ModifiedUnitedHealthcarePolicy CS121KY.12

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

Policy governing medical necessity and coverage criteria for cervical and lumbar total artificial disc replacement (TDR/TDA) in Kentucky, including stance on hybrid procedures and requirements for documentation to support medical necessity.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS121KY.12

Change TypeCoverage stance revised for hybrid/combined procedures

Effective DateApr 1, 2026

Next Review Date

Key ActionConfirm prior authorization documentation demonstrates the member meets InterQual/NASS selection criteria and includes required medical records.

SourceLink

POLICY UPDATE CHANGES

Cervical policy language was changed to limit previous coverage for one- or two-level cervical ADR after prior fusion and to clarify that removal/replacement for implant failure after prior disc replacement is proven and medically necessary.

Cervical hybrid surgery (one-level ADR combined with fusion at another level in same surgical plan) was restated and labeled unproven and not medically necessary.

Lumbar total disc replacement language was changed from previously 'proven and medically necessary in certain circumstances' to 'unproven and not medically necessary' when combined with existing fusion or performed as hybrid surgery.

Removed definition of 'Skeletally Mature'.

Updated Clinical Evidence and References sections to reflect the most current information; archived previous policy version CS121KY.11.

Kentucky-onlyGeographic application

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Coverage Criteria for Cervical and Lumbar Total Disc Replacement

inv-01: Cervical - Medically Necessary and Unproven Statements

Covered when ALL of the following are met:

Cervical - proven/medically necessary: Cervical artificial disc removal or replacement with an FDA-approved (one or two-level) prosthetic intervertebral disc is proven and medically necessary in individuals with implant failure after prior disc replacement.

Refer to InterQual clinical criteria for detailed patient-level medical necessity requirements.

inv-02: Cervical - Hybrid Cervical Surgery Not Medically Necessary

Not covered when performed as part of the same surgical plan:

Cervical - Hybrid Surgery: Cervical total artificial disc replacement is unproven and not medically necessary when performed at one level combined with cervical spinal fusion surgery at another level (adjacent or non-adjacent) as part of the same surgical plan (Hybrid Cervical Surgery).

Policy explicitly classifies Hybrid Cervical Surgery as unproven and not medically necessary.

inv-03: Lumbar - Not Medically Necessary / Unproven Scenarios

Lumbar total artificial disc replacement is unproven and not medically necessary in the following scenarios:

Lumbar - Not medically necessary conditions: Lumbar total artificial disc replacement is unproven and not medically necessary when: (1) performed at one level combined with an existing lumbar spinal fusion at another level (adjacent or nonadjacent); OR (2) performed with lumbar spinal fusion surgery as part of the same surgical plan (Hybrid Lumbar Surgery); OR (3) performed at more than one spinal level.

Policy references insufficient evidence for multilevel and hybrid lumbar constructs; refer to InterQual for other lumbar clinical criteria.

inv-04: Cervical HS and CADR outcomes

Evidence summary and outcome expectations for cervical hybrid surgery and cervical artificial disc replacement (including when treating adjacent segment disease):

Indications and prior therapy: Primary clinical problems include radiculopathy and/or myelopathy unresponsive to conservative treatment (commonly at least 6 weeks), and symptomatic adjacent segment disease after prior ACDF may be treated with TDR or ACDF.>=6 weeks conservative management

Multiple studies required failed conservative therapy before surgery

Expected outcomes: Studies report improvements in VAS and NDI after hybrid surgery, CADR, and revision procedures; hybrid surgery may preserve C2–C7 range of motion better than ACDF and reduce adjacent segment ROM increase.

