ModifiedUnitedHealthcarePolicy CS121ID.B

Total Artificial Disc Replacement for the Spine (for Idaho Only)

Medical policy governing coverage of cervical and lumbar total artificial disc replacement (TDR) for Idaho members, including Idaho Medicaid Plus. Specifies when cervical and lumbar TDR are considered medically necessary, unproven, or not medically necessary and references InterQual criteria for clinical details.

Policy Summary

PayerUnitedHealthcare

PolicyTotal Artificial Disc Replacement for the Spine (for Idaho Only)

Policy CodePolicy CS121ID.B

Change TypeRevised coverage rationaleadded documentation guidance

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument at least 6 months of prior nonoperative management and make medical records available on request to support authorization.

SourceLink

POLICY UPDATE CHANGES

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

Added explicit Medical Records Documentation Used for Reviews language describing the documentation that may be required and that documentation does not guarantee coverage.

Updated Clinical Evidence and References sections to reflect the most current information.

cervical: 1–2levels considered potentially medically necessary

lumbar: single levellumbar TDR coverage limitation

hybrid CDR+fusion

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classified as unproven/not medically necessary for simultaneous levels

InterQual referencedexternal clinical criteria source

≥6 monthsminimum nonoperative treatment prior to consideration

up to 33%reported reoperation/revision rate (long-term)

Coverage Criteria for Cervical and Lumbar Total Artificial Disc Replacement

Medically necessary indications

Covered when ALL of the following are met (see InterQual for full clinical detail):

Cervical TDR general coverage: Cervical artificial total disc replacement with an FDA-approved prosthetic intervertebral disc is medically necessary for one-level or two contiguous levels (C3–C7) in a skeletally mature individual with symptomatic radiculopathy and/or myelopathy.one or two contiguous levels

Refer to InterQual CP: Procedures, Artificial Disc Replacement, Cervical for full clinical criteria

Cervical TDR after prior fusion: Cervical artificial disc replacement is medically necessary for one or two contiguous levels in a skeletally mature individual with a history of cervical spinal fusion at another level (adjacent or non-adjacent).history of cervical fusion at another level

Lumbar TDR general coverage: Lumbar artificial total disc replacement with an FDA-approved prosthetic intervertebral disc is medically necessary for single-level lumbar degenerative disc disease with symptomatic intractable discogenic low back pain in a skeletally mature individual; lumbar TDR is unproven and not medically necessary at more than one spinal level.single level only

Refer to InterQual Client Defined CP: Procedures, Artificial Disc Replacement, Lumbar (Custom) - UHG for detailed criteria

Unproven / Not medically necessary

Not medically necessary / unproven:

Hybrid surgery (simultaneous CDR + fusion): Cervical artificial disc replacement at one level combined with cervical spinal fusion surgery at another level as part of the same surgical plan (hybrid surgery) is unproven and not medically necessary due to insufficient evidence of efficacy.simultaneous CDR + fusion

Few clinical trials and limited patient selection criteria; see policy references

Lumbar multilevel TDR: Lumbar artificial total disc replacement at more than one spinal level is unproven and not medically necessary due to insufficient evidence of efficacy.>1 lumbar levels

Insufficient published clinical evidence for multilevel lumbar TDR or hybrid lumbar disc arthroplasty with fusion

Eligibility signals from trials

Evidence and study inclusion patterns that inform coverage decisions

Common trial eligibility signals: Patients enrolled in randomized trials generally had symptomatic degenerative disc disease unresponsive to ≥6 months of nonsurgical management; most RCTs evaluated single-level disease; multilevel and hybrid constructs were less well represented in high-quality trials.>= 6 months

Use as typical documentation to support prior conservative management; refer to trial reports for specifics

Limited evidence / higher scrutiny

Areas with insufficient evidence

Indications with limited evidence: Multilevel lumbar total disc replacement and hybrid lumbar disc arthroplasty with fusion lack sufficient high-quality published evidence; available reviews and abstracts provide minimal or inconclusive support and no professional society guidelines specifically endorse these constructs.

