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ModifiedProvidence Health PlanPolicy 34

Artificial Intervertebral Discs

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Clinical coverage criteria and policy guidance for FDA‑approved cervical and lumbar artificial intervertebral disc replacement procedures for Providence Health Plan commercial members and associated product lines.

Policy Summary

PayerProvidence Health Plan

PolicyArtificial Intervertebral Discs

Policy CodePolicy 34

Change TypeInterim update — revision/replacement allowed for cervical ADR when criteria met

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateOct 1, 2026

Key ActionObtain prior authorization with documentation of device, levels treated, neurologic exam, imaging, and failure of required conservative therapy.

SourceLink

POLICY UPDATE CHANGES

Interim update allows revision/replacement of artificial cervical disc when criteria are met.

Up to 2cervical levels allowed

Single levellumbar levels allowed

3 monthsconservative treatment required

>=15NDI threshold

Commercial onlyplan applicability

2/2023–7/2026revision history range

Coverage Criteria for Artificial Intervertebral Disc Replacement

Cervical Artificial Disc Replacement — Primary criteria

Covered when ALL of the following are met for single-level or two contiguous levels:

Cervical ADR general criteria: A. Patient is skeletally mature (fully developed growth plates); B. The cervical intervertebral disc prosthesis is FDA‑approved for the implanted cervical level and the patient has none of the FDA contraindications for that device; C. A detailed neurological examination has been performed by, or reviewed by, the operating surgeon within 3 months prior to surgery; D. Replacement does not exceed two contiguous levels; E. At each proposed level one or more of: (1) herniated nucleus pulposus; or (2) spondylosis (osteophytes); or (3) visible loss of disc height compared to adjacent levels; F. Physical and neurological exam findings suggestive of nerve root or spinal cord compression at the affected level (e.g., weakness, sensory loss, hyperreflexia, reflex changes, myelopathy); G. At least one of: (1) imaging shows severe stenosis with cord signal changes; or (2) exam shows major progressive neurologic changes (myelopathy/progressive weakness); or (3) persistent debilitating neck or cervicobrachial radicular pain with documented activities-of-daily-living impact or Neck Disability Index ≥ 15 and failure of 3 months of conservative treatment (unless exceptions apply); H. Other reasonable sources of pain have been evaluated and ruled out.

See Policy Guidelines for definitions and exceptions.

Cervical Subsequent/Adjacent Level Implantation

Covered when ALL of the following are met for implantation at a second contiguous level adjacent to a prior cervical ADR:

Policy Summary

PayerProvidence Health Plan

PolicyArtificial Intervertebral Discs

Policy CodePolicy 34

Change TypeInterim update — revision/replacement allowed for cervical ADR when criteria met

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateOct 1, 2026

Key ActionObtain prior authorization with documentation of device, levels treated, neurologic exam, imaging, and failure of required conservative therapy.

SourceLink

On This Page

Lumbar Artificial Disc Replacement — Primary criteria

Covered when ALL of the following are met for single-level lumbar ADR:

Lumbar ADR general criteria: A. Patient is skeletally mature; B. The lumbar artificial disc prosthesis is FDA‑approved for the implanted lumbar/sacral level and the patient has none of the FDA contraindications for that device; C. Replacement is limited to one level; D. Persistent, debilitating pain with documented moderate to severe interference with age-appropriate activities of daily living or severe disability on the Oswestry Disability Index; E. Physical and neurological findings that correlate with cord or nerve root compression at the affected level and imaging (CT or MRI) demonstrates compression at that level; F. Symptoms have failed to improve after 3 months of conservative treatment (unless exceptions for intolerable pain, significant motor dysfunction, or progressive neurologic changes apply); G. Other reasonable sources of pain/neurologic causes have been evaluated and ruled out.

Per policy, lumbar ADR replacement/revision is not covered.

Coverage evidence groups

Evidence-based device and level-specific coverage considerations (from RCTs and systematic reviews):

Single-level cervical ADR evidence: Systematic reviews and randomized controlled trials indicate single-level cervical ADR is comparable or superior to ACDF for many clinical and safety outcomes in appropriately selected patients; evidence quality was rated moderate by Hayes for selected patients.

