Comparative Effectiveness Language In Stimulus Bill Raises Concerns
Full article reprinted from "The Gray Sheet" - January 26, 2009
Find out how the House Appropriations Committee Jan. 21 approved $1.1 billion to fund comparative effectiveness research as part of an economic stimulus 1package, but industry and some patient and physician groups are expressing strong reservations about the language of the bill, as well as accompanying report language.
The comparative effectiveness provision is part of H.R. 598, an $825 billion economic stimulus bill moving with lightning speed through Congress. Several House committees holding jurisdiction are marking it up with the goal of delivering it to the House floor for a vote this week.
Of the $1.1 billion, the bill directs $300 million to the Agency for Healthcare and Research Quality, $400 million to the National Institutes of Health, and the remaining $400 million to the Department of Health and Human Services to be used at the discretion of the secretary for accelerating the development and dissemination of research comparing the effectiveness of treatments and health care strategies.
The language requires a report by the Institute of Medicine recommending priorities for comparative effectiveness research and the formation of a Federal Coordinating Council for comparative effectiveness to advise HHS and Congress on priorities and on needed funding and infrastructure. The council would comprise senior officers from AHRQ, CMS, FDA, NIH and other HHS agencies.
Industry Emphasis On Clinical, Not Cost, Studies
The device industry is not completely opposed to comparative effectiveness research, but it has been vocal about guarding against its use to restrict individual patient coverage and its evolution into comparing treatment costs. Industry reps, along with allies in the patient and medical communities, say the new provisions do not meet their requirements.
AdvaMed Senior Executive VP David Nexon says that there are no protections in the bill to prevent the studies from focusing exclusively on cost, rather than clinical, effectiveness.
In addition, there "is no clear requirement for transparency" in the bill, he asserts. There is a section requiring recipients of the comparative effectiveness funds to offer an opportunity for public comment on the research, but, he says, H.R. 598 does not specify that patients and physicians can provide input on determining which studies would be done or on the studies' design.
"We need a clear statement in the language of the bill that it would fund clinical comparative effectiveness, not cost comparative effectiveness, and that the studies will not be used for national coverage determinations," he says.
The 2Partnership to Improve Patient Care, a group that includes AdvaMed, drug industry groups and two dozen patient and practitioner groups, was formed specifically to advocate for the priorities articulated by Nexon.
PIPC spokesman David Di Martino points to the 3report accompanying the House bill as the clearest sign that the current bill is not satisfactory.
In the section describing the comparative effectiveness provision, the report states that items, procedures, and interventions "that are found to be less effective and in some cases, more expensive, will no longer be prescribed."
While congressional reports are not binding, they do give an indication of intent. "The report language flat out says that more expensive treatments will no longer be prescribed," Di Martino laments.
Stakeholders are looking to the Senate to improve the language. Sen. Max Baucus, D-Mont., said Jan. 23 that his Finance Committee "contributed to the finalization" of the House bill's comparative effectiveness funding. However, same-day press reports suggest that the Senate Appropriations Committee, which will mark up the portion of the stimulus package containing the comparative effectiveness provision, plan to revise the report language to remove references to treatment costs.
Di Martino says his group is pushing for something closer to the comparative effectiveness bill introduced last year by Sen. Baucus. That legislation, which Baucus has pointed to as a key component of his health reform plans, would create a public-private entity to direct national comparative effectiveness efforts. The bill included $300 million in funding by 2013 and requires more participation from industry and patient groups (4"The Gray Sheet" Aug. 4, 2008, p. 12).
- Sue Darcey
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