Improvements reported across multiple observational and meta-analytic studies

Limitations of evidence: Most evidence consists of retrospective and nonrandomized studies, small sample sizes, and short-to-mid term follow-up; higher-quality long-term RCTs are lacking.

inv-05: Lumbar TDR and hybrid constructs

Evidence synthesis for lumbar TDR and hybrid lumbar constructs:

Patient selection and prior therapy: Candidates typically have symptomatic lumbar degenerative disc disease who failed >= 6 months of conservative management before consideration of TDR or fusion.>=6 months conservative therapy

ECRI, Hayes, and randomized trials used >=6 months as inclusion

Single-level TDR evidence: Moderate-quality RCT evidence indicates single-level lumbar TDR may be comparable to fusion in properly selected patients for pain and function, with benefits maintained through mid-term follow-up.single-level

Hayes and Radcliff 7-year IDE trial support single-level TDR

Multilevel/hybrid lumbar evidence: Evidence for two-level or hybrid lumbar TDR is limited or provides minimal support; comparative studies show similar outcomes to fusion but data are insufficient to confirm superiority or broad applicability.

inv-06: Revision/reoperation considerations

Revision and reoperation considerations for cervical disc arthroplasty:

Revision indications: Common reasons for revision include cervical spondylosis, mechanical complications, poor patient selection, insufficient decompression, malposition, subsidence, osteolysis, and infection.

Multiple case series and database analyses report these causes

Revision procedures: After ACDA removal, common subsequent procedures include anterior cervical fusion (with or without decompression), combined anterior/posterior fusion/decompression, and replacement of the ACDA; fusion is commonly chosen when osteolysis or infection is present.

Database and series data report distribution of revision procedures

Revision rates and outcomes: In a national database, revision after ACDA was reported at approximately 2.1% over the study period; small case series report symptomatic improvement after revision with high fusion rates and patient satisfaction.

Lee et al. and Park et al. report low revision rates and improved outcomes post-revision

inv-07: Indicated population (per NASS)

NASS (2024) recommends lumbar TDR only when ALL of the following are met:

NASS lumbar TDR indication: Pain arising from 1- or 2-level disc disruption involving L3-4, L4-5 and/or L5-S1 segments; symptoms present for at least six months and not responsive to multimodal nonoperative treatment (including physical therapy/rehabilitation and may include pain management, injections, cognitive behavioral therapy, and exercise); and primary complaint of axial pain (possible secondary lower extremity pain).>=6 months

From NASS 2024 guidance; all listed criteria must be met.

inv-08: Exclusion criteria (per NASS)

Lumbar TDR is not indicated if ANY of the following are present:

Exclusion list: Symptomatic degenerative disc disease at more than two levels; significant facet arthropathy at the index level or evidence the pain source is primarily facet-mediated; spinal instability with spondylolisthesis greater than Grade I; chronic radiculopathy with predominant leg pain over at least one year; osteopenia with DEXA T-score ≤ -1.0; poorly managed psychiatric disorder; age greater than 60 years or less than 18 years; presence of infection or tumor.

From NASS 2024 guidance.

inv-09: Coverage rationale updates

Summary of coverage rationale updates effective 04/01/2026:

Cervical - proven: Cervical artificial disc removal or replacement with an FDA-approved (one or two-level) prosthetic intervertebral disc is proven and medically necessary in individuals with implant failure after prior disc replacement.

Replaced prior coverage language to focus on implant failure indications.

Cervical - unproven hybrid: Cervical total artificial disc replacement is unproven and not medically necessary when performed at one level combined with cervical spinal fusion surgery at another level (adjacent or non-adjacent) as part of the same surgical plan (Hybrid Cervical Surgery).

Policy explicitly restates Hybrid Cervical Surgery as unproven/not medically necessary.

Lumbar - unproven combined/hybrid: Lumbar total artificial disc replacement is unproven and not medically necessary when performed at one level combined with an existing lumbar spinal fusion at another level, or when performed with lumbar spinal fusion as part of the same surgical plan (Hybrid Lumbar Surgery); prior language indicating certain single-level lumbar TDR were proven was removed.

Lumbar total artificial disc replacement performed at more than one spinal level is classified as unproven and not medically necessary. The policy states there is insufficient evidence to support safety and efficacy when TDR is performed at multiple lumbar levels, and therefore multilevel lumbar TDR is not an accepted covered indication.

