CurrentuniverahealthcarePolicy 7.01.80

Artificial Cervical Intervertebral Disc

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This policy governs medical necessity and coverage criteria for initial/primary total artificial cervical intervertebral disc implantation for patients with radiculopathy or myelopathy. It affects providers seeking authorization for cervical disc arthroplasty at covered levels.

Policy Summary

Payeruniverahealthcare

PolicyArtificial Cervical Intervertebral Disc

Policy CodePolicy 7.01.80

Change TypeAnnual review (minor)

Effective DateOct 15, 2026

Last ReviewJun 18, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization documenting FDA‑approved device, planned level(s) C3–C7, and that the patient meets listed clinical and imaging criteria.

SourceLink

POLICY UPDATE CHANGES

06/18/26: Annual review; policy intent unchanged.

06/26/25: Annual review; removed the ACDF criteria from the policy.

01/01/25: Summary of changes tracking implemented.

>=18minimum patient age for coverage

C3-C7vertebral levels specified

1-2allowed replacement levels

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CurrentuniverahealthcarePolicy 7.01.80

Artificial Cervical Intervertebral Disc

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Policy Summary

Payeruniverahealthcare

PolicyArtificial Cervical Intervertebral Disc

Policy CodePolicy 7.01.80

Change TypeAnnual review (minor)

Effective DateOct 15, 2026

Last ReviewJun 18, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization documenting FDA‑approved device, planned level(s) C3–C7, and that the patient meets listed clinical and imaging criteria.

SourceLink

POLICY UPDATE CHANGES

06/18/26: Annual review; policy intent unchanged.

06/26/25: Annual review; removed the ACDF criteria from the policy.

01/01/25: Summary of changes tracking implemented.

>=18minimum patient age for coverage

C3-C7vertebral levels specified

1-2allowed replacement levels

required conservative trials

< -1.5DEXA T-score contraindication

Coverage Criteria for Artificial Cervical Intervertebral Disc

Initial/Primary — Radiculopathy

Covered when ALL of the following are met for radiculopathy:

Age is at least 18 years>=18 years

Device Approval: Device has been approved by the U.S. FDA for an FDA-approved indication and is used in accordance with FDA labeling

Anatomic Levels: Planned implant(s) will be used in the reconstruction of cervical disc(s) at C3-C7 following discectomyC3-C7

Number of Levels: Planned implant(s) is/are for a single level or contiguous two-level replacement(s)1 or 2 contiguous levels

Surgical Candidacy: Individual is a candidate for single-level or two-level anterior cervical decompression(s) and interbody fusion(s)

Operative History: No previous surgeries at the operative level

Symptoms - Functional Impact: Significant level of pain on a daily basis defined as clinically significant functional impairment (e.g., inability to perform household chores, prolonged standing)daily significant pain

Symptoms - Radicular Pain: Unremitting radicular pain to shoulder girdle and/or upper extremity resulting in a disability

Physical Exam Findings: Physical exam showing ANY of dermatomal sensory deficit; motor deficit (e.g., biceps, triceps weakness); reflex changes; shoulder abduction relief sign; nerve root tension sign (e.g., Spurling's maneuver); or unremitting radicular pain without concordant objective findings

Any one suffices

Conservative Therapy: Less than clinically meaningful improvement with at least TWO (2) of the following unless contraindicated: prescription-strength analgesics/steroids/gabapentinoids/NSAIDs for six (6) weeks; provider-directed exercise program for six (6) weeks; epidural steroid injection(s)/selective nerve root block performed at the same level(s)>=2 therapies; 6 weeks for meds/PT

Myelopathy

Covered when ALL of the following are met

Age is at least 18 years>= 18 years

Device and labeling: The device has been approved by the FDA for an FDA-approved indication and is used in accordance with FDA labeling

Levels: Planned implant(s) will be used in reconstruction of cervical disc(s) at C3-C7C3-C7

Post-discectomy: Implantation follows discectomy

Number of levels:

Conservative treatment and imaging concordance

Covered when ALL of the following are met

Conservative therapy attempts: Less than clinically meaningful improvement with at least TWO (2) of the following unless contraindicated: prescription-strength analgesics/steroids/gabapentinoids/NSAIDs for six (6) weeks; provider-directed exercise program for six (6) weeks; epidural steroid injection(s)/selective nerve root block performed at the same level(s) as the requested surgery>=2 treatments; 6 weeks for meds/PT

Imaging concordance: MRI or CT shows neural structure compression at the requested level(s) that is concordant with the individual's symptoms and physical exam findings caused by any of: herniated disc (including retained or recurrent disc), synovial or arachnoid cyst, central/lateral/foraminal stenosis, or osteophytes

Imaging must correlate with clinical findings

Absence of clinically significant cervical instability

Covered only if ALL of the following ABSENT on plain X-rays

Translation: Subluxation or translation of more than 3.5 mm on static lateral or dynamic flexion/extension views is absent>3.5 mm

If present indicates clinically significant instability

Sagittal angulation: Sagittal plane angulation of more than 11 degrees between adjacent segments on static or dynamic flexion/extension views is absent>11 degrees

If present indicates clinically significant instability

Deformity/spondylolisthesis: Kyphotic deformity/significant reversal of lordosis or spondylolisthesis is absent

If present indicates clinically significant instability

Coverage criteria (partial)

Covered when ALL of the following are present:

Symptoms: At least one of: upper/lower extremity weakness, numbness or pain; fine motor dysfunction (e.g., buttoning or handwriting) or clumsiness of hands; new-onset bowel or bladder dysfunction due to neuro-compressive pathology; or frequent fallsat least 1

Clinical symptom criteria

Physical exam findings: At least one of: grip and release test abnormality; ataxic gait; hyperreflexia; Hoffmann sign; Babinski sign; tandem walking test abnormality; inverted brachioradialis reflex; increased muscle tone/spasticity; clonus; or myelopathic handat least 1

Physical exam criteria

Radiographic instability absent: Plain X-rays (static lateral or dynamic flexion/extension) do NOT show subluxation/translation > 3.5 mm, sagittal plane angulation > 11 degrees between adjacent segments, kyphotic deformity/significant reversal of lordosis, or spondylolisthesis

Adjacent Segment Disease — Radiculopathy (Medically Necessary)

Covered when ALL of the following are met for radiculopathy:

Prior adjacent TDA interval and age: Prior cervical total disc arthroplasty at an adjacent level was performed at least 6 months prior AND patient is at least 18 years of age>= 6 months; >= 18 years

Device and levels: Procedure will use an FDA‑approved cervical disc prosthesis for an FDA‑approved indication and in accordance with FDA labeling; planned implant(s) will be used in reconstruction of cervical disc(s) at C3‑C7 following discectomyC3‑C7

Adjacent-segment replacement: Planned implant is for a single‑level adjacent segment replacement and the individual is a candidate for single‑level anterior cervical decompression and interbody fusionsingle‑level

Radiculopathy

Covered when ALL of the following are met for radiculopathy:

