• Chemonucleolysis using chymopapain (which is the subject of this policy)
• Percutaneous Lumbar Discectomy (Please refer to policy #019 in the Surgery Section.)
• Disc decompression using laser or radiofrequency energy (Please refer to policy #077 in the Treatment Section.)

The following are considered to be red flags:
• Suspected unstable fractures of the spine which may be evidenced by a history of a recent fall or injury, and major motor weakness of a limb, or progressive neurological deficits, or bladder or bowel dysfunction.
• History of cancer with suspicion of metastatic spread which may be evidenced by major motor weakness of a limb, or pain which increases at night or at rest, or progressive neurological deficits, or bladder or bowel dysfunction, or unexplained weight loss of more than 10 pounds in 6 weeks.
• Infection with suspicion of an epidural abscess/diskitis which may be evidenced by progressive neurological deficits or fever of 100.4 for more than 48 hours, and C- reactive protein >10 mg/L, or recent (within 2 weeks) interventional spine procedures, or ESR >20 mm/hr, or immunocompromised (either immunodeficiency from any cause or IV drug abuse).
• Cauda equina syndrome which may be evidenced by bladder or bowel dysfunction, or saddle anesthesia, or progressive neurological deficits.
• Skeletal dysplasias, such as achondroplastic dwarfism, with dysplastic spinal canal or facet joints on a genetic/congenital basis

(NOTE: Red flags indicate comorbidities that require urgent/emergent diagnostic imaging and/or referral for definitive therapy.)

A. Persistent axial pain for at least 12 weeks, and

B. Failure of conservative treatment:
1. Less than clinically meaningful improvement* from NSAIDS and/or muscle relaxants for 6 weeks begun since the onset of pain, and
2. Less than clinically meaningful improvement* from conservative self–care (muscle stretching, OTC medications, regular exercise) for 6 weeks begun since the onset of pain, or
3. Less than clinically meaningful improvement* or worsening pain from a prescribed physical therapy core strengthening program begun since the onset of pain (6 weeks), and

C. Pain pattern and/or physical examination suggesting disc disease:
1. Axial pain worsening with upright postures, and
2. No significant radicular symptoms or lower extremity neurologic defect, and

D. MRI imaging (T2) suggestive of disc damage: [All of the following]
1. Uncomplicated herniation of a single lumbar disc, and
2. No evidence of a free fragment or sequestration of a portion of a disc, and
3. Retained disc height at least 50% of normal, and
4. No evidence of spinal stenosis or spondylolisthesis, and

E. Epidural injection has been attempted without relief, and

F. Discography demonstrates concordant pain provocation by low pressure discography; (< 50 psi above opening pressure), and

G. Procedure will be done under image guidance, and

H. Limitations: [None may exist]
1. More than 1 level is planned, or
2. Previous surgery/procedure on the disc for which the procedure is planned

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Chemonucleolysis
Chymopapain

References:
1. Blue Cross and Blue Shield Association. Technology Evaluation & Coverage. Chemonucleolysis of Herniated Lumbar Intervertebral Discs. Feb/May 1990.

2. Blue Cross and Blue Shield Association. Technology Evaluation & Coverage. Chemonucleolysis. August 1988.

3. Maroon JC. Current concepts in minimally invasive discectomy. Neurosurgery 2002 Nov;51(5 Suppl):137-45.

4. Deen HG, Fenton DS, Lamer TJ. Minimally invasive procedures for disorders of the lumbar spine. Mayo Clin Proc 2003 Oct;78(10):1249-56.

5. Andreula C, Muto M, Leonardi M. Interventional spinal procedures. Eur J Radiol 2004 May;50(2):112-19.

6. Guha AR, Debnath UK, D'Souza S. Chemonucleolysis revisited: a prospective outcome study in symptomatic lumbar disc prolapse. J Spinal Disord Tech 2006 May;19(3):167-70.

7. Couto JM, Castilho EA, Menezes PR. Chemonucleolysis in lumbar disc herniation: a meta-analysis. Clinics 2007 Apr;62(2):175-80.

8. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse: updated Cochrane Review. Spine. 2007 Jul 15;32(16):1735-47.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

62292