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7 Blue Cross and Blue Shield Association Initiatives in Technology Assessment SUSAN GLEESON The Blue Cross and Blue Shield Association (BCBSA) is the national coordi- nating agency for the 73 independent, locally governed Blue Cross and Blue Shield plans. BCBSA serves as the cohesive force that brings these autonomous, nonprofit plans together into a national system. As a system, BCBS is the nation's largest and oldest provider of health care coverage, currently covering 68 million members, or more than one in four Americans. The plans operate 92 health maintenance organizations (HMOs) and 56 preferred provider organizations (PPOs) nation- wide. This chapter describes the BCBSA technology assessment program and a recent initiative to support clinical trials for breast cancer treatments. Each independent Blue Cross and Blue Shield plan provides insurance cov- erage to its members in accordance with locally drafted contract language and coverage policies. In many cases, the contract terms and services covered are selected by the employer purchasing the coverage on behalf of his or her employ- ees. BCBSA provides many support services to Blue Cross and Blue Shield plans, and one of these services consists of technology assessment and the provi- sion of coverage information. The technology assessment and coverage guid- ance given to the plans, however, is advisory and informational. Local plans are responsible for formulating their own administrative and coverage policies. Nev- ertheless, certain large national accounts request that coverage for their employ- ees be administered in accordance with BCBSA coverage recommendations. TECHNOLOGY ASSESSMENT Health insurers have an increasingly important mission to be prudent pur- chasers of health care services for their members. With mounting national con 96

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BLUE CROSS AND BLUE SHIELD ASSOCIATION INITIATIVES 97 cern over the uninsured and underinsured, we must all find ways to moderate increases in health care costs if the promise of universal access to health insur- ance is to become a reality. The challenge of health care reform is to provide universal access to effective health care at a cost that is acceptable to govern- ment, employers, and the American people in general. The benefits contracts provided by Blue Cross and Blue Shield plans contain three types of provisions to ensure that premiums are used to purchase services of known efficacy and appropriateness. These provisions typically appear in tradi- tional, HMO, and PPO benefits contracts. The first type of provision requires that services be medically necessary, that is, appropriate and reasonable for the patient's disease or injury. The second type of provision excludes coverage for services that are determined by the local plan to be investigational, that is, of unknown efficacy. The third type of provision requires that services, procedures, medications, and devices have the approval of the appropriate regulatory body before they are covered, for example, Food and Drug Administration (FDA) approval of drugs and certain categories of devices. However, the requirement for consistency with regulatory agencies is broad and extends to the licensure of professionals and the accreditation of institutions. This chapter focuses on the Technology, Evaluation, and Coverage (TEC) Program of BCBSA that provides technology assessment information and guid- ance to plans. The TEC Program evaluates the health effects of a given technolo- gy, whether it is a service, drug, device, or procedure. The TEC Program uses five criteria (see below) to determine whether the technology in question improves health outcomes such as length of life, ability to function, or quality of life. The staff of BCBSA evaluate new technologies against the criteria and report to BCBSA's Medical Advisory Panel. The Medi- cal Advisory Panel determines whether or not a specific technology meets the criteria. BCBSA has also instituted semiannual forums at which clinical research experts present directly to the panel the most recent evidence regarding important new technologies. Recent forums have been on high-dose chemotherapy and autologous bone marrow transplantation for breast cancer and multiple myeloma, and on lung transplantation. Another forum addressed high dose chemotherapy and autologous bone marrow transplant for ovarian cancer and ambulatory home . . . uterine monitoring. Below is presented a brief summary of the five technology assessment crite- ria used by the BCBSA to determine whether a technology improves health out- comes and can be recommended as eligible for coverage. 1. The technology under consideration must have final approval from the appropriate government regulatory bodies when such approval is applicable. Sur- gical procedures such as transplants generally involve no regulatory approval (Blue Cross and Blue Shield Association, 1991~. A drug, biological product, or certain devices, however, must have final approval from the FDA. Any approval

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98 SUSAN GLEESON for use of a drug that is granted as an interim step in the FDA regulatory process is not sufficient. Final approval is not required for all indications for these technologies, however. The use of approved drugs for indications other than those listed on the label will be considered eligible for coverage when they are demonstrated to be effective in improving health outcomes. 2. The scientific evidence must permit conclusions to be made concerning the effect of technologies on health outcomes. The evidence should consist of well-designed and well-conducted investigations published in peer-reviewed journals. The quality of the studies and the consistency of the results are consid- ered in evaluating the evidence. 3. The technology under consideration must improve net health outcomes; that is, the technology's beneficial effects on health outcomes should outweigh any harmful effects on health outcomes. 4. The particular technology must be as beneficial as any established alter- natives. The technology should improve the net health outcomes as much or more than established alternatives. 5. The improvement must be attainable outside the investigational setting; the technology should be expected to satisfy the other above-mentioned criteria, when used under the usual conditions of medical practice. Recent Changes to Program In September 1993, BCBSA announced three major changes to the TEC Program. First, the Association announced that it would collaborate with Kaiser Permanente on technology assessment activities. Both organizations will con- tribute resources and expertise. This collaboration will allow the TEC Program to expand its activities. Second, BCBSA appointed a new nineteen-member Medical Advisory Panel, of which the majority of members have no affiliation with Kaiser Permanente or the BCBS plans. Members are noted experts in tech- nology assessment, research, and clinical areas and Dr. David Eddy is the scien- tific advisor to the Panel. Third, BCBSA made a policy decision that technology assessments were scientific information and should not be proprietary to the BCBS system. The information contained in the assessment would be useful to consumers, physicians, health plans, and other decisionmakers. Starting in 1994, the TEC assessments are available on an annual subscription basis. THE DEMONSTRATION PROJECT ON BREAST CANCER TREATMENT Major controversy has arisen in recent years over coverage for promising new treatments for life-threatening conditions that are considered to be investiga- tional. A treatment that has been the source of much controversy is high dose

