DraftPremera BluecrossPolicy 7.01.108

Artificial Intervertebral Disc: Cervical Spine

Medical necessity, site-of-service, documentation, and coding criteria for cervical artificial intervertebral disc (cervical disc arthroplasty) implantation for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyArtificial Intervertebral Disc: Cervical Spine

Policy CodePolicy 7.01.108

Change TypeMinor update — header addedno material clinical changes

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization with documentation of procedure and diagnosis codes, device identification and levels treated, clinical notes including failed conservative therapy, and imaging within the prior 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single- and two-levelFDA-approved device coverage scope

6 weeksMinimum conservative therapy

12 monthsImaging recency

C3–C7Cervical levels

4 codesProcedure codes listed

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Policy history entries

Coverage Criteria for Cervical Artificial Intervertebral Disc Implantation

Artificial cervical intervertebral disc implantation — Medically necessary

Covered when ALL of the following are met

Primary medical necessity criteria: Device is FDA-approved for the intended number of levels; individual is skeletally mature; has intractable cervical radicular pain or myelopathy that has failed at least 6 weeks of conservative nonoperative treatment including physical therapy and at least one of: acupuncture, cervical collar, corticosteroids, exercise program, or medical treatment with NSAIDs/other analgesics OR has severe or rapidly progressive nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment; degeneration documented by imaging within the prior 12 months (MRI, CT, or myelography); disease involves levels C3 through C7; individual is free from contraindications to artificial cervical disc.

Subsequent adjacent-level implantation

Subsequent implantation of a second artificial cervical disc at an adjacent level

Adjacent-level implant criteria: All primary medical necessity criteria are met for each disc level; device is FDA-approved for two contiguous levels (examples: Mobi-C, Prestige LP); and the initial cervical artificial disc implantation is fully healed.

Investigational / Not covered indications

The following indications are considered investigational (not covered)

Investigational indications: Active infection; anatomical deformity (e.g., ankylosing spondylitis); cervical artificial disc at one level combined simultaneously with cervical spinal fusion at another level (hybrid surgery); disc implantation at more than 2 levels; malignancy; metabolic bone disease (e.g., osteoporosis, osteopenia, osteomalacia); presence of facet arthritis; previous fusion at another cervical level; prior surgery at the treated level; rheumatoid arthritis or other autoimmune disease; translational instability.

General clinical appropriateness and device labeling

Covered when ALL of the following device-labeling and patient-selection conditions are met:

Device and patient-selection conditions: Device is FDA-approved for the intended cervical level(s) (single-level or two contiguous levels) and device labeling/inclusion–exclusion criteria from pivotal studies are followed; patient is skeletally mature with symptomatic radiculopathy and/or myelopathy documented by history and imaging; causes of nerve root or spinal cord compression (e.g., herniated disc or osteophyte) are consistent with device indications; surgery is performed in an appropriate specialist setting as recommended by society guidance and device labeling.

Based on FDA labeling, pivotal study inclusion/exclusion and society guidance

General coverage scope

Policy addresses single- and two-level cervical disc replacement when criteria are met.

Device approvals and applicability: FDA-approved single- and two-level cervical artificial discs are recognized and listed; specific device approvals (examples: M6-C, Simplify, Prestige LP, ProDisc variants, Mobi-C) and their approved use for one or two contiguous cervical levels are referenced and updated in the policy history and regulatory sections.

Device lists and approvals are maintained in the regulatory/status and history sections.

Cervical artificial intervertebral disc implantation is considered investigational (and therefore not covered) for a set of specific clinical contraindications and scenarios. These include: active infection; anatomical deformity (for example, ankylosing spondylitis); malignancy; metabolic bone disease (e.g., osteoporosis, osteopenia, osteomalacia); presence of facet arthritis; previous fusion at another cervical level; prior surgery at the treated level; rheumatoid arthritis or other autoimmune disease; translational instability; procedures combining a disc at one level with fusion at another during the same operation (hybrid surgery); and disc implantation at more than two levels.

