Description Erectile Dysfunction

Erectile dysfunction (ED) is the chronic inability to achieve or maintain an erection of sufficient duration and firmness to complete satisfactory intercourse. Causes may be psychological or organic (physical). Treatment options generally include devices, medications or surgical procedures.

Description Penile implants

Penile implants are prosthetic devices surgically inserted into the corpus cavernosum. Two types of penile implants are available; inflatable and semi rigid (noninflatable).

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Erectile Dysfunction and Peyronie’s Disease Treatments

Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0415-018
Page: 2 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Inflatable penile prostheses are designed to approximate the rigidity and flaccidity of the normally functioning penis and are available as two-piece or three-piece components. Inflation occurs by manually squeezing a pump.
• Semi-rigid (noninflatable) penile implants are made of firm yet malleable material so that the resulting permanent erection can be manually positioned downward close to the body unnoticeably.
• Penile arterial revascularization is a surgical procedure to improve blood flow to the corpora cavernosa. The most commonly performed technique for penile revascularization involves anastomosis of the inferior epigastric artery to the dorsal penile artery (dorsal artery arterialization).
• Nerve graft (eg, sural nerve graft) is a procedure that purportedly restores erectile function in an individual who has undergone deliberate excision of one or both neurovascular bundles during radical prostatectomy. An autologous sural nerve graft is interposed between the divided ends of the cavernous nerves. (Refer to Coverage Limitations section)
• Penile venous reconstructive or veno-occlusive surgery is a surgical procedure that purportedly improves blood flow to the corpora cavernosa, prevents the pathologic blood egress from the penis and corrects veno-occlusive ED. (Refer to Coverage Limitations section)
• Platelet-rich plasma (PRP) therapy is an adaptation of autologous whole blood injections. Whole blood is centrifuged to a concentrated state and is injected into penile erection tissue to purportedly assist in repairing and regenerating the tissue. (Refer to Coverage Limitations section)
• Shockwave therapy, also referred to as low-intensity extracorporeal shockwave therapy (LI-ESWT), is a noninvasive procedure that uses acoustic waves to purportedly induce neovascularization to improve erectile tissue function. (Refer to Coverage Limitations section)
• Stem cell therapy is an injection of stem cells into penile erection tissue that purportedly assists in replenishing, repairing or regenerating the tissue. (Refer to Coverage Limitations section)

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Vacuum erection devices (VEDs) offer a mechanical nonsurgical method of filling the penis with blood and creating an erection. VEDs are usually comprised of an airtight tube, a handheld or battery operated pump and a ring. Air is removed from the cylinder by the pump; thereby creating a vacuum and drawing blood into the penis. The erection is maintained by trapping the blood in the penis with a tight elastic band around its base.

(Refer to Coverage Limitations section)For information regarding Cialis (tadalafil) or erectile dysfunction medications, please refer to Cialis (tadalafil) or Erectile Dysfunction Medications Pharmacy Coverage Policies.

Peyronie’s Disease

Peyronie’s disease (PD) is an acquired, localized fibrotic disorder of the tunica albuginea, which can cause significant penile deformity and lead to sexual dysfunction and psychological trauma. The exact cause of PD has not yet been defined, although most would agree that some injurious stimulus is necessary to trigger the cascade of events that leads to PD in the susceptible individual. Trauma may be perceived as a single event experienced by the individual or may take the form of repetitive microtrauma to the penis. The nature and extent of Peyronie's plaque, and therefore severity or complexity of penile deformity, varies widely. The most frequent presenting symptoms of an individual with PD include penile pain, erect deformity and palpable plaque, as well as ED.

There are two phases. The first is the acute (active) phase, which is commonly associated with painful erections and changing deformity of the penis. This is followed by a chronic (stable) phase, which is characterized by stabilization of the deformity and disappearance of painful erections. Complete spontaneous resolution of PD is a rare occurrence.

Nonsurgical treatment for PD may include oral medications, injections, traction, vacuum therapy or a combination. Additional nonsurgical treatments such as electromotive drug administration have limited evidence of efficacy while treatments such as extracorporeal shockwave therapy (ESWT) and radiation therapy are not recommended for the treatment of PD. (Refer to Coverage Limitations Section)

Erectile Dysfunction and Peyronie’s Disease Treatments
Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0415-018
Page: 4 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Surgical management of PD includes plication, plaque excision and grafting or placement of a penile prosthesis. Important factors to consider in determining the best surgical approach include the length of the penis, configuration (eg, hourglass, curved) and severity of the deformity, erectile capacity and individual expectations.

Tunica plication is a surgical procedure to straighten the penis where plication is accomplished by shortening the convex side of the penis (opposite the plaque). All plication procedures result in loss of penile length as the tunica albuginea is shortened on the longer side to match the shorter side. Since the stretched penile length is determined by the shorter, less elastic side, the objective loss of penile length after plication is often less than what is perceived by the individual. The most common plication techniques are the Lue, Nesbit and Yachia procedure.

Tunical lengthening procedure (plaque excision or partial excision and grafting) is a surgical procedure to improve plaque-induced penile deformities associated with PD. Following management or removal of the plaque, a graft is placed. Grafting the concave side of the penis serves to lengthen that side and, therefore, straighten the penis.