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BLUE CROSS AND BLUE SHIELD ASSOCIATION INITIATIVES 99 chemotherapy with autologous bone marrow transplantation (HDC-ABMT) for breast cancer. Clinical studies of HDC-ABMT conducted thus far have not established that the treatment is as safe and effective as conventional chemotherapy in the treat- ment of advanced breast cancer. Many Blue Cross and Blue Shield plans exclude coverage for the treatment because they consider it to be investigational. HDC- ABMT for breast cancer has been evaluated twice by the Medical Advisory Panel since 1988, most recently in 1991 by David Eddy, M.D., Ph.D. Applica- tion of BCBSA's technology evaluation criteria clearly leads to the recommenda- tion that the treatment is investigational. There has been an absence of well- controlled trials, existing clinical series are poorly matched, and small differences in survival demonstrated between HDC-ABMT and conventional chemotherapy for breast cancer to date have not been statistically significant. Furthermore, treatment-related mortality and morbidity from HDC-ABMT exceed those from conventional chemotherapy. Despite the lack of conclusive evidence that HDC-ABMT is as good as, worse than, or better than conventional chemotherapy, coverage denials have generated unprecedented media concern and litigation. Some researchers advo- cate the treatment and women have sued to be allowed to receive the treatment, convinced that it is their last hope. Blue Cross and Blue Shield subscribers want access to this service, regardless of the lack of scientific evidence supporting efficacy. Unfortunately, as an editorial in the Journal of the National Cancer Institute stated, some members of the oncology community "have raised the public's expectation far above what is supported by the published data. We have no evidence as of yet that any patient will be cured by this therapy who would not have been cured by more conventional treatment" (Henderson, 1991~. The Demonstration Project on Breast Cancer Treatment is an innovative effort of the BCBSA, participating plans, and the Blue Cross and Blue Shield Federal Employee Program to help resolve the clinical controversy surrounding the efficacy of HDC-ABMT for treating breast cancer. The demonstration project is an attempt to return the debate to the appropriate forum of clinical research and away from the courtroom and mass media. Only clinical research can answer the question "does HDC-ABMT work for breast cancer?" The purpose of the demonstration project is to support randomized con- trolled clinical trials comparing the efficacy of HDC-ABMT with that of conven- tional chemotherapy in the treatment of advanced breast cancer with a poor prog- nosis. The clinical trials are sponsored by the National Cancer Institute, the Clinical Trials Cooperative Groups, and the Philadelphia Bone Marrow Trans- plant Group. It is hoped that increased financial support for this costly investiga- tional treatment will speed accruals to the trials while providing Blue Cross and Blue Shield subscribers with access to this treatment. The demonstration project is supporting two multicenter randomized trials for women with stage II or III disease and 10 or more positive nodes (CALGB 9082 and INT 0121) and two

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100 SUSAN GLEESON multicenter randomized mals for women with stage IV metastatic disease (INT 0127 and the Philadelphia Protocol, PBT-1~. The demonstration project provides payments on behalf of Blue Cross and Blue Shield subscribers to the bone marrow transplant centers that are participat- ing in the trials and that have entered into contracts with BCBSA. The all- inclusive payments are separate and distinct from payments made when a new technology is covered. They constitute support for clinical research and defray a significant portion of the patient care costs of HDC-ABMT. Participating institu- tions, however, are expected to share in the costs of treatment as well. Currently 17 plans and the Federal Employee Program, accounting for 40 percent of Blue Cross and Blue Shield membership, are participating in the dem- onstration project. To date, 41 hospitals are participating and contacting is ongoing. Several of the supported trials are accruing patients very well, and Blue Cross and Blue Shield believes its support contributes to the rapid accrual. FUTURE DIRECTIONS The Blue Cross and Blue Shield Association, the Blue Cross and Blue Shield plans, and all third-party payers are closely following the progress of the demon- s~ation project. It may serve as a model for how insurers can support clinical research for promising investigational treatments targeted to life-threatening or seriously disabling conditions. Key elements of such a model would be (1) limited support to networks of providers, (2) conducting clinical Dials approved or sponsored by peer-reviewed entities, and (3) continued exclusion of technolo- gy from full coverage until efficacy has been demonstrated. The Blue Cross and Blue Shield system wants to work cooperatively with the research community and sponsors to ensure that critical clinical mals are completed and that reimbursements are provided for new technologies when those technologies are known to be effective. REFERENCES Blue Cross and Blue Shield Association. 1991. Blue Cross and Blue Shield Association Technology Evaluation Criteria, revised 1991. Chicago, Ill.: Blue Cross and Blue Shield Association. Henderson, I. C. 1991. Window of opportunity. Journal of the National Cancer Institute 83~13~:895.