Clinical UM Guideline


Subject:Penile Prosthesis Implantation
Guideline #:  CG-SURG-12Current Effective Date:  01/14/2014
Status:ReviewedLast Review Date:  11/14/2013

Description

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

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:

−  Spinal cord injury/disease;

−  Multiple Sclerosis;

−  Spina Bifida;

−  Diabetes;

−  Syringomyelia;

−  Radical prostatectomy;

−  Rectal surgery;

−  Fractured pelvis.

OR 

−  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.

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 
54400Insertion of penile prosthesis; non-inflatable (semi-rigid)
54401Insertion of penile prosthesis; inflatable (self-contained)
54405Insertion of multi-component, inflatable penile prosthesis, including placement of pump, cylinders, and reservoir
54410Removal and replacement of all component(s) of a multi-component, inflatable penile prosthesis at the same operative session
54411Removal 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
54416Removal and replacement of non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis at the same operative session
54417Removal 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 
C1813Prosthesis, penile, inflatable
C2622Prosthesis, penile, non-inflatable
L8699Prosthetic implant, not otherwise specified
  
ICD-9 Procedure[For dates of service prior to 10/01/2014]
64.95Insertion or replacement of non-inflatable penile prosthesis
64.97Insertion or replacement of inflatable penile prosthesis
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
 All diagnoses
  
ICD-10 Procedure [For dates of service on or after 10/01/2014]
0VUS0JZSupplement penis with synthetic substitute, open approach
0VUS4JZSupplement penis with synthetic substitute, percutaneous endoscopic approach
  
ICD-10 Diagnosis [For dates of service on or after 10/01/2014]
 All diagnoses
Discussion/General Information

The American Urological Association (AUA), in their Guideline on the Management of Erectile Dysfunction: Diagnosis and Treatment Recommendations Management of Erectile Dysfunction, 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).  The European Association of Urology (EAU) defines ED as the "persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance" (Wespes, 2013). 

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.

The AUA (2007) guideline 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 (Wespes, 2013) recommend the implanted penile prosthesis as a third line of therapy for individuals that have failed other non-surgical treatments.

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 after failure of less invasive medical treatments.  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 has 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.  Outcomes showed at a mean follow-up of 7.2 years (maximum 17 years), 195 participants were reevaluated in the clinic.  In 122 participants (90.3%) urinary management problems were resolved.  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. 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.
  2. Hellstrom WJ, Montague DK, Moncada I, et al. Implants, mechanical devices and vascular surgery for erectile dysfunction.  J Sex Med. 2010: 501-523.
  3. Henry GD, Wilson SK. Updates in inflatable penile prostheses. Urol Clin North Am. 2007; 34(4):535-547.
  4. 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.
  5. 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.
  6. Mulcahy JJ, Austoni E, Barada JH, et al. The penile implant for erectile dysfunction. J Sex Med. 2004; 1(1): 98-109.
  7. PhĂ© V, RouprĂȘt 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.
  8. Selph JP, Carson CC. Penile prosthesis infection: approaches to prevention and treatment. Urol Clin North Am. 2011; 38(2):227-235.
  9. 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.
  10. 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. The American Urological Association (AUA). Guideline on the management of erectile dysfunction: an update. 2005/Update 2007. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=ed. Accessed on September 16, 2013.
  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: https://www.aace.com/files/sexdysguid.pdf. Accessed on September 16, 2013.
  3. Centers for Medicare and Medicaid Services. National Coverage Determination: Diagnosis and Treatment of Impotence. NCD #230.4. Effective date not posted. Available at: https://www.cms.gov/medicare-coverage-database/indexes/ncd-by-chapter-and-section-index.aspx?bc=AgAAAAAAAAAA&. Accessed on September 16, 2013.
  4. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Erectile Dysfunction. June 2009. Available at: http://www.kidney.niddk.nih.gov/KUDiseases/pubs/ED/index.aspx. Accessed on September 16, 2013.
  5. Wespes E, Eardley I, Giuliano D, et al. European Association of Urology. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2013.  Available at: http://www.uroweb.org/fileadmin/guidelines/Total_file_2013_large_guidelines_prints.pdf. Accessed on September 15, 2013.
  6. Wilt T J, Fink H A, MacDonald Ret al. 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://www.research.va.gov/resources/pubs/docs/ED_11.pdf. Accessed on September 16, 2013. 
Index

Erectile Dysfunction
Penile Prosthesis, Insertion

History
StatusDateAction
Reviewed11/14/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Background, References and Websites sections.
Reviewed11/08/2012MPTAC review. Discussion, Discussion and References updated
Reviewed11/17/2011MPTAC review. Discussion, Coding and References updated.
Reviewed11/18/2010MPTAC review. Discussion and References updated.
Reviewed11/19/2009MPTAC review. Place of Service section deleted. Discussion and references updated.
Reviewed11/20/2008MPTAC review. References updated.
Reviewed11/29/2007MPTAC review. References and coding were updated.
Reviewed12/07/2006MPTAC review. References updated; no change to guideline criteria.
Revised12/01/2005MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger OrganizationsLast Review DateDocument NumberTitle
Anthem, Inc.  No Document
Anthem BCBS  No Document
WellPoint Health Networks, Inc.12/02/2004Clinical GuidelinePenile Prosthesis Insertion