ModifiedColorado Rocky Mountain Health PlansPolicy CS031OH.D

Discogenic Pain Treatment (for Ohio Only)

State-specific (Ohio) medical policy governing coverage and medical necessity determinations for annular closure devices, thermal intradiscal procedures, and percutaneous injection of allogeneic cellular/tissue-based products for lumbar disc disease; applies to providers and members in Ohio.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDiscogenic Pain Treatment (for Ohio Only)

Policy CodePolicy CS031OH.D

Change TypeCodes updatedclinical evidence revised

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and document prior conservative care and imaging when requesting ACD implantation or novel intradiscal procedures.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 63032 to the applicable codes list.

Updated clinical evidence and references sections to reflect the most current information.

Archived previous policy version CS031OH.C.

3unproven procedures

Ohiojurisdiction

≥6 mmannular defect size cited

5% vs 13%ACD reherniation reduction

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Coverage and Medical Necessity Determinations

inv-01: Not medically necessary — unproven interventions

Procedures considered unproven / not medically necessary

Unproven procedures list: Annular closure devices (ACDs); percutaneous injection of allogeneic cellular/tissue-based products; thermal intradiscal procedures (TIPs) for treating discogenic pain are unproven and not medically necessary due to insufficient evidence of efficacy.

Refer to the Minimally Invasive Spine Surgery Procedures policy for percutaneous discectomy.

inv-02: Annular Closure Device — Covered with criteria

ACD implantation demonstrated benefit in randomized trials for select patients and is supported when ALL of the following are met:

ACD selection criteria: 1) Large post-discectomy annular defect (typically 6–10 mm width); 2) Adequate disc height preserved; 3) Acceptable bone quality (non-osteoporotic lumbar BMD); 4) Patient is an appropriate surgical candidate with documentation of shared decision-making regarding reoperation risk and alternatives; 5) Procedure performed at a single lumbar level L4–S1 in skeletally mature patients when device-specific indications are met (e.g., Barricaid PMA criteria).annular defect dimensions specified

Based on Thomé RCT and device PMA; limitations include low-to-moderate quality evidence, potential bias, and need for further RCTs.

inv-03: Allogeneic intradiscal injections — Not covered / experimental

Percutaneous intradiscal injection of allogeneic cellular/tissue-based products is considered experimental / insufficient when any of the following apply:

Allogeneic intradiscal injections — evidence summary: 1) Randomized trials and evidence reviews have not consistently demonstrated superiority versus placebo or nonsurgical management; 2) Available RCT(s) are limited by small sample size, loss to follow-up, crossover, heterogeneous treated levels, and short-term follow-up; 3) Single-arm and feasibility studies report improvements but lack adequate controls to establish efficacy; 4) Major technology assessments (Hayes, ECRI) conclude evidence is insufficient to determine clinical benefit.

Additional robust, independent RCTs with longer follow-up are required.

inv-04: Thermal intradiscal procedures — Mixed/inconclusive coverage stance

Thermal intradiscal procedures have mixed evidence; coverage depends on the specific procedure and strength of evidence:

IDB/IDET evidence: 1) Some systematic reviews and RCTs suggest benefit for biacuplasty (IDB) and mixed/moderate evidence for IDET; 2) Many supportive studies are small, single-center, nonrandomized, or have short follow-up; 3) Other intradiscal thermal therapies (PIRFT, discTRODE) have RCTs that did not demonstrate benefit versus sham; 4) Overall, evidence quality is inconsistent and larger, well-designed RCTs are needed to establish efficacy and long-term outcomes.

Consider use only in contexts supported by high-quality evidence or clinical trials.

inv-05: Evidence-based coverage considerations

Evidence-informed considerations and device-specific indications reflected in referenced guidelines and FDA approval:

PIRFT/electrothermal intradiscal therapies: Randomized sham-controlled trials do not consistently demonstrate benefit (e.g., Kvarstein RCT for PIRFT showed no difference at 6 months) and major guideline assessments (NICE, NASS) describe limited or insufficient evidence; consider these procedures primarily in research settings or when high-quality supportive evidence exists.

