Blue Cross Blue Shield SD Artificial Disc Coverage

Coverage and Medical Necessity Criteria

inv-01: Cervical Artificial Disc: Initial — Covered when ALL of the following are met

Covered when ALL of the following are met:

Cervical initial criteria: Is skeletally mature

Cervical initial criteria: Has intractable cervical radicular pain or myelopathy

Cervical initial criteria: Has failed at least 6 weeks of conservative nonoperative treatment that includes an active pain management program with appropriate pharmacotherapy (including agents addressing neuropathic pain) and physical therapy; exceptions allowed for severe or rapidly progressive neurologic compression or documented contraindication to physical therapy>= 6 weeks

See device labeling for exceptions

Cervical initial criteria: Degeneration documented from C3 through C7 by x-ray, MRI, CT, or myelography

Cervical initial criteria: Nerve root and/or cord compression due to herniated disc and/or spondylosis

Cervical initial criteria: Proposed implant is FDA-approved for the intended vertebral level(s) and will be used at the number of levels permitted by the device approval

Each device may have device-specific contraindications

Cervical initial criteria: Individual is free from device-specific FDA contraindications as identified on the device label

See investigational/contraindication lists for examples

inv-02: Two-Level Cervical Artificial Disc — Covered when ALL of the following are met

Covered when ALL of the following are met:

Two-level cervical criteria: All initial cervical artificial disc criteria (per single-level) are met for each disc level

Two-level cervical criteria: Proposed implant is FDA-approved for two contiguous levels

See device-specific PMA/labeling

Two-level cervical criteria: Procedure is performed at two contiguous levels simultaneously or at a second contiguous level after a prior arthroplasty when the initial implantation is fully healed

inv-03: Cervical Artificial Disc: Revision — Covered when ALL of the following are met

Covered when ALL of the following are met:

Cervical revision: Imaging confirms failure of the implanted cervical artificial disc (examples: loosening, dislodgement, fracture, or discitis/infection)

inv-04: Lumbar Artificial Disc: Initial — Covered when ALL of the following are met

Covered when ALL of the following are met:

Lumbar initial criteria: Age between 18 and 60 years18-60

Lumbar initial criteria: Chronic, unremitting, severe axial low back pain determined to be of discogenic origin

Lumbar initial criteria: Moderate to severe single-level degenerative disc disease confirmed by x-ray, MRI, or CTsingle level

Device-specific allowed levels apply

Lumbar initial criteria:

inv-05: Lumbar Artificial Disc: Revision — Covered when ALL of the following are met

Covered when ALL of the following are met:

Lumbar revision: Imaging confirms failure of the implanted lumbar artificial disc (examples: loosening, dislodgement, fracture, or discitis/infection)

inv-06: Coverage criteria for artificial disc replacement — Covered when ALL of the following are met (device-specific labeling applies)

Covered when ALL of the following are met (device-specific labeling applies):

Clinical indication: Patient has symptomatic degenerative disc disease (cervical: radiculopathy or myelopathy; lumbar: discogenic back pain) with correlated imaging findings

Per device labeling; see imaging confirmation requirements in device PMA summaries

Conservative therapy failure: Failure of appropriate conservative treatment for the duration specified by device labeling (commonly ≥6 weeks for cervical devices; commonly ≥6 months for lumbar devices)see device labeling (>=6 weeks cervical; >=6 months lumbar)

Progressive neurologic decline may alter timing per labeling

Anatomic/degenerative limitations: Disease limited to the number of levels appropriate for the device (e.g., single level or up to two contiguous levels per device) and without contraindicating multilevel disease, significant spondylolisthesis, spinal stenosis requiring decompression, or prior major surgery at the treated level unless specifically allowed by labeling

inv-07: Medical necessity criteria for artificial intervertebral disc implantation — Covered when ALL of the following are met

Covered when ALL of the following are met:

Patient selection: Patient is skeletally mature with symptomatic degenerative disc disease at levels indicated for the device; DDD is confirmed by history and radiographic studies

Device-specific level indications apply

Prior conservative therapy: Patient has failed an adequate trial of conservative therapy (device approvals and trials commonly required >=6 months or at least 6 weeks of nonoperative care prior to surgery)>=6 months typical (device/trial dependent)

Trial duration may vary by device/trial entry criteria

Anatomic/instability limits: Spondylolisthesis and instability are limited per device labeling (examples: Charite ≤3 mm; ProDisc-L ≤ Grade 1)<=3 mm or Grade 1

inv-08: Trial-defined success endpoints — Clinical trial inclusion/efficacy endpoints reported (trial-based criteria and outcomes)

