Treasurer
Gunnar B. J. Andersson, MD, PhD, USA

Michael Ogon, MD, Austria

Hee Kit Wong, MD, PhD, Singapore

Jeffrey Goldstein, MD, USA

Immediate Past President
Jean-Charles LeHuec, MD, France

ISASS Past Presidents

Thomas Errico, MD, USA

Chun-Kun Park, MD, PhD, South Korea

Karin Büttner-Janz, MD, PhD, Germany

Hansen A. Yuan, MD, USA

Stephen Hochschuler, MD, USA
Founding Member

Thierry Marnay, MD, France
Founding Member

Rudolf Bertagnoli, MD, Germany
Founding Member

(the late) Charles Ray, MD, USA
Founding Member

2013 Program Chairs

Overall Program Chair
Chris Bono, MD, USA

Basic Science Chair
Donna Ohnmeiss, DrMed, USA

Clinical Science Chair
Rick Sasso, MD, USA

MIS Chair
Rob Isaac, MD, USA

Poster Chair
Yu-Po Lee, MD, USA

Will Harms, MD, MBA
Medical Director of Medical Policy and Adjudication
Blue Cross & Blue Shield of Illinois
300 East Randolph Street
Chicago, Illinois 60601-5099

RE: Draft Medical Policy Number SUR712.036 – Lumbar Spinal Fusion

Dear Dr. Harms:

I am writing to you and Blue Cross and Blue Shield of Illinois on behalf of the International Society for the Advancement of Spine Surgery (ISASS). ISASS is an international, scientific, and educational society organized to discuss and assess existing strategies and innovative ideas in the clinical and basic sciences related to spine surgery to enhance patient care.

We are aware that BCBS of Illinois and HCSC are accepting comments on your recent proposed policy on lumbar spine fusion surgeries, and we appreciate the opportunity to comment.

While many patients with degenerative disc disease or facet syndrome will not have that diagnosis as their sole indication (which would disqualify them from fusions under your proposed policy), there are patients with chronic low back pain who have not responded to appropriate non-operative treatment and who will benefit from a surgical fusion procedure. With the promulgation of this policy, those patients may now lose the opportunity of a clinically meaningful improvement. Given that all patients are different, sweeping policy statements will exclude properly selected patients from receiving appropriate clinical care.

ISASS has specific concerns with your proposed policy as written. They include:

• The policy does not address the potential role of lumbar fusion for treatment of lumbar instability, apart from that accompanying spinal fracture (a medical necessity criterion). The policy also fails to address extensive decompression-associated instability; wide decompression and facetectomy(ies) (e.g. partial or complete removal of a large portion of bilateral facet joints) performed at the time of decompression may result in unavoidable destabilization and potentially result in predictable delayed deformity. Preoperative planning can usually identify such cases, though intraoperative analysis after decompression ultimately confirms the amount of supporting facet remaining. This type of instability during decompression procedures is a well-established indication for fusion and should be listed as a medically necessary indication for lumbar fusion.
• The policy does not include spondylolysis (without slippage) as a covered indication. Lumbar fusion for this diagnosis may be appropriate if it is accompanied by unremitting pain and other clinical signs and symptoms, as is often the case among athletic adolescents and young adults.
• The policy rules out access to lumbar fusion for patients with a sole indication of degenerative disc disease. Numerous studies (Fritzell, P., et al; CIGNA Medical Coverage Policy; Washington State Healthcare Authority) indicate that fusion may be appropriate for a subset of DDD patients suffering from pain after failed conservative care. Policies established by other carriers and agencies have instituted the following criteria to foster appropriate adoption of lumbar fusion for patients with DDD:1) Persistent debilitating pain despite a minimum of 6-months of non-surgical therapy, including psychosocial assessment and treatment, if warranted; and2) Focal disease – no more than 1-2 segment disease; and

  3) Evidence of DDD demonstrated on MRI, or concordant pain on provocative discography.

• The proposed policy does not adequately address the role of fusion for patients with degenerative spondylolisthesis with or without neurologic compromise. Degenerative spondylolisthesis is not listed as a diagnosis that may warrant fusion to address debilitating axial low back pain after inadequate response to conservative management. Patients with debilitating back pain due to degenerative spondylolisthesis should be eligible for fusion if they are unresponsive to all appropriate conservative care measures.

For recurrent, same level, disc herniation, the proposed policy would not permit fusion for patients who have an extruded disk fragment prior to 6-months after initial disk surgery. It appears that this 6-month cutoff is arbitrary, given the unpredictable course of post-discectomy healing, including temporal variability in the scarring and sealing of annular defects. This cutoff should therefore be removed from the policy so that patients with early disc re-herniation remain eligible for lumbar fusion after all non-surgical options have been exhausted.

