Medical Device Daily Associate

Insurance companies favor fusion surgery over back pain management therapies, according to a recent panel of orthopedic surgeons, interventional radiologists, physiatrists, and pain management specialists from leading academic centers nationwide.

Yet fusion surgery often is more than 10 times costlier than other methods of managing chronic discogenic lower back pain. The panel discussed and examined pain management strategies from medical specialties that routinely work with patients suffering from chronic lower back pain.

The panel was conducted by MedPanel (Cambridge, Massachusetts), an online medical market research company that convenes online physician panels to gain insights into various healthcare and clinical issues.

The discussion was sponsored by the American Society of Interventional Pain Physicians (ASIPP; Paducah, Kentucky) and Smith & Nephew Endoscopy (S&N; Andover, Massachusetts).

In discussing their treatment options for patients with chronic discogenic lower back pain, panelists agreed that the first course of treatment should always be physical therapy and/or chiropractic, muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs).

If the patient doesn’t respond to these treatments in four to six weeks, most of the panelists agreed that minimally invasive procedures should be considered. Panelists also agree that the last treatment to consider is fusion surgery, which fuses two or more damaged discs together, reducing or eliminating pain, but can also cause potential complications such as nerve damage and treatment failure.

The panel of physicians concluded that there is a bias toward the higher-cost fusion surgery option. This bias is the result of several factors – in particular, insurance companies opting to pay for more invasive treatments, rather than minimally invasive or pain management procedures, even though those pain management protocols and procedures are considerably less expensive and may be more clinically relevant.

David Kloth, MD, president of ASIPP and an interventional pain physician at Danbury Hospital (Danbury, Connecticut), expressed surprise that private insurers are so willing to reimburse fusion surgeries, which can run anywhere from $50,000 to $70,000, depending on how many levels of the spine are fused.

“For years, surgeons have done these big back operations with very little proof and evidence that they really do anything,” he told Medical Device Daily. “Yet, the surgeons do 200,000 [lumbar fusions] a year.”

He said that so far there have been no good randomized controlled studies to determine how effective these lumbar fusion procedures are. And while Kloth said some of these procedures are indicated, many are not.

A 1999 study in the Journal of the American Medical Association titled, “Avoiding the Unintended Consequences of the Growth in Medical Care,” bears out these findings, as do market data, according to the physicians panel.

The study found that while many believed that more medical care must lead to improved health and well-being, this thinking also has led to more expensive surgical procedures.

By comparison, a considerably less expensive, but effective and less-invasive procedure called intradiscal electrothermal therapy (IDET) costs about $7,000, but only between 5,000 and 7,000 of these procedures are performed each year.

IDET is sold by Smith & Nephew Endoscopy, but the procedure has not caught on though it is substantially less expensive, less invasive and reversible, un-like a fusion surgery.

S&N’s IDET procedure is for those who have failed a program of aggressive non-operative therapy. During the procedure, controlled levels of thermal heat are applied to the affected disc to contract and thicken the collagen fibers within the disc wall, potentially closing the cracks and tears and cauterizing the tiny nerve endings that cause the pain.

Kloth attributed the lack of uptake of the IDET and other less-invasive surgical procedures, in contrast to the substantial amount of fusion surgeries, to the fact that many orthopedic surgeons don’t want to give up any of the revenues that they can attain from the lucrative surgical procedure in which they stand to make up to nearly $40,000 for a single operation. Thus, they will not refer patients for the procedure even though it may be in the best interest of the patients.

“There is a huge financial incentive for surgeons not to see [IDET] done on a routine basis,” he said. However, Kloth noted that surgeons also may be less likely to refer patients for IDET because they are not familiar with it, and he acknowledged that the minimally invasive procedure is not for everyone. “I will tell you that the patients I see who have disc problems, more times than not I have to turn them away from these minimally invasive surgeries because they’re not a candidate because of their specific anatomy.”

Initially, Kloth said that perhaps some minimally invasive techniques such as IDET were first done on patients that perhaps were not good candidates for the procedures, but over the last six or seven years, “we’ve certainly refined [the population] and it’s much better.”

He defined a “good” candidate for IDET as someone with good disc height (70% or greater), no instability, no significant modic endplate changes and no sizeable disc herneations

Obviously, the cost of an IDET procedure vs. a lumbar fusion also is an issue that needs to be debated, and Kloth said he remains puzzled as to why more insurance carriers aren’t covering a procedure that costs nearly 10 times less than its more radical surgical cousin.

“Even if you take some of the worst [IDET] studies,” he said, “it’s still got a 50% success rate, so if 50% of the people get better without needing a $50,000 operation, it’s not hard to run those statistics and say ‘wait a minute, you would save millions of dollars if you did this on a cohort of patients.’”

He pointed out that “even if you fail at IDET, you can always go to fusion, [whereas] if you fail a fusion, you’re really up the creek,” which typically means having to do another fusion procedure at another level of the spine or having a spinal stimulation device implanted.

Kloth said he believes that patients should definitely get a second opinion before having a fusion done, adding that he thinks insurance companies, who are known for their desire to keep costs to a minimum, will come around to the notion that trying out the less-costly alternative first might be better for the bottom line.

“I think what you’re going to see five years from now are that the insurance companies are actually going to mandate a pain-management evaluation before you have a lumbar fusion,” he said.

While some have argued that the IDET’s success rate is not very good and has not been borne out long-term in studies, Kloth said that from personal experience he beli-eves that the right candidates can benefit from it. He pointed out that while some private insurers still will not pay for it, workers compensation in Connecticut, where he practices, “routinely” pays for these surgeries because “they know my return-to-work rate with the treatments that I do with these aggressive minimally invasive surgeries is 75%. Historically, fusion success return-to-work is 25%.”

One positive sign for IDET is the recent news that the Centers for Medicare & Medicaid Services (CMS; Baltmore) has increased reimbursement for the procedure, placing it in a more appropriate Ambulatory Payment Classification (APC).

The new reimbursement classification appears in the final rule for the Medicare Hospital Outpatient Prospective Payment System for 2006. Under the re-classification, CMS will reimburse $1,424.50 for the procedure in 2006, in place of the 2005 payment level of $622.43 (Medical Device Daily, Dec. 27, 2005).

Participants in the panel discussion included pain management specialists, spine surgeons, interventional radiologists and physiatrists from various institutions such as the Albany Medical College (Albany, New York), the Cleveland Clinic (Cleveland), Columbia University (New York), Johns Hopkins Hospital (Baltimore), Rush Presbyterian-St. Luke’s Medical Center (Chicago), Mayo Clinic (Jacksonville, Florida), UCLA/Cedars-Sinai Institute for Spinal Disorders (Los Angeles) and Stanford University Medical Center (Palo Alto, California).

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