CurrentPremera BluecrossPolicy N/A

Artificial Intervertebral Disc: Cervical Spine

Medical necessity and coverage criteria for cervical artificial intervertebral disc implantation (single- and selected two-level) and associated site-of-service determinations for Premera Blue Cross members and providers.

Policy Summary

PayerPremera Bluecross

PolicyArtificial Intervertebral Disc: Cervical Spine

Policy CodePolicy N/A

Change TypeMinor device list and formatting updates

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with submission of clinical documentation, device and level information, and imaging reports (MRI/CT/myelography within 12 months).

SourceLink

POLICY UPDATE CHANGES

Added ProDisc C Vivo and ProDisc C SK to list of FDA approved 2 level cervical spine artificial intervertebral discs for reviewer clarity.

Added header to indicate that site of service review does not apply to Indian Health Services (IHS) facilities.

Policy updated with literature review through February 20, 2025; no references added.

1- and select 2-levelFDA-approved device coverage

C3–C7Anatomic levels

>=6 wkConservative therapy

12 moImaging recency

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0098T,22856,22858,22861

07/01/25Most recent review

Coverage Criteria for Cervical Artificial Intervertebral Disc

Medical necessity criteria for artificial cervical intervertebral disc implantation

Covered when ALL of the following are met

FDA approval: Device is approved by the US Food and Drug Administration (FDA) for the specified number of levels (examples listed; list may not be all inclusive). For one level: Bryan, M6-C, Mobi-C, PCM, Prestige LP, Prestige, ProDisc-C, SECURE-C, Simplify. For two contiguous levels: Mobi-C, Prestige LP, ProDisc C SK, ProDisc C Vivo, Simplify.

Examples list may not be all inclusive

Skeletal maturity: Individual is skeletally mature.

Symptoms: Individual has intractable cervical radicular pain or myelopathy.

Symptoms must have failed at least 6 weeks of conservative nonoperative treatment including physical therapy and at least one other modality (e.g., acupuncture, cervical collar, corticosteroids, exercise program, NSAIDs/analgesics) unless severe/rapidly progressive symptoms require immediate surgery.

Imaging: Degeneration documented by MRI, CT, or myelography within the prior 12 months.within 12 months

Anatomic levels: Cervical degenerative disc disease is located from C3 through C7.

Contraindications absent: Individual is free from contraindications to artificial cervical disc implantation.

Contraindications include (but are not limited to) active infection; anatomical deformity (e.g., ankylosing spondylitis); hybrid surgery combining disc at one level with fusion at another; implantation at >2 levels; malignancy; metabolic bone disease (osteoporosis/osteopenia/osteomalacia); presence of facet arthritis; previous fusion at another cervical level; prior surgery at the treated level; rheumatoid or other autoimmune disease; translational instability.

Subsequent/adjacent level implantation

Subsequent implantation

Adjacent level subsequent implantation: Subsequent implantation of a second artificial cervical intervertebral disc at an adjacent (contiguous) level may be considered medically necessary if the above criteria are met for each disc level, the device is FDA-approved for two contiguous levels (examples: Mobi-C, Prestige LP), and the initial cervical artificial disc implantation is fully healed.

For elective cervical artificial intervertebral disc procedures, placement in an inpatient hospital setting is not medically necessary when site-of-service medical necessity criteria are not met. Exceptions include individuals with severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment. Providers should confirm site-of-service determinations and note that site-of-service medical necessity criteria do not apply to Indian Health Services (IHS) facilities.

Device approvals are limited by the anatomic labeling in manufacturers’ FDA approvals. Some cervical prostheses are approved for one or two contiguous levels, but there are no devices approved for non-contiguous sites; providers should ensure the planned level(s) of implantation match the device’s FDA-labeled indication when requesting authorization.

This medical policy is intended as a guide for evaluating medical necessity for Premera Blue Cross members and providers. This policy does not apply to Medicare Advantage. Coverage for services is subject to the member’s benefit contract; verify benefit coverage and any prior authorization requirements using the member benefit booklet or by contacting customer service.