May warrant denial or case-by-case review with additional justification

Coverage criteria for lumbar disc arthroplasty

Covered when ALL of the following are met

Patient selection: Adult skeletally mature patients (age 18–60) with primary complaint of axial low back pain due to 1- or 2-level degenerative disc disease involving L3–4, L4–5, and/or L5–S1; symptoms present for ≥6 months and not responsive to multimodal nonoperative therapy (including physical therapy and may include injections, pain management, cognitive behavioral therapy, and active exercise).age 18-60; ≥6 months nonoperative therapy

NASS 2024 indications referenced; document prior conservative care

Anatomic and radiographic suitability: Discogenic source of pain without significant facet arthropathy at the index level; no spinal instability (spondylolisthesis greater than Grade I excluded); adequate bone quality (DEXA T-score > -1.0).DEXA T-score > -1.0; spondylolisthesis ≤ Grade I

NASS exclusions referenced

Procedure-level limits and exclusions:

Lumbar total disc replacement (TDR) is considered medically necessary for a single lumbar level when InterQual clinical criteria and the policy’s selection criteria are met; however, lumbar TDR performed at more than one spinal level is explicitly stated as unproven and not medically necessary because of insufficient evidence of efficacy. Documentation submitted for authorization should therefore clearly identify the number of involved lumbar levels and reference prior nonoperative management of at least 6 months when applicable.

A focused evidence search identified no professional society position statements or clinical practice guidelines that specifically endorse hybrid lumbar disc arthroplasty constructs (TDR combined with fusion) for multilevel degenerative disc disease. This lack of guideline support is cited as a reason for higher scrutiny of these constructs in coverage determinations.

The policy lists specific clinical features that make a patient inappropriate for TDR. Examples of exclusions and contraindications include symptomatic degenerative disc disease at >2 levels, significant facet arthropathy at the index level, and spinal instability such as spondylolisthesis greater than Grade I. Other conditions cited by NASS that may preclude coverage include chronic predominance of radicular leg pain, osteopenia (DEXA T-score ≤ -1.0), poorly managed psychiatric disorder, age <18 or >60, and active infection or tumor.

Cervical total disc replacement (TDR) combined with cervical fusion at another level as part of the same operative plan (a hybrid cervical approach) is explicitly described in the policy as unproven and not medically necessary due to insufficient evidence demonstrating efficacy. The document notes few clinical trials and uncertain patient selection criteria for simultaneous CDR plus fusion.

The evidence base for multilevel lumbar TDR and hybrid lumbar constructs is limited. Systematic reviews and recent evidence briefs summarized by Hayes found only small trials, abstracts, and a small number of comparative studies; reviewers concluded there is insufficient published clinical evidence to demonstrate safety and long-term efficacy for lumbar TDR performed at multiple adjacent or non-adjacent levels, and recommended further larger, well-designed studies.

The National Institute for Health and Care Excellence (NICE) guideline NG59 (2020) recommends that clinicians do not offer disc replacement to people with low back pain, and this recommendation is noted as an external guideline relevant to the policy’s assessment of lumbar disc replacement technologies.

Procedure Codes, Devices, and Key Eligibility Parameters

Applicable procedure codes (reference)CPT

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.

Devices reported in trialsmixed

activL	activL lumbar total disc replacement device (device name reported in trials)
ProDisc-L	ProDisc-L lumbar total disc replacement device
Charité	Charité lumbar total disc replacement device

Minimum nonsurgical management duration

Minimum nonsurgical management duration>= 6 months of documented nonoperative therapy prior to consideration

Typical therapies includedPhysical therapy/rehabilitation, pain management, injections, active exercise, and cognitive behavioral therapy

Trial evidence basisRandomized and prospective IDE trials required failure of >= 6 months of nonsurgical management (e.g., activL, ProDisc-L studies)

Nonoperative treatment duration

Required nonoperative treatment duration>= 6 months of multimodal nonoperative therapy (documented) before surgical consideration

Examples of multimodal therapy

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for listed procedure codes. Review plan-specific PA rules before scheduling; affected codes commonly used for cervical and lumbar total disc arthroplasty are shown below.

Potential prior authorization requirement for CPT/HCPCS codes related to total disc arthroplasty and revisions (see code group below).
Authorization requests should include documentation of prior conservative care and all relevant medical records.

Step Therapy

Prior Conservative Treatment Requirement

Requests for lumbar or cervical total disc replacement should document failure of an adequate trial of conservative, nonsurgical management for at least 6 months. InterQual-directed criteria may specify the nature and sequence of conservative therapies required.

Document specific therapies tried (e.g., physical therapy, analgesics including NSAIDs/opioids if used, activity modification, epidural steroid injections) and dates/duration.

