Full article reprinted from "The Gray Sheet" - April 06, 2009
Find out how a 181-page grant application request from the National Institutes of Health has struck a nerve among congressional lawmakers debating the particulars of comparative-effectiveness research and comprehensive health reform.
NIH, looking to use some of its funding from the recently enacted economic stimulus package, last month announced opportunities for interested parties to obtain support for performing any of hundreds of research projects proposed by the agency, including dozens of proposed comparative-effectiveness studies. Applications will be accepted through April 27.
But the agency has attracted the indignation of Republican lawmakers because some of the studies would include cost-effectiveness analyses of new technologies.
New Grants Use Small Portion Of Stimulus Funding
The American Recovery and Reinvestment Act supplies NIH with $8.2 billion for external research grants. The agency is applying $200 million of that money to a new "challenge grant" program, meant to fund "high impact" projects in biomedical, behavioral science and public health.
In addition, the stimulus bill directs $400 million to NIH specifically to fund comparative-effectiveness research.
The recent NIH request for applications identifies both of these pools as potential funding sources for the prospective grants. The document identifies projects in categories ranging from bioethics to genomics to regenerative medicine. About 70 projects are listed under the heading "comparative effectiveness," including a number of medical-device-related studies targeting advanced imaging, stress urinary incontinence sling surgery and non-invasive ultrasound techniques, among others (see chart, "2NIH Challenge Grant Topics: Device Comparative Effectiveness Studies").
The NIH document notes that projects will qualify for a portion of the $400 million comparative-effectiveness research funds only if they strictly meet the definition of CER: "A rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy."
While many of the project proposals focus solely on clinical outcome comparisons, several include explicit requests for cost analysis.
For instance, a proposed project on robotic surgery asks for data on the "comparative effectiveness and comparative cost of robotic interventions for the clinical treatment of disease." A cancer screening comparative effectiveness opportunity may include "head-to-head studies of the technical performance characteristics, physician and patient acceptability and cost of alternative screening technologies."
Another proposed project specifically attracted the ire of Sen. Jon Kyl, R-Ariz. The project, titled "integrating cost-effectiveness analysis into clinical research," calls for the "inclusion of rigorous cost-effectiveness analysis in the design and testing of new and innovative interventions" as a means to "provide accurate and objective information to guide future policies that support allocation of health resources."
During a speech on the Senate floor April 1, Kyl called that proposal "chilling."
"The allocation of health resources is, of course, a euphemism for rationing," he said. "For some of the sickest patients suffering from chronic diseases, the government wants to decide if their treatment is a good allocation of resources."
Comp. Effectiveness Quarrels Reignited On Hill
The controversy picks up on an intense debate surrounding comparative effectiveness funding (totaling $1.1 billion) in the stimulus package (3"The Gray Sheet" Feb. 16, 2009, p. 3).
Comparative effectiveness is an important component of comprehensive health reform as envisioned by Democratic leaders in Congress. They say it will help save costs by more clearly illustrating which treatments work and which do not.
But skeptics, including conservatives in Congress and many device and drug companies, worry that without explicit statutory limitations, federally funded comparative-effectiveness research will be used to support national treatment protocols that restrict patient access to treatments not meeting a certain cost-effectiveness threshold.
Efforts to insert the word "clinical" before "comparative effectiveness" in the stimulus bill were ultimately unsuccessful, but the conference report for that legislation specifies that the research is expected to address "clinical outcomes;" that the results are not meant to mandate coverage policies; and that lawmakers "recognize that a 'one-size-fits-all' approach to patient treatment is not the most medically appropriate solution to treating various conditions."
Some in Congress don't think that went far enough. Sen. Pat Roberts, R-Kan., highlighted the concern at the March 31 Health, Education, Labor and Pensions Committee hearing on Kansas Governor Kathleen Sebelius' nomination to be secretary of the Department of Health and Human Services.
He cited NIH's plans to fund cost-effectiveness research as a clear sign that the government was moving closer to an outright rationing program.
Sebelius, though, pointed out to Roberts her interpretation of the law. "Current statutory authority prevents Medicare from using comparative effectiveness as a cost decision maker," she said. "I can commit to you, if I am confirmed secretary, ... that CMS follows the law."
Issue Enters Senate Budget Resolution Debate
Roberts was unconvinced. The following day he and 43 other senators, almost all Republicans, voted for an ultimately unsuccessful amendment offered by Kyl to the 2010 budget resolution that would enunciate more restrictions. The budget resolution, which passed the Senate April 2, is non-binding, but it identifies priorities for upcoming legislation.
Kyl's amendment sought to prevent any health reform legislation from curbing spending by using comparative effectiveness to deny coverage. It also would have ensured that "comparative-effectiveness research accounts for advancements in genomics and personalized medicine, the unique needs of health disparity populations, and differences in the treatment response and the treatment preferences of patients."
Sen. Max Baucus, D-Mont., a leader on health reform efforts among Democrats, also supports federal funding only for clinical, not cost, comparative research, but asserted that Kyl's amendment went too far.
To Baucus, Kyl's language "says there can be a procedure determined to be totally ineffective or may be harmful, but it has to be used."
Debate Underscores Barriers To Reform Agreement
For its part, NIH says it is still assessing whether the comparative effectiveness funds in the stimulus package can legally be applied to cost-effectiveness research. If not, other money from the Recovery and Reinvestment Act could be used to fund those grants, suggested Raynard Kington, acting director of NIH, during a March 26 House Appropriations Subcommittee hearing, according to a news report by CQ HealthBeat.
But that doesn't get at the larger struggle of how the issue will be dealt with as part of a far-reaching health reform package that congressional leaders are shooting for this year.
Sen. Mike Enzi, R-Wyo., a moderate who is trying to help forge a bipartisan health reform agreement, suggests the comparative effectiveness debate that surfaced during the budget consideration represents the type of intractable partisan squabbling that threatens to keep Congress from accomplishing comprehensive reform in 2009.
"We were talking about cost effectiveness and clinical effectiveness, but the two sides were not listening," he said April 2 during Sebelius' confirmation hearing before the Senate Finance Committee.
"Both sides resolved it to their own satisfaction. But we are going to have to come together on that issue. And the biggest thing we are going to have to do," he said to some laughs, "is come up with a whole [new] name that does not have the letters 'C' or 'E' or 'R' in it in order to get past that."
- David Filmore
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