HCSC/BCBSIL’s draft policy is moderately onerous in the sense that most indications for a spinal fusion are still covered. The areas where lumbar spinal fusions procedures “are not considered medically necessary” include patients where the sole indication is a disc herniation or neuro structure compression (initial discectomy/laminectomy) “as well as” degenerative disc disease and facet syndrome. This is the area where the primary controversy exists.
While many patients with degenerative disc disease or facet syndrome will not have that diagnosis as their sole indication, there are patients with chronic low back pain who have not responded to appropriate non-operative treatment and who will benefit from a surgical procedure. Those patients may now lose the opportunity of a clinically meaningful improvement. Given that all patients are different, sweeping policy statements can exclude appropriate patients from appropriate clinical care.
HCSC/BCBSIL bases their decision on the “lack of evidence of improved outcomes for spinal fusions.” There are six randomized controlled trials of fusion surgery versus nonsurgical therapy of which HCSC/BCBSIL reviews. In addition there are at least 15 publications comparing prospectively in randomized trials fusion surgery versus a different fusion technique or lumbar arthroplasty. There are also retrospective controlled trials, prospective non-comparative cohort studies and studies of surgery only cohorts.
Except for one retrospective cohort study, these other studies are not considered. Instead HCSC/BCBSIL quotes a study from 1992 which states that there were no randomized trials of fusion which is correct and another study from 1999 which also did not find any randomized controlled trial which is also correct.
They also quote a guideline for the performance of fusion procedures published by the American Association of Neurological Surgeons and the Congress of Neurological Surgeons in 2005 which concluded that the evidence at that time was weak and recommend the need for the neurosurgical community to design and complete prospective randomized trials to answer the many lingering questions with rigorous scientific power.
What they did not quote was the recommendation from the guideline that fusion surgery be considered as treatment options for carefully selected patients with disabling low back pain due to degenerative disease at one or two levels.
They also quote a technology assessment by the Agency for Healthcare Research and Quality (AHRQ) in 2006 which correctly concluded that are no randomized controlled trial evidence that directly compares lumbar spinal fusion with nonsurgical conservative treatments in populations older than 65 years of age for any indication. It is unlikely that randomized controlled trials for this particular purpose will be specifically performed in populations older than 65 years.
However, AHRQ also concluded that “lumbar fusion may result in some benefit compared with conservative treatment in middle age patients with axial back pain who have severe disability or pain from disc disease”. This statement was not included in the reviews. In aggregate all the studies show that there are patients who clearly benefit from spinal fusion surgery. It is also true that not all patients require surgery.
ISASS will provide a formal response to HCSC/BCBSIL prior to the May 31, 2012 deadline, including our evidence based policy statement on lumbar fusion to help inform the insurer. Additionally, we will alert the membership in Illinois, New Mexico, Oklahoma, and Texas asking them to get involved in the process of drafting a medical policy which is in the best interest of patients with chronic back pain.
Steven Garfin, MD
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