CurrentUnitedHealthcarePolicy CS1ZILAN

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

This UnitedHealthcare Community Plan medical policy governs coverage and medical necessity criteria for cervical and lumbar total artificial disc replacement (TDR) in Louisiana, including statements on single-level and multilevel procedures, hybrid surgery, revisions, and applicable procedure codes. It references InterQual criteria for detailed clinical necessity determinations.

Policy Summary

PayerUnitedHealthcare Community Plan

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

Policy CodePolicy CS1ZILAN

Change TypeRevised coverage rationaleevidence and references updated

Effective DateJun 1, 2025

Next Review Date

Key ActionProviders must refer to the InterQual criteria for detailed medical necessity clinical coverage criteria.

SourceLink

POLICY UPDATE CHANGES

Coverage rationale wording was revised to replace absolute language with conditional language stating lumbar artificial total disc replacement is proven and medically necessary 'in certain circumstances' for single-level lumbar degenerative disc disease.

Supporting Information: Clinical Evidence and References sections were updated to reflect current information.

LAApplies to Louisiana only

CervicalCervical coverage: single- or two-level covered; hybrid cervical not covered

LumbarLumbar coverage: single-level covered; multilevel not covered

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>=6 moRequired nonoperative treatment duration

1-2Allowed treated levels

T-score>-1.0DEXA bone density requirement

Coverage Summary

Policy CS1ZILAN (Total Artificial Disc Replacement for the Spine) applies to Louisiana only and is effective June 1, 2025. The policy subject is Total artificial disc replacement for the spine and the coverage stance is mixed, with cervical and lumbar recommendations that depend on device approval, patient selection, and InterQual clinical criteria.

High-level cervical coverage: Cervical TDR with an FDA-approved prosthetic intervertebral disc is considered proven and medically necessary in certain circumstances for treating one-level or two contiguous levels (C3–C7) in skeletally mature individuals with symptomatic radiculopathy and/or myelopathy; cervical TDR with a history of prior cervical fusion at another level is also addressed as medically necessary in specified cases, while combining cervical TDR and fusion at different levels in the same surgical plan (hybrid cervical surgery) is not medically necessary due to insufficient evidence.

High-level lumbar coverage: Lumbar TDR with an FDA-approved prosthetic intervertebral disc is considered proven and medically necessary in certain circumstances for single-level lumbar degenerative disc disease in skeletally mature individuals with symptomatic intractable discogenic low back pain (see InterQual for detailed clinical criteria); lumbar TDR at >1 level is unproven and not medically necessary.

Key short facts (stats): Geographic scope: Louisiana only; Allowed treated levels: 1–2 (cervical covered 1–2, lumbar covered single-level only); Required nonoperative treatment duration (lumbar): >= 6 months; DEXA bone density requirement (exclusion threshold): T-score <= -1.0 is exclusionary per guidance. Refer to the listed procedure codes for billing and denial risk (see policy codes).

Medical Necessity Criteria

Cervical artificial total disc replacement - Medically necessary

Covered when ALL of the following are met:

ALL of the following

Use of FDA‑approved prosthetic intervertebral disc: Use of an FDA‑approved prosthetic intervertebral disc
Treated levels: Treatment of one‑level or two contiguous levels of cervical degenerative disc disease (C3 to C7)
Skeletal maturity: Individual is skeletally mature
See Definitions: Skeletally Mature
Symptoms: Presence of symptomatic radiculopathy and/or myelopathy

Provider Actions & Authorization

Documentation Required

Refer to InterQual clinical criteria

Refer to the InterQual CP: Procedures, Artificial Disc Replacement; Cervical and the InterQual Client Defined CP: Procedures, Artificial Disc Replacement; Lumbar for the detailed medical necessity clinical coverage criteria.

Documentation Required

Skeletal maturity determination

Skeletal maturity must be determined with radiological studies and documented as defined in policy (Skeletally Mature).

Denial Risk

Hybrid cervical surgery coverage restriction

Claims for cervical artificial disc replacement at one level combined with cervical spinal fusion at another level as part of the same surgical plan are considered unproven and not medically necessary and are at risk for denial.