See Hayes 2021 review and Cochrane 2013 summary

Bi-level (two-level contiguous) ADR evidence: Device-specific pivotal RCTs (e.g., Prestige LP, Mobi-C) and systematic reviews demonstrate bi-level contiguous cervical ADR can show superior overall success, lower reoperation rates, and improved NDI versus two-level fusion through mid-term follow-up (2–7 years); two devices (Mobi-C, Prestige LP) have FDA approval for contiguous two-level implantation.

Mobi-C and Prestige LP RCTs reported superiority or sustained benefit through multi-year follow-up

Multilevel (>2 levels) ADR: No high-quality studies meeting inclusion criteria evaluated more than two-level cervical TDR; evidence is insufficient to support multilevel (>2) ADR beyond contiguous two-level devices.

Hayes found no qualifying >2-level studies

Hybrid procedures evidence: Controlled and nonrandomized studies of cervical hybrid procedures suggest preserved range of motion and comparable outcomes to fusion, but the evidence is limited and heterogenous; additional high-quality studies are needed.

Systematic reviews show limited RCT data and methodological heterogeneity

Guideline indications and contraindications

NASS and other guideline recommendations summarized (eligibility and contraindications):

Cervical ADR indication (NASS): Radiculopathy related to nerve root compression from 1- or 2-level degenerative disease (C3–C7) OR myelopathy/myeloradiculopathy from 1- or 2-level degenerative disease; persistent symptoms despite ≥6 weeks of nonoperative management OR progressive/functional weakness OR inability to perform work/ADLs despite conservative care.

Use as part of a hybrid construct may be considered for multilevel disease when other levels receive ACDF; not supported for ≥3 levels or isolated axial neck pain.

Cervical ADR contraindications (NASS): Any of: active local or systemic infection; osteoporosis or osteopenia; instability (translation >3mm or angular difference ≥11° on flexion-extension at the symptomatic level); sensitivity/allergy to implant materials; severe spondylosis (>50% disc height loss, bridging osteophytes, or absence of motion); severe facet joint arthropathy; ankylosing spondylitis; rheumatoid arthritis; previous fracture with anatomical deformity; ossification of the posterior longitudinal ligament (OPLL); active malignancy in the cervical spine.

Presence of any contraindication excludes candidacy per guideline statement.

Lumbar ADR: single-level vs multilevel/hybrid evidence

Evidence summaries and stance for lumbar ADR and multilevel procedures:

Single-level lumbar ADR: Randomized trials and systematic reviews show single-level lumbar ADR is comparable to fusion for clinical and safety outcomes in properly selected patients; Hayes rated single-level lumbar TDR as 'B' (moderate-quality evidence) as an alternative to fusion after failed conservative treatment.

Follow-up in trials ranged up to 17 years; study limitations include lack of blinding and limited long-term data.

Two-level lumbar ADR: Evidence for two-level lumbar TDR is limited and mixed; Hayes (2024) found clinically meaningful improvements from baseline but comparative outcomes versus fusion/hybrid were inconsistent and overall support was assessed as 'minimal'.

Reoperation and complication rates varied and higher-quality long-term comparative trials are needed.

Lumbar hybrid procedures: Available studies of lumbar hybrid procedures are poor-quality (retrospective, small sample sizes, short follow-up) and insufficient to support routine use; additional high-quality trials are needed.

Current evidence does not establish clinical utility.

Cervical ADR — Contraindications / Not appropriate when ANY of the following are present

NASS contraindications specify cervical ADR is not indicated when any of the following apply:

Cervical ADR contraindications: 1. Active infection at the proposed implantation site or systemic infection; 2. Osteoporosis or osteopenia; 3. Instability defined as translation >3 mm on lateral flexion-extension views or angular difference ≥11° at the symptomatic level; 4. Sensitivity or allergy to implant materials; 5. Severe spondylosis (›50% disc height loss, bridging osteophytes, or absence of motion on flexion-extension); 6. Severe facet joint arthropathy on imaging; 7. Ankylosing spondylitis; 8. Rheumatoid arthritis; 9. Previous fracture with anatomical deformity; 10. Ossification of the posterior longitudinal ligament (OPLL); 11. Active malignancy in the cervical spine.