Your proposed policy quotes a 2005 guideline for the performance of fusion procedures published by the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, which concluded that the evidence at that time was weak and which recommended the need for the neurosurgical community to design and complete prospective randomized trials to answer the many lingering questions with rigorous scientific power. What you did not quote from that guideline was the recommendation that fusion surgeries be considered as treatment options for carefully selected patients with disabling low back pain due to degenerative disease at one or two levels.

Your proposed policy also quotes a 2006 technology assessment by the federal Agency for Healthcare Research and Quality in which correctly concluded that there is 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 should be noted that it is unlikely that randomized controlled trials for this particular purpose will be specifically performed in populations older than 65 years old. Your policy omits the fact that AHRQ’s technology assessment 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.” In aggregate, all the studies show that there are patients who clearly benefit from spinal fusion surgery.

Despite overwhelming evidence in numerous scientific publications (SPORT, et al.), that clearly supports the need for spine fusion surgery for specific indications and in select patients, your proposed policy appears to be more closely linked to existing Milliman guidelines for spinal fusions, which are neither grounded in scientific literature nor vetted by surgeons. In fact, we reached out to two Illinois-based professional associations – the Illinois Neurosurgical Society, and the Illinois Society of Orthopedic Surgeons – both of which were unaware of this new proposed policy, and both of which indicated that their members were not involved in the creation or vetting of this proposed policy.

To that end, we would welcome an opportunity to work with you and HCSC to identify in-state surgeons to help develop and review policies that ensure appropriate patient access to medically indicated surgeries and procedures that will improve outcomes and positively change lives. We already have several Illinois-based surgeons who would be more than willing to work with BCBS-IL on this and other policies.

Finally, we are concerned that in this proposed policy, there appears to be 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 surgeons need to do a better job in selecting the appropriate patient for spinal fusions, insurers should refrain from using sweeping decisions that will unfairly deny patients access to needed care. By doing so a number of patients who would have significant clinical benefit will be excluded from that opportunity.

Thank you for your consideration of our comments. We very much look forward to hearing how you might respond to the issues raised herein.

Sincerely,

Steven Garfin, MD, USA
President

Relevant Citations:

Brox, J.I., Sørensen, R., Friis, A., Nygaard, Ø., Indahl, A., Keller, A., Ingebrigtsen, T., Eriksen, H.R., Holm, I., Koller, A.K., Riise, R., Reikerås, O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21.

CIGNA Medical Coverage Policy, Lumbar Fusion for Spinal Instability and Degenerative Disc Conditions. 1/15/2011]; Available from: Cigna.com.

Fairbank, J., Frost, H., Wilson-MacDonald, J., Yu, L.M., Barker, K., Collins, R. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ, 2005, May 28; 330 (7502):1233.

Fritz, J.M., R.E. Erhard, and B.F. Hagen. Segmental instability of the lumbar spine. Phys Ther, 1998. 78(8): p. 889-96.

Fritzell, P., et al. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976), 2001. 26(23): p. 2521-32; discussion 2532-4.

Hanley, E.N., Jr. and S.M. David. Lumbar arthrodesis for the treatment of back pain. J Bone Joint Surg Am, 1999. 81(5): p. 716-30.

Herkowitz HN, Sidhu KS. Lumbar Spine Fusion in the Treatment of Degenerative Conditions: Current Indications and Recommendations. J Am Acad Orthop Surg 1995;3:123-35.

Herkowitz HN. Spine update. Degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976) 1995;20:1084-90.

Kwon, B.K., et al. Indications, techniques, and outcomes of posterior surgery for chronic low back pain. Orthopedic Clinics of North America, 2003. 34(2): p. 297-308.

Moliterno, J.A., et al. Results and risk factors for recurrence following single-level tubular lumbar microdiscectomy. J Neurosurg Spine. 12(6): p. 680-6.

Polly, D.W., Glassman, S.D., Schwender, J.D., Shaffrey, C.I., Branch, C., Burkus, J.K., Gomet, M.F. Lumbar Spine Study Group. SF-36 PCS Benefit-Cost Ratio of Lumbar Fusion Compression to Other Surgical Interventions: a thought experiment. Spine 2007; 32(11S); S20-S26.

Reitman, C.A. and S.I. Esses. Direct repair of spondylolytic defects in young competitive athletes. Spine J, 2002. 2(2): p. 142-4.

Resnick DK, Choudhri TF, Dailey AT, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: fusion in patients with stenosis and spondylolisthesis. J Neurosurg Spine 2005;2:679-85.

Resnick DK, Choudhri TF, Dailey AT, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg Spine 2005;2:686-91.

Sonntag, V.K. and F.F. Marciano. Is fusion indicated for lumbar spinal disorders? Spine (Phila Pa 1976), 1995. 20(24 Suppl): p. 138S-142S.

Washington State Healthcare Authority. Health Technology Clinical Committee, Findings and Coverage Decision, Lumbar Fusion. 2/15/2008 [cited 11/22/2010]; Available from: www.hta.hca.wa.gov.

Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. Jama. 2006;296:2441–50.