RetiredUnitedHealthcarePolicy CS031LA.P

Discogenic Pain Treatment (Louisiana) — Coverage Criteria (Retired)

Policy governs coverage determinations for procedures to treat discogenic lumbar spine pain for members in Louisiana, specifying treatments considered unproven and not medically necessary and listing associated procedure codes for reference.

Policy Summary

PayerUnitedHealthcare

PolicyDiscogenic Pain Treatment (Louisiana) — Coverage Criteria (Retired)

Policy CodePolicy CS031LA.P

Change TypeRetirement / Plan disenrollment

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization and detailed documentation (large annular defect size, prior conservative care, imaging) when requesting ACD or intradiscal biologic procedures.

SourceLink

POLICY UPDATE CHANGES

Retired policy; Louisiana plan membership disenrolled on April 1, 2026.

3procedures unproven / NMN

LA-onlystate application

CS031LA.Ppolicy id

K201676Barricaid PMA

Coverage determinations and investigational interventions

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inv-01: Not Medically Necessary / Unproven Interventions

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

Not medically necessary procedures: Annular closure devices (ACDs)

Listed as unproven/not medically necessary in this policy.

Not medically necessary procedures: Percutaneous injection of allogeneic cellular/tissue-based products

Listed as unproven/not medically necessary in this policy.

Not medically necessary procedures: Thermal intradiscal procedures (TIPs) for treating discogenic pain (including IDET, IDB, PIRFT)

Listed as unproven/not medically necessary in this policy.

inv-02: Procedures with insufficient evidence

Not established as effective based on current evidence

Insufficient evidence for clinical benefit: Percutaneous injection of allogeneic cellular/tissue-based products for discogenic pain and thermal intradiscal procedures have insufficient high-quality evidence (randomized controlled trials and long-term outcomes) to support routine use.evidence

Further robust RCTs with larger sample sizes and long-term outcomes required.

inv-03: Annular Closure Devices (ACD)

Evidence summary indicating possible reduction in reherniation in select patients

ACD RCT findings: Industry-sponsored randomized trial reported lower recurrent herniation and fewer reoperations when a bone-anchored annular closure device was implanted at time of lumbar microdiscectomy in patients with large annular defects; clinical pain and disability scores were comparable between groups over follow-up. Findings limited by lack of masking and potential conflicts of interest.study results

Vertebral endplate changes were more frequent with ACD; additional independent RCTs needed.

inv-04: IDB/IDET Evidence

Mixed quality evidence with some RCTs showing benefit for IDB

IDB/IDET evidence: Systematic review identified Level I (strong) evidence for biacuplasty based on two RCTs and Level III (moderate) evidence for IDET from available trials; existing studies are limited by small sample sizes, heterogeneity, and in some cases lack of sham control or long-term follow-up.evidence level

Larger randomized sham-controlled trials with longer follow-up are recommended.

inv-05: PIRFT and intradiscal thermal therapies

Evidence-based stance summary for intradiscal thermal procedures

PIRFT coverage rationale: Randomized and controlled evidence for PIRFT and related intradiscal thermal therapies is limited and inconsistent; a double-blind RCT of PIRFT found no difference versus sham at six months and no significant functional benefit at 12 months. Small case series report mixed results but are limited by design and size.

Guideline reviews (NICE, NASS, ASIPP) characterize the evidence as limited or insufficient; further high-quality studies needed.

inv-06: Annular closure device (Barricaid) — covered with device-specific indications

Coverage considerations for bone-anchored annular closure devices (Barricaid)

Barricaid device indication: The Barricaid annular closure device (FDA PMA K201676) is indicated to reduce reherniation and reoperation in skeletally mature patients with radiculopathy after primary discectomy at a single level L4–S1 when imaging demonstrates a large annular defect (4–6 mm tall and 6–10 mm wide).annular defect size as specified

Randomized and pooled evidence indicate reduced recurrent LDH and reoperation in high-risk patients; device use should follow device-specific labeling and required documentation.

