Correspondence
Variations in Insurance Coverage for Autologous Bone Marrow Transplantation for Breast Cancer
N Engl J Med 1994; 331:329-331August 4, 1994
- Article
To the Editor:
In concluding that the current process for making decisions about coverage of high-dose chemotherapy for breast cancer is “arbitrary and capricious,” Drs. Peters and Rogers (Feb. 17 issue)1 assume that . . . only insurers have a financial interest in making determinations about coverage. At the commonly quoted price of $150,000 per course of treatment, however, treatment of the 533 women in their analysis represents an annual income of $20 million to their institution alone. Institutions, providers, and suppliers all benefit substantially from insurance coverage for this treatment.
Though the authors indicate otherwise, publication of their article comes at a time when there is probably more cooperation and exchange of information between insurers and researchers than at any other time since this issue arose. The exchange will no doubt continue2. Society at large, not researchers or insurers, should ultimately decide on the amount and allocation of funds available for medical research.
(The opinions expressed in this letter are my own and not those of Metropolitan Life Insurance Company or its affiliates).
2 ReferencesKenneth J. Krause, M.D.
Metropolitan Life Insurance Company, New York, NY 100101
Peters WP ,Rogers MC . Variation in approval by insurance companies of coverage for autologous bone marrow transplantation for breast cancer. N Engl J Med 1994;330:473-477
Full Text | Web of Science | Medline2
Volkers N . Cover costs, test treatments, pay patients: health care reform hearings hot on Hill. J Natl Cancer Inst 1994;86:336-337
CrossRef | Web of Science | Medline
To the Editor:
High-dose chemotherapy with autologous bone marrow transplantation for breast cancer has not been evaluated adequately in clinical trials and is a controversial treatment. A team from our organization evaluated 35 centers offering such treatment and found tremendous variation in indications for the procedure and outcomes. Drs. Peters and Rogers should acknowledge the inconsistency in the medical community when it comes to recommending and performing this potentially lethal, investigational procedure. They should also acknowledge the financial incentives for performing it1.
There is no evidence that high-dose chemotherapy with autologous bone marrow transplantation results in longer survival than conventional treatment2. The decision by Blue Cross-Blue Shield to limit coverage to patients enrolled in the phase 3 trials sponsored by the National Cancer Institute (NCI) made sense, and other organizations have attempted to do the same, because the widespread use of this treatment, which has a 5 to 10 percent mortality rate, should be based on its proved relative effectiveness. The literature contains clear examples of clinical interventions that were thought beneficial but, when subjected to the scrutiny of adequate clinical investigation, were actually found to be deleterious3. Unfortunately, the pressure for unrestricted coverage, as well as the media's portrayal of this treatment as a magic bullet, has undermined the NCI's ability to conduct trials by curtailing the recruitment of patients.
Variation in coverage is not limited to private-sector decisions. A survey of 34 state Medicaid programs revealed that 16 do not provide coverage for high-dose chemotherapy with autologous bone marrow transplantation for breast cancer, nor does the federal Medicare program. Among the Medicaid programs that do provide coverage, there is no consistent guideline for coverage. Even if insurers and health plans wanted to standardize coverage policies, any meeting among them to address this objective would have serious antitrust implications for all parties.
3 ReferencesCharles M. Cutler, M.D.
I. Steven Udvarhelyi, M.D.
William Winkenwerder, M.D.
Prudential Health Care System, Atlanta, GA 303391
Bone marrow transplant services for the competitive edgeECRI Health Technology Trends 1993;5:8-8
2
Eddy DM . High-dose chemotherapy with autologous bone marrow transplantation for the treatment of metastatic breast cancer. J Clin Oncol 1992;10:657-670
Web of Science | Medline3
The Cardiac Arrhythmia Suppression Trial (CAST) Investigators
Full Text | Web of Science | Medline
To the Editor:
. . . The decision not to provide insurance coverage for breast cancer therapy of an investigational nature would have eliminated access to all the studies that confirmed the usefulness of adjuvant chemotherapy, partial mastectomy, or hormonal therapy. But these investigational therapies differed from autologous bone marrow transplantation solely in the cost of the treatment. Lack of coverage for experimental or investigational therapy should be considered anachronistic and improper in these times. Most modern oncologic care is investigational or experimental. A new standard should be adopted based on a classification of treatments, guided by peer review, as proved effective, possibly effective, or ineffective. The terms “standard,” “investigational,” and “experimental” should be discarded. Insurers should agree that the exclusion from coverage of therapy on the basis of its investigational nature is disingenuous, since they are already covering a substantial amount of less-expensive care that is investigational in nature. . . .
John K. Erban, M.D.
New England Medical Center, Boston, MA 02111To the Editor:
It does not appear that Drs. Peters and Rogers actually reviewed the policy certificates of the people seeking prior authorization of benefits. Most insurance companies do not have one standard policy. In addition, many health insurance companies provide third-party administrative services to self-insured groups. The language of a policy for a self-insured group typically is specific to that group and different from the language of an indemnity policy offered by the same insurance company.
The language of an insurance policy is critical in determining what benefits are provided and how terms such as “investigative” and “experimental” are defined. Without a careful review of the actual language of the policy certificate, comparisons of coverage determinations between insurance companies and even within a single company are not meaningful. In addition, it does not appear that Drs. Peters and Rogers are aware that in the case of a self-insured group, it is the group, not the insurance company, that makes the final decision about the payment of benefits.
Katherine M. Templeton, M.D.
