ModifiedUnitedHealthcarePolicy CSO31TN.Q

Discogenic Pain Treatment (for Tennessee Only)

Defines UnitedHealthcare Medical Policy coverage stance for certain intradiscal and annular repair procedures for Medicaid and CoverKids in Tennessee. Affects providers performing or requesting coverage for percutaneous intradiscal therapies, annular closure devices, and allogeneic cell/tissue injections.

Policy Summary

PayerUnitedHealthcare

PolicyDiscogenic Pain Treatment (for Tennessee Only)

Policy CodePolicy CSO31TN.Q

Change TypeClinical evidence and references updatedprior version archived

Effective DateMarch 1, 2025

Next Review DateN/A

Key ActionConfirm prior authorization and document imaging showing a large annular defect (4–6 mm tall x 6–10 mm wide), single-level L4–S1, and skeletal maturity when requesting ACD implantation.

SourceLink

POLICY UPDATE CHANGES

Supporting Information and Clinical Evidence and References sections were updated to reflect the most current information.

3unproven procedures

0627T-0630T, 22526-22527, 22899, S2348procedure codes cited

554patients in pivotal RCT

03/01/2025revision date

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inv-01: Not Medically Necessary

The following procedures are identified as unproven and not medically necessary due to insufficient evidence of efficacy:

Unproven / Not Medically Necessary Procedures: Percutaneous injection of allogeneic cellular/tissue-based products; Annular closure devices (ACDs); Thermal intradiscal procedures (TIPs) for treating discogenic pain.

Listed explicitly as unproven and not medically necessary in policy.

inv-02: Annular Closure Device (ACD) — Coverage Criteria

Covered when ALL of the following are met (alignment with trial population and FDA indication)

ACD coverage criteria: Patient is skeletally mature; primary single-level lumbar discectomy at L4–S1 was performed; postoperative imaging documents a large annular defect (4–6 mm tall and 6–10 mm wide); implantation is performed at the time of primary discectomy as an adjunct to reduce risk of recurrent herniation/reoperation; clinical presentation includes radiculopathy attributable to the treated level.

Criteria reflect RCT inclusion criteria and FDA PMA indication for Barricaid; evidence shows reduced recurrent herniation and reoperation but increased vertebral endplate changes (VEPC).

inv-03: Intradiscal procedures — Coverage stance

Not routinely covered (insufficient evidence) — thermal intradiscal procedures and allogeneic intradiscal injections

Intradiscal thermal and cellular procedures (investigational): Percutaneous intradiscal thermal procedures (eg, IDET, intradiscal biacuplasty/IDB, PIRFT, ID-PRF) and percutaneous injection of allogeneic cellular/tissue-based products for discogenic pain are considered investigational/insufficient evidence for routine coverage due to limited, inconsistent, or small trials and need for further randomized controlled trials with long-term outcomes.

Some IDB RCTs show benefit but overall evidence judged insufficient or mixed; intradiscal allograft trials are limited and require additional research.

The policy identifies specific procedures as unproven and not medically necessary because evidence is insufficient to demonstrate clinical efficacy. These procedures include: percutaneous injection of allogeneic cellular/tissue-based products, annular closure devices (ACDs), and thermal intradiscal procedures (TIPs) for treating discogenic pain. Requests for these services may therefore be denied or considered exclusions under the policy.

The use of thermal intradiscal procedures (TIPs) (e.g., IDET, biacuplasty, PIRFT) and percutaneous intradiscal allogeneic cellular/tissue-based injections for discogenic low back pain is explicitly noted as having insufficient high-quality evidence to support routine coverage. The policy states that further randomized controlled trials with larger samples and long-term outcomes are required before these interventions are considered medically necessary.

FDA regulatory actions and product approvals are provided for informational context only. The policy clarifies that FDA approval alone is not a basis for coverage decisions, and coverage determinations rely on the totality of clinical evidence and plan-specific benefit rules.

The policy notes that percutaneous injection of allogeneic cellular/tissue-based products, annular closure devices (ACDs), and thermal intradiscal procedures (TIPs) are identified as unproven and not medically necessary for routine treatment of discogenic pain. For ACDs, the document references the device-specific FDA premarket approval and trial populations; when coverage is considered for an ACD (per FDA indication), documentation must align with the device labeling (for example, skeletally mature patient, single-level L4–S1 primary discectomy with a documented large annular defect).

