ARTICLE IN BRIEF
In an analysis of Medicare data, investigators reported that complex fusion surgeries rose from 1.3 to 19.9 per 100,000 Medicare beneficiaries over the five-year period.
Although the overall number of spinal fusion procedures remained fairly static between 2002 and 2007, there was a sharp increase in more complex fusion procedures among elderly patients, accompanied by a corresponding rise in treatment costs, serious complications, and deaths.
But financial incentives to do expensive procedures combined with aggressive marketing by the device companies have contributed to this trend, according to experts who were not involved with the study. And they say what is particularly disturbing is the lack of evidence to support the procedures for elderly patients.
In the retrospective review of Medicare claims between 2002–2007, conducted by researchers at several institutions, investigators reported that complex fusion procedures increased 15-fold over that time period, with twice as many life-threatening complications from complex procedures compared with patients who underwent decompression alone, according to an analysis of data published in the April 7 issue of the Journal of the American Medical Association.
A team of researchers led by Richard A. Deyo, MD, the Kaiser Permanente Professor of Evidence-Based Family Medicine at Oregon Health and Science University in Portland, found complex fusion surgeries rose from 1.3 to 19.9 per 100,000 Medicare beneficiaries over the five-year period.
“In planning spine procedures, surgeons have wide discretion,” noted the authors, adding that even though there have been a number of randomized studies comparing spine surgery procedures for different conditions, there is little consensus on the indications for specific procedures.
“Furthermore, individual surgeon preferences may outweigh patient and disease characteristics in choosing procedures,” they wrote. “Risks of spine surgery are particularly important in older adults, for whom stenosis is the most common surgical indication.”
Procedures for spinal stenosis have grown the fastest among the elderly in recent years, and many surgeons recommend more invasive fusion procedures, despite higher risks and cost.
The researchers grouped patients undergoing surgery for lumbar stenosis in 2007, assigning them into one of three procedure groups: decompression alone, simple fusion (1 or 2 disk levels, single surgical approach), or complex fusion (more than 2 disk levels or combined anterior and posterior approach).
They discovered average hospital charges for complex fusion procedures were $80,888 compared with $23,724 for decompression alone.
Published complication rates ranged between 30 percent and 40 percent, while rehospitalization was necessary in almost 20 percent of patients. Moreover, the success rate was only in the 30- to 40-percent range, so the risks often outweigh any benefit.
In an accompanying editorial, Eugene J. Carragee, MD, chief of the Spinal Surgery Division at the Stanford University Outpatient Medical Center in Redwood City, CA, asserted that more complex fusion procedures in the elderly should be restricted to those with spinal deformity and more advanced degeneration, largely because such procedures are “a difficult and dangerous enterprise” in older patients.
In the new study, most of the elderly patients did not have any deformity, and fully half of the cases were in older patients with spinal stenosis alone, and only 6 percent had stenosis with scoliosis.
“Newer and more complex technologies are being used for patients with little specific indication for the approaches, and for whom there is good evidence that simpler methods are highly effective,” Dr. Carragee noted.
“Financial incentives appear to be a large part of the problem,” according to Dr. Carragee, who noted that reimbursement for spinal decompression averages between $600 and $800, while complex procedures can cost 10 times that amount. In addition, there are financial incentives to use new implants, devices, and biologic agents.
Implants can cost $50,000, and are marketed “aggressively” by manufacturers, he observed. Moreover, many surgeons do not weigh the cost-benefits of such procedures in insured patients, nor do patients have any incentives when Medicare/Medicaid covers in-hospital care.
The new findings, however, show “the human cost” of performing complex spinal fusion in seniors, with significantly increased risk of surgical mortality, major complications, and prolonged morbidity.
The efficacy of basic spinal techniques should be carefully assessed “against the plethora of unproven but financially attractive alternatives [and] serve as an important reminder that as currently configured, financial incentives and market forces do not favor this careful assessment before technologies are widely adopted,” he said.
Gary Franklin, MD, a research professor of environmental and occupational health sciences at the University of Washington School of Public Health and Community Medicine in Seattle, WA, said he hopes the findings will lead to fewer procedures in older patients, but he doubts it.
“I think this is a great study, and one that is badly needed,” he told Neurology Today in a telephone interview. “Once again, it calls out for restraint when considering lumbar fusion in the elderly.”
These are very complex procedures, even in younger patients, he noted, and efficacy varies by indication. In younger patients, fusion is usually performed for degenerative disc disease for chronic low back pain, but a number of studies have shown that their outcomes are no better than a combination of graded exercise and cognitive behavioral therapy.
Because spinal fusion carries a risk of serious adverse events and costs considerably more, it should only be done under highly selected circumstances, such as spinal instability, according to Dr. Franklin.
“The only definite proof we have that fusion surgery works for elderly patients is in treating degenerative spondylolisthesis, and perhaps scoliosis. I don't think there is any need to do more extensive surgery in most patients, yet procedures involving two or more levels, and 360 degree procedures, have become much more common in the last decade.”
So is supply or demand driving the sharp rise in procedures?
Dr. Franklin said spine surgeons are most at fault. “It's all supply — patients are not demanding these procedures,” he said. “There are a lot more fellowship trained spine surgeons out there doing them, as well as these newer technologies being used more often, like threaded [spinal fusion] cages and implants.”
While insurers do not seem overly concerned about the increase in spinal fusion among patients of all ages, he said he suspects Medicare is paying close attention to the trend.
“Lumbar fusion is one of the most widely used spinal procedures, but the number of these operations varies significantly between regions, with the rate in the highest regions being nearly twenty-fold greater than in the lowest areas,” Dr. Franklin said. “This usually indicates some question about the appropriateness of any procedure.”
Despite the risks highlighted by the new study, Dr. Franklin said he doubts the study will change things. “One would hope that a study like this would draw attention to a procedure that needs more careful consideration, but it is unlikely it will change policies or practices.”•
Neurology Today Associate Editor Orly Avitzur, MD, Comments:
Richard Deyo, MD, and colleagues provide an important service to clinicians by highlighting the overuse of complex spinal fusions among the elderly. And as the commentators on this paper rightly point out, there are powerful financial incentives and aggressive marketing forces driving this trend.
But unlike some who might speculate that these forces might be too powerful to change practice, I would submit that the publication of health outcomes data like these are especially timely and will get attention in important places, especially as the government focuses on cutting health care costs.
When there's an uptick in utilization to this degree, the Centers for Medicare and Medicaid Services begins to pay close attention. The current emphasis by the federal government is on reining in costs and increasing quality by decreasing volume of unnecessary procedures, so it is inconceivable that studies like this will go unnoticed.
I would not be surprised to see carriers re-evaluating the indications for coverage and not authorizing or denying procedures. Consequently, surgeons will do less of these. (This is similar to what happened to tonsillectomies decades ago.)
Since comparative effectiveness research is being increasingly funded we can expect to see quite a few more such studies in the future. Also, we can expect faster action as a result of such studies in the near future.
A new payment commission, the independent payment advisory board (IPAB) — coming out in 2015 — will be dedicated to making decisions about cuts in Medicare payment, and this is a good example of the type of service that could be cut.
This kind of news also reaches the public and patients will have begun to ask why they need this more complicated surgery when a risk-benefit analysis does not seem to justify using complex fusion over simple fusion or decompression alone.•