CurrentUnitedHealthcarePolicy CS031.S

Discogenic Pain Treatment

Defines UnitedHealthcare's medical policy on treatments for discogenic low back pain, stating which procedures are considered unproven/not medically necessary (annular closure devices, percutaneous injection of allogeneic cellular/tissue-based products, and thermal intradiscal procedures) and providing clinical evidence, applicable procedure codes, FDA context, and state-specific application exceptions.

Policy Summary

PayerUnitedHealthcare

PolicyDiscogenic Pain Treatment

Policy CodePolicy CS031.S

Change TypeApplication / Supporting Information updates

Effective DateFeb 1, 2025

Next Review Date

Key ActionVerify state-specific applicability — this Medical Policy does not apply in Idaho, Indiana, Kansas, Kentucky, Louisiana, New Jersey, New Mexico, Ohio, Pennsylvania, and Tennessee; refer to the state-specific policy/guideline noted for those states.

POLICY UPDATE CHANGES

Application Idaho and Kansas - Added language indicating this Medical Policy does not apply to the states of Idaho and Kansas; refer to the state-specific policy versions.

Supporting Information - Updated Clinical Evidence and References sections to reflect the most current information.

3Procedures listed as unproven / not medically necessary

9States with alternate policy applicability listed

1States explicitly excluded (Idaho, Kansas)

4FDA product codes referenced

Coverage Summary

Overview: This policy (Policy Number CS031.S, effective February 1, 2025) defines UnitedHealthcare’s position on treatments for discogenic low back pain. The policy’s coverage stance is mixed and it identifies specific procedures considered unproven and not medically necessary due to insufficient evidence of efficacy: annular closure devices (ACDs), percutaneous injection of allogeneic cellular/tissue-based products, and thermal intradiscal procedures (TIPs) (e.g., IDET, IDB, PIRFT).

State and regulatory context: This Medical Policy does not apply in certain states; refer to state-specific policy versions (including Idaho and Kansas). The policy notes FDA premarket approval of the Barricaid annular closure device (PMA granted February 8, 2019) with a specific indication to reduce reherniation and reoperation in skeletally mature patients with a large annular defect after single-level L4–S1 primary discectomy.

Key policy stats and identifiers

Procedures listed as unproven / not medically necessaryAnnular closure devices (ACDs); Percutaneous injection of allogeneic cellular/tissue-based products; Thermal intradiscal procedures (TIPs)

States with alternate policy applicability listedIdaho, Indiana, Kansas, Kentucky, Louisiana, New Jersey, New Mexico, Ohio, Pennsylvania, Tennessee

States explicitly excludedIdaho and Kansas (policy does not apply; refer to state-specific versions)

FDA product codes referencedFTL, GAT, FTM, GEI

References citedHayes HTA (2023); ECRI Assessment (2020/2023); Barricaid FDA PMA (Feb 8, 2019); Helm systematic review (2017); Thome et al. RCT and 5-yr follow-up; Beall VAST RCT

Effective DateFebruary 1, 2025

Policy NumberCS031.S

Medical Necessity / Unproven Procedures

Not Medically Necessary / Unproven Procedures

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

Not Medically Necessary / Unproven Procedures - Top Level

Annular closure devices (ACDs) are unproven and not medically necessary due to insufficient evidence of efficacy.
Percutaneous injection of allogeneic cellular/tissue-based products is unproven and not medically necessary due to insufficient evidence of efficacy.
Thermal intradiscal procedures (TIPs) for treating discogenic pain are unproven and not medically necessary due to insufficient evidence of efficacy.

ref

Codes and Product Codes (reference)

Referenced Procedure / HCPCS / CPT / Unlisted Codes (reference only)mixed

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

FDA product codes (informational)mixed

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

FDA product codes referencedmixed

FTL	surgical mesh, polymeric (annulus fibrosus closure / closure devices)
GAT	suture, nonabsorbable, synthetic, polyethylene
FTM	mesh, surgical
GEI	electrosurgical cutting and coagulation devices and accessories

Provider Actions and Operational Guidance

Denial Risk

Claims for unproven procedures at risk of denial

Claims for annular closure devices, percutaneous injection of allogeneic cellular/tissue-based products, and thermal intradiscal procedures for discogenic pain are considered unproven and not medically necessary and are therefore subject to denial unless covered by state-specific policies or contractual/federal requirements.

0627T
0628T
0629T
0630T
22526
22527
22899
S2348

Background and Evidence Summary

Background: Annular closure devices (ACDs) are implantable devices intended to close or reinforce defects in the annulus fibrosus created during discectomy to reduce reherniation. Thermal intradiscal procedures (TIPs) are percutaneous techniques that apply heat within the disc (examples include intradiscal electrothermal therapy/IDET, intradiscal biacuplasty/IDB, and percutaneous intradiscal radiofrequency thermocoagulation/PIRFT) to denature collagen, modify disc biomechanics, or ablate nociceptive fibers. Percutaneous injection of allogeneic cellular/tissue-based products refers to donor-derived cell therapies injected into the intervertebral disc to stimulate tissue repair.

Regulatory note: The Barricaid bone-anchored annular closure device received FDA premarket approval on February 8, 2019 with a labeled indication to reduce reherniation and reoperation in skeletally mature patients with a large annular defect (4–6 mm tall and 6–10 mm wide) following single-level primary discectomy between L4 and S1.

Source	Key Finding
Hayes Technology Assessment (2023)
Concluded overall quality of evidence for annular closure devices is low; limitations include small samples and insufficient follow-up.
ECRI (2023)
Systematic review/meta-analysis somewhat favorable for Barricaid but additional US RCTs recommended.
Barricaid FDA PMA
PMA (Feb 8, 2019) for reducing reherniation and reoperation in skeletally mature patients with large annular defect (4-6 mm tall and 6-10 mm wide) at single level L4-S1 after primary discectomy.
Helm systematic review (2017)
Identified strong evidence for biacuplasty and moderate evidence for IDET; evidence for other TIPs limited or variable.
Beall et al. (VAST RCT, 2021)
Reported one-year results of viable disc allograft vs saline/NSM; limitations include small sample and loss to follow-up; insufficient high-quality evidence to support percutaneous allogeneic injections.
Hayes HTA (listed in brief)
Health Technology Assessment on annular closure for prevention of lumbar disc reherniation (June 2023) — overall low-quality evidence and need for larger, longer RCTs.
ECRI Assessment (listed in brief)
Clinical Evidence Assessment: Barricaid Annular Closure Device (June 2020) — evidence somewhat favorable but additional US RCTs useful to confirm results.

Definitions

ACD: Annular closure device — implantable device to close annulus fibrosus defect after discectomy.

TIPs: Thermal intradiscal procedures — percutaneous procedures applying heat within the disc (e.g., IDET, IDB, PIRFT).

Revision History

2025-02-01material_changeLatest

Application Idaho and Kansas - Added language indicating this Medical Policy does not apply to the states of Idaho and Kansas; refer to the state-specific policy versions.

2025-02-01revised_supporting_information

Supporting Information - Updated Clinical Evidence and References sections to reflect the most current information; archived previous policy version CS031.R.