Based on NASS guidance.

Lumbar ADR — Indications (per NASS) and HERC restrictions

Lumbar ADR is indicated only when ALL of the following are met:

Lumbar ADR inclusion criteria: 1. Discogenic low back pain arising from 1- or 2-level disc disruption 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 low back pain (may have secondary lower-extremity pain); 4. Patients meet FDA‑approved device-specific indications and are skeletally mature.

Per NASS; however, policy limits lumbar ADR to single-level implantation.

Lumbar ADR absolute exclusions (if any apply): Not indicated if: degenerative disease at more than two levels; significant facet arthropathy or primarily facet-mediated pain; spinal instability with spondylolisthesis > Grade I; chronic radiculopathy predominating with leg pain ≥1 year; osteopenia DEXA T-score ≤ -1.0; poorly managed psychiatric disorder; age >60 or <18; infection or tumor.

Based on NASS and HERC restrictions.

Device‑specific contraindications and exclusions are listed in the FDA‑approved device tables and must be confirmed for the selected prosthesis. Typical device table exclusions include active local or systemic infection, DEXA T‑score thresholds (device dependent, commonly osteoporosis or osteopenia cutpoints such as ≤ -2.5 or device‑specific values), marked segmental instability (translation thresholds or angular differences per device labeling), severe facet arthropathy, bridging osteophytes/marked spondylosis or loss of disc height >50% or absence of motion, compromised vertebral bodies (prior trauma/deformity or inflammatory disease), sensitivity/allergy to implant materials, congenital stenosis or other anatomic constraints, and inadequate endplate or disc space dimensions for the implant.

Billing and Coding Guidance

Billing/Coding examples and revision/removal codesCPT

0098T	Unlisted/replacement/revision related CPT (document notes 0098T may be billed with 22861)
0095T	Revision including replacement of total disc arthroplasty, anterior approach, each additional interspace (cervical) — referenced in coding notes
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
22864	Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical
22865	Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar

Coding referenced but not specifiedmixed

affected codes

The provided chunks do not list specific CPT/HCPCS/ICD-10 codes; references note device PMAs and literature but not billing codes.

inv-26: Neck Disability Index (NDI) — threshold value for cervical ADR candidacy

NDI threshold>= 15 points

NDI scalePatient‑reported index 0–50 across 10 domains; 15–24 = moderate disability

Use in cervical ADR criteriaNDI >=15 can satisfy functional disability requirement for cervical ADR when correlated with imaging and failed conservative care

inv-27: Conservative treatment duration — required duration prior to surgery

Required duration (general)3 months of conservative treatment prior to lumbar or cervical ADR (unless exceptions apply)

Cervical guideline noteNASS recommends ≥6 weeks conservative therapy for cervical radiculopathy prior to ADR consideration (policy references this as guideline-based)

ExceptionsConservative care may be waived for severe/progressive neurologic signs, cauda equina, severe weakness, or intolerable pain

inv-28: DEXA T-score contraindication examples — bone density thresholds referenced

Example device contraindication (osteoporosis)DEXA T‑score ≤ -2.5 referenced as contraindication for some cervical devices (osteoporosis)

Osteopenia examplesSome device labels reference osteopenia thresholds (e.g., T‑score < -1.0 or < -1.5) as exclusionary or cautionary

Device‑specific variabilityFDA‑approved device tables list device‑specific DEXA T‑score contraindications—refer to Table 2 for exact device wording

inv-29: Age — patient age limits for lumbar ADR per HERC guidance

Age limits for lumbar ADR (HERC/NASS)Patient age must be >18 and ≤60 years for lumbar ADR per HERC guidance referenced in policy

RationaleAge criteria intended to align with device indications and limit use in older patients with higher comorbidity/osteopenia risk

Exceptions/noted exclusionsPolicy notes age <18 or >60 as exclusionary for lumbar ADR per NASS/HERC statements

inv-30: Bone mineral density (DEXA T-score) — numeric requirement for candidacy

Required bone density for candidacyDEXA T‑score must be greater than -1.0 (osteopenia defined as ≤ -1.0 is an exclusion per HERC/NASS statements)

