WASHINGTON — More than two years ago, studies found that injecting medical cement into compression fractures of the spine produced no better pain relief than "sham" injections. Yet doctors continue to perform the $5,000-plus procedure and most insurers, including Medicare, still cover it.
The continued use of spinal cement injections is a cautionary tale for those who hope to slow the rise of health care spending by compiling evidence about what works and what doesn't.
Congress is betting more than $3 billion over the next decade that "comparative effectiveness" research can transform medical care by helping to determine the best approaches to particular illnesses. On Wednesday, an independent board established by the 2010 health care law — the Patient-Centered Outcomes Research Institute — will release national priorities for spending that money.
But mustering evidence about risks and benefits — often a difficult process — may prove easier than persuading doctors and patients to abandon less-effective or even discredited tests and treatments, particularly those that already are in widespread use.
"Once it's out of the box, it's hard to reel stuff back in," said Elizabeth McGlynn, a former RAND researcher who heads the Kaiser Permanente Center for Effectiveness and Safety Research. (Kaiser Health News isn't affiliated with Kaiser Permanente.)
It's hard because those who market particular drugs, devices or tests have financial interests in protecting the status quo. Hard, too, because consumers embrace research when they're shopping for dishwashers or cars but may be unable or unwilling to apply that approach to the complex issues that surround medical care.
Doctors who are trained to do things one way may be more likely to trust the consensus of their colleagues and their patients' preferences than new data. Some also fear that the data will be used for payment decisions, undermining their autonomy and leading to rationing.
While research can shed light on what treatments don't work for the majority of people, a subset of patients may still benefit. Study methods also can be faulty and results contradictory.
"That's still a subjective call they (researchers) are making," said Jennifer Jaff, the executive director of Advocacy for Patients with Chronic Illness, a Connecticut-based group that helps patients appeal medical coverage decisions. "If you find a medical journal article that says no" — meaning it says a particular treatment doesn't work — "I can find you one that says yes, it does."
When the two spinal cement studies were published in The New England Journal of Medicine in 2009, for instance, some people immediately questioned their validity.
"Health plans didn't stop coverage, and doctor groups fought back against the results," said Steven Pearson of The Institute for Clinical and Economic Review, a private firm that assesses medical technology.
Professional societies that represent interventional radiologists, who often do the procedure, called vertebroplasty, said the studies were too small to be meaningful, and they successfully fought insurers' attempts to limit coverage, according to an article Pearson co-authored in the December issue of the journal Health Affairs.
"We believe it is premature — and possibly incorrect — to conclude that vertebroplasty is no better than a sham," said a November 2009 statement from the Society of Interventional Radiology.
At the time, Medicare had covered the procedure for eight years, with about 73,000 vertebroplasties performed annually on Medicare patients.
Similar controversy occurred in October, when a government-backed panel of experts issued draft recommendations against routine screening of men for prostate cancer, saying the prostate specific antigen test may lead to more harm than good. The American Urological Association was among the groups that strongly opposed the recommendations, saying they would do men "a great disservice."
A month later, reaction also was split when the Food and Drug Administration withdrew its approval of the costly drug Avastin for advanced breast cancer, saying it wasn't safe for that use. Even as some praised the move, saying the drug could shorten women's lives, others insisted that it could help some patients.
"If we're ever going to have a hope of spending less money on medicine, we're going to have to stop paying for things that don't work or hurt people," said Sean Tunis, the founder and director of the Center for Medical Technology Policy, a nonprofit organization in Baltimore that studies ways to improve medical research. "You could not ask for two more clear examples."
The executive director of the Patient-Centered Outcomes Research Institute, Joe Selby, doesn't minimize the challenge of changing medical practice, but he remains optimistic about the value of credible evidence. The key, he said, is getting doctors and other health professionals involved "in every phase of our work, from the selection of research topics to the dissemination of research results."
Congress set up the institute's 21-member board to represent a broad cross-section of health care stakeholders, including representatives of drug and device makers, insurers, consumers, researchers and government agencies. It's funded in part by a new $1 to $2 per-person annual fee on Medicare and most health insurance policies.
The law prohibits its findings from being "construed as mandates for practice guidelines, coverage recommendations, payment or policy recommendations." But government health programs can use the findings for coverage determinations if that's done through an "iterative and transparent process which includes public comment" and that considers subgroups of patients.
That may reassure those who fear that insurers will use the data for payment decisions, but on the flip side, Tunis worries that comparative research won't translate into change in medical practice without "financial incentives to be cost conscious — some kind of sensitivity to spending."
While the institute's findings can't be used to set payments for medical services, other parts of the health care law encourage greater attention to the relative cost-effectiveness of treatments.
For example, new types of lump-sum payments to hospitals and doctors who team up in "accountable care organizations" make them "responsible for quality and efficiency of care in a way they never have been before," Pearson said.
He said that many policy experts thought this would give accountable care organizations "a tremendous incentive to look at (medical) evidence and be more thoughtful of cost-effectiveness."
While calling that an ideal vision for the long term, Pearson said action was needed in the short term, including insurers limiting coverage of new drugs or devices until they were proved to be safe and effective. "We have to get better studies first before something is out of the barn."
Once practices are in wide use, it's more difficult to set restrictions. Neither Medicare nor commercial insurers have taken steps, for instance, to limit routine prostate cancer screenings or to bar coverage for treating breast cancer patients with Avastin.
Lee Newcomer, the senior vice president for oncology at UnitedHealth Group, said that insurer would continue to cover PSA tests because some men, such as those with family histories of prostate cancer, might benefit from routine testing.
United also will cover Avastin for breast cancer, although Newcomer said the FDA's move most likely meant that doctors and patients would "have a much more honest discussion about Avastin's role in breast cancer therapy."
Like other insurers, he said, United defers coverage decisions on chemotherapy to the National Comprehensive Cancer Network, a coalition of 21 academic medical centers, which is still recommending the treatment.
Insurers use the network, Newcomer said, because "no matter how fair and honest we are on our assessments, if we said no, people would say, 'Oh, they're doing it to save money.' "
(Kaiser Health News is an editorially independent news service of the Kaiser Family Foundation, a nonpartisan health care policy organization that isn't affiliated with Kaiser Permanente.)
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