Healthcare Plans as Gatekeepers

Alternative Medicine
  • Grace Powers Monaco
  • Gilbert Smith
Part of the Biomedical Ethics Reviews book series (BER)


Healthcare plans have traditionally covered standard medical care. This category includes therapies generally recognized as beneficial to patients by medical consensus, or, increasingly, in the last thirty years, particularly as pertains to therapies for life-threatening illness, includes therapies demonstrated effective through the results of scientifically adequate clinical trials. The experimental/ investigational exclusion clause became part of most health care plan contracts by the mid-1970s. This exclusion clause recognized a division ofresponsibility. Healthcare plans covered standard therapies—those that had already been sorted out through medical consensus or clinical trial. The federal government, pharmaceuticals, and philanthropy covered the costs relating to the development of new and improved therapies as part of a social/ public obligation or commercial interest. In the last 30 years, acceptance of new therapies into a benefit package has been increasingly contingent upon demonstration of their therapeutic worth through clinical trials producing usable outcome data. Therapies antedating that period are included based on medical consensus, which is usually reflected in drug or procedure compendia.

Gatekeeping by healthcare plans became publicly visible during the mid-1970s and involved the application of the experimental/investigational exclusion to unproven and untested therapies—usually quackery or “fringe” medicine. The courts generally upheld the exclusion from coverage of therapies that had no systemic process in place to study a therapy and produce reliable outcome information on whether it could be expected to benefit patients. Application of the exclusion in this fashion was considered to be appropriate for the wise use of premium dollars. With the erosion offederal support for treatment development through support of patient care costs for participating in clinical trials, the gatekeeper function has expanded beyond “fringe” medicine to the appropriate coverage of specific applications of high-technology medicine, such as high-dose chemotherapy with autologous, allogeneic, or cord-blood rescue while still in clinical trial.

Examination of cases involving “fringe” medicine vis a vis standard therapies or those on clinical trial appears to demonstrate that the gatekeeper function has been applied evenhandedly to therapies regardless of their provenance. The underlying requirement for coverage is the level of objective, reliable, and verifiable data that is available on the approach and whether it has demonstrated that it can be expected to benefit the patient or that the patient will be participating in a scientifically adequate study that will produce information on the place of the therapy in the medical armamentarium. It would be unfair to have a double standard of gatekeeping for so-called “alternative” therapies. To win coverage as a basic benefit, “alternative ” therapies should be expected to participate in systems, appropriate to their particular class of therapy, that will produce objective and verifiable data on patient benefit.


