Nerve Graft With Radical Prostatectomy

POLICY NUMBER

L.7.01.451

DESCRIPTION

Nerve graftingat the time of radical prostatectomy, most commonly using the sural nerve, has been proposed to reduce the risk ofpostoperative 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 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 the use of other nerves (eg, genitofemoral nerve) for grafting.

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).

POLICY

Unilateral or bilateral nerve graft is considered investigational in individuals who have had resection of one or both neurovascular bundles as part of a radical prostatectomy.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2003: Approved by Medical Policy Advisory Committee (MPAC).

1/21/2004: Code Reference section completed.

1/22/2007: Policy reviewed, no changes.

5/16/2007: Policy reviewed, description updated.

5/9/2008: Policy reviewed, no changes.

04/22/2010: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section.

02/23/2011: Policy reviewed; no changes.

01/18/2012: Policy reviewed; no changes.

04/02/2013: Policy reviewed; no changes.

03/07/2014: Policy reviewed; no changes.

01/30/2015: Policy reviewed; description updated. Policy statement unchanged.

07/31/2015: Code Reference section updated for ICD-10.

05/31/2016: Policy number A.7.01.81 added. Investigative definition updated in Policy Guidelines section.

06/16/2016: Policy title changed from "Nerve Graft in Association with Radical Prostatectomy" to "Nerve Graft With Radical Prostatectomy." Policy description updated. Policy statement updated to change "undergone" to "had." Policy statement intent unchanged.

06/19/17: Policy description updated regarding products. Policy statement unchanged.

05/04/2018: Policy description updated. Policy statement unchanged.

05/13/2019: Policy reviewed; no changes.

05/26/2020: Policy reviewed; no changes.

07/23/2021: Policy reviewed; no changes.

06/02/2022: Policy description and policy statement updated to change "patients" to "individuals."

05/22/2023: Policy reviewed; no changes.

05/22/2024: Policy reviewed; no changes.

07/01/2025: Policy number changed from "A.7.01.81" to "L.7.01.451." Policy reviewed. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.81

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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