ModifiedUnitedHealthcarePolicy CS121LA.N

Artificial intervertebral disc replacement (cervical and lumbar)

Medical policy governing use and coverage of FDA‑approved cervical and lumbar artificial total disc replacement (single- and select multilevel indications) for Louisiana Medicaid membership. Specifies circumstances considered medically necessary and those considered unproven or not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyArtificial intervertebral disc replacement (cervical and lumbar)

Policy CodePolicy CS121LA.N

Change TypeRevised coverage wordingoperational updates

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting failure of ≥6 months of multimodal nonoperative care and that patient selection meets device inclusion/exclusion criteria (e.g., single-level lumbar DDD or eligible cervical levels).

SourceLink

POLICY UPDATE CHANGES

Replaced language stating lumbar artificial total disc replacement is proven and medically necessary for single-level lumbar DDD in skeletally mature individuals with language that it is proven and medically necessary in certain circumstances for treating single-level lumbar DDD in skeletally mature individuals.

singlelumbar levels considered medically necessary

1-2levels indicated by NASS for lumbar disc arthroplasty

>1lumbar not medically necessary

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clinical criteria source

0–39%reoperation range reported

Coverage Criteria for Artificial Disc Replacement

Medical necessity statements (summary)

Covered when ALL of the following are met for the specified regions:

Cervical CADR eligibility: Cervical artificial total disc replacement with an FDA-approved prosthetic intervertebral disc is proven and medically necessary in certain circumstances for treating one-level or two contiguous levels of cervical degenerative disc disease (C3 to C7) in a skeletally mature individual with symptomatic radiculopathy and/or myelopathy.

Cervical CADR after prior fusion: Cervical artificial disc replacement with an FDA-approved prosthetic intervertebral disc is proven and medically necessary for treating one level or two contiguous levels in a skeletally mature individual with a history of cervical spinal fusion at another level (adjacent or non-adjacent).

Lumbar TDR eligibility: Lumbar artificial total disc replacement with an FDA-approved prosthetic intervertebral disc is proven and medically necessary in certain circumstances for treating single-level lumbar degenerative disc disease with symptomatic intractable discogenic low back pain in a skeletally mature individual.

Coverage evidence groups

Coverage considerations based on available evidence and device trial inclusion criteria

Single-level lumbar TDR (general): Supported by moderate-quality evidence from randomized controlled trials and IDE studies for properly selected patients with symptomatic single-level lumbar degenerative disc disease (DDD) who have failed ≥ 6 months of nonsurgical management; reported outcomes include improved ODI, VAS, and high patient satisfaction through mid-term follow-up.≥6 months failed conservative care

See RCTs and IDE trial data (Garcia 2015; Radcliff 2021) for comparative outcomes and follow-up.

Multilevel lumbar TDR, hybrid constructs, and multilevel cervical HS: Evidence is limited and mixed; systematic reviews, evolving evidence reviews, and brief reports identify insufficient high-quality evidence to establish long-term safety and effectiveness for multilevel lumbar TDR and hybrid lumbar disc arthroplasty with fusion.evidence insufficient

Hayes reviews and evidence briefs summarize limited support and lack of guideline endorsement.

Covered with criteria (Selected patients)

Covered when ALL of the following are met (per NASS recommendations and policy revision language):

Lumbar TDR coverage criteria: Patient has discogenic low back pain arising from 1 or 2 level disc disruption involving L3-4, L4-5, and/or L5-S1; symptoms for ≥ 6 months not responsive to multimodal nonoperative treatment (including physical therapy/rehabilitation and may include pain management, injections, cognitive behavioral therapy, and active exercise); primary complaint is axial (back) pain (leg pain may be secondary); patient meets device FDA study/labeling inclusion and exclusion criteria and is skeletally mature; age between 18 and 60 years; absence of contraindications such as significant facet arthropathy at the index level, spinal instability with spondylolisthesis greater than Grade I, chronic radiculopathy with predominant leg pain > 1 year, osteopenia (DEXA T-score ≤ -1.0), poorly managed psychiatric disorder, active infection, or tumor.

