ModifiedUnitedHealthcarePolicy CS121PAW

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

Medical policy governing cervical and lumbar total artificial disc replacement (TDR) for members in Pennsylvania, describing coverage rationale, clinical evidence, and applicable procedure codes for UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS121PAW

Change TypeClarification / Modified coverage stance

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization and document ≥6 months of failed multimodal nonoperative care and imaging that supports single-level lumbar or one- to two-level cervical indications per InterQual criteria.

SourceLink

POLICY UPDATE CHANGES

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

Related policy link added to Spinal Fusion and Bone Healing Enhancement Products (for Pennsylvania only).

Removed reference link to the policy 'Minimally Invasive Spine Surgery Procedures (for Pennsylvania Only)'.

single-levelTDR indicated for

single level onlyLumbar coverage scope

1-2 levelsCervical coverage scope

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

5+ yrsFollow-up evidence

<= -1.0DEXA exclusion threshold

Coverage Criteria for Cervical and Lumbar TDR

Cervical Artificial Disc Replacement (CADR) Coverage

Covered when ALL of the following are met

Cervical CADR coverage: 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; and is proven and medically necessary for 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).one or two contiguous levels, C3-C7

For medical necessity clinical coverage criteria, refer to the InterQual CP: Procedures, Artificial Disc Replacement.

Cervical Hybrid Surgery (CADR plus fusion) Stance

Not medically necessary when combined in the same surgical plan

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

Clinical trials are limited; refer to InterQual for case-by-case review guidance.

Lumbar Artificial Disc Replacement Coverage

Covered when ALL of the following are met

Lumbar TDR single level: 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.single level only

For medical necessity clinical coverage criteria, refer to the InterQual Client Defined CP: Procedures, Artificial Disc Replacement; Lumbar (Custom).

Lumbar Multilevel and Hybrid Procedures

Not covered / unproven

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

Hayes reviews and the policy review indicate minimal or unclear support for hybrid and multilevel lumbar TDR.

Lumbar TDR candidate and evidence limits

Coverage considerations reflected in the literature and professional society statements (as presented):

Lumbar TDR candidate criteria frequently used in trials and guidelines: Patient with symptomatic discogenic low back pain involving 1 or 2 levels (L3-4, L4-5, L5-S1) AND symptoms present for at least 6 months not responsive to multimodal nonoperative care (including physical therapy, injections, cognitive behavioral or active exercise programs) AND failure of conservative management for ≥ 6 months.≥ 6 months

Referenced in NASS 2024 statements and multiple RCTs/IDE trials

Device/technique limits noted in guidance: Single-level TDR has moderate-quality RCT evidence comparing favorably with fusion; evidence for two-level or multilevel TDR, hybrid constructs, and multilevel use is limited or mixed across reviews.

Hayes evidence reviews and NASS statements summarize evidence limitations.

Cervical ACDR post-ACDF evidence

Cervical arthroplasty in patients with prior ACDF (adjacent-segment disease) — small retrospective series evidence:

Cervical ACDR after prior fusion: Small retrospective series (n = 11–32) report improved VAS, NDI, and JOA scores and preserved range of motion in many patients treated with ACDR for adjacent-segment disease after prior ACDF; some cases reported heterotopic ossification and progression of adjacent degeneration. Evidence is limited by small sample sizes and retrospective design (e.g., Bin et al. 2017; Rajakumar et al. 2017).

Early series suggest feasibility but are insufficient for definitive effectiveness conclusions.

Medical necessity criteria for lumbar TDR

Covered when ALL of the following are met

Primary indications: Patient has discogenic low back pain arising from 1 (preferred) or 2 contiguous levels (L3-4, L4-5, L5-S1) with primary complaint of axial pain (secondary lower extremity pain acceptable).levels: 1-2

NASS indicates 1–2 levels; UnitedHealthcare specifies single-level as proven in certain circumstances.

Duration and prior therapy: Symptoms present for at least 6 months and refractory to multimodal nonoperative treatment including physical therapy/rehabilitation and possibly injections, cognitive behavioral therapy, and active exercise programs.>= 6 months

Randomized trials and systematic reviews typically enrolled patients after failure of ≥6 months of nonsurgical treatment; documentation of prior conservative care is required for authorization.