Conservative treatment failure: Less than clinically meaningful improvement with at least TWO (2) of: prescription‑strength analgesics/steroids/gabapentinoids/NSAIDs for six (6) weeks; provider‑directed exercise program for six (6) weeks; or epidural steroid injections/selective nerve root block at the same level(s)>=2 of listed therapies; 6 weeks

Adjacent level success on imaging: Imaging studies of the cervical spine, including flexion/extension lateral views, demonstrate successful cervical total disc arthroplasty at the adjacent level

No clinically significant instability: Absence of clinically significant cervical instability on resting plain X‑rays: no subluxation/translation > 3.5 mm, no sagittal plane angulation > 11 degrees between adjacent segments, and no kyphotic deformity/significant reversal of lordosis or spondylolisthesistranslation <=3.5 mm; angulation <=11 deg

Instability findings would preclude coverage

Myelopathy

Covered when ALL of the following are met for myelopathy:

Age is at least 18 years>=18 years

Device and labeling: Procedure performed using a cervical disc prosthesis approved by the FDA for an FDA‑approved indication and in accordance with FDA labeling

Levels and procedure: Planned implant(s) will be used in reconstruction of cervical disc(s) at C3‑C7 following discectomyC3‑C7

Single‑level adjacent replacement: Planned implant is for a single‑level adjacent segment replacementsingle‑level

Myelopathy

Covered when ALL of the following are met:

No prior surgery: No previous surgeries at the operative level

Myelopathy symptoms: Patient has one or more of: upper/lower extremity weakness, numbness or pain; fine motor dysfunction (e.g., difficulty with buttoning/handwriting, clumsiness); gait disturbance; new‑onset bowel or bladder dysfunction; or frequent falls

Any one suffices

Physical exam findings of myelopathy: Presence of one or more of: grip and release test abnormality; ataxic gait; hyperreflexia; Hoffmann sign; Babinski sign; tandem walking test demonstrating ataxia; inverted brachioradialis reflex; increased muscle tone/spasticity; clonus; or myelopathic hand

Any one suffices

No clinically significant cervical instability on X‑ray: Resting plain X‑rays must NOT show subluxation/translation > 3.5 mm, sagittal plane angulation > 11 degrees between adjacent segments, kyphotic deformity/significant reversal of lordosis, or spondylolisthesis

Initial coverage criteria

Covered only when ALL applicable imaging and clinical criteria in the policy guidelines and procedure-specific sections are met; otherwise not covered.

Imaging and clinical concordance: Absence of clinically significant cervical instability on resting plain X‑rays (no sagittal plane angulation >11 degrees between adjacent segments on static or dynamic views; no kyphotic deformity/significant reversal of lordosis or spondylolisthesis) AND MRI/CT findings consistent with the individual's symptoms or physical exam caused by either cervical spinal cord compression OR cervical spinal stenosissagittal angulation >11 degrees; see imaging thresholds

Coverage contingent on meeting all applicable imaging and clinical criteria

Imaging-based contraindications

Artificial cervical intervertebral disc implant is considered investigational when ANY of the following contraindications are present:

Severe facet arthropathy: Imaging evidence of severe facet joint arthropathy

If present, device considered investigational

OPLL: Imaging evidence of ossification of the posterior longitudinal ligament (OPLL)

If present, device considered investigational

Urgent/Emergent indications

Urgent/emergent conditions for cervical total disc arthroplasty include ANY of the following:

Central cord syndrome

Urgent/emergent indication

Myelopathy or cord signal changes on MRI due to cord compression

Urgent/emergent indication

Progressive neurological deficit documented on two (2) separate physical exams

Urgent/emergent indication

Motor weakness of grade 3/5 or less of specified muscle(s) due to neurocompressive pathologygrade <= 3/5

Urgent/emergent indication

Rapidly progressive motor loss:

Urgent/Emergent Indications

Urgent/emergent conditions include ANY of the following related to neurocompressive pathology:

Motor weakness grade: Motor weakness of grade 3/5 or less of specified muscle(s)<= 3/5

Rapidly progressive motor loss: Rapidly progressive symptoms of motor loss

Bowel incontinence

Bladder incontinence/retention: Bladder incontinence or retention

Severe incapacitating condition: Condition otherwise meeting applicable procedure criteria with documentation of severe debilitating pain and/or dysfunction to the point of being incapacitated

NASS-based Indications

Covered when ALL of the following are met per cited guideline:

NASS - Primary indications: Radiculopathy related to nerve root compression from one‑ or two‑level degenerative disease (herniated disc or spondylotic osteophyte) from C3‑C7 OR myelopathy/myeloradiculopathy related to central spinal stenosis from one‑ or two‑level degenerative disease (e.g., C3‑4)one or two levels

Per NASS guidance (revised Feb 2024)

NASS - Nonoperative management: Persistent symptoms despite at least 6 weeks of nonoperative management unless progressive or functionally limiting weakness is present>= 6 weeks

Exception for progressive weakness or severe functional limitation

Functional impairment: Inability to perform normal work duties or activities of daily living because of severity of symptoms despite nonoperative management

Previous surgery at the planned operative level is an exclusion for initial/primary artificial cervical intervertebral disc implantation. The policy explicitly requires no previous surgeries at the operative level for patients being considered for primary disc arthroplasty; presence of prior surgery at the index level may result in denial of the request.

The policy reiterates that prior surgery at the operative level is explicitly excluded from meeting the criteria for initial or primary cervical artificial disc implantation. Documentation of any prior procedure at the index level should be considered disqualifying for primary implant candidacy.

Cases demonstrating radiographic evidence of clinically significant cervical instability are excluded from coverage. Specifically, plain X-rays showing subluxation or translation > 3.5 mm, sagittal plane angulation > 11 degrees between adjacent segments, or the presence of a kyphotic deformity/significant reversal of lordosis or spondylolisthesis indicate instability and preclude eligibility for disc arthroplasty under the policy.

For the single-level adjacent segment replacement indication, the policy requires no previous surgeries at the operative level. Prior surgery at the index level disqualifies a candidate from this adjacent-segment single-level replacement coverage.

The policy states that either previous surgeries at the operative level or the presence of clinically significant cervical instability (as defined by the imaging thresholds) are exclusionary conditions for coverage. Documentation confirming absence of both prior surgery at the level and radiographic instability is required to establish eligibility.

Radiographic evidence of clinically significant cervical instability is defined for the purposes of exclusion. Resting plain X-rays showing translation or subluxation > 3.5 mm on static lateral or flexion/extension views, or sagittal plane angulation > 11 degrees between adjacent segments, or findings such as kyphotic deformity/reversal of lordosis or spondylolisthesis meet the definition of instability and render the patient ineligible.

The policy identifies specific imaging thresholds that constitute clinically significant cervical instability. These include translation (subluxation) > 3.5 mm on static lateral or flexion/extension views and sagittal plane angulation > 11 degrees between adjacent segments; additional exclusionary imaging findings include kyphotic deformity/significant reversal of lordosis or spondylolisthesis.

