Care. How Might More be Worse?,” JAMA, 281 (1999): 446–453; Franks P. Clancy C.M. and Nutting P.A. , “Gatekeeping Revisited—Protecting Patients from Overtreatment,” N. Engl. J. Med., 327 (1992): 424–429; Burnum J.F. , “Medical Practice A La Mode,” N. Engl. J. Med., 317 (1987): 1220–1222; Hardison J.E. , “To Be Complete,” N. Engl. J. Med., 300 (1979): 193–194.

Wennberg J.E. , “Which Rate is Right?,” N. Engl. J. Med., 314 (1986): 310–311; Chassin M.R. Brook R.H. , and Park R.E. , “Variations in the Use of Medical and Surgical Services by the Medicare Population” N. Engl. J. Med., 314 (1986): 285–290; Wennberg J.E. Freeman J.L. and Culp W.J. , “Are Hospital Services Rationed in New Haven or Overutilized in Boston?,” Lancet, 1 (1987): 1185–1188; Welch H.G.HG Miller M.E. and Welch W.P. , “An Analysis of Inpatient Practice Patterns in Florida and Oregon,” N. Engl. J. Med., 330 (1994): 607–612; Wennberg J.E. , “The Paradox of Appropriate Care,” JAMA, 258 (1987): 2568–2569; Chassin M.R. , “Does Inappropriate Use Explain Geographic Variations in the Use of Health Care Services?,” JAMA, 258 (1987): 2533–37; Wennberg J.E. , “Outcomes Research, Cost Containment, and the Fear of Rationing,” N. Engl. J. Med., 323 (1990): 1202–1204; Leape L.L. , “Does Inappropriate Use Explain Small-Area Variations in the Use of Health Care Services?,” JAMA, 263 (1990): 669–672; Leape L.L. , “Relation Between Surgeons' Practice Volumes and Geographic Variation in the Rate of Carotid Endarterectomy,” N. Engl. J. Med., 321 (1989): 653–657; Wennberg J.E. , “Unwanted Variations in the Rule of Practice,” JAMA, 265 (1991): 1306–1307; Cleary P.D. , “Variations in Length of Stay and Outcomes for Six Medical and Surgical Conditions in Massachusetts and California,” JAMA, 26 (1991): 73–79; Fisher E.S. Welch H.G. and Wennberg J.E. , “Prioritizing Oregon's Hospital Resources: An Example Based on Variations in Discretionary Medical Utilization,” JAMA, 267 (1992): 1925–1931; Greenfield S. , “Variations in Resource Utilization Among Medical Specialties and Systems of Care: Results from the Medical Outcomes Study,” JAMA, 267 (1992): 1624–1630; Welch W.P. , “Geographic Variation in Expenditures for Physicians' Services in the United States,” N. Engl. J. Med., 328 (1993): 621–627; Miller M.G. , “Variation in Practice for Discretionary Admissions,” JAMA, 271 (1994): 1493–1498; Detsky A.S. , “Regional Variation in Medical Care,” N. Engl. J. Med., 333 (1995): 589–590; Guadagnoli E. , “Variation in the Use of Cardiac Procedures After Acute Myocardial Infarction,” N. Engl. J. Med., 333 (1995): 573–578; Pilote L. , for the GUSTO-1 Investigators, “Regional Variation Across the United States in the Management of Acute Myocardial Infarction,” N. Engl. J. Med., 333 (1995): 565–572; Ashton C.M. , “Geographic Variations in Utilization Rates in Veterans Affairs Hospitals and Clinics,” N. Engl. J. Med., 340 (1999): 32–39; O'Connor G.T. , “Geographic Variation in the Treatment of Acute Myocardial Infraction: The Cooperative Cardiovascular Project,” JAMA, 281 (1999): 627–633; Wennberg J.E. , Understanding Geographic Variations in Health Care Delivery,” N. Engl. J. Med., 340 (1999): 52–53.

Retchin S.M. , “Outcomes of Stroke Patients in Medicare Fee For Service and Managed Care,” JAMA, 278 (1997): 119–124.

Webster J.R. and Feinglass J. , “Stroke Patients, ‘Managed Care,’ and Distributive Justice,” JAMA, 278 (1997): 161–62.

Adelson v. GTE Corp., 790 F. Supp. 1265 (D. Md. 1992).

Bedrick v. Travelers Insur. Co., 93 F.3d 149 (4th Cir, 1996). By the same token, people needing motorized wheelchairs or other specialized durable medical equipment may find their health plans exceedingly reluctant to authorize them. See, for example, Iezzoni L. , “Boundaries,” Health Affairs, 18, no. 6 (1999): 156–64; Batavia A.I. , “Of Wheelchairs and Managed Care,” Health Affairs, 18, no. 6 (1999): 177–82.

