A Medicare advisory panel has concluded that it has low confidence in spinal fusion as a treatment for lower-back pain, but for now, the federal insurance program has no plans to deny coverage for the procedure.
The Medicare Coverage Advisory Committee met in late 2006 to weigh the available evidence on spinal fusion. The panel voted on six questions. It said that the available data provide an intermediate level of confidence in addressing the outcomes needed to determine whether fusion is effective for low-back pain resulting from degenerative disk disease.
For all the other questions posed, which all pertained to degenerative disk disease, MCAC found that the evidence fell below the intermediate level of confidence for determining improved outcomes—as compared with conservative treatment—for both the first 2 years post surgery and beyond 2 years. They said the data were similarly lacking for fusions both with and without instrumentation. And, said the panel, the results in the literature are reasonably likely to generalize to the Medicare population.
The Centers for Medicare and Medicaid Services decided to hold a meeting to explore fusions after it denied coverage to the Charité artificial disk, according to an agency spokesman.
“It was also to identify where the holes are so that medical societies and industry and others could start to develop better data on those areas,” said Eric Muehlbauer, executive director of the North American Spine Society, in an interview.
Mr. Muehlbauer said that CMS is essentially wielding its clout to spur better data collection.
The North American Spine Society is considering three proposals on how to improve the evidence base on fusion, he said. There is an especially glaring need for data specific to the Medicare population, partly because fusions are rarer in that age group, said Mr. Muehlbauer.
Medical device makers, represented by the Advanced Medical Technology Association (AdvaMed), said that access should not be restricted during the evidence gathering process.
“We encourage the Centers for Medicare and Medicaid Services to allow Medicare patients access to spinal fusion surgery as a treatment option as the body of clinical evidence develops over time,” said AdvaMed president and CEO Stephen J. Ubl in a statement.
The American Academy of Neurological Surgeons and the Congress of Neurological Surgeons are starting the second year of a pilot program to collect outcomes data on patients who have operations for lumbar stenosis, said Dr. Daniel Resnick, of the department of neurological surgery at the University of Wisconsin, Madison, in an interview.
Fifteen practices are taking part in the pilot, which is testing the best way to gather data, Dr. Resnick said. Expansion is likely if a grant comes through, he said.
There are several obstacles to getting good data, said Dr. Resnick. “We're hampered by an imperfect understanding of the physiology of pain in many patients,” he noted. And most patients will not enroll in a study in which there's a 50% chance they would get conservative treatment instead of surgery, he said, adding that most U.S. patients have already undergone many therapies before they undergo a procedure.
Both he and Mr. Muehlbauer said there is evidence that fusions work in the right patient. But they said they weren't surprised that CMS is examining the procedure, given the increase in fusions since the introduction of instrumentation.
A study on trends estimated that lumbar fusion increased 250% from 1992 to 2003 (Spine 2006;31:2707–14). Medicare payments for fusion rose from $75 million in 1992 to $482 million in 2003, estimated the authors, who are affiliated with Dartmouth Medical School and Dartmouth-Hitchcock Medical Center. They also found geographic variations.
Dr. Resnick said that fusions have increased partly because there are new technologies and techniques that offer options to previously untreatable patients.