|MP 7.01.81||Nerve Graft in Association with Radical Prostatectomy|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/12:2014
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
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 nerve grafts; there are also reports of unilateral grafts when only 1 neurovascular bundle has been resected.
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 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 are also being published using other nerves, such as the genitofemoral nerve.
A nerve graft in association with radical prostatectomy is a surgical procedure and as such is not subject to regulation by the U.S. Food and Drug Administration.
Unilateral or bilateral nerve graft is considered investigational in patients who have undergone resection of one or both neurovascular bundles as part of a radical prostatectomy.
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 (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 64911 - may be used.
BlueCard/National Account Issues
Nerve grafting in association with radical prostatectomy is a specialized procedure that may require out-of-network referral.
In some cases, the nerve-harvesting procedure may be performed by a plastic surgeon or a neurosurgeon; in other cases, a urologist may perform both the nerve-harvesting, graft, and radical prostatectomy.
Specific contractual exclusions regarding treatment of impotence may apply.
After an initial literature search was performed in 2001, the policy was updated regularly with a literature review using MEDLINE. Most recently, the literature was reviewed through November 11, 2014. Following is a summary of the literature to date.
A single 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-report baseline erectile function who were scheduled for a unilateral nervesparing radical prostatectomy with preservation of 1 neurovascular bundle. All patients had the other neurovascular bundle removed, 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 estimated that the control group would have a 40% potency rate and powered the study to detect an absolute difference of 20% between groups. A sample size of 200 was originally planned to provide 80% power. However, after 107 patients were randomly assigned, a preplanned interim analysis of evaluable patients found similar rates of potency in the 2 groups; the Data Monitoring Committee estimated that there was less than a 5% chance that there would be a significant difference between groups with additional recruitment, and the trial was stopped early. When data collection ended, end point data were available for 66 patients who had either achieved potency or had been followed up for 2 years without potency. Potency was achieved in 32 of 45 (71%) sural nerve graft patients and 14 of 21 (67%) control patients (p=0.78). The authors concluded that unilateral sural nerve graft did not result in an absolute improvement of 20% in the rate of potency but that a smaller effect cannot be ruled out. A limitation of the study was that it was nonblinded, which could have impacted self-report of potency.
Other than the Davis et al study, the published literature consists of case series. The largest published series and those with the longest follow-up are described next.
In 2007, Namiki et al published a series in Japan with 3-year follow-up.(2) A total of 113 patients were evaluated: 19 patients with unilateral nerve-sparing plus sural nerve graft, 60 patients with unilateral nerve-sparing but no grafting, and 34 patients with bilateral nerve-sparing surgery. Sexual function was assessed with validated questionnaires, and at 2 years, there was no difference between the nervegrafted and the bilateral nerve-sparing patients with regard to sexual function scores. At 3 years, 25% and 28% of patients in the nerve-grafted and bilateral nerve-sparing groups, respectively, considered their sexual function as fair or good. Urinary function returned to baseline in the nerve-grafted and bilateral nerve-sparing groups at 6 months and in the unilateral nerve-sparing group at 12 months. Differences in sexual function were present at baseline with the nerve-grafted and bilateral nerve-sparing patients reporting higher baseline function than the unilateral nerve-sparing group.
A 2010 case series reviewed the records of 131 men who had unilateral nerve grafts after radical prostatectomy with unilateral neurovascular bundle resection.(3) Men who had prior radiotherapy or hormonal treatment were excluded. Another eligibility criterion was satisfactory erections presurgery as assessed by a 5-point scale (1 = full erections; 2 = diminished erections, but routinely sufficient for sexual intercourse; 3 = partial erections occasionally satisfactory for intercourse; 4 = partial erections unsatisfactory for intercourse; and 5 = no erections). A total of 49 men received sural nerve grafts, 79 received genitofemoral nerve grafts, and 3 received ilioinguinal nerve grafts. Recovery of erections was evaluated at each follow-up visit according to the 5-point scale (also called 5 levels). The median patient age was 58.7 years, and the median follow-up was 37 months. According to actuarial analysis, the 5-year probability of recovering erections of level 3 or better was 46%. The probability of recovering erections of at least level 2 or level 1 was 34% and 12%, respectively.
In 2014, Siddiqui et al reported 3-year follow-up on 66 men with clinically localized prostate cancer who had undergone sural nerve grafting during radical retropublic prostatectomy.(4) Forty-three (65%) were unilateral nerve grafts, and 23 (36%) were bilateral. All procedures were performed by a single surgeon. Recovery of potency was defined as a postoperative International Inventory of Erectile Function (IIEF) score greater than 22. Patients were permitted to use phosphodiesterase type 5 inhibitors for erectile dysfunction. The mean preoperative IIEF score was 23.4 (SD=1.6), and postoperatively, 19 patients (28.8%) recovered potency ie, had an IIEF score greater than 22. When stratified by graft type, erectile function recovery rates were 28% after unilateral and 30% after bilateral nerve grafting.