Weiner J.P. , “Variation in Office-Based Quality: A Claims-Based Profile of Care Provided to Medicare Patients with Diabetes,” JAMA, 273 (1995): 1503–1508; The Diabetes Control and Complications Trial Research Group, Lifetime Benefits and Costs of Intensive Therapy as Practiced in the Diabetes Control and Complications Trial,” JAMA, 276 (1996): 1409–1415; Leape L.L. , “Translating Medical Science into Medical Practice: Do We Need A National Medical Standards Board?” JAMA, 273 (1995): 1534–37; Harris H.M. , “Disease Management: New Wine in New Bottles?” Annals of Internal Medicine, 124 (1996): 838–42; Newcomer L.N. , “Physician, Measure Thyself,” Health Affairs, 17, no. 4 (1998): 32–35; Grandinetti D. , “Can You Trust an HMO with Your Elderly Patients?” Medical Economics, 74 no. 8 (1997): 94–109, at 101; Epstein R.S. and Sherwood L.M. , “From Outcomes Research to Disease Management: A Guide for the Perplexed,” Annals of Internal Medicine, 124 (1996): 832–37; Donohoe M.T. , “Comparing Generalist and Specialty Care: Discrepancies, Deficiencies, and Excesses,” Archives of Internal Medicine, 158 (1998): 1596–1608, at 1600; Page L. , “Can Plans Manage the Preventive Care Diabetics Need?” American Medical News, March 20, 1995, at 4–5; Kraft S.K. , “Primary Care Physicians' Practice Patterns and Diabetic Retinopathy,” Archives of Family Medicine, 6 (1997): 29–37; Wender R.C. , “Preventive Health Care for Diabetics: A Realistic Vision,” Archives of Family Medicine, 6 (1997): 38–41.

Unfortunately, good care for these people can penalize health plans. First, if its good care attracts more diabetic patients, the plan suffers economically because typical premium structures have little or no risk adjustment to bring in extra revenue for these patients' higher-cost care. Second, a given plan may not enjoy the economic savings that long-term prevention can generate, because the patients they help today will likely be in some other health plan a few years hence. Enthoven A.C. and Vorhaus C.B. , “A Vision of Quality in Health Care Delivery,” Health Affairs, 16, no. 3 (1997): 44–57, at 53.

Retchin S.M. , “Perioperative Management of Colon Cancer Under Medicare Risk Programs,” Archives of Family Medicine, 157 (1997): 1878–84.

Stern R.S. , “Managed Care and the Treatment of Skin Diseases,” Archives of Dermatology, 132 (1996): 1039–1042; James W.D. , “Dermatologic Formularies in the Managed Care Setting,” Archives of Dermatology, 132 (1996): 1120–1121; Lober C.W. , “Dermatology: Positioned for Health Care Reform,” Archives of Dermatology, 132 (1996): 1065–1067; Russell P.S. and Kaplan L.J. , “The American Academy of Dermatology's Response to Managed Care and Capitation,” Archives of Dermatology, 132 (1996): 1125–1127; Hammes B.J. and Webster S. , “Professional Ethics and Managed Care in Dermatology,” Archives of Dermatology, 132 (1996): 1070–1073; Kirsner R.S. and Federman D.G. , “Lack of Correlation Between Internists' Ability in Dermatology and their Patterns of Treating Patients with Skin Disease,” Archives of Dermatology, 132 (1996): 1043–1046; Penneys N.S. , “Quality Assessment of Skin Biopsy Specimens Referred to Anonymous Consultants,” Archives of Dermatology, 132 (1996): 1053–1056; Resnick S.D. Hornung R. and Konrad T.R. , “A Comparison of Dermatologists and Generalists,” Archives of Dermatology, 132 (1996): 1047–1052; Federman D.G. Concato J. and Kirsner R.S. , “Comparison of Dermatologic Diagnoses by Primary Care Practitioners and Dermatologists: A Review of the Literature,” Archives of Family Medicine, 8 (1999): 170–172.

Goldzweig C.L. , “Variations in Cataract Extraction Rates in Medicare Prepaid and Fee-For-Service Settings,” JAMA, 277 (1997): 1765–68; Obstbaum S.A. , “Should Rates of Cataract Surgery Vary by Insurance Status?” JAMA, 277 (1997): 1807–08. As noted above, less care is not invariably worse care. It is entirely possible that patients in FFS plans have received this service too frequently, or too early in the course of the disease. Nevertheless, cataracts do affect QL. An unduly narrow standard for authorizing the procedure could leave lives considerably disrupted by an inability to see well enough for such routine activities as reading, driving, or watching television.

Jacobson P.D. and Rosenquist C.J. , “The Introduction of Low-Osmolar Contrast Agents in Radiology,” JAMA, 260 (1988): 1586–1592; Eddy D.M. , “Applying Cost-Effectiveness Analysis: The Inside Story,” JAMA, 268 (1992): 2575–2582; Ellis J.H. , “Selective Use of Radiographic Low-Osmolality Contrast Media in the 1990s.” Radiology 1996; 200: 297–311; Palmisano S.M. , “Low-Osmolality Contrast Media in the 1990s: Prices Change,” Radiology, 203 (1996): 309–315; Radensky P.W. and Cahill N.E. , “Universal Use of Low-Osmolality Contrast Media for the 1990s,” Radiology, 203 (1996): 310–11.

Hirshfeld E. , “The Case for Physician Direction in Health Plans,” Annals of Health Law, 3 (1994): 81–102, at 93; Crittenden D. , “Don't Give Birth up Here,” Wall Street Journal, March 31, 1994, A-14.

“Medi-Cal Patients in Labor Can't Be Denied Pain Meds,” American Medical News, September 21, 1998, p. 21.

