CurrentBlue Cross Blue Shield - North DakotaPolicy 127

Artificial Intervertebral Disc

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This policy governs medical necessity and investigational status for anterior cervical and total lumbar artificial intervertebral disc replacement. It applies to providers requesting coverage for cervical or lumbar disc arthroplasty; revision or replacement of artificial intervertebral discs is not addressed.

Policy Summary

PayerBlue Cross Blue Shield - North Dakota

PolicyArtificial Intervertebral Disc

Policy CodePolicy 127

Change TypeRevision

Effective DateApril 1, 2026

Last ReviewMar 1, 2026

Next Review DateFebruary 1, 2027

Key ActionSubmit the listed clinical records and the specific requested device name for review to determine whether policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy document states that the policy has been revised.

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CurrentBlue Cross Blue Shield - North DakotaPolicy 127

Artificial Intervertebral Disc

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Policy Summary

PayerBlue Cross Blue Shield - North Dakota

PolicyArtificial Intervertebral Disc

Policy CodePolicy 127

Change TypeRevision

Effective DateApril 1, 2026

Last ReviewMar 1, 2026

Next Review DateFebruary 1, 2027

Key ActionSubmit the listed clinical records and the specific requested device name for review to determine whether policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

The policy document states that the policy has been revised.

Medical Necessity and Investigational Criteria

Initial cervical disc replacement

Covered as medically necessary when all of the following criteria are met:

Initial anterior total cervical disc replacement

Device, levels, maturity, and diagnosis: The request is for an FDA-approved artificial intervertebral disc; replacement is at a single level or simultaneous two contiguous levels; the patient is skeletally mature; and the operative level is between C3 and C7.C3-C7; one level or two contiguous levels
Cervical neurologic diagnosis and treatment pathway
- At least one treatment pathway
  - Failed conservative therapy: Documentation shows at least six weeks of failed conservative nonoperative therapy, including at least two of analgesics or NSAIDs when not contraindicated, physical therapy, or activity alteration.At least six weeks; at least two therapies
  - Urgent compression pathway: Severe or rapidly progressive nerve-root or spinal-cord compression requires immediate surgical treatment.
    Examples include increasing numbness or tingling, increasing motor loss, or muscle strength less than or equal to 3/5.
Imaging: MRI, CT, or other imaging is consistent with the patient's symptoms and demonstrates moderate to severe spinal stenosis, cord compression, or nerve-root compression at the operative level from a herniated disc or spondylosis with osteophytes.
For a requested second-level disc replacement, imaging must be within six months.
Appropriate anterior cervical surgical candidate: The patient is an appropriate candidate for anterior cervical spinal surgery and has none of the following: prior surgery at the operative levels; prior cervical artificial disc replacement at two or more levels; severe facet joint pathology of the involved vertebral bodies; or a condition affecting osteogenesis.
Osteogenesis-related conditions include metabolic bone disease, primary or metastatic spinal malignancy, or a condition requiring daily high-dose oral steroids. Osteoporosis is defined by a DXA T-score less than or equal to -2.5.

Subsequent second-level cervical disc replacement

May be considered medically necessary when all of the following criteria are met:

Subsequent second-level anterior total cervical disc replacement

FDA-approved device: The request is for an FDA-approved artificial intervertebral disc.
Skeletal maturity: The patient is skeletally mature.
Different cervical level: The planned procedure is at a different cervical level than the initial cervical artificial disc replacement.
Healed initial replacement: Clinical documentation establishes that the initial cervical artificial disc replacement is fully healed.

