Effectiveness research gains support

WASHINGTON, D.C. - Health policy experts have been debating how to obtain more reliable, unbiased information on which drugs and medical procedures are most effective. Last month, Senate Finance Committee Chairman Max Baucus (D-Mont.) and Senate Budget Committee Chairman Kent Conrad (D-N.D.) introduced legislation spelling out many of the specifics for such a program.

The Comparative Effectiveness Research Act of 2008 establishes an independent entity to conduct research on the effectiveness of different healthcare treatments and services. Many of the provisions in the bill reflect a desire to balance public oversight of such analysis with the need for independence and minimal political influence over the research agenda.

The proposed Health Care Comparative Effectiveness Research Institute would be a private, nonprofit, non-governmental entity. It would contract with government agencies, such as the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), as well as private research organizations to conduct systematic reviews, observational studies and randomized controlled clinical trials to obtain evidence on the clinical effectiveness of therapies and treatments.

The Institute would be managed by a large Board of Governors that includes government officials and representatives of private payers, pharmaceutical companies, patients, physicians and public health agencies. An expert methodology committee would oversee the development of standards and methods for conducting scientifically sound comparative research.

CONSIDERING COSTS

To reduce opposition, the legislation specifies that the Institute will not consider cost and health plan design factors in its assessments. However, the bill leaves the door open for Congress to revise the policy to include such analysis in the future. In sidestepping another thorny issue, the measure specifies that the Institute will disseminate its research findings, but will not issue specific practice or policy recommendations or coverage guidelines.

Despite these provisions, there is considerable trepidation among medical product manufacturers and providers about how comparative effectiveness analysis will be used by payers and insurers. Physicians remain leery of overly specific treatment guidelines.

Pharmaceutical companies and medical device makers fear that future cost comparisons will limit patient access to new products.

Although it's possible for the bill to be included in broader legislation moving through Congress, Sen. Baucus acknowledges that approval is unlikely this year. The aim of introducing the legislation now is to provide a starting point for serious deliberations on the proposal in 2009.