The available published clinical evidence is limited for multi-level lumbar total disc replacement. Systematic and evidence reviews (ECRI 2025; Hayes 2024–2025 updates) and primary studies document small sample sizes, retrospective designs, and few high-quality randomized trials comparing multilevel LTDR or hybrid constructs with fusion. These reviews conclude there is insufficient published clinical evidence to confirm safety and long-term effectiveness of lumbar TDR performed at multiple adjacent or non-adjacent levels.

Total disc replacement is not indicated when the case does not meet the selection criteria (for example, symptomatic degenerative disc disease at more than two levels or other NASS exclusions) or when multilevel symptomatic disease or contraindications (e.g., significant facet arthropathy, spondylolisthesis > Grade I, osteopenia with DEXA T-score ≤ -1.0, poorly managed psychiatric disorder, age >60 or <18, infection or tumor) are present. The policy specifically designates multi-level (>1) lumbar TDR and scenarios outside NASS/InterQual criteria as unproven or noncovered.

Procedures combining disc arthroplasty with fusion in the same surgical plan (hybrid surgeries) are explicitly described as unproven and not medically necessary for both cervical and lumbar spine when performed as part of a single planned operation. Evidence syntheses report minimal or unclear clinical support for hybrid lumbar constructs and recommend further well-designed studies before considering hybrid procedures as established therapy.

This policy provides interpretive guidance and does not itself determine benefit coverage; applicable federal, state, or contractual plan terms govern coverage decisions. UnitedHealthcare uses InterQual® as the primary clinical criteria; prior authorization reviews may require medical record documentation to verify that the patient meets clinical selection criteria and to support medical necessity. Documentation must be legible, maintained in the patient chart, and made available upon request.

For the cervical spine, the policy distinguishes two positions: removal or replacement of a cervical artificial disc for implant failure is proven and medically necessary when using an FDA‑approved one- or two-level prosthesis; conversely, performing cervical total artificial disc replacement at one level combined with cervical fusion at another level within the same operative plan (a Hybrid Cervical Surgery) is classified as unproven and not medically necessary.

Two-level and multilevel lumbar total disc replacement, as well as hybrid lumbar disc arthroplasty constructs, have limited and inconclusive support in the literature. Comparative studies and evidence reviews report similar short- to mid-term outcomes to fusion in some series, but overall the data are sparse, often underpowered, and lack durable long-term outcomes; therefore the policy finds the support for multilevel lumbar TDR to be minimal or unclear and does not establish it as a proven indication.

Cervical artificial disc replacement performed at one level combined with cervical fusion at another level as part of the same surgical plan (Hybrid Cervical Surgery) is specifically identified in the policy as unproven and not medically necessary. The policy change clarifies that hybrid cervical constructs performed within a single operative plan are not supported by sufficient evidence to be considered medically necessary.

Lumbar TDR performed in the presence of an existing lumbar fusion at another level, or performed concurrently with fusion as part of the same surgical plan, is described as unproven and not medically necessary. The policy revision removed previous language that had supported some single-level lumbar TDR uses and now classifies combined or hybrid lumbar TDR/fusion procedures as noncovered absent stronger evidence.

Procedure and Product Codes

Applicable Procedure Codesmixed

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

Coding methods reported in database studymixed

CPT/ICD (used in database identification)

Both Current Procedural Terminology (CPT) and ICD-9/10 coding were utilized to identify reasons for revisional surgery and subsequent procedures after removal of ACDA.

FDA/Product codes referencedmixed

MJO	FDA product code referenced for artificial discs (informational)

inv-22: Fusion radiographic cutoff

Radiographic cutoff< 1 mm movement between spinous processes on lateral flexion-extension radiographs

Use caseRecommended when confirming fusion after anterior cervical discectomy and fusion (ACDF)

Supporting reviewSystematic review (Oshina et al., 2018) identified this cutoff as supported across studies

Provider Actions, Prior Authorization, and Documentation Requirements

Note

Applicable Codes (for review/reference)

The following codes are provided for review and reference; inclusion does not imply coverage or payment. Verify applicable benefit plan provisions and obtain prior authorization when required.