Ongoing and Unpublished Clinical Trials
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial (NCT01770340)(5): This single-blind study includes 60 patients with prostate cancer. Patients have been randomized to receive radical prostatectomy with or without implantation of an allogenic nerve graft. The primary outcome is erectile function, and follow-up is at least 24 months postsurgery. In October 2014, the website still lists the expected date of final data collection as January 2014.
Clinical Input Received From Physician Specialty Societies and Academic Medical Centers
In response to requests, input was received from 4 academic medical centers while this policy was under review in 2008; no input was received from physician specialty societies. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. Input from these 4 centers agreed that this procedure is considered investigational as adopted in the policy in May 2008.
Summary of Evidence
Nerve grafting, most commonly using the sural nerve, at the time of radical prostatectomy has been proposed to reduce the risk of postoperative erectile dysfunction. Only 1 randomized controlled trial (RCT) has evaluated sural nerve grafting with radical prostatectomy, and this study did not find that unilateral nerve grafting was associated with a statistically significant improvement in potency rates 2 years postsurgery. Due to the negative findings of the single published RCT study, and the lack of other
published controlled studies evaluating unilateral or bilateral nerve grafting, the technique is considered investigational.
Practice Guidelines and Position Statements
The 2014 (v.2) National Comprehensive Care Network prostate cancer guideline states that replacement of resected nerves has not been shown to be beneficial for recovery of erectile function after radical prostatectomy.(6)
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force has not addressed nerve grafts in association with radical prostatectomy to reduce the risk of erectile dysfunction.
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
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
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
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
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
Sponsored by Kantonsspital Winterthur KSW (Switzerland). Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial (NCT01770340). www.clinicaltrials.gov. Accessed October 22, 2014.
National Comprehensive Cancer Network. Prostate Cancer. Clinical practice guidelines in oncology, V4.2013. http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Accessed October, 2014.
|CPT||64999||Unlisted procedure, nervous system|
|55840 – 55845||Radical retropubic prostatectomy, code range|
|ICD-9 Diagnosis||185||Malignant neoplasm of prostate|
|607.84||Impotence of organic origin|
|997.99||Complications affecting other specified body systems, not elsewhere classified, other (to be reported with 607.84 when the impotence is a result of a previous radical prostatectomy)|
|V45.77||Other postprocedural states; acquired absence of genital organs|
|ICD-10-CM (effective 10/1/15)||Investigational for all relevant diagnoses|
|C61||Malignant neoplasm of prostate|
|N52.01-N52.9||Male erectile dysfunction code range (includes N52.31 Erectile dysfunction following radical prostatectomy)|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.|
|0VT00ZZ||Surgical, male reproductive system, resection, prostate, open|
|Type of Service||Surgery|
|Place of Service||Inpatient|
Genitofemoral Nerve Graft, Prostatectomy
Nerve Graft, Prostatectomy
Prostatectomy, Genitofemoral Nerve Graft
Prostatectomy, Sural Nerve Graft
Sural Nerve Graft, Prostatectomy
|11/20/01||Add to Surgery section||New policy|
|04/29/03||Replace policy||Policy revised; sural nerve grafting now considered investigational|
|11/9/04||Replace policy||Policy updated, reference added, no change in policy statement (editorial correction made to policy statement language)|
|08/17/05||Replace policy||Policy updated with literature search, no change in policy statement|
|04/17/07||Replace policy||Policy updated with literature search, no change in policy statement. “Sural nerve graft” replaced with “Nerve graft” in title and policy. Reference numbers 4 to 6 added|
|05/08/08||Replace policy||Policy updated with literature search; reference numbers 7 and 8 added; clinical input reviewed. No change in policy statement|
|12/10/09||Replace policy||Literature review update through October 2009; Rationale extensively rewritten; Reference number 1 added; other references re-numbered/removed. No change in policy statement.|
|12/09/10||Replace policy||Literature review update through October 2010. Reference numbers 6 to 8 added. No change in policy statement.|
|12/08/11||Replace policy||Literature review update through October 2011. No change in policy statement.|
|12/12/13||Replace policy||Literature review update through October 29, 2013. Reference number 5 added. No change in policy statement.|
|12/11/14||Replace policy||Policy updated with literature review through November 11, 2014; reference 4 added. No change in policy statement.|