“In 1998, congress Enacted the ‘Women's Health and Cancer Rights Act of 1998,’ amending ERISA. The Act requires all group health plans and health insurance issuers offering coverage for mastectomies to provide reimbursement for reconstructive surgery that is associated with a mastectomy” (citing: 29 U.S.C. § 1185(b) (Supp. 1999)). Hoffman S. “A Proposal for Federal Legislation to Address Health Insurance Coverage for Experimental and Investigational Treatments,” Oregon Law Review 78 (1999): 203–274, at 252. See also TN Code Ann. 56-7-2507. California's law more broadly covers reconstructive surgery. See Page L. , “Will New California Law Hike Surgery Demand?” American Medical News, October 19, 1998, pp. 1, 58, 59.

Jeffrey N. , “Corrective or Cosmetic? Plastic Surgery Stirs A Debate,” Wall Street Journal, June 25, 1998, at B-1, B-15.

“Since 1995, 41 states have mandated coverage for extended postpartum hospital stays … Colorado, Hawaii, Michigan, Mississippi, Nebraska, Utah, Vermont, Wisconsin, and Wyoming have not mandated such coverage; Hawaii and Mississippi lawmakers, however, introduced bills in 1997.” Korobkin, at 17, n. 84. Fourteen states have enacted legislation mandating minimumstay requirements for mastectomy patients: Arkansas, Connecticut, Florida, Illinois, Maine, Montana, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, and Texas. … New York was the first to enact such legislation, requiring every health insurance policy that provides inpatient hospital care to include inpatient care hospital coverage for those who undergo a mastectomy or lymph node dissection for a length to be determined appropriate by the attending physician. See N.Y. Ins. Law § 4303 (McKinney, WESTLAW through L. 1999, ch. 6–13). (Korobkin, at 17, n. 85.)

For a discussion of litigation and legislation regarding patients' rights to file grievances and appeals, see Miller T.E. , “Center Stage on the Patient Protection Agenda: Grievance and Appeal Rights,” Journal of Law, Medicine & Ethics, 26 (1998): 89–99.

Beebe S.A. , “Neonatal Mortality and Length of Newborn Hospital Stay,” Pediatrics, 98 (1996): 231–235; Chin M.H. , “Health Outcomes and Managed Care: Discussing the Hidden Issues,” American Journal of Managed Care, 3, (1997): 756–762; Edmonson M.B. Stoddard J.J. and Owens L.M. , “Hospital Readmission with Feeding-Related Problems After Early Postpartum Discharge of Normal Newborns,” JAMA, 278 (1997): 299–303; Liu L.L. , “The Safety of Newborn Early Discharge: The Washington State Experience,” JAMA, 278 (1997): 293–298; Gazmarian J.A. , “Maternity Experiences in a Managed Care Organization,” Health Affairs, 16, no. 3 (1997): 198–208; Lane D.A. , “Early Postpartum Discharges: Impact On Distress and Outpatient Problems,” Archives of Family Medicine, 8 (1999): 237–242.

Luce B.R. Lyles C.A. and Rentz A.M. , “The View From Managed Care Pharmacy,” Health Affairs, 15, no.4 (1996): 168–76; Quinn C.E. , “How An HMO Doctor Determines ‘Medical Necessity’,” Medical Economics, 74, no. 4 (1997): 198–202.

TAP Pharmaceuticals v U.S. Dept. of Health, 163 F.3d 199 (4th Cir. 1998).

Schreter R.K. , “Ten Trends in Managed Care and Their Impact on the Biopsychosocial Model,” Hospital and Community Psychiatry, 44 (1993): 325–27, at 326.

Cook D.J. , “The Relation Between Systematic Reviews and Practice Guidelines,” Annals of Internal Medicine, 127 (1997): 210–16, at 213.

Roulidis A.C. and Schulman K.A. , “Physician Communication in Managed Care Organizations: Opinions of Primary Care Physicians,” Journal of Family Practice, 39 (1994): 446–51; Epstein R.M. , “Communication Between Primary Care Physicians and Consultants,” Archives of Family Medicine, 4 (1995): 403–09; Kaplan S.S.H. , “Characteristics of Physicians with Participatory Decision-Making Styles,” Annals of Internal Medicine, 124 (1996): 497–504.

Kenagy J.W. Berwick D.M. and Shore M.F. , “Service Quality in Health Care,” JAMA, 281 (1999): 661–665.

Kovner C. and Gergen P.J. , “Nurse Staffing Levels and Adverse Events Following Surgery in U.S. Hospital,” Imag J Nurs Sch, 30, no. 4 (1998): 315–21.

Tanouye E. , “U.S. Has Developed An Expensive Habit: Now, How to Pay for It? Scores of Pricey New Pills Improve Quality of Life, but Bust Health Budgets,” Wall Street Journal, November 16, 1998, at A-1, A-10

Ferguson J.H. Dubinsky M. and Kirsch P.J. , “Court-Ordered Reimbursement for Unproven Medical Technology: Circumventing Technology Assessment,” JAMA, 269 (1993): 2116–2121; Peters W.P. and Rogers M.C. , “Variation in Approval by Insurance Companies of Coverage for Autologous Bone Marrow Transplantation for Breast Cancer,” N. Engl. J. Med. 330 (1994): 473–477; Morreim E.H. , “Moral Justice and Legal Justice in Managed Care: The Ascent of Contributive Justice,” Journal of Law, Medicine, & Ethics, 23 (1995): 247–265.

