Comparative effectiveness research: New ways to say "no"

Health plans have stepped up their efforts in using this tool to decide what to cover. Doctors ask: Is the goal better medicine, or just cheaper medicine?

By Emily Berry — Posted Sept. 21, 2009

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Before the federal stimulus package dedicated $1.1 billion to comparative effectiveness research, health plans had their own ways to determine the right combination of quality and cost. To physicians, plans' coverage decisions often appeared to be based on cost above all else.

But plans say they are doing more comparative effectiveness research in a way that mirrors the federal effort: Performing an objective analysis of treatments and costs to determine the best treatment or medication for a certain condition. While not revealing how much they've spent, plans say they have stepped up their efforts in the last few years.

America's Health Insurance Plans, the health insurers' trade group, released a position paper in 2007 supporting a central entity for comparative effectiveness research, specifically a "public-private partnership" model that allowed health plans to be part of the national effort.

Instead, Congress established the Council for Comparative Effectiveness Research as part of the American Recovery and Reinvestment Act passed in February. The council is made up of representatives of various federal health agencies and is to guide and oversee research efforts. It is specifically barred from recommending coverage or clinical guidelines.

While the American Medical Association and others in organized medicine support the federal effort in comparative effectiveness research, they also said such research should not be the final say on how a physician may treat a patient, or how he or she is paid for treating that patient.

"There is a fear of many physicians that [for] some particular treatment they do, research will be done that says it doesn't work and shouldn't be done, and the next day insurance companies are not paying for it," said James King, MD, board chair of the American Academy of Family Physicians.

Health plans know their coverage and reimbursement decisions are perceived as profit-driven, said Ed Pezalla, MD, MPH, national medical director and chief clinical officer for Aetna Pharmacy Management. "This is why it's good to have the evidence get out there in the world and be debated. We'd like to see more of that get done in the world so it can be debated away from those of us that have a vested interest" in cost control.

Health plans' comparative effectiveness research dates back at least to 1985, when the BlueCross BlueShield Assn. established its Technology Evaluation Center. The office, which continues to oversee reviews of clinical evidence on behalf of member plans and for Kaiser Permanente, now makes its reviews public. TEC's analyses have shaped medical policy on a variety of issues, including statins, genetic testing and identification of patients at risk for breast cancer.

The center is one of 14 groups with which the Agency for Healthcare Research and Quality contracted as an Evidence-based Practice Center. The others are mostly academic research centers but include the ECRI Institute, a private firm in Plymouth Meeting, Pa. The EPCs don't consider cost, except to gauge the potential for a treatment to reduce spending on a disease or condition.

Health plans are more apt to use comparative effectiveness research to draft formulary lists or set up required prior authorizations than to exclude a treatment or medication from coverage entirely, said Wini Hayes, PhD, RN. She is president and CEO of Hayes Inc., an independent health technology research and consulting company based in Lansdale, Pa.

In recent years, the largest plans, including WellPoint and Aetna, have established or bought companies to create subsidiaries for comparative effectiveness research. Others pay private companies such as Hayes or ECRI for access to research.

"Every single health plan has its own research entity or contract," said Linda Bergthold, PhD, a health care consultant and senior adviser to the Center for Medical Technology Policy, a San Francisco-based comparative effectiveness research group. The organization gets about a third of its funding from health insurers, the rest from drug companies, professional organizations and groups like the Commonwealth Fund and the Institute of Medicine.

Barriers to using the research

Private efforts by health plans have one practical problem: In many cases, they are doing the same research simultaneously.

"I think one of the real tragedies in this moment in time is that there are so many people doing the same thing in so many places," said Mark Gibson, deputy director of the Center for Evidence-based Policy, at Oregon Health Sciences University.

This hasn't helped make medical policies more consistent, Bergthold said. "Even if it's nationally done research, the way it gets applied may vary from plan to plan. [Doctors] can't possibly look up 10 policies for everything they do, so more or less they do what they think is right and hope it doesn't get denied."

Meanwhile, physicians are concerned about the conflict of interest inherent in a system in which private payers conduct, fund or oversee comparative effectiveness research.

"My big concern, whether government or insurance does it, is that they'll base the final decision on cost," AAFP's Dr. King said. He testified before Congress in support of comparative effectiveness research. The AAFP supports establishing a central body to oversee the research.

Dr. King said he doesn't think most physicians realize that health plans do their own comparative effectiveness research, or that they might use that information to make coverage decisions. When a drug is placed in a higher tier, or a test requires preauthorization, the assumption is it's solely because of cost.

Health plans want physicians to trust that coverage decisions are based on reliable research, said Steven Pearson, MD, president of the Institute for Clinical and Economic Review, based at Massachusetts General Hospital and affiliated with Harvard Medical School.