Use of an artificial cervical disc outside FDA-approved indications or device labeling is not supported. Authorization and coverage require that the device be FDA-approved for the intended cervical level(s) (single-level or two contiguous levels as applicable) and that device-specific inclusion and exclusion criteria from pivotal studies and labeling be followed. Devices are approved only for one-site or two-contiguous-site use; there are no devices approved for non-contiguous multilevel implantation.

This medical policy does not apply to Medicare Advantage plans. Coverage determinations and site-of-service reviews described in this policy are intended for applicable commercial and other non–Medicare Advantage benefit plans; providers should consult member-specific benefit documents for Medicare Advantage applicability.

Cervical artificial intervertebral disc implantation for any indications other than those specified as medically necessary in this policy is considered investigational and therefore not medically necessary. Requests for coverage should meet all medical necessity criteria in the policy (including device FDA-approval for the intended number of levels, skeletally mature patient, appropriate clinical presentation, conservative therapy or urgent indication, imaging within the prior 12 months, and treatment levels C3–C7) to be considered for approval.

During the 2015 review, specialty societies and academic centers agreed that cervical disc replacement may be medically necessary under specified conditions. Reviewers also concurred that the combined use of an artificial disc and fusion over two levels was investigational. Input was mixed regarding the broader medical necessity of two-level arthroplasty, and this historical feedback informed the policy’s cautious stance on hybrid procedures and multilevel use.

InterQual criteria were considered during a 2020 interim review, but the policy was retained and reinstated for continued use. The policy explicitly identifies indications considered investigational and states that procedures not meeting the specified medical necessity criteria are not covered. Providers should follow the policy’s current criteria and documentation requirements when submitting requests for authorization.

Coding and Procedural Codes

CPT codesCPT

0098T	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace; cervical.
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; second level, cervical.
22861	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical.

Regulatory/Product Codes and PMA numbersmixed

MJO	Product code for cervical disc prostheses (FDA product code)
P060018	PMA number associated with Prestige ST Cervical Disc
P070001	PMA number associated with ProDisc-C
P100012	PMA supplement/related number (PCM Cervical Disc)
P100003	PMA supplement/related number (SECURE-C)
P110002	PMA number associated with Mobi-C (one-level)
P110009	PMA number associated with Mobi-C (two-level)
P090029	PMA number associated with Prestige LP
P170036	PMA number associated with M6-C
P200022/S003	PMA/supplement number associated with Simplify Cervical Artificial Disc

Historic CPT codes mentioned in policy historyCPT

0092T	Deleted 12/31/14 (historical mention)
0375T	Removed; termed 1/1/2020 (historical mention)
0095T	Deleted (historical mention)
22864	Removed from policy (historical mention)

Imaging recency — required timeframe for diagnostic imaging documentation

Required imaging timeframeDiagnostic imaging (MRI, CT, or myelography) must be documented within the prior 12 months

Acceptable imaging reportsSubmit radiologist's reports for the diagnostic imaging performed

Imaging modalities specifiedMagnetic resonance imaging (MRI), computed tomography (CT), or myelography

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization and coding submission — prior auth review required

Prior authorization is required for cervical artificial intervertebral disc implantation. Requests must include procedure and diagnosis codes, device identification, and the specific cervical level(s) to be treated. Authorization will be reviewed for medical necessity and site-of-service appropriateness.

Submit specific procedure and diagnosis codes (CPT/ICD-10) and identify device and disc level(s)

Prior Authorization

Authorization requires device labeling and level-specific indication

Authorization will only be considered when the proposed device is FDA-approved for the requested number and configuration of levels and used in accordance with the device labeling and level-specific indications (e.g., devices FDA-approved for one level vs. two contiguous levels). Requests for devices or level combinations not reflected in FDA labeling are not supported.

Provide device name, manufacturer, and FDA approval (PMA) number when requesting authorization
Two-level implantation is allowed only when the device is FDA-approved for two contiguous levels (e.g., Mobi-C, Prestige LP, ProDisc C SK/Vivo)

Background and Clinical Context

Cervical disc arthroplasty replaces a degenerative cervical disc to preserve motion and disc height as an alternative to anterior cervical discectomy and fusion (ACDF). It is intended for symptomatic cervical radiculopathy and/or myelopathy documented by history and imaging when conservative treatment has failed or when severe/progressive neurologic compromise requires urgent surgery. FDA-approved devices are intended for levels typically between C3 and C7 and for single- or two-contiguous-level use per device labeling; continued FDA approval requires post-approval studies and adherence to device-specific indications.