Device labels may differFDA device tables include device‑specific BMD thresholds (some reference T‑score ≤ -1.0, ≤ -1.5, or ≤ -2.5 for osteoporosis)

Denial riskOsteopenia/osteoporosis on DEXA may trigger noncoverage if T‑score meets exclusionary thresholds

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior authorization expectations — confirm device, exam, imaging, and conservative care

Prior authorization is implied for cervical (single- or two-contiguous level) and lumbar (single-level) artificial disc replacement: the request should confirm the device is FDA‑approved for the specific level(s), document a detailed neurologic exam performed or reviewed by the operating surgeon within 3 months of surgery, correlate imaging with clinical findings, and include conservative therapy details per policy guidelines.

Confirm device FDA approval for the intended cervical or lumbar level (see Table 2/Table 3).
Provide neurologic exam documentation within 3 months reviewed by the operating surgeon.
Attach imaging reports that correlate with clinical findings and symptoms.
Document conservative therapy and its duration or applicable exceptions.

Prior Authorization

Prior authorization documentation required — full submission checklist

Submit the following with the prior authorization request: indication for surgery; documentation that the patient was evaluated at least once by the requesting surgeon prior to the request; clinical documentation of extent and response to conservative care (including procedural interventions, medication use and PT notes); evaluation of functional impairments; management of cognitive/behavioral/addiction issues when present; and independent radiologist reports for diagnostic imaging performed within the past 12 months or at symptom onset.

Indication for the requested surgery and surgeon evaluation encounter note.
Conservative care records including PT visit notes (≥3 visits where applicable), medications, injections and outcomes.
Functional impairment or ADL impact documentation (e.g., NDI or ODI scores).
Independent radiologist reports for MRI/CT within 12 months (radiologist report supersedes if discrepancies).
Documentation of evaluation/management of cognitive, behavioral, or addiction issues if present.

Prior Authorization

Prior authorization must cite device, levels, and supporting evidence

For pre-service review, identify the device and treated level(s) and include device-specific supporting evidence (device name/model and FDA approval status, relevant RCT or pivotal-trial outcomes, and device-specific follow-up data) to justify device selection and level coverage.

State device name (e.g., Prestige LP, Mobi-C) and cite FDA approval for the indicated contiguous levels.
Include pivotal RCT or device trial outcomes (overall success, NDI/ODI changes, reoperation rates) when available.
Provide follow-up duration and device-specific safety/efficacy data to support medical necessity.

Prior Authorization

Prior authorization — confirm device indications and absence of contraindications

Confirm that the patient meets the device- and FDA-specific indications and does not have any device contraindications listed for cervical ADR (e.g., active infection, osteopenia/osteoporosis, instability, severe spondylosis, severe facet arthropathy, OPLL, allergy to implant materials).

Verify FDA labeling allows implantation at the proposed cervical levels (typically C3–C7) and for single or two contiguous levels where applicable.
Document absence of contraindications enumerated by NASS and device labeling (infection, poor bone quality, instability, severe spondylosis/facet disease, OPLL, malignancy).

Prior Authorization

Prior authorization recommended — avoid post-service denial and unlisted-code issues

Request prior authorization for any potentially covered ADR services to avoid post‑service denial; submit pre-service review for unlisted codes or services not explicitly enumerated in the coding notes.

Unlisted codes are reviewed for medical necessity at the claim level — pre-service review recommended for potentially covered but unlisted procedures.
Prior authorization is recommended (and may be required) to prevent post-service denial.

Prior Authorization

Prior authorization for revision/replacement — cervical ADR (interim update)

Revision or replacement of an artificial cervical disc is allowed by the interim 7/2026 update when the policy criteria are met; prior authorization is implied for such procedures and should be submitted with the same documentation requirements as primary ADR.

Provide evidence that revision/replacement meets policy criteria and submit prior authorization with documentation per the policy's documentation checklist.
Note: lumbar ADR revision/replacement remains considered not medically necessary per policy sections addressing lumbar replacement.