Total lumbar disc replacement

May be considered medically necessary when all of the following criteria are met:

Device, level, age, and procedure design: The request is for an FDA-approved artificial intervertebral disc; replacement is at a single level at L3-4, L4-5, or L5-S1; the individual is 18-60 years old; and no simultaneous fusion is planned at an adjacent lumbar level.Age 18-60; L3-4, L4-5, or L5-S1
Lumbar imaging: MRI, CT, or other imaging demonstrates moderate to severe single-level disc degeneration at the operative level, absence of degenerative disc disease at more than one level, and absence of degenerative disc disease above L3-L4.
Failed conservative therapy: Documentation shows at least six weeks of failed conservative nonoperative therapy, including at least two of analgesics or NSAIDs when not contraindicated, physical therapy, or activity alteration.At least six weeks; at least two therapies

Not medically necessary and investigational indications

The following uses are not covered as medically necessary or are investigational:

Noncovered or investigational scenario: Total cervical disc replacement that does not meet the initial or subsequent second-level cervical criteria is not medically necessary; total lumbar disc replacement that does not meet the lumbar criteria is not medically necessary; and total disc replacement with artificial intervertebral discs is investigational for all other indications.

Cervical replacement

Covered as medically necessary when applicable policy criteria are met:

Cervical artificial disc replacement: Single-level, simultaneous two-level, or subsequent second-level placement of an artificial intervertebral disc at cervical spinal levels between C3 and C7.C3-C7; one or two levels

Cervical guideline indications

The policy cites the following NASS qualifying cervical indications:

Qualifying cervical indication: Radiculopathy related to nerve-root compression from one- or two-level degenerative disease, due to a herniated disc or spondylotic osteophyte, from C3-4 to C6-7, with or without neck pain, refractory to medical or nonoperative management; or myelopathy or myeloradiculopathy related to central spinal stenosis from one- or two-level degenerative disc disease from C3-4 to C6-7, with or without neck pain.One or two levels; C3-4 through C6-7

Lumbar replacement

Covered as medically necessary when applicable policy criteria are met:

Lumbar artificial disc replacement: Single-level placement of an artificial intervertebral disc at lumbar spinal levels between L4 and S1.Single level; L4-S1

Lumbar guideline criteria

The policy cites the following NASS lumbar coverage recommendation:

NASS lumbar selection criteria: The patient has symptomatic single-level lumbar disc disease at L3-L4, L4-L5, or L5-S1; symptoms have been present for at least six months and have not responded to multimodal nonoperative treatment, including a physical therapy or rehabilitation program; any underlying psychiatric disorder, such as depression, has been diagnosed and management optimized before surgery; and the primary complaint is axial pain, with a possible secondary complaint of lower-extremity pain.Symptoms for at least six months; multimodal nonoperative treatment including physical therapy or rehabilitation

Multimodal treatment may also include pain management, injections, cognitive behavior therapy, and active exercise programs.

Investigational or not covered uses

The following uses are considered investigational:

Uses outside covered indications: Placement at spinal levels other than cervical segments between C3 and C7; cervical artificial disc placement at more than two spinal levels; and lumbar artificial disc placement outside the covered single-level L4-S1 indication.Outside C3-C7 cervical range; more than two cervical levels; or outside single-level L4-S1 lumbar indication

Current research does not show improvement in health outcomes for these other uses.

Revision or replacement of artificial intervertebral discs is not addressed by this policy.

Cervical and lumbar artificial disc replacement is not medically necessary when the applicable policy criteria are not met. Other uses are considered investigational as described in the policy.

Artificial intervertebral disc placement at cervical spinal levels outside C3-C7 is considered investigational.

Artificial intervertebral cervical disc placement at more than two spinal levels is considered investigational.

Total cervical disc replacement that does not meet Criterion I or Criterion II is considered not medically necessary.

Total lumbar disc replacement that does not meet Criterion III is considered not medically necessary.

Single-level or two-level cervical artificial disc replacement is not medically necessary when the applicable policy criteria are not met.

Single-level lumbar artificial disc replacement is not medically necessary when the applicable policy criteria are not met.

Codes and Key Coverage Parameters

FDA Product Codemixed

MJO	Artificial intervertebral discs

CodesCPT

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
22857	Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); single interspace, lumbar
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)
22862	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical
22864	Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical

CodesCPT

22865	Removal of total disc arthroplasty (artificial disc), anterior approach, lumbar, single interspace
22899	Unlisted procedure, spine
0095T	Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure)
0098T	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure)

Cervical replacement levels

ProcedureAnterior total cervical disc replacement with or without a hybrid construct following complete decompression.

Permitted levelsSingle level or simultaneous two contiguous levels between C3 and C7.