Cervical artificial intervertebral disc implantation is considered investigational and not medically necessary for all other indications not meeting the coverage criteria. Examples of excluded or contraindicated scenarios include: active infection; anatomical deformity (e.g., ankylosing spondylitis); hybrid surgery combining artificial disc at one level with fusion at another (adjacent or nonadjacent); implantation at >2 levels; malignancy; metabolic bone disease (osteoporosis, osteopenia, osteomalacia); presence of facet arthritis; previous fusion at another cervical level; prior surgery at the treated level; rheumatoid or other autoimmune disease; and translational instability.

Coding and Procedural Codes

Covered CPT / CPT-like codesCPTCovered

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 and microdissection; second level, cervical.
22861	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical.

Historical codes referencedICD-9

84.61

ICD-9 procedure code added historically

CPT codes historically added/removedCPT

0092T	CPT code deleted 12/31/14 (historical)
22864	Removed from policy historically
0375T	Removed/termed 1/1/2020 (historical)
0095T	Removed historically

Related informationmixed

professional claims codes

Placed in Related Information (no specific codes listed in these chunks)

Conservative therapy duration — minimum duration prior to consideration

Minimum durationAt least 6 weeks of conservative nonoperative treatment (including physical therapy plus at least one other modality) is required prior to consideration unless severe/rapidly progressive symptoms require immediate surgery.

Required componentsConservative therapy should include physical therapy and at least one additional modality (e.g., cervical collar, corticosteroids, exercise program, NSAIDs/analgesics, acupuncture).

ExceptionSevere or rapidly progressive myelopathy or nerve root compression may require immediate surgical treatment without completion of the 6-week trial.

Imaging recency requirement — degeneration documented by imaging within prior 12 months

Imaging timeframe

Provider Actions, Documentation & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for artificial cervical intervertebral disc implantation. Submit a prior authorization request with the specific procedure(s) and related procedure/diagnosis codes, identification of disc level(s) to be treated, the device make/model to be implanted, and supporting clinical documentation (current history and physical, imaging reports). Coverage is subject to member benefit plan limits; verify eligibility and benefit coverage before scheduling.

Submit specific procedure(s) with related procedure and diagnosis codes and identification of disc level(s).
Identify the device to be implanted (manufacturer and model) and confirm the device is FDA-approved for the requested number and configuration of levels.
Include current history & physical and radiology reports (MRI/CT/myelography) performed within the prior 12 months.

Documentation Required

Device Labeling and Level/Site Indication

Devices must be used within the FDA-labeled indication for level and site. Most approved cervical discs are indicated for a single level; only certain devices are FDA-approved for two contiguous levels. Request must specify levels and demonstrate that the device labeling supports implantation at those levels (no devices are approved for non-contiguous sites).

Background and Clinical Context

Cervical degenerative disc disease (DDD) involves deterioration of cervical intervertebral discs and can produce radiculopathy (neck pain radiating into the shoulder or arm in a dermatomal pattern) or myelopathy (loss of function in the upper and/or lower extremities from spinal cord compression). Cervical disc arthroplasty replaces the damaged disc to preserve motion and, in appropriately selected patients, may reduce adjacent-level degeneration compared with anterior cervical discectomy and fusion (ACDF). The policy supports single-level and selected two-level artificial cervical disc implantation for skeletally mature individuals with intractable cervical radicular pain or myelopathy who have failed at least 6 weeks of conservative nonoperative treatment and have degeneration documented by MRI, CT, or myelography within the prior 12 months, provided anatomic levels treated are between C3 and C7 and there are no contraindications to artificial cervical disc.

Definitions

Cervical myelopathy definition

DefinitionCervical myelopathy: loss of function in the upper and lower extremities due to compression of the spinal cord within the neck.

Clinical findingsMay present with neck and/or arm pain, functional deficit, neurologic deficit, weakness, sensory changes, paresthesias, and abnormal deep tendon reflexes.

Supporting requirementSymptomatic spinal cord compression should be documented by patient history and radiographic studies (e.g., MRI, CT, x-rays).