Its initial sponsors include major corporations such as AT&T, GTE, Electronic Data Systems, Ameritech, and American Express, although it also includes federal government entities such as HCFA and the Dept of Defense, state governments including Wisconsin and Oregon, and organizations such as the AARP and the AFL-CIO labor union. See Ellwood P.M. , “How Doctors Can Regain Control of Health Care,” Medical Economics, 73, no. 9 (1996): 178–92; Terry K. , “Can Functional-Status Surveys Improve Your Care?” Medical Economics, 73, no. 14 (1996): 126–44; Epstein A.M. , “Rolling Down the Runway: The Challenges Ahead for Quality Report Cards,” JAMA, 279 (1998): 1691–96; Bodenheimer T. , “The American Health Care System: The Movement for Improved Quality in Health Care,” N. Engl. J. Med., 340 (1999): 488–492; Keister L.W. , “With Health Costs Finally Moderating, Employers' Focus Turns to Quality,” Managed Care, October 1995; 4(10): 20–24.

Stuck A.E. , “A Trial of Annual In-Home Comprehensive Geriatric Assessments for Elderly People Living in the Community,” N. Engl. J. Med., 333 (1995): 1184–89; Rich M.W. , “A Multidisciplinary Intervention to Prevent the Readmission of Elderly Patients with Congestive Heart Failure,” N. Engl. J. Med., 33 (1995): 1190–95; Campion E.W. , “New Hope for Home Care?” N. Engl. J. Med., 333 (1995): 1213–14; Clark F. , “Occupational Therapy for Independent-Living Older Adults: A Randomized Controlled Trial,” JAMA, 278 (1997): 1321–26

Winslow R. , “Big Study Shows Workers Under Stress Likely to Have Higher Health-Care Costs,” Wall Street Journal, October 16, 1998, at B-5.

Coulehan J. , “Treating Depressed Primary Care Patients Improves Their Physical, Mental, and Social Functioning,” Archives of Internal Medicine, 157 (1997): 1113–1120; Clark F. , “Occupational Therapy for Independent-Living Older Adults: A Randomized Controlled Trial,” JAMA, 278 (1997): 1321–26.

Lipson D.J. and De Sa J.M. , “Impact of Purchasing Strategies on Local Health Care Systems,” Health Affairs, 15, no. 2 (1996): 62–76, at 75; Miller R.H. , “Competition in the Health System: Good News and Bad News,” Health Affairs, 15, no. 2 (1996): 107–120.

Many HMOs now participate in national quality evaluations called “HEDIS” (Healthplan Employer Data Information Set) that require the HMO to conduct annual reviews to ensure quality of care along a number of parameters such as immunizations, mammography, and the like. McDonald C.J. , “Quality Measures and Electronic Medical Systems,” JAMA, 282 (1999): 1181–82; Epstein A.M. , “Rolling Down the Runway: The Challenges Ahead for Quality Report Cards,” JAMA, 279 (1998): 1691–96; Bodenheimer T. , “The American Health Care System: The Movement for Improved Quality in Health Care,” N. Engl. J. Med., 340 (1999): 488–492; Spoeri R.K. and Ullman R , “Measuring and Reporting Managed Care Performance: Lessons Learned and New Initiatives,” Annals of Internal Medicine, 127 (1997): 726–32.

However, recent studies conclude it is no better than conventional chemotherapy. Of five studies released in 1999, four indicated that high-dose chemotherapy with bone marrow transplant was no better for breast cancer than conventional chemotherapy. A fifth study, done in South Africa, suggested some benefit. However, several months later, as scientists looked at this study more closely in an effort to replicate its results, the principal investigator admitted to having falsified some of the data “out of a foolish desire to make the presentation more acceptable” to the scientific meeting sponsored by the American Society of Clinical Oncology. Weiss R.B. , “High-Dose Chemotherapy for High-Risk Primary Breast Cancer: An On-Site Review of the Bezwoda Study,” Lancet, 355 (2000): 999–1003, at 1003. See also Antman K.H. Heitjan D.F. and Hortobagyi G.N. , “High-Dose Chemotherapy for Breast Cancer,” JAMA, 282 (1999): 1701–1703; Gradishar W.J. , “High-Dose Chemotherapy and Breast Cancer,” JAMA, 282 (1999): 1378–80; Rowlings P.A. , “Factors Correlated with Progression-Free Survival After High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Metastatic Breast Cancer,” JAMA, 282 (1999): 1335–43; Horton R. , “After Bezwoda,” Lancet, 355 (2000): 942–43; Bergh J. , “Where Next with Stem-Cell-Supported High-Dose Therapy for Breast Cancer?” Lancet, 355 (2000): 944–45.

