CurrentUnitedHealthcarePolicy CS121TN.V

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

Defines medical necessity criteria, covered and not medically necessary indications, documentation expectations, and applicable procedure codes for cervical and lumbar total artificial disc replacement for Tennessee Medicaid and CoverKids.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS121TN.V

Change TypeRevised (criteria, definitions, evidence updates)

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure patient medical records fully document history, exam, and diagnostic test results to support InterQual criteria and FDA-approved device use for medical necessity determinations.

SourceLink

POLICY UPDATE CHANGES

Revised coverage rationale for cervical and lumbar TDR to specify criteria (FDA-approved device, level limits, skeletally mature, symptomatology) and reference InterQual for clinical criteria.

Removed reference link to the Medical Policy titled 'Interspinous Fusion and Decompression Devices (for Tennessee Only)'.

Added definitions for Contiguous Levels, Hybrid Cervical Surgery, Hybrid Lumbar Surgery, Radiographically Confirmed Complete Arthrodesis and updated definition of 'Skeletally Mature'.

Updated supporting information, clinical evidence and references sections to reflect current literature.

Archived previous policy version CS121TN.U.

1–2 levelsCervical allowed levels

single levelLumbar allowed levels

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restrictedHybrid surgery (cervical/lumbar)

InterQual requiredClinical criteria source

multilevel lumbar/hybridNot covered scenarios

4New/Updated Definitions

Coverage Summary

This policy (Policy No. CS121TN.V, effective 2026-03-01) defines coverage for Total Artificial Disc Replacement (TADR/TDR) of the spine for Tennessee Medicaid and CoverKids. Cervical replacement is covered for one or two contiguous levels (C3–C7) and lumbar replacement is covered for a single level only when an FDA‑approved prosthetic intervertebral disc is used and the patient meets clinical criteria in the applicable InterQual artificial disc replacement guideline. The policy requires documentation in the medical record to substantiate medical necessity and notes that certain scenarios—such as hybrid procedures combining disc replacement with fusion or multilevel lumbar procedures—are considered unproven/not medically necessary per the policy.

Key facts — scope and statistics

Cervical allowed levelscervical one or two levels

Lumbar allowed levelslumbar single level only

Hybrid surgery (cervical/lumbar)hybrid surgeries restricted

Clinical criteria sourceInterQual required

Covered Indications (summary)Proven - Cervical (1-2 levels) & Lumbar (single level only)

Not Covered / Unproven ScenariosUnproven - Hybrid and multilevel lumbar

Medical-Necessity Criteria

Cervical Total Artificial Disc Replacement - Medically Necessary

Proven and medically necessary when ALL of the following are present and InterQual criteria are met:

ALL of the following

An FDA-approved prosthetic intervertebral disc is utilized
Individual diagnosed with only one or two Contiguous Levels of cervical degenerative disc disease (C3-C7)
Skeletally Mature individual with radiculopathy and/or myelopathy
The arthroplasty will be performed at all symptomatic Contiguous Levels (up to two levels between C3-C7)

Cervical Total Artificial Disc Replacement with Prior Cervical Spinal Fusion - Medically Necessary

Coding

Applicable Procedure Codes (reference only)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; 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

FDA device product code reference (informational)mixed

MJO	FDA product code for spinal arthroplasty devices (refer to PMA database)

Provider Actions & Authorization

Prior Authorization

InterQual criteria requirement

InterQual® clinical policy (CP) criteria must be met for approval of cervical or lumbar total artificial disc replacement procedures. Refer to the InterQual® CP: Procedures, Artificial Disc Replacement, Cervical for cervical cases and the InterQual® Client Defined CP: Procedures, Artificial Disc Replacement, Lumbar (Custom) - UHG for lumbar cases. Meeting InterQual® criteria is a requirement for medical necessity determination and prior authorization decisions.

Prior Authorization

InterQual criteria and device FDA-approval required

Approval requires both that the InterQual® clinical criteria are met and that an FDA‑approved prosthetic intervertebral disc is used. For two‑level cervical procedures, the device must be FDA‑approved for two levels when applicable. Devices not FDA‑approved for the indicated number of levels may result in denial.

Use of an FDA‑approved prosthetic intervertebral disc is required
For two‑level cervical TADR, the implant must be FDA‑approved for two levels

Background & Evidence Summary

Artificial disc replacement is the prosthetic replacement of a degenerating intervertebral disc intended to preserve range of motion and reduce pain in adults with degenerative disc disease. FDA‑regulated devices are available for cervical and lumbar use; coverage requires use of an FDA‑approved prosthetic intervertebral disc and adherence to device labeling and InterQual clinical criteria. While evidence supports single‑level lumbar and one‑ or two‑level cervical use in appropriately selected patients, the literature and technology assessments note limited or insufficient evidence for multilevel lumbar TDR and for hybrid constructs combining fusion and arthroplasty; therefore these scenarios are treated as unproven or not medically necessary within the Tennessee Medicaid/CoverKids scope.