Cervical radiculopathy definition

DefinitionCervical radiculopathy: persistent neck pain that radiates into the shoulder/arm in a dermatomal or single-nerve pattern, or progressive weakness caused by irritation or injury near the root of a spinal nerve in the neck.

Common signs

Revision History

2026-06-01annual_reviewLatest

Annual review conducted with literature review through February 20, 2025; policy statements unchanged (effective date 2025-07-01).

2026-03-02minor_update

Added ProDisc C Vivo and ProDisc C SK to list of FDA-approved two-level cervical artificial intervertebral discs for reviewer clarity.

2026-06-01minor_update

Policy Summary

PayerPremera Bluecross

PolicyArtificial Intervertebral Disc: Cervical Spine

Policy CodePolicy N/A

Change TypeMinor device list and formatting updates

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with submission of clinical documentation, device and level information, and imaging reports (MRI/CT/myelography within 12 months).

SourceLink

On This Page

Degeneration must be documented by MRI, CT, or myelography within the prior 12 months.

Accepted modalitiesMagnetic resonance imaging (MRI), computed tomography (CT), or myelography reports are acceptable evidence of degeneration.

Documentation requirementSubmit radiologist's reports for diagnostic imaging completed within the past 12 months as part of the documentation package.

Confirm the device is FDA-approved for the number of levels requested (e.g., Mobi‑C, Prestige LP, ProDisc C variants for two contiguous levels).
Ensure requested levels are contiguous when using a device labeled for two-level implantation; devices are approved for one site or two contiguous sites only.

Note

Confirm Member Coverage / Prior Authorization

Always verify member coverage and benefits prior to performing the procedure. Consult the member benefit booklet or contact a customer service representative to confirm eligibility, prior authorization requirements, and any plan-specific limits that may apply.

Coverage is subject to the member's benefit plan limits and conditions.
Prior authorization approval does not guarantee payment; check for site-of-service or other plan-specific requirements.

Denial Risk

Triggers for Potential Denial

Coverage may be denied if the requested procedure or device is outside FDA-approved indications, if documentation of adequate conservative therapy is insufficient, or if required documentation is missing or incomplete.

Non–FDA-approved levels or non-contiguous multi-level requests.
Failure to document >= 6 weeks of conservative nonoperative therapy (including physical therapy plus at least one other modality) unless urgent surgical indications exist.
Missing clinical records: history & physical, detailed conservative therapy records, or radiology reports within 12 months.

Note

Regulatory Post-Approval Requirements

FDA approvals for cervical disc devices have been contingent on post-approval study commitments. Continued device approval and surveillance may require manufacturers to complete multi-year follow-up studies and submit annual reports of device performance and adverse events.

Manufacturers may be required to perform extended follow-up (e.g., 7-year) of pivotal cohorts and enhanced surveillance (e.g., 5–10 year) for adverse events.
Annual reports to the FDA may include number of devices sold, heterotopic ossification, device malfunction/removal, serious device-related complications, and analysis of explanted discs.

Documentation Required

Required Documentation

Complete documentation must be submitted with the prior authorization request to allow timely review: procedure/diagnosis codes and disc level(s), device identification, current history & physical, detailed conservative therapy records including outcomes and medications, and radiologist reports for diagnostic imaging performed within the past 12 months.

Procedure and diagnosis codes, and identification of exact disc level(s) for surgery.
Device make and model (to confirm FDA approval and labeled levels/sites).
Current history and physical exam.
Detailed documentation of extent and response to conservative nonoperative therapy (physical therapy plus at least one other modality) including outcomes of interventions and medications.
Radiologist's report(s) for MRI/CT/myelography completed within the prior 12 months.

Note

FDA Post-Approval Documentation Expectations

The FDA has required, for some devices, multi-year post-approval clinical studies and enhanced surveillance to characterize device safety and performance in broader populations. These studies typically include extended follow-up of pivotal trial cohorts and long-term adverse event surveillance, which manufacturers must complete to maintain approval.