Clinical trial inclusion/efficacy endpoints reported (trial-based criteria and outcomes):

FDA trial success endpoints: Improvement in Neck Disability Index (NDI) >15 points, maintenance or improvement in neurologic function, and absence of serious device- or procedure-related adverse events or supplemental surgical proceduresNDI >15 pts

Endpoint used in FDA SSED summaries

inv-09: Evidence-based coverage considerations — Clinical trial evidence summary relevant to coverage assessments

Clinical trial evidence summary relevant to coverage assessments:

Pivotal trial outcomes: At 2-year follow-up, pivotal trials of multiple cervical artificial discs met noninferiority criteria versus ACDF, with some devices achieving statistical superiority; mid-term (3–7 year) outcomes remain consistent with noninferiority and some trials report lower cumulative reoperation rates

Summarizes pivotal trial findings

Long-term evidence: Longer-term outcomes include up to 20-year follow-up for the Bryan cervical disc showing maintained clinical improvements and lower reoperation rates in that randomized cohort; other devices have published outcomes up to 10 years

Device-specific long-term data vary

inv-10: General medical necessity considerations — Coverage considerations informed by evidence summarized in this section

Coverage considerations informed by evidence summarized in this section

General coverage logic: Patient has degenerative disc disease confirmed by history and radiographs; implantation is of an FDA-cleared artificial disc used per device-specific approvals; conservative treatments were attempted as appropriate; expected benefits include improved pain and function (measured by ODI/VAS/NDI) and potential reduction in adjacent-level degeneration compared with fusion; device and patient selection should align with pivotal trial and FDA inclusion/exclusion criteria; documentation of baseline disability and prior treatments is required

Synthesis of clinical context and device notes

inv-11: Cervical (including 2-level) criteria — Cervical 2-level specific considerations

Cervical 2-level specific considerations

Cervical 2-level evidence: FDA approvals exist for certain devices for implantation at 2 contiguous levels based on noninferiority or superiority to 2-level ACDF in pivotal trials; reported outcomes include overall success, NDI, reoperation rates, and longer-term follow-up up to 10 years for some devices

See device-specific approvals and trial summaries

inv-12: Safety and registry evidence — Key safety and longer-term outcome considerations

Key safety and longer-term outcome considerations

Adverse events and registry findings: Heterotopic ossification is common (pooled prevalence ~58% any HO at 24 months; advanced HO ~16.7%); clinically relevant HO is present in a substantial minority at longer follow-up and may have small effects on NDI and neck pain; registry data show small differences favoring CDA for some outcomes but are limited by selection bias and study quality

Summarizes registry and adverse event data

inv-13: Evidence-based eligibility features — Coverage-relevant evidence and typical trial-based eligibility features (not an explicit policy decision in this excerpt)

Coverage-relevant evidence and typical trial-based eligibility features (not an explicit policy decision in this excerpt):

Trial-based eligibility features: Patient has symptomatic degenerative disc disease at the index level(s) documented radiographically (examples: reduced disc height, Modic changes, posterior high-intensity zone) AND has failed conservative management (commonly ≥6 months for lumbar trials) AND baseline disability reaching trial thresholds (ODI ≥30–40 in some trials) AND absence of exclusion conditions commonly excluded from trials (scoliosis, spondylolisthesis beyond allowed grade, instability, predominant radiculopathy),see trial criteria (eg ODI >=30–40; >=6 months conservative therapy)

Derived from pivotal trial inclusion/exclusion features

inv-14: Not established as improving net health outcome — Summary of evidence and coverage stance for lumbar artificial discs

Covered when ALL of the following are met:

Primary conclusion: Evidence is insufficient to determine that lumbar artificial intervertebral disc technology results in an improvement in the net health outcome

RCTs limited by lack of blinding, insufficient long-term follow-up, and limited comparisons for some devices (eg, activL)

inv-15: Hybrid surgery: no evidence identified — Hybrid surgery (artificial disc combined with fusion)

Covered when ALL of the following are met:

Hybrid surgery evidence: No randomized controlled trials or systematic reviews identified evaluating lumbar artificial discs used in hybrid surgery for lumbar degenerative disc disease

No evidence that hybrid use improves health outcomes

inv-16: Cervical disc replacement — supported with specified selection — Coverage stance and selection considerations reflected in cited society and guideline input