Patient characteristics and imaging:

Lumbar artificial total disc replacement performed at more than one spinal level is considered unproven and not medically necessary due to insufficient evidence of safety and long-term effectiveness. The policy cites reviews and evidence summaries indicating minimal or unclear support for multilevel or hybrid lumbar TDR constructs and the need for larger, well-designed studies to evaluate multilevel use.

Cervical artificial disc replacement performed at one level combined with cervical spinal fusion at another level as part of the same surgical plan is considered unproven and not medically necessary due to insufficient evidence of efficacy; such hybrid constructs are not covered when planned within the same operation.

Professional guidance is mixed: the National Institute for Health and Care Excellence (NICE) issued a 2020 recommendation advising clinicians not to offer disc replacement for low back pain, while some specialty groups (e.g., ISASS) state that cervical and lumbar TDR may be an effective alternative to fusion for selected patients who meet established device inclusion/exclusion criteria. The North American Spine Society (NASS) provides condition-specific limits and contraindications (see policy exclusions) and notes limited literature on hybrid lumbar constructs.

Common exclusion criteria summarized from NASS and policy guidance include: symptomatic degenerative disc disease involving more than two levels; significant facet arthropathy at the index level suggesting a primary facet pain source; chronic radiculopathy with predominant leg pain lasting over one year; spinal instability (spondylolisthesis greater than Grade I); osteopenia/low bone density meeting DEXA thresholds; age outside recommended range (<18 or >60); poorly managed psychiatric disorders; and active infection or tumor. Multilevel lumbar TDR and hybrid constructs are specifically identified as not supported by current evidence.

Cervical artificial disc replacement combined with cervical fusion within the same operative plan (hybrid cervical surgery performed concurrently at separate levels) is considered unproven and not medically necessary because available evidence is insufficient to demonstrate efficacy for simultaneous CADR plus fusion.

Multilevel lumbar total disc replacement (use of TDR at more than one spinal level) is considered unproven and not medically necessary. The policy references evidence reviews that report insufficient clinical data to support safety and effectiveness for multiple adjacent or non-adjacent lumbar levels.

The NICE 2020 guideline for low back pain and sciatica explicitly recommends that physicians do not offer disc replacement for low back pain, representing a negative guidance statement that informs the policy context and supports restrictive coverage for multilevel lumbar TDR.

NASS-specified contraindications summarized for clinical decision-making include: patient age <18 or >60 years; symptomatic degenerative disc disease at more than two levels; DEXA T-score ≤ -1.0 (osteopenia/osteoporosis exclusion); significant facet arthropathy at the index level; spinal instability (spondylolisthesis > Grade I); chronic predominance of radicular leg pain >1 year; poorly managed psychiatric disorder; and presence of infection or tumor.

Applicable Procedure and Device Codes

Applicable Procedure CodesCPT

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

No explicit codes in this segmentmixed

No codes listed

Informational device/product codemixed

MJO	FDA product code referenced for artificial discs (informational)

inv-19: Minimum nonsurgical treatment duration — ≥ 6 months

Minimum required durationAt least 6 months of nonsurgical (conservative) management prior to considering TDR

Types of conservative care referencedMultimodal nonoperative treatment including physical therapy/rehabilitation, injections, cognitive behavioral therapy, and active exercise programs

Documentation expectationClinical records should document failure to improve after >=6 months of these nonsurgical therapies

inv-20: Duration of nonoperative treatment — >= 6 months (supporting detail)

Duration threshold>= 6 months of symptoms refractory to multimodal nonoperative treatment before authorization consideration

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required per UnitedHealthcare policy processes when requesting cervical or lumbar total disc replacement (TDR) procedures. Requests must reference the listed TDR procedure codes and be submitted for review prior to scheduling surgery.

Prior authorization required for listed cervical and lumbar TDR procedure codes

Documentation Required

Conservative Management and InterQual Reference

Prior authorization requests must document prior conservative management consistent with InterQual clinical coverage criteria and clinical evidence. Refer to the InterQual CP: Procedures, Artificial Disc Replacement (including the Lumbar custom client-defined criteria) for the specific medical necessity criteria that will be evaluated.

