Discogenic Pain Treatment (for North Carolina Only)

Coverage Summary

Scope: This policy (Policy Number CSNCT0105.04, effective 2026-02-01) addresses coverage determinations for procedures to treat discogenic low back pain in the state of North Carolina. Subject matter includes annular closure devices (ACDs), percutaneous injection of allogeneic cellular/tissue-based products, and thermal intradiscal procedures (TIPs).

Applicability and status: This Medical Policy applies only to North Carolina and is CURRENT. It is designated as covered with criteria overall but identifies specific procedures considered unproven and not medically necessary. State-specific billing implications are noted (certain CPT/HCPCS codes may not be on the North Carolina Medicaid Fee Schedule and therefore may not be covered).

Policy summary: The policy states that annular closure (Barricaid) has an FDA PMA indication for skeletally mature patients with radiculopathy due to posterior/posterolateral herniation and a large annular defect (between 4–6 mm tall and 6–10 mm wide) after primary discectomy at L4–S1, while other annular closure devices and the broader categories of percutaneous allogeneic injections and TIPs are considered insufficient/ unproven or not medically necessary due to low or inconsistent quality of evidence.

Quick facts and thresholds

Annular defect width threshold>= 6 mm wide

Barricaid PMA annular defect dimensions4-6 mm tall and 6-10 mm wide

Number of procedures listed as not medically necessary3

Policy geographic applicabilityApplies to North Carolina only

Codes not on NC Medicaid Fee Schedule (billing note)CPT/HCPCS codes 0627T, 0628T, 0629T, 0630T, 22526, 22527, 22899, and S2348 may not be covered by NC Medicaid

Medical-Necessity Criteria

Not Medically Necessary / Unproven Procedures

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

Annular closure devices (ACDs)
Percutaneous injection of allogeneic cellular/tissue based products
Thermal intradiscal procedures (TIPs) for treating discogenic pain

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Evidence-based conclusions and recommendations (narrative)

Summarized positions from RCTs, systematic reviews, and professional societies:

Coding

Reference CPT / HCPCS codes for percutaneous injection of allogeneic cellular/tissue-based product (not necessarily covered)CPT

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).

Reference CPT / HCPCS codes for thermal intradiscal procedures and related unlisted spine proceduresCPT

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) ...; 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 list; annual edits)CPT

63032	Added to applicable CPT codes per policy history (02/01/2026)
0627T	Percutaneous injection of allogeneic cellular and/or tissue-based product... (not on State of North Carolina Medicaid Fee Schedule)
0628T	Percutaneous injection of allogeneic cellular and/or tissue-based product... (not on State of North Carolina Medicaid Fee Schedule)
0629T	Percutaneous injection of allogeneic cellular and/or tissue-based product... (not on State of North Carolina Medicaid Fee Schedule)
0630T	Percutaneous injection of allogeneic cellular and/or tissue-based product... (not on State of North Carolina Medicaid Fee Schedule)
22526	Percutaneous intradiscal electrothermal annuloplasty... (not on State of North Carolina Medicaid Fee Schedule)
22527	Percutaneous intradiscal electrothermal annuloplasty... (not on State of North Carolina Medicaid Fee Schedule)
22899	Unlisted procedure, spine (listed; state-specific fee schedule caution)
S2348	Decompression procedure, percutaneous, of nucleus pulposus... (not on State of North Carolina Medicaid Fee Schedule)

FDA product codes referenced for annular closure/mesh/suture devicesmixed

FTL	surgical mesh, polymeric (product code)
FTM	mesh, surgical (product code)
GAT	suture, nonabsorbable, synthetic, polyethylene (product code)
GEI/GXI/HRX/BSO/BSP	electrosurgical cutting and coagulation devices and accessories (product codes)

Provider Actions & Billing Notes

Documentation Required

State-specific applicability

This Medical Policy applies only to the state of North Carolina; providers must follow North Carolina-specific coverage determinations and the state Medicaid fee schedule when determining coverage and billing.

Billing Rule

Codes not on NC Medicaid Fee Schedule

Codes indicated with an asterisk in the policy are not on the North Carolina Medicaid Fee Schedule and therefore may not be covered by NC Medicaid. Verify reimbursement eligibility with the State of North Carolina Medicaid Program prior to billing.

0627T
0628T
0629T
0630T

Background and Evidence Summary

Background: This policy reviews systematic reviews, randomized controlled trials, prospective and retrospective observational studies, and technology assessments relevant to annular closure devices (ACDs), percutaneous allogeneic disc injections, and thermal intradiscal procedures (TIPs).

Overall evidence quality: Across device and biologic categories the evidence is described as low or insufficient quality, with limitations including small sample sizes, nonrandomized designs or lack of masking, heterogeneous study methods, potential conflicts of interest, and inadequate long-term follow-up. Technology assessments and systematic reviews call for larger randomized trials and longer follow-up to confirm efficacy and safety.

