214 Form

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Medical Policy Peripheral Nerve Injury Repair Using Synthetic Conduits or Processed Nerve Allografts
Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 214 BCBSA Reference Number: 7.01.177 (For Plan internal use only) NCD/LCD: N/A Related Policies
Bioengineered Skin and Soft Tissue Substitutes, #663 Nerve Graft with Radical Prostatectomy, #590 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

The use of processed nerve allografts for the repair and closure of peripheral nerve gaps up to 70 mm is considered MEDICALLY NECESSARY when direct primary repair is not feasible (see Policy Guidelines).

The use of synthetic nerve conduits for the repair and closure of peripheral nerve gaps is considered MEDICALLY NECESSARY in the following scenarios (see Policy Guidelines): • Repair of digital nerve injuries with gaps <15 mm; OR • Repair of digital nerve injuries with gaps 15-25 mm, where allograft nerve is not available; OR • Repair of major nerves with small gaps not exceeding 6 mm, where allograft nerve is not available; OR • In the context of conduit-assisted repair as a technique for tension-relief at the peripheral nerve repair site.

All other uses of processed nerve allografts and synthetic nerve conduits for individuals with peripheral nerve gaps are considered INVESTIGATIONAL.

Policy Guidelines Feasibility of direct repair may be limited in individuals with large nerve gaps, segmental nerve loss, or chronic and complex injuries. While there are mixed data regarding comparability of autograft versus allograft repair, allograft repair offers the benefit of avoiding donor site morbidity. This is of particular importance where the primary consideration is the management or prevention of neuropathic pain. For

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larger sensory, motor, or mixed nerves, autograft repair should be considered the standard intervention except if there is insufficient donor material for autografting. The maximum available allograft length is 70 mm, and there is no data to support the technique of connecting allografts end-to-end.

For digital nerve injuries with gaps 15-25 mm, conduit repair yields acceptable sensory outcomes but is inferior to allograft repair. Therefore, conduit repair should only be used in such scenarios when allograft nerve is not immediately available (e.g. in the context of urgent traumatic injuries).

Nerve wraps are bioresorbable surgical implants designed to protect and support peripheral nerve healing following end-to-end repair with no gap. These devices provide a physical barrier that purports to reduce scar formation, reduce mechanical irritation, and promote a favorable environment for nerve regeneration.
These materials are addressed in policy 663 Bioengineered Skin and Soft Tissue Substitutes.

Contraindications Both allograft and conduit repair are contraindicated in a surgical field with active infection. Synthetic conduits are contraindicated for individuals with a history of an allergic reaction or sensitivity to any component of the synthetic conduit (e.g., bovine, porcine, or chondroitin materials).

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) Prior authorization is not required. Commercial PPO and Indemnity Prior authorization is not required. Medicare HMO BlueSM Prior authorization is not required. Medicare PPO BlueSM Prior authorization is not required.

CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes:

Code Description 64910 Nerve repair; with synthetic conduit or vein allograft (eg, nerve tube), each nerve 64912 Nerve repair; with nerve allograft, each nerve, first strand (cable) 64913 Nerve repair; with nerve allograft, each additional strand (List separately in addition to code for primary procedure)

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Description Peripheral Nerve Injury Injuries to the peripheral nerves are common and occur in approximately 2.5% of trauma patients in the United States, with an average incidence of over 550,000 annually.1, Based on hospital ICD-9 coding, the most commonly injured peripheral nerves reported by hospitals were the upper extremity digital nerves, ulnar nerve, radial nerve, and the brachial plexus. 2, Functional regeneration of injured nerves requires peripheral nerve surgery to allow axon regrowth and remyelination.3,

Conventional Treatment Direct surgical repair (e.g. end-to-end coaptation or neurorrhaphy) is the standard of care for transected nerves when the gap distance permits tensionless suturing. However, when the size of the peripheral nerve gap precludes tensionless direct surgical repair, the standard of care is nerve autograft.4,Alternatives to autografting are being investigated to bridge nerve discontinuities to avoid complications from harvesting (e.g., pain or numbness) at the donor site as well as issues such as nerve fascicle mismatch and damage to the autograft from tissue handling.3,

Alternative Treatments Allogenic nerve grafts are derived from human donors and are generally used to bridge gaps resulting from peripheral nerve injuries that are > 5 mm.4, Allogenic grafts are preferred for their potential to minimize donor site morbidity, as they eliminate the need for autografts. Allogenic grafts also address the challenge of obtaining sufficient graft length as they are available in multiple lengths and diameters; this is particularly relevant in cases where the injury site is extensive. Before transplantation, allografts undergo processing to ensure immunological compatibility and reduce the risk of rejection, allowing for successful integration into the recipient's nervous system. 5,

Synthetic nerve conduits are hollow tubular structures designed to bridge nerve gaps caused by injury or trauma, providing a supportive environment for the regrowth of damaged nerve fibers.6, They are available in various biocompatible materials, lengths, and diameters and are designed to degrade over time. The conduits serve as guidance channels for regenerating nerves, facilitating directional growth, and preventing scar tissue formation.3,Conduits are generally used for nerve gap repairs of < 5 mm.4,

Summary
Description Peripheral nerve injuries are common traumatic events for which the conventional treatment is the microsurgical repair for gaps <5 mm in length. Autologous grafting is used for repairing nerve gaps of greater length. Because autologous grafts must be harvested from the patient, there is a risk of donor site complications, and the overall success rate of autografting may be limited. Therapies such as processed nerve allografts and synthetic nerve conduits are being investigated to provide improved treatment alternatives.

