Discogenic Pain Treatment

Coverage Summary

This policy (Policy Number: OUTPATIENT 037.25, Effective Date: February 1, 2025) addresses coverage and evidence for treatments of discogenic low back pain including annular closure devices (ACDs), thermal intradiscal procedures (TIPs) such as IDET, IDB, and PIRFT, and percutaneous injection of allogeneic cellular/tissue-based products. The policy takes a mixed coverage stance (procedures are listed as unproven/not medically necessary due to insufficient evidence) and notes that coverage and authorization for percutaneous discectomy are governed by a separate Clinical Policy titled "Minimally Invasive Spine Surgery Procedures."

Quick facts and key thresholds

Effective dateFebruary 1, 2025

Policy numberOUTPATIENT 037.25

Coverage stanceMixed — procedures including ACDs, TIPs, and percutaneous allogeneic injections are listed as unproven/not medically necessary (policy: mixed stance).

Annular defect threshold (height)4-6 mm tall

Annular defect threshold (width)6-10 mm wide

Procedures listed as unproven (count)3

Number of CPT/HCPCS codes listed6

FDA‑approved device discussed (Barricaid)Yes — Barricaid received FDA premarket approval (Feb 8, 2019) for specified indication

Medical Necessity / Device Indication Criteria

Not medically necessary / Unproven procedures

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

Percutaneous injection of allogeneic cellular/tissue-based products
Annular closure devices (ACDs)
Thermal intradiscal procedures (TIPs) for treating discogenic pain (includes IDET, IDB, PIRFT)

FDA Indication (device-specific)

Barricaid Anular Closure Device FDA premarket approval indication:

Coding

Procedure codes referenced (for reference only)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, 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.
22526	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level.
22527	Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; one or more additional levels.

Unlisted/billing instruction codes mentionedmixed

22899	Unlisted procedure, spine.
S2348	Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, radiofrequency energy, single or multiple levels, lumbar.

Referenced device/material codeHCPCS

GAT	suture, nonabsorbable, synthetic, polyethylene (reference/accessed Aug 29, 2024)

Provider Actions & Authorization

Documentation Required

Reference other policy for percutaneous discectomy

For percutaneous discectomy for axial or radicular pain, refer to the Clinical Policy titled "Minimally Invasive Spine Surgery Procedures" for coverage and authorization requirements.

Documentation Required

Benefit determination per member plan

The listing of procedure and diagnosis codes in this policy is provided for reference only. Benefit coverage and payment are determined by the member-specific benefit plan document and applicable laws; inclusion of a code does not imply coverage or guarantee payment.

Background & Evidence Summary

Background: The policy summarizes the clinical evidence base including randomized controlled trials, observational studies, systematic reviews and technology assessments (for example, Hayes and ECRI) and specialty society guidance. It notes that the Barricaid bone-anchored annular closure device received FDA premarket approval (February 8, 2019) for skeletally mature patients with radiculopathy and a large annular defect between 4-6 mm tall and between 6-10 mm wide after single-level L4–S1 discectomy. Key studies and assessments referenced include randomized trials and longer-term follow-up (Thome et al.; Kienzler et al.; Nadá/Parker cohort reports), meta-analyses and technology assessments (Wang 2023 meta-analysis; ECRI 2020; Hayes 2023), and trials of allograft intradiscal injection (VAST/Beall et al.). The policy summarizes that overall evidence quality is limited and further large RCTs with longer follow-up are needed to establish safety and efficacy for these interventions.

Source	Conclusion / Note
Hayes 2023
Concluded overall low quality evidence for ACD; need for larger RCTs and longer follow-up.
ECRI 2023
Evidence somewhat favorable for Barricaid based on SR/meta-analysis of 2 RCTs and 2 nonrandomized studies; additional U.S. RCTs useful.
Thome et al. RCT
Randomized trial showed ACD reduced recurrent herniation and reoperation vs microdiscectomy alone; limitations include lack of blinding and loss to follow-up.
VAST RCT (Beall et al. 2021)
Allograft vs saline/NSM: 76% responders in allograft vs 57% in saline at 12 months; limitations include small size and loss to follow-up.
Helm systematic review
Identified Level I evidence for biacuplasty and Level III for IDET; overall limited number of RCTs.
FDA approval date/indication
Feb 8, 2019 — Barricaid premarket approval indicated to reduce reherniation/reoperation in skeletally mature patients with radiculopathy and a large annular defect (4–6 mm tall and 6–10 mm wide) after primary L4–S1 discectomy.
Health technology assessments
Includes ECRI Institute (June 2020) and Hayes, Inc. (June 2023) assessments summarizing limited/low-quality evidence and recommending further RCTs.
Key RCT/clinical studies
Multiple randomized and cohort studies cited (Thome et al. 2018/2021; Kienzler et al. 2019; Beall et al.; Parker et al.) reporting reduced reherniation and reoperation but noting limitations such as loss to follow-up and potential biases.

Definitions (brief)

Annular Closure Device (ACD)Implantable device designed to reinforce or bridge the annulus fibrosus to close a defect after discectomy to reduce reherniation.

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

Percutaneous injection of allogeneic cellular/tissue-based products

Medicare Determinations

Date	Name	Type	Notes
2019-02-08
FDA premarket approval - Barricaid Anular Closure Device
informational
On February 8, 2019, Barricaid received FDA premarket approval for reducing reherniation and reoperation in skeletally mature patients with radiculopathy attributed to posterior or posterolateral herniation and a large annular defect (4-6 mm tall and 6-10 mm wide) following a primary single-level L4–S1 discectomy.

Revision History

2025-02-01revisionLatest

Supporting Information Updated Clinical Evidence and References sections to reflect the most current information (02/01/2025).

2025-02-01archival

Archived previous policy version OUTPATIENT 037.24