Should the US government mount a comprehensive effort to evaluate the strengths and weaknesses of various treatments for health conditions? That question is at the heart of a dispute over whether some provisions in the healthcare reform bills now under consideration in Congress eventually might lead to the rationing of care.
At issue is comparative effectiveness research, which tries to figure out just how well drugs, medical devices, and surgical techniques work, compared with alternatives. Both the House and current Senate versions of health legislation would expand exisitng federal efforts in this area.
To supporters, the move is a no-brainer way to try to increase the efficiency of the bloated US healthcare system. But opponents see it as something that Washington in time might use to restrict patient access to risky, unproven, or expensive treatments.
“Cost or a federal health board could be the deciding factor” in treatment decisions, concludes a Heritage Foundation critique of the issue.
Whether Congress approves healthcare reform or not, Washington will be overseeing substantial comparative effectiveness research. The stimulus bill that passed Congress earlier this year contained more than $1 billion for grants in the area.
But provisions contained in the fine print of both the House bill and the current most comprehensive piece of Senate legislation, produced by the Senate Health, Education and Labor committee, would centralize and enlarge US comparative effectiveness activity.
The House bill would establish a federal Center for Comparative Effectiveness Research under the Department of Health and Human Services. This new center would be empowered to “conduct, support, and synthesize” research on the “outcomes, effectiveness, and appropriateness” of healthcare services and procedures.
The “full spectrum” of healthcare items, including drugs, medical devices, and surgical procedures, would fall under the center’s purview, according to bill language.
The House bill would also establish a 15-person commission to oversee this effort, with members drawn from a wide array of interested parties, from patients to physicians and insurers. Per a House Energy and Commerce Committee amendment, the legislation also prohibits use of comparative effectiveness research findings to deny or ration care, or to make coverage decisions in Medicare.
The Senate Health, Education and Labor bill would also create a new federal entity, though with a different name: the Center for Health Outcomes Research and Evaluation.
It also would be charged with conducting its own studies, as well as synthesizing research done by others. Its charge: give providers and patients information on the “most effective therapies” for preventing and treating health conditions.
Many physicians believe the value of such research is obvious. Why waste money on treatments that don’t work – or, at least, don’t work as well as they should?
Right now, most medical research focuses on randomized clinical trials of new drugs, devices, or treatments, points out a recent analysis of the subject published in the New England Journal of Medicine. Much less time and money are devoted to comparing current treatments with one another.
But health policymakers, insurers, and health providers are increasingly interested in just such comparative research.
“The need for CER [comparative-effectiveness research] is clear,” says the analysis, written by physicians Aanand Naik and Laura Petersen. But Drs. Naik and Petersen note that currently there is little established evidence that actually shows comparative effectiveness research can change physician behavior and improve patient care.
And political opponents of the current healthcare reform bills charge that the research could even be the first step to government allocation of healthcare resources.
In the British national health service, a government board approves only expensive treatments that add at least the equivalent of one year of quality life for every $50,000 in spending, pointed out Harvard economist Martin Feldstein, former chief economic adviser to former president Ronald Reagan, in an August opinion piece on the subject.
In the US “comparative effectiveness could become the vehicle for deciding whether each method of treatment provides enough of an improvement in health care to justify its cost,” writes Feldstein.