Another study completed even more recently came to the same conclusion, namely, that bone marrow transplant offers no advantage over conventional chemotherapy. See Stadtmauer E.A. , “Conventional-Dose Chemotherapy Compared with High-Dose Chemotherapy Plus Autologous Hematopoietic Stem-Cell Transplantation for Metastatic Breast Cancer,” N. Engl. J. Med., 342 (2000): 1069–1076; Lippman M.E. , “High-Dose Chemotherapy Plus Autologous Bone Marrow Transplantation for Metastatic Breast Cancer,” N. Engl. J. Med., 342 (2000): 1119–1120. See also Steinberg E.P. Tunis S. and Shapiro D. , “Insurance Coverage for Experimental Technologies,” Health Affairs, 14, no. 4 (1995): 143–58; ECRI, “High-Dose Chemotherapy with Autologous Bone Marrow Transplantation and/or Blood Cell Transplantation for the Treatment of Metastatic Breast Cancer,” Healthy Technology Assessment Information Service: Executive Briefings, February (1995); Peters and Rogers , supra note 35; United States General Accounting Office, “Health Insurance: Coverage of Autologous Bone Marrow Transplantation for Breast Cancer,” Report to the Honorable Ron Wyden, U.S. Senate (1996): April: 125.

Eddy D.M. , “Benefit Language: Criteria That Will Improve Quality While Reducing Costs,” JAMA, 275 (1996): 650–657; Bergthold L.A. , “Medical Necessity: Do We Need It?,” Health Affairs, 14, no. 4 (1995): 180–90; Jacobson P.D. , “Defining and Implementing Medical Necessity in Washington State and Oregon,” Inquiry, 34 (1997): 143–54; Mariner W.K. , “Patients' Rights After Health Care Reform: Who Decides What Is Medically Necessary?,” American Journal of Public Health, 84 (1994): 1515–20; Glassman P.A. , “The Role of Medical Necessity and Cost-Effectiveness in Making Medical Decisions,” Annals of Internal Medicine, 126 (1997): 152–156.

Aston G. , “No Consensus On Medical Necessity,” American Medical News, May 10, 1999, p. 28.

Some of the historical discussion in the following four paragraphs is adapted from Morreim E.H. , “Playing Doctor: Corporate Medical Practice and Medical Malpractice,” Michigan Journal of Law Reform, 32 (1999): 939–1040.

This historical overview is based largely on Anderson G.F. Hall M.A. and Steinberg E.P. , “Medical Technology Assessment and Practice Guidelines: Their Day In Court,” American Journal of Public Health, 83 (1993): 1635–1639; Hall M.A. and Anderson G.F. , “Health Insurers' Assessment of Medical Necessity,” University of Pennsylvania Law Review, 140 (1992): 1637–1712; Havighurst C.C. , “Health Care Choices: Private Contracts as Instruments of Health Reform. (Washington, D.C.: The AEI Press, 1995).

See, for example, Van Vactor v. Blue Cross Ass'n, 365 N.E. 2d 638 (Ill. 1977); McLaughlin v. Connecticut General Life Ins. Co., 565 F. Supp. 434 (Calif. 1983); Ex Parte Blue Cross-Blue Shield of Ala., 401 So.2d 783 (Ala. 1981); Haggard v. Blue Cross-Blue Shield of Ala., 401 So.2d 781 (Ala. App. 1980); Group Hospitalization, Inc. v. Levin, 305 A.2d 248 (D.C. App. 1973); Hughes v. Blue Cross of Northern Calif., 245 Cal. Rptr. 273 (Cal. App. 1 Dist. 1988); McGraw v. Prudential Ins. Co. of America, 137 F.3d 1253 (10th Cir. 1998).

See supra note 11.

Anderson Hall and Steinberg , supra note 46; Hall and Anderson , supra note 46; Havighurst , supra note 46.

Hirshfeld E.B. and Harris G.H. , “Medical Necessity Determinations: The Need for a New Legal Structure,” Health Matrix, 6, no. 3 (1996): 3–52; Rosenbaum S. , “Who Should Determine When Health Care Is Medically Necessary?,” N. Engl. J. Med., 340 (1999): 229–232; Bergthold , supra note 43, at 182; Mariner W.K. , “Patients' Rights After Health Care Reform: Who Decides What Is Medically Necessary?,” American Journal of Public Health, 84 (1994): 1515–20; Eddy , supra note 43, at 652; Anderson Hall and Steinberg , supra note 46, at 1636–37; Hall and Anderson , supra note 46, at 1644–57;

As noted by Hirshfeld: “When a health plan agrees to cover health care services, the contract with the beneficiary generally specifies that the services must be paid for when they are reasonable and necessary for the diagnosis or treatment of an illness or injury suffered by the beneficiary.” Hirshfeld and Harris , supra note 50, at 4.

In some cases such listed services include procedures traditionally done by specialists, including dermatologic procedures such as skin biopsies, casting of undisplaced fractures, colposcopies, sigmoidoscopy, joint aspiration and injections, stress tests, and the like. Terry K. , “Surprise! Capitation Can Be A Boon,” Medical Economics, 73, no. 7 (1996): 126–138; Cheney K. , “What You Can Learn From An M.D. Mutiny in a Managed-Care Plan,” Money, December 1995, p. 21; Novak J. , “How We Wrote Our Own Managed-Care Success Story,” Medical Economics, 75, no. 15 (1998): 116–27; “How Do Non-Physician Providers Function in HMOs?,” HMO Practice, 8, no. 4 (1994): 151–56.

