HHS in the 21st Century Charting a New Course for a Healthier America (2009) / Chapter Skim
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Appendix F Dissenting Opinions on Recommendation 3a
Appendix F Dissenting Opinions on Recommendation 3a
Pages 175-190
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From page 175... ...
The dissenting opinions of David Beier, J.D., Senior Vice President of Global Government and Corporate Affairs, Amgen; Kathleen Buto, M.P.A., Vice President, Health Policy, Johnson & Johnson; and Myrl Weinberg, C.A.E., President, National Health Council, are presented in this appendix. BOX F-1 Recommendation 3a The secretary should work with Congress to establish a capability for assess ing the comparative value -- including clinical and cost-effectiveness -- of medical interventions and procedures, preventive and treatment technologies, and methods of organizing and delivering care.
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From page 176... ...
Congress and the administration. However, the report moves immediately beyond the needed analytic assessment phase and issues specific and detailed recommendations on the topics of comparative effectiveness and costeffectiveness assessments.
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From page 177... ...
This approach, as outlined in a preliminary analysis by the Congressional Budget Office (CBO) , assumes that the increased costs in more intensive geographic locations are attributable to the use of more costly technology.
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From page 178... ...
In Learning what works best: The nation's need for evidence on comparative effectiveness in health care, a background paper prepared for the IOM's Roundtable on Evidence-Based Medicine, the roundtable staff noted that primary comparative effectiveness research involves the direct generation of clinical information on the relative merits or outcomes of one intervention in comparison to one or more others and that secondary comparative effectiveness research involves the synthesis of primary studies (usually multiple) to allow conclusions to be drawn.
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From page 179... ...
7 as opposed to a comprehensive or holistic qualitative assessment of the best treatment for an individual patient. 6 An analysis by the McKinsey Global Institute found that the additional spending seen in the United States compared to other Western economies is due primarily to operational and intermediation process, not the cost of inputs (e.g., drugs)
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From page 180... ...
to establish whether any particular technology is "worth it." Experience with other countries suggests that when cost-effectiveness analysis is part of comparative effectiveness assessments, the strong tendency is to rely on these cost effectiveness ratios and thresholds to make determinations about comparative "value," which in turn are applied to make coverage and reimbursement decisions at the population rather than the individual patient level. • Timing: Cost-effectiveness analyses conducted using standard methods based on questions (and comparisons)
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From page 181... ...
Basing the assessment on a single average QALY value or a sin gle threshold could provide payers with justification to limit coverage for all. • Rapidly changing prices and technology: Cost-effectiveness is not well suited to assessing the efficiency of products and mar kets with dynamic competition involving rapidly changing prices and technological obsolescence.
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From page 182... ...
For example, cost effectiveness may differ depending on the kind of insurance or public program providing the financing. A fully integrated, pre paid health plan with a stable enrollee base might treat a costly prescription drug treatment as cost-effective in avoiding poten tially more expensive care, while a Medicare stand-alone pre scription drug plan or an insurer facing rapid turnover in enrollees might view the cost-effectiveness very differently.
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From page 183... ...
[bold added for emphasis] I support having the secretary work with Congress to establish a capability to assess comparative effectiveness on the range of preventive and treatment approaches as described but strongly disagree that the ca 11 See G
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From page 184... ...
A fully integrated, prepaid health plan with a stable enrollee base might treat costly prescription drug treatment as cost-effective in avoiding potentially more expen sive care, while a Medicare stand-alone prescription plan or an insurer facing rapid turnover in enrollees might view the cost effectiveness very differently. This can lead to the denial of good treatments for those patients who have a clinical need for them, simply because they may appear less cost-effective for the "av erage" patient.
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From page 185... ...
If cost-effectiveness analysis is used to limit coverage of certain treatments, patients will have to pay the full costs of these treatments if they need them. • Methods for assessing cost-effectiveness are imperfect and con troversial: In other countries -- the United Kingdom, Australia, Germany, and Canada, cost-effectiveness is assessed using dif ferent methods; however, the challenges in all are how to define a comprehensive assessment of effectiveness and how to ensure 14 For prescription drugs, the Centers for Medicare and Medicaid Services estimates spending in 2006 was about 11 percent of total health care spending.
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From page 186... ...
• Cost-effectiveness is not well suited to assessing the efficiency of products or markets with dynamic competition involving rapidly changing prices and technological obsolescence: At best, it is a static assessment of average costs for many technologies subject to rapid change. If cost-effectiveness is used to limit access to some products, it may actually keep costs higher for covered products.
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From page 187... ...
from Congressmen Waxman and Davis was to undertake a study of "whether HHS is ideally organized to meet the public health and health care cost challenges that the nation faces" and to focus on the missions and organization of the individual agencies. I believe a more appropriate recommendation for improving HHS's leadership in advancing comparative effectiveness research might be to focus first on what HHS can do almost immediately: The secretary should drive improvements in health care in the United States by leveraging the compre hensive data collected by the Centers for Medicare and Medicaid Services, the Food and Drug Admini stration, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Cen ters for Disease Control and Prevention to assess real-world comparative effectiveness of medical in terventions and procedures, preventive and treat ment technologies, and methods of organizing and delivering care.
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From page 188... ...
Basing the assessment on averages could provide payers with justification to limit coverage for all. A fully integrated, prepaid health plan with a stable enrollee base might treat costly prescription drug treatment as cost-effective in avoiding potentially more expen sive care, while a Medicare stand-alone prescription plan or an insurer facing rapid turnover in enrollees might view the cost effectiveness very differently.
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From page 189... ...
Direct spending by the federal government -- mostly for Medicare, Medicaid, and the Federal Employees Health Benefits program -- would be reduced by $.1 billion over the 2008–2012 period and $1.3 billion over the 2008–2017 period." A RAND COMPARE analysis reaches a similar conclusion, that comparative effectiveness research will not result in significant savings in the near term. See www.randcompare.org.
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From page 190... ...
Buto) and I believe that a more appropriate recommendation on improving comparative effectiveness capability might be the following: The secretary should drive improvements in health care in the United States by leveraging the compre hensive data collected by Centers for Medicare and Medicaid Services, the Food and Drug Administra tion, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention to assess real world comparative effectiveness of medical interven tions and procedures, preventive and treatment tech nologies, and methods of organizing and delivering care.
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