Comment Letters
|
July 17, 2000 Nancy-Ann Min DeParle Re: HCFA-3432 NOI -- Medicare Program: Criteria for Making Coverage Decisions (65 Federal Register 31124), May 16, 2000 Dear Ms. DeParle: The American Hospital Association (AHA) represents nearly 5,000 hospitals, health systems and networks, all of which are affected by Medicare coverage decisions. On behalf of our members, we would like to express our support for HCFA's efforts to bring greater transparency to the Medicare coverage process and to make broader use of scientific evidence in coverage decisions. Because many other health plans look to the Medicare program to model their own policies and procedures, its coverage decision process has far-reaching implications well beyond the 39 million Americans entitled to Medicare benefits and the providers who serve them. Therefore, we also appreciate HCFA's willingness to genuinely engage the health care field in the debate around appropriate criteria upon which to base coverage decisions, as signaled by its use of a "notice of intent," which affords the public an opportunity to comment on these issues in the earliest stages of rulemaking. An environment characterized by ever more frequent scientific and technological advances in health care will necessarily place increasing demands on the Medicare program for coverage decisions, whether national or local in scope. To be responsive, the Medicare coverage determination process must be both nimble and flexible. In the case of a new drug or device that has been approved by the Food and Drug Administration (FDA) as safe and effective for specific indications or applications, we believe that it is incumbent upon HCFA to demonstrate what value its coverage decision process adds to the care of Medicare beneficiaries. Arguably, HCFA should impose limits on the circumstances under which FDA-approved items or services are covered only to the extent that those limits improve overall outcomes for the Medicare beneficiary population. If HCFA proposes coverage criteria that are not seen as adding such value to health care delivery, the agency runs the risk that its coverage determination process will be seen as impeding rather than fostering the availability of such advances to the Medicare population. While the AHA recognizes the need for a better-defined conceptual framework for making coverage decisions, we are concerned that the framework HCFA outlines in the notice is gravely flawed because it confounds issues of medical benefit and quality with issues of cost and relative effectiveness. We understand and appreciate HCFA's need to exercise prudent stewardship over the Medicare Trust Funds; however, we believe that consideration of the cost of new technologies has no place in the coverage decision. This is particularly true if it is intended that the coverage process not inhibit diffusion of new technologies, because the cost of many new technologies starts out relatively high and gradually declines as the technology is diffused and efficiencies are realized. Thus, by weighing cost when a new technology is introduced, HCFA's "value added" criteria set a higher bar for a new technology because the added benefit (however measured) it is expected to yield must be comparatively greater than a similar but older technology that has already had an opportunity to diffuse. Such a coverage process can hardly be viewed as facilitating "timely and expanded access for Medicare beneficiaries to appropriate new technologies." In fact, once an item or service is approved for Medicare coverage, recognizing and adjusting for the cost of the newly covered item or service can be accomplished through the payment system(s) applicable to the setting(s) in which it will be used. HCFA has significant discretion regarding the establishment of an appropriate payment level for newly covered items or services, and the payment system is the more appropriate venue for addressing relative costliness. Moreover, we see no statutory authority for HCFA to limit what is "reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member" on the basis of cost or other comparisons to existing technologies. Therefore, we believe the agency has no legitimate policy basis for bringing cost considerations into the coverage decision. Finally, while the AHA supports efforts to conduct research into the comparative efficacy of different technologies or therapies, we believe that the results of such research should not be a precursor to the agency's coverage determinations. Until such new technology or therapy is covered, at least on a limited basis, it is unlikely that there would be sufficient data available to make such comparisons of costs and benefits. In addition, the results of such research should not be a basis for HCFA denying or withdrawing coverage for medically beneficial items or services unless a new treatment or therapy unambiguously defines a new standard of care such that continued use of alternatives could potentially be construed as substandard care. In most instances, where differences between technologies or therapies are less clear-cut, the Medicare program should not limit the choices available to caregivers and their patients. Even breakthrough technologies are not necessarily appropriate for every patient. The AHA recommends that instead of demanding research into the comparative efficacy of new technologies as a basis for its coverage determinations, HCFA should:
The coverage process described in the April 1999 Federal Register notice created the Medicare Coverage Advisory Committee (MCAC), consisting of six panels and an executive committee, which had its first meeting in late 1999. This broad-based group of 120 well-recognized individuals brings years of expertise in research and clinical applications of new technologies, pharmaceuticals, and procedures to HCFA's process. As HCFA and the MCAC continue to refine their relationship and the process by which the committee evaluates evidence and makes Medicare coverage recommendations, much can be gleaned from the conscientious use of advice from these experts, to the potential benefit of all stakeholders. HCFA would do well to work with the MCAC to identify and make explicit the implicit criteria the committee members bring to the table from their respective areas of expertise. In light of the foregoing comments, the AHA recommends that HCFA work collaboratively with the health care industry to develop a conceptual framework that distinguishes coverage from payment from quality improvement issues and addresses each separately. We would be more than willing to work with the agency in such an endeavor and believe that it is critical to bringing credibility and engendering the broadest possible support to its revamped coverage decision process. The AHA appreciates the opportunity to submit these comments on HCFA's intent to publish criteria for making coverage decisions. If you have any questions regarding our comments, please contact me, Carmela Coyle, senior vice president for policy at (202) 626-2266, or Barbara Marone at (202) 626-2344. Sincerely, Rick Pollack |
Back to Table of Contents |