Device requirementThe requested artificial intervertebral disc must be FDA-approved.

Conservative therapy

Minimum durationAt least six weeks of failed conservative nonoperative therapy.

Required therapiesAt least two of analgesics or NSAIDs when not contraindicated, physical therapy, or activity alteration.

Submission Requirements and Denial Risks

Documentation Required

Submit Complete Review Records

Submit the clinical records needed for medical-necessity review, including the specific artificial intervertebral disc device name requested.

History and physical or chart notes
Symptoms and associated diagnoses
MRI, CT, or other imaging with documented findings
Planned artificial intervertebral disc placement level(s)
Completed conservative nonoperative therapy and symptom response
Specific name of the requested device

Step Therapy

Document the Conservative-Treatment Trial

When required by the applicable pathway, document that at least six weeks of conservative nonoperative therapy failed to adequately treat symptoms. The trial must include at least two therapies; urgent cervical nerve-root or spinal-cord compression with severe or rapidly progressive symptoms may qualify for immediate surgery instead.

Clinical Background

Artificial intervertebral discs are synthetic replacements for damaged cervical or lumbar intervertebral discs. They are intended as a motion-preserving alternative to spinal fusion. The policy distinguishes FDA-approved devices and specified cervical or lumbar clinical scenarios from investigational devices or indications.

Terms and Clinical Measures

Artificial intervertebral discs

DefinitionArtificial intervertebral discs are synthetic replacements for damaged intervertebral discs.

Spinal regionsThey are used in the cervical or lumbar regions of the spine.

Alternate descriptionThey are also known as intervertebral disc prostheses.

Hybrid surgery

DefinitionHybrid surgery contains elements of traditional discectomy and fusion, artificial disc replacement, and anterior cervical corpectomy and fusion.

CombinationThe surgical elements may be included in varying proportions.

Lumbar criterion

Policy Summary

PayerBlue Cross Blue Shield - North Dakota

PolicyArtificial Intervertebral Disc

Policy CodePolicy 127

Change TypeRevision

Effective DateApril 1, 2026

Last ReviewMar 1, 2026

Next Review DateFebruary 1, 2027

Key ActionSubmit the listed clinical records and the specific requested device name for review to determine whether policy criteria are met.

SourceLink

On This Page

No lumbar contraindications: None of the listed contraindications is present, including revision of a failed lumbar total disc arthroplasty; facet ankylosis or severe facet degeneration; osteopenia or osteoporosis; degenerative or lytic spondylolisthesis greater than 3 mm; lumbar spinal stenosis; pars defect with spondylolysis or isthmic spondylolisthesis; scoliosis greater than 11 degrees of sagittal plane deformity; spinal fracture; tumor or active infection; lumbar nerve-root compression or bony spinal stenosis; remaining disc height less than 3 mm; mid-sagittal stenosis less than 8 mm; ankylosing spondylitis, rheumatoid arthritis, lupus, or another autoimmune disorder; or an isolated radicular compression syndrome.Spondylolisthesis ≤3 mm; scoliosis ≤11 degrees; remaining disc height ≥3 mm; mid-sagittal stenosis ≥8 mm

Alternative pathwayThe requirement may be replaced by severe or rapidly progressive nerve-root or spinal-cord compression requiring immediate surgery.

Osteoporosis exclusion

ExclusionOsteoporosis is a contraindication to the applicable cervical replacement pathway.

DXA thresholdA DXA T-score less than or equal to -2.5 meets the policy definition of osteoporosis.

Clinical contextThe osteoporosis exclusion appears under conditions known to affect osteogenesis.

Lumbar age range

Eligible ageThe individual must be 18-60 years old.

ProcedureThe criterion applies to total lumbar disc replacement.

Associated requirementThe request must also be for an FDA-approved artificial intervertebral disc.

Lumbar operative levels

Number of levelsSingle-level replacement only.

Permitted levelsL3-4, L4-5, or L5-S1.

Adjacent fusionA planned simultaneous fusion at an adjacent lumbar level is not permitted.

Lumbar spondylolisthesis threshold

Imaging exclusionDegenerative or lytic spondylolisthesis greater than 3 mm is a contraindicating imaging finding.

