Sierra Health and Life disc replacement Coverage Update

Coverage Criteria for Total Artificial Disc Replacement

inv-01: Cervical — Medically necessary

Cervical total artificial disc replacement is proven and medically necessary when ALL of the following are met and InterQual criteria are met:

Cervical TADR criteria: 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)

For two-level contiguous cervical TADR, the device must be FDA-approved for two levels. Refer to InterQual CP for full clinical criteria.

inv-02: Cervical after prior fusion — Medically necessary

Cervical TADR after prior fusion is proven and medically necessary when ALL of the following are met and InterQual criteria are met:

Cervical TADR after prior fusion: 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)

Second contiguous level device must be FDA-approved for two levels if applicable; refer to InterQual CP for full clinical criteria.

inv-03: Cervical — Unproven / Not medically necessary

Cervical not medically necessary / unproven:

Cervical unproven: Cervical total artificial disc replacement 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)

Described in policy as unproven and not medically necessary.

inv-04: Lumbar — Medically necessary

Lumbar total artificial disc replacement is proven and medically necessary when ALL of the following are met and InterQual criteria are met:

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

Refer to InterQual Client Defined CP: Procedures, Artificial Disc Replacement, Lumbar for full clinical criteria.

inv-05: Lumbar — Unproven / Not medically necessary

Lumbar not medically necessary / unproven:

Lumbar unproven: 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

Described as unproven and not medically necessary due to insufficient evidence of efficacy for multilevel or hybrid constructs.

inv-06: Coverage-relevant clinical criteria and evidence statements

Evidence-based coverage considerations derived from the reviewed studies and reviews

General candidate requirements: Symptomatic degenerative disc disease (cervical or lumbar) with radiculopathy and/or myelopathy unresponsive to conservative management for a defined period (studies often required ≥6 weeks to ≥6 months), and meeting device-specific selection criteria.failed conservative management (variable: ≥6 weeks to ≥6 months)

Multiple studies noted requirement of failed conservative therapy prior to surgical enrollment.

Cervical hybrid surgery potential benefits: Hybrid surgery may preserve C2-C7 range of motion and reduce adjacent segment ROM increase and allow faster return to work compared with ACDF in observational studies and meta-analyses, but high-quality randomized evidence is lacking.

Findings derive largely from nonrandomized studies and meta-analyses of lower-quality trials.

Cervical TDR for adjacent segment disease after prior fusion: TDR has been reported as an effective option for symptomatic adjacent segment disease after prior ACDF with comparable or improved NDI, VAS, and ROM outcomes versus revisional fusion in small retrospective series and meta-analyses.

inv-07: Lumbar TDR (including hybrid constructs when selection criteria met)

Covered when ALL of the following are met

Lumbar TDR coverage criteria: 1) Discogenic low back pain arising from one or two levels involving L3-4, L4-5, and/or L5-S1; 2) Symptoms present for ≥6 months and not responsive to multimodal nonoperative treatment over that period (including physical therapy/rehabilitation and may include injections, pain management, CBT, active exercise); 3) Primary complaint of axial back pain (secondary leg pain allowed); 4) Absence of exclusionary conditions such as significant facet arthropathy at the index level, spinal instability with spondylolisthesis > Grade I, chronic predominant radiculopathy (>1 year) with leg pain predominance, osteopenia with DEXA T-score ≤ -1.0, poorly managed psychiatric disorder, active infection or tumor, or age <18 or >60; 5) Patient selection and surgical planning consistent with FDA labeling and device-specific inclusion/exclusion criteria.symptoms ≥6 months; DEXA T-score ≤ -1.0 is exclusion

Based on NASS 2024 recommendations; insufficient evidence supports multilevel or hybrid lumbar constructs except in research contexts.

inv-08: Cervical total artificial disc replacement – medically necessary criteria

Covered when ALL of the following are met (examples pulled from policy revisions and summary):

Cervical TADR eligibility: An FDA-approved prosthetic intervertebral disc is utilized; individual has only one or two contiguous levels of cervical degenerative disc disease (C3-C7); skeletally mature with radiculopathy and/or myelopathy; arthroplasty performed at all symptomatic contiguous levels (up to two levels); for two-level contiguous TADR the device must be FDA-approved for two levels; when prior cervical fusion exists and TADR is considered, there must be radiographically confirmed complete arthrodesis of the previous fusion level.