NICE: efficacy limited/poor quality; NASS: insufficient evidence.

Bipolar RFTC / small case series: Small case series and pilot studies (e.g., Zhang, L'DISQ, bipolar RFTC) report improvements in pain and function but are limited by lack of controls and small sample sizes; interpret these results cautiously and do not generalize to routine practice without stronger evidence.

Supports potential but not definitive efficacy.

Annular closure device (Barricaid): FDA PMA indicates use to reduce reherniation and reoperation after primary discectomy in skeletally mature patients with a large annular defect (between 4–6 mm tall and between 6–10 mm wide) at a single level L4–S1; professional society review (ISASS) supports use in high-risk patients with large defects based on reduced recurrent LDH and reoperation in pooled analyses.

Refer to the policy titled Minimally Invasive Spine Surgery Procedures (for Ohio Only) for coverage and medical necessity determinations specific to percutaneous discectomy for axial or radicular pain. This policy excerpt excludes percutaneous discectomy discussions and instead focuses on annular closure devices, intradiscal biologic injections, and thermal intradiscal procedures; percutaneous discectomy decisions should be handled under the separate referenced policy.

The policy finds insufficient high-quality evidence to support routine use of both percutaneous intradiscal injection of allogeneic cellular/tissue-based products and thermal intradiscal procedures (TIPs) to treat discogenic pain. Available studies are limited by small sample sizes, heterogeneous populations, short follow-up, and methodological weaknesses; further robust randomized controlled trials with larger samples and longer-term outcomes are required to demonstrate safety and efficacy.

Authors of randomized trials of thermal intra‑annular therapies (for example, the discTRODE PIRFT RCT) reported no consistent benefit compared with sham and cautioned against routine use. Trial authors specifically stated they would not recommend intra‑annular thermal therapy with the discTRODE probe based on their findings, and guidance bodies note the evidence for efficacy is inconsistent and of limited quality.

The policy scope includes device and biologic intradiscal interventions. Annular closure devices (ACDs) are addressed with conditional coverage criteria when trial enrollment characteristics and surgical findings match study inclusion (e.g., large post‑discectomy annular defect and preserved disc height). In contrast, percutaneous intradiscal allogeneic cellular/tissue‑based product injections are considered experimental/insufficient, and the policy does not support their routine use outside clinical trials based on current evidence.

Procedures for which randomized controlled trials have not demonstrated clear safety and efficacy — and which the policy designates as unproven — include annular closure devices in contexts without trial‑based selection criteria, percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) as evaluated with discTRODE where RCTs showed no benefit, and other thermal intradiscal techniques lacking high‑quality supporting data. These procedures are at risk for denial when presented as proven therapies.

The policy concludes there is insufficient evidence to support routine use of PIRFT and similar intradiscal thermal therapies for discogenic low back pain. Randomized sham‑controlled data do not consistently show benefit, and guideline panels (e.g., NASS) state evidence is insufficient to recommend for or against PIRFT; therefore these therapies are considered investigational or not medically necessary for routine care.

Coding and Procedure Codes

Codes referencedmixed

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.
63032	Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc; with repair of annular defect by implantation of bone-anchored annular closure device, including all imaging guidance, 1 interspace, lumbar (List separately in addition to code for primary procedure).
S2348	Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar.

No explicit CPT/HCPCS/ICD codes provided in this sectionmixed

No codes listed

Applicable CPT codes (changes noted)CPT

63032

Added CPT code 63032 (Laminotomy with repair of annular defect by implantation of bone-anchored annular closure device) per Policy History; description appears in policy code list.

FDA device identifiermixed

K201676

FDA PMA identifier for the Barricaid Annular Closure Device (see FDA PMA K201676 indicating indication for use and annular defect dimensions).

