The Centers for Medicare & Medicaid Services has reported that it has opened a national coverage determination (NCD) for a minimally invasive low back pain treatment that it says costs about 10 times less than spinal fusion surgery.

Thermal intradiscal therapy for patients with chronic discogenic lower back pain has been around for almost 10 years, but has failed to catch on with surgeons, either because the insurance companies seem more willing to pay for more invasive treatments or because surgeons stand to lose income with a less costly, minimally invasive procedure alternative.

That was the finding of an expert panel that reviewed the issue two years ago (MDD, March 1, 2006).

In an unusual move, CMS said that it initiated the NCD internally, rather than following its usual protocol of responding to an outside requestor.

“We decided to open it up ourselves,” Marcel Salive, MD, MPH, director, Division of Medical & Surgical Services, in the CMS’ Coverage and Analysis Group, told Medical Device Daily. “We were hearing about the technology and had some information about it and thought it was a good topic to review. Some of the contractors had looked at it and raised some questions, but that we wanted to take a closer look at it.”

Thermal intradiscal therapy — such as intradiscal electrothermal annuloplasty (IDET), percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), or disc biacuplasty — is a minimally invasive treatment for patients with low back pain believed to originate in the disc. The procedure involves the insertion of a special wire or probes into the disc under imaging guidance through a small incision in the back. Heat is applied to the disc through the use of various energy sources, such as electrical or radiofrequency.

If the NCD is approved, one company especially stands to gain from the reimbursement coverage: Smith & Nephew (S&N, Andover, Massachusetts).

“CMS has grouped three or four distinct procedures under the umbrella of thermal intradiscal therapies,” said Barbara Rohan, VP of government relations for S&N’s Clinical Therapies Division in Memphis, Tennessee.

“S&N manufacturers the Spinecath Intradiscal Catheter, which is used to perform IDET. Currently, the Spinecath Intradiscal Catheter is the only device on the market that generates electrothermal energy for thermal intradiscal therapy. Any physician who is properly trained may perform this procedure. The term IDET, though, is a Smith & Nephew trademark.”

IDET is one of just a few interventional spinal procedures that has ever been studied in several randomized controlled trials, which is one reason why the American Medical Association (Chicago) created separate, distinct CPT codes for IDET. Those codes, according to S&N, were intended to distinguish IDET from similar procedures.

“Since the clinical evidence and clinical acceptance of each procedure differs, it is important that CMS consider each one according to its unique merits,” Rohan said. “We feel that the evidence supporting a positive decision for IDET is very strong.”

IDET has been discussed favorably in multiple evidence-based practice guidelines.

For example, the Evidence-Based Practice Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain of the American Society of Interventional Pain Physicians () noted that the evidence for IDET “was strong for short-term relief and moderate for long-term relief in managing chronic discogenic low back pain,” said Gail Daubert, partner with Reed Smith (Washington) and an attorney for S&N.

The panel that reviewed treatment options for chronic discogenic lower back pain, conducted by MedPanel (Cambridge, Massachusetts) in 2006, agreed that the first course of treatment for these patients should always be physical therapy and/or chiropractic, muscle relaxants and non-steroidal anti-inflammatory drugs. If a patient doesn’t respond to these treatments in four to six weeks, most of the panelists agreed that minimally invasive procedures should be considered and spinal fusion surgery should be used as a last resort.

The panel of physicians concluded that there is a bias toward the higher-cost fusion surgery option on the part of insurance companies choosing 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.

Spinal fusion surgery can cost $50,000 to $70,000, depending on how many levels of the spine are fused, compared to IDET, which costs an average $7,000.

An estimated 7,000 to 10,000 IDET procedures are performed annually in the U.S. by pain management physicians, interventional radiologists and spine surgeons.

Among the reported studies for IDET is a randomized, sham-controlled trial, which won the 2003 Outstanding Paper Award for Nonoperative Science from the North American Spine Society (Burr Ridge, Illinois).

Randomized, sham-controlled trials are rarely conducted for medical devices making this paper and this study all the more significant.

The American Academy of Orthopaedic Surgeons (Rosemont, Illinois) reports that there were 324,000 spinal fusion surgeries in 2005, the latest year for which data were reported.

The public comment period for the NCD will end on Feb.14, and the CMS is expected to issue an opinion by July 15.