Pending Policies - Surgery

Nerve Graft With Radical Prostatectomy


Effective Date:11-15-2018



Unilateral or bilateral nerve graft is considered experimental, investigational, and/or unproven in patients who have had resection of one or both neurovascular bundles as part of a radical prostatectomy.


Nerve grafting at the time of radical prostatectomy, most commonly using the sural nerve, has been proposed to reduce the risk of postoperative erectile dysfunction.

Erectile Dysfunction

Erectile dysfunction is a common problem after radical prostatectomy. In particular, spontaneous erections are usually absent in men whose prostate cancer required bilateral resection of the neurovascular bundles as part of the radical prostatectomy procedure.


A variety of noninvasive treatments are available, including vacuum constriction devices and intracavernosal injection therapy. However, spontaneous erectile activity is preferred by patients. Studies have reported results from bilateral and unilateral nerve grafts, the latter involving resection of 1 neurovascular bundle.

There has been interest in sural nerve grafting to replace cavernous nerves resection during prostatectomy. The sural nerve is considered expendable and has been extensively used in other nerve grafting procedures, such as brachial plexus and peripheral nerve injuries. As applied to prostatectomy, a portion of the sural nerve is harvested from 1 leg and then anastomosed to the divided ends of the cavernous nerve. Reports also indicate use of other nerves (e.g., genitofemoral nerve) for grafting.

Regulatory Status

A nerve graft with radical prostatectomy is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA).

Several nerve cuff products have been cleared for marketing by the FDA through the 510(k) process. FDA product code: JXI. An example of a human tissue nerve graft product, the Avance® nerve graft (AxoGen), is regulated by the FDA under the 21 CFR Part 1271 regulations for Human Cellular and Tissue-Based Products (HCT/P).


This medical policy was originally created in 2003 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through February 5, 2018. Following is a summary of the literature to date.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Nerve Grafting

One RCT evaluating nerve grafting to reduce risk of erectile dysfunction has been published; findings were reported in 2009 by Davis et al. (1) The trial included men age 65 years or younger with normal self-reported baseline erectile function selected for a unilateral nerve sparing radical prostatectomy with preservation of 1 neurovascular bundle. All patients had unilateral neurovascular bundle removal, and patients were randomized to receive or not sural nerve grafting after removal. The primary outcome was potency 2 years postsurgery, defined as the ability to have intercourse with or without erectile dysfunction medication. All patients received the same early erectile dysfunction therapy, including medication and mechanical devices. The investigators sought to detect an absolute difference of 20% between groups (graft, 60% potency rate vs no graft, 40% potency rate). A sample of 200 men was originally planned to provide 80% power. However, after 107 men were randomized, a preplanned interim analysis of evaluable patients found similar potency rates between groups. The data monitoring committee stopped the trial based on its estimate of less than a 5% chance that additional recruitment would result in a significant difference between groups. End point data were available for 66 patients. Potency was achieved in 32 (71%) of 45 sural nerve graft patients and 14 (67%) of 21 control patients (p=0.78). Trialists concluded that unilateral sural nerve graft did not result in an absolute improvement of 20% between groups, but that a smaller effect could not be ruled out. A limitation of the trial was that it was unblinded, which, because men knew the procedure they received, could have impacted self-report of potency.

The literature also includes 2 retrospective cohort studies and 3 case series. (2-6) The cohort studies are described below.

The cohort study by Kung et al. (2015) included 38 patients who underwent nerve grafting after radical prostatectomy and a random sample of 53 control patients who had open prostatectomy without nerve grafting. (2) Control patients had unilateral or bilateral nerve sparing prostatectomy, or non-nerve sparing prostatectomy. Complete urinary incontinence, no erectile capacity at baseline, and follow-up data less than 12 months were study exclusion criteria. Unilateral nerve grafting (n=29) and unilateral nerve sparing (n=10) patients did not differ significantly between groups (p>0.05) on various outcomes, including urinary continence, erections sufficient for sex, spontaneous erections, and use of erectile dysfunction medications. Bilateral nerve grafting (n=9) and bilateral non-nerve sparing (n=10) patients had similar outcomes (p>0.05). This study lacked randomization and blinding, and subgroup analyses included small numbers of patients.