Coding

Primary and additional procedure codes for total disc arthroplastyCPT

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

Codes not on Louisiana Medicaid Fee ScheduleCPT

0098T	Not on State of Louisiana Medicaid Fee Schedule
0165T	Not on State of Louisiana Medicaid Fee Schedule

Regulatory / Informationalmixed

No codes listed

Background, Evidence, and Definitions

Artificial total disc replacement (TDR) replaces a degenerating intervertebral disc with an artificial prosthesis intended to preserve range of motion and reduce pain; it may be performed in the cervical or lumbar spine. Hybrid surgery (HS or hybrid construct) refers to combining disc arthroplasty at one level with fusion at another level (e.g., TDR plus ALIF), and evidence for hybrid procedures varies by region and procedure type. This policy uses InterQual clinical criteria for detailed medical necessity determinations for both cervical and lumbar artificial disc replacement.

Study / Source	Key findings
Systematic reviews / RCTs (multiple meta-analyses summarized)
Multiple systematic reviews and meta-analyses report improvements in VAS and ODI with TDR versus fusion; conclusions generally that single-level lumbar TDR is comparable or superior to fusion in selected patients, but long-term durability and multilevel evidence are mixed/limited.
activL IDE trial (Garcia et al. 2015)
At 2 years: >90% patient satisfaction; back severity improved 74% (activL) vs 68% (controls); ODI improved 67% vs 61%; device-related serious adverse events 12% vs 19%; reintervention rates comparable.
5-year randomized IDE trial (Yue & Garcia 2017)
At 5 years: comparable effectiveness between activL (Test) and control devices; reductions in back severity in 88% (Test) vs 90% (Control); ODI improvement 83% vs 86%; patient satisfaction 96% vs 94%; lack of serious adverse event through 5 years 58% vs 40%.
Radcliff et al. 7-year RCT (activL vs ProDisc-L / ProDisc-L cohort)
At 7 years: sustained improvements in ODI and VAS for activL and ProDisc-L; low reoperation rates and sustained benefits in pain, function, and opioid use reduction.
Hayes and comparative effectiveness reviews (2020–2024)
Moderate-quality evidence that single-level LTDR is comparable with fusion in properly selected patients; insufficient evidence for multilevel LTDR and for hybrid lumbar constructs; limited evidence for hybrid lumbar arthroplasty with fusion.
Prospective cohort and observational studies of multilevel TDR and hybrid constructs (Scott-Young 2020, Cuellar 2021, Scott-Young 2022)
Cohort/series report sustained PROMs improvement and high patient satisfaction for multilevel TDR and hybrid constructs in some series, but limitations include lack of control groups, single-surgeon series, and small samples; overall evidence for multilevel procedures considered insufficient/limited.
Systematic reviews / meta-analyses favoring TDR (e.g., Zigler et al., Lang et al., Bai et al.)
Meta-analyses show TDR associated with superior or comparable outcomes (ODI, VAS, patient satisfaction) and similar or lower reoperation rates versus fusion in single-level disease; results sensitive to definitions and follow-up duration.
Systematic reviews of hybrid cervical surgery (Baumann 2024 and others)
Evidence for cervical hybrid surgery shows similar clinical outcomes to CDA or ACDF in many studies but limited high-level data; insufficient evidence to support cervical CDA combined with fusion as part of the same surgical plan (policy labels this unproven/not medically necessary).

Revision History

2025-06-01material changeLatest

Summary of Changes (06/01/2025): Replaced prior definitive coverage wording with conditional phrasing; updated clinical evidence and references. Coverage rationale wording was revised to replace absolute language with conditional language stating lumbar artificial total disc replacement is proven and medically necessary 'in certain circumstances' for single-level lumbar degenerative disc disease.

Archived - previous version CS1ZILAMarchived previous version

Archived previous policy version CS1ZILAM.

