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A centerpiece of this effort is the Health Technology Assessment (HTA) program.2 The statute authorizing this program, which was supported by the Washington State Medical Association, was passed with only one "nay" vote by the Washington State legislature in 2006. The HTA program is an unusual initiative in the United States: a government-sponsored program in which formal methods are used to conduct critical appraisals of surgical devices and procedures, medical equipment, and diagnostic tests and to translate the results of those evaluations into coverage recommendations.2
Assessing these types of products and services is particularly challenging. Whereas the Food and Drug Administration adheres to the standard of the randomized, controlled trial for the approval of drugs, the agency's approval standards for devices are lower, and thanks to Section 510(k) of the Food, Drug, and Cosmetic Act, the vast majority of devices are approved on the basis of the demonstration of substantial technical equivalence to devices that were on the market before May 1976. Since surgical procedures are not specifically regulated, the evidence available for their critical appraisal is generally very limited — and usually comes in the form of case series, most of which are not prospective and do not include an independent assessment of outcomes. Even some surgical procedures that have been in use for decades have never been subjected to a well-performed randomized trial; for instance, the first such randomized trial on thymectomy for myasthenia gravis, a procedure that has been used since 1912, is just now under way.3
The uniqueness of the HTA program rests on a number of key characteristics.2 The program's assessments are based on a thorough, systematic review of the evidence related to the effectiveness, safety, and cost-effectiveness of a product or service, with each type of evidence examined separately. After considering the "most valid and reliable" evidence on all three of these dimensions, the health technology clinical committee — which must be made up of practicing clinicians — arrives at one of three recommendations: covered without conditions, covered with conditions (such as criteria defining medical necessity), or not covered. The entire process must be transparent. Any recommendation the committee issues must be followed by public payers in Washington State (unless it conflicts with a state or federal statute), although investigators conducting clinical trials that have been approved by the relevant institutional review board may be exempted from adherence to a given coverage decision. If the committee determines that a technology should not be covered, that recommendation supersedes any determination of medical necessity — public payers in Washington State simply cannot cover it.
Of the nine health technology assessments that have been completed under Washington's program thus far, six were of surgical devices or procedures and three were of advanced imaging procedures (see table).4 Five of the decisions resulted in noncoverage because the evidence of effectiveness, safety, cost-effectiveness, or some combination of these was deemed insufficient.4 The other four decisions resulted in coverage with conditions (as summarized in the table). Thanks to a rigorous prioritization process, reviews are conducted only for technologies thought to have a high likelihood of substantial overuse or underuse or those about which there are substantial concerns related to safety or cost-effectiveness. Thus far, no assessments have resulted in coverage without conditions.
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Second, since there is little precedent for synthesizing the three key dimensions of evidence (effectiveness, safety, and cost-effectiveness) into a coverage decision, that step has been difficult to achieve operationally.
Third, it is challenging to predict the program's results in terms of specific cost savings and precise effects on the quality of care and health outcomes. It has been conservatively estimated that the program would result in first-year savings of $21 million, at a cost of $1 million. Some decisions, such as the recommendation about artificial disks, will probably lead to increased costs. It is difficult, however, to generate accurate projections, in part because estimating downstream cost savings — for example, from avoiding an inappropriate procedure that would have been performed had an inaccurate test remained a covered benefit — will require a much longer follow-up and probably a formal evaluation.
Fourth, despite the appearance of several articles about the HTA program in regional newspapers, patients and consumers are probably not keenly aware of the program or of its significance in terms of improved value — and they continue to be driven toward greater use of expensive health technologies by direct-to-consumer advertising and by physicians who prize their decision-making autonomy and have a financial interest in ordering or performing tests and procedures.
And fifth, though all public payers in Washington come under the program's authority, it has proved challenging to extend coverage decisions to the minority of patients who are covered under public-payer–contracted health plans. These carriers are excluded in the authorizing legislation.
In addition to reducing the use of products and services that are of questionable value, the HTA program has the potential to increase the use of currently underutilized health care services. There is a widely recognized need to improve the quality of U.S. health care and to realign the allocation of health care resources. Programs like Washington's HTA program hold promise for achieving these goals on a population-wide basis; however, more comprehensive approaches that shift delivery-system incentives will also be required to improve the integration and efficiency of care and the system's accountability for health outcomes.1,5 Only with both types of strategies are we likely to see a sustained decrease in cost escalation that is sufficient to balance the long-term costs of health care reform. Clearly, improved strategic communication with the public about the value of these programs will be required as the federal government and states move forward.
No potential conflict of interest relevant to this article was reported.
Source Information
From the Department of Environmental and Occupational Health Sciences, University of Washington School of Public Health, Seattle (G.M.F.); the Washington State Department of Labor and Industries, Olympia (G.M.F.); the Washington Health Technology Assessment Clinical Committee and the Washington Health Technology Assessment Program, Olympia (B.R.B.); and Group Health Cooperative, Spokane, WA (B.R.B.).
References
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