Adopting New Medical Technology (1994) / Chapter Skim
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13. PAYING FOR EVALUATIVE RESEARCH
13. PAYING FOR EVALUATIVE RESEARCH
Pages 172-192
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From page 172... ...
GARBER AND DOUGLAS K OWENS The sponsors of medical technology assessment, the principal form of evaluative research concerning medical interventions, are as diverse as the goals and methods of the research itself.
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From page 173... ...
Stage II includes most traditional randomized clinical trials as well as nonrandomized evaluations of the efficacy of treatment. The purview of stage III trials encompasses comprehensive clinical, economic, and social endpoints.
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From page 174... ...
WlIO PERFORMS TECHNOLOGY ASSESSMENTS IN THE UNITED STATES? The United States has long been a leader in performing medical technology assessment, even though countries with national health insurance would seem to have stronger reasons to support evaluative research.
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From page 175... ...
NIH, which discovered the drug, holds one patent and has applied for another patent concerning its production (Gerber et al., 1992~. NIH also has a very large budget for evaluative research, including small clinical studies, small and large randomized clinical trials and, to a limited extent, some stage III evaluations, including cost-effectiveness analyses.
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From page 176... ...
Privatesector payers that sponsor technology assessments include insurance companies (for example, the Blue Cross and Blue Shield Association Technology Evaluation and Coverage Program) , health maintenance organizations (McGuire, 1990)
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From page 177... ...
In addition to clinical trials, NIH funds the Consensus Development Program, which sponsors six to eight consensus conferences per year at a cost of $130,000 to $140,000 each (William Hall, Office of Medical Applications Research, NIH, personal communication, September 8, 19921. HCFA sponsors approximately 10 technology assessments per year via contracts from the Bureau of Eligibility, Reimbursement and Coverage to the Office of Health Technology Assessment at AHCPR.
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From page 178... ...
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From page 179... ...
In summary, a diverse group of people and organizations sponsors medical technology assessments. Although it is difficult to identify all of the participants, it is helpful to categorize the sponsors by the roles they play.
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From page 180... ...
Producers of Medical Technology Ordinarily, the producers of a technology sponsor or perform an evaluation of the technology in the early stages of its development. One of the costs of developing a product or technology is establishing its technical characteristics.
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From page 181... ...
In summary, when a producer is not a monopolist, when an evaluative study is unlikely to demonstrate the superiority of the product, or if the producer will no longer be a monopolist by the time the research is completed, the producer will have little incentive to sponsor a technology assessment. Even when the proper incentives are in place for the producer, however, there are additional reasons why the public, as consumers or payers, might not place much credence in producer-sponsored technology assessments, unless there is clear evidence that the study adheres to rigorous methodologic standards.
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From page 182... ...
Yet, as the preceding section suggests, despite the exceptions of federal agencies and occasional provider groups that may represent consumers, consumers and consumer groups infrequently sponsor formal evaluations of medical technology. The reasons are not hard to appreciate.
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From page 183... ...
Payers, whether they are insurers selling policies to enrollees or companies financing health care for their employees, cannot long retain subscribers or employees if the coverage package they offer does not seem worth the cost. If current insurers are systematically attempting to deny valuable health technologies to enrollees, they are not very successful; it is probably easier for privately insured Americans than for the citizens of any other country to gain access to expensive medical technologies.
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From page 184... ...
Other methods for sponsoring evaluative research may overcome this problem. SPONSORING EVALUATIONS OF MEDICAL TECHNOLOGY Previous Proposals for Sponsoring Technology Assessment Each of the parties identified above can benefit from evaluations of technology.
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From page 185... ...
Most of the published proposals for changing the funding of technology assessment suggest that payers take a prominent role (Bunker et al., 1982; McGivney, 1992; Relman, 1980; Yarbro and Mortenson, 1985~. Of the many individuals and organizations that have an interest in the evaluation of medical technology, payers have the most to gain from accurate assessments.
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From page 186... ...
For example, the payers might cover the medical care costs of patients enrolled in clinical trials but not the incremental research costs attributable to the trial itself. Sponsorship of Stage III Assessments: The Leading Role of Payers The chief reason for focusing on payers is that they have both the ability and the need to sponsor evaluative research, particularly stage III studies.
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From page 187... ...
Furthermore, payers have unique access to the claims databases that can be used as part of the assessment of the costs and cost-effectiveness of medical technologies. These arguments have far less force for stage I assessments than for stage III assessments because, as we have noted, producers usually have the best access to the information relevant to stage I assessments and also have greater incentives to sponsor them.
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From page 188... ...
If insurers did not cover the health care expenditure tax, the tax would look to the insured individual like an increase in the copayment rate. Since most insured patients prefer insurance coverage for essentially all health expenses (about 80 percent of Medicare enrollees have "Medigap" plans that pay a substantial fraction of Medicare copayments and deductibles)
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From page 189... ...
Sponsorship for Early-Stage Technology Assessment The published recommendations for financing and sponsoring technology assessment typically do not distinguish the stages of research, but most of the recommendations seem to focus on what we call stage II or stage III assessments. Payers have much less to contribute to stage I assessments.
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From page 190... ...
Most proposals for funding technology assessments and most international approaches to sponsoring technology assessments, whether they are part of coverage decisions or not, incorporate representation from the many interested parties. CONCLUSIONS Evaluative research has a critical role to play in determination of the efficacy and effectiveness of medical technologies.
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From page 191... ...
Payers have the most direct incentives to sponsor stage III assessments, because they need to anticipate the economic, health, and to a lesser extent, social consequences of covering a technology. We believe that they should be the primary sponsors of stage III technology assessments.
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