Source	Summary
Hayes / ECRI assessments	Hayes: overall low-quality/insufficient evidence for ACDs; Evolving Evidence Review for Via Disc NP found one fair RCT without clear benefit. ECRI: somewhat favorable for Barricaid but noted bias risk and limited generalizability; additional RCTs needed.
Key RCTs / trials	Thomé et al. RCT and Kienzler multicenter RCT (NCT01283438) reported reduced reherniation with Barricaid but noted limitations (industry sponsorship, lack of masking, VEPC, implantation risks); Beall et al. VAST RCT for ViaDisc showed no clear advantage over placebo at 12 months.
Bipolar RFTC outcomes	Small case series (Zhang et al. 2016) reported significant decreases in VAS and ODI at all follow-up points (p < 0.05) and no serious complications; limited by small sample and lack of control.
PIRFT RCT (Kvarstein et al. 2009)	Randomized double-blind placebo RCT (n=20) found no trend toward benefit at 6 months; at 12 months overall pain reduction vs baseline but no difference between active and sham; authors did not recommend discTRODE intraannular thermal therapy.
Barricaid PMA	FDA PMA (Feb 8, 2019): Barricaid indicated to reduce reherniation and reoperation in skeletally mature patients with radiculopathy and a large annular defect (4–6 mm tall and 6–10 mm wide) after primary discectomy at a single level L4–S1.
ISASS 2025 conclusion	ISASS (2025) concluded bone-anchored annular closure reduces symptomatic recurrent LDH and revision surgery in patients with large annular defects (≥ 6 mm wide) and found a positive benefit–risk ratio for that at-risk population.

Definitions: Thermal Intradiscal Procedures (TIPs): procedures that insert a catheter or probe into the intervertebral disc to apply heat (examples: IDET, IDB/biacuplasty, PIRFT) to treat discogenic low back pain.

Annular Closure Device (ACD): a device intended to close or reinforce an annulus fibrosus defect after discectomy to prevent recurrent herniation.

Allogeneic cellular/tissue-based products: cell therapies derived from donors injected percutaneously into intervertebral discs to stimulate repair (examples: ViaDisc NP / viable disc allograft).

PIRFT: Percutaneous Intradiscal Radiofrequency Thermocoagulation (also called intradiscal electrothermal annuloplasty or discTRODE probe therapy).

RFTC: Radiofrequency Thermocoagulation (used in bipolar RFTC procedures).

VAS: Visual Analog Scale (measure of pain intensity).

ODI: Oswestry Disability Index (measure of functional disability).

Evidence-based Conclusions

Evidence takeaways: Annular closure (Barricaid) — The Barricaid device received FDA premarket approval (Feb 8, 2019) for reducing reherniation and reoperation in skeletally mature patients with radiculopathy and a large annular defect (between 4–6 mm tall and 6–10 mm wide) after primary discectomy at a single level between L4 and S1, and multiple RCTs and meta-analyses report reduced symptomatic recurrent herniation and reoperation in selected patients with large annular defects. ISASS (2025) concluded bone-anchored annular closure reduces risk for recurrent LDH and reoperation in patients with large annular defects (≥ 6 mm wide).

Broader ACD evidence: Technology assessments (ECRI, Hayes) and meta-analyses find somewhat favorable results for Barricaid but overall quality of evidence for ACDs is low or insufficient due to methodological limitations, heterogeneity, potential bias, and limited generalizability; additional large RCTs and long-term data are needed.

Percutaneous allogeneic injections: RCTs and assessments (Beall/VAST, Hayes, ECRI) have not demonstrated clear, consistent superiority over placebo or nonsurgical management at 12 months; evidence is insufficient and further independent RCTs with longer follow-up are required.

Thermal intradiscal procedures and other minimally invasive thermal techniques: Evidence is mixed — PIRFT RCT (Kvarstein et al. 2009) found no difference versus sham at 6 months and no group difference at 12 months and authors did not recommend the device; bipolar RFTC and L'DISQ have small case series or pilot studies reporting improvements in VAS and ODI but are limited by small size and lack of controls. Overall, TIPs lack sufficient high-quality evidence to support routine use.

Definitions

Thermal Intradiscal Procedures (TIPs): Procedures inserting a catheter or probe into the disc to apply heat (examples: IDET, IDB/biacuplasty, PIRFT) to relieve low back pain.

Annular Closure Device (ACD): Device intended to close or reinforce annulus fibrosus defects after discectomy to prevent recurrent herniation.

Allogeneic cellular/tissue-based products: Cell therapies derived from donors injected percutaneously into intervertebral discs to stimulate repair (e.g., Via Disc NP / viable disc allograft).

PIRFT: Percutaneous Intradiscal Radiofrequency Thermocoagulation — a radiofrequency probe placed into the center of the disc and activated (for example, 90 seconds at 70°C) to alter disc biomechanics or destroy nociceptive fibers.

RFTC: Radiofrequency Thermocoagulation — radiofrequency-based thermal lesioning techniques including bipolar RFTC.

VAS: Visual Analog Scale for pain measurement.

ODI: Oswestry Disability Index for functional assessment.

PMA: Premarket Approval (FDA) — regulatory approval pathway (Barricaid has an FDA PMA with specific size and indication criteria).

Revision History

02/01/2026revisedLatest

Updated list of applicable CPT codes to reflect annual edits; added CPT code 63032 to the policy's applicable codes.

02/01/2026clarifiedLatest

Noted that CPT/HCPCS codes 0627T, 0628T, 0629T, 0630T, 22526, 22527, 22899, and S2348 are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the North Carolina Medicaid Program (state-specific coverage limitation and billing implication).

02/01/2026revised