MeasurementThe threshold is more than 3 mm.

Procedure contextThe threshold applies to total lumbar disc replacement eligibility.

Lumbar scoliosis threshold

Imaging exclusionLumbar scoliosis greater than 11 degrees of sagittal plane deformity is a contraindication.

MeasurementThe threshold is more than 11 degrees.

Procedure contextThe threshold applies to total lumbar disc replacement eligibility.

Remaining disc height threshold

Imaging exclusionPreoperative remaining disc height less than 3 mm is a contraindicating imaging finding.

MeasurementThe threshold is below 3 mm.

Procedure contextThe threshold applies to total lumbar disc replacement eligibility.

Mid-sagittal stenosis threshold

Imaging exclusionMid-sagittal stenosis less than 8 mm is a contraindicating imaging finding.

MeasurementThe threshold is below 8 mm.

Procedure contextThe threshold applies to total lumbar disc replacement eligibility.

Duration of lumbar symptoms

Minimum durationSymptoms must have been present for at least six months.

Treatment responseSymptoms must not have responded to multimodal nonoperative treatment over that period.

Required programThe nonoperative treatment must include a physical therapy or rehabilitation program.

Analgesics and/or NSAIDs, when not contraindicated
Physical therapy
Activity modification, including stopping activities that worsen symptoms

Documentation Required

Required Review Documentation

Include the records necessary to verify the planned treatment and policy criteria. Missing information may affect the review and decision outcome.

History and physical or chart notes
Symptoms and associated diagnoses
MRI, CT, or other imaging findings
Planned treatment and operative disc level(s)
Conservative therapy completed and symptom response
Specific requested device name

Prior Authorization

Support Medical Necessity

Support medical necessity by documenting the diagnosis, neurologic findings, operative level, imaging severity and concordance, and skeletal and surgical eligibility. Records should show that symptoms and neurologic deficits correspond to the operative level and that applicable contraindications are absent.

Cervical radiculopathy or myelopathy with radicular arm pain and a nerve-root or myelopathic-level neurologic deficit
Moderate-to-severe stenosis, cord compression, or nerve-root compression from a herniated disc or spondylosis at the operative level
Imaging consistent with the patient's symptoms; second-level cervical requests require imaging within six months
Skeletal maturity and candidacy for anterior cervical surgery
No applicable contraindications, including severe facet pathology, relevant prior surgery, qualifying bone disease, malignancy, or high-dose steroid use

Denial Risk

Cervical Eligibility Gaps

Cervical requests may be denied when eligibility parameters are not documented. The device must be FDA-approved, the patient must be skeletally mature, and the request must be for a single level or simultaneous two contiguous levels between C3 and C7.

Requests involving more than two cervical levels or noncontiguous levels fall outside the stated pathway
The operative levels must be between C3 and C7
The request must address symptomatic cervical degeneration with the required neurologic findings and concordant imaging

Prior Authorization

Second-Level Cervical Requirements

For a subsequent second-level cervical replacement, document that the new procedure is at a different cervical level than the initial replacement and that the initial cervical artificial disc replacement is fully healed. The request must also use an FDA-approved device, involve a skeletally mature patient, and meet all initial cervical Criteria I.A–G.

Different cervical level from the initial cervical artificial disc replacement
Documentation that the initial replacement is fully healed
All applicable initial cervical eligibility, imaging, conservative-treatment, and contraindication requirements

Denial Risk

Lumbar Eligibility Gaps

Lumbar requests may be denied when any pathway condition is missing. Coverage requires an FDA-approved device, a single-level replacement at L3-4, L4-5, or L5-S1, an age of 18–60 years, symptomatic single-level discogenic low back pain, and no planned adjacent-level simultaneous fusion.

