LCD/NCD Portal

L32074

 

LUMBAR SPINAL FUSION FOR INSTABILITY AND DEGENERATIVE DISC CONDITIONS

 

 

01/01/2013

 

 

Indications and Limitations of Coverage and/or Medical Necessity

• The presacral interbody technique (CPT codes 0195T, 0196T, 0309T, and 22586) (e.g., AxiaLIF) is noted in a separate LCD, titled Noncovered Services, and, therefore, is not a covered service.

• However, this LCD does not address lumbar spinal fusion techniques, devices, instrumentation, or bone graft substitutes.

• Some of the emerging techniques and associated tools (devices, spinal instrumentation, bone graft substitutes, etc.) are investigational, and this LCD does not endorse such procedures.

• The scope of this LCD is the indications and medical need of Lumbar Spinal Fusion for instability and degenerative disc conditions.

• Prior to elective fusions, co-morbidities to be considered include:

o The patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to planned surgery, or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted.

o Cognitive, behavioral, or addiction issues are identified.

o Documentation should support assessment and treatment prior to surgical management.

o Weight reduction as appropriate.

• Any historical data supporting the medical necessity for the fusion:

o Duration and Outcomes of physiotherapy.

o Injection therapy.

o Anatomic factors influencing the decision for surgery, etc.

• Must be included in the inpatient medical record as noted in the:

o History and physical examination.

o Operative note.

o Copies of office notes.

 

For example, fusion of iatrogenic instability (i.e., surgical resection of facet as essential portion of the required decompression rendering an unstable segment) should be documented in a pre-operative note and/or an operative note.

 

• Any major procedure has significant benefit and risk (injury or death) that the treating physician discusses with the patient.

• To meet Medicare’s reasonable and necessary (R&N) threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives & the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition).

• Lacking compelling arguments for an exception in the supporting documentation, the hospital (FISS claim) and physician services (MCS claim) can be denied.

• If in certain circumstances the patient does not meet all of the required criteria outlined in the local coverage determination (LCD) for a procedure, but the treating physician feels that the procedure is a covered procedure given the current standards of care, then the documentation must clearly outline the patient’s episode of care that supports the major procedure and must clearly address the reason(s) for coverage.

• For example, if clinical findings (or lack of) for an indication are not consistent with the LCD criteria, it should be directly addressed in the pre-procedure documentation.

• For example, if certain conservative therapies are not necessary for a given patient, it should be directly noted in the pre-procedure documentation.

• For example, if lumbar fusion for multiple levels for pure DDD is the planned intervention, the pre-procedure documentation should address this debated indication.

• The clinical judgment of the treating physician is always a consideration if clearly addressed in the pre-procedure record and if consistent with the episode of care for the patient as documented in patient records and claim history.

• When reviewing claims for procedures with DRGs, the CMS Online Manual, Pub. 100-08, Chapter 6, Section 6.5.2 states the following:

o Review of the medical record must indicate that inpatient hospital care was medically necessary, reasonable, and appropriate for the diagnosis and condition of the beneficiary at any time during the stay.

o The beneficiary must demonstrate signs and/or symptoms severe enough to warrant the need for medical care and must receive services of such intensity that they can be furnished safely and effectively only on an inpatient basis.

 

 

Indications:

• Spinal fusion should only be considered as a last step in the treatment of chronic back pain and is not indicated for most persons suffering from back pain.

 

Lumbar spinal fusion surgery may be considered medically necessary and covered for the following indications:

 

I. Lumbar spinal instability for ANY of the following indications when confirmed by appropriate diagnostic testing (e.g., radiographic imaging, biopsy, bone aspirate, bone scan and gallium scan):

• Acute spinal fracture.

• Progressive or significant acute neurological impairment (e.g., increased weakness or bladder instability)

• Neural compression after spinal fracture.

• Epidural compression or vertebral destruction from tumor or abscess.

• Spinal tuberculosis.

• Spinal debridement for infection (e.g., osteomyelitis).