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

inv-09: Lumbar total artificial disc replacement – medically necessary criteria

Covered when ALL of the following are met (examples pulled from policy revisions and summary):

Lumbar TDR eligibility: An FDA-approved prosthetic intervertebral disc is utilized; treating individuals with only a single level of lumbar degenerative disc disease; skeletally mature individual; symptomatic intractable discogenic low back pain attributable to that level; documentation that conservative treatments were tried, failed, or contraindicated (including dates, duration, reasons); provide psychosocial-behavioral evaluation when applicable; physician treatment plan including surgical technique and number/location of levels.documented conservative treatment (dates and duration)

Refer to InterQual Client Defined CP for lumbar artificial disc replacement for full clinical criteria; NASS guidance recommends symptoms ≥6 months and multimodal nonoperative care prior to surgery.

Hybrid surgeries combining disc replacement and fusion as part of the same surgical plan (cervical or lumbar) are described in the policy as unproven and not medically necessary. The policy explicitly states that a cervical total artificial disc replacement performed at one level combined with cervical spinal fusion at another level (adjacent or non-adjacent) as part of the same operative plan — termed Hybrid Cervical Surgery — is unproven and not medically necessary, and similarly classifies lumbar hybrid constructs as unproven when performed with fusion as part of the same surgical plan.

Because hybrid procedures are categorized as unproven/not medically necessary, these cases may trigger coverage denial under the policy; prior authorization reviewers should therefore confirm whether a proposed procedure is part of a hybrid plan and apply the policy exclusion accordingly.

The policy indicates there is insufficient evidence to support lumbar total disc replacement (TDR) for multilevel (two or more) degenerative disc disease outside of investigational contexts. Multiple evidence reviews (ECRI, Hayes) and primary studies summarized in the policy note limited sample sizes, short or incomplete follow-up, and high risk of bias that preclude definitive conclusions for multilevel lumbar TDR.

Consequently, the policy classifies lumbar TDR when performed at more than one level — including two-level TDR — as unproven and not medically necessary unless performed in settings consistent with specific investigational or payer-defined research allowances.

The policy adopts selection criteria and exclusions consistent with NASS guidance: procedures are not indicated when there is symptomatic degenerative disc disease at more than two levels, significant facet arthropathy at the index level, or spinal instability such as spondylolisthesis greater than Grade I.

Additional exclusionary conditions that may preclude coverage include chronic predominance of radicular (leg) pain exceeding one year, osteopenia with a DEXA T-score ≤ -1.0, poorly managed psychiatric disorder, age <18 or >60 years, and presence of active infection or tumor — any of which may render a patient ineligible for disc arthroplasty per the policy.

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

The policy also describes that TADR after prior fusion can be medically necessary only when the prior fusion is a radiographically confirmed complete arthrodesis and all other cervical TADR criteria and InterQual requirements are met; by contrast, combining a new TADR and fusion in a single operative plan is not supported.

Hybrid cervical or lumbar procedures — defined as use of disc replacement at one level combined with fusion at another level as part of the same surgical plan — are described in the policy as unproven and not medically necessary and therefore excluded from coverage.

For cervical cases, the policy clarifies that TADR is allowable in patients with prior fusion only when that prior fusion demonstrates radiographically confirmed complete arthrodesis; however, performing a new TADR and a fusion together in the same operative plan (hybrid cervical surgery) is not supported and is considered noncovered.

Two-level lumbar TDR and lumbar hybrid constructs (TDR combined with fusion) have minimal or unclear support in current evidence reviews. Multiple Hayes and ECRI reports summarized in the policy conclude that available studies provide limited evidence, often with small samples, abstract-only data, or methodological limitations.

As a result, the policy treats two-level lumbar TDR and hybrid lumbar TDR with fusion as unproven and not medically necessary for routine clinical use outside of research settings or explicit payer-approved exceptions.

