Just Don’t Call it “Comparative Effectiveness Research”

Two bills introduced in the Senate this week give further impetus to comparative effectiveness research, but both avoid the term “comparative effectiveness research” in the names of the entities they create to pursue the research. One, introduced by Senators Baucus and Conrad in the Senate Finance Committee, is solely devoted to the creation of a “Patient-Centered Outcomes Research Institute.” The other, the “Affordable Health Choices Act” introduced by Senator Kennedy in the Senate Health, Education, Labor and Pensions Committee, is a more complete version of draft healthcare reform legislation Senator Kennedy circulated at the end of last week, and it includes one short provision that would create a “Center for Health Outcomes Research and Evaluation” within the Agency for Healthcare Research and Quality (AHRQ).

Why the conspicuous absence of “comparative effectiveness research” in the names of these entities? Critics of the Obama administration’s effort to establish comprehensive healthcare reform legislation have tried to mobilize opposition by claiming it would use the results of comparative effectiveness research to dictate patient treatment regimens to doctors or provide insurance coverage in Medicare or other government health insurance programs only to “government-approved” treatment regimens.

Both bills take pains to ensure that comparative effectiveness research results will not constrain coverage or treatment options. The bill by Senators Baucus and Conrad states that research findings “shall not include practice guidelines, coverage recommendations, or policy recommendations” and that neither the reports nor research findings of the Institute “shall be construed as mandates, guidelines, or recommendations for payment, coverage, or treatment.” Similarly, Senator Kennedy’s bill states that “Center reports and recommendations shall not be construed as mandates for payment, coverage, or treatment.”

Despite these similarities, however, the two bills are quite different. Senator Kennedy’s Center mainly appears to be an extension of what the AHRQ is already doing, and no specific budget or funding mechanism is mentioned in the bill. By contrast, the bill by Senators Baucus and Conrad creates a new non-profit entity that would be governed by a board appointed by the Comptroller General composed of a broad spectrum of stakeholders, including representatives from drug and device manufacturers. In addition to annual appropriations of $150 million, the Institute would be funded by a surcharge of $2 per person to be paid by all public and private insurance plans based on their number of covered lives, resulting in an annual budget of roughly $750 million. Moreover, up to 20% of this amount can be used to fund organizations that currently perform comparative effectiveness research, such as the Cochrane Collaboration. With such a significant budget, the Institute could certainly fund a lot of comparative effectiveness research, including large-scale comparative clinical trials.