Clinical UM Guideline
Subject: Penile Prosthesis Implantation
Guideline #: CG-SURG-12 Publish Date: 07/07/2021
Status: Revised Last Review Date: 05/13/2021
Description

This document addresses the criteria for implantation of a penile prosthesis, which is an established technique for treating erectile dysfunction (ED).

Note: Please refer to the following document for additional information:

Clinical Indications

Medically Necessary:

The implantation of a penile prosthesis is considered medically necessary for individuals who:

  1. Have erectile dysfunction of greater than 6 months duration; and
  2. Experienced failure of or have contraindication to less invasive treatments including, but not limited to oral medications, intracavernosal injection, intra-urethral medications and vacuum constriction devices.  

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.

When services may be Medically Necessary when criteria are met:

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

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met.

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.”

According to the AUA guideline, independent risk factors for ED are similar to those for cardiovascular disease. These include, among others, smoking, diabetes mellitus, hypertension, dyslipidemia and obesity. Between 20% and 85% of men with diabetes, and approximately 35% of men with dyslipidemia, experience ED (AUA, 2018). Moreover, approximately 75% of men with heart failure experience ED, and causes of ED in men with heart failure include arterial insufficiency, endothelial dysfunction, reduced cardiac capacity and side effects of medication for cardiovascular disease (Rastogi, 2005). In addition, surgery (especially radical prostate and bladder surgery for cancer) and radiotherapy can injure nerves and arteries near the penis, causing ED (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. For those without other comorbidities, oral phosphodiesterase-5 (PDE5) inhibitors such as sildenafil and tadalafil are usually first-line therapies, unless contraindicated. Recent meta-analyses have found that all available oral PDE5 inhibitors are effective, compared with placebo, with similar efficacy of the various PDE5 inhibitors (Allen, 2019). For men with testosterone deficiency, PDE5 inhibitors can be supplemented with testosterone therapy (AUA, 2018). If oral medications are not sufficient, a vacuum device, which is a noninvasive modality, is often recommended before a penile prosthesis. Underlying causes for erectile dysfunction are important to identify and address, if possible, with appropriate interventions.

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.

In 2018, the AUA published an updated guideline on ED. Recommendations in this guideline that are specific to penile prosthesis implantation are as follows:

Men with ED should be informed regarding the treatment option of penile prosthesis implantation, including discussion of benefits and risks/burdens. (Strong Recommendation; Evidence Level: Grade C)

Men with ED who have decided on penile implantation surgery should be counseled regarding post-operative expectations. (Clinical Principle)

Penile prosthetic surgery should not be performed in the presence of systemic, cutaneous, or urinary tract infection. (Clinical Principle)

The guideline stated, “the potential risks and burdens of prosthesis surgery include the risks inherent in the surgical procedure, possible changes in the appearance of the penis, and the potential for device malfunction or failure”.

Penile prostheses have primarily 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%). A total of 43 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, 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 1180 individuals with ED were included in the registry. Of these, 250 individuals (21.2%) had Peyronie’s disease (PD). At 1- and 2-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 1-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 included 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 (odds ratio [OR], 2.48; 95% confidence interval [CI], 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. 

A 2020 systematic review by Dick and colleagues identified 14 studies reporting on outcomes after penile prosthesis implantation in individuals with solid organ transplant. Most of the studies were case reports or case series but there were also 2 retrospective cohort studies. Overall, the studies included 143 individuals with solid organ transplant and 191 controls without solid organ transplant, all of whom received penile prostheses. In a pooled analysis, the authors did not find a significant difference in the prosthetic infection rate among individuals with solid organ transplant (2.1%) and controls (3.7%), p=0.53. They also did not find a statistically significant difference in the rate of non-infective complications in individuals with solid organ transplant (9.8%) versus controls (4.7%), p=0.08. A limitation of the literature on this topic is that most studies were small and uncontrolled, and all were retrospective.

References

Peer Reviewed Publications:

  1. Allen MS, Walter EE. Erectile Dysfunction: An umbrella review of meta-analyses of risk-factors, treatment, and prevalence outcomes. J Sex Med. 2019; 16(4):531-541.
  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. 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; 32(6):587-597.
  4. 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.
  5. Darouiche RO, Bella AJ, Boone TB, et al. North American consensus document on infection of penile prostheses. Urology. 2013; 82(4):937-942.
  6. Dick B, Greenberg JW, Polchert M et al. A systematic review of penile prosthesis surgery in organ transplant recipients. Sex Med Rev. 2020 July 5; Online ahead of print.
  7. 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.
  8. Henry GD, Wilson SK. Updates in inflatable penile prostheses. Urol Clin North Am. 2007; 34(4):535-547.
  9. 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.
  10. 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.
  11. 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.
  12. Mulcahy JJ, Austoni E, Barada JH, et al. The penile implant for erectile dysfunction. J Sex Med. 2004; 1(1): 98-109.
  13. 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.
  14. 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.
  15. 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.
  16. Rastogi S, Rodriguez JJ, Kapur V et al. Why do patients with heart failure suffer from erectile dysfunction? A critical review and suggestions on how to approach this problem. Int J Impot Res. 2005c; 17 Suppl 1:S25-36.
  17. Selph JP, Carson CC. Penile prosthesis infection: approaches to prevention and treatment. Urol Clin North Am. 2011; 38(2):227-235.
  18. 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.
  19. 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.
  20. Trost L, Wanzek P, Bailey G. A practical overview of considerations for penile prosthesis placement. Nat Rev Urol. 2016; 13(1):33-46.
  21. 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. Available at https://pro.aace.com/disease-state-resources/reproductive-and-gonad/clinical-practice-guidelines/aace-medical-0. Accessed on March 8, 2021.
  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 8, 2021.
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 8, 2021.
Index

Erectile Dysfunction
Penile Prosthesis, Insertion

History

Status

Date

Action

Revised

05/13/2021

Medical Policy & Technology Assessmen Committee (MPTAC) review. In Medically Necessary statement, changed “impotence” to “erectile dysfunction; changed required duration from 1 year to 6 months; and reformatted and simplified criteria. Discussion/General Information and References sections updated. Reformatted Coding section.

Reviewed

05/14/2020

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


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