Step Therapy

Conservative care requirement — document PT (≥3 visits), medications, and steroids

Document completion of conservative care prior to ADR unless an exception applies: conservative care must be recent (within the last year), include participation in a PT program (including at least 3 visits), oral analgesics (and anti-inflammatories if not contraindicated), and oral corticosteroids if appropriate.

Include physical therapy notes showing at least 3 visits and overall conservative management plan.
Record medication trials (oral analgesics/anti-inflammatories) and any steroid use, with response.

Step Therapy

Conservative therapies should be tried and documented before surgical referral

Ensure conservative therapies (medications, exercise, physical therapy, immobilization) were tried as initial management for non‑trauma degenerative conditions and document the patient’s response to those therapies when submitting for ADR consideration.

Document nature and duration of nonoperative interventions (exercise program, PT, bracing/immobilization, injections if given).
If conservative treatment was not completed, document the clinical reason an exception applies (e.g., severe/progressive neurologic deficit).

Documentation Required

Ensure patient is a fusion candidate and lacks ADR contraindications

Document that the patient is a candidate for fusion and lacks contraindications to ADR — comparative reviews evaluated ADR in patients who were candidates for fusion and without device contraindications, so candidacy for fusion and absence of exclusionary conditions should be shown.

Include assessment of fusion candidacy and whether alternative fusion would be clinically appropriate.
Confirm absence of device-specific anatomical constraints or contraindications.

Step Therapy

Conservative management prerequisite — ≥6 weeks for cervical radiculopathy per guidelines

For cervical radiculopathy, document at least 6 weeks of conservative therapy prior to considering ADR per guideline recommendations, unless exceptions (progressive neurologic deficit, intolerable pain) apply.

Note duration and content of conservative care (e.g., PT, medications) and any documented exceptions.
Use guideline-based criteria to justify expedited intervention if applicable.

Step Therapy

Conservative therapy requirement — failure of structured multidisciplinary care (often ≥6 months) for lumbar ADR

For lumbar ADR, document failure of structured conservative and multidisciplinary treatments—HERC and NASS guidance expect failure of therapies typically for ≥6 months (including PT/rehabilitation and other multimodal programs) before consideration of ADR.

Provide records of multidisciplinary conservative programs, duration (≥6 months where required), and responses.
If criteria are not met, document the clinical rationale for earlier surgical consideration (e.g., progressive neurologic deficit).

Documentation Required

Required documentation — skeletal maturity, neurologic exam, imaging, and conservative care

Medical records must document skeletal maturity, a recent neurologic exam (within 3 months) reviewed by the operating surgeon, imaging that correlates with symptoms, failure and specifics of conservative therapy, and that other sources of pain have been evaluated and ruled out.

Skeletal maturity statement and patient age.
Neurologic exam note within 3 months signed or reviewed by operating surgeon.
Imaging reports (MRI/CT) with correlation to exam findings and symptoms.
Documentation showing conservative therapy attempts and outcomes or documented exception.

Documentation Required

Required documentation for medical necessity review — indication, surgeon evaluation, conservative care, imaging, function

For medical necessity review include: the surgical indication; surgeon evaluation prior to request; detailed conservative care documentation (procedural interventions, medications, PT notes and outcomes); evaluation of functional impairments or disabilities (NDI/ODI); and independent radiologist imaging reports (performed within past 12 months).

Submit NDI (cervical) or ODI (lumbar) scores where applicable and notes describing ADL impact.
Attach independent radiologist reports; if interpretation discrepancies arise, radiologist report supersedes.

Documentation Required

Document trial outcomes and follow-up — include device-specific RCT/pivotal trial data

To support device selection and medical necessity, document relevant trial outcomes and follow-up for the specific device (RCT results, overall success definitions, NDI/ODI changes, reoperation rates, and duration of follow-up).

Include pivotal trial follow-up duration and key outcomes (e.g., overall success, NDI improvement, reoperation rates).
Cite device-specific RCT evidence when available to support anticipated outcomes.