• Spinal deformity (examples include but not limited to idiopathic scoliosis over 40°, progressive degenerative scoliosis including spinal levels from the cranial to caudal ends of the deformity and the adjacent normal segment, and sagittal plane deformity + sagittal balance over 10cm).

 

II. Spinal stenosis for a single level (for example, L4-L5) with

• Associated spondylolisthesis (see classifications below in section III).

• Other documented evidence of instability (for example, facet joint instability [iatrogenic] related to decompression), AND symptoms of spinal claudication and radicular pain.

o The pain must represent a significant functional impairment despite a history of 3 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following:

 Activity lifestyle modification.

 Daily exercise.

 Supervised physical therapy (PT) (activities of daily living [ADLs] diminished despite completing a plan of care).

 Anti-inflammatory medications, oral or injection therapy as appropriate, and analgesics.

 

III. Spondylolisthesis manifested by back pain WITH OR WITHOUT spinal claudication, radicular pain, motor deficit when ANY of the following criteria are met:

• Confirmed progressive deformity usually Grade II or higher.

• Multilevel spondylolysis.

• Symptomatic low-grade spondylolisthesis associated with back pain and significant functional impairment despite a history of 3 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following:

o Activity lifestyle modification.

o Daily exercise.

o Supervised PT (ADLs diminished despite completing a plan of care).

o Anti-inflammatory medications.

o Oral or injection therapy as appropriate.

o Analgesics.

• Classification of slippage in spondylolisthesis is defined as follows:

o Grade I =1% to 25%.

o Grade II=26% to 50.

o Grade III=51% to 75%.

o Grade IV= 76% to 100%.

o Grade V = spondyloptosis and occurs when the L5 vertebra completely slides over the top of the sacrum.

 

IV. Degenerative disc disease (DDD) in the absence of instability when all of the following criteria have been met as clinically appropriate for the patient’s current episode of care:

• Single level DDD demonstrated on imaging studies (e.g., CT scan, MRI, or discography) as the likely cause of pain.

• The case specific indications for two level or the rare three or more level planned fusion procedure must be directly addressed in the pre procedure record with clinical correlation to diagnostic testing results (such as disk-space narrowing, end plate changes, annular changes, etc.).

• Pain and significant functional impairment despite a history of at least 6 months of conservative therapy (non-surgical medical management) as clinically appropriate addressing the following:

o Anti-inflammatory medications, oral or injection therapy as appropriate, and analgesics.

o Daily exercise.

o Activity lifestyle modification.

o Weight reduction as appropriate.

o Supervised PT [ADLs diminished despite completing a plan of care].

OR

o Unsuccessful improvement after completion of intense multidisciplinary rehabilitation (IMR). IMR is defined as onsite program that includes supervised PT, cognitive behavior component, and other coordinated interventions by health care professionals.

 

V. Lumbar fusion following prior spinal surgery for the following:

• Recurrent disc herniation despite clinically appropriate post-operative nonsurgical medical management (post-operative case specific conservative therapy is prescribed as clinically appropriate in addition to documentation of pain and functional impairment).

• Adjacent segment degeneration or disc herniation despite clinically appropriate post-operative nonsurgical medical management (post-operative case specific conservative therapy is prescribed as clinically appropriate in addition to documentation of pain and functional impairment).

• Associated spondylolisthesis (for example anterolisthesis) after prior spinal surgery with ALL the following as clinically appropriate:

o Recurrent symptoms consistent with neurological compromise.

o Significant functional impairment.

o Neural compression is documented by recent post-operative imaging.

o Unsuccessful improvement despite 3 months of clinically appropriate post-operative nonsurgical medical management (post-operative case specific conservative therapy is prescribed as clinically appropriate in addition to documentation of pain and functional impairment).

o Instability is documented by appropriate imaging.

o Patient had some relief of pain symptoms following the prior spinal surgery.

 

VI. Treatment of pseudoarthrosis (i.e., nonunion of prior fusion) at the same level after 12 months from prior surgery and ALL of the following are met (unless imaging demonstrates failed spinal instrumentation [for example, fractured rod or loosened screw):

• Imaging studies confirm evidence of pseudoarthrosis (e.g., radiographs, CT).