Background and Rationale

Artificial total disc replacement replaces a degenerating intervertebral disc with an implanted prosthesis intended to preserve spinal motion while relieving discogenic pain. Cervical and lumbar TDR are designed to maintain segmental range of motion and, compared with fusion, may reduce stresses at adjacent levels; eligibility generally requires a skeletally mature adult with degenerative disc disease after an adequate trial of conservative care.

Key Definitions

Skeletally Mature

DefinitionSkeletally Mature: the apparent stage of development of the bones determined by radiological studies

Assessment methodDetermined with radiographic imaging to evaluate bone development/maturity

Use in policyUsed to assess appropriateness of TDR in patients (per Venes, 2021)

Hybrid construct (HC)

DefinitionHybrid construct (HC): a combined procedure involving total disc arthroplasty at one or more levels with fusion (e.g., ALIF) at adjacent levels

Evidence statusHayes and systematic reviews report limited and variable evidence for hybrid lumbar constructs

Policy Summary

PayerUnitedHealthcare

PolicyTotal Artificial Disc Replacement for the Spine (for Idaho Only)

Policy CodePolicy CS121ID.B

Change TypeRevised coverage rationaleadded documentation guidance

Effective DateDec 1, 2025

Next Review Date

Key ActionDocument at least 6 months of prior nonoperative management and make medical records available on request to support authorization.

SourceLink

On This Page

Not indicated for symptomatic degenerative disc disease at more than two levels; not indicated when primary pain is chronic unremitting radiculopathy with predominance of leg pain for ≥1 year; age <18 or >60, osteopenia (DEXA T-score ≤ -1.0), significant facet arthropathy at the index level, poorly managed psychiatric disorder, infection, or tumor are exclusions.

NASS: scenarios not indicated for lumbar disc arthroplasty

Physical therapy, pain management, possible injections, cognitive behavioral therapy, and active exercise programs

Evidence citationProspective randomized IDE trials and NASS recommendations reference >= 6 months of nonoperative care

Age

Age window for eligibility18–60 years

Age-related exclusion notePatients younger than 18 or older than 60 are listed as not indicated per NASS criteria

Evidence sourceNASS coverage policy recommendation (Feb 2024)

DEXA T-score

DEXA T-score requirement> -1.0 (DEXA T-score greater than -1.0)

InterpretationOsteopenia (T-score ≤ -1.0) is listed as a contraindication per NASS

SourceNASS coverage policy recommendation (Feb 2024)

Spondylolisthesis

Allowed spondylolisthesis grade≤ Grade I

Exclusion noteSpondylolisthesis greater than Grade I is listed as not indicated per NASS

SourceNASS coverage policy recommendation (Feb 2024)

Note response to each therapy and reasons for discontinuation or failure.

Documentation Required

Prior Authorization / Documentation Notice

Medical records documentation may be requested to assess whether clinical criteria are met; absence of adequate documentation can result in denial or delay.

Provide complete operative reports if prior surgery is relevant (e.g., prior cervical fusion).
Include device-specific information when applicable (FDA-approved prosthetic disc model and level).

Note

InterQual-Directed Step/Coverage Requirements

Refer to InterQual clinical criteria for required conservative treatment steps, specific eligibility details, and any additional clinical thresholds that must be met for medical necessity determinations.

InterQual may specify exact duration, number, and type of conservative modalities required prior to surgical consideration.
Use InterQual guidance to structure documentation submitted with authorization requests.

Documentation Required

Document Prior Nonoperative Management

Document trials of nonoperative management in the medical record, including start/end dates and objective measures of failure after ≥6 months when applicable.

Specify duration (e.g., physical therapy 8–12 weeks, injection dates), frequency, and measurable outcomes.
Explain contraindications or intolerance to conservative options if an abbreviated trial is claimed.

Documentation Required

Medical Record Documentation — Required Elements

Medical record elements required to support medical necessity include a detailed history, focused physical examination, and results of pertinent diagnostic tests or procedures. Missing elements can lead to denial or delay.

History: symptom duration, severity, neurologic symptoms (radiculopathy/myelopathy), prior treatments and outcomes.
Physical exam: neurologic assessment, provocative tests, focal deficits.
Diagnostic tests: relevant imaging (MRI, CT, flexion/extension radiographs), electromyography/nerve conduction studies when indicated, and bone density testing if osteoporosis/osteopenia is a concern.