Study / Source	Key finding
ECRI 2021 Simplify study	One prospective historical‑control trial (n=267) reported improved NDI, VAS, QoL and higher satisfaction with Simplify versus historical ACDF at 2 years but evidence limited and at high risk of bias (lack of randomization, blinding, parallel control).
Hayes reviews (2020-2024)	Hayes reviews conclude moderate‑quality evidence that single‑level lumbar TDR is comparable with fusion; evidence insufficient for two‑level LTDR, multilevel TDR, and hybrid lumbar constructs.
activL post hoc analysis (5-year)	Post‑hoc analysis of the activL IDE trial (n=376) showed ODI, VAS, SF‑36 improvements maintained through 5 years with no significant differences in safety or reoperation rates between prior‑surgery and no‑prior‑surgery groups.
Hayes 2022 review conclusion	Hayes (2022) concluded moderate‑quality evidence that 1‑level LTDR is comparable to fusion in properly selected patients; insufficient evidence for multilevel LTDR or comparison with continued conservative care.
Radcliff et al. 7‑year IDE study	Randomized IDE trial (activL vs ProDisc‑L) reported sustained improvements in ODI and VAS and low reoperation rates at 7 years; benefits maintained through long‑term follow‑up.
Meta‑analyses (various)	Multiple meta‑analyses report TDR is superior or comparable to fusion for ODI, VAS, satisfaction and sometimes lower reoperation rates; longer‑term durability findings are mixed across analyses.

Definitions

Definitions (policy terms):

Contiguous Levels: Vertebral segments adjacent to each other.

Hybrid Cervical Surgery: Combination of anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA); when performed as part of the same surgical plan with disc replacement at one level and fusion at another it is considered unproven/not medically necessary in the policy.

Hybrid Lumbar Surgery: Combination of total disc arthroplasty (TDA) and anterior lumbar interbody fusion (ALIF); when performed as part of the same surgical plan it is considered unproven/not medically necessary in the policy.

Radiographically Confirmed Complete Arthrodesis: Radiographic evidence of trabecular bone across the interspace, absence of lucency between graft and endplate, absence of hardware loosening, and < 1 mm motion between spinous processes on flexion‑extension radiographs.

Skeletally Mature: Classification when endochondral ossification ceases and the physis closes by becoming totally ossified.

Revision History

03/01/2026revisedLatest

Revised coverage rationale: clarified cervical TADR criteria (FDA-approved device; one- or two-Contiguous Levels C3-C7; skeletally mature with radiculopathy/myelopathy; arthroplasty performed at all symptomatic contiguous levels) and specified for two-level devices the device must be FDA-approved for two levels; added coverage condition for prior cervical fusion requiring radiographically confirmed complete arthrodesis; referenced InterQual clinical criteria.

03/01/2026revised

Revised coverage rationale: clarified lumbar TDR criteria (FDA-approved device; single-level lumbar degenerative disc disease; skeletally mature; symptomatic intractable discogenic low back pain attributable to that level) and specified unproven/not medically necessary scenarios (performed at one level combined with existing lumbar fusion at another level; performed with lumbar fusion as part of same surgical plan — Hybrid Lumbar Surgery; performed at more than one spinal level); referenced InterQual clinical criteria.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS121TN.V

Change TypeRevised (criteria, definitions, evidence updates)

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure patient medical records fully document history, exam, and diagnostic test results to support InterQual criteria and FDA-approved device use for medical necessity determinations.

SourceLink

On This Page

Proven and medically necessary when ALL of the following are present and InterQual criteria are met:

ALL of the following

An FDA-approved prosthetic intervertebral disc is utilized
Treating individuals with only one level or two Contiguous Levels of cervical degenerative disc disease (C3-C7)
Skeletally Mature individual with radiculopathy and/or myelopathy
The arthroplasty will be performed at all symptomatic Contiguous Levels (up to two levels between C3-C7)
Radiographically Confirmed Complete Arthrodesis of a previous cervical spinal fusion at another level (adjacent or non-adjacent)

Cervical Artificial Disc Removal or Replacement - Medically Necessary

Indication:

Removal or replacement with an FDA-approved (one or two-level) prosthetic intervertebral disc is medically necessary in individuals with implant failure after prior disc replacement

Cervical Total Artificial Disc Replacement - Not Medically Necessary

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)

Lumbar Total Artificial Disc Replacement - Medically Necessary

Proven and medically necessary when ALL of the following are present and InterQual criteria are met:

ALL of the following

An FDA-approved prosthetic intervertebral disc is utilized
Treating individuals with only single level of lumbar degenerative disc disease
Skeletally Mature individual
Symptomatic intractable discogenic low back pain attributable to that level

Lumbar Total Artificial Disc Replacement - Not Medically Necessary / Unproven

Unproven and not medically necessary due to insufficient evidence when any of the following are present:

Performed at one level combined with an existing lumbar spinal fusion surgery at another level (adjacent or nonadjacent)