Follow FDA labeling and IDE study inclusion/exclusion criteria; prior authorization documentation recommended to demonstrate failed conservative care and exclusion of contraindications.

Cervical artificial disc replacement combined with cervical spinal fusion performed as part of the same surgical plan (hybrid cervical surgery) is described in the policy as unproven and not medically necessary because available evidence is insufficient to demonstrate efficacy. The policy notes that combining a one‑level cervical disc replacement with fusion at another cervical level (adjacent or non‑adjacent) lacks adequate clinical trial support to establish benefit and therefore is not considered medically necessary for coverage decisions.

For clinical medical necessity criteria for standalone cervical artificial disc replacement, the policy refers providers to the InterQual® criteria; however, hybrid cervical constructs performed in a single operative plan are explicitly listed as not medically necessary due to limited evidence supporting improved outcomes.

The policy states that lumbar artificial total disc replacement is unproven and not medically necessary at more than one spinal level because evidence for multilevel lumbar TDR is insufficient. Systematic reviews and evidence evaluations (Hayes and others) have concluded there is moderate‑quality evidence supporting single‑level LTDR but insufficient evidence for two‑level or multilevel procedures, and the policy uses this as the basis to deny coverage for LTDR performed at >1 level.

Providers seeking authorization should note that published RCTs and cohort studies support single‑level LTDR in selected patients, but the policy specifically excludes multilevel lumbar TDR from coverage due to lack of adequate evidence on safety and long‑term effectiveness.

The policy highlights that no professional society guidelines were identified that specifically endorse hybrid lumbar disc arthroplasty with fusion for multilevel degenerative disc disease. A recent Hayes evidence review found minimal support in the literature and noted the absence of position statements or guideline recommendations endorsing hybrid lumbar constructs, which the policy cites as a reason for regarding these constructs as having limited evidence.

Indications and contraindications for lumbar disc arthroplasty in the policy align with established selection criteria: lumbar TDR is intended for symptomatic discogenic low back pain arising from one or two levels (L3‑4, L4‑5, L5‑S1) in skeletally mature patients who have failed conservative care. The policy lists specific contraindications and exclusions, including significant facet arthropathy at the index level, spinal instability with spondylolisthesis greater than Grade I, chronic radiculopathy with predominant leg pain for ≥1 year, osteopenia (DEXA T‑score ≤ -1.0), poorly managed psychiatric disorder, age <18 or >60, infection, or tumor.

Evidence summaries cited in the policy (including comparative effectiveness reviews) support single‑level LTDR in properly selected patients but note limited evidence for multilevel disease and emphasize adherence to device labeling and study inclusion/exclusion criteria when determining eligibility.

The policy explicitly states that hybrid cervical surgery—defined as artificial disc replacement at one cervical level combined with fusion at another level during the same surgical plan—is unproven and not medically necessary because there are few clinical trials and insufficient evidence to support improved health outcomes or established patient selection criteria for this approach.

Although cervical CADR alone (one or two contiguous levels) may be considered proven and medically necessary in selected patients, combining CADR with fusion in the same operative session is not supported by the evidence cited in the policy and is therefore excluded from coverage.

The policy reaffirms that lumbar total disc replacement performed at more than one level is unproven and not medically necessary. Comparative effectiveness reviews and evidence briefs concluded that while single‑level LTDR has moderate‑quality support in selected patients, the literature is insufficient to support two‑level or multilevel LTDR and therefore multilevel procedures are excluded from coverage.

Providers should document that lumbar TDR is limited to the single‑level indication when requesting authorization, since the policy does not cover LTDR at >1 level.

Two‑level lumbar TDR and hybrid lumbar constructs combining disc replacement with fusion are treated in the policy as procedures with insufficient evidence to establish safety and long‑term effectiveness. Hayes evidence analyses and reviews identified a small number of trials and observational studies (including RCTs and abstracts) but concluded that the existing data do not provide conclusive support for routine use of two‑level LTDR or hybrid lumbar constructs.

Because the evidence base is limited and heterogeneous, the policy considers these multilevel and hybrid lumbar approaches investigational or not medically necessary in the absence of high‑quality supporting data.