The artificial cervical intervertebral disc implant is considered investigational (not medically necessary) when any of the listed contraindications are present. These include device revision scenarios (e.g., revision of a failed or infected cervical disc arthroplasty), systemic or metabolic contraindications (e.g., DEXA T-score < -1.5), allergy to implant materials, active systemic infection, severe comorbid conditions, and imaging evidence of significant anatomic compromise such as severe spondylosis (disc space collapse > 50%), severe facet arthropathy, spinal metastases, or ossification of the posterior longitudinal ligament (OPLL).

The policy references related corporate medical policies for context. No additional exclusions beyond the imaging- and condition-based contraindications listed in this section are specified here; providers should also consult the referenced corporate policies when applicable.

Discography or MR spectroscopy results are not accepted as determinants of medical necessity for disc arthroplasty. The policy states that discography or MR Spectroscopy will not be used to establish coverage and their use is not endorsed.

The policy does not support use of artificial cervical disc replacement for three or more levels or for isolated axial neck pain due to insufficient evidence. Partial disc replacement systems (nucleus arthroplasty) and hybrid procedures are considered investigational because of lack of FDA approval and limited long‑term outcomes data.

Available evidence does not support cervical artificial disc replacement for three or more levels or for isolated axial neck pain. These uses are considered unsupported by significant evidence and therefore are not covered indications under this policy.

Coverage of services under this policy is dependent on the specific product contract. If a product does not cover a service, the medical policy criteria do not apply and the request may be denied on that basis.

Cervical total disc arthroplasty performed for degenerative disc disease as the sole indication is considered not medically necessary under this policy.

A cervical total disc arthroplasty performed after a prior cervical total disc arthroplasty at the same level (repeat procedure at the index level) is considered not medically necessary and is excluded from coverage.

Procedures for cervical total disc arthroplasty that do not meet the policy's listed clinical, imaging, and procedure‑specific criteria (or applicable urgent/emergent exceptions) are considered not medically necessary and will not be covered.

The policy specifies that when imaging demonstrates severe facet joint arthropathy or ossification of the posterior longitudinal ligament (OPLL), use of an artificial cervical intervertebral disc implant is considered investigational and therefore not medically necessary.

Cervical artificial disc replacement for three or more levels and use for isolated axial neck pain lack sufficient evidence and are therefore not supported by the policy. Clinical trials and device studies cited in the policy address single‑ and two‑level applications; broader use beyond those indications is considered investigational or unsupported.

Procedure and Diagnosis Coding

Requested procedure/diagnosis codes and levels (must be provided)mixed

No codes listed

CPT CodesCPT

22856	Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation, single interspace, cervical
22858	Total disc arthroplasty (artificial disc), anterior approach; second level, cervical (add-on)
22861	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace, cervical
22864	Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace, cervical
0095T	Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical
0098T	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (add-on)

HCPCS CodesHCPCS

No codes listed

ICD-10 CodesICD-10

M50.00-M50.023	Cervical disc disorder with myelopathy (code range)
M50.10-M50.123	Cervical disc disorder with radiculopathy (code range)
M54.12	Radiculopathy, cervical region

inv-40: conservative therapy duration

Conservative therapy duration6 weeks (for prescription-strength analgesics/steroids/gabapentinoids/NSAIDs and for a provider-directed exercise program)

Minimum number of conservative treatmentsAt least 2 different conservative therapies unless contraindicated

Examples of allowed conservative therapiesPrescription-strength analgesics/steroids/gabapentinoids/NSAIDs; provider-directed exercise program (physical therapy, chiropractic, physician-directed)

inv-41: translation threshold

Translation threshold> 3.5 mm (subluxation or translation on static lateral or dynamic flexion/extension views)

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization: device, levels, and candidacy

Prior authorization is required and must document that the planned implant is an FDA‑approved cervical disc prosthesis used for an FDA‑approved indication, that planned reconstruction levels are within C3–C7, and that the implant(s) are single‑level or contiguous two‑level replacements with candidacy for anterior cervical decompression and interbody fusion.

Document device is FDA‑approved and will be used per FDA labeling.
Specify intended reconstructive level(s) (C3–C7).
Confirm number of levels: single or contiguous two‑level.
Confirm patient is a candidate for single‑ or two‑level anterior cervical decompression and interbody fusion.

Prior Authorization

Prior authorization required for single‑ or two‑level ACID

Submit prior authorization for single‑level or contiguous two‑level artificial cervical disc replacement at C3–C7 following discectomy; authorization must reflect candidacy for anterior cervical decompression and interbody fusion.

Background and Clinical Evidence

Cervical radiculopathy or myelopathy may be treated with cervical disc replacement to restore intervertebral function following discectomy. The policy references randomized controlled trials and device‑specific long‑term follow-up (for example, Prestige, Mobi‑C, ProDisc‑C) demonstrating clinical outcomes and durability that inform the coverage criteria for appropriate candidates.

The policy cites device‑specific clinical trial follow‑up and outcomes data to support the background rationale for coverage criteria. Examples include randomized non‑inferiority trials and multi‑year follow‑up reports for devices such as the Prestige, Mobi‑C, ProDisc‑C, and others, which provide the evidence base referenced in the policy.

The policy reiterates that there is insufficient evidence to support cervical artificial disc replacement for three or more levels and for isolated axial neck pain, and that partial disc replacement systems remain investigational. These limitations are reflected both in the NASS guidance cited and in the policy's investigational statements.

Partial disc replacement and hybrid procedures are considered investigational or of insufficient evidence in this policy. The document references limitations in device approval status and long‑term outcomes data for these approaches, and they are not endorsed as standard care.

Definitions and Thresholds

inv-114: clinically significant functional impairment

DefinitionDaily significant pain causing inability to perform household chores, prolonged standing, or comparable functional limitations

Role in criteriaUsed to establish 'clinically significant functional impairment' for symptom severity

DocumentationClinical notes should describe examples of functional limitation (e.g., inability to perform household chores)

inv-115: nerve root tension sign

DefinitionClinical maneuvers indicating nerve root irritation (e.g., Spurling's maneuver)

Clinical useCounts as a nerve root tension sign supporting radiculopathy criteria

Policy Revision History

2026-06-18annual_reviewLatest

Annual review completed; policy intent unchanged.

2025-06-26annual_review

Annual review completed and ACDF criteria were removed from the policy.

2025-01-01process_update

Policy Summary

Payeruniverahealthcare

PolicyArtificial Cervical Intervertebral Disc

Policy CodePolicy 7.01.80

Change TypeAnnual review (minor)

Effective DateOct 15, 2026

Last ReviewJun 18, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization documenting FDA‑approved device, planned level(s) C3–C7, and that the patient meets listed clinical and imaging criteria.