Policy Summary

PayerUnitedHealthcare Community Plan

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

Policy CodePolicy CS1ZILAN

Change TypeRevised coverage rationaleevidence and references updated

Effective DateJun 1, 2025

Next Review Date

Key ActionProviders must refer to the InterQual criteria for detailed medical necessity clinical coverage criteria.

SourceLink

On This Page

Cervical artificial disc replacement with prior fusion - Medically necessary

Covered when ALL of the following are met:

ALL of the following

Use of FDA‑approved prosthetic intervertebral disc: Use of an FDA‑approved prosthetic intervertebral disc
Treated levels: Treatment of one level or two contiguous levels of cervical degenerative disc disease
Skeletal maturity: Individual is skeletally mature
See Definitions: Skeletally Mature
Prior fusion: History of cervical spinal fusion at another level (adjacent or non‑adjacent)
Symptoms: Symptomatic radiculopathy and/or myelopathy

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Cervical artificial disc replacement combined with fusion (Hybrid Surgery) - Not medically necessary

Unproven / Not medically necessary when:

Hybrid cervical (within same surgical plan): Cervical artificial disc replacement at one level combined with cervical spinal fusion surgery at another level (adjacent or non‑adjacent) as part of the same surgical plan

Reason: insufficient evidence of efficacy (Not medically necessary)

Lumbar artificial total disc replacement - Medically necessary (single level)

Covered when ALL of the following are met:

ALL of the following

Use of FDA‑approved prosthetic intervertebral disc: Use of an FDA‑approved prosthetic intervertebral disc
Single‑level disease: Treatment of single‑level lumbar degenerative disc disease
Skeletal maturity: Skeletally mature individual
See Definitions: Skeletally Mature
Symptoms: Symptomatic intractable discogenic low back pain
Conservative care: Failure of conservative treatment per referenced InterQual criteria (policy directs to InterQual for clinical necessity criteria)
Refer to InterQual CP: Procedures, Artificial Disc Replacement; Lumbar

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Lumbar artificial total disc replacement - Not medically necessary (multilevel)

Unproven / Not medically necessary when:

Multilevel lumbar TDR: Lumbar artificial total disc replacement at more than one spinal level (adjacent or non‑adjacent)

Reason: insufficient evidence of efficacy (Not medically necessary)

Indication Criteria (as summarized from NASS 2024 recommendation and policy change)

Lumbar artificial disc replacement is indicated when ALL of the following are met:

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Absolute/Relative Exclusion Criteria (scenarios where lumbar disc arthroplasty is not indicated per NASS 2024)

Lumbar disc arthroplasty is NOT indicated when ANY of the following are present:

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Denial Risk

Multilevel lumbar TDR not covered

Lumbar artificial total disc replacement performed at more than one spinal level is considered unproven and not medically necessary and is at risk for denial.

22857
22860
22862
0165T

Documentation Required

Document nonoperative treatment

Provide documentation that the patient had at least 6 months of multimodal nonoperative treatment, including a physical therapy/rehabilitation program (may include injections, cognitive behavioral therapy, active exercise), prior to consideration of lumbar TDR; see InterQual for detailed clinical necessity criteria.

Documentation Required

Document symptom origin and level(s)

Document that pain is primarily axial and that imaging/clinical evaluation localizes disease to 1- or 2-level disc disruption at L3-4, L4-5, and/or L5-S1 and record the specific level(s) treated.

Documentation Required

Document exclusion criteria

Document the absence of exclusion criteria prior to lumbar TDR; examples of exclusion conditions should be recorded in the chart.

Facet arthropathy at the index level
Chronic predominant radiculopathy > 1 year
Instability greater than Grade I (spondylolisthesis)
DEXA T-score <= -1.0
Active infection or tumor
Unmanaged or poorly managed psychiatric disorder

Prior Authorization

Follow FDA labeling/inclusion criteria

Follow FDA study guidelines and device labeling regarding inclusion and exclusion criteria when determining eligibility for a specific FDA‑approved prosthetic intervertebral disc; note that FDA approval alone is informational and is not a sole basis for coverage decisions.