Latest Review Date: April 2024

Category: Surgery                                                                  

POLICY:

Unilateral or bilateral nerve graft is considered not medically necessary in individuals who have undergone resection of one or both neurovascular bundles as part of a radical prostatectomy.

DESCRIPTION OF PROCEDURE OR SERVICE:

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

Treatment

A variety of noninvasive treatments are available, including vacuum constriction devices and intracavernosal injection therapy. However, spontaneous erectile activity is preferred by individuals. 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 resected at the time of prostatectomy. The sural nerve is considered expendable and has been used extensively 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.

KEY POINTS:

Most recently, the literature was reviewed through February 8, 2024.

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 that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network

The National Comprehensive Care Network (NCCN) on the treatment of prostate cancer (V.4.2023) states “Replacement of resected nerves with nerve grafts has not been shown to be beneficial,” for recovery of erectile function after radical prostatectomy.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Genitofemoral Nerve Graft, Prostatectomy, Sural Nerve Graft, prostate cancer, bilateral nerve graft, unilateral nerve graft, radical prostatectomy, Avance®, AxoGen

APPROVED BY GOVERNING BODIES:

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.

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).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:  

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 64999 may be used to describe the nerve harvest and grafting component of the procedure. 

A nonspecific CPT code for nerve repair may be used:

This procedure may be billed in conjunction with the radical prostatectomy CPT code range of 55840-55845.

REFERENCES:

1. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
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.
3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer. v4.2023. Available online at: www.nccn.org/professionals/physician_gls/PDF/prostate.pdf.
4. Nerve grafting with an allograft during radical prostatectomy - Extended follow-up in a prospective randomized trial (NCT01770340). Sponsored by Kantonsspital Winterthur KSW (Switzerland). Last updated February 21, 2021. Available online at: clinicaltrials.gov.
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.
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.
7. Study of nerve reconstruction using AVANCE in subjects who undergo robotic assisted prostatectomy for treatment of prostate cancer (NCT00953277). Sponsored by AxoGen, Inc. Last updated May 21, 2015. Available online at: clinicaltrials.gov.

POLICY HISTORY:

Medical Policy Group, March 2011 (2)

Medical Policy Administration Committee, March 2011

Available for comment April 4 – May 18, 2011

Medical Policy Group, October 2012 (2): 2012 Updates to Key Points and References

Medical Policy Panel, December 2012

Medical Policy Group, December 2012 (3): 2012 Updates to Key Points and References.  Policy statement remains unchanged.

Medical Policy Panel December 2013

Medical Policy Group December 2013 (4): Updated Key Points and References. Policy statement remains changed.

Medical Policy Panel, December 2014

Medical Policy Group, January 2015 (4): 2014 Updates to Key Points and References, no changes to policy statement.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (4): Updates to Description, Key Points, Key Words, Approved Governing Bodies, Coding, and References.  Update to policy title by removing “in Association”. No change to policy statement.

Medical Policy Panel, April 2017

Medical Policy Group, April 2017 (4): Updates to Key Points, Key Words, Approved by Governing Bodies and References.  No change to policy statement.

Medical Policy Group, December 2017:  Annual Coding Update 2018.  Added new codes 64912 and 64913 effective 01/01/18 to Current Coding.

Medical Policy Panel, April 2018

Medical Policy Group, April 2018 (4): Updates to Description, Key Points, Coding, and References.  No change to policy statement.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (4): Updates to Key Points.  No change to policy statement.

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (5): Updates to Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “investigational,” no change to policy intent.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (5): Updates to Description, Key Points, and References. Replaced the word “patients” with the word “individuals” in Policy Statement. No change to policy intent. 

Medical Policy Panel, April 2023

Medical Policy Group, April 2023 (11): Updates to Key Points, Benefit Application, and References. No change to policy statement.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (11): Updates to Key Points, Benefit Application, and References. No change to policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment. 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting. 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.