Imaging must show moderate-to-severe single-level degeneration, no degeneration at more than one level, and no degenerative disc disease above L3-L4
Document at least six weeks of failed conservative therapy, including at least two specified therapies
Exclude revision of failed lumbar arthroplasty, severe facet disease or ankylosis, osteopenia or osteoporosis, autoimmune disease, isolated radicular compression, and specified stenosis, instability, deformity, fracture, tumor, infection, or inadequate disc-height findings

Denial Risk

Criteria Failure or Other Indication

Cervical or lumbar total disc replacement is not medically necessary when the applicable cervical Criterion I or II, or lumbar Criterion III, is not met. Uses for indications outside those covered criteria are investigational.

Document every applicable criterion before submitting the request
Do not rely on the policy's covered pathway for an indication that falls outside the stated cervical or lumbar requirements

Denial Risk

Criteria Not Met

Coverage is not medically necessary when the applicable policy criteria are not met, including the requirements for covered cervical or lumbar disc replacement pathways.

Cervical replacement must meet Criterion I or the subsequent second-level pathway in Criterion II
Lumbar replacement must meet Criterion III

Denial Risk

Investigational Indication or Level

Uses outside the covered cervical and lumbar ranges are investigational rather than medically necessary. This includes artificial disc placement at other spinal levels and cervical placement at more than two spinal levels.

Cervical levels outside C3–C7
Cervical replacement involving more than two spinal levels
Other indications or uses not addressed by the covered cervical or lumbar criteria

A planned simultaneous fusion at an adjacent lumbar level is not permitted for the covered lumbar replacement pathway.

Investigational device exemption (IDE)

PurposeAn investigational device exemption permits an investigational device to be used in a clinical study.

Study objectiveThe study collects safety and effectiveness data.

Approval requirementClinical evaluations of investigational devices generally require an approved IDE before study initiation unless exempt.

Neck Disability Index (NDI)

DefinitionThe Neck Disability Index is a validated multidimensional instrument measuring the effects of pain and disability on everyday life.

ContentIt is based on 10 questions addressing neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation.

ScoringScores range from 0% to 100%; a lower percentage indicates less pain and disability.

Neurologic status

DefinitionNeurologic status is a composite measure of motor function, sensory function, and deep tendon reflexes.

AssessmentIt is used to judge whether patients are within normal physiologic parameters for those categories.

Neurologic successNeurologic success is generally based on postoperative maintenance or improvement compared with preoperative status for each component.

Overall success

TrialFor the two-level Prestige LP trial, overall success was the primary outcome.

NDI requirementOverall success required a 15-point improvement on the NDI.

Additional componentsIt also required maintenance or improvement in neurologic status, no serious implant- or surgery-related adverse event, and no additional surgical procedure classified as a failure.

Functional spinal unit (FSU) height

DefinitionFunctional spinal unit height is a radiographic measure of the interdiscal space.

ComparisonImmediate postoperative FSU height is compared with the six-week postoperative measurement.

Clinical significanceA decrease may indicate graft or device subsidence.

AIDA

Full termAIDA means artificial intervertebral disc arthroplasty.

Use in evidenceThe abbreviation is used in the evidence discussion.

Comparator relationshipAIDA is compared with ACDF for cervical disc disease.

ACDF

Full termACDF means anterior cervical discectomy and fusion.

Role in trialsACDF is the surgical comparator used in cervical artificial disc trials.

ComparisonCervical AIDA outcomes are compared with ACDF outcomes.

Heterotopic ossification

DefinitionHeterotopic ossification is abnormal bone formation after artificial disc arthroplasty.

Clinical significanceIt may progress to loss of segmental motion.

Evidence contextHeterotopic ossification appears to be common with artificial intervertebral disc arthroplasty, although the evidence cited reports no large impact on clinical outcomes.

Cervical artificial disc replacement

DefinitionCervical artificial disc replacement is placement of an artificial disc for cervical spinal disease.

Alternate termIt is also called cervical total disc replacement.

Another termIt is also called cervical arthroplasty.

Lumbar artificial disc replacement

DefinitionLumbar artificial disc replacement is a lumbar procedure for selected patients with discogenic low back pain.

Clinical roleIt is considered an alternative to lumbar fusion.

Selection contextThe cited recommendation applies to symptomatic single-level lumbar disc disease at L3-L4, L4-L5, or L5-S1 with symptoms for at least six months that have not responded to multimodal nonoperative treatment.