Examples: 7‑year post‑approval clinical follow-up of pivotal cohorts and 5–10 year enhanced surveillance studies to capture adverse events under general conditions of use.
Continued approval may be contingent on submission of annual reports summarizing sales, complications, removals, and explant analyses.

Documentation Required

Coding / Documentation Note

Documentation and coding history should be maintained consistently. Provide clear clinical narratives tying diagnoses to procedure codes and document prior conservative treatments and their duration to support medical necessity.

Include explicit linkage between diagnosis codes and the clinical rationale for arthroplasty vs fusion.
Maintain records of prior conservative therapy with dates, modalities, and patient response to support the required >= 6 weeks trial.

Prior Authorization

Conservative Therapy Prerequisite

Conservative nonoperative therapy must generally have failed prior to elective artificial cervical disc implantation: at least 6 weeks of conservative treatment including physical therapy plus at least one additional modality (e.g., acupuncture, cervical collar, corticosteroid injection, exercise program, NSAIDs or other analgesics), unless the patient has severe or rapidly progressive neurologic compromise requiring immediate surgery.

Document duration and outcomes of physical therapy and at least one other conservative modality.
Exception: severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment.

Note

Selection Considerations vs Fusion

Selection of cervical disc replacement versus fusion should follow device labeling, clinical indications, and patient selection criteria. Evidence and specialty society guidance support disc replacement as an alternative to fusion in appropriately selected patients when FDA study guidelines and labeling are followed.

Consider artificial disc replacement as an alternative to fusion for eligible patients meeting clinical and radiographic criteria.
Follow FDA labeling and study inclusion/exclusion criteria and specialist guidance when selecting between disc arthroplasty and fusion.

Step Therapy

No step therapy statements apply to this policy.

There are no step therapy or prior authorization sequencing requirements specified beyond the conservative therapy prerequisite described above.

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

DocumentationSymptomatic nerve root compression should be documented by patient history and radiographic studies (e.g., MRI, CT, x-rays).

ASA Score definition

PurposeASA (American Society of Anesthesiologists) Score classifies preoperative anesthesia risk.

ASA 1Normal healthy patient.

ASA 2–5ASA 2: mild systemic disease; ASA 3: severe systemic disease; ASA 4: severe disease that is a constant threat to life; ASA 5: moribund patient not expected to survive.

Indication — reconstruction of the disc from C3 through C7 following single-level discectomy for intractable radiculopathy and/or myelopathy

Indication summaryReconstruction of the disc from C3 through C7 following single-level discectomy for intractable radiculopathy and/or myelopathy.

Clinical documentationIntractable radiculopathy and/or myelopathy should be present with symptomatic nerve root and/or spinal cord compression documented by patient history (pain, functional or neurologic deficit) and radiographic studies (e.g., MRI, CT, x-rays).

Device and approachFDA-approved devices (e.g., Prestige ST) are implanted using an open anterior approach per labeling; post-approval study requirements may apply.

cervical myelopathy (alternate entry)

Alternate entry — definitionCervical myelopathy: loss of function in the upper and lower extremities due to compression of the spinal cord within the neck.

Associated featuresMay include weakness, sensory changes, abnormal reflexes, and functional decline; imaging should corroborate spinal cord compression.

Relevance to policyPresence of cervical myelopathy is an eligible indication for artificial cervical disc when other medical necessity criteria are met.

cervical radiculopathy (alternate entry)

Alternate entry — definitionCervical radiculopathy: persistent neck pain radiating into the shoulder/arm in a dermatomal pattern or progressive weakness from nerve root irritation.

Typical presentationArm/shoulder pain, paresthesias, numbness, sensory deficit, or motor weakness in a nerve-root distribution; corroborated by imaging for nerve root compression.

Relevance to policyIntractable cervical radiculopathy documented clinically and radiographically meets an indication for artificial cervical disc when criteria are otherwise satisfied.

Added header indicating site-of-service review does not apply to Indian Health Services (IHS) facilities.

2025-07-01annual_review

Annual review approved June 9, 2025 with literature review through February 20, 2025; policy statements unchanged.