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An NIH study of treatments for high blood pressure, called the ALLHAT trial, shows some of the strengths and limitations of comparative effectiveness research to improve patient care. More...
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Comparative effectiveness provisions in Sen. Max Baucus' health care reform bill adhere largely to the stand-alone bill that the Finance Chair released earlier in the year, garnering support from drug industry stakeholders that have expressed concern about other proposals. Baucus' framework would keep comparative effectiveness research outside of HHS and would prohibit the department from making coverage determinations based solely on the results of comparative studies.
The Biotechnology Industry Organization and other drug groups say they support comparative safety and efficacy studies but are concerned that some proposals, including the House health reform bill, would put too much emphasis on the research and give it too much prominence in determining which treatments Medicare will cover. People respond to drugs differently, so a product that works better than its competitions for most patients could still be the wrong choice for certain individual patients, the industry says.
BIO referred questions about the comparative effectiveness policy in Baucus' bill to the Partnership to Improve Patient Care, which praised the policies as a "sound framework for independent, sustained, and objective research." PIPC Chairman Tony Coelho said the Baucus (D-MT) proposals would ensure that CMS does not misuse comparative effectiveness findings.
"Sen. Baucus' proposal puts patients at the center of comparative effectiveness research, providing assurance that research will be focused on improving patient care and not cutting costs by restricting access to treatment options," Coelho said in a statement.
The proposal that Baucus unveiled Wednesday (Sept. 17) would establish a Patient-Centered Outcomes Research Institute as a private, non-profit entity outside of HHS. The institute would create advisory panels to help identify research needs, and its studies would need to be peer-reviewed. Results would be available to physicians and the public, but the bill places strict limits on the purpose of the institute's communications.
"The Institute would be prohibited from disseminating research findings from a study or assessment that would include practice guidelines, coverage recommendations, or policy recommendations … The Institute would be required to consult with stakeholders in determining the types of dissemination that would be most useful to the stakeholders and would be allowed to utilize multiple formats for conveying findings to different audiences," Baucus' chairman's mark states.
Furthermore, the mark would prohibit CMS from using the comparative effectiveness institute's findings as the sole basis for coverage or reimbursement decisions. HHS could use the research, but only in combination with other relevant studies. For small patient groups, the chairman's mark explicitly requires HHS to consider any relevant studies that contradict negative findings from the institute. And the bill also appears to respond directly to conservatives' claims that comparative effectiveness would lead to rationing and denial of care to the elderly.
HHS "would be prohibited from using the Institute's research in determining coverage, or creating reimbursement or incentive programs, for a treatment in ways that treat extending the life of an elderly, disabled, or terminally ill patient of lower value than extending the life of a person who is younger, non-disabled, or not terminally ill," the mark states.