The policy notes that some guideline panels have explicitly identified insufficient evidence to evaluate long‑term benefits and harms of disc replacement. For example, the American Pain Society concluded data beyond two years are limited and insufficient to assess long‑term outcomes, and the 2020 NICE guideline recommends that physicians do not offer disc replacement for low back pain.

These guideline statements are cited in the policy to support the position that long‑term effectiveness and safety of disc replacement—particularly for multilevel or hybrid procedures—remain uncertain and warrant caution in coverage decisions.

Procedure Codes, Key Criteria, and Coding Notes

Applicable Procedure CPT/HCPCS Codes (reference)mixed

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).
0165T	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure).
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).
22860	Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar (List separately in addition to code for primary procedure).
22861	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical.
22862	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar.
22899	Unlisted procedure, spine

Regulatory / informational codesmixed

MJO (FDA product code)

FDA product code for artificial discs (informational reference)

Duration of nonoperative management — ≥ 6 months

Minimum duration of failed nonoperative careAt least 6 months of multimodal nonoperative management (e.g., physical therapy/rehabilitation, pain management, injections, CBT, active exercise) must have failed before considering TDR.

Trial documentationClinical records should document the types and duration of conservative therapies attempted over the ≥6-month period.

Clinical-trial consistencyIDE and RCT enrollment required failure of ≥6 months of nonsurgical management; policy follows these trial selection expectations.

Number of involved spinal levels appropriate for lumbar TDR — 1–2 levels (L3-4, L4-5, L5-S1)

Allowed lumbar levels for considerationOne to two involved lumbar levels (L3-4, L4-5, L5-S1) may be considered in selection criteria, with single-level lumbar TDR supported; multilevel procedures have limited evidence.

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Codes (Reference)

Prior authorization is required for cervical and lumbar total disc replacement (TDR). Coverage is determined by medical necessity clinical criteria (refer to InterQual® Procedures, Artificial Disc Replacement, Cervical and InterQual® Client Defined, CP: Procedures, Artificial Disc Replacement, Lumbar (Custom) - UnitedHealth Group). Submission of applicable procedure and revision CPT codes is required for prior authorization review; listing of a code does not guarantee coverage.

Prior authorization must document that selection criteria in the InterQual criteria are met (including level count and device-specific indications).
Include relevant CPT codes and any revision codes submitted (see Applicable Codes in policy).
Codes listed are provided for reference and do not guarantee payment or coverage.

Documentation Required

Confirm Conservative Management Failure and Prior-Fusion Status

Prior authorization must confirm that the patient has failed an adequate course of conservative (nonsurgical) management and document any prior lumbar fusion status when applicable. For lumbar TDR, documentation should confirm failure of at least 6 months of multimodal nonsurgical therapy before consideration for surgery, unless device-specific IDE or FDA-labeled indications specify otherwise.

Background and Rationale

Artificial total disc replacement is a surgical intervention that replaces a degenerating intervertebral disc with a prosthetic device with the aim of preserving segmental range of motion and reducing pain in adults with degenerative disc disease. Cervical devices are intended for one or two contiguous levels in skeletally mature individuals with symptomatic radiculopathy and/or myelopathy, while lumbar devices are indicated primarily for single‑level symptomatic discogenic low back pain in skeletally mature patients.

The policy emphasizes appropriate patient selection and adherence to device labeling and study inclusion/exclusion criteria, and it references InterQual guidance for detailed clinical coverage criteria applicable to both cervical and lumbar artificial disc procedures.

Definitions

Skeletally Mature — definition and use

DefinitionSkeletally mature: the apparent stage of bone development in a growing child or adolescent as determined by radiological studies.

Use in eligibilityPolicy requires the patient be skeletally mature for cervical or lumbar disc arthroplasty eligibility.

Assessment methodRadiographic determination of bone development is the basis for assessing skeletal maturity.

Hybrid construct (HS/HC) — definition of combined TDR + fusion construct

DefinitionHybrid construct (HS/HC): a surgical construct combining total disc replacement at one or more levels with fusion (e.g., TDR + ALIF) performed simultaneously across multiple lumbar or cervical levels.