The policy references guideline bodies that have raised concerns about the limited long-term evidence for disc replacement. The American Pain Society noted that data beyond two years are limited and there is insufficient evidence to evaluate long-term benefits and harms of vertebral disc replacement for nonradicular low back pain.

The UK’s NICE guidance similarly recommends not offering disc replacement for low back pain, citing inadequate evidence to support long-term effectiveness and safety. These guideline conclusions underpin the policy’s conservative stance on multilevel and hybrid disc replacement procedures.

The policy reiterates that cervical TADR is not medically necessary when it is performed at one level combined with cervical fusion at another level as part of the same surgical plan (Hybrid Cervical Surgery).

It also notes that TADR after prior fusion may be considered medically necessary only if the prior fusion is a radiographically confirmed complete arthrodesis and all InterQual criteria and device-specific requirements are met.

Coding and Procedure 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

Coding referenced in studiesmixed

CPT and ICD-9/10 used in database study

Lee et al. used CPT and ICD-9/10 coding to identify primary ACDA and revision procedures

Regulatory/Product codesmixed

MJO	FDA product code referenced for artificial discs (informational)

Conservative treatment prior to surgery (example reported in studies)

Typical duration reported in studiesAt least 6 weeks of conservative management prior to surgery (some studies and cohorts used ≥6 weeks; others required longer durations up to ≥6 months)

Types of conservative therapiesMultimodal nonoperative care such as physical therapy/rehabilitation, activity modification, pain management, and injections (reported across trials and observational studies)

Study enrollment requirement variabilityRandomized trials and registries variably required failed conservative therapy; some trials specified ≥6 months while others allowed shorter preoperative conservative periods

Radiographic fusion cutoff

Radiographic fusion cutoff (objective)< 1 mm movement between spinous processes on lateral flexion-extension radiographs

Provider Actions, Authorization, and Documentation Requirements

Denial Risk

NASS-specified exclusions may lead to denial

NASS-specified exclusions that may lead to denial: review the North American Spine Society (NASS) coverage recommendations before submitting prior authorization. Cases that do not meet NASS selection criteria or that meet any of the exclusion criteria below may be denied.

Any case that does not fulfill the NASS indication criteria for lumbar disc arthroplasty (e.g., pain arising from 1- or 2-level disc disruption at L3-4, L4-5, and/or L5-S1; symptoms ≥ 6 months; failure of multi-modal nonoperative treatment).
Presence of symptomatic degenerative disc disease at more than two levels.
Significant facet arthropathy at the index level or clinical/radiographic evidence that pain is primarily facet-mediated.
Spinal instability with spondylolisthesis greater than Grade I.
Chronic radiculopathy defined as unremitting leg-predominant pain > 1 year.
Osteopenia with DEXA T-score ≤ -1.0.
Poorly managed psychiatric disorder unless optimized prior to surgery.
Age > 60 years or < 18 years.
Active infection or tumor at the operative site.

Definitions

Contiguous Levels

DefinitionVertebral segments adjacent to each other

Cervical policy contextUsed to define eligible contiguous cervical levels (up to two contiguous C3-C7 levels per policy)

Synonyms/usageAlso referenced in device-level selection criteria describing adjacent treated segments

Hybrid Cervical Surgery

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

Policy stanceHybrid Cervical Surgery (disc replacement at one level combined with fusion at another level as part of the same surgical plan) is described as unproven and not medically necessary when performed in the same surgical plan

Background

Artificial disc replacement is a surgical treatment intended to replace a degenerating intervertebral disc while preserving motion at the treated level and reducing pain for adults with degenerative disc disease.

The policy describes the typical indications: cervical arthroplasty for skeletally mature individuals with radiculopathy and/or myelopathy at one or two contiguous levels (C3–C7), and lumbar arthroplasty reserved for a single symptomatic lumbar level (commonly L3–4, L4–5, or L5–S1) when conservative therapies have failed.

Revision History

2026-02-01policy_revisionLatest

Revised Coverage Rationale language: clarified FDA‑approved device requirement, limits on levels treated, and documentation additions including psychosocial‑behavioral evaluation for lumbar surgery; updated coverage criteria for cervical TADR and lumbar TDR.

definitions_added

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

OpenPayer

Total Artificial Disc Replacement for the Spine