CG-SURG-12 Penile Prosthesis Implantation

This document addresses the criteria for implantation of a penile prosthesis, which is an established technique for treating male impotence or erectile dysfunction (ED) due to neurogenic or vasculogenic causes.

The implantation of a penile prosthesis is considered medically necessary for individuals who have not responded to intracavernosal injection, intra-urethral medications, a vacuum constriction device and oral medications, or such treatment is not acceptable to the individual or his partner and who meet one of the following criteria:

The implantation of a penile prosthesis is considered not medically necessary when the above criteria are not met.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

The American Urological Association (AUA) 2018 erectile dysfunction (ED) guideline defines ED as “…the consistent or recurrent inability to attain and/or maintain penile erection sufficient for sexual satisfaction, including satisfactory sexual performance.”

Damage to nerves, arteries, smooth muscles, and fibrous tissues, often as a result of disease, is the most common cause of ED. Vascular disease and neurologic disease account for about 70% of ED cases. Between 35% and 50% of men with diabetes experience ED. Surgery (especially radical prostate and bladder surgery for cancer) and radiotherapy can injure nerves and arteries near the penis, causing ED (AUA, 2011; Chung, 2014). Injury to the penis, spinal cord, prostate, bladder, and pelvis can lead to ED by harming nerves, smooth muscles, arteries, and fibrous tissues of the corpora cavernosa.

Penile prosthesis implantation is a treatment option for men with ED who have failed less invasive treatments. The U.S. Food and Drug Administration (FDA) considers the rigid penile implant as a Class II device. The semi-rigid rods are implanted into the corpora cavernosa of the penis to provide rigidity. Inflatable penile implants are considered Class III devices by the FDA. Inflatable cylinders are implanted in the penis and are connected to a reservoir filled with fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. Penile rigidity is achieved when the cylinders are filled with fluid.

The AUA (2018) guideline on ED states that treatment is generally applied beginning with the least invasive approach. However, some men may choose to begin with another type of treatment. The AUA recommendation on penile prosthesis implantation is that men should be informed of this intervention as a treatment option, including a discussion of potential risks and benefits (Evidence Level: Grade C). The EAU 2018 guidelines on male sexual dysfunction recommend the implanted penile prosthesis as a third line of therapy for individuals that have failed oral PDE5 inhibitors and intracavernous injections. As the placement of a penile prosthesis requires the dislocation of cavernosal tissue, it is considered a permanent and irreversible procedure that should be reserved in those who have failed or are intolerant of conservative measures (Trost, 2016).

Penile prostheses have been evaluated in uncontrolled case series. For example, Zermann and colleagues (2006) studied penile implant efficacy in 245 neurologically impaired men. Men were categorized into 3 groups based on the indication for penile prosthetic surgery. Group 1 consisted of 134 participants with urinary management only, Group 2 had 60 participants with erectile dysfunction only, and Group 3 had 51 participants with urinary management and erectile dysfunction. At a mean follow-up of 7.2 years (maximum 17 years), 195 participants were reevaluated in the clinic. Outcomes showed that in 122 participants (90.3%) urinary management problems were resolved, and erectile dysfunction treatment was successful in 76 participants (82.6%). Forty-three revisions were performed for complications (e.g., infections and device perforation).

Sevinc and colleagues (2017) evaluated outcomes after penile prosthesis implantation in 181 men with ED of different etiologies. Primary causes of ED were diabetes in 81 men (44.7%), vascular disease in 45 men (25.4%), radical pelvic surgery in 29 men (16%) and a variety of other reasons in the remaining 25 men (13.8%). The most common post-operative complications were superficial wound infection (n=17, 9.4%), dehiscence of the glans penis (n=10, 5.5%), which resolved after 1 month, and pain during intercourse (n=10, 5.5%), which resolved within a few months. The mean time to first intercourse was 54 days (range: 9 to 150 days). Individuals were followed for at least 12 months. At follow-up, a total of 104 individuals (57.5%) reported being very satisfied with the penile prosthesis, 48 (26.5%) were satisfied and 21 (11.6%) were not satisfied. A total of 21 prostheses (11.6%) were removed because of complications or patient dissatisfaction.

Khera and colleagues (2018) reported data from an industry-sponsored registry of individuals who were implanted with American Medical Systems (AMS) penile implants. A total of 1,180 individuals with ED were included in the registry. Of these, 250 individuals (21.2%) had Peyronie’s disease (PD). At one- and two-year follow-ups, 88.6% and 88.5%, respectively, of individuals with PD stated that they were either satisfied or very satisfied with treatment. The rate of self-reported depression in individuals with PD decreased from 19.3% at baseline to 10.5% at the one-year follow-up (p=0.02).

