Blue Cross Blue Shield of Minnesota Medical Policy

 
 
Medical Policy:
IV-166-003
Topic:
Penile Prosthesis Implantation
Section:
Surgery
Effective Date:
June 1, 2020
Issued Date:
November 16, 2020
Last Revision Date:
March 2020
Annual Review:
March 2020
 
 

This policy version was replaced on March 29, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Erectile dysfunction (ED) may result from systemic disorders such as hypertension, ischemic heart disease and diabetes mellitus and its prevalence increases with age. First-and second-line therapies include oral, self-injectable or transdermal medications as well as external penile pumps. Surgical implantation of a penile prosthesis is also a treatment option for ED, particularly among men who cannot use or who have not responded to first-and second-line therapies.

Penile rigidity implants are regulated by the U.S. Food and Drug Administration (FDA) as class II devices with special controls and 510(k) premarket notification. Examples of FDA cleared devices include the Coloplast Genesis®,  AMS Spectra™ and Tactra™ Malleable Penile Prosthesis. Inflatable prostheses are regulated by the FDA as class III devices requiring premarket approval (PMA).  Examples of inflatable penile prostheses include the AMS 700 Series (LGX, CX and CXR), AMS Ambicor™ and Coloplast Titan®.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I.    A surgically implanted penile prosthesis may be considered MEDICALLY NECESSARY for treatment of erectile dysfunction when all of the following criteria are met:

  • Erectile dysfunction is due to one or more of the following:
    • Neurologic condition (e.g., diabetic neuropathy, multiple sclerosis, spina bifida)
    • Vascular condition (e.g., hypertension, intrapenile arterial disease)
    • Peyronie’s disease
    • Pelvic trauma with urinary system injury
    • Previous radiation therapy to the pelvis
    • Renal failure
    • Spinal cord injury/disease
    • Complication of surgery (e.g., cystectomy, prostatectomy) AND
  • One or more of the following medical therapies have been tried and failed or patient has contraindications to ALL of the following:
    • Oral medications (i.e., phosphodiesterase-5 [PDE5] inhibitors);
    • Vacuum constriction device;
    • Intracavernosal injection;
    • Intraurethral medications. AND
  • Patient is free of contraindications including but not limited to:
    • Systemic  infection
    • Active urogenital infection or
    • Active skin infection in the region of surgery.

II.   Removal of an implanted penile prosthesis may be considered MEDICALLY NECESSARY for any of the following:

  • infection; or
  • mechanical failure; or
  • urinary obstruction; or
  • intractable pain.

III.  Replacement of an implanted penile prosthesis may be considered MEDICALLY NECESSARY when medical necessity criteria in section I continue to be met.

IV.   Implantation, removal and/or replacement of a penile prosthesis is considered NOT MEDICALLY NECESSARY when criteria above are not met.

54400, 54405, 54410, 54416, C1813, C2622







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Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies.

Medicaid products and some self-insured plans may have additional policies and prior authorization requirements. As applicable, review the provisions relating to a specific coverage determination, including exclusions and limitations. Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.


For Medicare NCD and/or Medicare LCD, please consult CMS or National Government Services websites.


Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and /or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only, and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.