Medicare Coverage for Technological Innovations
http://www.100md.com
《新英格兰医药杂志》
To the Editor: The Sounding Board article by Gillick and the accompanying editorial by Tunis (May 20 issue)1,2 illustrate why it is so hard for Medicare to make coverage decisions that are fair and acceptable to all parties. Too many stakeholders misunderstand and mistrust the complex and often opaque systems through which coverage decisions are made. But the lessons drawn are too narrow. Most important, we need systemwide attention to the ethics of decision making with regard to coverage — not just greater use of cost-effectiveness data and not just in the Medicare system.
Although substantive criteria for coverage may be elusive, it is both essential and possible to agree on criteria for ethical decision-making processes. In a recent multistakeholder consensus project on fair coverage decisions, the Ethical Force Program resolved that all coverage decisions should be transparent, participatory, equitable and consistent, sensitive to value, and compassionate — and we laid out more than 70 specific ways for organizations to ensure that these criteria are being met. By adopting clear and measurable process criteria, all public and private payers can move toward fairer and more acceptable decision making about coverage.
Matthew K. Wynia, M.D., M.P.H.
Renee Witlen, B.A.
Institute for Ethics at the American Medical Association
Chicago, IL 60610
matthew_wynia@ama-assn.org
References
Gillick MR. Medicare coverage for technological innovations -- time for new criteria? N Engl J Med 2004;350:2199-2203.
Tunis SR. Why Medicare has not established criteria for coverage decisions. N Engl J Med 2004;350:2196-2198.
To the Editor: I am a consulting attorney with the Center for Medicare Advocacy and a former public member of the Medicare Coverage Advisory Committee. Medicare coverage rules have long been of concern to the center, because they often result in the denial of services that are needed by beneficiaries. The impression that cost is not currently a factor in the National Coverage Rules and the Local Coverage Rules is incorrect. Despite the fact that there is no authorization in the Medicare legislation for the Centers for Medicare and Medicaid Services (CMS) to deny coverage for new kinds of services that are costly, it does so. This is accomplished both by using unpublished criteria that include consideration of cost and by simply delaying coverage of the use of new technologies by insisting on multiple studies before an agonizingly slow approval process is initiated.
Thus, consumers as well as technology manufacturers are concerned about the lack of clear standards for Medicare coverage rules. The CMS tried several times to promulgate its criteria for coverage rules with such public input, but withdrew them because of public opposition to restrictions such as cost. The agency should undertake once again to adopt regulations setting out its criteria for coverage rules and incorporate the views expressed by the public in the final product.
Sally Hart, J.D., M.B.T.
Center for Medicare Advocacy
Willimantic, CT 06226
Dr. Gillick replies: Dr. Wynia and Ms. Witlen suggest that criteria beyond scientific efficacy and cost-effectiveness be used in decisions about reimbursement for therapies that involve technological innovations. I agree: the CMS should explicitly integrate both costs and values into its decision making. As an example of other value judgments that should be considered, beyond those included as part of a cost-effectiveness analysis, in my Sounding Board article I mentioned giving preference to those who are worst off and to patients who require palliative care. I also concur that such criteria should be applied to programs other than Medicare. Since there is no national health system in the United States, health plans are the natural unit of analysis in an examination of coverage. Medicare, as the largest insurer and a program that should be publicly accountable, seems to me to be a good place to start.
The correspondents also emphasize the use of process criteria over and above substantive criteria. In many ways, the process as currently articulated by the CMS is transparent and accountable, and it includes representatives from a broad cross section of society. What is lacking is not so much a good process as agreed-on criteria to be used by the participants in the process.
Ms. Hart argues that cost is currently a consideration in CMS deliberations about reimbursement. She is correct. Coverage decisions are inherently value-laden; hence, it is impossible to fail to include considerations of cost and value. The challenge is to try to articulate these considerations explicitly, so that they can be incorporated into the decision-making process fairly and uniformly. I think, however, that we need to be careful in leaping to the conclusion that the CMS denies "services that are needed by beneficiaries." Beneficiaries want many services, and, indeed, these services are often recommended by their physicians. But the point of making decisions about reimbursement is precisely that the CMS — and other health plans engaged in an analogous process — must evaluate just which treatments are "reasonable and necessary" on the basis of a legitimate process and with the use of clear criteria.
Muriel R. Gillick, M.D.
Harvard Vanguard Medical Associates
Boston, MA 02215
Dr. Tunis replies: Dr. Wynia and Ms. Witlen highlight the important point that the nature of the process for making coverage decisions is critical to their fairness and acceptability. The Medicare program has made significant modifications to improve the transparency, consistency, and participatory nature of Medicare's national coverage process — changes consistent with the recommendations of the Ethical Force Program.1 Although these and additional process improvements are essential, coverage decisions will inevitably be the source of significant tension for the reasons articulated in my editorial, primarily because payers will not pay for every service that a clinician or patient may believe is necessary.
Ms. Hart's assertion that Medicare denies coverage for expensive technologies is contradicted by the case studies presented by Dr. Gillick, which describe the recent decisions to cover lung-volume–reduction surgery and the left ventricular assist device, both extremely costly procedures with modest benefits. Whether these decisions represent a wise use of limited resources is a question that some might reasonably ask, but it was not part of Medicare's decision to cover these services. Although it is true that an evidence-based coverage process may delay reimbursement for the use of technologies that have not been adequately evaluated, widespread underuse and overuse of medical technology suggest that better evidence may lead to better decisions, resulting in greater benefits and fewer risks to patients. I agree with Ms. Hart that clear and consistent standards for coverage would be beneficial, and the Medicare program has begun to develop guidance documents that will contain such standards for coverage. The process for developing these documents will include multiple opportunities for public input.