Overall, percutaneous injection of allogeneic cellular/tissue-based products and thermal intradiscal procedures are characterized as lacking sufficient evidence of safety and effectiveness. The policy emphasizes that current data are limited, inconsistent, or from small studies, and thus these intradiscal interventions remain investigational for routine coverage.

Consistent with the coverage rationale and exclusions, the following services are listed as not covered: percutaneous injection of allogeneic cellular/tissue-based products; annular closure devices (ACDs); and thermal intradiscal procedures (TIPs) for discogenic pain. For ACDs, although a device (Barricaid) has FDA premarket approval for a narrow indication, the policy treats routine use of ACDs as excluded unless documentation strictly meets the device-specific criteria and applicable plan requirements.

Coding Reference

Referenced CPT/Category III and unlisted spine proceduresCPT

0627T	Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; first level.
0628T	Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; each additional level (List separately in addition to code for primary procedure).
0629T	Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection; with CT guidance, lumbar; first level.
0630T	Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with CT guidance, lumbar; each additional level (List separately in addition to code for primary procedure).
22526	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level.
22527	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; 1 or more additional levels (List separately in addition to code for primary procedure).
22899	Unlisted procedure, spine.

Referenced HCPCS/S codesHCPCS

S2348

Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar.

Device product codes (informational)mixed

FTL	Product code FTL — surgical mesh, polymeric (informational).
FTM	Product code FTM — mesh, surgical (informational).
GAT	Product code GAT — suture, nonabsorbable, synthetic, polyethylene (informational).

Provider Actions and Requirements

Prior Authorization

Prior Authorization for Annular Closure Device

Prior authorization is required for implantation of an annular closure device (ACD). Prior authorization requests must document that the patient meets the device-specific FDA indication and device criteria (see required documentation bullets below) and that the requested use is consistent with any applicable federal, state, or contractual benefit requirements.

Confirm prior authorization before scheduling/implantation.
Barricaid (Barricaid Annular Closure Device) is FDA PMA-approved with a labeled indication — use must match the approved indication and device-specific criteria.
Prior authorization should include device model and manufacturer when applicable.

Documentation Required

Regulatory Indication Alignment

Use of an ACD must align with the device’s regulatory indication. The Barricaid device is indicated only for skeletally mature patients with radiculopathy (with or without back pain) attributable to a posterior or posterolateral herniation and confirmed by history, exam, and imaging. The indication is limited to a single-level primary discectomy at L4–S1 for a large annular defect meeting the dimension criteria described below.

Do not use ACDs outside the FDA-labeled population (for example: skeletally immature patients, multilevel procedures, or levels outside L4–S1) without documentation justifying off-label use; off-label use may be denied.
If the device is not FDA-approved for the requested use, include supporting evidence and note that such use may be investigational and not covered.

Denial Risk

Documentation / Indication Mismatch May Trigger Denial

Requests that lack clear documentation matching the indication and device criteria may be denied. Typical documentation/indication mismatches that can trigger denial include: absence of documented skeletally mature status, annular defect dimensions outside the required range, multilevel disease or prior discectomy at the same level, or lack of imaging confirming neural compression and defect size.

Missing or incomplete MRI reports or operative notes that do not document annular defect dimensions (height and width) or level (L4–S1) may result in denial.
If conservative therapy requirements (when applicable) are not documented, coverage may be denied.

Note

Applicability and Documentation

This policy applies to Tennessee Medicaid and CoverKids populations; providers should verify plan-specific coverage rules, federal/state contract terms, and benefit limitations before submission. Inclusion of procedure or diagnosis codes in this policy is for reference only and does not guarantee coverage or payment.

Verify member benefits, prior authorization requirements, and any state-specific mandates before scheduling procedures.
Provide the policy number (CSO31TN.Q) and effective date (2025-03-01) on authorization requests when applicable.

Documentation Required

Required Clinical and Imaging Documentation

Required imaging and device-specific measurements must be provided with prior authorization and claims. Imaging should include preoperative MRI demonstrating neural compression and imaging or intraoperative documentation confirming a large annular defect of the size specified by the device labeling.

MRI report demonstrating neural compression attributable to a posterior or posterolateral herniation at a single level between L4 and S1.
Documentation of annular defect dimensions consistent with device labeling: between 4–6 mm tall and between 6–10 mm wide (or as specified by the device manufacturer).
Operative report from the primary discectomy describing the defect and confirming single-level procedure.

