Lumbar spinal stenosis affects 8 percent to 11 percent of people in the United States; by 2021, around 2.4 million Americans are expected to have spinal stenosis. The typical spinal stenosis sufferer is more than 50 years old and can present with varying degrees of the disease. For years, there were two options for treating spinal stenosis patients: a simple decompression or decompression and spinal fusion.
The two most common treatment options are at the opposite ends of the spectrum. A simple decompression can provide the patient with temporary pain relief, but often eventually that patient will need additional procedures including redecompression and often the addition of spinal fusion. However, moving to a fusion too quickly limits the patient's range of motion and puts them at risk for adjacent segment disease.
"Clearly lumbar spinal stenosis is very prevalent," says Hallett Mathews, MD, MBA, executive vice president and chief medical officer for Paradigm Spine. "It's a huge part of the aging population. We are healthier, more active and we want to do our athletics and aerobics. But certain people have progressive degenerative diseases, which makes it difficult to engage in everyday activities; sometimes people can't even walk to the mailbox. When conservative care fails, patients have the choice of continuing on that path or undergoing surgery. But not all patients need the most aggressive treatment; everyone needs a different thought process for stenosis management."
In the article "Spine surgery for patients in the transition zone" published on the Becker's Spine Review website on Nov. 10, 2016, Todd H. Lanman, MD, of Beverly Hills, Calif.-based Lanman Spinal Neurosurgery, discussed the middle section between the decompression and fusion — the "transition zone."
New solutions are emerging for patients in the transition zone: disc replacement, and interlaminar stabilization. Both solutions are more permanent options to alleviate the patient's pain and preserve motion. Based on his experience, Dr. Mathews sees spinal stenosis patients fall on a bell curve; around 20 percent need a simple decompression and 20 percent require fusion, but the 60 percent in the middle may be candidates for interlaminar stabilization.
In 2012, the FDA granted pre-market approval to Paradigm Spine's coflex® Interlaminar Stabilization® device designed to fit at one or two contiguous levels in the L1-L5 interlaminar space. There is strong evidence published in the literature to support the clinical outcomes, proving equal or superior to the other available treatment options. For the pre-market approval, the company examined 344 patient outcomes, with a 90 percent follow-up rate. The data shows:
1. A 57.6 percent success rate for interlaminar stabilization and 46.7 percent success rate for fusion; the study authors defined success as patients who reported Oswestry Disability Index scores of 15 or more and who didn't undergo a second intervention.
2. Important clinical success of stenosis surgical management — described as the absence of adjacent level issues and maintaining foraminal height — was 36.6 percent in the interlaminar stabilization group and 35.6 percent in the fusion group.
3. When considering the lack of fusion in the interlaminar stabilization cohort and successful fusion in the fusion cohort, the composite clinical success rate was 42.7 percent in the interlaminar stabilization group and 33.3 percent in the fusion group.
The study was published in a 2015 issue of the International Journal for Spine Surgery. The company's five-year data also supports decompression and interlaminar stabilization as an effective treatment for patients with moderate to severe spinal stenosis.
"If you can define the patient group, the evidence is clear that moderate to severe spinal stenosis patients — those with a high VAS and ODI scores — can do well with interlaminar stabilization," says Dr. Mathews. "If you select the right procedure, you can do better than the Medicare data set showing simple decompression and spinal fusion, both of which have about a 9 percent per year failure rate. The coflex device has a lower overall failure rate."
Until recently, payers also existed within the two-bucket system, creating a reimbursement framework around simple decompression or fusion with nothing in between. However, since Paradigm Spine achieved FDA approval for coflex, interlaminar stabilization has gained traction among surgeons across the country, and payers are taking notice. CMS granted interlaminar stabilization new reimbursement codes for 2017 in ambulatory surgery centers and third-party payers may be expected to follow. With the payment codes intact, surgeons can take the procedure to an outpatient ASC for additional clinical quality and reduced costs when the patient is appropriately indicated.
"The rules changed in 2015 and now in 2017 we can see a significant policy shift toward traditional procedures that were only being done in the inpatient setting going into the outpatient setting," says Dr. Mathews. "It's a pivot shift from everything being inpatient and nothing allowed outpatient to CMS realizing that there is safety and efficacy in the procedure. Now patients and surgeons may have the ability to choose the site of service that fits their medical preference and needs."
The new codes for interlaminar stabilization and final ASC payment indicator are:
1. CPT 22867: Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar, single level: $10,541
2. CPT 22868: Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar, second level: Packaged, no separate payment
3. CPT 22869: Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar, single level: $10,541
4. CPT 22870: Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level: Packaged, no separate payment
By comparison to the inpatient setting, reimbursement for some spinal fusions in the ASC setting covers less of the procedure. CMS de-emphasizes spinal fusion with their new reimbursement policy — providing less for these materials-heavy procedures with the potential for re-operations — and places emphasis on motion-sparing surgeries such as interlaminar stabilization.
Milliman recently prepared a report titled "Utilization and Cost of Surgery for Lumbar Spinal Stenosis in a Commercially Insured Population" which found if decompression and interlaminar stabilization replaced 20 percent to 40 percent of the primary lumbar fusion surgeries, there would be around $1.77 in savings per member per month.
However, Dr. Mathews notes the patient's safety and medical conditions must dictate the site of service over any financial considerations. ASCs have proven to all stakeholders that safety, quality, and lower costs are possible for spinal procedures. "There is no doubt that the wrong procedure on the wrong patient at the wrong site of service doesn't benefit anyone," he says. "If one is able to have the choice of site of service, have input on where the procedure is done, and their anesthesiologist and internist think their procedure could be safely done in the outpatient ASC, then the coding changes open up that opportunity."
This article is sponsored by Paradigm Spine.