Alternative Therapy Health Care Plan Healthcare Plan United States Pharmacopeial Convention Blue Cross Blue Shield 
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  1. 1.
    RA v. Prudential(Docket No. L.8093–79 Sup. Ct. NJ).Google Scholar
  2. 2.
    Monaco, G. P., and Burke, R. (1982) Insurer as gatekeeper: Handling claims for unproven methods of medical management. Forum: J. Torts Ins. Prac. Sect. Am. Bar Assoc 18 (4), 591–614.Google Scholar
  3. 3.
    Monaco, G. P. and Burke, R. (1985) Insurer as gatekeeper, part two: policy obstacles in unproven methods litigation. Forum: J. Torts Ins. Prac. Sec. Am. Bar Assoc 20 (3), 400–417.Google Scholar
  4. 4.
    Victum v. Martin, 326 N.E.2d. 12, 14, 16 (Mass. 1975 ).Google Scholar
  5. 5.
    Duvoric v. Richardson,479 F.2d. 242 (7th cir. 1973) cert denied, 414 U.S. 44.Google Scholar
  6. 6.
    Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 617 (1973).Google Scholar
  7. 7.
    Final Report of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS. June 26, 1990. National Cancer Institute, US Government Printing Office, p. 13.Google Scholar
  8. 8.
    Wilson, L. and Goldschmidt, P. (1995) Quality management in health care. McGraw-Hill, New York, pp. 146–349.Google Scholar
  9. 9.
    Monaco, G. P., and Gottlieb, M. G. (1987) Commentary: treatment INDs: research for hire? JAMA 258(22), 3296, 3297.Google Scholar
  10. 10.
    Square D Company v. Tipton,No. 92-SC-743-WC, Kentucky Supreme Court, July 1, 1993, 40 KLS 6, p. 27 HLD 21(8) 43,44: Under state law, there was no obligation to pay for treatments known to be umproductive, not generally accepted, controversial and dangerous, not supported by objective evidence-scalenectomy.Google Scholar
  11. 11.
    James, F. P. (1991) The experimental treatment exclusion clause: A tool for silent rationing of health care? J. Legal Med 12, 359–418.CrossRefGoogle Scholar
  12. 12.
    Pirozzi v. Blue Cross Blue Shield of Virginia, 741 F. Supp. 586 (E.D. 1990 ).Google Scholar
  13. 13.
    Sweeney v. Gerber Products Company Medical Benefits Plan, 728 F. Supp. 594 (D. Neb. 1989 ).Google Scholar
  14. 14.
    Thomas v. Gulf Health Plan, Inc., 688 F. Supp. 590 (SD Ala. 1988 ).Google Scholar
  15. 15.
    Free v. Travelers, 551 F. Supp. 544, 58–60 (D. Md. 1982 ).Google Scholar
  16. 16.
    Zuckerberg v. BC/BS ofGreater New York, 487 NYS2d 595 (April 8, 1995 ).Google Scholar
  17. 17.
    Monaco, G. P. (1980) The laetrile phenomenon: legal perspective, in Politics, Science, and Cancer: The Laetrile Phenomenon. Markle, G. E., and Peterson, J. C. eds.), AAAS Selected Symposium 46. Westview Press, Boulder, CO, pp. 99–132.Google Scholar
  18. 18.
    Decision on the Status of Laetrile, August 5, 1977, FDA Docket No. 77N-0048, 42 Federal Register 151, 39768.Google Scholar
  19. 19.
    Spelson v. CBS Inc., 581 F. Supp. 1195, 1206 ( N.D. Ill. 1984 ).Google Scholar
  20. 20.
    Farnsworth v. Tribune Company,43 I11.2d at 286, 291, 253 N.E. 2d 408, 411.Google Scholar
  21. 21.
    Harris v. Mutual ofOmaha Companies, 992 F.2d 706 (7th Cir. 1993 ).Google Scholar
  22. 22.
    Exbom v. Central States Southeast and Southwest Areas Health and Welfare Fund, 900 F.2d 1138 (7th Cir. 1990 ).Google Scholar
  23. 23.
    Goodman v. Sullivan, 891 F.2d 449 (2nd Cir. 1989 ).Google Scholar
  24. 24.
    Holder v. Prudential, 951 F.2d 89 (5th Cir. 1992 ).Google Scholar
  25. 25.
    Mire v. Blue Cross/Blue Shield of Florida, No. 94–5181 (11th Cir. December 9, 1994), 43 F. 3d 567 (Dec. 9, 1994 ).Google Scholar
  26. 26.
    Odenwaller v. Aetna Life Insurance Co.,docket No. K-86–283CA4 (WD Mich.).Google Scholar
  27. 27.
    US v. Rutherford, 442 U.S. 544, 551, 555–56, 59 (1979).Google Scholar
  28. 28.
    Henne v. Mutual of Omaha (No. 81–1359, DDC Jan. 10, 1983 ).Google Scholar
  29. 29.
    A. Wah Jun Tze, CM, MD FRCP (C), President, Tzu Chi Institute for Complementary and Alternative Medicine. The meaning of alternative and complementary and medicine. Online. Internet. The Newsletter of the Tzu Chi Institute,vol. 1, issue 1, September 1996. Available: Google Scholar
  30. 29.
    Hedrick, H. (ed.) (1995) ACHP SPIG mission statement: Alternative and complementary health practices, SPIG Newsletter, (Fall), APHA, Washington, D.C., p. 4.Google Scholar
  31. 31.
    ) USP Open Conference On Botanicals For Medical And Dietary Uses: Standards And Information Issues. (July 7–9), United States Pharmacopeial Convention, Inc., Rockville, MD, p. 141.Google Scholar
  32. 32.
    Blumenthal, M. (1996) A New Regulatory Category for Herbs as Traditional Medicines: A Review of the American Botanical Council ‘s Traditional Medicine Research Project. USP Open Conference On Botanicals For Medical And Dietary Uses: Standards And Information Issues. (July 7–9). ANA Hotel DC. United States Pharmacopeial Convention, Inc., Rockville, MD, pp. 4, 5.Google Scholar
  33. 33.
    Moss, K. (ed.) (1996) Medical Utilization Management Directory Faulkner & Gray, Washington, DC, 24(21).Google Scholar