Performed with lumbar spinal fusion surgery as part of the same surgical plan (Hybrid Lumbar Surgery)

Performed at more than one spinal level

Cervical total artificial disc replacement (TADR) - Proven and medically necessary (summary of revised language)

Covered when ALL of the following are present and InterQual criteria are met:

ALL of the following

An FDA-approved prosthetic intervertebral disc is utilized
Individual diagnosed with only one or two Contiguous Levels of cervical degenerative disc disease (C3-C7)
Skeletally mature individual with radiculopathy and/or myelopathy
The arthroplasty will be performed at all symptomatic contiguous levels (up to two levels between C3-C7)
InterQual criteria are met
InterQual CP reference: Procedures, Artificial Disc Replacement, Cervical

Cervical total artificial disc replacement - Additional conditions for two-level and prior fusion

For two-level contiguous cervical TADR, the device being utilized must be FDA-approved for two levels

When a cervical total artificial disc replacement was previously performed, the second contiguous level artificial disc must be FDA approved for two levels

ALL of the following

An FDA-approved prosthetic intervertebral disc is utilized
Treating individuals with only one level or two contiguous levels of cervical degenerative disc disease (C3-C7)
Skeletally mature individual with radiculopathy and/or myelopathy
The arthroplasty will be performed at all symptomatic contiguous levels (up to two levels between C3-C7)
Radiographically confirmed complete arthrodesis of a previous cervical spinal fusion at another level (adjacent or non-adjacent)

Cervical - Not medically necessary / Unproven

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)

Lumbar total artificial disc replacement (TDR) - Proven and medically necessary (summary)

Covered when ALL of the following are present and InterQual criteria are met:

ALL of the following

An FDA-approved prosthetic intervertebral disc is utilized
Treating individuals with only single level of lumbar degenerative disc disease
Skeletally mature individual
Symptomatic intractable discogenic low back pain attributable to that level
InterQual criteria are met
InterQual Client Defined CP reference

Lumbar TDR - Unproven and not medically necessary (specified scenarios)

Lumbar TDR is unproven and not medically necessary due to insufficient evidence of efficacy when ANY of the following are present:

Performed at one level combined with an existing lumbar spinal fusion surgery at another level (adjacent or non-adjacent)

Performed with lumbar spinal fusion surgery as part of the same surgical plan (Hybrid Lumbar Surgery)

Performed at more than one spinal level

Documentation requirement / General coverage governance

Covered when ALL of the following governance and documentation conditions are met:

Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws; in event of conflict, those requirements govern

Medical records documentation may be required to assess whether the member meets clinical criteria for coverage (documentation does not guarantee coverage)

Patient's medical record must contain documentation that fully supports medical necessity for the requested services

Required documentation includes but is not limited to relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures

Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and made available upon request

Documentation Required

Medical record documentation required

The patient's medical record must contain complete, legible documentation that supports medical necessity. Submission of medical records may be required for review but does not guarantee coverage.

Relevant medical history and physical examination findings
Results of pertinent diagnostic tests or procedures (e.g., imaging, electrodiagnostic studies)
Documentation that the clinical indications meet InterQual® criteria
Operative reports, device details (manufacturer/model/levels), and prior surgical history when applicable
Maintain and make available complete medical records upon request

Denial Risk

Denial risk for hybrid or multi-level procedures

Hybrid surgeries (combining total disc replacement and fusion in the same surgical plan) and multi‑level lumbar disc replacements (more than one level) are at risk for denial. Cervical two‑level contiguous replacement is allowed when criteria and device approvals are met; however, one‑level disc arthroplasty combined with fusion at another level (hybrid cervical surgery) is considered not medically necessary and may be denied.

Hybrid Cervical Surgery (one‑level disc replacement + fusion at another level in same plan) — not medically necessary; denial risk
Hybrid Lumbar Surgery (disc replacement + fusion in same plan) — not medically necessary; denial risk
Lumbar procedures performed at more than one spinal level — not medically necessary; denial risk

Prior Authorization

Potential prior authorization / medical records review

Prior authorization or medical records review may be required to confirm that InterQual® criteria and device requirements are met. Providers should be prepared to supply complete documentation when requested; lack of available documentation may result in claim denial or adverse coverage determination.

Documentation may be requested to assess InterQual® criteria compliance
Device approval documentation and operative/device details may be requested
Availability of complete medical records is required for review

03/01/2026added

Added definitions: Contiguous Levels, Hybrid Cervical Surgery, Hybrid Lumbar Surgery, Radiographically Confirmed Complete Arthrodesis.

03/01/2026revised

Updated definition of 'Skeletally Mature'.

03/01/2026removed

Removed reference link to the Medical Policy titled 'Interspinous Fusion and Decompression Devices (for Tennessee Only)'.

03/01/2026updated

Updated supporting information, Clinical Evidence, and References sections to reflect most current literature.

03/01/2026archived

Archived previous policy version CS121TN.U.