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Coverage criteria policies

Artificial intervertebral disc replacement-cervical

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Prior authorization is required for artificial cervical intervertebral disc replacement.

Coverage

Artificial cervical intervertebral disc replacement is generally covered subject to the indications listed below and per your plan documents. This policy does not apply to artificial lumbar intervertebral disc replacement. Please see the lumbar-specific policy for details and applicable coverage criteria.

Indications that are covered

Artificial cervical intervertebral disc may be eligible for coverage when all of the following criteria are met:

  1. Clinical documentation indicates intractable radiculopathy and/or myelopathy with at least one of the following conditions producing symptomatic nerve root and/or spinal cord compression:
    1. Herniated disc; and/or
    2. Osteophyte formation
  2. Reports of radiographic studies such as CT, MRI or x-rays are submitted which confirm the conditions listed above.
  3. Patient must be skeletally mature.
  4. Patient must have tried and failed at least 6 weeks of conservative management (including rest, application of heat /ice, physical therapy, exercise, pain and/or anti-inflammatory medications).

Note: Conservative therapy must include physical therapy (PT) and may include activity modification, weight loss, and drug therapy. Documentation must correspond to the current episode of pain (within 6 months).

Formal physical therapy, at least four visits over a six week course, including active muscle conditioning is required, or there must be an explicit statement in the clinical documents that explains why such physical therapy is contraindicated. The requirement for physical therapy will not be met if there is a failure to complete prescribed physical therapy for non-clinical reasons. Documentation of formal physical therapy would be the therapist’s notes. If a patient is unable to complete physical therapy (PT) due to progressively, worsening pain and disability, the case will be reviewed on an individual basis by an internal physician reviewer. Documentation in the physical therapist’s notes demonstrating this must be submitted.

  1. Clinical documentation indicates a history of neck and/or arm pain as well as functional and/or neurological deficits.
  2. Intervertebral area being replaced and reconstructed is from C3-C7, and involves either a single-level or a contiguous 2-level discectomy for intractable radiculopathy and/or myelopathy.
  3. The proposed device is FDA approved for both the condition being treated and for the number of levels being treated.

Note: Examples of FDA-approved artificial cervical spinal discs include: The Prestige® Cervical Disc System, the Bryan® Cervical Disc System, the ProDisc®-C, the MOBI-C Cervical Disc Prosthesis, the Secure-C Artificial Disc System, and the PCM Cervical Disc System. The MOBI-C and the Prestige LP Cervical Disc are the only artificial discs FDA-approved for use at both one and two contiguous levels.

Indications that are not covered

Artificial cervical intervertebral disc replacement is not covered for any additional indication, including, but not limited to the following as it is considered investigative:

  1. Active systemic infection or infection at the surgical site
  2. Allergy to any of the device materials
  3. Osteopenia or osteoporosis
  4. Marked cervical instability on radiographs, defined as vertebral misalignment (subluxation) >3.5mm or angulation of the disc space >11 degrees greater than adjacent segments.
  5. Moderate to advanced degeneration of the intervertebral discs, characterized by bridging osteophytes, marked reduction or absence of motion, or collapse of the intervertebral disc space of > 50% of its normal height.
  6. Presence of significant facet arthritis at the level to be treated
  7. Significant cervical anatomical deformity or clinically compromised vertebral bodies at the level to be treated due to systemic disease, previous surgery, or trauma.
  8. Significant kyphotic deformity, significant reversal of lordosis, or significant spondylolisthesis
  9. Disc replacement(s) for symptoms necessitating concurrent additional surgical treatment (i.e. fusion)
  10. Disc replacement(s) for cervical level adjacent to a previous cervical fusion

Definitions

Arthroplasty is the surgical repair of a joint.

Artificial cervical intervertebral disc replacement, also known as cervical disc arthroplasty, is a procedure which replaces a degenerated cervical (neck) disc with an artificial disc. The artificial disc is intended to relieve pain, preserve alignment, maintain spinal stability and flexibility, and prevent degeneration of adjacent discs. This type of surgery is an alternative to anterior cervical discectomy and fusion surgery.

Axial neck pain is musculoskeletal, characterized as neck or soft tissue pain which occurs solely along the spinal column.

Degenerative Disc Disease (DDD) is a general term used to describe the progressive drying out and deterioration of the intervertebral discs of the spine which lead to loss of flexibility and function. DDD develops over time as part of the normal aging process. It may cause neck stiffness and pain.

Herniated disc is a condition in which the outer portion (annulus fibrosus) of the vertebral disc is torn, enabling the inner portion (nucleus) to herniate or extrude through the fibers.

Kyphosis is an excessive outward curvature of the spine, which causes hunching of the back.

Lordosis is an excessive inward curvature of the spine.

Myelopathy is any functional disturbance or disease of the spinal cord.

Osteopenia refers to bone density that is lower than normal peak density but not low enough to be classified as osteoporosis.

Osteoporosis refers to a bone disease in which there is a thinning of the bones with reduction in bone mass due to depletion of calcium and bone protein. It predisposes a person to bone fractures. Osteoporosis is defined as a DEXA bone mineral density T-score equal to or worse than 2.5.