SourceLink

On This Page

Planned implant(s) for a single level or contiguous two-level replacement(s)

single or contiguous two-level

Surgical candidacy: Individual is a candidate for single-level or two-level anterior cervical decompression(s) and interbody fusion(s)

No prior surgery at level: No previous surgeries at the operative level

Symptoms include ANY of: upper/lower extremity weakness, numbness or pain; fine motor dysfunction (e.g., difficulty with buttoning or handwriting) or clumsiness of hands; new-onset bowel or bladder dysfunction due to neuro-compressive pathology; or frequent falls

Any one suffices

no instability findings present

Radiographic stability requirement

Imaging concordance: MRI or CT shows findings concordant with the individual's symptoms and physical exam caused by cervical spinal cord compression or cervical spinal stenosisimaging demonstrates cord compression or stenosis concordant with clinical findings

Radiologic correlation required

Operative history: No previous surgeries at the operative level

Symptoms: Patient has BOTH: significant daily pain causing functional impairment AND unremitting radicular pain to shoulder girdle and/or upper extremity resulting in disabilityboth required

Physical exam includes ANY of: dermatomal sensory deficit; motor deficit (e.g., biceps, triceps weakness); reflex changes; shoulder abduction relief sign; nerve root tension sign (e.g., Spurling's maneuver); or unremitting radicular pain without concordant objective findingsany one suffices

Conservative therapy: Less than clinically meaningful improvement with at least TWO (2) of the following unless contraindicated: prescription‑strength analgesics/steroids/gabapentinoids/NSAIDs for six (6) weeks; provider‑directed exercise program for six (6) weeks; or epidural steroid injection(s)/selective nerve root block at the same level(s)>=2 therapies; 6 weeks

Imaging‑correlated compression: MRI/CT shows neural structure compression at the requested level(s) concordant with symptoms and physical exam caused by herniated disc(s), synovial/arachnoid cyst, central/lateral/foraminal stenosis, or osteophytes

Behavioral health: Patient has no unmanaged, significant behavioral health disorders (e.g., major depressive disorder, chronic pain syndrome, secondary gain, opioid or alcohol use disorder)

Surgical candidacy: Individual is a candidate for single‑level anterior cervical decompression and interbody fusion

Operative history: No previous surgeries at the operative level

translation <=3.5 mm; angulation <=11 deg

Rapidly progressive symptoms of motor loss due to neurocompressive pathology

Urgent/emergent indication

Considered in indication

Assessed on static lateral or dynamic flexion/extension plain X-rays

ImplicationValues above this threshold indicate clinically significant cervical instability and preclude coverage

inv-42: sagittal plane angulation threshold

Sagittal plane angulation threshold> 11 degrees between adjacent segments on static or dynamic flexion/extension views

Measurement contextDetermined on static lateral or dynamic flexion/extension plain X-rays between adjacent segments

ImplicationAngulation above this threshold indicates clinically significant instability and is exclusionary

inv-43: minimum age

Minimum age for coverage>= 18 years

ApplicabilityApplies to myelopathy criteria and generally across device indications requiring adult candidacy

DocumentationPrior authorization must confirm age ≥ 18 years

inv-44: radiographic instability thresholds

Radiographic instability thresholdsTranslation > 3.5 mm; sagittal plane angulation > 11 degrees between adjacent segments

Additional instability findingsKyphotic deformity/significant reversal of lordosis or spondylolisthesis are also considered instability

Assessment modalityResting plain X-rays (static lateral or flexion/extension views)

inv-45: Minimum interval since prior cervical TDA

Minimum interval since prior cervical TDA>= 6 months (prior adjacent-level cervical TDA must have been performed at least 6 months earlier)

Use caseRequirement for adjacent-segment cervical total disc arthroplasty indications

DocumentationPrior authorization should document timing of prior adjacent-level TDA

inv-46: Minimum age

Minimum age>= 18 years

Applies toMyelopathy and adjacent-segment TDA indications (adult candidacy)

VerificationAge must be confirmed in prior authorization and documentation

inv-47: Instability thresholds

Instability thresholdsTranslation > 3.5 mm; sagittal plane angulation > 11 degrees between adjacent segments

Imaging viewsResting plain X‑rays including flexion/extension lateral views

ConsequencePresence of these findings indicates clinically significant instability and precludes coverage

inv-48: Translation on static or dynamic lateral or flexion/extension views

Translation on static or dynamic lateral or flexion/extension views> 3.5 mm

Imaging modalityStatic lateral or dynamic flexion/extension plain X-rays

Clinical meaningIndicates clinically significant cervical instability if exceeded

inv-49: Sagittal plane angulation between adjacent segments

Sagittal plane angulation between adjacent segments> 11 degrees

AssessmentMeasured on static or dynamic flexion/extension lateral views

ImplicationAngulation >11° indicates clinically significant instability and is exclusionary

inv-50: DEXA T-score

DEXA T-score threshold< -1.5 (decreased bone mineral density)

ContextDEXA T-score worse than -1.5 is listed as a contraindication rendering device investigational

DocumentationPrior imaging (DEXA) should be available to support assessment when relevant

inv-51: Intervertebral disc space collapse

Intervertebral disc space collapse threshold> 50% of normal height (collapse >50%)

Associated findingPart of definition of severe spondylosis that is a contraindication to AIDA

Imaging modalityPlain radiographs demonstrating disc space collapse at the treated level

inv-52: Clinically meaningful improvement

Clinically meaningful improvement≥ 50% (global assessment)

Use in policyUsed to define 'less than clinically meaningful improvement' after conservative therapy trials

DocumentationPrior authorization should document responses relative to this threshold for each therapy attempted

inv-53: Nonoperative management duration

Nonoperative management durationAt least 6 weeks (for medications and provider-directed exercise) prior to considering disc arthroplasty unless progressive/functionally limiting weakness is present)

Required conservative trialsAt least two conservative treatments unless contraindicated (medication trial, PT/exercise, and/or injection)

Documentation expectationType, duration, frequency, and response to each nonsurgical treatment must be provided

Procedure must be for a single level or contiguous two levels.
Implantation must follow discectomy.
Patient must be a candidate for anterior cervical decompression and interbody fusion.

Prior Authorization

Imaging required with prior authorization

Include imaging with the prior authorization: resting plain X‑rays (including flexion/extension when indicated) and MRI or CT demonstrating absence of clinically significant instability and imaging concordant with symptoms (cord compression or spinal stenosis).

Plain X‑rays must show no subluxation/translation >3.5 mm or sagittal angulation >11° (and no kyphotic deformity/spondylolisthesis).
Provide MRI/CT reports showing neural structure compression concordant with symptoms (e.g., cord compression or cervical stenosis).
Include flexion/extension lateral views when assessing instability or adjacent‑level TDA success.

Prior Authorization

Prior authorization for adjacent‑segment cervical TDA

Prior authorization is required for single‑level adjacent‑segment cervical total disc arthroplasty at C3–C7 and must confirm the prior adjacent‑level TDA was performed ≥6 months earlier and that the device to be used is FDA‑approved and used per labeling.

Prior adjacent‑level TDA must have been performed at least 6 months prior.
Planned procedure must use an FDA‑approved cervical disc prosthesis consistent with FDA labeling.
Planned implant must be for a single‑level adjacent segment replacement at C3–C7 following discectomy.