This policy identifies several interventions for discogenic lumbar pain as not medically necessary because available evidence does not demonstrate sufficient benefit. Specifically, the policy lists annular closure devices (ACDs), percutaneous injection of allogeneic cellular/tissue-based products, and thermal intradiscal procedures (TIPs) as unproven and not medically necessary for treating discogenic pain.

Thermal intradiscal procedures (TIPs), including modalities such as IDET and IDB as umbrella TIPs, are considered to have insufficient quality evidence to support routine use for discogenic pain. The policy notes the need for randomized controlled studies, larger sample sizes, and longer-term outcome data before these procedures can be considered established therapies.

Similarly, percutaneous injection of allogeneic cellular/tissue-based products for intradiscal therapy is identified as lacking sufficient high-quality evidence; robust RCTs and longer follow-up are required to establish safety and efficacy.

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) specifically lacks convincing evidence of efficacy. A double-blind randomized trial (discTRODE) found no difference between active PIRFT and sham at six months and no clear advantage at 12 months, and guideline reviews (NICE, NASS) summarize the evidence as limited or inconsistent. On this basis PIRFT is considered to lack sufficient evidence to support routine clinical use.

For clarity, the policy reiterates the interventions that are excluded or treated as investigational: annular closure devices (ACDs), percutaneous injection of allogeneic cellular/tissue-based products, and thermal intradiscal procedures (TIPs) for treatment of discogenic low back pain.

The policy calls out percutaneous allogeneic intradiscal injections and thermal procedures together as areas where evidence is insufficient. Allogeneic intradiscal injections need larger, controlled trials with long-term follow-up to establish benefit and safety. Thermal procedures such as PIRFT have randomized data that do not demonstrate clear clinical benefit and therefore remain unsupported for routine use.

The randomized, double-blind placebo-controlled trial of PIRFT (discTRODE) enrolled 20 patients and was stopped after interim analysis because there was no signal of benefit at six months; after 12 months both groups showed reductions in pain but no significant difference between active and sham arms. This trial is cited as primary randomized evidence that does not support routine PIRFT use.

Procedure and product codes (reference only)

Allogeneic intradiscal injection codesCPT

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.

TIPs / ACD / related spine procedure codesmixed

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.

Applicable CPT Codes (updated)CPT

63032

Added to list of applicable CPT codes (notation: not on LA Medicaid Fee Schedule)

FDA device PMAmixed

K201676

FDA PMA for Barricaid Annular Closure Device

FDA product codes mentionedmixed

FTL	Surgical mesh, polymeric (product code referenced for annulus closure device).
FTM	Mesh, surgical (product code referenced).
GAT	Suture, nonabsorbable, synthetic, polyethylene (product code referenced).

Annular defect size — typical sizing (e.g., 8 mm)

Typical annular defect sizing used in studiesStudies and technology assessments recruited patients with sizable annular defects typically ≥ 6 mm

Device-labeled width for trial enrollmentPrimary ACD trials included patients with large annular defects 6–10 mm width

Clinical context for selectionMost ACD studies enrolled patients with symptomatic radiculopathy after failed conservative care (>6 weeks)

Prior authorization, documentation, and billing notes for providers

Prior Authorization

Prior Authorization Expected

Prior authorization is likely required for implantation of annular closure devices (ACDs) and for percutaneous intradiscal injection of allogeneic cellular/tissue‑based products. Providers should verify payer-specific prior authorization requirements before scheduling these procedures.

Affected procedures: Barricaid annular closure device implantation; intradiscal allogeneic cellular/tissue‑based product injections (CPT codes 0627T–0630T)
Verify state Medicaid coverage rules — codes marked with an asterisk (*) may not be on the Louisiana Medicaid Fee Schedule

Billing Rule

Coding Reference and Documentation Note

Listing of a procedure code in this policy is for reference only and does not guarantee coverage or payment. Benefit coverage is determined by the member’s contract, federal/state law, and other applicable policies.

