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Ensuring technological competence and leadership in medicine.

The introduction and diffusion of high-dose chemotherapy with autologous bone marrow or peripheral stem cell transplantation (HDCT-ABMT/PSCT) for indications such as breast cancer, ovarian cancer, and testicular cancer can be characterized as disorganized; at times unscientific; confrontational; inetffcient; and, in recent limited circumstances, avaricious. It is not described as an unmitigated disaster only because many patients have received beneficial care and many dedicated investigators have persevered in attempts to demonstrate the effectiveness and relative safety of HDCT-ABMT for certain indications. How much more rational, responsible, efficient, and valuable to patients, physicians, and payers it would have been if HDCT-ABMT had been introduced into medical practice through a systematic approach based on explicit evaluation of outcomes data on safety and effectiveness. I would like to set forth a new, efficient, and expeditious system for the introduction and diffusion of health care technologies.


A national advisory body should be established to oversee evaluative outcomes research on important new technologies. The use and study of these new technologies would be restricted to a network of designated academic health centers. Reimbursement for the use of new technologies (i.e., procedures, procedures involving Food and Drug Administration (FDA)-approved devices, drugs used beyond FDA-approved indications) would be provided, but it would be restricted to use under the study protocol and within the identified academic health centers. Outcomes data would be collected and analyzed under the auspices of the independent advisory body. A comprehensive evaluation would be undertaken, using the outcomes data. Once the national advisory body concluded that a technology was safe and effective for the specified indication, it would be allowed to diffuse into practice. At this point, individual payers would decide whether they would pay for the specified use of the technology.


Under this proposal, outcomes data so desperately needed to make informed risk/benefit determinations integral to the formulation of sound coverage policy and to sound clinical decision making would be generated, collected, and analyzed in a cooperative scientific environment. Inadequate investigator participation in clinical trials would be rectified through the offer of use of the most advanced technology and through the financial--incentive of reimbursement early on= Assurance of reimbursement would permit early access to technology for patients in need. The "hassle factor" for payers, providers, and patients would be mitigated, if not eliminated. Expansion of access under the studies and restriction of general diffusion would improve the patient base for academic health centers. Designs used in studies would also be expanded. Studies and patient care would be conducted in institutions with rigid quality assurance standards. Society would receive answers to important medical issues in a much more efficient and expeditious manner. As an added bonus, the sagging infrastructure of academic medicine would be buttressed by the restriction of payment for new technology to the setting where its initial diffusion and study belong--that is, in institutions dedicated to the deliberate evaluation and advancement of patient care.

This proposal builds on the belief that all constituents of the health care community should seek to identify and prevent application of ineffective, unproven, or harmful clinical interventions. It seeks to establish a logical and orderly mechanism for the diffusion and utilization of important new technologies that is based on solid outcomes data and expert consensus. Implementation of this proposal would contribute to enhancement of societal good by:

* Supporting study of technologies that will lead te either widespread use of the technology or agreement that it should be discarded.

* Making important new technologies available to needy and appropriate patients early on.

* Shoring up the sagging infrastructure of academic medical centers.

Introduction and utilization of health care technology are the most controllable factors contributing to the rate of increase in health care expenditures. Yet, as solutions are proposed to slow health care costs increases, the issue of technology utilization has not been directly addressed. When rates of inappropriate utilization of 15-30 percent are determined, two important factors are missing from the computation. First, there are technologies (e.g., EC-IC bypass, Garren Gastric Bubble, gastric freezing) that should never have been introduced into general practice; for them, the rate of inappropriate utilization is 100 percent. Second, there are specific devices (e.g., MRI) that, even though applied for an approved indication, are useless because of insufficient unit capacity or technical failings. Thus, the cost of inappropriate utilization of technology may well exceed present estimates.

What will happen to a new technology in the year 2000?

Will it be guided expertly through an orderly and scientific evaluation process with expanded patient access and, then, into full clinical practice? Or will it proceed, as HDCT-ABMT is now doing, with limited scientific study paralleled by rapid and somewhat chaotic diffusion, resulting in irretrievable patient outcomes data.

There are many issues that will be integral to any discussion and development of this proposal.

* How will this proposal fit in the new administration's health care reform proposal?

* What are the sources of authority for the national advisory board? How will the board be constituted? How will it relate to the Food and Drug Administration or to Agency for Health Care Policy and Research (AHCPR)? Will it be AHCPR?

* How will technologies be identified, prioritized, and selected for study?

* What is the role of cost-effectiveness as a variable for study and as a criterion for decision making?

* What involvement would the Health Care Financing Administration, CHAMPUS, Medicaid, the Department of Veterans Affairs, the Indian Health Service, and the armed forces have in this system?

* What is the likelihood of this proposal, or one similar in orientation, being implemented? Would federal legislation be needed? Could such legislation ever be passed?

These are critical questions. However, a workable solution to maintaining the delicate balance between sustaining the technological imperative in medicine and avoiding technological Armageddon must be achieved. All sides will have to give on something. This proposal is predicated on the premise that the major parties will be willing to subordinate individual interests to preserve a health care system that has served this country and the world very well.

William T. McGivney, PhD, is Head, Technology Assessment and Policy, Aetna Health Plans, Hartford, Conn. The views expressed in this article are those of the author and do not necessarily reflect those of Aetna Health Plans.
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Title Annotation:Health Care Technology
Author:McGivney, William T.
Publication:Physician Executive
Date:Jan 1, 1993
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