A new $1.1 billion federal effort to compare medical treatments head-to-head--called comparative-effectiveness research--could help physicians, patients, and even insurers figure out which treatments work best, proponents say. But critics say such research ultimately could be used to deny insurance coverage for certain therapies, resulting in a rationing of care. Congressional negotiators, in a report issued earlier this year, said the research shouldn't be used to dictate coverage or reimbursement policies.
KHN's Chris Weaver talked to Gail Wilensky, a long-time advocate of comparative-effectiveness research and a senior fellow at Project Hope, an international health education foundation about the issue. She was administrator of the Medicare and Medicaid programs under President George H.W. Bush and later chaired the Medicare Payment Advisory Commission. She said that comparative-effectiveness research will lay the foundation to "look at the various ways medical conditions are being treated and begin to provide better guidance about which of those seem to be the most clinically important." More details follow:
Q: In a 2006 issue of Health Affairs, you wrote that the biggest payoff from this kind of research would come from comparisons involving (surgical) procedures. What would be your top priorities?
A: The way I would proceed is to look at how certain medical conditions are being treated. Lower back pain is a notorious area… some parts of the country are much more likely to produce surgical interventions and other parts are much less. The way to prioritize… is to look at where there are significant variations (in treatment) and to see whether the financial consequences are significant.
Q: Last summer, you wrote… that it's "vitally important to keep comparative clinical effectiveness analysis and cost-effectiveness analysis separate from each other." Can you tell us a little more about what that means?
A: I believe that the information from comparative clinical effectiveness needs to be paired with financial incentives to encourage their more appropriate use... What that means is that when there is good clinical evidence… for treating a particular type of cardiac disease or orthopedic disease or whatever, you ought to have the lowest copayments… and higher copayments when the likelihood (of a positive outcome) is very uncertain or very low.
You've already seen people who are raising the flag of rationing, (saying the research is) just a backdoor way to deny effective care because you don't want to pay for it. I don't want to arm those critics.
Q: What are your thoughts on the opposition from the pharmaceutical industry, some congressional Republicans and some consumer groups?
A: I don't want to lump the whole pharmaceutical industry in terms of the opponents. I have had very good discussions with very senior people in the pharmaceutical industry who have indicated that as long as the process is transparent (and) that it doesn’t delay entry to market, they wouldn't object… There obviously have been some groups and some individuals (who are) very aggressive in their attacks. My attitude is we can't proceed with the growth rate in spending and with the poor clinical outcomes that we show…
Q: What about the suggestion by Sen. Jon Kyl, R-Ariz., that this research could "deny or delay health care for Americans"?
A: Many things could deny and delay health care for Americans if they're enacted inappropriately. In a country where your likelihood of getting what's clinically appropriate is 53 percent, it's not a very useful threat.
Q: Do you think the research should be used in making coverage decisions?
A: I think that the safety and efficacy decisions made by the Food and Drug Administration are adequate, but I think the reimbursement decisions, both how much you reimburse and what kind of copayments you use, ought to reflect what we know about clinical appropriateness. I would prefer not doing it for coverage, but doing it for reimbursements.
Q: Some private insurance plans use similar research to make coverage and reimbursement decisions. Should Medicare be held to a different standard than those plans?
A: Medicare has so little ability to use financial incentives. I think that Medicare is very much behind, and it needs to be armed with many tools to allow it to produce more clinically appropriate outcomes.