Refer to InterQual CP: Procedures, Artificial Disc Replacement; Lumbar (Custom) for specific step requirements
Failure to meet InterQual medical necessity criteria may result in denial

Background and Rationale

Artificial total disc replacement replaces a degenerated intervertebral disc with a prosthetic device to preserve range of motion and reduce pain for degenerative disc disease in the cervical or lumbar spine. Cervical TDR is supported for one or two contiguous levels in skeletally mature patients with symptomatic radiculopathy and/or myelopathy; lumbar TDR has supporting evidence for single-level use in selected patients, while evidence for multilevel and hybrid lumbar constructs is limited.

Definitions

inv-36: Skeletally Mature — Definition entry

DefinitionSkeletally mature: The apparent stage of development of the bones of a growing child or adolescent determined with radiological studies.

Use in policyDetermination of skeletal maturity is required for considering TDR candidacy and must be supported by radiological documentation where applicable.

Source referencePolicy definitions section uses radiological assessment as the basis for skeletal maturity determination (Venes, 2021).

inv-37: Hybrid Surgery (HS) — Definition entry

DefinitionHybrid Surgery (HS): Artificial disc replacement at one level combined with spinal fusion surgery at another level (adjacent or non-adjacent).

Evidence noteClinical trials are few and patient selection criteria have not been firmly established.

Policy Revision History

2025-06-01revisionLatest

Revised lumbar coverage language to clarify that single‑level lumbar artificial total disc replacement is proven and medically necessary in certain circumstances rather than a blanket statement of proven medical necessity; also removed a reference link to the 'Minimally Invasive Spine Surgery Procedures (for Pennsylvania Only)' policy.

2025-06-01administrative_added_link

Added related policy reference: Spinal Fusion and Bone Healing Enhancement Products (for Pennsylvania only).

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS121PAW

Change TypeClarification / Modified coverage stance

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

Skeletally mature individual without significant facet arthropathy or primary facet-mediated pain, no spinal instability (spondylolisthesis ≤ Grade I), no infection or tumor, and not meeting other NASS-listed exclusions (e.g., age <18 or >60, DEXA T-score ≤ -1.0).

spondylolisthesis <= Grade I; DEXA T-score > -1.0

Exclusion criteria from NASS and policy; documentation should support absence of contraindications.

Recommended conservative modalities

Physical therapy/rehabilitation; may include injections, cognitive behavioral therapy, and active exercise

Clinical rationaleRandomized trials and guidelines typically enrolled patients after failure of ≥6 months of nonsurgical treatment

inv-21: DEXA T-score — > -1.0 (Osteopenia exclusion at <= -1.0)

DEXA T-score thresholdDEXA T-score greater than -1.0 required (osteopenia exclusion at T-score <= -1.0)

ImplicationT-score <= -1.0 is listed as an exclusion for lumbar disc arthroplasty per NASS guidance

AssessmentBone mineral density testing (DEXA) should be documented when bone quality is a concern

Prior Authorization

Prior Authorization Requirement and Denial Risk

Coverage and prior authorization are limited to cases that meet the policy’s specified clinical criteria (see InterQual). Procedures that do not meet the medical necessity clinical coverage criteria may be denied.

Prior authorization required when requesting lumbar artificial total disc replacement
Coverage limited to patients meeting InterQual clinical criteria

Documentation Required

Conservative Therapy Prerequisite and Required Documentation

Documentatation must demonstrate at least 6 months of multimodal nonoperative treatment failure unless otherwise justified. This conservative therapy prerequisite typically includes physical therapy/rehabilitation, analgesic/adjunctive medications, targeted injections, and may include cognitive behavioral therapy or other structured behavioral interventions.

Conservative care duration: ≥ 6 months of nonoperative management
Multimodal treatments should include physical therapy/rehabilitation, injections, medications, and behavioral therapy where applicable

Documentation Required

Required Clinical and Outcome Documentation

Clinical documentation submitted with prior authorization must include: history and duration of symptoms (documenting ≥6 months when applicable), objective findings, prior nonoperative treatments and outcomes, device/label selection rationale, and imaging or other studies demonstrating skeletal maturity when applicable.