"They would love for there to be better evidence and for other people to make these tough calls," he said. Health plans help fund ICER, along with other medical organizations and foundations. Health plans use the institute's research as a source for evidence they can show clinicians to back up coverage decisions. Unlike similar research bodies, ICER is up front about making cost-effectiveness part of its work. According to its Web site, the institute "develops tools to support patient decisions and medical policy that share the goal of achieving maximum value for every health care dollar." Its reviews are made available to the public.

On the public-payer side, comparative effectiveness research, including the work done at OHSU's Center for Evidence-based Policy, has been used since 2004 to determine some pharmacy coverage and preauthorization requirements under Washington's Medicaid plan and state employee benefit plan.

In addition to its evidence-based pharmacy purchasing program, the state Dept. of Social and Health Services also has targeted specific treatments by subjecting each case to evidence-based review before Medicaid will cover them.

The Washington State Medical Assn. helped support the legislation that established its evidence-based drug-purchasing program and has supported the state's efforts to incorporate comparative effectiveness research into policy, said WSMA spokeswoman Jennifer Hanscom.

The pharmacy coverage policy also uses research from the Cochrane Collaboration, a group of 15,000 academics working through 12 centers around the world doing systematic literature reviews. The Cochrane reviews, like ICER research and TEC evaluations, are available to the public.

Private companies keep up work

Those in the field say they expect that even if the government funds its own research, health plans will keep doing their own and using it for medical policy. There are good reasons for that, said Brian Sweet, chief pharmacy officer for WellPoint. "I think that one of the interesting roles we can play here is in fact bringing claims data, assets and registries the size of WellPoint's to the table for the improvement of public health."

In August, Mayo Clinic Proceedings published a study by WellPoint's comparative effectiveness research subsidiary HealthCore. It found asthma patients generally had better outcomes with oral controllers than with inhaled corticosteroids.

Health plans also are likely to further tweak medical policy to allow for gradients of coverage, as there is often conflicting or incomplete evidence about effectiveness, and even less data about short- and long-term costs associated with a specific treatment, experts said.

Insurers are beginning to move beyond simply refusing to cover a treatment and are considering alternatives, such as value-based benefit design. That can mean covering all insulin for a patient with diabetes, but it also could mean paying a flat amount for treating a given condition based on the least costly therapy, Pezalla said.

Future policies also could use varied co-pays not only for prescriptions but also for treatments, depending on the cost of treatment and the evidence supporting its use, experts said.

"What's coming is a more nuanced approach," ICER's Dr. Pearson said. "Comparative effectiveness research may save money, it may not, but it will get us better value out of every health care dollar we spend."

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What the feds are doing

The stimulus package allocated $1.1 billion to comparative effectiveness research and established the Federal Coordinating Council for Comparative Effectiveness Research. The stimulus bill provides that:

  • $700 million be allocated for research by public health agencies, including the Agency for Healthcare Research Quality and Medicare, with $400 million for the National Institutes of Health.
  • An additional $400 million be allocated at the discretion of the secretary of the Dept. of Health and Human Services to be "used to accelerate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies." Included in that amount is up to $1.5 million to pay the Institute of Medicine to create a list of priority research projects. (The list was released June 30.)
  • The Federal Coordinating Council for Comparative Effectiveness Research be chaired by the HHS secretary must be at least half made up of physicians "or other experts with clinical expertise."
  • The council "foster optimum coordination of comparative effectiveness and related health services research conducted by or supported by relevant federal departments and agencies, with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources."
  • The council's reports and recommendations not be interpreted as mandates or guidance for coverage or reimbursement by any payer, public or private. (The initial council report was released June 30.)

Source: Bill text, Recovery Accountability and Transparency Board (link)

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Where did the term come from?

Experts say that although the studies have been going on in some form for decades, and have sometimes been funded by health plans, the phrase "comparative effectiveness research" has been in widespread use by the government for only a few years.

A December 2007 report by the Congressional Budget Office was among the first places the phrase appeared and was clearly defined (link).

Previous efforts at the same work were referred to as "technology assessment," "cost-benefit analysis" or the development of "evidence-based medicine."

The CBO report defines the term as "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy."

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Research may not save money, RAND analysis finds

Can comparative effectiveness research result in higher-quality medicine at a lower cost? One analysis said that's just about impossible to determine.

The RAND Corp., a Washington-based think tank, examined the potential for comparative effectiveness research to impact both health and health care spending. It found that any fiscal impact would depend on so many variables, it makes predictions difficult.

The analysis did find, however, that unless health plans change coverage because of comparative research findings -- for instance, declining to cover a treatment found to be less effective and more expensive than others --the research is not likely to slow spending.

"Information dissemination alone, without use of other incentives or mechanisms to chance behavior, may not be sufficient to change practice," the report said. The research also could find more expensive treatments are more effective, which could drive up spending.

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External links

"Initial National Priorities for Comparative Effectiveness Research," Institute of Medicine, June 30 (link)

Federal Coordinating Council for Comparative Effectiveness Research Report to the President and the Congress, June 30, in pdf (link)

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