Annular defect size

Typical annular defect size targeted in ACD studiesTypically ≥ 6 mm (sizable defects targeted in ACD studies)

Context in trialsThomé RCT enrolled patients with large post-discectomy annular defects (6–10 mm width)

Role in documentationAnnular defect measurement may be required in operative notes and imaging when evaluating ACD requests

Annular defect width

Annular defect width range cited in trials6–10 mm width (Thomé RCT)

Device-specific width guidance

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for device-based or novel intradiscal procedures prior to scheduling. This includes annular closure devices (ACDs), percutaneous injection of allogeneic cellular/tissue‑based products, thermal intradiscal procedures (TIPs), intradiscal electrothermal therapy (IDET), intradiscal biacuplasty (IDB), percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), and other device-specific or novel intradiscal interventions.

Applicable CPT/HCPCS/Device codes should be submitted with the prior authorization request.
If a code is not listed, submit full procedure description, device model, and operative report for review.

Documentation Required

Supporting Clinical Data to Include

Provide supporting clinical data with the request to demonstrate medical necessity and patient selection consistent with available evidence. Include: relevant imaging (MRI) confirming disc pathology, provocation discography results if used, baseline pain and function scores (e.g., NRS, ODI), prior conservative treatment documentation, and any relevant diagnostic testing or specialist evaluations.

Conservative Care Pre-requisites

inv-40: Failure of conservative management

Failure of conservative management

Conservative care duration: Patients considered for intradiscal procedures or adjunctive annular closure devices should have persistent symptoms despite an adequate trial of conservative therapy (commonly >6 weeks in many studies); longer durations (e.g., ≥3 months) may be expected depending on study inclusion criteria and guideline recommendations.>6 weeks

Document prior conservative therapies and indications/contraindications to nonoperative care.

inv-41: Documentation of failed conservative therapy prior to intradiscal interventions

Documentation of failed conservative therapy prior to intradiscal interventions

Documentation requirements: Documented failure of conservative management is required and commonly includes evidence of: at least 3 months of conventional medical management (physical therapy, medications, activity modification) and prior interventional treatments where appropriate; persistent pain with functional limitation despite these measures; and reasons for proceeding to invasive intradiscal therapy.

Procedure Frequency and Use Limits

No explicit frequency limits specified in this section

Frequency limits statementNo explicit frequency limits specified in this section

Implication for ACDACD use described as a single-procedure adjunct to primary discectomy (device intended at time of index surgery)

Prior authorization implicationPA may be required per plan for listed procedure codes despite no numeric frequency limits

Use of FDA-approved annular closure device is single-procedure adjunct to primary discectomy at time of surgery

Single-procedure adjunct noteUse of an FDA‑approved annular closure device is described as a single‑procedure adjunct to primary discectomy at the time of surgery (Barricaid PMA)

Level and patient population

Imaging and Diagnostic Documentation

Billing Rule

Imaging guidance (fluoroscopy or CT) required for percutaneous intradiscal procedures

TIPs and percutaneous intradiscal injections referenced in this policy are described in the coding text as performed under fluoroscopic or CT guidance; ensure imaging guidance modality is documented.

Policy coding and procedure descriptions reference fluoroscopy or CT guidance for these procedures

Documentation Required

Document provocation discography / MRI findings for IDET/IDB

Selection and reporting in IDET/IDB and other intradiscal procedures commonly used provocative discography findings (high‑grade Modified Dallas/DDS) and MRI features such as a high‑intensity zone (HIZ); include these imaging/diagnostic findings in documentation.

Provocation discography (DDS) and HIZ on MRI were predictive factors in several studies

Background and Rationale

Annulus fibrosus repair devices are designed to close or reinforce annular defects created or exposed during lumbar discectomy with the goal of reducing recurrent disc herniation and subsequent reoperation. Selected randomized trials and device approvals have evaluated bone‑anchored implants placed at the time of primary discectomy for patients with a sizable post‑discectomy annular defect; these devices function as an adjunct to the index decompression procedure rather than as standalone disc therapy.