Definitions

ASA Score definitions

ASA 1A normal healthy patient.

ASA 2A patient with mild systemic disease.

ASA 3A patient with severe systemic disease.

ASA 4A patient with severe systemic disease that is a constant threat to life.

ASA 5A moribund patient who is not expected to survive.

Cervical radiculopathy definition

Core definitionPersistent neck pain radiating into the shoulder/arm in a dermatomal/single nerve pattern, or progressive weakness caused by irritation or injury near the nerve root in the neck.

Policy Revision History

2015-08-11New policy

New policy created (replacing policy 7.01.537), definitions of cervical myelopathy and cervical radiculopathy added; ICD-9 procedure code 84.61 added.

2016-01-08Minor update

Removed CPT code 0092T (deleted 12/31/14) from policy.

2016-10-01Annual review

Added statement that 2-level cervical disc replacement may be considered medically necessary when criteria are met; literature review updated through June 2016.

Policy Summary

PayerPremera Bluecross

PolicyArtificial Intervertebral Disc: Cervical Spine

Policy CodePolicy 7.01.108

Change TypeMinor update — header addedno material clinical changes

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Documentation Required

Required documentation for review

Submit complete clinical documentation to support medical necessity. Incomplete submissions or failure to provide required documentation may delay review or result in denial.

Current history and physical exam
Detailed documentation of extent and response to nonoperative conservative therapy (see conservative therapy requirement)
Radiology reports for MR/CT/myelography within the prior 12 months
Device identification and operative plan including levels to be treated

Denial Risk

Failure to meet medical necessity criteria — denials when ALL criteria are not met

Medical necessity requires that ALL applicable policy criteria are met, including: FDA device approval for the proposed use, skeletally mature patient, intractable radiculopathy or myelopathy, imaging confirmation within 12 months, and either failed ≥6 weeks of conservative nonoperative treatment or presence of severe/rapidly progressive neurologic compromise. Failure to meet any required criterion (including device labeling) may result in denial.

ALL criteria must be met for approval
If severe or rapidly progressive symptoms requiring immediate surgery exist, the conservative therapy requirement may be waived

Billing Rule

Site-of-service requirements and risk of noncompliance

The site of service must be appropriate for an elective surgical procedure. Ambulatory surgical center or outpatient hospital/medical center sites are preferred. Inpatient hospital setting is medically necessary only when patient-specific clinical risks are present (e.g., high anesthesia or cardiac risk, pregnancy, need for anticipated transfusion, morbid obesity, significant comorbidity). Performing an elective procedure inpatient when inpatient criteria are not met may result in claim denial.

Preferred sites: ambulatory surgical center, off-campus outpatient hospital/medical center, on-campus outpatient hospital/medical center
Inpatient setting is permitted only when documented clinical risk factors for inpatient care are present

Note

Regulatory reporting and post-approval study obligations

Document and submit regulatory information when available. For devices approved via PMA, include PMA number and note any post-approval study obligations. FDA approvals for cervical discs have required multi-year post-approval follow-up (typically 7-year clinical follow-up and enhanced surveillance studies) and ongoing annual reporting of device sales and adverse events. Continued FDA approval may be contingent on completion of post-approval studies and submission of annual reports.

Include PMA or approval identifiers (e.g., P060018, P070001, P110002, P090029, etc.) when known
Be aware of device-specific post-approval study and surveillance obligations (7-year follow-up and enhanced adverse event surveillance)

Note

Policy reinstatement and documentation refinement — administrative note

Policy history: this policy was deleted effective July 2, 2020 and replaced with InterQual criteria, but was reinstated effective June 10, 2020 and will no longer be deleted or replaced. Documentation requirements and other administrative elements have been refined over time; check the current policy effective date and history when preparing prior authorization requests.

Policy deleted 04/01/20 (effective 07/02/20) and reinstated 06/10/20
Review history for changes to documentation, site-of-service, and device lists

Prior Authorization

Conservative therapy requirement — failed ≥6 weeks required unless severe/progressive

Conservative therapy: Except for patients with severe or rapidly progressive neurologic compromise requiring immediate surgery, authorization requires documentation of failure of at least 6 weeks of conservative nonoperative treatment. Conservative measures should be documented in detail, including type, duration, response, and any interventional procedures.