“Ultimately, medical necessity can be thought of as a continuum, whereby services at one end of the continuum are clearly necessary for the diagnosis and treatment of an illness or injury, and services at the other end of the continuum are clearly unnecessary, and in between are services that have some degree of likelihood of benefiting a patient. As one moves along the continuum from clearly necessary to clearly unnecessary, the percentage of likelihood of a benefit from the provision of the health care involved decreases. The value judgment that must be made is how large the percentage of likelihood of a benefit should be for care to be provided. The closer that percentage is to 100%, the more likely it is that some individuals will be harmed by the withholding of care that could have benefited them.” Hirshfeld E.B. and Harris G.H. , “Medical Necessity Determinations: The Need for a New Legal Structure,” Health Matrix, 6, no. 3 (1996): 3–52, at 24–25. See also Rosenbaum , supra note 50.

McGinley L. , “HMO Fracas Moves to Who Makes Medical Decisions,” Wall Street Journal, February 18, 1999, at A-24.

Glazer W.M. , “Psychiatry and Medical Necessity,” Psychiatric Annals, 22 (1992): 362–366, at 362.

Steinberg E.P. Tunis S. and Shapiro D. , “Insurance Coverage for Experimental Technologies,” Health Affairs, 14, no. 4 (1995): 143–58, at 144–45; Mariner W.K. , “Patients' Rights After Health Care Reform: Who Decides What is Medically Necessary?,” American Journal of Public Health, 84 (1994): 1515–20, at 1516–17.

*for office visit: Blue Shield of Northern California denied 12.1, while Wisconsin Physicians' Service denied 109.7 *for real-time echocardiography: BCBS of Illinois denied zero, while BS of Calif denied 2.2, while Transamerica Occidental denied 198.5.

*for myocardial perfusion imaging: BCBS of Ill and Wisc Physicians' Service denied zero, while Transamerica Occidental denied 252.3.

*for ambulance with basic life support: BS of Calif denied 1.5, BCBS of So. Carolina denied 1.5, while Connecticut General denied 413.2. (Pretzer at 93.)

See also Gleason S.C. , “Health System Deregulation: Some Aspects of Health Care System Reform Need Not Be Held Hostage,” JAMA, 274 (1995): 1483–86, at 1483; Mariner W.K. , “Business vs. Medical Ethics: Conflicting Standards for Managed Care,” Journal of Law, Medicine and Ethics, 23 (1995): 236–246.

Burnum , supra note 10; Wong and Lincoln , supra note 10; Hardison , supra note 10; Mold and Stein , supra note 10.

Eddy , supra note 43, at 654–55; Truog R.D. Brett A.S. and Frader J. , “The Problem with Futility,” N. Engl. J. Med., 326 (1992): 1560–1564.

Havighurst , supra note 46.

Studies have found that, depending on the type and size of corporation, somewhere between 56% and 85% of the costs of health care are directly shifted back to workers through reduced wages. Another study found that, with respect to states' assorted mandates for health plans cover various specified services, from 59% to 90% of the costs of these mandates are translated into wage reductions. Blumberg L.J. , “Who Pays for Employer-Sponsored Health Insurance?,” Health Affairs, 18, no. 6 (1999): 58–61, at 58.

Report to the Board of Trustees, AMA, “Direct Contracting with Employers: A Strategy to Increase Physician Involvement in the Current Health Care Market,” Board of Trustees Report, 27–A-95, at p. 1.

Corcoran v. United Healthcare, Inc., 965 F2d 1321 (5th Cir 1992), cert denied 113 SCt 812 (1992); Morreim , supra note 45.

For further discussion, see Morreim , supra note 45.

Morreim E.H. , “Medicine Meets Resource Limits: Restructuring the Legal Standard of Care,” University of Pittsburgh Law Journal, 59 (1997): 1–95 (hereinafter, “Medicine Meets”); Morreim , supra note 45; Van Vactor v. Blue Cross Ass'n, 365 N.E. 2d 638 (Ill. 1977); McLaughlin v. Connecticut General Life Ins. Co., 565 F. Supp. 434 (Calif. 1983); Ex Parte Blue Cross-Blue Shield of Ala., 401 So.2d 783 (Ala. 1981); Haggard v. Blue Cross-Blue Shield of Ala., 401 So.2d 781 (Ala. App. 1980); Group Hospitalization, Inc. v. Levin, 305 A.2d 248 (D.C. App. 1973); Hughes v. Blue Cross of Northern Calif., 245 Cal. Rptr. 273 (Cal. App. 1 Dist. 1988); McGraw v. Prudential Ins. Co. of America, 137 F.3d 1253 (10th Cir. 1998).

Morreim , “Medicine Meets,” supra note 65.

