Use of a penile prosthesis is an established technique for treating male impotence due to neurogenic or vasculogenic causes.  This document addresses the criteria for implantation of a penile prosthesis.

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 one year duration due to one of the following:

• Spinal cord injury/disease;
• Multiple Sclerosis;
• Spina Bifida;
• Diabetes;
• Syringomyelia;
• Radical prostatectomy;
• Rectal surgery;
• Fractured pelvis.
  OR

2. Vasculogenic impotence of greater than one year duration due to one of the following:

• Intrapenile arterial disease;
• Status post cavernosal infection;
• Peyronie's disease;
• Penile contusion;
• Hypertension;
• Penile fracture;
• Smoking.

Not Medically Necessary: 

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) in their Guideline on the Management of Erectile Dysfunction: Diagnosis and Treatment Recommendations Management of Erectile Dysfunction define 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).

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 percent of ED cases. Between 35 and 50 percent of men with diabetes experience ED.

Surgery (especially radical prostate and bladder surgery for cancer) can injure nerves and arteries near the penis, causing ED. 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. Penile implants involve surgical insertion of malleable or inflatable rods or tubes into the penis. The surgery is not without possible complications. Minervini et al (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.

Zermann et al (2006) studied 245 neurologically impaired men who had penile prosthetics implanted. There were 3 patient groups based on the indication for penile prosthetic surgery. Group 1 consisted of 134 participants with urinary management only; Group 2 60 participants with erectile dysfunction only, and Group 3 51 participant with urinary management and erectile dysfunction. Outcomes showed at a mean follow-up of 7.2 years (maximum 17 years) 195 patients were reevaluated in clinic. In 122 patients (90.3%) urinary management problems were resolved. Erectile dysfunction treatment was successful in 76 patients (82.6%). 43 revisions were performed for complications (e.g. infections and device perforation).

Peer Reviewed Publications:

1. Henry GD, Wilson SK. Updates in inflatable penile prostheses. Urol Clin North Am. 2007; 34(4): 535-547.
2. 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.
3. 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.
4. Mulcahy JJ, Austoni E, Barada JH, et al. The penile implant for erectile dysfunction. J Sex Med. 2004; 1(1):98-109.
5. 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.
6. 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; Discussion 1044.

Government Agency, Medical Society, and Other Authoritative Publications:

1. The American Urological Association (AUA). Guideline on the Management of Erectile Dysfunction: Diagnosis and Treatment Recommendations. 2006. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=ed .  Accessed on October 4, 2009.
2. 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: http://www.aace.com/pub/pdf/guidelines/sexdysguid.pdf . Accessed on October 5, 2009.
3. Centers for Medicare and Medicaid Services. National Coverage Determination: Diagnosis and Treatment of Impotence. NCD #230.4. Effective date not posted. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=230.4&ncd_version=1&basket=ncd%3A230%2E4%3A1%3ADiagnosis+and+Treatment+of+Impotence.  Accessed on October 05, 2009.
4. National Institutes of Health (NIH). Consensus statement: Impotence. 1992; 10(4):1-31.
5. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Erectile Dysfunction. Available at: http://www.kidney.niddk.nih.gov/kudiseases/pubs/impotence/. Accessed on October 5, 2009.
6. Wilt T J, Fink H A, MacDonald R, Rutks I R, Schow D. Treatment options for male erectile dysfunction: a systematic review of published studies of effectiveness. Boston, MA, USA: Veterans Affairs Medical Center, Health Services Research and Development Service, Management Decision and Research Center. Technology Assessment Program; 1999. Available at: http://www1.va.gov/resdev/resources/pubs/docs/PET_11.pdf. Accessed on October 5, 2009. 

Erectile Dysfunction
Penile Prosthesis, Insertion