• Unsuccessful improvement despite 3 months of clinically appropriate post-operative nonsurgical medical management (post-operative case specific conservative therapy is prescribed as clinically appropriate in addition to documentation of pain and functional impairment).

• Patient had some relief of pain symptoms following the prior spinal surgery.

 

 

Limitations:

 

Lumbar spinal fusion for the following conditions is not considered medically necessary and is noncovered:

• When performed with initial primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without:

o Documented spondylolisthesis.

Or

o Documentation of instability. (e.g., documented intraoperative iatrogenic instability).

• Lumbar fusion at multi-levels (2 or more) for pure DDD unless case specific indications for two level or the rare three or more level planned fusion procedure is directly addressed in the pre-procedure record

 

 

Coding Information

 

Bill Type Codes

 

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

11x Hospital Inpatient (Including Medicare Part A)

12x Hospital Inpatient (Medicare Part B only)

 

 

Revenue Codes

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

0360 Operating Room Services - General Classification

0960 Professional Fees - General Classification

 

 

CPT/HCPCS Codes

 

22533 ARTHRODESIS, LATERAL EXTRACAVITARY TECHNIQUE, INCLUDING MINIMAL DISCECTOMY TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION); LUMBAR

22534 ARTHRODESIS, LATERAL EXTRACAVITARY TECHNIQUE, INCLUDING MINIMAL DISCECTOMY TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION); THORACIC OR LUMBAR, EACH ADDITIONAL VERTEBRAL SEGMENT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

22558 ARTHRODESIS, ANTERIOR INTERBODY TECHNIQUE, INCLUDING MINIMAL DISCECTOMY TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION); LUMBAR

22585 ARTHRODESIS, ANTERIOR INTERBODY TECHNIQUE, INCLUDING MINIMAL DISCECTOMY TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION); EACH ADDITIONAL INTERSPACE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

22612 ARTHRODESIS, POSTERIOR OR POSTEROLATERAL TECHNIQUE, SINGLE LEVEL; LUMBAR (WITH LATERAL TRANSVERSE TECHNIQUE, WHEN PERFORMED)

22614 ARTHRODESIS, POSTERIOR OR POSTEROLATERAL TECHNIQUE, SINGLE LEVEL; EACH ADDITIONAL VERTEBRAL SEGMENT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

22630 ARTHRODESIS, POSTERIOR INTERBODY TECHNIQUE, INCLUDING LAMINECTOMY AND/OR DISCECTOMY TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION), SINGLE INTERSPACE; LUMBAR

22632 ARTHRODESIS, POSTERIOR INTERBODY TECHNIQUE, INCLUDING LAMINECTOMY AND/OR DISCECTOMY TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION), SINGLE INTERSPACE; EACH ADDITIONAL INTERSPACE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

22633 ARTHRODESIS, COMBINED POSTERIOR OR POSTEROLATERAL TECHNIQUE WITH POSTERIOR INTERBODY TECHNIQUE INCLUDING LAMINECTOMY AND/ OR DISCECTOMY SUFFICIENT TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION), SINGLE INTERSPACE AND SEGMENT; LUMBAR

22634 ARTHRODESIS, COMBINED POSTERIOR OR POSTEROLATERAL TECHNIQUE WITH POSTERIOR INTERBODY TECHNIQUE INCLUDING LAMINECTOMY AND/ OR DISCECTOMY SUFFICIENT TO PREPARE INTERSPACE (OTHER THAN FOR DECOMPRESSION), SINGLE INTERSPACE AND SEGMENT; EACH ADDITIONAL INTERSPACE AND SEGMENT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