Documentation Required

Required clinical documentation — diagnosis, levels treated, conservative therapy, and contraindication exclusion

Document clinical details required by the policy: diagnosis, treated levels (cervical: 1–2 contiguous levels; lumbar: single level), prior nonoperative management duration (e.g., ≥6 weeks for cervical, ≥3 months or device/HERC-specified periods for lumbar), and evidence excluding listed contraindications.

Specify levels to be treated and anatomical correlation on imaging.
Provide documentation that contraindications (infection, bone quality, instability, severe spondylosis/facet arthropathy, systemic disease) have been ruled out.

Documentation Required

Documentation should support FDA-device indications, conservative therapy duration, imaging, age, and bone density

Documentation should explicitly address device-specific FDA indications and criteria (including duration and failure of conservative therapy as specified), imaging confirmation of single- or two-level disease, patient age and bone density (DEXA T-score where applicable), and completion of structured multidisciplinary management when required.

Provide DEXA T-score results if bone quality is relevant to device contraindications.
Document patient age relative to device/HERC limits (e.g., ≤60 where specified).
Attach records of structured multidisciplinary pain management when required by HERC guidance.

Note

Use references (FDA PMAs, systematic reviews, society guidance) to support documentation

Cite FDA PMAs, systematic reviews, and professional society guidance in the clinical submission to support medical necessity; these references are identified in the policy and may strengthen device‑ and level‑specific arguments.

Reference FDA PMA summaries or device-specific approval documents when available.
Attach or cite systematic reviews (e.g., Hayes, Cochrane) or NASS guidance relevant to the device/indication.

Denial Risk

Denial triggers — procedures not meeting policy criteria may be denied

Claims for procedures that do not meet the policy criteria may be denied — examples include lumbar ADR at more than one level, lumbar ADR replacement/revision, cervical ADR at non-contiguous or >2 levels, and hybrid procedures that do not meet policy conditions.

Lumbar ADR replacement or revision is considered not medically necessary per policy.
Cervical ADR beyond two contiguous levels or at non-contiguous levels risks noncoverage.
Hybrid or multilevel procedures lacking support in the policy or evidence base risk denial.

Denial Risk

Documentation-based denial risk — incomplete submission may cause denial or delay

Failure to submit required documentation (indication, preoperative surgeon evaluation, conservative care records, imaging reports, and functional assessments) may result in denial or delayed review of the request.

Incomplete conservative care documentation or missing imaging reports are common documentation-based denial risks.
Ensure independent radiologist reports are included to avoid superseding interpretation issues.

Note

Methodological limitations may affect coverage — limited-quality studies for multilevel/hybrid procedures

Methodological limitations in the evidence base (short follow-up, small samples, retrospective nonrandomized designs) may limit the policy’s evidentiary support for multilevel or hybrid procedures and can affect coverage decisions for such indications.

Nonrandomized and small retrospective studies were judged to have significant limitations and may not suffice to support coverage for multilevel procedures.
Providers should acknowledge evidence limitations when proposing off-label or less-supported procedures.

Denial Risk

Contraindications may trigger denial — verify absence of listed exclusionary conditions

Use of ADR outside established indications or in patients with listed contraindications (e.g., active infection, osteoporosis/osteopenia, radiographic instability, severe spondylosis, severe facet arthropathy, inflammatory arthritides, OPLL, malignancy) may lead to noncoverage or denial.

Explicitly document absence of infection, adequate bone quality, and no radiographic instability to mitigate denial risk.
If any contraindication is present, provide documentation and rationale; policy guidance indicates such conditions exclude candidacy.

Denial Risk

Denial triggers for lumbar ADR — non-fulfillment of lumbar candidate criteria

Cases that do not meet lumbar ADR candidate criteria (e.g., disease at more than two levels, significant facet arthropathy, instability, osteopenia DEXA T-score ≤ -1.0, age outside HERC limits, infection or tumor) risk denial and should not be submitted as medically necessary ADR requests.

Include DEXA results and age documentation when submitting lumbar ADR requests.
If facet-mediated pain or spondylolisthesis > Grade I is present, ADR is not indicated per guidance.

