Clinical UM Guideline



Subject: Penile Prosthesis Implantation
Guideline #:  CG-SURG-12 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

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) Guideline on the Management of Erectile Dysfunction: Diagnosis and Treatment Recommendations defines the index case of ED as the absence of hypogonadism or hyperprolactinemia in a man who develops, after a well-established period of normal erectile function, ED that is primarily organic in nature (AUA, 2005, Update 2007).  The European Association of Urology (EAU) defines ED as the "Persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance" (Hatzimouratidis, 2015). 

The AUA (2007) guidelines note "Cardiovascular disease and ED may share a common etiology when endothelial dysfunction and atherosclerosis affect both coronary arteries and penile vasculature."  The EAU guideline notes "ED shares both unmodifiable and modifiable common risk factors with CVD (e.g., obesity, diabetes mellitus, dyslipidemia, metabolic syndrome, lack of exercise, and smoking)" (Hatzimouratidis, 2015).  The Princeton guideline for sexual medicine addressed sexual dysfunction and cardiac risk and was updated in 2006 with the publication of the second consensus statement.  The guideline noted individuals with no known cardiovascular disease but presenting with ED may have other comorbidities (e.g., diabetes, hypertension, hyperlipidemia, heart disease) (Jackson, 2006).

The AUA (2007) guideline update for erectile dysfunction states:

The management of erectile dysfunction begins with the identification of organic comorbidities and psychosexual dysfunctions; both should be appropriately treated or their care triaged.  The currently available therapies that should be considered for the treatment of erectile dysfunction include the following: oral phosphodiesterase type 5 [PDE5] inhibitors, intra-urethral alprostadil, intracavernous vasoactive drug injection, vacuum constriction devices, and penile prosthesis implantation.  These appropriate treatment options should be applied in a stepwise fashion with increasing invasiveness and risk balanced against the likelihood of efficacy.

The EAU guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation (Hatzimouratidis, 2015) recommend the implanted penile prosthesis as a third line of therapy for individuals that have failed other non-surgical treatments. 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).

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, 2007; Chung, 2014; NCCN, 2015).  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. 

Use of a penile prosthesis is an established technique for treating male impotence due to neurogenic or vasculogenic disease processes after failure of less invasive medical treatments with approximately 20,000 procedures performed annually (AUA, 2007; Chung, 2014; Hatzimouratidis, 2015; Lee, 2015).  Penile implants involve surgical insertion of malleable or inflatable rods or tubes into the penis.  The surgery is not without possible complications.  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 had decreased to 1% with the utilization of antibiotic impregnated implants.

Zermann and colleagues (2006) studied 245 neurologically impaired men who had penile prosthetics implanted.  There were 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).

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.

References

Peer Reviewed Publications:

  1. Bratu O, Oprea I, Marcu D, et al. Erectile dysfunction post-radical prostatectomy - a challenge for both patient and physician. J Med Life. 2017; 10(1):13-18.
  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. Israilov S, Shmuely J, Niv E, et al. Evaluation of a progressive treatment program for erectile dysfunction in patients with diabetes mellitus. Int J Impot Res. 2005; 17(5):431-436.
  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. 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.
  13. Selph JP, Carson CC. Penile prosthesis infection: approaches to prevention and treatment. Urol Clin North Am. 2011; 38(2):227-235.
  14. 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.
  15. Stephenson RA, Mori M, Hsieh YC, et al. Treatment of erectile dysfunction following therapy for clinically localized prostate cancer: patient reported use and outcomes from the surveillance, epidemiology and end results prostate cancer outcomes study. J Urol. 2005; 174(2):646-650.
  16. Trost L, Wanzek P, Bailey G. A practical overview of considerations for penile prosthesis placement. Nat Rev Urol. 2016; 13(1):33-46.
  17. 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/files/sexdysguid.pdf . Accessed on June 25, 2017.
  2. American Urological Association (AUA).
  3. Hatzimouratidis, Eardley I, Giuliano D, et al. European Association of Urology. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2015. Available at: http://uroweb.org/guideline/male-sexual-dysfunction/. Accessed on June 24, 2017.
  4. Jackson G, Rosen RC, Kloner RA, Kostis JB. The second Princeton consensus on sexual dysfunction and cardiac risk: new guidelines for sexual medicine. J Sex Med. 2006; 3(1):28-36.
  5. NCCN Clinical Practice Guidelines in Oncology® . © 2017 National Comprehensive Cancer Network, Inc. Prostate Cancer. V.2.2017. Revised February 21, 2017. For additional information visit the NCCN website: http://www.nccn.org/index.asp.
  6. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Erectile Dysfunction. November 2015. Available at: http://www.kidney.niddk.nih.gov/KUDiseases/pubs/ED/index.aspx. Accessed on June 24, 2017.
Index

Erectile Dysfunction
Penile Prosthesis, Insertion

History
Status Date Action
Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (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