CHICAGO – A study of Medicare patients shows that costlier, more complex spinal fusion surgeries are on the rise — and sometimes done unnecessarily — for a common lower back condition caused by aging and arthritis.
What's more alarming is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths.
"This is exactly what the health care debate has been dancing around," said Dr. Eugene Carragee of Stanford University Medical Center.
"You have one kind of operation that could cost $20,000 and another that could cost $80,000 and there's not good evidence the expensive one is being used appropriately in the majority of cases," Carragee said.
Add to that the expense for patients whose problems after surgery send them back to the hospital or to a nursing home and "that's not a trivial amount of money" for Medicare, said Carragee. He wrote an accompanying editorial in the Journal of the American Medical Association where the federally funded study appears Wednesday.
The cost to Medicare, just for the hospital charges for the three types of back surgery reviewed is about $1.65 billion a year, according to the researchers.
All the patients in the study had stenosis in their lower backs, a painful squeezing in the spine that's most common in people over 50. The researchers compared the risks for three different types of surgery for the condition: decompression, simple fusion and complex fusion.
"All operations aren't the same and some seem to be associated with higher complication rates than others," said lead author Dr. Richard Deyo of Oregon Health and Science University in Portland. "It's not necessarily true that the more aggressive surgery is better, at least in terms of safety."
There's little agreement about the best way to treat chronic lower back pain, and much depends on what's causing the pain.
Patients should ask their doctors about alternatives to complicated operations, Deyo said. Could steroid injections and physical therapy be tried? Would a simple decompression procedure be as helpful as a spinal fusion and with less risk?
In a decompression procedure, the simplest method in the Medicare study, a surgeon cuts away part of the bone that's painfully pressing on nerves. It can cost about $30,000 in hospital and surgeon fees.
For a fusion, a surgeon binds two or more vertebrae together using a bone graft, with or without plates and screws. The researchers defined a complex fusion as one involving three or more vertebrae or more than one side of the spine. Fusions cost $60,000 to $90,000.
The researchers analyzed data on more than 32,000 Medicare patients who had one of the three types of surgeries in 2007.
About 5 in 100 patients who had simple or complex fusions suffered major complications such as stroke compared to 2 in 100 with decompressions. The risk of death within 30 days after surgery was different too: 6 in 1,000 for complex fusions compared with 5 in 1,000 for simple fusions and 3 in 1,000 for decompressions.
The study didn't address how successful the various types of surgeries were at relieving pain.
More than half the patients who had complex fusions had a simple stenosis, which usually calls for decompression alone. They did not have the curvature of the spine or a slipped vertebra — additional conditions that might suggest a fusion is needed. There's not much evidence for doing a complex fusion for a person with simple stenosis, Carragee and other experts said.
"It certainly looks like there's more complex surgery being done than we have very good evidence to support," Carragee said.
Rates of complex fusions in Medicare patients rose 15-fold from 2002 to 2007, while decompressions and simple fusions declined, the study found. Although the overall procedure rate fell, hospital charges grew 40 percent.
Aggressive marketing of devices used in complex fusions is likely playing a role in the increase, Deyo said. The marketing includes ads in medical journals and lectures by surgeons on the payroll of device manufacturers.
Allegations of kickbacks to spine surgeons for using products and questionable financial arrangements to doctors as consultants have plagued the multibillion-dollar industry. One company, Medtronic Inc., reached a $40 million settlement with the U.S. Justice Department in a whistleblower case that included allegations the company paid doctors to use its spine surgery products. The company denied any wrongdoing.
Dr. Charles Rosen, a spine surgeon at the University of California, Irvine, founded the Association for Medical Ethics to nudge doctors toward scientific evidence over vested interests. Forty-nine spine surgeons have joined, pledging to refuse any type of compensation or earnings from companies for using a product.
Rosen applauded a provision in the new health care law that requires device makers and others to file annual reports to the government on their financial ties to doctors. Patients will be able to look up possible conflicts in a government database.
"Too much fusion surgery is done in this country and often for inappropriate reasons," Rosen said. While complex fusions are needed for some conditions, he said, patients "should not hesitate to get a second opinion."