Covered when ALL of the following are met:

Cervical ADR stance: Cervical disc replacement may be medically necessary in appropriately selected patients; evidence shows short-term efficacy comparable to fusion and some longer-term data support use

Supported by multiple randomized trials and guideline input

inv-17: Lumbar disc replacement — criteria and exclusions — Lumbar ADR — conditional/limited indications per guideline input

Covered when ALL of the following are met:

Lumbar ADR candidate criteria (per NASS/NICE): Patient has symptomatic single-level lumbar disc disease at L3-L4, L4-L5, or L5-S1 with symptoms for ≥6 months unresponsive to multimodal nonoperative treatment (including physical therapy/rehabilitation); primary complaint is axial back pain (possible secondary leg pain); psychiatric disorders must be diagnosed and optimized prior to surgery

NASS guidance summarized

Lumbar ADR absolute exclusions (per NASS): One or more of the following: multilevel symptomatic degenerative disk disease; spinal instability with spondylolisthesis > Grade I; chronic predominant radiculopathy (>1 year); osteopenia with DEXA T-score ≤ -1.0; poorly managed psychiatric disorder; significant facet arthropathy at index level; age >60 or <18; infection or tumor

If any present, ADR is not indicated

The policy lists multiple investigational or contraindicated conditions for cervical and lumbar artificial disc implantation. Notable exclusions include active infection, allergy or sensitivity to implant materials, and any FDA off‑label utilization. Metabolic or bone health contraindications include osteopenia/osteoporosis with a DEXA T‑score <1.0. Other device‑ or anatomy‑based contraindications include significant anatomic deformity (e.g., ankylosing spondylitis), facet arthritis, malignancy, and autoimmune disease (eg, rheumatoid arthritis). Prior surgery at the target level or prior fusion at another cervical or lumbar level also excludes candidacy per the investigational lists.

The investigational sections additionally identify procedure‑related exclusions relevant to device use: planned implantation at more than two cervical levels or more than one lumbar level is listed among contraindications, as is combined use of a prosthesis with fusion or another stabilizing procedure (a hybrid construct). These investigational/contraindicated conditions are cited as reasons the technology is considered investigational when present.

Patients who require additional decompressive procedures (for example, laminectomy or other interventions beyond discectomy and disc reconstruction) or who have multilevel degenerative disease are not considered appropriate candidates for artificial disc implantation. The policy identifies multilevel disease, significant scoliosis, prior major spine surgery, and neurologic symptoms inconsistent with device labeling as exclusions from candidate selection.

Similarly, lumbar investigational criteria specify imaging‑based exclusions such as moderate or greater bony lumbar spinal stenosis, multilevel degenerative disc disease (≥2 levels), and significant spondylolisthesis or pars defects; such findings indicate the patient may require additional procedures or fusion rather than disc arthroplasty.

The policy states that devices for thoracic-level disc arthroplasty have not been approved by the FDA. Implantation at thoracic levels is therefore outside FDA‑approved indications and is not supported by the device approvals summarized in this document.

Within the provided text segments there are no explicit standalone coverage exclusion statements; investigational and contraindication lists and device‑specific labeling language serve to identify scenarios that are unsupported or investigational, but an explicit separate exclusion section is not present in these chunks.

The Hayes Health Technology Assessment (2017; reviewed 2021) rated 2‑level total disc replacement for cervical DDD as a ‘C’ — characterized as a potential but unproven benefit. The HTA indicates uncertainty remains regarding safety and impact on health outcomes due to study quality, sparse or conflicting data, and other concerns.

Hayes HTA also evaluated multilevel total disc replacement and hybrid surgery for cervical DDD and rated these uses ‘D2’ (insufficient evidence). The assessment found low‑quality evidence and no consistent between‑group differences, concluding that evidence is insufficient to assess safety or impact on health outcomes for multilevel or hybrid approaches.

Key pivotal randomized trials generally excluded patients with significant spinal deformity or neurologic conditions. The policy notes that individuals with scoliosis, spondylolisthesis, instability, or radiculopathy were excluded from the pivotal lumbar trials and therefore were not represented in the trial‑supported populations.

Some pivotal trials had limitations in their comparators and generalizability. The ProDisc‑L two‑level trial and other IDE studies sometimes used comparators that were not the current standard or lacked direct comparison to fusion or conservative care; such comparator limitations reduce the applicability of trial results to routine coverage decisions.

