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

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.

Clinical Indications

Medically Necessary:

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:

  1. Neurogenic impotence of greater than 1 year duration due to one of the following:
    1. Diabetes
    2. Fractured pelvis
    3. Major surgery of the pelvis or retroperitoneum, radical prostatectomy, or colorectal surgery
    4. Multiple Sclerosis
    5. Spina Bifida
    6. Spinal cord injury/disease
    7. Syringomyelia
      or
  2. Vasculogenic impotence of greater than 1 year duration due to one of the following:
    1. Hypertension
    2. Intrapenile arterial disease
    3. Penile contusion
    4. Penile fracture
    5. Peyronie’s disease
    6. Smoking
    7. Status post cavernosal infection
      or
  3. Impotence of greater than 1 year duration due to radiation therapy to the pelvis or retroperitoneum.

Not Medically Necessary:

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

Coding

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.

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

Discussion/General Information

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. 

References

Peer Reviewed Publications:

  1. Carvajal A, Benavides J, García-Perdomo HA, et al. Risk factors associated with penile prosthesis infection: systematic review and meta-analysis. Int J Impot Res. 2020 Feb 3 [Epub ahead of print].
  2. Carson CC, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup. J Urol. 2011; 185(2):614-618.
  3. Chung E, Gilliman M. Prostate cancer survivorship: a review of erectile dysfunction and penile rehabilitation after prostate cancer therapy. Med J Aust. 2014; 200(10):582-585.
  4. Darouiche RO, Bella AJ, Boone TB, et al. North American consensus document on infection of penile prostheses. Urology. 2013; 82(4):937-942.
  5. Hellstrom WJ, Montague DK, Moncada I, et al. Implants, mechanical devices and vascular surgery for erectile dysfunction. J Sex Med. 2010; 7(1 Pt 2):501-523.
  6. Henry GD, Wilson SK. Updates in inflatable penile prostheses. Urol Clin North Am. 2007; 34(4):535-547.
  7. Khera M, Bella A, Karpman E, et al. Penile prosthesis implantation in patients with Peyronie's disease: results of the PROPPER study demonstrates a decrease in patient-reported depression. J Sex Med. 2018; 15(5):786-788.
  8. Lee DJ, Najari BB, Davison WL, et al. Trends in the utilization of penile prostheses in the treatment of erectile dysfunction in the United States. J Sex Med. 2015; 12(7):1638-1645.
  9. Minervini A, Ralph DJ, Pryor JP. Outcome of penile prosthesis implantation for treating erectile dysfunction: experience with 504 procedures. BJU Int. 2006; 97(1):129-133.
  10. Mulcahy JJ, Austoni E, Barada JH, et al. The penile implant for erectile dysfunction. J Sex Med. 2004; 1(1): 98-109.
  11. Ong WL, Hindson BR, Beaufort C, et al. Long-term erectile function following permanent seed brachytherapy treatment for localized prostate cancer. Radiother Oncol. 2014; 112(1):72-76.
  12. Palma-Zamora I, Sood A, Dabaja AA. 30-day adverse event rates following penile prosthesis surgery: an American College of Surgeons National Surgical Quality Improvement Program-based evaluation. Trans Androl Urol. 2017; 6: S767-S773.
  13. Phé V, Rouprêt M. Erectile dysfunction and diabetes: a review of the current evidence-based medicine and a synthesis of the main available therapies. Diabetes Metab. 2012; 38(1):1-13.
  14. Selph JP, Carson CC. Penile prosthesis infection: approaches to prevention and treatment. Urol Clin North Am. 2011; 38(2):227-235.
  15. Sevinc C, Ozkaptan O, Balaban M, et al. Outcome of penile prosthesis implantation: are malleable prostheses an appropriate treatment option in patients with erectile dysfunction causes by prior radical surgery? Asian J Androl 2017; 19: 477-481.
  16. Stember DS, Mulhall JP. The concept of erectile function preservation (penile rehabilitation) in the patient after brachytherapy for prostate cancer. Brachytherapy. 2012; 11(2):87-96.
  17. Trost L, Wanzek P, Bailey G. A practical overview of considerations for penile prosthesis placement. Nat Rev Urol. 2016; 13(1):33-46.
  18. Zermann DH, Kutzenberger J, Sauerwein D, et al. Penile prosthetic surgery in neurologically impaired patients: long-term follow-up. J Urol. 2006; 175(3 Pt 1):1041-1044.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Association of Clinical Endocrinologists (AACE) Male Sexual Dysfunction Task Force. Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Male Sexual Dysfunction: A couple’s problem. 2003 Update. Available at: https://www.aace.com/disease-state-resources/search?keys=male+sexual+dysfunction&field_disease_state_content_t_value%5BGuidelines%5D=Guidelines. Accessed on March 13, 2030.
  2. American Urological Association (AUA). Erectile Dysfunction: AUA Guideline. Last updated 2018. Available at: https://www.auanet.org/guidelines/erectile-dysfunction-(ed)-guideline. Accessed on March 13, 2020.
  3. European Association of Urology. Guidelines on male sexual dysfunction. Last updated 2018. Available at: http://uroweb.org/guideline/male-sexual-dysfunction/. Accessed on March 13, 2020.
Websites for Additional Information
  1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Treatment for erectile dysfunction. Available at: https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/treatment. Accessed on March 13, 2020.
Index

Erectile Dysfunction
Penile Prosthesis, Insertion

History

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


Federal and State law, as well as contract language, and Medical Policy take precedence over Clinical UM Guidelines. We reserve the right to review and update Clinical UM Guidelines periodically. Clinical guidelines approved by the Medical Policy & Technology Assessment Committee are available for general adoption by plans or lines of business for consistent review of the medical necessity of services related to the clinical guideline when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the member's card.

Alternatively, commercial or FEP plans or lines of business which determine there is not a need to adopt the guideline to review services generally across all providers delivering services to Plan’s or line of business’s members may instead use the clinical guideline for provider education and/or to review the medical necessity of services for any provider who has been notified that his/her/its claims will be reviewed for medical necessity due to billing practices or claims that are not consistent with other providers, in terms of frequency or in some other manner.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only - American Medical Association