Summary of Evidence For individuals with peripheral nerve injury requiring repair and closure of the nerve gap who receive processed nerve allografts, the evidence includes 2 meta-analyses, 2 randomized controlled trials (RCTs) comparing allograft to collagen conduit repair with NeuraGen, 1 comparative case series, 1 retrospective cohort study, 1 case series, and 1 registry study. All studies, with the exception of 1 non-randomized controlled trial, used Avance allografts. The evidence base consisted primarily of peripheral nerve injuries to the fingers or upper extremities. Relevant outcomes were sensory and motor function changes, quality of life, and treatment-related morbidity. In 1 RCT that compared allograft to NeuraGen synthetic conduit, allograft patients had a greater return of protective sensation rate on the static 2-point discrimination (S2PD) score but did not differ on overall S2PD score or other outcome measures. The second RCT comparing allograft to Neuragen found that S2PD favored the Avance allograft group at 1-year follow-up, but no differences were noted in moving 2-point discrimination (M2PD), Semmes Weinstein Monofilament (SWMF) test, or the Disability of the Arm and Shoulder (DASH) questionnaire. Limitations in the RCT evidence base included a lack of intention to treat (ITT) analysis, high loss to follow-up, lack of reporting power calculations, and insufficient follow-up duration. Three non-randomized comparative studies found

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no difference between NeuraGen (n=2) and direct surgical repair (n=2) in sensory or functional outcomes and complications compared to allograft. One meta-analysis found comparable pooled rates of S2PD and M2PD across assessed interventions, including allograft, autograft, artificial conduits, and direct surgical repair, but all estimates had extreme heterogeneity. Another meta-analysis found that meaningful recovery (≥S3 on the British Medical Research Council [BMRC] recovery grading system) was significantly higher in allograft and autografting than for synthetic conduits. Data from the ongoing Avance registry study suggested durability of outcomes and safety at more than 2 years of follow-up. There is an absence of comparison of Avance to autografting in the included literature, which is a significant limitation as this is the current standard of care for repairing peripheral nerve gap discontinuities larger than 5 mm. Additionally, substantial interventional, comparator, and outcome heterogeneity across the evidence base makes it challenging to compare outcomes across studies reliably. Randomized comparisons of allograft to autograft with sufficient follow-up using validated outcome measures are needed to evaluate the relative risk-benefit of allografting. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with peripheral nerve injury requiring repair and closure of the nerve gap who receive synthetic nerve conduits, the evidence includes 3 meta-analyses, 8 RCTs (2 comparing NeuraGen to allograft, 1 comparing Neurotube to autologous vein grafting, and 4 comparing conduit [1 Neurolac, 1 Polyhydroxybutyrate {PHB}, 1 polyglycolic acid {PGA}, and 1 silicone tube] to direct surgical repair), 1 non- randomized clinical trial, 1 comparative retrospective cohort study, 1 comparative case series, and 1 non- comparative case series. The evidence base consisted primarily of peripheral nerve injuries to the fingers or upper extremities. NeuraGen was evaluated in 3 studies, and all other synthetic conduits were represented by a single study (Neuromatrix, Neuroflex, Neurotube, Neurolac, PHB conduit, PGA conduit, and collagen-filled conduit). In 1 RCT that compared Avance allograft to NeuraGen, allograft patients had a greater return of protective sensation rate on static 2-point discrimination (S2PD), but did not differ on overall S2PD score or other outcome measures. The second RCT comparing Avance allograft to Neuragen found that S2PD favored the allograft group at 1-year follow-up, but no differences were noted in moving 2-point discrimination (M2PD), Semmes Weinstein Monofilament (SWMF) test, or the Disability of the Arm and Shoulder (DASH) questionnaire. One RCT compared Neurotube conduit to an autologous vein conduit and found similar outcomes at a 2-year follow-up, but at 1-year analysis, the motor domain of the Rosen Model Instrument (RMI) favored the autologous treatment arm. Five other trials compared different types of conduits to direct surgical repair with generally equivalent outcomes; one RCT observed a significant difference in cold intolerance, which favored the synthetic conduit group, and another found that at short (<4 mm) and long nerve gaps (> 8 mm) M2PD was better in the PGA conduit group than in direct surgical repair or autograft. Major limitations identified in the trial evidence base included an absence of participant blinding, lack of intention to treat analysis, high loss to follow-up, absence of power calculations, and short duration of follow-up. Three non-randomized comparative studies found no difference between synthetic conduits and Avance (n=2), direct surgical repair (n=1), or autograft (n=1) in sensory or functional outcomes as well as complications. A Cochrane review found that there is no clear benefit to patients treated with artificial nerve conduits or nerve wraps over direct surgical repair, and that complications may be greater for participants treated with synthetic nerve conduits or wraps. The overall evidence base was considered very uncertain, with few outcomes having more than 1 included study. One other meta-analysis found comparable pooled rates of S2PD and M2PD across assessed interventions, but all estimates had extreme heterogeneity. The third meta-analysis found that meaningful recovery (≥S3 on the British Medical Research Council [BMRC] recovery grading system) was significantly higher in allograft and autografting than for synthetic conduits. No guideline evidence was identified for synthetic nerve conduits for the treatment of peripheral nerve injuries. Many of the included trials have significant limitations, and the substantial heterogeneity in patient and intervention characteristics makes it challenging to compare outcomes reliably across studies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 2/2026 Annual policy review. References updated. Policy statements unchanged.

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8/2025 New medical policy describing medically necessary and investigational indications.
Effective 8/1/2025. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References

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