22800 ARTHRODESIS, POSTERIOR, FOR SPINAL DEFORMITY, WITH OR WITHOUT CAST; UP TO 6 VERTEBRAL SEGMENTS

22802 ARTHRODESIS, POSTERIOR, FOR SPINAL DEFORMITY, WITH OR WITHOUT CAST; 7 TO 12 VERTEBRAL SEGMENTS

22804 ARTHRODESIS, POSTERIOR, FOR SPINAL DEFORMITY, WITH OR WITHOUT CAST; 13 OR MORE VERTEBRAL SEGMENTS

22808 ARTHRODESIS, ANTERIOR, FOR SPINAL DEFORMITY, WITH OR WITHOUT CAST; 2 TO 3 VERTEBRAL SEGMENTS

22810 ARTHRODESIS, ANTERIOR, FOR SPINAL DEFORMITY, WITH OR WITHOUT CAST; 4 TO 7 VERTEBRAL SEGMENTS

22812 ARTHRODESIS, ANTERIOR, FOR SPINAL DEFORMITY, WITH OR WITHOUT CAST; 8 OR MORE VERTEBRAL SEGMENTS

 

 

 

Documentation Requirements

• Medical record documentation maintained by the physician must substantiate the medical need for lumbar spinal fusion surgery and must include the following:

o Office notes/hospital record, including history and physical by the attending/treating physician.

o Documentation of the history and duration of unsuccessful conservative therapy (non-surgical medical management) when applicable.

 Failure of non-surgical medical management can be historical and does not have to be under the direction of the operating surgeon.

o Interpretation and reports for X-rays, MRI’s, CT’s, etc.

o Medical clearance reports (as applicable).

o Documentation of smoking history, and that the patient has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted (if applicable).

o Complete operative report outlining operative approach used and all the components of the spine surgery.

 

 

Treatment Logic:

• Low back pain is a common disorder affecting 80% of people at some point in their lives.

• Causes stem from a wide variety of conditions, although in some cases no specific etiology is identified.

• Age-related intervertebral disc degeneration, typically resulting in degeneration of the discs themselves, facet joint arthrosis and segmental instability are causative factors.

• Initial management can include rest, exercise program, avoidance of activities that aggravate pain, application of heat/cold modalities, pharmacotherapy, local injections, lumbar bracing, chiropractic manipulation, and physical therapy.

• When conservative therapy (non-surgical medical management) is unsuccessful after at least 3 to 12 months, depending on the diagnosis, lumbar spinal fusion may be considered for certain conditions.

• The goal of lumbar spinal fusion, also referred to as lumbar arthrodesis, is to permanently immobilize the spinal column vertebrae surrounding the disc(s) that are causing the discogenic low back pain.

• Surgical techniques to achieve lumbar spinal fusion are numerous, and include different surgical approaches (anterior, posterior, lateral) to the spine, different areas of fusion (intervertebral body (interbody), transverse process (posterolateral), different fusion materials (bone graft and/or metal instrumentation), and a variety of ancillary techniques to augment fusion.

• Arthrodesis is usually performed for conditions that involve only one vertebral segment, however, it is necessary to fuse two segments in order to stop movement, which is referred to as a single level fusion.

• Lumbar fusion of more than a single level is not typically recommended except in some situations such as trauma, deformity, or for neoplasm.

• For the majority of Medicare population (age 65 or older) pure degenerative disc disease (DDD) without co-morbidities/co-diagnoses is rare and multilevel lumbar fusion in this population is not well studied.

• Prior to elective fusions, co-morbidities to be considered include

o The patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to planned surgery, or has received counseling on the effects of smoking on surgical outcomes and treatment for smoking cessation if accepted.

o Cognitive, behavioral, or addiction issues are identified.

o Documentation should support assessment and treatment prior to surgical management.

o Weight reduction as appropriate.

 

 

Sources of Information and Basis for Decision

 

Abbott, A., Tyni-Lenné, R., and Hedlund, R. (2010). Early rehabilitation targeting cognition, behavior, and motor function after lumbar fusion. Spine, 35(8), 848-857.

 

Aetna Clinical Policy Bulletin: Spinal Surgery: Laminectomy and fusion, # 0743. (2010).