Documentation Required

Required Clinical Documentation

Clinical documentation should include a complete history and physical exam correlating symptoms to imaging and confirmation that symptoms (radiculopathy with or without back pain) are attributable to the identified herniation. Provide prior treatment history and symptom duration.

History and physical exam notes linking radiculopathy to the identified posterior or posterolateral herniation.
Documentation of symptom duration and prior nonoperative treatments (see conservative care bullets).
Operative notes verifying primary discectomy and description of the annular defect and level.

Step Therapy

Conservative Care Prior to Surgical/Device Interventions

Conservative management must be documented prior to surgical or device interventions when clinical evidence or study inclusion criteria require it. Many trials of ACDs and other disc interventions enrolled patients after failure of conservative care (typically ≥6 weeks) or when conservative care was contraindicated due to neurologic deficits.

Document trials of nonoperative care such as physical therapy, activity modification, anti-inflammatory medications, and targeted injections when applicable, with dates and responses.
If the patient had contraindications to conservative care (for example, progressive neurologic deficit), document the clinical rationale.

Step Therapy

Conservative Management Prior to Investigational Procedures

For investigational procedures addressed by this policy (percutaneous injection of allogeneic cellular/tissue-based products and thermal intradiscal procedures), document prior conservative management and include rationale and supporting records. Requests for these procedures should clearly show failure of appropriate conservative therapy per plan requirements.

Include documentation of nonoperative care attempts (duration and modalities) for intradiscal injections or TIPs.
Specify whether the request is for an investigational procedure; note that these procedures are considered unproven and not medically necessary under this policy unless plan terms allow otherwise.

Step Therapy

Step / Conservative Therapy Considerations

Consider conservative therapy and applicable plan requirements in all care decisions. This policy is advisory and intended to be used with the provider’s clinical judgment and applicable benefit rules; where step therapy or prior authorization pathways exist, follow those processes.

Before requesting advanced interventions, verify whether the member’s plan requires documented trial of specified conservative therapies and follow any step-therapy protocols.
Use evidence from prior treatment trials and objective findings in authorization requests to support medical necessity.

Conservative Treatment Requirements

inv-31: Failure of conservative care prior to consideration of surgical or device-based interventions in the cited studies.

Failure of conservative care prior to consideration of surgical or device-based interventions in the cited studies.

Conservative care requirement: Documented failure of conservative management (typically >6 weeks) prior to consideration of surgical or device-based interventions as reflected in cited trials evaluating annular closure devices.>6 weeks

Conservative care in trials included therapies such as physical therapy, medications, and other nonoperative treatments or presence of indications (eg, neurological deficits) that precluded conservative care.

inv-32: Document prior trial of conventional medical management before intradiscal interventions considered investigational.

Document prior trial of conventional medical management before intradiscal interventions considered investigational.

Conventional medical management (CMM) trial: Document trial of conventional medical management (CMM) prior to intradiscal thermal procedures or percutaneous allogeneic intradiscal injections. CMM may include physical therapy, pharmacologic treatment, interventional injections (eg, epidural, facet), and lifestyle measures.

Required because intradiscal procedures and allogeneic injections are investigational and trials compared interventions to CMM; lack of adequate prior CMM documentation supports denial risk.

Imaging Requirements

Billing Rule

Fluoroscopy or CT guidance required for TIPs (IDET, IDB/biacuplasty, PIRFT)

Perform IDET, IDB/biacuplasty, and PIRFT under fluoroscopic (X‑ray) or CT guidance as described in the procedure definitions and imaging requirements.

Fluoroscopy or CT guidance is required for probe/catheter placement in TIPs and related procedures.
Document the imaging guidance used when submitting claims or authorization requests.

Documentation Required

Provide MRI to document neural compression and annular defect for ACD implantation

For annular closure device implantation, provide MRI demonstrating neural compression and measurement of the annular defect size consistent with the device indication.

MRI must document neural compression and annular defect dimensions in the range specified for the Barricaid device.
Include MRI images/reports with authorization requests and claims as applicable.

Documentation Required

Include MRI when proposing ACD placement after discectomy

When annular closure device placement is proposed following discectomy, include MRI that characterizes the annular defect and correlates with clinical findings as part of the authorization and documentation package.