Document duration of symptoms and response to each conservative treatment modality
Include standardized outcome measures where available (e.g., ODI, VAS) and documentation of inadequate response
Provide imaging to support diagnosis and to document skeletal maturity (radiologic determination as applicable)
Provide rationale for device selection consistent with FDA labeling

Denial Risk

Multilevel Lumbar TDR Not Covered

Multilevel lumbar TDR (more than one spinal level) is considered unproven and not medically necessary due to insufficient evidence and may be denied. Hybrid constructs and multilevel procedures have limited and inconsistent evidence and require careful justification; absence of adequate evidence can support denial.

Lumbar TDR at more than one spinal level is not covered/considered unproven
Hybrid lumbar constructs have limited evidence and are generally not supported without strong justification

Denial Risk

NICE Recommendation — Caution

NICE (2020) recommends clinicians do not offer disc replacement for people with low back pain. This negative recommendation may be considered in case review and supports careful adherence to InterQual/NASS criteria and insurer coverage determinations.

NICE guideline (2020) recommends against offering disc replacement for low back pain

Denial Risk

Contraindications per NASS

Contraindications and exclusion criteria per North American Spine Society (NASS) should be evaluated and documented. Cases with contraindications are not appropriate for TDR and may be denied.

Symptomatic degenerative disc disease at >2 levels — not indicated
Significant facet arthropathy at the index level or primarily facet-mediated pain — contraindicated
Chronic radiculopathy dominated by leg pain >1 year — contraindicated
Spinal instability (spondylolisthesis > Grade I) — contraindicated
DEXA T-score ≤ -1.0 (osteopenia/osteoporosis) — contraindicated
Age <18 or >60 years — contraindicated
Poorly managed psychiatric disorder, active infection, or tumor — contraindicated

Documentation Required

Skeletal Maturity Documentation

Skeletal maturity must be demonstrated where applicable. Provide radiographic or other appropriate imaging evidence that the patient is skeletally mature as part of the prior authorization packet.

Include radiologic documentation supporting skeletal maturity when applicable

ImplicationHS is considered distinct from isolated TDR and may have limited/uncertain evidence depending on anatomic region and construct.

inv-38: Hybrid construct — Definition entry

DefinitionHybrid construct: Combination of total disc arthroplasty (TDA/TDR) at one or more levels with fusion (e.g., ALIF) at adjacent levels performed in the same procedure.

Examples in literatureStudies report hybrid constructs combining TDA and ALIF across multiple levels with variable follow-up and limited comparative evidence.

Clinical implicationHybrid constructs are evaluated separately from single-level TDR due to differing indications and limited evidence for multilevel use.

inv-39: Adjacent segment disease (ASD) — Definition entry

DefinitionAdjacent segment disease (ASD): New or progressive symptomatic degeneration at vertebral levels adjacent to a prior fusion, sometimes treated with disc arthroplasty in studies of post-fusion patients.

Clinical contextASD may present with new arm/neck or back/leg symptoms after prior fusion and has been treated with ACDR/TDR in small retrospective series with documented symptom improvement in some patients.

Evidence notePublished series are small and retrospective; outcomes include improved pain and preserved range of motion in many cases.

inv-40: Discogenic low back pain — Definition entry describing axial pain from degenerative disc disruption

DefinitionDiscogenic low back pain: Axial pain primarily from degenerative disc disruption, potentially with secondary lower extremity pain; typically persistent despite nonoperative care.

Typical levels implicatedOften involves L3-4, L4-5, and/or L5-S1 when considered for lumbar TDR.

Clinical requirementIdentification of discogenic origin and refractory symptoms after conservative therapy is expected prior to surgical consideration.

inv-41: Hybrid surgery — Definition entry (combination of TDR with anterior discectomy and fusion at adjacent levels).

DefinitionHybrid surgery: Combination of total disc arthroplasty (TDA/TDR) with anterior discectomy and fusion at adjacent levels.

NASS statementNASS recognizes hybrid surgery as a construct combining TDA and anterior discectomy/fusion to treat radiculopathy or myeloradiculopathy, with evidence that is less robust than for single-level TDA.

Clinical implicationHybrid surgery may preserve motion at some levels while fusing others but has limited high-quality evidence compared with single-level procedures.