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Advocates Debate the Effect of Comparative Effectiveness

By Rebecca Adams, CQ HealthBeat Associate Editor

July 22, 2010 -- Research comparing different treatment strategies for the same disease has the potential to provide better information about what works in medicine, said advocates at a forum Thursday about the science—but one speaker warned that minorities could be harmed if insurers or Medicaid officials used the studies in reimbursement decisions.

The morning-long forum on "comparative effectiveness" research—sponsored by the Partnership to Improve Patient Care (PIPC)—featured remarks by eight advocates and Senate Finance Committee Chairman Max Baucus, D-Mont.

The most vocal critic was Gary Puckrein, the president and chief executive of the National Minority Quality Forum, a group that aims to reduce health disparities among minority populations.

"Minority populations have been truly disadvantaged," Puckrein said, by comparative effectiveness research that has been used by states to limit services for patients enrolled in Medicaid, the federal-state program for the low-income. For instance, state officials have sometimes decided to require patients to pay more for medications that were shown to be inferior to other alternatives.

Puckrein said that officials for insurance companies, Medicaid programs and other programs should not charge more or refuse to pay for services that are shown in studies to be less effective than others. He said that the effect on individual patients may differ.

The health care legislation signed by President Obama calls for the creation of a new institute that will fund comparative effectiveness research (CER). The new institute will build on previous work, including studies funded through $1.1 billion provided through the 2009 economic stimulus law (PL 111-5).

Acknowledging that the federal government is poised to spend billions over the next decade on comparative studies, Puckrein asked that policymakers and those involved in coverage decisions recognize that the conclusions in studies may not apply to all patients. Minorities are often underrepresented in studies and the effects of various treatments on them may not be completely understood.

"Even though I don't get it, I understand the train is out of the station," Puckrein said, referring to the enthusiasm and funding for CER. "When you start putting out these CER studies, let's be very careful that we articulate who the study applies to.... It's really a very narrow group of individuals that these studies should be applied to. If we can do that, I'll live through the CER experience."

Baucus, taking the microphone after Puckrein, noted that the health care law requires that the new institute consider that the effects of treatments may be different for certain subpopulations, such as minorities, people with certain genetic compositions, patients with disabilities, and others. He also said that the institute will not develop medical guidelines, treatment protocols or coverage recommendations of any sort.

The chairman defended the funding for CER and the health care law in general, saying that doctors and patients have more tests and treatment options than ever, but comparative effectiveness research is needed because "in many cases, we simply don't have enough available evidence to choose between options."

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