Key Definitions

Annulus fibrosus definition

DefinitionAnnulus fibrosus: ring of fibrocartilage and fibrous tissue around the intervertebral disc surrounding the nucleus pulposus

Clinical relevanceSurgical discectomy creates an annular defect that may be targeted by repair devices to close or reinforce the annulus

Device targetAnnulus fibrosus repair devices aim to form a barrier between the annulus and nucleus to reduce reherniation risk

Thermal Intradiscal Procedures (TIPs) / IDET / IDB / PIRFT

General descriptionThermal Intradiscal Procedures (TIPs) involve percutaneous insertion of a catheter or probe into the disc under fluoroscopic guidance to apply heat or radiofrequency energy to the disc aiming to denature collagen, shrink tissue, or ablate nociceptors

Common types

Services Not Covered

The following procedures are designated not covered / unproven in this policy excerpt due to insufficient evidence: annular closure devices when used outside established trial selection criteria; percutaneous intradiscal injection of allogeneic cellular/tissue‑based products; and thermal intradiscal procedures including IDET, IDB, PIRFT, and related intradiscal thermal therapies. Specifically, PIRFT/discTRODE and other intradiscal thermal approaches lacking randomized evidence of benefit versus sham are considered unproven for routine treatment of discogenic low back pain.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyDiscogenic Pain Treatment (for Ohio Only)

Policy CodePolicy CS031OH.D

Change TypeCodes updatedclinical evidence revised

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and document prior conservative care and imaging when requesting ACD implantation or novel intradiscal procedures.

SourceLink

On This Page

annular defect dimensions specified

Document imaging demonstrating annular defect dimensions, level, and confirmation of primary discectomy per device labeling.

Barricaid PMA specifies 6–10 mm wide defects for device indication

Selection implicationWidth measurement used to identify patients at higher risk of recurrent herniation and candidates for ACD

Annular defect size for Barricaid

Barricaid PMA annular defect dimensionsBetween 4–6 mm tall and between 6–10 mm wide (FDA PMA for Barricaid)

PMA treatment contextIndicated following a primary discectomy at a single level between L4 and S1 in skeletally mature patients

Documentation noteMRI demonstrating neural compression and imaging showing defect dimensions are part of the PMA indication

Imaging: MRI reports/images demonstrating the target level and annular defect size when applicable (e.g., for ACDs).
Clinical measures: baseline NRS, ODI, and duration of symptoms.
Diagnostic procedures: results of provocation discography or other diagnostic tests if relied upon for patient selection.
Operative plan: device model, implantation technique, and manufacturer instructions for use when device implantation is proposed.

Documentation Required

ACD Patient Selection and Informed Consent

For annular closure devices (ACDs), ensure patient selection and informed decision‑making align with trial and regulatory criteria. Document that patients had symptomatic lumbar disc herniation with a large annular defect (typically ≥6 mm width), have failed an adequate course of conservative therapy or have contraindications to conservative care, and meet device-specific labeling (e.g., FDA indications for Barricaid where applicable). Discuss risks, benefits, alternatives (including continued conservative management and reoperation risk), and obtain informed consent.

Document annular defect measurements (width/height) from intraoperative assessment or preoperative imaging.
Record duration and specifics of prior conservative care (see conservative therapy callout).
Include evidence of shared decision-making and signed informed consent referencing device-specific risks (e.g., mesh migration, vertebral endplate changes).

Documentation Required

Device‑Specific Documentation Required

When devices are involved, submit device‑specific documentation with the authorization and claim. This should include device name and model, FDA approval/clearance status if available, manufacturer's instructions for use, and the implant log/catalog number. For investigational or novel devices lacking regulatory clearance, indicate investigational status and provide supporting clinical evidence and study protocols if used within a trial.

Device name, model, and manufacturer.
FDA approval/clearance citation or PMA/510(k) number when applicable (e.g., Barricaid PMA K201676).
Implant lot/serial numbers and operative device log at time of service.
If investigational, include IRB approval, informed consent form, and study protocol.

Documentation Required

Conservative Therapy Documented

Document prior conservative therapy attempts and objective evidence that conservative care was inadequate before performing intradiscal interventions. Conservative measures should be consistent with studies and guideline-recommended management and must be tailored to the patient’s condition and documented in the medical record.

Conservative therapy examples: structured physical therapy, non‑opioid and opioid analgesics as appropriate, activity modification, targeted epidural or facet injections, cognitive behavioral therapy, and at least 6–12 weeks duration unless contraindicated.
Document dates, duration, response to each therapy, and reasons for discontinuation or contraindication.
For ACD candidates, note whether conservative care was attempted or why surgery was indicated without extended conservative management (e.g., neurological deficits).