0098T — Revision including replacement of total disc arthroplasty, cervical (add-on)
0165T — Revision including replacement of total disc arthroplasty, lumbar (add-on)
22856 — Total disc arthroplasty, cervical, single interspace
22857 — Total disc arthroplasty, lumbar, single interspace
22858 — Total disc arthroplasty, cervical, second level (add-on)
22860 — Total disc arthroplasty, lumbar, second interspace (add-on)
22861 — Revision including replacement of total disc arthroplasty, cervical, single interspace
22862 — Revision including replacement of total disc arthroplasty, lumbar, single interspace
22899 — Unlisted procedure, spine

Background and Evidence Summary

Total artificial disc replacement replaces a degenerating intervertebral disc with an artificial prosthesis intended to preserve range of motion and reduce pain in adults with degenerative disc disease. Single‑level cervical and lumbar disc arthroplasty have been studied in randomized trials and observational cohorts; evidence for single-level lumbar TDR suggests comparable outcomes to fusion in selected patients, while multilevel and hybrid constructs lack robust long-term data. The policy emphasizes selection criteria (for example, NASS/InterQual guidance) and notes that hybrid procedures have heterogeneous evidence and require further high-quality research to establish safety and durability.

inv-04: Cervical HS and CADR outcomes (also relevant to background evidence)

Additional evidence relevant to cervical HS and CADR (background/supporting evidence):

Cervical HS outcomes supporting evidence: Observational studies and meta-analyses report preserved C2–C7 ROM, reduced adjacent segment ROM, and improvements in NDI and VAS after hybrid cervical constructs, with mean follow-up in some studies around 45 months; however, study designs are mostly nonrandomized and limited in sample size.

Yilmaz et al. and meta-analyses report improved ROM and PROMs but note limitations.

Long-term outcomes for cervical revision: Case series and retrospective cohorts demonstrate symptomatic improvement and high fusion rates after revision/removal of failed cervical disc arthroplasty, though data are limited by small numbers.

Definitions

inv-44: Hybrid Cervical Surgery

DefinitionThe combination of an anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA)

Policy stanceWhen performed as part of the same surgical plan (one-level ADR combined with fusion at another level), Hybrid Cervical Surgery is classified as unproven and not medically necessary

Evidence noteSystematic reviews and meta-analyses report improved NDI and preserved cervical ROM with HS but highlight low-quality evidence and need for longer-term RCTs

inv-45: Hybrid Lumbar Surgery

DefinitionThe combination of a total disc arthroplasty (TDA) and anterior lumbar interbody fusion (ALIF)

Policy stanceLumbar hybrid procedures (TDR combined with fusion as part of the same surgical plan) are unproven and not medically necessary

Policy Revision History and Changes

2026-04-01revision

Added explicit operational language that medical records documentation may be required for reviews and must be legible, maintained in the patient’s medical record, and made available upon request; examples of required documentation elements were listed.

2026-04-01material_revisionLatest

Summary of Changes effective 04/01/2026: revised cervical and lumbar coverage rationale — cervical ADR language changed to limit prior coverage and clarify implant failure removal/replacement is proven; lumbar TDR language changed to classify combined/hybrid scenarios as unproven and not medically necessary.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS121KY.12

Change TypeCoverage stance revised for hybrid/combined procedures

Effective DateApr 1, 2026

Next Review Date

Key ActionConfirm prior authorization documentation demonstrates the member meets InterQual/NASS selection criteria and includes required medical records.

SourceLink

On This Page

Prior Authorization

Prior Authorization Likely for Multilevel/Hybrid Lumbar TDR

Prior authorization is likely required for multilevel lumbar total disc replacement (TDR) procedures and for hybrid constructs combining TDR with fusion. Due to limited and inconsistent evidence for multilevel and hybrid lumbar TDR, obtain authorization and submit comprehensive documentation to support medical necessity.