Morreim , supra note 35; Loyola University of Chicago v. Humana Ins. Co., 996 F.2d 895 (7th Cir 1993); Fuja v. Benefit Trust Life Ins. Co., 18 F.3d 1405 (7th Cir. 1994); Free v. Travelers Ins. Co., 551 F. Supp. 554, 560 (D.Md. 1982); McLeroy v. Blue Cross/Blue Shield of Oregon, Inc., 825 F. Supp. 1064, 1071 (N.D. Ga. 1993); McGee v. Equicor-Equitable HCA Corp., 953 F.2d 1192 (10th Cir. 1992); Nazay v. Miller, 949 F.2d 1323, 1336 (3rd Cir. 1991); Harris v. Mutual of Omaha Companies, 992 F.2d 706, 713 (7th Cir. 1993); Gee v. Utah State Retirement Bd, 842 P.2d 919, 920–21 (Utah App. 1992); Arrington v. Group Hospitalization & Med. Serv., 806 F. Supp. 287, 290 (D.D.C. 1992); Barnett v. Kaiser Foundation Health Plan, Inc., 32 F.3d 413 (9th Cir., 1994); Nesseim v. Mail Handlers Ben. Plan, 995 F.2d 804 (8th Cir., 1993); Farley v. Benefit Trust Life Ins. Co., 979 F.2d 653 (8th Cir. 1992); Harris v. Blue Cross Blue Shield of Missouri, 995 F.2d 877 (8th Cir. 1993); McLeroy v. Blue Cross/Blue Shield of Oregon, Inc., 825 F. Supp. 1064 (N.D. Ga. 1993); Thomas v. Gulf Health Plan, Inc., 688 F. Supp. 590 (S.D. Ala. 1988); Doe v. Group Hospitalization & Medical Services, 3 F.3d 80 (4th Cir. 1993).

Morreim , supra note 45.

“Leveling up would require such a staggering commitment of resources that other public priorities would unduly suffer; leveling down would promote gross inefficiency, lower quality, achieve a dubious sort of equity in which waiting time would be the main resource allocator, and threaten fundamental precepts of freedom by barring individual expenditures for health above some arbitrary limit set by government.” Blumstein and Sloan , “Redefining Government's Role in Health Care: Is a Dose of Competition What the Doctor Should Order?,” Vanderbilt Law Review, 34 (1981): 849,865.

Admittedly, one barrier to exposure of such guidelines is the fact that some of them are proprietary, and require the plans that purchase them not to disclose their contents. If open, guidelines-based contracting is to become the norm, some resolution—perhaps a broad-based buy-out—must be found for this problem. See, for example, Rosenbaum Frankford Moore and Borzi , supra note 50, at 231.

Morreim , supra note 45; Morreim , “Medicine Meets,” supra note 65; Morreim E.H. , “Diverse and Perverse Incentives in Managed Care: Bringing the Patient into Alignment,” Widener Law Symposium, 1 (1995): 89–139 (hereinafter, “Diverse”); Morreim E.H. , “Saving Lives, Spending Money: Shepherding the Role of Technology,” Bono J. and Wear S. , eds., Ethics and Values in Health Care and Medicine on the Frontiers of the Twenty-First Century, Philosophy and Medicine Series; (Dordrecht: Kluwer Academic Publishers, 2000): 63–110 (hereinafter, “Saving Lives”); Havighurst , supra note 46; Daniels N. and Sabin J.E. , “Limits to Health Care: Fair Procedures, Democratic Deliberation, and the Legitimacy Problem for Insurers,” Philosophy and Public Affairs, 26 (1997): 303–50; Eddy , supra note 43; Bergthold , supra note 43.

Morreim , “Medicine Meets,” supra note 65; Morreim , “Diverse,” supra note 71; Morreim , supra note 35; Morreim , supra note 45; Morreim , “Saving Lives,” supra note 71.

Havighurst , supra note 46, at 183 ff.; Morreim , “Medicine Meets,” supra note 65; Morreim , “Saving Lives,” supra note 71.

Morreim , “Saving Lives,” supra note 71.

“Most health insurers and managed care plans rely on ad hoc opinion by experts; only in a few instances are there HTA [health technology assessment] programs or structured processes for coverage decision making.” Perry S. and Thamer M. , “Medical Innovation and the Critical Role of Health Technology Assessment,” JAMA, 282 (1999): 1869–1872, at 1870. As several commentators recently observed, “materials such as the practice guidelines prepared by Milliman and Robertson, a well-known actuarial firm, often rely on insurers' own decisions rather than on well-designed scientific research.” Rosenbaum Frankford Moore and Borzi , supra note 50, at 231 (citing: M&R: Healthcare management guidelines. New York: Milliman and Robertson , 1996–1998).

Even when subscribers do not take the opportunity to study the plan's details—or don't understand them when they do try to study them—the “sunshine” of openness introduces a measure of accountability that health plans would be hard-pressed to evade.

Hadorn D.C. , “The Problem of Discrimination in Health Care Priority Setting,” JAMA, 268 (1992): 1454–1459, at 1454.

Daniels N. , Just Health Care (Cambridge: Cambridge University Press, 1985).

Jonsen A. , “Bentham in a Box: Technology Assessment and Health Care Allocation,” Law, Medicine and Health Care, 14 (1986): 172–174; Hadorn D.C. , “Setting Health Care Priorities in Oregon: Cost-Effectiveness Meets the Rule of Rescue,” JAMA, 265 (1991): 2218–25; Morreim E.H. , “Of Rescue and Responsibility: Learning to Live with Limits,” Journal of Medicine and Philosophy, 19 (1994): 455–470.

