**History/Background and/or General Information**

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

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 the
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.  
  
 **Covered  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:  
  
 **1.** 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 degrees, 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)

**2.** Spinal stenosis for a single level (for example, L4-L5) with associated
spondylolisthesis (see classifications below in section 3) or other documented
evidence of instability (for example, facet joint instability [iatrogenic]
related to decompression), AND symptoms of spinal claudication and radicular
pain. 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

**3.** 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: activity lifestyle modification; daily exercise; supervised PT (ADLs diminished despite completing a plan of care); and anti-inflammatory medications, oral or injection therapy as appropriate, and analgesics
  * Classification of slippage in spondylolisthesis is defined as follows: 
    * Grade I =1% to 25%
    * Grade II =26% to 50%
    * Grade III =51% to 75%
    * Grade IV = 76% to 100%
    * Grade V = spondyloptosis and occurs when the L5 vertebra completely slides over the top of the sacrum

**4.** 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:
    * Anti-inflammatory medications, oral or injection therapy as appropriate, and analgesics
    * Daily exercise
    * Activity lifestyle modification
    * Weight reduction as appropriate
    * Supervised PT [ADLs diminished despite completing a plan of care]

**OR**

    * 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.

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

**5.** 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: 
    * Recurrent symptoms consistent with neurological compromise
    * Significant functional impairment
    * Neural compression is documented by recent post-operative imaging
    * 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)
    * Instability is documented by appropriate imaging
    * Patient had some relief of pain symptoms following the prior spinal surgery

**6.** 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:

  1. When performed with initial primary laminectomy/discectomy for nerve root decompression or spinal stenosis, without documented spondylolisthesis or documentation of instability (e.g., documented intraoperative iatrogenic instability).
  2. 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.

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

The hospital records are the primary source of information for the audit of
hospital/procedure services. Therefore, any historical data supporting the
medical necessity for the fusion (for example, duration and outcomes of
physiotherapy, injection therapy, anatomic factors influencing the decision
for surgery, etc.) must be included in the inpatient medical record as noted
in the history and physical examination, operative note and/or 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.

When reviewing claims for procedures with DRGs please refer to CMS IOM
Publication 100-08, _Medicare Program Integrity Manual_ , Chapter 6, Section
6.5.2.  

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.