MRI evidence of a large annular defect post-discectomy and clinical correlation with radiculopathy are required to align with device labeling.
Attach operative notes indicating primary discectomy and timing of the proposed implant.

Definitions

Annular closure device (ACD)

DefinitionDevice designed to reinforce or bridge the annulus fibrosus defect created during discectomy to close the defect and repair the annulus fibrosus of the intervertebral disc.

Typical usePlaced at time of primary discectomy to reduce risk of recurrent herniation and reoperation by closing a large annular defect.

Implantation settingImplanted by spine surgeons as an adjunct to lumbar microdiscectomy procedures.

Evidence noteRCTs have evaluated bone-anchored ACDs showing reduced reherniation and reoperation but potential imaging changes; quality and applicability should be reviewed.

Related device examplesBarricaid (bone-anchored annular closure device) is an example referenced in evidence and FDA materials.

Thermal intradiscal procedures (TIPs)

DefinitionPercutaneous procedures inserting a catheter or probe into the disc, under fluoroscopic guidance, to apply heat within the disc to denature collagen, shrink tissue, and ablate nociceptors (examples: IDET, IDB/biacuplasty, PIRFT).

Common modalitiesIDET (intradiscal electrothermal therapy), IDB/biacuplasty (bipolar radiofrequency biacuplasty), PIRFT (percutaneous intradiscal radiofrequency thermocoagulation).

Guidance requirementPerformed under fluoroscopic (X-ray) or CT guidance as described in device/procedure technique summaries.

Evidence stanceInsufficient high-quality evidence to support routine use for discogenic pain; further randomized studies with larger samples and long-term outcomes are required.

Clinical goalAim to relieve chronic discogenic low back pain by altering disc biomechanics and destroying nociceptive fibers.

Percutaneous injection of allogeneic cellular/tissue-based products

DefinitionInjection of donor-derived (allogeneic) cellular or tissue-based products into lumbar intervertebral discs via a percutaneous approach intended to stimulate tissue repair.

Regulatory oversightCellular therapy products are regulated by FDA CBER; regulatory status is informational and not by itself a basis for coverage decisions.

Evidence stanceThere is insufficient high-quality evidence to support percutaneous intradiscal allogeneic cellular/tissue injections for discogenic pain.

Typical intentIntended to stimulate disc tissue repair and improve symptoms of discogenic low back pain when injected into the disc space.

Large annular defect

DefinitionAn annular defect measuring approximately 4–6 mm in height (tall) and 6–10 mm in width as specified in the Barricaid FDA indication and key trial inclusion criteria.

Context of assessmentDocumented post-primary discectomy (lumbar microdiscectomy) and used to determine eligibility for annular closure device implantation in trials and device labeling.

Imaging modalityMeasured and confirmed on MRI demonstrating the defect dimensions and correlation with neural compression.

IDB (Intradiscal Biacuplasty)

DefinitionThermal intradiscal biacuplasty (IDB) uses bipolar radiofrequency energy delivered via paired electrodes to ablate nociceptive fibers within the annulus while cooling adjacent tissue.

Procedure settingMinimally invasive outpatient procedure performed under local anesthesia and mild sedation with imaging guidance.

Evidence summarySome RCTs have shown efficacy of biacuplasty for chronic refractory discogenic pain, but overall evidence across TIPs is insufficient and further trials are recommended.

Clinical goalAims to destroy pain-generating nerve fibers and produce controlled lesioning between electrodes to reduce discogenic back pain.

Annular defect sized between 4-6 mm tall and 6-10 mm wide (FDA indication)

Specified dimensionsAnnular defect sized between 4–6 mm tall and 6–10 mm wide as specified for the FDA PMA indication (Barricaid) and pivotal trial inclusion criteria.

Anatomic level restrictionIndication and trial inclusion limited to single-level lumbar discectomy between L4 and S1.

Patient maturity requirementDevice indicated for skeletally mature patients per FDA labeling and trial criteria.

Documentation requirementMRI demonstrating neural compression and measurable annular defect dimensions consistent with the device indication should be included in clinical records.

OpenPayer

Discogenic Pain Treatment (for Tennessee Only)

Coverage Criteria

Coding Reference

Provider Actions and Requirements

Conservative Treatment Requirements

Imaging Requirements

Definitions

Background

Revision History