The North American Spine Society guidance and device labeling summarized in the policy indicate that lumbar artificial disc replacement is not indicated for multilevel symptomatic degenerative disc disease, for spondylolisthesis greater than Grade I, or for chronic preponderant radiculopathy. These device‑ and guideline‑based statements support restricting lumbar ADR to appropriately selected single‑level patients.

This segment of the document provides coding references and supporting citations but does not present additional explicit coverage criteria or exclusions. Clinical coverage rules and exclusions are described elsewhere in the policy text and investigational lists.

The policy states that any use that does not meet the listed coverage criteria or that falls under the investigational sections (for example, FDA off‑label use or use of non‑FDA‑approved devices) is considered investigational or not medically necessary. This principle is used to indicate that procedures performed outside device labeling, trial eligibility, or stated contraindication lists will generally be unsupported for routine coverage.

Examples called investigational include combined prosthesis and fusion (hybrid constructs), implantation of non‑FDA‑approved prostheses, and use in patients with active infection or other contraindications specified in the investigational lists.

The policy discourages use of artificial discs in patients with contraindicating conditions identified in the investigational lists — specifically multilevel disease beyond device indication, significant spinal stenosis requiring decompression, and spondylolisthesis or other instability beyond device limits. These conditions either preclude adequate device function or indicate that fusion or decompression is a more appropriate surgical strategy.

Where imaging demonstrates exclusionary findings (e.g., multilevel degenerative disease, moderate or greater facet arthropathy, significant scoliosis), the candidate should not be considered appropriate for ADR per the policy statements.

The document lists several artificial lumbar devices that are not currently approved or marketed in the U.S. (for example, FlexiCore, INMOTION, Kineflex‑L, Maverick) and emphasizes that thoracic‑level devices have no FDA approvals. Use of devices that are not FDA‑approved or not marketed in the U.S. is not supported for routine coverage and would be considered investigational.

Examples of currently marketed lumbar devices with FDA approval (ProDisc‑L, ActivL) are distinguished from devices that completed IDE trials or are withdrawn; device regulatory status must be confirmed prior to considering coverage.

Within the provided excerpts there are no explicit statements that label particular indications as ‘not medically necessary’ in a separate template phrase. Instead, the policy uses investigational lists and device labeling constraints to identify unsupported uses and indicates that uses not meeting criteria are investigational/not medically necessary elsewhere in the policy.

The provided text does not enumerate a discrete list of specific conditions labeled not medically necessary in this excerpt. However, elsewhere the policy equates uses outside the coverage criteria and investigational lists (such as non‑FDA‑approved devices or off‑label implantations) with investigational or not‑medically‑necessary status.

Long‑term durability concerns are emphasized for lumbar artificial discs. The policy highlights uncertainty about polyethylene wear debris, the lifespan of prostheses, and the technical complexity and risk of surgical revision, all of which contribute to uncertainty about long‑term outcomes.

These durability and revision concerns underpin caution in expanding routine use beyond the specific, trial‑eligible populations and contribute to the policy’s position that evidence is insufficient to demonstrate improved net health outcomes for some lumbar devices.

The policy explicitly states that activL artificial disc use is not supported by randomized controlled trial evidence demonstrating a net health benefit compared with spinal fusion or conservative care. Absence of RCT comparisons to fusion or conservative therapy for activL is cited as a basis for insufficient evidence regarding net health outcome.

Historically, lumbar artificial discs have been considered investigational in part because randomized controlled trials were limited and concerns remained about long‑term implant complications. External clinical input in 2008 reflected disagreement about investigational labeling, but the policy retained a cautious stance due to trial limitations and unresolved safety and durability questions.

This excerpt does not present an explicit labeled list stating ‘not medically necessary’ for specific conditions. The policy instead uses investigational lists, device labeling, and trial eligibility constraints to identify uses that are unsupported or investigational.