Denial Risk

Denial triggers for cervical ADR — listed contraindications may preclude coverage

Presence of listed contraindications for cervical ADR (e.g., active infection, osteoporosis/osteopenia, instability >3 mm translation or ≥11° angular difference, severe spondylosis, severe facet arthropathy, ankylosing spondylitis, rheumatoid arthritis, prior fracture with deformity, OPLL, active malignancy) may result in noncoverage.

Provide flexion-extension radiographic measurements to document absence of instability when applicable.
Document bone quality (DEXA) and absence of severe spondylosis or facet arthropathy to support candidacy.

Note

No explicit additional denial triggers stated — cervical revision allowed only when criteria met

The policy revision (7/2026) permits cervical artificial disc revision/replacement when policy criteria are met; no additional explicit denial triggers beyond those in policy chunks are listed here — ensure revision requests meet the same documentation and clinical criteria as primary ADR.

Submit full prior authorization with documentation demonstrating that revision/replacement meets policy criteria.
Note: the policy update specifies allowance but detailed criteria for revision are located elsewhere in the policy.

Definitions and Measurement Scales

inv-57: Conservative treatments — definition for recent nonoperative care including PT (≥3 visits) and medications

Physical therapy requirementParticipation in a physical therapy program during conservative management, including at least 3 PT visits within the year prior to surgery

Medication optionsOral analgesics (including anti‑inflammatories if not contraindicated) and oral corticosteroids (if not contraindicated) are part of conservative care

Timing and recencyConservative care must be recent (within the last year) unless waived for urgent neurologic findings

inv-58: Neck Disability Index (NDI) — description and threshold for moderate disability

NDI descriptionPatient‑reported index (0–50) across 10 domains assessing neck pain and function

Moderate disability thresholdScores 15–24 correspond to moderate disability; NDI >=15 indicates moderate or greater disability relevant to cervical ADR candidacy

Scoring categories0–4 no disability; 5–14 mild; 15–24 moderate; 25–34 severe; 35–50 complete

inv-59: Oswestry Disability Index (ODI) — description for lumbar disability measurement

ODI descriptionOswestry Disability Index (ODI) quantifies low back pain disability (0–100) from 10 topics; higher scores indicate greater disability

Scoring ranges0–20% minimal; 21–40% moderate; 41–60% severe; 61–80% crippled; 81–100% bed‑bound or exaggerated

Use in lumbar ADRSevere disability on ODI may be used to satisfy functional criteria for lumbar ADR per policy

inv-60: Artificial Disc Replacement (ADR) — definition of the procedure and intent

Procedure definitionArtificial Disc Replacement (ADR) is surgical implantation of an intervertebral disc prosthesis after discectomy intended to preserve motion at the treated level

PurposeADR aims to restore flexibility and potentially reduce adjacent segment degeneration compared to fusion

Typical recoveryImplantation typically performed by orthopedic surgeon or neurosurgeon; recovery usually achieved in ~4–6 weeks

inv-61: Bi-level cervical ADR — definition and RCT context

Bi‑level cervical ADR definitionTotal disc replacement performed at two contiguous cervical levels (contiguous two‑level TDR)

RCT contextBi‑level cervical ADR has been evaluated in RCTs comparing it to bi‑level ACDF with outcomes including overall success, NDI, pain, and reoperation rates

Regulatory noteTwo devices (e.g., Mobi‑C, Prestige LP) have FDA approval for contiguous two‑level implantation

inv-62: Hybrid surgery (HS) — definition: combination of fusion and ADR

Hybrid surgery definitionHybrid surgery (HS) combines cervical fusion and cervical artificial disc implantation for multilevel cervical degenerative disease

Intended benefitHS aims to preserve motion at treated levels while addressing multilevel disease where fusion is required at other levels

Evidence statusSystematic reviews identify limited and heterogeneous studies; Hayes rated evidence insufficient for firm conclusions

inv-63: ASDeg — Adjacent Segment Degeneration definition (radiographic)

ASDeg definitionAdjacent Segment Degeneration (ASDeg) = radiographic deterioration adjacent to a surgically treated disc

FindingsSystematic reviews reported lower radiographic ASDeg rates with TDR versus fusion in some studies, though evidence quality varies