 

American Academy of Orthopaedic Surgeons (AAOS). (2008). Position statement: The effects of tobacco exposure on the musculoskeletal system. Retrieved on 05/03/2011 from http://www.aaos.org/about/papers/position/1153.asp

 

Carreon, L., Glassman, S., & Howard, J. (2008).

 

Chou, R., Qaseem, A., Snow, V., Casey, D., Cross, T., Shekelle, P. and et al. (2007). Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medicine, 147, 7.

 

Chou, R., Loeser, J., Owens, D., Rosenquist, R., Atlas, S., Baisden, J., et al (2009). Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain. An evidence-based clinical practice guideline from The American Pain Society, 34 (10), 1066-1077.

 

Cigna Medical Coverage Policy. Lumbar fusion for spinal instability and degenerative disc conditions, # 0303. (2011)

 

CPT® Changes Archives: An Insider's View 2000-2011

 

Crawford, C., Smail, J., Carreon, L., & Glassman, S. (2011). Health-related quality of life after posterolateral lumbar arthrodesis in patients seventy-five years of age and older. Spine, 36, 1065-1068.

 

Deyo, R., Nachemson, A., & Mirza, S. (2004). Spinal-fusion surgery – The case for restraint. The New England Journal of Medicine, 350(7), 722-726.

 

FCSO LCD 32076, Lumbar Spinal Fusion for Instability and Degenerative Disc Conditions, 01/01/2013. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/ .

 

International Society for the Advancement of Spine Surgery (ISASS). (2011). Policy statement on Lumbar spinal fusion surgery

 

InterQual®2011 Procedures Adult Criteria, Lumbar spine fusion.

 

Kishner, S. & Keenan, M. (2011). Degenerative disk disease. Medscape. Retrieved on 05/04/2011 from http://emedicine.medscape.com/article/1265453-overview

 

Lettice, J., Kula, T., Derby, R.; Kim, B., Lee, S., & Seo, K. (2005). Does the number of levels affect lumbar fusion outcome? Spine, 30(6), 675-681.

 

McCrory, D., Turner, D., Patwardhan, M., & Richardson, W. (2006). Spinal fusion for treatment of degenerative disease affecting the lumbar spine. Technology Assessment (draft) prepared for the Agency for Healthcare Research and Quality (AHRQ) by Duke Evidence-based Practice Center. Retrieved on 05/04/2011 from http://www.cms.hhs.gov/determinationprocess/downloads/id41ta.pdf.

 

Milliman Care Guidelines®, Lumbar fusion. 2010.

 

North American Spine Society. (2007). Evidence-based clinical guidelines for multidisciplinary spine care. Diagnosis and treatment of degenerative lumbar spinal stenosis. Retrived on 05/03/2011 from http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx

 

North American Spine Society. (2008). Evidence-based guidelines for multidisciplinary spine care. Diagnosis and treatment of degenerative lumbar spondylolisthesis. Retrieved on 05/03/2011 from http://www.spine.org/Pages/PracticePolicy/ClinicalCare/ClinicalGuidlines/Default.aspx

 

Resnick, D., Choudhri, T., Dailey, A., Groff, M., Khoo, L., Matz, P., et al. (2005). Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 6: magnetic resonance imaging and discography for patient selection for lumbar fusion. Journal of Neurosurgery: Spine, 2, 670-672.

 

Resnick, D., Choudhri, T., Dailey, A., Groff, M., Khoo, L., Matz, P., et al. (2005). Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 7: intractable low-back pain without stenosis or spondylolisthesis.>i> Journal of Neurosurgery: Spine, 2, 662-669.

 

Schoelles, K., Reston, J., Treadwell, J., Nobel, M., & Snyder, D. (2007). Spinal fusion and discography for chronic low back pain and uncomplicated lumbar degenerative disc disease. ECRI Institute, Washington State Health Care Authority. Available at http://www.ecri.org

 

Wellmark Blue Cross and Blue Shield. (2010). Spinal Fusion, Medical Policy 07.01.49.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD LUMBAR SPINAL FUSION FOR INSTABILITY AND DEGENERATIVE DISC CONDITIONS