Sean R. Tunis, M.D.
Centers for Medicare and Medicaid Services
Baltimore, MD 21244
stunis@cms.hhs.gov
References
Tunis SR, Kang JL. Improvements in Medicare coverage of new technology. Health Aff (Millwood) 2001;20:83-85.
Although substantive criteria for coverage may be elusive, it is both essential and possible to agree on criteria for ethical decision-making processes. In a recent multistakeholder consensus project on fair coverage decisions, the Ethical Force Program resolved that all coverage decisions should be transparent, participatory, equitable and consistent, sensitive to value, and compassionate — and we laid out more than 70 specific ways for organizations to ensure that these criteria are being met. By adopting clear and measurable process criteria, all public and private payers can move toward fairer and more acceptable decision making about coverage.
Matthew K. Wynia, M.D., M.P.H.
Renee Witlen, B.A.
Institute for Ethics at the American Medical Association
Chicago, IL 60610
matthew_wynia@ama-assn.org
References
Gillick MR. Medicare coverage for technological innovations -- time for new criteria? N Engl J Med 2004;350:2199-2203.
Tunis SR. Why Medicare has not established criteria for coverage decisions. N Engl J Med 2004;350:2196-2198.
To the Editor: I am a consulting attorney with the Center for Medicare Advocacy and a former public member of the Medicare Coverage Advisory Committee. Medicare coverage rules have long been of concern to the center, because they often result in the denial of services that are needed by beneficiaries. The impression that cost is not currently a factor in the National Coverage Rules and the Local Coverage Rules is incorrect. Despite the fact that there is no authorization in the Medicare legislation for the Centers for Medicare and Medicaid Services (CMS) to deny coverage for new kinds of services that are costly, it does so. This is accomplished both by using unpublished criteria that include consideration of cost and by simply delaying coverage of the use of new technologies by insisting on multiple studies before an agonizingly slow approval process is initiated.
Thus, consumers as well as technology manufacturers are concerned about the lack of clear standards for Medicare coverage rules. The CMS tried several times to promulgate its criteria for coverage rules with such public input, but withdrew them because of public opposition to restrictions such as cost. The agency should undertake once again to adopt regulations setting out its criteria for coverage rules and incorporate the views expressed by the public in the final product.
Sally Hart, J.D., M.B.T.
Center for Medicare Advocacy
Willimantic, CT 06226
Dr. Gillick replies: Dr. Wynia and Ms. Witlen suggest that criteria beyond scientific efficacy and cost-effectiveness be used in decisions about reimbursement for therapies that involve technological innovations. I agree: the CMS should explicitly integrate both costs and values into its decision making. As an example of other value judgments that should be considered, beyond those included as part of a cost-effectiveness analysis, in my Sounding Board article I mentioned giving preference to those who are worst off and to patients who require palliative care. I also concur that such criteria should be applied to programs other than Medicare. Since there is no national health system in the United States, health plans are the natural unit of analysis in an examination of coverage. Medicare, as the largest insurer and a program that should be publicly accountable, seems to me to be a good place to start.
The correspondents also emphasize the use of process criteria over and above substantive criteria. In many ways, the process as currently articulated by the CMS is transparent and accountable, and it includes representatives from a broad cross section of society. What is lacking is not so much a good process as agreed-on criteria to be used by the participants in the process.
Ms. Hart argues that cost is currently a consideration in CMS deliberations about reimbursement. She is correct. Coverage decisions are inherently value-laden; hence, it is impossible to fail to include considerations of cost and value. The challenge is to try to articulate these considerations explicitly, so that they can be incorporated into the decision-making process fairly and uniformly. I think, however, that we need to be careful in leaping to the conclusion that the CMS denies "services that are needed by beneficiaries." Beneficiaries want many services, and, indeed, these services are often recommended by their physicians. But the point of making decisions about reimbursement is precisely that the CMS — and other health plans engaged in an analogous process — must evaluate just which treatments are "reasonable and necessary" on the basis of a legitimate process and with the use of clear criteria.
Muriel R. Gillick, M.D.
Harvard Vanguard Medical Associates
Boston, MA 02215
Dr. Tunis replies: Dr. Wynia and Ms. Witlen highlight the important point that the nature of the process for making coverage decisions is critical to their fairness and acceptability. The Medicare program has made significant modifications to improve the transparency, consistency, and participatory nature of Medicare's national coverage process — changes consistent with the recommendations of the Ethical Force Program.1 Although these and additional process improvements are essential, coverage decisions will inevitably be the source of significant tension for the reasons articulated in my editorial, primarily because payers will not pay for every service that a clinician or patient may believe is necessary.
Ms. Hart's assertion that Medicare denies coverage for expensive technologies is contradicted by the case studies presented by Dr. Gillick, which describe the recent decisions to cover lung-volume–reduction surgery and the left ventricular assist device, both extremely costly procedures with modest benefits. Whether these decisions represent a wise use of limited resources is a question that some might reasonably ask, but it was not part of Medicare's decision to cover these services. Although it is true that an evidence-based coverage process may delay reimbursement for the use of technologies that have not been adequately evaluated, widespread underuse and overuse of medical technology suggest that better evidence may lead to better decisions, resulting in greater benefits and fewer risks to patients. I agree with Ms. Hart that clear and consistent standards for coverage would be beneficial, and the Medicare program has begun to develop guidance documents that will contain such standards for coverage. The process for developing these documents will include multiple opportunities for public input.
Sean R. Tunis, M.D.
Centers for Medicare and Medicaid Services
Baltimore, MD 21244
stunis@cms.hhs.gov
References
Tunis SR, Kang JL. Improvements in Medicare coverage of new technology. Health Aff (Millwood) 2001;20:83-85.