Procedure and Device Coding

Codes table (referenced)mixed

No codes listed

Devices (FDA approved and not currently marketed)mixed

ActivL (device)	ActivL Artificial Disc — FDA approved for single level L4-S1 (2018)
ProDisc-L (device)	ProDisc-L Total Disc Replacement — FDA approved for single or two contiguous levels L3-S1 (2017; 2020 supplement)
Charite (device)	Charite Artificial Disc — FDA approved 2004; withdrawn 1/5/2012 (single level L4-S1)
FlexiCore (device)	FlexiCore Artificial Disc — not currently approved/marketed in U.S. (IDE/completed trial)
INMOTION (device)	INMOTION lumbar artificial disc — not currently marketed in U.S.
Kineflex-L (device)	Kineflex-L — device not marketed in U.S.; advisory committee meeting canceled
Maverick (device)	Maverick artificial disc — not marketed in U.S. due to litigation

Thoracic-level devicesmixedNot Covered

Thoracic devices

No FDA-approved devices for thoracic levels

Codes mentionedmixed

No codes listed

Codes mentionedmixed

No codes listed

Devices mentionedmixed

ProdiscL	Lumbar artificial intervertebral disc device marketed in U.S.
activL	Lumbar artificial intervertebral disc device marketed in U.S.

Procedure CPT/HCPCS codes listed in policyCPT

0095T	Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure).
0098T	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure).
0164T	Removal of total disc arthroplasty, anterior approach, lumbar, each additional interspace.
0165T	Revision of total disc arthroplasty, anterior approach, lumbar, each additional interspace.
22856	Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical.
22857	Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); single interspace, lumbar.
22858	Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (List separately in addition to code for primary procedure).
22860	Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar (List separately in addition to code for primary procedure).
22861	Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical.
22862	Revision including replacement of total disc arthroplasty (artificial disc) anterior approach, single interspace; lumbar.

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Age — typical age range specified

Age range18–60 years

Cervical conservative therapy duration — minimum duration

Minimum cervical conservative therapyAt least 6 weeks of conservative nonoperative treatment including active pain management with pharmacotherapy addressing neuropathic pain and physical therapy

Lumbar conservative therapy duration — minimum duration

Minimum lumbar conservative therapyAt least 6 months of consistent nonoperative treatment including pharmacotherapy and formal physical therapy

Preauthorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for disc arthroplasty. Requests must document the specific FDA‑approved device (model/name) and that the planned vertebral level(s) match the device labeling. Provide surgeon evaluation notes and complete clinical documentation as listed below when submitting for authorization.

Prior authorization required per payer coding table and device-specific indications.
Document device model/name and FDA approval status; verify levels to be treated align with device labeling.
Surgeon must have personally evaluated the patient prior to authorization request (exceptions: malignancy, trauma, infection, or rapidly progressive neurologic symptoms).

Documentation Required

Prior Conservative Therapy and Baseline ODI

When requesting authorization for cervical or lumbar disc arthroplasty, include evidence of failed conservative therapy and baseline functional scores. For lumbar devices, trials typically required at least 6 months of multimodal nonoperative care and an ODI threshold used in pivotal studies; for cervical devices, at least 6 weeks of conservative care is expected.

Clinical Background and Evidence Summary

Cervical disc arthroplasty is presented as an alternative to anterior cervical discectomy and fusion for symptomatic cervical degenerative disc disease. Randomized trials summarized in the policy have demonstrated noninferiority of several cervical devices to ACDF, and some devices show sustained benefits in mid‑ to long‑term follow‑up for selected patients.

The document segments cited do not contain additional explicit coverage exclusions beyond the investigational and contraindication lists; absence of a separate exclusion statement in these chunks is noted to contextualize the background and evidence summaries.

In the provided excerpts there are no explicit statements that label particular services or patient groups as universally not medically necessary. The document uses investigational designations and device‑label contraindications to indicate unsupported uses; therefore an explicit ‘not medically necessary’ list is not present in these specific chunks.

Key Definitions and Measures

Artificial intervertebral disc / total disc replacement — definition

DefinitionA prosthetic device implanted at a cervical or lumbar intervertebral level intended to replace the diseased disc and preserve motion as an alternative to spinal fusion

Degenerative disc disease (cervical/lumbar) — definition

DefinitionDeterioration of intervertebral discs causing symptoms (radiculopathy, myelopathy, or discogenic back pain) typically confirmed by imaging and clinical correlation

FDA-approved device — definition

DefinitionA prosthetic disc that has received U.S. FDA premarket approval for specific vertebral levels and indications (may include postmarketing study requirements)

Policy History and References

2025-06Annual reviewLatest

Policy renewed following annual review.

2024-06Annual review

Policy revised after annual review.

2023-06Annual review

Policy renewed following annual review.

OpenPayer

Artificial Intervertebral Disc (Cervical and Lumbar) Coverage Criteria

Coverage and Medical Necessity Criteria

Procedure and Device Coding

Preauthorization, Documentation, and Operational Requirements

Clinical Background and Evidence Summary

Key Definitions and Measures

Policy History and References