Archived Policies - Surgery


Nerve Graft With Radical Prostatectomy

Number:SUR710.019

Effective Date:01-01-2017

End Date:07-14-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

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.

Description:

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.

Background

Erectile dysfunction is a common problem after radical prostatectomy. In particular, spontaneous erections are usually absent in patients whose extent of prostate cancer requires 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 one 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 one 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).

Rationale:

This policy was created in 2003 and has been updated regularly with scientific literature reviews, most recently through November 7, 2016. The following is a summary of the key literature.

One randomized controlled trial (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 randomly assigned to receive or not receive sural nerve grafting after its 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 then 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). The authors 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 study was that it was nonblinded, which, because men knew the procedure they received, could have impacted self-report of potency.

The literature also includes 2 retrospective cohort studies and 2 case series. (2-5) The cohort studies are described below.

A 2015 cohort study by Kung et al. 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 (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 in 2007 by Namiki et al., 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) Sexual 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 percentage 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.

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 No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT01770340

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

60

Jan 2019

NCT: national clinical trial

Practice Guidelines and Position Statements

The National Comprehensive Cancer Network prostate cancer guideline (v.3.2016) states that replacement of resected nerves with nerve grafts has not been shown to be beneficial for recovery of erectile function after radical prostatectomy. (6)

Summary of Evidence

The evidence for nerve grafting in individuals who have radical prostatectomy with resection of neurovascular bundles includes 1 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, limited by lack of randomization and blinding, also did not result in better outcomes with nerve grafting. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

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.

Coding:

There are no specific CPT codes describing sural nerve grafting of the cavernous nerves; the CPT codes describing nerve grafts specifically identify the anatomic site and do not include the cavernous nerves. Therefore, CPT code 64999 may be used to describe the nerve harvest and grafting component of the procedure. Alternatively, a nonspecific CPT code for nerve repair—64910 or 64911—may be used.

CODING:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

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

CPT Codes

55840, 55842, 55845, 55899, 64999

HCPCS Codes

None

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 <http://www.cms.hhs.gov>.

References:

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. Aug 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. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: Prostate cancer. Version 3.2016. Available at <http://www.nccn.org> (accessed - 2016 November 4).

7. Nerve Graft With Radical Prostatectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 April) Surgery 7.01.81.

Policy History:

Date Reason
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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