Comparative effectiveness research (CER) is not a new concept. However, understanding what CER is, what it does, and what it could do has seemingly taken on a life of its own in recent months.
Depending on who you talk to in Washington or even throughout the country, opinions have widely varied: some say it could be an effective way to promote quality healthcare while others say it could hinder patient choices—hurting provider and patient relationships.
To understand the source of the arguments, the starting point is found in the immense economic stimulus package approved by Congress in March. Tucked into the legislation was a CER provision calling for $1.1 billion to "conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness" of medical drugs, procedures, treatments, and devices.
The idea has been around for a while. CER moved into the national spotlight when the Medicare Modernization Act (MMA) of 2003 authorized the Agency for Healthcare Research and Quality (AHRQ) to compare clinical effectiveness and outcomes of healthcare items and services to the initial tune of $15 million annually. (This is a drop in the bucket, though, compared to the $300 million proposed for AHRQ in the stimulus bill.)
Under the stimulus package provisions, the government established a Federal Coordinating Council to hear public comments on CER and make recommendations to AHRQ, the National Institutes of Health, and the Department of Health and Human Service (HHS). The Institute of Medicine will publish recommendations on national priorities by June 30 on national comparative effectiveness.
So far, simple: Find out which treatments and procedures really work better than others, and patients and providers will flock to them. Right? Well, not quite.
Remember, this is still the year, as the Obama administration has stated, for healthcare reform. Enter stage right are numerous Republicans on Capitol Hill who have characterized CER as a move to deny patients treatment or medications in part based on cost.
One of the more vocal critics has been Sen. Jon Kyl (R-AZ), whoraised the issue April 21 when the Senate Finance Committee voted on—and approved—the nomination of Kansas Governor Kathleen Sebelius as HHS secretary. He criticized the governor for not considering "appropriate safeguards" that would prevent denial or delay of treatments based on CER—essentially rationing care based on costs. "No Washington bureaucrat should . . . substitute the government's judgment for that of a physician," he said.
Sebelius, though, has maintained that information obtained from CER can lead to better decision-making by patients and providers.
"Comparative effectiveness research is one component of building a high-quality, value-oriented health system. It is not about government rationing," said Sebelius in response to questions about CER posed by Finance Committee members in an April 2 letter. Sebelius, who was not in attendance at the confirmation hearing, added that under the MMA of 2003, Medicare cannot make coverage decisions based on that research.
But the public perception of what CER will do remains on the wary side. Will it provide better value or restrict care? In a Kaiser Family Foundation/Harvard University/National Public Radio poll released April 22, a majority of those polled supported having an outside group make decisions about which tests and treatments should be paid for insurers—until it was realized that the panel members would be selected by the government.
When asked about having an insurer pay for a more expensive medical treatment that has not been proven to be more effective than other less expensive treatments, more than half (55%) of those polled thought the insurers should have to pay for it anyway.
Similarly, at the listening session conducted by the Federal Coordinating Council on April 14, Myrl Weinberg, president of the National Health Council, which represents the interests of individuals with chronic diseases and disabilities, noted in a nationwide telephone survey a reticence by patients in her group to support comparative research. Their greatest concern was that CER will be used "inappropriately to deny access or to funnel them into a one-size-fits-all mode of care," she said.
So what to do? At the listening session, many of those participating suggested the same thing: Make sure any reforms in healthcare are designed to keep providers—and particularly patients' own physicians--in the loop when decisions are made about treatments and procedures. CER can be an important building block in providing quality healthcare—but the users of the healthcare system need to be able to know their trust is well-placed.