Prior authorization expected for two-level lumbar TDR and any multilevel procedures
Prior authorization expected for hybrid lumbar constructs (TDR combined with fusion)
Authorization review will consider the limited evidence base and potential for denial if documentation is insufficient

Denial Risk

Noncompliant Patient Selection May Lead to Denial

Selection of patients who do not meet established clinical criteria (for example, NASS criteria) or who have contraindications may result in denial of coverage. Ensure patient selection aligns with guidance and documented findings.

Do not submit cases for patients with >2-level symptomatic degenerative disc disease for lumbar TDR
Avoid selecting patients with significant facet arthropathy, spondylolisthesis > Grade I, osteoporosis (DEXA T-score ≤ -1.0), poorly managed psychiatric disorders, or age outside the recommended range
Document the failure of nonoperative therapy of at least six months

Denial Risk

Denial Risk for Hybrid/Combined Procedures

There is an increased risk of denial for hybrid or combined procedures (TDR performed with fusion at another level, or TDR combined with fusion as part of the same surgical plan) when evidence is limited or contraindications exist. Obtain prior authorization and provide explicit clinical rationale and supporting evidence.

Hybrid cervical or lumbar procedures performed as part of the same surgical plan are considered unproven/not medically necessary in certain circumstances per policy updates
Provide detailed justification when proposing hybrid surgery; lack of supporting evidence can lead to denial

Note

Fusion Confirmation Radiographic Threshold

Radiographic confirmation of fusion following prior fusion procedures should use objective thresholds. When confirming fusion on flexion-extension radiographs, a relative motion cutoff of < 1 mm between spinous processes is recommended.

Use lateral flexion-extension radiographs to assess spinous process motion
< 1 mm of movement between spinous processes supports fusion
CT or plain radiographs may be used as adjuncts; document imaging modality and measurements

Documentation Required

Medical Records Documentation Requirements

The patient's medical record must contain documentation that fully supports medical necessity. Incomplete or missing documentation may result in delayed reviews or denials.

Relevant medical history and physical examination notes
Duration and details of conservative (nonoperative) therapy, including modalities used and response (minimum six months for lumbar TDR candidates)
Results of pertinent diagnostic tests and imaging (e.g., MRI, X-ray, CT, DEXA) with objective measurements
Operative notes, device details (manufacturer, model, level[s]), and prior spine surgery reports when applicable
Consultation notes and justification for surgery, including failure of nonoperative management
Behavioral health and optimization documentation if psychiatric comorbidity is present

Documentation Required

Pre-use Checks and Referenced Tools

Before device implantation, perform pre-use checks and reference applicable tools and criteria during authorization and operative planning.

Confirm device is FDA-approved for the intended level(s) and indication
Document device model, size, and intraoperative checks in the operative record
Reference InterQual criteria when available for medical necessity determinations
Ensure all imaging and objective measurements required by guidelines (e.g., NASS) are uploaded for review

Prior Authorization

Nonoperative Therapy Prerequisite

Nonoperative therapy is a prerequisite for consideration of lumbar disc arthroplasty. Document failure to improve after an adequate course of multimodal conservative management prior to submitting authorization requests.

Minimum six months of nonoperative treatment, including a documented physical therapy/rehabilitation program
May include pain management, injections, cognitive behavioral therapy, and active exercise programs
Describe response to each modality and reasons for proceeding to surgical intervention

inv-05: Lumbar TDR and hybrid constructs (evidence synthesis placed in Background as well)

Additional evidence synthesis relevant to lumbar TDR and hybrid constructs (background/supporting evidence):

Limited evidence for multilevel/hybrid lumbar constructs: Systematic reviews and evidence analyses (ECRI, Hayes) conclude minimal or unclear support for two-level and hybrid lumbar TDR; larger high-quality long-term RCTs are lacking.two-level or multilevel

Hayes evolving reviews and ECRI analyses report insufficient evidence for multilevel/hybrid lumbar TDR.

Single-level lumbar TDR RCT data: Randomized IDE trials with mid- to long-term follow-up (e.g., 7-year activL vs ProDisc-L) show maintained improvements in ODI and VAS and low reoperation rates in selected single-level patients.up to 7 years

Radcliff et al. 7-year data supports sustained benefit for single-level TDR.