Prior Authorization

Medical‑necessity prior authorization: document qualifying criteria

Prior authorization must document that the patient meets all applicable clinical criteria for radiculopathy or myelopathy (including age ≥18 for myelopathy) and that an FDA‑approved cervical disc prosthesis will be used in accordance with labeling.

Confirm patient meets the policy’s listed symptom and exam criteria for radiculopathy or myelopathy.
Document patient age ≥18 years where specified.
Confirm device FDA approval and intended use per labeling.

Prior Authorization

Prior authorization: prior surgery and instability confirmation

Prior authorization must confirm no prior surgery at the operative level and absence of radiographic instability using the policy’s numeric thresholds; include these findings in the submission.

State explicitly that there are no previous surgeries at the operative level.
Provide plain X‑ray measurements showing translation ≤3.5 mm and sagittal plane angulation ≤11 degrees.
If instability findings are present, note that criteria are not met (may result in denial).

Prior Authorization

Confirm procedure meets policy and procedure‑specific criteria

Ensure the requested procedure meets all policy guidelines and applicable procedure‑specific criteria; prior authorization will be reviewed against those criteria.

Verify that clinical, imaging, and nonoperative management criteria in the policy are met before submission.
Prior authorization is required when applying these policy and procedure‑specific criteria.

Prior Authorization

Screening and imaging requirement for surgical evaluation

Screen all patients being evaluated for spine surgery for urgent/emergent indications and include required imaging findings and documentation of urgency when applicable in the prior authorization.

Document presence or absence of urgent/emergent criteria per policy.
Include imaging findings cited in the applicable procedure sections to support urgency if claimed.

Prior Authorization

Prior authorization: required submission elements (codes, levels, docs)

Include minimum documentation elements with prior authorization: CPT/ICD‑10 codes, disc levels/motion segments, and supporting clinical and imaging documentation as listed under minimum requirements.

Provide CPT and ICD‑10 codes and specify disc levels/motion segments involved.
Attach supporting clinical records and imaging reports per the policy’s minimum documentation list.

Prior Authorization

Prior authorization: indication and nonoperative management

Prior authorization should document diagnosis (radiculopathy or myeloradiculopathy), involved levels (one or two levels C3–C7), and failure of at least 6 weeks of nonoperative management when applicable.

Specify diagnosis and the exact levels to be treated (one‑ or two‑level C3–C7).
Document at least 6 weeks of nonoperative management unless progressive or functionally limiting weakness is present.

Billing Rule

Prior authorization required for listed CPT and ICD‑10 codes

Obtain prior authorization for procedures billed with the listed CPT codes and supported by the referenced ICD‑10 diagnosis ranges; ensure documentation demonstrates qualifying clinical criteria.

Include applicable CPT codes (e.g., 22856, 22858, 22861, 22864, 0095T, 0098T).
Include supporting ICD‑10 diagnosis codes (e.g., M50.00‑M50.023, M50.10‑M50.123, M54.12).

Prior Authorization

Prior authorization is product‑dependent

Prior authorization requirements depend on product coverage; if the member’s product does not cover the service, medical policy criteria may not apply and the request could be denied by the product.

Verify product coverage before submitting a prior authorization request.
If product excludes the service, the medical policy criteria will not authorize coverage.

Documentation Required

Conservative therapy: document ≥2 failed treatments (6‑week trials)

Document less than clinically meaningful improvement after at least two conservative treatments: a six‑week trial of prescription‑strength analgesics/steroids/gabapentinoids/NSAIDs and a six‑week provider‑directed exercise program, unless contraindicated.

Provide records showing 6‑week medication trial and response.
Provide documentation of a 6‑week provider‑directed exercise program and response.
If injections were used, document level and response (see additional conservative options).

Documentation Required

Conservative therapy requirement: detail treatments and responses

Document inadequate improvement after at least two conservative treatments (medication for 6 weeks, supervised exercise for 6 weeks, and/or epidural/nerve‑root injection at the same level) unless contraindicated.

Include type, duration, frequency, and response for each nonsurgical treatment.
If a trial was contraindicated, provide explanation and supporting documentation.

Step Therapy

Conservative therapy requirement: at least two treatments documented

Providers must document at least two conservative treatments (prescription analgesics/steroids/gabapentinoids/NSAIDs for 6 weeks and/or a 6‑week supervised exercise program) with less than clinically meaningful improvement, unless contraindicated.

List each conservative therapy tried and state the outcome (less than clinically meaningful improvement defined as <50% global improvement).
Include dates and providers who supervised the treatments.

Step Therapy

Radiculopathy: conservative therapy requirements for authorization

For radiculopathy, prior authorization must document failure of at least two conservative treatments such as 6 weeks of prescription‑strength analgesics/steroids/gabapentinoids/NSAIDs, a 6‑week provider‑directed exercise program, or an epidural steroid/selective nerve root block at the same level(s).

Specify which two (or more) therapies were tried and their durations.
Document that improvement was less than clinically meaningful for each therapy.

Documentation Required

Waiver of routine prerequisites for urgent/emergent cases

For confirmed urgent/emergent conditions, routine prerequisites (e.g., requirement for prior nonoperative management, proof of smoking cessation, absence of unmanaged significant behavioral health disorders, or time frame for repeat procedure) may be waived; document the urgent/emergent indication.

State the urgent/emergent condition and supporting documentation.
Explain which usual prerequisites are being waived and why, referencing the policy’s urgent/emergent criteria.

Documentation Required

Conservative care documentation: detail trials or contraindications

Provide detailed documentation of adequate trials of provider‑directed nonsurgical treatments (type, duration, frequency, response) or document why such trials were contraindicated when submitting prior authorization.

Include dates, providers, and objective measures of response for each nonsurgical treatment.
If contraindicated, include clinical rationale and supporting records.

Step Therapy

Nonoperative management: document ≥6 weeks before AIDA for radiculopathy

Patients should generally have failed nonoperative care (at least 6 weeks) prior to cervical disc arthroplasty for radiculopathy; prior authorization should document at least 6 weeks of nonoperative management unless progressive or functionally limiting weakness is present.

Document at least 6 weeks of nonoperative management or rationale for exception (e.g., progressive weakness).
Include dates and descriptions of nonoperative therapies tried.

Documentation Required

Document FDA approval and device labeling, intended levels and number of levels

Document FDA approval status of the device and that it will be used consistent with FDA labeling; include intended reconstructive level(s) (C3–C7) and number of levels (single or contiguous two‑level).

State device make/model and FDA approval (PMA/approval date) when available.
Confirm device will be used per FDA labeling.
Specify intended levels (C3–C7) and number of levels (single or contiguous two‑level).

Documentation Required

Required clinical and imaging documentation: MRI/CT concordant with symptoms

Provide MRI/CT reports showing neural structure compression at the requested level(s) that correlate with symptoms and exam, and clearly document the causative pathology (e.g., herniated disc, synovial/arachnoid cyst, central/lateral/foraminal stenosis, or osteophytes).