Osteophytes, or bone spurs, are bony outgrowths that form on the spine over a period of time. They are physical indications of degeneration in the spine.

Radiculopathy or radicular neck pain is caused by a compressed nerve in the spine. It can cause pain, numbness, tingling, or weakness along the course of the compressed nerve.

Spondylolisthesis is a condition in which one vertebrae slides over the one below it. It may lead to the spinal cord or nerve roots being squeezed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:

Codes

Description

22856

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical

22858

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (List separately in addition to code for primary procedure)

22861

Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical

0095T

Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical

0098T

Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical

The services associated with these codes are considered investigational and are not covered:

Codes

Description

0375T

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), cervical, three or more levels.

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. BlueCross BlueShield Association Technology Evaluation Center (2014) Artificial Intervertebral Disc Arthroplasty for Treatment of Degenerative Disc Disease of the Cervical Spine. Technology Assessment Program 28(13):1-40.
  2. Darden, Bruce V. (2012) ProDisc-C Cervical Disk Arthroplasty. Seminars in Spine Surgery, 24:8-13.
  3. Davis, R.J., Kim, K.D., Hisey, M.S., Hoffman, G.A., Bae, H.W., Gaede, S. E. …Stokes, J.K. (2013) Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective randomized, controlled multicenter clinical trial. Journal of Neurosurgery:Spine, 2013;19:532-545.
  4. Davis, R.J., Nunley, P.D., Kim, K.D., Hisey, M.S., Jackson, R.J., Hoffman, G.A., Bae, H.W., Gaede, S. E. …Stone, M. (2015) Two-Level total disc replacement with the Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective randomized, controlled multicenter clinical trial with 4-year follow-up results. Journal of Neurosurgery: Spine, 2015; 22(1):15-25.
  5. ECRI Institute. (2016). Mobi-C Artificial Cervical Disc (Zimmer Biomet) For Treating Two Level Degenerative Cervical Disc Disease. Plymouth Meeting, PA: ECRI Institute.
  6. Gao. Y., Liu, M. Li, T., Huang, F., Tang, T., & Xiang, Z (2013) A Meta-Analysis Comparing the Results of Cervical Disc Arthroplasty with Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Disc Disease. The Journal of Bone and Joint Surgery. 2013; 95: 555-561.
  7. Hayes, Inc. Hayes Medical Technology Directory Report. Artificial Disc Replacement for Cervical Degenerative Disc Disease, Lansdale, PA: Hayes, Inc.; December, 2014. Reviewed October, 2017
  8. Hayes, Inc. Hayes Medical Technology Directory Report. Single-Level Artificial Disc Replacement for Cervical Degenerative Disc Disease. Lansdale, PA: Hayes, Inc.; August, 2017.
  9. Jackson, R.J., Davis, R.J., Hoffman, G.A., Bae, H.W., Hisey, M.S., Kim, K.D., Gaede, S.E. & Nunley, P.D. (2016) Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. Journal of Neurosurgery: Spine. Published online January 22, 2016.
  10. Lanman, T., Burkus, J. K., Dryer, R., Gornet, M., McConnell, J. & Hodges, S. (2017). Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a perspective randomized controlled clinical trial. Journal of Neurosurgery Spine, 27: 7-19.
  11. National Institute for Health and Care Excellence (2010). Prosthetic intervertebral disc replacement in the cervical spine: Interventional procedures guidance. Retrieved from https://www.nice.org.uk/guidance/ipg341
  12. North American Spine Society (2010). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care- Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders. Retrieved from https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines
  13. North American Spine Society (2014). Coverage Policy Recommendations. Cervical Artificial Disc Replacement. Retrieved from https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations
  14. Pandey, P., Pawar, I. Gupta, J. & Verma, R. (2016). Comparison of Outcomes of Singel-Level Anterior Cervical Discectomy With Fusion and Single-Level Artificial Cervical Disc Replacement for Single-Level Cervical Degenerative Disc Disease. Spine; 42(1): E41-E49.
  15. Robinson, J. & Kothari, M. Treatment and Prognosis of cervical radiculopathy. In: UpToDate, Shefner, J. (Ed), UpToDate, Waltham, MA. (Accessed on February 12, 2018).
  16. Zigler, J.E., Delamarter, R., Murrey, D. Spivak, J. & Janssen, M. (2013). ProDisc-C and Anterior Cervical Discectomy and Fusion as Surgical Treatment for Single-Level Cervical Symptomatic Degenerative Disc Disease: Five-Year Results of a Food and Drug Administration Study. Spine 2013; 38:203-209
  17. Robinson, J. & Kothari, M. Treatment and prognosis of cervical neuropathy. In: UpToDate, Shefner, J. & Dashe, J. (Ed), UpToDate, Waltham, MA. (Accessed on January 5, 2017).

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Policy activity

  • 09/11/2012 - Date of origin
  • 01/01/2017 - Effective date
Review date
  • 01/2018
Revision date
  • 06/21/2016

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