Note

Clinical Measures and Radiographic Documentation Commonly Reported

Commonly reported clinical outcome measures and radiographic findings helpful for review include standardized pain and function scores, and imaging reports that correlate with clinical symptoms and surgical levels.

Clinical measures: Visual Analog Scale (VAS) for neck/back and arm/leg pain, Neck Disability Index (NDI) for cervical cases, Oswestry Disability Index (ODI) for lumbar cases, JOA score when reported, and patient-reported outcome measures (PROMs) with baseline and follow-up values.
Radiographic documentation: MRI or CT demonstrating disc degeneration at the index level(s), plain radiographs (including flexion/extension views) documenting instability or preserved motion as applicable, and postoperative imaging when prior surgery is present.
Other useful reports: EMG/NCS to support radiculopathy, DEXA scan results if bone quality is a concern, and device-specific imaging or manufacturer information when available.

Documentation Required

Required Medical Records — May Be Requested

Copies of medical records submitted for review may include but are not limited to the elements listed below. Providing comprehensive records does not guarantee coverage but facilitates timely and accurate review.

Relevant clinic notes, consultation reports, and problem lists.
Imaging reports and actual DICOM images or radiology films when requested.
Physical therapy notes, procedure notes (e.g., epidural injections), and prior operative reports.
Outcome measure scores (VAS, NDI, ODI, PROMs) with dates and comparisons to baseline.

Denial Risk

Insufficient Evidence — Multilevel Lumbar TDR / Hybrid Constructs

Multilevel lumbar total disc replacement, hybrid constructs, and other indications with limited or insufficient evidence may receive higher scrutiny and risk denial; include robust documentation if pursuing authorization.

Two-level or more lumbar TDR and hybrid TDR/fusion constructs lack sufficient evidence and may be considered not medically necessary or investigational.
Provide detailed rationale and supporting literature if requesting coverage for nonstandard configurations.

Denial Risk

Documentation-Related Denial Risk

Failure to provide requested documentation may result in denial or delayed decision; ensure records are complete, legible, and promptly supplied.

Incomplete or missing documentation is a common reason for denial; proactively include all items noted above with the authorization request.
Timely submission of additional records when requested can prevent delays in care.

Denial Risk

Clinical-Exclusion Denial Risk — High-Risk Scenarios

Certain clinical scenarios are explicitly excluded or are high-risk for denial (e.g., >2 levels, significant facet arthropathy, spondylolisthesis > Grade I); verify exclusion criteria before requesting authorization.

Exclusions: symptomatic degenerative disc disease at more than two levels, significant facet arthropathy at the index level, spinal instability with spondylolisthesis > Grade I, chronic predominately leg-pain radiculopathy >1 year, osteopenia (DEXA T-score ≤ -1.0), age <18 or >60 years, active infection or tumor, or poorly managed psychiatric disorder.
If any exclusion is present, clearly document clinical judgment and any mitigating factors when requesting review.

Hybrid constructs are described in comparative studies and meta-analyses but lack clear guideline support for multilevel lumbar use

Adjacent segment degeneration (ASD)

DefinitionAdjacent segment degeneration (ASD): degenerative changes occurring at spinal levels adjacent to a prior fusion

Clinical contextASD has been an indication for cervical TDR in revision settings and is reported in retrospective series

Reporting measuresStudies report ASD radiographic changes and clinical outcomes (e.g., VAS, NDI) following TDR or revision procedures

Artificial disc

DefinitionArtificial disc: an FDA-regulated prosthetic intervertebral disc (products regulated under FDA product code MJO)

Regulatory noteFDA approval is informational and not by itself a basis for coverage

Reference sourceFDA device regulation database (PMA/510k listings) as referenced in policy

Hybrid lumbar disc arthroplasty (HC)

DefinitionHybrid lumbar disc arthroplasty (HC): a hybrid construct combining total disc arthroplasty (TDA) at one level with anterior lumbar interbody fusion (ALIF) at an adjacent level

Evidence summarySystematic reviews and limited trials have evaluated HC versus multi-level TDA or fusion but conclude evidence is insufficient to declare superiority

Guideline statusNo professional society guidelines specifically endorse hybrid lumbar disc arthroplasty for multilevel DDD (Hayes reviews)