In terms of complication rates, Minervini and colleagues (2006) studied 447 men who had 504 penile prosthetics implanted and found that infection was the most frequent complication. Other complications were implant migration and tissue erosion. In a review by Phe (2012), the rate of infection decreased to 1% with the utilization of antibiotic impregnated implants. In a report on 98 men in a national database who had penile prosthesis implantation between 2005 and 2013 (Palma-Zamora, 2017), the overall 30-day complication rate was 11% (n=11). The complications include surgical site infection (n=6), transfusion (n=3), urinary tract infection (n=1) and sepsis/shock (n=1).

Carvajal and colleagues (2020) published a systematic review of studies on factors associated with infection in individuals with penile prostheses. They included 40 studies with a total of 175,592 individuals. Fifteen studies focused on diabetes mellitus which was found in pooled analyses to be significantly associated with risk of infection (OR [odds ratio], 2.48, 95% CI [confidence interval], 1.38 to 4.47). Other factors significantly increasing risk of infection in individuals with penile prostheses were immunosuppression (3 studies, OR, 20.99, 95% CI, 0.71 to 622.34) and obesity (2 studies, OR, 18.24, 95% CI, 1.43 to 231.98). However, other than in the analysis on diabetes mellitus, numbers of studies and total sample sizes were small and thus estimates of increased risk were imprecise as indicated by wide confidence intervals.

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Subject: Penile Prosthesis Implantation
Guideline #: CG-SURG-12	Publish Date: 07/08/2020
Status: Reviewed	Last Review Date: 05/14/2020

CPT
54400	Insertion of penile prosthesis; non-inflatable (semi-rigid)
54401	Insertion of penile prosthesis; inflatable (self-contained)
54405	Insertion of multi-component, inflatable penile prosthesis, including placement of pump, cylinders, and reservoir
54410	Removal and replacement of all component(s) of a multi-component, inflatable penile prosthesis at the same operative session
54411	Removal and replacement of all components of a multi-component inflatable penile prosthesis through an infected field at the same operative session, including irrigation and debridement of infected tissue
54416	Removal and replacement of non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis at the same operative session
54417	Removal and replacement of a non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis through an infected field at the same operative session, including irrigation and debridement of infected tissue

HCPCS
C1813	Prosthesis, penile, inflatable
C2622	Prosthesis, penile, non-inflatable
L8699	Prosthetic implant, not otherwise specified

ICD-10 Procedure
0VUS0JZ	Supplement penis with synthetic substitute, open approach
0VUS4JZ	Supplement penis with synthetic substitute, percutaneous endoscopic approach

ICD-10 Diagnosis
	All diagnoses

Status	Date	Action
Reviewed	05/14/2020	Medical Policy & Technology Assessment Committee (MPTAC) review. Discussion/General Information and References sections updated.
Reviewed	06/06/2019	MPTAC review. Discussion/General Information and References sections updated.
Reviewed	07/26/2018	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date”. Discussion/General information and References sections updated.
Reviewed	08/03/2017	MPTAC review. Updated formatting in the Position Statement section. Updated References section.
Reviewed	08/04/2016	MPTAC review. Updated Discussion/General Background, and References sections. Updated formatting in Position Statement section. Removed ICD-9 codes from Coding section.
Revised	08/06/2015	MPTAC review. Reformatted and reorganized criteria. Added medically necessary criteria for radiation therapy. Added pelvis and retroperitoneum to major surgery group. Updated Description, Discussion/General Background, and References sections.
Reviewed	11/13/2014	MPTAC review. Updated Description, Discussion/General Background, and References sections.
Reviewed	11/14/2013	MPTAC review. Updated Discussion/General Background, References and Websites sections.
Reviewed	11/08/2012	MPTAC review. Discussion and References updated.
Reviewed	11/17/2011	MPTAC review. Discussion, Coding and References updated.
Reviewed	11/18/2010	MPTAC review. Discussion and References updated.
Reviewed	11/19/2009	MPTAC review. Place of Service section deleted. Discussion and References updated.
Reviewed	11/20/2008	MPTAC review. References updated.
Reviewed	11/29/2007	MPTAC review. References and coding were updated.
Reviewed	12/07/2006	MPTAC review. References updated; no change to guideline criteria.
Revised	12/01/2005	MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations	Last Review Date	Document Number	Title
Anthem, Inc.			No Document
Anthem BCBS			No Document
WellPoint Health Networks, Inc.	12/02/2004	Clinical Guideline	Penile Prosthesis Insertion