For curvature associated with significant ED, a penile prosthesis can be placed, and additional corrective procedures (plication or grafting) may be performed if the prosthesis does not provide adequate straightening.

Coverage Determination

Please refer to the member's applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of erectile dysfunction/impotence/sexual dysfunction.

Penile Implant

Humana members may be eligible under the Plan for a penile implant for erectile dysfunction when ALL of the following criteria are met:

• Erectile dysfunction has persisted at least 6 months; AND
• Nonsurgical methods (eg, medications) have proven ineffective or are contraindicated (eg, cardiac disease that precludes medication); AND
• Erectile dysfunction of vasculogenic etiology as a result of any one or more of the following:

• Documented injury to perineum/genitalia; OR
• Following radiation therapy for prostate cancer; OR
• Following pelvic trauma affecting anal and/or bladder and/or erection control; OR
• Following vascular surgery involving aorta or femoral blood vessels; OR
• Peyronie’s disease; OR
• Vascular insufficiency or venous incompetence documented by either duplex doppler ultrasound (DDUS) or dynamic infusion cavernosometry and cavernosography (DICC); OR
• Venous leak of the penis; OR

• Erectile dysfunction of neurogenic etiology as a result of one or more of the following:

• Following bladder, bowel, prostate or spinal surgery; OR
• Neurological disease (eg, diabetic neuropathy, multiple sclerosis, spina bifida); OR
• Secondary to spinal cord injury; OR

• For erectile dysfunction without a definitive neurogenic or vasculogenic etiology listed above (eg, impaired renal function), endocrine (hormonal) or other causes have been ruled out or treated, as evidenced by the following:

• Absence of active alcohol, anabolic steroid and substance abuse; AND
• Absence of psychogenic erectile dysfunction, untreated depression and untreated psychiatric illness; AND

Erectile Dysfunction and Peyronie’s Disease Treatments
Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0415-018
Page: 5 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Erectile Dysfunction and Peyronie’s Disease Treatments
Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0415-018
Page: 6 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Documentation that prolactin, testosterone and thyroid levels are within normal limits

Humana members, may be eligible under the Plan for removal of a penile implant for ANY of the following indications:

• Infection; OR
• Intractable pain; OR
• Mechanical failure; OR
• Urinary obstruction

Humana members may be eligible under the Plan for a medically necessary reimplantation of a penile implant following removal of a penile implant as indicated above.

Penile Arterial Revascularization

Humana members may be eligible under the Plan for a penile arterial revascularization surgery when ALL of the following criteria are met:

• 55 years of age or younger; AND
• Absence of diabetes mellitus; AND
• Absence of venous leakage of the penis confirmed by either DDUS or DICC; AND
• Documentation of testosterone levels within normal limits; AND
• Individual must be nicotine-free for 6 weeks prior to the date of the anticipated surgery (unless the surgical procedure is emergent); AND
• Individual who has been a nicotine user prior to the anticipated surgery must provide documentation of nicotine cessation, as evidenced by negative lab test report for cotinine, to have been performed within 30 days of the planned surgical procedure; AND
• Radiographic confirmation of arterial stenosis by DDUS or penile arteriogram; AND
• Vasculogenic erectile dysfunction as a result of pelvic or perineal trauma

Note: The criteria for erectile dysfunction treatments are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Peyronie’s Disease

Humana members may be eligible under the Plan for surgical treatment (eg, plaque excisions and grafting, tunica plication, Nesbit tuck procedure) of PD when the following criteria are met:

• Failure of conservative treatment which includes, but not limited to:

• Intralesional injections; OR
• Mechanical and medication therapy; OR
• Oral medications; OR
• Penile traction; OR
• Topical drug applications; AND

• Penile deformity compromising sexual function related to pain; AND
• Peyronie's disease that has persisted for more than 12 months

Coverage Limitations

Erectile Dysfunction

Humana members may NOT be eligible under the Plan for penile implants for psychogenic erectile dysfunction or any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for penile arterial revascularization surgery for any indications other than those listed above. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Erectile Dysfunction and Peyronie’s Disease Treatments
Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0415-018
Page: 8 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for vacuum erection devices for any indication. Although they may be prescribed by a health care practitioner, vacuum erection devices are also available without a prescription and may be obtained over the counter (OTC) and are therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, these devices are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for treatment of ED with any of the following:

• Nerve graft (eg, sural nerve graft); OR
• Penile venous reconstructive or veno-occlusive surgery; OR
• PRP therapy; OR
• Stem cell therapy; OR
• Shockwave therapy or LI-ESWT

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Peyronie’s Disease

Humana members may NOT be eligible under the Plan for surgical treatment of PD for any indications other than those listed above. This is considered experimental/ investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for treatment of PD with any of the following:

• Electromotive drug administration; OR
• ESWT; OR
• Radiation therapy

Erectile Dysfunction and Peyronie’s Disease Treatments

Effective Date: 03/01/2023
Revision Date: 03/01/2023
Review Date: 03/01/2023
Policy Number: HUM-0415-018
Page: 9 of 14

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about erectile dysfunction and Peyronie’s disease may be found from the following websites:

• Background
• American Urological Association
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.