Attach radiology reports that describe compressive pathology at the planned level(s).
State how imaging findings are concordant with the patient’s symptoms and physical exam.

Documentation Required

Conservative therapy documentation: record trials and insufficient response

Document prior conservative treatments showing less than clinically meaningful improvement after at least two of the listed options (prescription‑strength analgesics/steroids/gabapentinoids/NSAIDs for 6 weeks; provider‑directed exercise for 6 weeks; epidural/selective nerve root injection), unless contraindicated.

Include dates, duration, supervising provider, and patient response for each conservative therapy.
If injections were used, state the level(s) treated and outcome.

Documentation Required

Stability imaging documentation: plain X‑rays for instability assessment

Include plain X‑ray reports that document absence of clinically significant cervical instability (no subluxation/translation >3.5 mm, sagittal plane angulation ≤11 degrees, and no kyphotic deformity/reversal of lordosis or spondylolisthesis).

Provide static lateral and, when indicated, dynamic flexion/extension plain X‑rays with measurements.
State measured translation and sagittal angulation values.

Documentation Required

Behavioral health documentation requirement

Include behavioral health assessment documenting absence of unmanaged significant behavioral health disorders (e.g., major depressive disorder, chronic pain syndrome, secondary gain, or opioid/alcohol use disorder) when submitting documentation.

Provide behavioral health evaluation or statement indicating no unmanaged significant behavioral health disorder.
If disorder is present, document management plan and stability.

Documentation Required

Document device FDA approval and use per labeling

Document that the device to be implanted is FDA‑approved for the intended indication and that implantation will follow FDA labeling.

Identify device and provide FDA approval documentation or reference.
Confirm intended use matches FDA‑approved indication and labeling.

Documentation Required

Imaging concordance documentation: MRI/CT linking findings to symptoms

Attach MRI or CT reports that explicitly state findings concordant with the patient's symptoms and physical exam demonstrating cervical spinal cord compression or cervical spinal stenosis.

Ensure radiology interpretation links imaging abnormalities to clinical signs/symptoms.
Include images/reports demonstrating cord compression or stenosis at the requested level(s).

Documentation Required

Symptom documentation: record listed neurologic symptoms

Document at least one qualifying symptom (e.g., extremity weakness, numbness or pain; fine motor dysfunction or clumsiness; new‑onset bowel/bladder dysfunction; frequent falls) in the clinical record.

Record specific symptom(s) present and their onset/severity.
Explain functional impact (e.g., inability to perform ADLs).

Documentation Required

Physical exam documentation: record myelopathic/radicular signs

Document physical exam findings supporting the indication (e.g., grip‑and‑release abnormality, ataxic gait, hyperreflexia, Hoffman or Babinski sign, tandem gait ataxia, inverted brachioradialis reflex, increased tone/spasticity, clonus, or myelopathic hand).

Record which specific exam signs are present and on which side.
Include serial exam findings when available.

Documentation Required

Use FDA‑approved implant and document labeling compliance

Use only cervical disc prostheses approved by the FDA for the intended indication and in accordance with FDA labeling; document the device’s approval status in the submission.

State device is FDA‑approved and cite approval if available (PMA or approval statement).
Confirm device will be used per FDA labeling.

Documentation Required

Conservative therapy documentation: inadequate improvement after ≥2 therapies

Document inadequate improvement after at least two conservative therapies (prescription‑strength analgesics, steroids, gabapentinoids and/or NSAIDs) for six weeks, unless contraindicated, when submitting prior authorization.

List the two (or more) conservative therapies tried and provide objective or subjective measures of insufficient improvement.
Include dates and supervising clinicians.

Documentation Required

Imaging documentation: adjacent‑level TDA success and compression at requested level(s)

Provide imaging demonstrating successful adjacent‑level cervical TDA when applicable and MRI/CT evidence of neural structure compression at the requested level(s) concordant with symptoms.

Include imaging showing adjacent‑level TDA function (flexion/extension views) when evaluating adjacent segment disease.
Attach MRI/CT reports showing compressive pathology at the requested level(s).

Documentation Required

Required clinical documentation: prior surgery status and myelopathy findings

Document no prior surgeries at the operative level and record myelopathic symptoms and detailed physical exam findings per policy when seeking authorization for myelopathy indications.

State explicitly that there are no previous surgeries at the operative level.
Document myelopathic symptoms (weakness, numbness, gait disturbance, bowel/bladder dysfunction) and exam signs (grip‑and‑release, hyperreflexia, Hoffmann, Babinski, etc.).

Documentation Required

Required imaging correlation: absence of instability and concordant MRI/CT

Provide plain X‑rays and MRI/CT demonstrating absence of clinically significant cervical instability on resting plain X‑rays and imaging findings consistent with symptoms or exam (e.g., cord compression or stenosis).

Include resting plain X‑rays showing translation ≤3.5 mm and angulation ≤11° and no kyphotic deformity or spondylolisthesis.
Attach MRI/CT showing compression or stenosis consistent with clinical findings.

Documentation Required

Required imaging documentation: include procedure‑specific imaging

Include the imaging findings required by the applicable procedure sections when evaluating individuals for spine surgery; do not omit procedure‑specific imaging requirements.

Review and include any procedure‑specific imaging elements noted in the policy.
Attach the cited imaging studies and reports to the authorization.

Billing Rule

Procedure coding and levels: include CPT/ICD‑10 and disc levels

Provide CPT codes, ICD‑10 diagnosis codes, and specify disc levels or motion segments involved for the planned surgery in the prior authorization submission.

List the CPT and ICD‑10 codes being billed.
Specify the exact disc level(s) or motion segments to be treated.

Documentation Required

Nonsurgical treatment history: detail trials and responses

Provide a detailed nonsurgical treatment history: type, duration, frequency, response, and documentation of less than clinically meaningful improvement for each treatment; if contraindicated, document why.

For each nonsurgical treatment, list start/end dates, provider, frequency, and clinical response.
If no trial was possible, include documented contraindication rationale.

Documentation Required

Advanced imaging reports: include independent radiologist interpretation

Attach written reports/interpretations of the most recent advanced diagnostic imaging (CT, MRI, or Myelography) read by an independent radiologist; reconcile any clinically significant discrepancies between surgeon and radiologist prior to submission.

Provide final radiology reports and images for recent CT/MRI/Myelography.
Document reconciliation of any discrepant interpretations between surgeon and radiologist.

Documentation Required

Plain X‑rays requirement for fusion requests

For spinal fusion requests include flexion‑extension plain X‑rays when indicated for instability and/or plain X‑rays documenting failure of instrumentation or fusion.

Provide flexion‑extension views when assessing for instability in fusion requests.
Include X‑rays documenting failed instrumentation or nonunion when relevant.

Documentation Required

Clinical trial and device‑specific outcome documentation

When citing clinical trial follow‑up data or device‑specific outcomes in support of a request, include device type, level(s) treated, and prior nonoperative treatment duration.

State device type and levels treated in clinical trial data provided.
Include prior nonoperative treatment duration when using trial outcomes as supporting evidence.