The second cohort study, published by Namiki et al. (2007), included 113 patients: 19 had unilateral nerve sparing plus sural nerve graft, 60 patients had unilateral nerve sparing with no grafting, and 34 patients had bilateral nerve sparing surgery. (3) Function was assessed using validated questionnaires and, at 2 years, no difference in sexual function scores was found between the unilateral nerve graft and bilateral nerve sparing patients. At 3 years, similar percentages of patients in the unilateral nerve graft (25%) and bilateral nerve sparing (28%) groups considered their sexual function as fair or good. Urinary function returned to baseline continence in the unilateral nerve graft and bilateral nerve sparing groups at 6 months and in the unilateral nerve sparing group at 12 months. Baseline sexual function differed between groups, which could have biased study findings: the nerve grafted and bilateral nerve sparing patients reported higher baseline function than the unilateral nerve sparing group.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

The NCCN guidelines on the treatment of prostate cancer (v.2.2018) states: “Replacement of resected nerves with nerve grafts has not been shown to be beneficial” for recovery of erectile function after radical prostatectomy”. (7)

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date



Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial


Jan 2019

NCT: national clinical trial.

Summary of Evidence

For individuals who have radical prostatectomy with resection of neurovascular bundles who receive nerve grafting, the evidence includes a randomized controlled trial (RCT), cohort studies, and case series. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. The RCT did not find that unilateral nerve grafting was associated with a statistically significant improvement in potency rates at 2 years postsurgery. Cohort studies also did not result in better outcomes with nerve grafting. The evidence is insufficient to determine the effects of the technology on health outcomes.


Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.


There are no specific CPT codes describing sural nerve grafting of the cavernous nerves; CPT codes describing nerve grafts specifically identify the anatomic site and do not include the cavernous nerves. Therefore, CPT code 64999 (unlisted procedure, nervous system) may be used to describe the nerve harvest and grafting component of the procedure. Alternatively, a nonspecific CPT code for nerve repair—64910 or 64913 may be used.


Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.


The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

55840, 55842, 55845, 55899, 64912, 64913, 64999



ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual

Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <>.


1. Davis JW, Chang DW, Chevray P, et al. Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer. Eur Urol. May 2009; 55(5):1135-1143. PMID 18783876

2. Kung TA, Waljee JF, Curtin CM, et al. Interpositional nerve grafting of the prostatic plexus after radical prostatectomy. Plast Reconstr Surg Glob Open. Jul 2015; 3(7):e452. PMID 26301141

3. Namiki S, Saito S, Nakagawa H, et al. Impact of unilateral sural nerve graft on recovery of potency and continence following radical prostatectomy: 3-year longitudinal study. J Urol. Jul 2007; 178(1):212-216; discussion 216. PMID 17499797

4. Rabbani F, Ramasamy R, Patel MI, et al. Predictors of recovery of erectile function after unilateral cavernous nerve graft reconstruction at radical retropubic prostatectomy. J Sex Med. Jan 2010; 7(1 Pt 1):166-181. PMID 19686422

5. Siddiqui KM, Billia M, Mazzola CR, et al. Three-year outcomes of recovery of erectile function after open radical prostatectomy with sural nerve grafting. J Sex Med. Aug 2014; 11(8):2119-2124. PMID 24903070

6. Souza Trindade JC, Viterbo F, Petean Trindade A, et al. Long-term follow-up of treatment of erectile dysfunction after radical prostatectomy using nerve grafts and end-to-side somatic-autonomic neurorraphy: a new technique. BJU Int. Jun 2017;119(6):948-954. PMID 28093890

7. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. Version 2.2018; Available at <> (accessed March 12, 2017).

8. Nerve Graft With Radical Prostatectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 April) Surgery 7.01.81.

Policy History:

Date Reason
11/15/2018 Document updated with literature review. Coverage unchanged.
1/1/2018 Document updated with literature review. Coverage unchanged.
7/15/2017 Reviewed. No changes.
1/1/2017 Document updated with literature review. Coverage unchanged. Editorial change made as follows: “undergone” changed to “had” in the coverage statement. Title changed from “Nerve Graft in Association With Radical Prostatectomy”.
5/15/2015 Reviewed. No changes.
7/1/2014 Document updated with literature review, coverage unchanged. CPT/HCPCS code(s) updated.
10/15/2013 Document updated with literature review, coverage unchanged and entire rationale section revised. Codes updated.
9/1/2009 Revised/ updated entire document. Coverage remains experimental, investigational and unproven.
9/1/2007 Revised/updated entire document.
8/15/2003 New Medical document

Archived Document(s):

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