Inclusion of a CPT/HCPCS/ICD code does not imply medical necessity or reimbursement
Providers must submit documentation demonstrating benefit eligibility and medical necessity to support claims

Denial Risk

Insufficient Evidence May Trigger Denial

The evidence for percutaneous intradiscal injection of allogeneic cellular/tissue‑based products is insufficient to establish safety and effectiveness. When documentation does not demonstrate meeting coverage criteria or when evidence is lacking, services may be denied as not medically necessary.

Procedures at risk for denial: intradiscal allogeneic cellular/tissue‑based injections; other procedures identified in this policy as unproven
Document rationale for treatment and prior conservative management attempts to mitigate denial risk

Denial Risk

Evidence Does Not Support PIRFT

Randomized controlled trial evidence does not support the benefit of percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) over sham/placebo. A double‑blind RCT found no difference between PIRFT and sham at six months.

PIRFT is considered unproven for treatment of discogenic low back pain based on available RCT data
Conservative care should be optimized prior to consideration of intradiscal thermal procedures

Documentation Required

Documentation for Barricaid Use

For Barricaid (annular closure device) use, document imaging and intraoperative findings that meet device labeling: a large annular defect demonstrated on MRI and intraoperative measurement (typically 4–6 mm tall and 6–10 mm wide) following primary discectomy at a single level between L4 and S1. Include device model, lot numbers, and FDA premarket approval reference when applicable.

Imaging requirement: MRI showing neural compression and annular defect size within labeled range
Operative report must describe annular defect measurement and rationale for device implantation
Include device identifiers (model/lot) in documentation for implant tracking

Note

Conservative Care Prerequisite

Clinical trials and observational studies of annular closure devices generally enrolled patients after failure of conservative management and/or meeting specific surgical indications. Prior to considering ACD implantation, document that the patient underwent appropriate conservative care.

Conservative care may include: activity modification, physical therapy, medications, and image‑guided injections as appropriate
Document duration and modalities tried (e.g., ≥6 weeks of conservative care when applicable)

Note

Conservative Care Before PIRFT

Conservative management should be tried and documented before consideration of intradiscal thermal procedures (IDET/IDB/PIRFT) or intradiscal biologic injections. Studies reporting outcomes for these procedures typically required prior failure of noninvasive therapies.

Document specifics: therapies tried, duration, response, and reason for escalation to procedural therapy
Ensure noninvasive options were exhausted or deemed inappropriate prior to authorization requests

Key definitions and procedure descriptions

Annulus fibrosus — definition

TermAnnulus fibrosus

DefinitionA ring of fibrocartilage and fibrous tissue around the intervertebral disc that surrounds the nucleus pulposus

Clinical relevanceSurgical discectomy creates an annular defect that annulus repair devices aim to reinforce or bridge to prevent reherniation

Thermal intradiscal procedures (TIPs) — umbrella term

Umbrella termThermal intradiscal procedures (TIPs) include IDET, intradiscal biacuplasty (IDB), and percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)

MechanismInvolves insertion of a catheter or probe into the disc under imaging guidance to apply heat to denature nociceptors and alter disc tissue

Allogeneic cellular/tissue-based product injection — percutaneous donor-derived injections

TermPercutaneous injection of allogeneic cellular/tissue-based product

DefinitionInjection of donor-derived cell or tissue therapies through the skin into the intervertebral disc to stimulate tissue repair

CodingReported CPT codes for these injections include 0627T, 0628T, 0629T, 0630T (listed for reference only)

Annular Closure Device (ACD) — definition and intent

TermAnnular Closure Device (ACD)

DefinitionA bone-anchored implant placed after lumbar microdiscectomy intended to close/repair a large annular defect and reduce recurrent herniation and reoperation

Allogeneic nucleus pulposus injection — ViaDisc NP / VIADISC

TermAllogeneic nucleus pulposus injection (ViaDisc NP / VIADISC)