Documentation Required

Device regulatory documentation: cite FDA approval status and indications

Reference device FDA approval status and indication (e.g., device‑specific PMA or approval statement) in the documentation when applicable.

Cite PMA or FDA approval statement for the device when available.
Include approval date and indicated levels/uses per FDA labeling.

Note

Applicability: confirm product coverage before submitting

Verify product coverage before applying the medical policy; if the member’s product does not cover the service, the medical policy criteria do not authorize benefit and the request may be denied by the product.

Confirm whether the commercial, Medicaid, or Medicare product covers the specific service.
If product excludes the service, do not rely solely on the medical policy for authorization.

Denial Risk

Denial risk: prior surgery at the operative level

Prior surgery at the operative level disqualifies initial/primary implant eligibility and should be documented; presence of prior surgery may lead to denial.

State explicitly if there has been any previous surgery at the operative level.
If prior surgery exists, note that initial/primary implant criteria are not met.

Denial Risk

Denial risk: radiographic cervical instability

Document and report radiographic cervical instability; the presence of subluxation/translation >3.5 mm, sagittal plane angulation >11 degrees, kyphotic deformity/reversal of lordosis, or spondylolisthesis will contraindicate coverage and may result in denial.

Provide measured translation and sagittal angulation values on plain X‑rays.
If any instability finding is present, note that coverage criteria are not met.

Denial Risk

Denial risk: prior surgery excludes adjacent‑segment indication

Prior surgery at the operative level is disqualifying for the single‑level adjacent segment replacement indication; document absence of prior surgery to avoid denial.

Confirm no prior surgery at the operative level when requesting adjacent‑segment TDA.
If prior surgery exists, the adjacent‑segment replacement indication is not met.

Denial Risk

Denial risk: instability findings contraindicate coverage

Presence of clinically significant cervical instability (subluxation/translation >3.5 mm, sagittal angulation >11°, kyphotic deformity or spondylolisthesis) may contraindicate coverage and lead to denial.

Ensure flexion/extension and resting plain X‑rays are included to assess for instability.
If instability is present, document and counsel that coverage criteria are unmet.

Denial Risk

Denial risk: radiographic instability exclusions on plain X‑rays

Resting plain X‑rays showing clinically significant cervical instability (translation >3.5 mm, sagittal plane angulation >11 degrees, kyphotic deformity or spondylolisthesis) will trigger denial; include X‑ray measurements in the record.

Provide static lateral and flexion/extension X‑ray measurements.
Note that any listed instability findings render the request not consistent with coverage.

Denial Risk

Denial risk: non‑indicated procedures and repeat TDA

Procedures performed for degenerative disc disease as the sole indication, repeat cervical TDA at the same level, or procedures not meeting policy guidelines/procedure‑specific criteria are considered not medically necessary and may be denied.

Do not submit for degenerative disc disease as sole indication without other qualifying criteria.
Repeat cervical TDA at the same level is considered not medically necessary.

Denial Risk

Denial risk: imaging‑based contraindications (severe facet arthropathy, OPLL)

Imaging evidence of severe facet joint arthropathy or OPLL are contraindications that render the artificial cervical intervertebral disc investigational and may trigger denial; report these imaging findings if present.

If severe facet arthropathy or OPLL is present on imaging, indicate that the device is investigational for this indication.
Such findings may result in denial of coverage.

Denial Risk

Denial risk: incomplete advanced imaging documentation

Failure to provide written reports/interpretations of the most recent advanced diagnostic imaging (CT, MRI, or Myelography) read by an independent radiologist, or failure to reconcile significant discrepancies between surgeon and radiologist, may risk denial.

Include independent radiologist’s report for recent CT/MRI/Myelography.
Document reconciliation of any clinically significant interpretation discrepancies.

Denial Risk

Denial risk: incomplete procedure and nonsurgical treatment documentation

Insufficient documentation of CPT/ICD‑10 codes, disc levels, or inadequate detail on type, duration, frequency, and response to nonsurgical treatments (including lack of documentation of less than clinically meaningful improvement) may trigger denial.

Provide full CPT/ICD‑10 coding and exact disc levels.
Include detailed nonsurgical treatment history with outcomes for each therapy.

Denial Risk

Denial risk: use of non‑FDA‑approved devices (investigational)

Devices that are not FDA‑approved (for example, partial disc replacement systems) are considered investigational and may be denied; do not propose non‑FDA‑approved devices for covered indications.

Use only devices with documented FDA approval for the intended indication.
Partial disc replacement systems and other non‑FDA‑approved devices are investigational.

Denial Risk

Denial risk: unsupported indications (≥3 levels or isolated axial neck pain)

Procedures for three or more levels or for isolated axial neck pain are not supported by significant evidence and may be denied; ensure requests are limited to one or two levels and have radiculopathy/myeloradiculopathy indications.

Do not request coverage for three or more levels.
Do not request coverage for isolated axial neck pain without radiculopathy/myeloradiculopathy.

Denial Risk

Denial risk: product coverage dependency

Services are contract dependent; if the member’s product does not cover the service, medical policy criteria do not authorize benefit and the request may be denied by the product—verify contract coverage before submission.

Confirm beneficiary’s product covers the service before relying on the medical policy.
If product excludes the service, authorization under this policy will not ensure coverage.

Documentation Required

Plain X‑rays required for fusion requests

Plain X‑rays are required for evaluation of fusion requests to document instability (flexion‑extension views when indicated) and/or failure of instrumentation or fusion; include these films and reports when applicable.

Include flexion‑extension views for instability assessment in fusion requests.
Attach plain X‑rays documenting failed instrumentation or nonunion when relevant.

Documentation Required

Clinical trial follow‑up and device‑specific outcome documentation

When clinical trial follow‑up data or device‑specific outcomes are cited, documentation should include the device type, treated level(s), and prior nonoperative treatment duration to support the request.

Provide device type and levels treated when citing trial data.
Include prior nonoperative treatment duration in the supporting documentation.

DocumentationPhysical exam should record presence/absence of nerve root tension signs

inv-116: clinically significant cervical instability

DefinitionRadiographic findings such as subluxation/translation > 3.5 mm, sagittal plane angulation > 11 degrees between adjacent segments, kyphotic deformity/significant reversal of lordosis, or spondylolisthesis

Assessment modalityDetermined on plain X-rays (static lateral or flexion/extension views)

ConsequencePresence of any listed finding indicates clinically significant cervical instability and precludes coverage

inv-117: sagittal plane angulation threshold

Sagittal plane angulation threshold> 11 degrees between adjacent segments on static or dynamic flexion/extension views

Measurement contextMeasured on static lateral or dynamic flexion/extension plain X-rays

Clinical implicationAngulation above this threshold indicates clinically significant instability and is exclusionary

inv-118: clinically significant cervical instability

Definition summaryClinically significant cervical instability: translation >3.5 mm, sagittal plane angulation >11°, kyphotic deformity/significant reversal of lordosis, or spondylolisthesis on plain X-rays

Imaging requiredResting plain X-rays including flexion/extension views for dynamic assessment