  34. 34.
    Graham v. State, 480 N.E.2d 981, (Ind. App 1985 ).Google Scholar
  35. 35.
    Monaco, G. P., and Green, S. (1993) Recognizing deception in the promotion of untested and unproven medical treatments. NY St. J. Med 93 (2) 88–91.Google Scholar
  36. 36.
    Pendergrass, T. W. (1997) Alternative therapies in the treatment of childhood cancer, in Principle and Practices of Pediatric Oncology, (3rd ed.), Pizzo, P. A. and Poplack, D. G., eds. Lippincott-Raven, Philadelphia, PA, pp. 1383–1393.Google Scholar
  37. 37.
    Morton, M. and Morton, M. (1997) Ten most commonly asked questions about alternative medicine. Health World http:// II, p. 2.Google Scholar
  38. 38.
    Erickson, J. (1997) Dr. Andrew Weil starts fellowship program in “Integrative Medicine.” Oncology Times 19(10), 3–6, at. 4.Google Scholar
  39. 39.
    Moore v. Baker, 989 F.2d 1129, 1132, 1133 (11th Cir. 1993 ).Google Scholar
  40. 40.
    The term “medically necessary” generally covers services or supplies provided by a hospital or covered provider of healthcare services that are appropriate to diagnose or treat the patient’s condition, illness, or injury, consistent with standards of good medical practice, and are not primarily for the personal comfort of the patient, the family, physician, or other provider. Usually exclusions for experimental/investigational treatments attempt to factor out procedures that are “meant to investigate,” are limited to research, are not proven in an objective way to have therapeutic value or benefit, or are medically questionable.Google Scholar
  41. 41.
    Dallis v. Aetna, 768 F.2d 1303 (11th Cir. 1985); Dallis v. Aetna, 574 F. Supp. 44547 (ND Ga. 1983 ).Google Scholar
  42. 42.
    A. Stupar, B. Alternative Nutrition Resource, What Is Alternative Medicine Online. Internet. April 30, 1997. Available: http:// www.rural.nethbobstu/a-fag02.html. (National Institute ofHealth says that “alternative medicine is an unrelated group of non-orthodox therapeutic practices, often with explanatory systems that do not follow conventional biomedical explantions”).Google Scholar
  43. 43.
    US v. BCRL, 819 F.2d 1301, 1314,1315 (D. S.D. 1987 ).Google Scholar
  44. 44.
    People v. Burroughs, 678 P.2d 894 (Ca. App. 1984 ).Google Scholar
  45. 45.
    Sullivan v. Henry, 287 SE2d 652 (CA GA, 1982 ).Google Scholar
  46. 46.
    Clark v. Board of Medical Examiners, 463 So.2d 328 (Fla. App. 1985 ).Google Scholar
  47. 47.
    Peters v. Dr. Harold Manner et al.Docket No. 83L 22441, Circuit Court of Cook County, Illinois County Department, Law Division.Google Scholar
  48. 48.
    DiPalma, J. R. and Ritchie, D. M. (1977) Vitamin toxicity. Ann. Rev. Pharmacol. Toxicol 17, 133–148.CrossRefGoogle Scholar
  49. 49.
    Stich, H. F. (1976) Letter to the editor: mutagenic action of ascorbic acid. Nature 160, 722–723.CrossRefGoogle Scholar
  50. 50.
    Humbert, J. R., Tress, J. H., and Braico, K. T. (1977) Fatal cyanide poisoning: Accidental ingestion of laetrile. JAMA 238 (6), 482.PubMedCrossRefGoogle Scholar
  51. 51.
    Custody ofa Minor (Chad Green), 379 N.E.2d 1053 (Mass. 1978), on review, affirmed, 393 F.E.2d 836, 845 (1979) (Court found that laetrile and metabolic therapy resulted in a low-grade chronic toxicity).Google Scholar
  52. 52.
    Miller, J. (1997) The Insurance Industry Discovers a Cost-EffectiveAlternative (January 22) Insur/htm.Google Scholar
  53. 53.
    USP Open Conference On Botanicals For Medical And Dietary Uses: Standards And Information Issues. July 7–9, 1996 ANA Hotel DC. Publisher: United States Pharmacopeial Convention, Inc., Rockville, MD, p. 144.Google Scholar
  54. 51a.
    See, e.g., cases discussing contract exclusions: Barley v. Blue Cross & Blue Shield of Virginia, 67 F.3d 53 (4th cir. 1995), cert. denied, 116 S.Ct. 1043 (1996), Bushman v. State Mutual Life Assurance Co. of America, 915 F. Supp. 945 (N.D. Ill. 1996), Empire Blue Cross Blue Shield, 920 F. Supp., 477 (S.D. N. Y. 1996) and Hilliard v. Bellsouth Medical Assistance Plan, 918 F. Supp. 1016 ( S.D. Miss. 1995 ).Google Scholar
  55. 52.
    USP Open Conference On Botanicals, see note 57 supra., p. 139.Google Scholar
  56. 53.
    Halperin, J. (1996) Closing remarks. USP Open Conference On Botanicals for Medical and Dietary Uses: Standards and Information Issues. (July 7–9). United States Pharmacopeial Convention, Inc., Rockville. MD, pp. 130, 131.Google Scholar
  57. 54.
    Soloway, R. A. (ed.) (1996) A.B.A.T.: Potential health risks. USP Open Conference on Botanicals for Medical and Dietary Uses: Standards and Information Issues. (July 7–9 ). United States Pharmacopeial Convention, Inc., Rockville, MD, pp. 125–127.Google Scholar

Copyright information

© Springer Science+Business Media New York 1998

Authors and Affiliations

  • Grace Powers Monaco
  • Gilbert Smith

There are no affiliations available

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