“Spinal fusion is considered not medically necessary when the sole indication is disc herniation, DDD, facet syndrome, or initial discectomy and/or laminectomy for neural structure decompression.”
So says Blue Cross Blue Shield of Illinois (BCBSI) in a May 14, draft medical policy summary. The reason? “Lack of evidence of improved outcomes.” Within hours, spine surgeons were online alerting colleagues.
“This is a new draft policy for public comments. It is by no means a final policy, ” BCBSI’s media and public affairs manager told us in an email on May 17.
Health Care Service Corporation (HCSC) operates the Blue Cross and Blue Shield plans in Illinois, New Mexico, Oklahoma, and Texas, employing more than 16, 000 people and serving more than 13 million members. It is the fourth largest health insurance company in the country.
Death by a Thousand Increments
Illinois’ BCBSI is just the latest. Blues in North Carolina, Florida and Minnesota have placed new restrictions on backs of policyholders whose physicians have recommended spine fusion surgery. The insurers have responded to the ensuing outcry from physician societies by walking back the more onerous portions of the proposed restrictions, but not back to where the original policy started. Call it death by a thousand increments.
Milliman Care Guidelines
The Blues in North Carolina made the same proposal in 2010 and, in June 2011, a Local Coverage Determination (LCD) in Florida, citing Milliman Care Guidelines said that Medicare will no longer cover multi-level lumbar fusion for symptomatic degenerative disc disease (DDD).
Milliman Company develops and produces “evidence-based clinical guidelines used by more than 1, 800 clients, including more than 1, 000 hospitals and 7 of the 8 largest U.S. health plans.” The guidelines are not peer reviewed and are developed internally.
In both cases, physician societies were able to convince the insurers to modify their proposals, slightly.
The Blues Proposal
In Illinois, BCBSI lists 11 conditions for which surgery may be considered necessary, in addition to the four “non-necessary” conditions noted above. They also listed three conservative non-surgical therapies which must be included before surgery will be considered.
The insurer listed a number of studies (see OTW Summary of the Proposed BCBSI Policy) to justify their proposal of limiting surgery and requiring additional non-surgical treatments.
Surgeon’s Push Back
Gunnar Andersson, M.D., Ph.D., and Frank Phillips, M.D. of Midwest Orthopaedics at Rush (Rush University Medical Center in Chicago) are deeply concerned.
Disappointing Literature Review by Insurers
Gunnar Andersson, M.D., Ph.D.“There is a tendency to select those studies that support your opinion and deselect others” noted Dr. Andersson. “There is also a tendency to lump all patients together and make sweeping decisions regarding groups of patients some of who would respond very well to fusion treatments and others who probably would not. So while we need to make a better job in selecting the appropriate patient as surgeons the insurers should refrain from using sweeping decisions. By doing so a number of patients who would have significant clinical benefit will be excluded from that opportunity.”
Of course, added Dr. Andersson, the scientific community is struggling with how to best treat chronic back pain and degenerative disc disease.
“There are several reasons for this, ” said Andersson. “One is pain itself, which when it becomes chronic does not always have a specific anatomic cause. Another is the fact that many of our patients are different and therefore unlikely to all respond to the same treatment. I’m not surprised that the insurers are challenging the use of spinal fusions for treatment of chronic back pain. The numbers of fusions are increasing and the costs are increasing even faster making a legitimate target for the insurance companies when they are trying to reduce their costs.”
However, he said he is disappointed at how insurers are reviewing the literature.
“Non-Transparent, Non-Validated Guidelines”
Frank Phillips, M.D.Dr. Phillips said there is no doubt that everyone should strive towards more efficient delivery of health care. “However the use of non-transparent, non-validated guidelines to direct treatment decisions is not in our patients best interests.”
“The insistence that surgical treatments be compared to non-surgical therapies represents the wrong paradigm. These should not be viewed as competitive treatments as they are typically applied in series rather than in parallel. For most conditions, and in particularly the treatment of low back pain, surgery should only be considered after failure of appropriate non-surgical interventions.”
Considerable Evidence Supporting Fusion
Phillips said there is a considerable body of literature supporting the premise that fusion can reduce pain and disability in the treatment of low back pain from DDD in carefully selected patients. He added, “In addition to the surgical versus non-surgical trials mentioned in the BCBSI statement, data from Level 1 studies comparing various surgical strategies (including the U.S. IDE TDR FDA Trials) have been published supporting effectiveness. Furthermore numerous high quality non-randomized trials should be considered as part of the evidence base.”