Coverage effectIf present, these findings exclude the patient from meeting the 'absence of instability' requirement

inv-119: imaging concordant with symptoms

Imaging concordant with symptomsMRI or CT demonstrating findings that correlate with the individual's symptoms and physical exam and that show cervical spinal cord compression or cervical spinal stenosis

Causative pathology examplesHerniated disc, synovial/arachnoid cyst, central/lateral/foraminal stenosis, or osteophytes

DocumentationAdvanced imaging reports must be provided with interpretation to confirm concordance

inv-120: Operative levels

Operative levelsC3–C7 (planned implant(s) used in reconstruction of cervical disc(s) at these levels following discectomy)

Device labelingImplant use must be consistent with FDA-approved indication and labeling for these levels

DocumentationPrior authorization should list planned disc levels (C3–C7)

inv-121: Imaging concordance

Imaging concordanceImaging (including flexion/extension lateral views and MRI/CT) must show a successful adjacent-level cervical TDA and neural structure compression at the requested level(s) concordant with symptoms

Required findingsMRI/CT evidence of neural compression caused by herniated disc, retained/recurrent herniation, synovial cyst, stenosis, or osteophytes

ContextApplies to adjacent-segment TDA prior authorization and eligibility

inv-122: Clinically significant cervical instability

Clinically significant cervical instabilitySubluxation/translation > 3.5 mm; sagittal plane angulation > 11 degrees between adjacent segments; kyphotic deformity or spondylolisthesis

Assessment viewsResting plain X-rays and flexion/extension lateral views for dynamic assessment

Coverage implicationPresence of any of these findings excludes the individual from device eligibility

inv-123: Sagittal plane angulation threshold

Sagittal plane angulation threshold> 11 degrees between adjacent segments on static or dynamic flexion/extension views

Measurement guidanceEvaluate on plain X-rays (static lateral or flexion/extension) between adjacent segments

OutcomeValues above threshold indicate instability and preclude coverage

inv-124: Decreased bone mineral density

Decreased bone mineral densityDEXA T-score < -1.5

Policy effectT-score worse than -1.5 is a contraindication and renders the artificial cervical intervertebral disc investigational

DocumentationDEXA results should be provided when bone mineral density is a concern

inv-125: Severe spondylosis

Severe spondylosis criteriaBridging osteophytes, marked reduction or absence of motion, or collapse of disc space > 50% of normal height

Clinical implicationSevere spondylosis is a contraindication and makes AIDA investigational at that level

Imaging modalityPlain radiographs showing the described features

inv-126: Urgent/Emergent request

Urgent/Emergent request definitionRequest where routine time frames could seriously jeopardize life/health or ability to regain maximum function (per 2019 NCQA)

Examples relevant to policyCentral cord syndrome and other listed urgent neurocompressive conditions may warrant expedited consideration

Waiver of prerequisitesFor confirmed urgent/emergent conditions, some routine preconditions may be waived (e.g., nonoperative management trials)

inv-127: Central cord syndrome

Central cord syndromeCentral cord syndrome is listed as an urgent/emergent indication for cervical TDA

Related urgent indicationsMyelopathy or cord signal changes on MRI, progressive neurologic deficit on separate exams, and marked motor weakness are also urgent indications

DocumentationUrgent/emergent status must be documented and supported by imaging/serial exams

inv-128: Radiculopathy

Radiculopathy (definition)Pain, dysesthesia, or paresthesia in a level-specific referral pattern of an involved named spinal root(s) causing significant functional limitations

Clinical significanceUsed to define indications for AIDA when symptoms correlate with imaging and exam

DocumentationClinical notes should record level-specific symptom patterns to support diagnosis

inv-129: Spinal stenosis

Spinal stenosis (definition)Narrowing of the spinal canal often due to degeneration, may result from disc herniation, osteoarthritis, or tumor

Relation to myelopathySpinal stenosis causing cord compression can produce myelopathy or myeloradiculopathy

ImagingMRI/CT demonstrates stenosis/cord compression concordant with clinical findings

inv-130: Clinically meaningful improvement

Clinically meaningful improvement threshold≥ 50% improvement on global assessment

Role in conservative therapy assessmentUsed to define inadequate response to conservative care (i.e., less than 50% improvement)

DocumentationResponses to each conservative therapy should be documented relative to this threshold

inv-131: Cervical DDD

Cervical DDDDeterioration of cervical intervertebral discs (spondylosis) causing arm pain, weakness, paresthesia; may lead to myelopathy when cord compression present

Clinical manifestationsRadiculopathy or myelopathy symptoms depending on root or cord involvement

Implication for AIDAAIDA is considered as alternative to ACDF when selection criteria are met

inv-132: ACDF

ACDF (definition)Anterior cervical discectomy and fusion — definitive surgical treatment for symptomatic cervical DDD aiming to decompress nerves and restore alignment/stability

RoleACDF is the comparator/conventional surgical option to AIDA

DocumentationCandidacy for ACDF is part of patient selection for cervical disc arthroplasty

inv-133: Anterior Cervical Discectomy and Fusion (ACDF)

Artificial Intervertebral Disc Arthroplasty (AIDA)Replacement of the intervertebral disc with an artificial device (total or partial) intended to restore anatomy and mechanical function and preserve motion

Device typesTotal artificial disc replaces nucleus, annulus, and end plate; partial (nucleus arthroplasty) replaces only nucleus

Investigational notePartial disc replacement and hybrid constructs remain investigational in many contexts

inv-134: Artificial Intervertebral Disc Arthroplasty (AIDA)

AIDA (alternate label)Artificial Intervertebral Disc Arthroplasty — replacement of intervertebral disc with artificial device to restore anatomy and preserve motion

ScopeIncludes total and partial disc replacement concepts referenced in policy

Regulatory noteUse limited to FDA-approved devices/indications; partial devices often investigational

inv-135: Radiculopathy (definition)

Radiculopathy (definition)Presence of pain, dysesthesias, or paresthesias in a level-specific referral pattern of an involved named spinal root(s) causing significant functional limitations

Policy useDefines the clinical syndrome supporting AIDA for radiculopathy when imaging/exam concordant

DocumentationSymptom descriptions should be level-specific to correlate with imaging

inv-136: Myelopathy / Myeloradiculopathy (definition)

Myelopathy / Myeloradiculopathy (definition)Spinal cord dysfunction or combined cord and nerve root dysfunction due to central spinal stenosis or degenerative disc disease

Clinical signsMay present with gait/balance changes, fine motor dysfunction, or limb weakness/numbness

Imaging correlationMRI/CT must show cord compression or stenosis concordant with exam for coverage

inv-137: CMS coverage status

CMS coverage statusNo national or regional CMS coverage determination addressing artificial cervical intervertebral disc

ImplicationMedicare policy not established; coverage decisions may be product- or contract-dependent

ReferencePolicy notes absence of CMS determination

Summary of changes tracking implemented in the policy document.

2008-03-20committee_approval

Policy committee approval recorded (start of recorded approval history).