DefinitionPercutaneous intradiscal injection of viable allogeneic disc tissue intended to supplement nucleus pulposus to treat degenerative disc disease

Evidence noteAvailable RCT(s) (e.g., Beall et al.) did not demonstrate clear superiority over placebo for primary patient-oriented outcomes at 12 months

Intradiscal Biacuplasty (IDB) — cooled RF thermal procedure

TermIntradiscal Biacuplasty (IDB)

DefinitionA cooled radiofrequency thermal procedure applied intradiscally using bilateral electrodes and circulating water to create controlled lesioning between electrodes to destroy nociceptive fibers

Evidence summarySystematic reviews identified Level I evidence for biacuplasty based on two RCTs, though trials are limited in number and size

Large annular defect — device-labeled sizing for Barricaid

Device-specific contextThese measurements are the device-labeled sizing for the FDA-approved Barricaid annular closure device indication

Prerequisites and trial of conservative management

inv-39: Study enrollment context

Clinical studies generally enrolled patients who were nonresponsive to conservative treatment prior to trial enrollment:

Study enrollment context: Most studies of annular closure devices and intradiscal procedures enrolled patients who had failed more than six weeks of conservative care or had contraindications to conservative treatment (e.g., neurological deficits).typically >6 weeks

Study context — not an absolute coverage step requirement in this policy.

inv-40: Documented failure of conservative management prior to consideration of intradiscal procedures

Documented failure of conservative management is generally expected prior to considering intradiscal procedures:

Conservative management failure: Studies typically required documented failure of several months of conservative care (including physical therapy, medications, and interventional injections) prior to enrollment; many series specified at least three months of nonresponse before proceeding to intradiscal interventions.at least 3 months typically

Document prior conservative therapies in the medical record before considering intradiscal procedures or trial enrollment.

inv-41: Conservative therapy recommended prior to considering intradiscal thermal procedures.

Conservative therapy is recommended before considering intradiscal thermal procedures:

Conservative therapy recommended: Given limited and inconsistent evidence for PIRFT and other intradiscal thermal therapies, conservative management (physical therapy, optimized medical management, and selected interventional injections) and/or enrollment in clinical trials is prudent prior to invasive intradiscal thermal procedures.

Consider imaging and diagnostic confirmation (MRI, provocation discography) and document prior conservative care attempts.

Imaging and diagnostic procedures used in selection

Documentation Required

Use imaging guidance (fluoroscopy or CT) per procedure technique

Fluoroscopic or CT imaging guidance is required/used as described for percutaneous intradiscal procedures (IDET, IDB, PIRFT) and for percutaneous intradiscal injections to ensure accurate probe/catheter placement.

IDET/IDB procedures are performed under x-ray imaging (fluoroscopy).
PIRFT and percutaneous injections use fluoroscopy or CT guidance per procedure technique.

Documentation Required

MRI and/or provocation discography often used for patient selection

Patient selection in studies commonly included MRI and/or provocation discography (e.g., Modified Dallas scale) to confirm disc degeneration or painful disc and identify predictors of success used in trial enrollment.

Yoo et al. reported positive predictive value for high-grade Modified Dallas discogram scale.
Trials and cohorts often required imaging-confirmed disc degeneration and preserved disc height criteria.

Documentation Required

MRI confirmation required for ACD placement after primary discectomy

For annular closure device placement after primary discectomy, document MRI demonstrating neural compression and measurements confirming a large annular defect in the device-indicated range.

Barricaid indication requires confirmation of a large annular defect (4–6 mm tall and 6–10 mm wide) on imaging after primary discectomy at a single level L4–S1.

OpenPayer

Discogenic Pain Treatment (Louisiana) — Coverage Criteria (Retired)

Coverage determinations and investigational interventions

Procedure and product codes (reference only)

Prior authorization, documentation, and billing notes for providers

Clinical background and scope

Key definitions and procedure descriptions

Prerequisites and trial of conservative management

Limits and single-use device notes

Imaging and diagnostic procedures used in selection

Explicit non-covered items