Document at least 6 weeks of conservative treatment (physical therapy, medications, cervical collar, acupuncture, corticosteroid injections, etc.) unless urgent indications exist
Include outcomes and dates for each conservative modality tried

Step Therapy

No step therapy specified — follow policy guidance

No step therapy program is specified in this policy for cervical disc arthroplasty; follow the policy criteria for conservative treatment and device/level labeling instead.

No payer step-therapy protocol mandated by this policy

Common clinical findingsArm pain, neck pain, scapular or periscapular pain, paresthesias, numbness, sensory changes, weakness, or abnormal deep tendon reflexes in the arm.

Documentation supporting diagnosisHistory and radiographic studies (e.g., MRI, CT, x-rays) showing herniated disc and/or osteophyte producing nerve root compression.

Cervical myelopathy definition

DefinitionLoss of function in the upper and lower extremities due to compression of the spinal cord within the neck.

Typical manifestationsMay present with gait or balance changes and weakness reflecting spinal cord involvement.

Diagnostic supportClinical history and imaging demonstrating spinal cord compression (e.g., herniated disc or osteophyte) are used to establish the diagnosis.

FDA-approved cervical disc prosthesis — definition and scope (single/two contiguous levels)

Regulatory pathwayAn implantable device cleared via FDA premarket approval (PMA) for reconstruction of cervical discs.

Anatomic scopeApproved for use at cervical levels commonly between C3 and C7; devices described for one site or two contiguous sites only (no devices approved for non-contiguous sites).

Level use specificsDevice labeling may specify single-level or two contiguous-level use; continued approval often requires post-approval follow-up studies.

Cervical disc arthroplasty definition

Procedure definitionSurgical replacement of a degenerative cervical disc with an artificial disc device as an alternative to anterior cervical discectomy and fusion (ACDF).

Intended goalsRestore disc height and preserve motion while decompressing neural elements (e.g., nerve root or spinal cord) caused by herniated disc or osteophyte.

Relation to FDA labelingCervical disc arthroplasty devices are marketed under PMA approvals with specific indications and post-approval study requirements that should be followed.

2017-07-01Annual review/format change

Policy moved into new format with literature update through February 23, 2017; rationale revised but policy statements unchanged.

2018-03-01Interim review

Policy revised and Surgery Site of Service criteria added (effective June 1, 2018).

2018-07-01Annual review

Medical necessity criteria revised to include subsequent implantation of a second artificial cervical intervertebral disc at an adjacent level when criteria are met; investigational statements regarding prior artificial disc placement changed.

2019-07-01Annual review

M6-C Artificial Cervical Disc added to list of single-level FDA-approved devices; CPT code 22864 removed.

2020-04-01Deletion approved

Policy approved for deletion effective July 2, 2020 (policy deleted 04/01/20 entry).

2021-02-01Policy clarification

Updated device approvals: PrestigeLP listed as FDA approved for both single- and two-level use to accurately reflect approvals.

2021-07-01Annual review

Literature review through March 11, 2021; CPT code 0375T removed (termed 1/1/2020); policy statements unchanged.

2021-09-01Interim update

Simplify added to FDA-approved list of cervical artificial discs.

2022-04-01Interim update

Minor edits to list of example one- and two-level cervical artificial discs; CPT code 0095T removed.

2022-07-01Annual review

Literature review through March 1, 2022; references added; policy statements unchanged.

2022-11-04Minor update

Updated manufacturer name from Spinal Kinetics LLC to Orthofix for clarity.

2024-07-01Annual review

Literature review through February 27, 2024; references added; policy statements unchanged.

2025-07-01Annual review

Literature review through February 20, 2025; policy statements unchanged.

2025-08-01Minor update

Removed Related Policy 11.01.524 Site of Service Surgical Procedures; professional claims codes placed in Related Information.

2026-03-02Minor updateLatest

Added ProDisc C Vivo and ProDisc C SK to list of FDA-approved devices for reviewer clarity.