Evidence noteSystematic reviews and evidence briefs note increasing use but less robust data for multilevel hybrid constructs; evidence for hybrid lumbar constructs is limited.

Policy Summary

PayerUnitedHealthcare

PolicyArtificial intervertebral disc replacement (cervical and lumbar)

Policy CodePolicy CS121LA.N

Change TypeRevised coverage wordingoperational updates

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

CADR after prior cervical fusion: Small retrospective series and cohort data suggest CADR/ACDR may improve pain and function for adjacent-segment disease after prior ACDF with preserved motion in many patients, but study sizes and follow-up are limited.prior ACDF documented

Observational studies report improvements in patient-reported outcomes but are limited in number and duration.

Primary targetSingle-level symptomatic degenerative disc disease is the principal indication supported by RCT/IDE evidence.

Multilevel cautionEvidence is limited for multilevel lumbar TDR and hybrid constructs; procedures for disease at more than two levels are not indicated.

DEXA T-score exclusion threshold — T-score <= -1.0

DEXA exclusion thresholdOsteopenia defined as a DEXA T-score ≤ -1.0 is an exclusionary finding and risks denial of coverage for disc arthroplasty.

Assessment requirementPreoperative bone mineral density assessment (DEXA) should be documented when clinically indicated to rule out osteopenia/osteoporosis.

Relation to contraindicationsPresence of osteopenia (T-score ≤ -1.0) is listed among contraindications (with age and instability) and may make TDR not indicated.

Age limits — 18–60 years

Age eligibility rangePatients should be between 18 and 60 years of age to be eligible for consideration of disc arthroplasty.

Age-related exclusionsAge greater than 60 years or less than 18 years is listed as an exclusionary criterion and may lead to denial.

Alignment with device studiesPolicy age limits align with device trial and FDA labeling inclusion/exclusion ranges used in evidence summaries.

Document duration and types of conservative therapies tried (≥ 6 months total), including outcomes.
If prior lumbar fusion exists, specify level(s) and whether the planned TDR is at an adjacent or non-adjacent level.
Indicate whether the case is primary TDR or revision (include revision CPT if applicable).

Prior Authorization

Prior Authorization Required for Lumbar TDR When Selection Criteria Documented

For lumbar TDR, prior authorization must show that patient selection meets policy and InterQual criteria for single-level TDR (lumbar TDR is proven and medically necessary for single-level symptomatic degenerative disc disease in properly selected, skeletally mature patients). Lumbar TDR is considered unproven and not medically necessary at more than one spinal level; hybrid constructs (TDR + fusion) and multilevel TDR have insufficient evidence and may be denied.

Prior authorization should explicitly state number of levels to be treated (single level vs >1).
Requests for >1 level lumbar TDR or hybrid TDR+fusion should include evidence supporting use; expect higher risk of denial due to insufficient evidence.
For cervical TDR, prior authorization should document that one- or two-level procedures meet criteria; simultaneous cervical TDR combined with fusion at another level is considered unproven and not medically necessary.

Denial Risk

Procedures Performed for Disease at More Than One Level

Procedures that do not meet the clinical selection criteria or that treat disease at more levels than supported by evidence are subject to denial. Examples include multilevel (>1) lumbar TDR, cervical TDR combined with fusion at another level as part of the same surgical plan, and hybrid lumbar constructs without sufficient supporting evidence.

Do not submit prior authorization assuming coverage for multilevel or hybrid procedures; provide robust justification if pursuing.
Specify if planned procedure is staged or single-session and include rationale.
Document any investigational device exemption (IDE) study enrollment or FDA-labeled indications that may affect consideration.

Billing Rule

Coding and Documentation

Coding and documentation supporting the prior authorization and claims must include the applicable CPT codes (primary and any add-on/revision codes) and relevant diagnosis codes. Use the codes listed in the policy as reference and attach operative reports, imaging, and conservative-treatment records to substantiate medical necessity.

Include primary procedure CPT and any add-on or revision CPTs (e.g., 22858, 22860, 22861, 22862, 0098T, 0165T where applicable).
Attach preoperative imaging reports (MRI, dynamic X-rays), conservative therapy records, and prior surgery documentation.
If submitting unlisted code 22899, include complete operative documentation to support code choice and medical necessity.