Wisconsin Physicians Service Insurance, Madison, WI 53708To the Editor:
The report by Peters and Rogers on their center's experience in seeking approval for high-dose chemotherapy and autologous bone marrow transplantation reflects the ambivalence of some insurers toward the value of this treatment. Some insurance plans, including one offered to federal employees,1 have specifically excluded coverage of such treatment for breast cancer. It is puzzling to me that high-dose chemotherapy with autologous bone marrow transplantation is covered as a treatment for testicular carcinoma in the same plan. Preliminary analyses of data from a randomized trial of this treatment, as compared with less intensive chemotherapy, in patients with testicular cancer have failed to demonstrate an improved survival with the combination of high-dose chemotherapy and bone marrow transplantation2. Thus, I am baffled about what standard was applied in deciding to provide coverage for treatment of a disease occurring only in men but not for a disease occurring primarily in women.
2 ReferencesJohn R. Wingard, M.D.
Emory University School of Medicine, Atlanta, GA 303221
Blue Cross and Blue Shield Service Benefit Plan, 1993. United States Office of Personnel Management (FEHB # RI-71-5).
2
Chevreau C ,Droz JP ,Pico JL , et al. Early intensified chemotherapy with autologous bone marrow transplantation in first line treatment of poor risk non-seminomatous germ cell tumours: preliminary results of a French randomized trial. Eur Urol 1993;23:213-218
Web of Science | Medline
To the Editor:
Peters and Rogers document a market run amok. It operates without uniform standards and is often outside the purview of state regulatory agencies. That 533 patients were covered by 187 different insurers, each with different standards and procedures, constitutes an assault on hospitals and physicians. It encumbers efficient patient care and forces physicians to expend energy on administrative jousting rather than treatment. What is most disturbing is that the behavior of insurers in Peters and Rogers's study frequently results not from substantive disagreement over the merits of a treatment but from avarice and disregard for the patient's best interest.
Dr. Boren's missive (Feb. 17 issue)1 should not generate sympathy. His experiences point to the weaknesses of the current system. It is untenable for physicians trained in one specialty to exercise such extraordinary unilateral decision-making power over a range of clinical issues. Relying on outside consultants does not wholly solve the problem, because the relationship is covert and fraught with conflicts. This consulting relationship should be publicly disclosed and scrutinized: How are consultants selected, who pays them and how much, what are their qualifications to provide consultation, and do they represent their clinical communities?
1 ReferencesVikram Khanna, M.H.S.
6721 Quiet Hours, Columbia, MD 210451
Boren SD . I had a tough day today, Hillary. N Engl J Med 1994;330:500-502
Full Text | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: Given that only about 2 percent of patients with cancer are participants in clinical trials, Dr. Krause's adversarial comments ignore the fact that the alternative to participation in a clinical trial is not no care (i.e., no cost) but rather marginally effective and often more expensive care that provides no scientific information. Even with the wrong number of patients (actually 378) and excessive cost estimate (actually approximately $89,0001) used by Dr. Krause, this revenue represents only 2.7 percent of total hospital revenues and is less than the $21 million spent by MetLife for advertising2 that encourages us to “Get Met -- it pays.”
Since the cost of insurance is ultimately borne by the individual, whether indirectly through a reduced total salary with a part (called a benefit) being shunted by employers to insurers and providers, directly through an individual or group contract, or obliquely through taxes routed by the government to providers, it is the individual, not researchers, insurers, or society, who should ultimately decide about the funding of his or her participation in medical research.
The Prudential team highlights the capriciousness of the public-sector coverage decisions as a defense of the private sector, but this should provide little comfort. Although Prudential argues about the established efficacy of high-dose chemotherapy with autologous bone marrow transplantation as a treatment for breast cancer, such arguments miss the point that every public and private organization that has examined the issue has concluded that therapy provided in peer-reviewed clinical trials is equivalent or superior to conventional therapies and should be covered by insurance. We do not propose that coverage be provided for all trials at all institutions or for any therapy dreamed up by a physician, but we do believe that well-designed, peer-reviewed clinical trials represent not only state-of-the-art care but also a standard of care for patients with cancer.
We agree (as have most courts) with Dr. Erban that the terms “investigational” and “experimental” as used in insurance contracts are so vague as to be devoid of meaning and should be discarded. However, unlike Dr. Templeton, we find it remarkable that the wide and daily variation in decisions about coverage for the same treatment that results from the single word “experimental” is so easily accepted by insurers as a natural and appropriate consequence of contract language. Surely, the effects of such variation in the interpretation of language are not known to the purchasers of the insurance.
Dr. Wingard's suggestion that the decisions are not only arbitrary but also sexist is alarming but outside the area that our data addressed.
In the end, improving the process of making decisions about coverage will require legislation to establish a method for approving trials of treatment for which coverage will be required. We hope that the pending health care-reform legislation will contain such a provision.
2 ReferencesWilliam P. Peters, M.D., Ph.D., M.B.A.
Mark C. Rogers, M.D., M.B.A.
Duke University, Durham, NC 277101
Peters WP ,Ross M ,Vredenburgh JJ , et al. High-dose chemotherapy and autologous bone marrow support as consolidation after standard-dose adjuvant therapy for high-risk primary breast cancer. J Clin Oncol 1993;11:1132-1143
Web of Science | Medline2
Ad $ summary, January-December 1991. New York: Leading National Advertisers, 1991:332.
- Citing Articles (1)
Citing Articles
1
Sigrid Droste, Annegret Herrmann-Frank, Fueloep Scheibler, Tanja Krones. (2011) Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review. BMC Medical Ethics 12:1, 6
CrossRef