Though controversial, and perhaps not duplicable on a national level, the state of Oregon has attempted just such a prioritization with considerable success. Bodenheimer T. , “The Oregon Health Plan—Lessons for the Nation,” First of two parts. N. Engl. J. Med., 337 (1997): 651–55; Bodenheimer T. , “The Oregon Health Plan—Lessons for the Nation,” Second of two parts. N. Engl. J. Med., 337 (1997): 720–723.

Morreim , “Medicine Meets,” supra note 65; Morreim , “Diverse,” supra note 71; Morreim , supra note 35; Morreim , supra note 45; Morreim , “Saving Lives,” supra note 71.

Blendon R.J. Brodie M. and Benson J. , “What Should be Done Now that National Health System Reform is Dead?,” JAMA, 273 (1995): 243–44; American College of Physicians, “Voluntary Purchasing Pools: A Market Model for Improving Access, Quality, and Cost in Health Care,” Annals of Internal Medicine, 124 (1996): 845–53; Berenson R.A. , “Beyond Competition,” Health Affairs, 16, no. 2 (1997): 171–80; Etheredge L. Jones S.B. and Lewin L. , “What is Driving Health System Change?,” Health Affairs, 15, no. 4 (1996): 93–104.

Butler S.M. and Moffit R.E. , “The FEHBP as a Model for a New Medicare Program,” Health Affairs, 14, no. 4 (1995): 47–61.

American College of Physicians, “Voluntary Purchasing Pools: A Market Model for Improving Access, Quality, and Cost in Health Care,” Annals of Internal Medicine, 124 (1996): 845–853; Schauffler H.H. and Rodriquez T. , “Exercising Purchasing Power for Preventive Care,” Health Affairs, 15, no. 1 (1996): 73–85; Robinson J.C. , “Health Care and Purchasing and Market Changes in California,” Health Affairs, Winter, (1995): 117–130; Iglehart J.K. , “The Struggle to Reform Medicare,” N. Engl. J. Med., 334 (1996): 1071–75; Luft H.S. , “Modifying Managed Competition to Address Cost and Quality,” Health Affairs, 15, no. 1 (1995): 23–38; Etheredge L. Jones S.B. and Lewin L. , “What is Driving Health System Change?,” Health Affairs, 15, no. 4 (1996): 93–104

Choice among plans does not require a vast smorgasbord of variety, with endless combinations and permutations of benefits. A handful of basic plan options might enhance choice far better, especially where individuals have some measure of freedom to make choices within plans. Hibbard J.H. , “Choosing a Health Plan: Do Large Employers Use the Data?” Health Affairs, 16, no. 6 (1997): 172–80, at 176; Farrell M.G. , “ERISA Preemption and Regulation of Managed Health Care: The Case for Managed Federalism,” American Journal of Law and Medicine, 23 (1997): 251–89, at 287; Morreim , “Saving Lives,” supra note 71.

Morreim Diverse , supra note 71.

Without entering into debates that are already addressed elsewhere, three potential drawbacks can be quickly addressed. First, people can make choices they later regret. Reply: so long as every plan must meet basic needs, no one's choice can go too badly wrong. And making one's own mistakes is not necessarily worse than what happens now: health plans making all sorts of bad choices for people, without their knowledge or consent, then pocketing the savings.

Second, it is possible, even likely, that some employers will buy the leanest plan and then expect employees to pay for better. Reply: this is precisely what already happens, as many firms downshift health benefits. Although some employers might be criticized for reducing coverage, others have done so out of economic necessity. In either case, arguably the greater problem is that the reduction is hidden as plans continue to promise all “necessary” care while delivering much less than before. In the alternative outlined here, a reasonable minimum of basic care, combined with explicit coverage policies, enhanced choice, and a sharing of money saved, would at least let patients make informed decisions, while giving plans a much greater incentive to provide reasonable benefit levels and upgrade opportunities.

Third, administrative complexities won't permit all the choices people might want. Reply: as suggested just above, human autonomy is often better enhanced by a limited range of real choices than by an endless array of minutae. A few basic plan-types would be far easier for patients to learn about and choose among, than an endless variety of guidelines and lists. In any case, a reasonable range of options is better than the few-to-none seen in most health plans. And there is no requirement that plans spring forth instantly with a wide array of choices. They can begin modestly and add new options, one by one, as they become feasible.

Winslow R. , “Co-Payments Rise for Prescriptions,” Wall Street Journal, January 12, 1999, at B-1, B-4.

Davis K. Collins K.S. Schoen C. and Morris C. , “Choice Matters: Enrollees' Views of Their Health Plans,” Health Affairs, 14, no. 2 (1995): 99–112; Ullman R. , “Satisfaction and Choice: A View from the Plans,” Health Affairs, 16, no. 3 (1997): 209–17.

Szabo E. Moody H. , and Hamilton T. , “Choice of Treatment Improves Quality of Life: A Study on Patients Undergoing Dialysis,” Archives of Internal Medicine, 157 (1997): 1352–1356.

See Section IV-B-1, above. As noted there, even choices among antibiotics to treat a life-threatening infection challenge the black/white notion of “necessary,” e.g., as one drug may have a slightly greater chance of success, but at the price of riskier side-effects and high financial cost.