>= 3 months when specified in studies

Provide medical records summarizing therapies tried, duration, response, and rationale for proceeding to procedural intervention.

PMA indicates use after primary discectomy at a single level between L4 and S1 in skeletally mature patients with specified annular defect dimensions

Timing implicationDevice is intended for implantation at the index discectomy procedure rather than as a separate subsequent procedure

Documentation Required

MRI required to document annular defect and neural compression for Barricaid

For Barricaid annular closure device placement after primary discectomy, MRI confirmation of neural compression and imaging demonstrating the large annular defect dimensions required by the PMA (4–6 mm tall and 6–10 mm wide) should be provided.

Barricaid PMA indication requires MRI demonstrating neural compression and annular defect between 4–6 mm tall and 6–10 mm wide at a single level L4–S1

Includes Intradiscal Electrothermal Therapy (IDET), Intradiscal Biacuplasty (IDB), and Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)

Intended effectIntended to reduce discogenic low back pain by sealing tears, altering disc biomechanics, or destroying pain-generating nerve fibers

Allogeneic cellular/tissue-based product definition

DefinitionAllogeneic cellular/tissue-based product: cell therapies injected percutaneously into intervertebral discs to stimulate tissue repair

Delivery routePrepared donor-derived cellular or tissue material is delivered via percutaneous intradiscal injection

Evidence contextExisting RCTs and reviews have not consistently demonstrated superiority versus placebo or nonsurgical management

Annular Closure Device (ACD) definition

DefinitionAnnular Closure Device (ACD): a bone‑anchored implant placed after lumbar microdiscectomy intended to close large annular defects and reduce recurrent herniation and reoperation

Clinical trial contextACDs have been evaluated in RCTs (e.g., Thomé et al.) showing reduced reherniation and reoperation in select patients with large defects

Selection factorsUsed in patients with large post‑discectomy annular defects, preserved disc height, and acceptable bone quality per trial criteria

Allogeneic nucleus pulposus (NP) injection definition

DefinitionAllogeneic nucleus pulposus (NP) injection: percutaneous intradiscal injection of donor‑derived nucleus pulposus material intended to treat degenerative disc disease symptoms

ExamplesProducts such as ViaDisc NP (Vivex) have been evaluated in RCTs and feasibility studies

Evidence summaryAvailable RCT(s) and reviews have not consistently demonstrated superiority versus placebo or nonsurgical management; evidence judged insufficient

Intradiscal Biacuplasty (IDB) / IDET definition

DefinitionIntradiscal Biacuplasty (IDB) / Intradiscal Electrothermal Therapy (IDET): thermal intradiscal procedures applying radiofrequency or heat to annular tissue to reduce discogenic pain

Procedure characteristicsMinimally invasive outpatient procedures using catheter or electrodes placed into the disc under imaging guidance to heat annular tissue

Evidence noteSystematic reviews identify some RCT evidence supporting biacuplasty (Level I by one review) and mixed evidence for IDET; many studies are small or have methodological limitations

Barricaid definition

DefinitionBarricaid: an FDA‑approved annular closure device indicated to reduce reherniation and reoperation in skeletally mature patients with a large annular defect following primary discectomy

PMA specificsPMA indicates use for defects between 4–6 mm tall and 6–10 mm wide at a single level L4–S1 (FDA PMA dated Feb 8, 2019)

Clinical positioningISASS and RCT evidence support use in selected high‑risk patients with large annular defects to reduce recurrent LDH

PIRFT definition

DefinitionPercutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT): a minimally invasive intradiscal procedure using a radiofrequency probe placed into the center of the disc to apply heat (typically ~70°C) to alter disc biomechanics or destroy nociceptive fibers

Procedure parametersDevice activation example: 90 seconds at 70° Celsius (described for PIRFT)

Evidence cautionRandomized sham‑controlled trials (e.g., Kvarstein RCT) did not demonstrate consistent benefit; some authors do not recommend intra‑annular discTRODE use