ImplicationRadiographic ASDeg may not always correlate with clinical symptoms (ASDis); interpret with clinical correlation

inv-64: ASDis — Adjacent Segment Disease definition (clinical)

ASDis definitionAdjacent Segment Disease (ASDis) = clinically symptomatic junctional degeneration adjacent to a surgically treated disc

Distinction from ASDegASDis refers to symptomatic disease requiring clinical management, whereas ASDeg refers to radiographic changes

Evidence noteSome reviews found lower ASDis rates with TDR versus fusion, but strength of evidence is limited

inv-65: Instability (radiographic) — definition and numeric thresholds

Radiographic instability definitionInstability defined as translation >3 mm between lateral flexion‑extension views or angular difference ≥11° at the symptomatic level

Policy consequencePresence of instability excludes ADR candidacy per NASS/device contraindications

Device-specific thresholdsSome device labels reference translation >3.5 mm or angulation >11° as exclusionary—refer to FDA device table for specifics

inv-66: Severe spondylosis — definition criteria (disc height loss, bridging osteophytes, absence of motion)

Severe spondylosis criteriaDefined as >50% disc height loss compared to minimally/non‑degenerated levels, presence of bridging osteophytes, or absence of motion on flexion‑extension at the symptomatic site

Clinical implicationSevere spondylosis is listed as a contraindication to ADR per NASS and device labels

Device examplesSeveral cervical device PMAs list severe spondylosis (loss of disc height >50% or bridging osteophytes) as an exclusion

inv-67: Artificial intervertebral disc (total disc replacement) — device definition and general description

Device definitionAn artificial intervertebral disc (total disc replacement) is an implantable device intended to replace a degenerated intervertebral disc to preserve motion at the treated level

Device variabilityMultiple device‑specific PMAs and product briefs exist; indications and contraindications are device specific and listed in Tables 2 and 3

Clinical roleADR developed as an alternative to fusion to preserve motion and potentially reduce adjacent segment degeneration

Background, Evidence Summary, and Guidelines

Artificial disc replacement (ADR) is a surgical option for symptomatic degenerative disc disease or herniated disc when specific clinical, imaging, and functional disability criteria are met. Cervical ADR may be appropriate for up to two contiguous levels (C3–C7) in skeletally mature patients with correlating neurologic findings or imaging and failure of conservative care, while lumbar ADR is generally limited to single‑level disease in appropriately selected adult patients. Evidence from systematic reviews and RCTs supports single‑ and some bi‑level cervical ADR and single‑level lumbar ADR for selected patients, but multilevel and hybrid indications lack high‑quality data and require careful case‑by‑case consideration.

Bi‑level contiguous cervical ADR has been evaluated in randomized trials versus bi‑level ACDF with mid‑term follow‑up showing improvements in overall success, lower reoperation rates, and improved Neck Disability Index in some pivotal trials (e.g., Prestige LP, Mobi‑C). Systematic reviews and comparative effectiveness assessments report moderate‑quality evidence for appropriately selected bi‑level cervical ADR patients, although longer‑term and additional studies are still needed.

Hybrid surgery — combined cervical fusion and ADR at adjacent levels — has limited but consistent low‑quality evidence suggesting preserved range of motion and comparable functional outcomes versus multilevel ACDF in short‑ to mid‑term follow‑up. The policy notes that hybrid procedures have methodological heterogeneity across studies and that higher‑quality randomized data are needed before broader conclusions can be drawn.

Evidence limitations are repeatedly highlighted: many multilevel and hybrid studies are small, retrospective, nonrandomized, or have short follow‑up, reducing confidence in estimates of benefit and harms. Systematic reviews and evidence assessments call for more rigorous, long‑term randomized trials to better define the comparative effectiveness and durability of multilevel and hybrid ADR procedures.

Artificial Intervertebral Discs

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Coverage Criteria for Artificial Intervertebral Disc Replacement

Billing and Coding Guidance

Prior Authorization, Documentation, and Provider Responsibilities

Definitions and Measurement Scales

Background, Evidence Summary, and Guidelines

Policy Revision History