Societies Respond
Steven Garfin, M.D.Chicago is also home to the largest spine surgery societies: North American Spine Society (NASS), American Academy of Orthopaedic Surgeons (AAOS) and The International Society for the Advancement of Spine Surgery (ISASS).
ISASS President Steven Garfin, M.D., provided OTW with a statement that BCBSI was basically cherry picking evidence that supports their view and ignores evidence that recommends 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.
NASS is reviewing the BCBSI policy and will submit its comments by the May 31st deadline.
ISASS Rebuttal (Steven Garfin, M.D., President)
BCBSI’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.
BCBSI 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 BCBSI 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 BCBSI 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 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. 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.
NuVasive’s Lukianov – “A New Reality”
Alex LukianovAlex Lukianov, chairman and CEO of NuVasive, Inc. said he believes that what we are seeing in Illinois is an unintended consequence of “Obamacare” [The Affordable Care Act], whereby payers are deeply concerned about their future bottom line and taking steps to improve it now.
“Given the forthcoming changes associated with Obamacare, [resulting] in higher costs to payers as well as their subscribers, the payers are playing a financially driven game of reducing access to needed spine surgery, ” observed Lukianov.
Lukianov says that this is unfortunately the new reality in terms of what it will take to get appropriate surgical spine care in the U.S.
Un-vetted Milliman Guidelines
“Despite overwhelming evidence in the form of the HTA [Health Technology Assessment] and various other scientific publications (SPORT, et al.), which clearly support the need for spine surgery for specific indications. The BCBSI requirements are more closely linked to the Milliman style guidelines, neither of which are grounded in scientific literature or vetted by surgeons, ” continues Lukianov
Lastly, Lukianov feels the spine market has bottomed out versus growing in the U.S. “The ongoing attacks by payers have created a surgery lag effect. Patients still get treated albeit later rather than sooner. This lag effect is largely factored into spine market growth projections.”
End Game
If history is a guide, the surgical societies, physicians and their patients will hammer at Blue Cross Blue Shield until May 31. Then the insurer will announce modifications to their proposal based on evidence of their choosing and declare themselves reasonable and flexible.
In the meantime, more patients will have to endure non-surgical treatments until they meet the new guidelines. That is the new reality as the science of spine care continues to search for the elusive pain generator of lower back pain.
OTW Summary of the Proposed Blue Cross Blue Shield of Illinois Policy
Intervertebral disc pain is a potential cause of low back pain [LBP]…There is a lack of consensus in the medical literature as to what extent the intervertebral disc is innervated.
The vast majority of cases of chronic LBP do not require surgery, and conservative non-surgical treatment will nearly always be tried first.
National survey data indicate that the number of spinal fusion operations rose 77% between 1996 and 2001, in contrast with hip replacement and knee arthroplasty, which increased 13-14% during the same period (UW Med Report 2004).
Treatment for lumbar disc disorders is controversial. The relationship between an abnormal disc and neural dysfunction does not correlate statistically with the imaged pathology. Biochemical and inflammatory factors play primary roles.
Biological influence of a disc herniation is expected to change over time and to be altered by passive and active non-surgical interventions (Wheeler et al. 2011).
A 1992 review by Turner et al. could find no randomized trials of fusion. Combining many studies of fusion performed for many different clinical indications, they found an average of 68% of patients reported a satisfactory outcome. A 1999 Cochrane review (Gibson et al.) concluded that at that time there was no acceptable evidence of any form of fusion for degenerative lumbar spondylosis, back pain, or “instability.” The authors could find no randomized clinical trials (RCTs) comparing fusion to a nonsurgical alternative, only trials which compared surgical techniques of fusion to each other.
In a 2004 article, Deyo and Mirza state that it is not clear whether some patients really benefit from spinal fusion compared to rehabilitative approaches, and the complication rate is relatively high compared to other types of back surgery and to non-surgical treatment.
In 2005, two spine surgeon societies (AANS/CNS [American Association of Neurological Surgeons/Congress of Neurological Surgeons]) found that many of the published studies had flawed results due to poorly defined outcome measures, inadequate numbers of patients, and comparison of dissimilar treatment groups (Heary 2005).
In 2005, Fairbank et al. conducted a multicenter randomized controlled trial to assess the clinical effectiveness of surgical stabilization (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain. Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.
In 2006, Maghout et al. concluded that increased use of intervertebral fusion devices after their introduction in 1996 was associated with an increased complication risk, without improving disability or reoperation rates.
In 2006, the Agency for Healthcare Research and Quality (AHRQ) concluded that there is no RCT evidence that directly compares lumbar spinal fusion with non-surgical conservative treatments in populations older than 65 years of age for any indication.