Documentation Required

Selection and Prior-Surgery Documentation

Selection criteria and prior-surgery documentation must be present in the prior authorization package. Providers must demonstrate that the patient meets device and policy selection criteria (age, symptomatic profile, imaging concordance) and clearly state any prior lumbar surgery or fusion history.

Document primary complaint (e.g., intractable discogenic low back pain vs radiculopathy), level(s) involved, and imaging correlates.
List prior operative reports and dates; indicate how prior procedures affect current candidacy.
For cervical cases, specify if prior fusion exists at adjacent or non-adjacent levels.

Documentation Required

Documentation Should Support at Least 6 Months Failed Multimodal Nonoperative Care

Provider documentation should explicitly support at least 6 months of failed multimodal nonoperative care prior to lumbar TDR unless device labeling or IDE protocol specifies otherwise. Records should detail the types, duration, frequency, and outcomes of conservative treatments attempted.

List physical therapy dates and frequency, medication trials (including opioid use and outcomes), interventional procedures (epidural steroid injections, nerve root blocks) with dates and responses, and any behavioral therapies (CBT, pain management).
State clearly the total duration of nonoperative care (must be ≥ 6 months for lumbar TDR candidates per policy expectations).
If shorter trial is claimed due to severity or device-specific criteria, include justification and supporting documentation.

Step Therapy

Step/Sequence Requirements

Follow the step/sequence and conservative-treatment expectations outlined in InterQual clinical criteria when preparing prior authorization requests. Prior authorization review will reference InterQual for specifics on required prior conservative treatments, diagnostic findings, and functional impairment thresholds.

Ensure the prior authorization narrative maps each InterQual criterion to supporting documentation (e.g., imaging, clinical exam, trial therapies).
If deviation from InterQual pathways is proposed, document rationale and supporting evidence in the request.

Prior Authorization

Conservative Therapy Prerequisite

Conservative therapy prerequisite: candidates for lumbar TDR must have undergone adequate nonsurgical therapy. IDE and pivotal studies typically required ≥ 6 months of nonsurgical care prior to enrollment; this expectation should be reflected in prior authorization documentation.

Conservative care includes supervised physical therapy, medication management, activity modification, and selective injections as clinically indicated.
Document dates, clinicians, and objective response (or lack thereof) to each modality.

Documentation Required

Nonoperative Multimodal Therapy Expectations

Nonoperative multimodal therapy expectations include formal physical therapy/rehabilitation and may include interventional pain procedures and behavioral interventions. Prior authorization should list and document these modalities and their outcomes.

Physical therapy/structured rehabilitation program with dates and progress notes.
Interventional procedures (epidural steroid injections, selective nerve root blocks) with dates and documented response.
Pain management strategies (medication trials, opioid usage history) and psychological/behavioral interventions if used.

Coverage stanceHybrid lumbar constructs have limited supporting evidence and may be considered investigational or not medically necessary in many cases.

CADR/ACDR/CTDR — definitions for cervical artificial disc replacement terms

DefinitionCADR/ACDR/CTDR: cervical artificial (total) disc replacement used as primary or revision surgery, including for adjacent-segment degeneration after prior anterior cervical discectomy and fusion (ACDF).

Clinical outcomesRetrospective series report improved VAS and NDI scores and preserved or improved cervical ROM after CADR in primary and post-fusion (adjacent segment) cases.

Evidence limitationsAvailable studies are generally small retrospective series with limited follow-up; systematic assessment calls for larger, higher-quality data for multilevel HS.

Discogenic low back pain / DDD — definition and scope (1–2 lumbar discs)

Definition and scopeDiscogenic low back pain / DDD: axial low back pain attributed primarily to symptomatic degeneration of one or two lumbar intervertebral discs (commonly L3-4, L4-5, L5-S1) in patients unresponsive to nonoperative management.

Level limitationPolicy-supported TDR indications focus on single-level lumbar DDD; involvement of more than two levels is not indicated.

Clinical presentationPrimary complaint should be axial (back) pain; predominant chronic radiculopathy with leg-predominant pain is an exclusion if >1 year.