Erectile Dysfunction (ED) Treatment

may be considered medically necessary when the clinical criteria described in this policy. Self-administered ED drugs including oral, suppository and injectable medications are generally excluded from coverage. ED medication coverage is determined by Pharmacy formulary and plan coverage documents.

Definitions:

• Corpus Cavernosum - Spongy erectile tissue of the penis.
• Erectile Dysfunction (ED) - The inability to achieve or maintain an erection sufficient for satisfactory sexual performance. ED may be caused by disease, injury, alcohol or substance use/abuse, smoking, low testosterone or other hormonal imbalances, medication side effects, psychological conditions, or inadequate blood flow. Additionally, some disorders may interfere with the corporal vascular-occlusive mechanism and result in failure to trap blood within the penis or produce leakage such that an erection cannot be maintained or is easily lost. ED can often be successfully treated with drugs or medical therapies or with assistance from external or implantable devices. A variety of evidence-based treatments are addressed in this policy.
• Peyronie’s Disease - Curvature of the penis caused by fibrous scar tissue developing under the skin of the penis; causes painful erection and intercourse, and difficulty with penetration.
• Vasculogenic - Means caused by disorder or dysfunction of the blood vessels.

Clinical Criteria: (Indications/Limitations)

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HeatthFirst Health Plans

I. Erectile Dysfunction Etiology

A. Physical Etiology:

ED treatment IS considered medically necessary ONLY when ED is caused by a physical condition. Physical conditions include one or more of the following conditions:

1. Injury to perineum/genitalia
2. Major vascular surgery involving aorta or femoral blood vessels
3. Neurological disease such as diabetic neuropathy
4. Peyronie’s disease
5. Renal failure
6. Spinal cord injury
7. Status post-prostate, bladder, bowel, or spinal surgery
8. Vascular insufficiency or venous incompetence documented by dynamic infusion cavernosometry and cavernosography (DICC)
9. Venous leak of the penis

B. Non-Physical Etiology:

ED treatment is NOT considered medically necessary when ED is caused by one or more of the following:

1. A psychological condition
2. Untreated depression or other psychiatric illness
3. Active alcohol or substance abuse
4. Suboptimal drug therapy

Treatments – When erectile dysfunction has a physical etiology, the following treatments may be considered medically necessary as described:

A. Medications:

1. Self-administered ED drugs, including oral, suppository and injectable medications, are generally excluded from coverage even when medical necessity has been established.
2. ED medication coverage is determined by Pharmacy formulary and/or plan documents.

B. External Vacuum Assisted Erection Devices:

1. Mechanical devices have been developed that utilize vacuum pressure to encourage increases in arterial inflow and occlusive rings to limit venous egress from the penile corpora cavernosa.
2. Vacuum erection devices are considered medically necessary to treat ED when ALL the following criteria are met:

• The member meets the definition of physical etiology above.
• Drug therapy fails or is contraindicated
• A penile implant it NOT currently in place
• Contraindications do NOT exist

Vacuum erection devices are NOT considered medically necessary to prevent erectile dysfunction post-prostatectomy.

C. Implantable Devices:

Implantation of a semi-rigid or inflatable penile prosthesis (penile pump) is considered medically necessary to treat ED when ALL the following criteria are met:

1. Patient has normal thyroid and testosterone hormone levels, or abnormal levels do NOT respond to appropriate hormone replacement therapy
2. Patient does NOT have drug-induced ED related to anabolic steroids, anticholinergics, antidepressants, antipsychotics or central nervous system depressants
3. Patient does NOT have untreated mental illness
4. Surgical contraindications do not exist

D. Removal and Replacement of a medically necessary penile prosthesis is considered medically necessary when ANY of the following criteria are met:

1. Infection,
2. Intractable pain,
3. Mechanical failure,
4. Urinary obstruction.

Note: Replacement coverage applies ONLY if member meets current HFHP coverage requirements for initial implantation of penile prosthesis.

E. Surgical Revascularization is considered medically necessary to treat vasculogenic ED when ALL of the following criteria are met:

1. Member is under the age of 55
2. ED is the direct result of an arterial injury caused by blunt trauma to the pelvis and/or perineum
3. Focal blockage of arterial flow is demonstrated by duplex Doppler ultrasonography or arteriography
4. Member does NOT have peripheral vascular occlusive disease
5. Member is NOT diabetic
6. Member does NOT actively smoke

F. Peyronie’s Disease Treatment:

1. Intraplaque injection medical necessity and coverage determinations are governed by Pharmacy formulary and plan documents.
2. Injection medication used to treat Peyronies Disease (i.e. Xiaflex) may be covered if the member meets FDA medication labeling requirements for penile curvature
3. Extracorporeal shockwave therapy and Iontophoresis (Verapamil) are NOT considered medically necessary to treat Peyronie’s disease, as there is insufficient evidence of effectiveness.
4. Surgical procedures listed below are considered medically necessary to treat Peyronie’s disease when symptoms persist despite conservative treatment ≥ 12 months:

• Plaque excision
• venous grafting
• tunica placation
• Nesbit tuck procedure

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HeatthFirst Health Plans

Other Treatments and Indications:

All other treatments and indications are NOT considered medically necessary as there is insufficient evidence proving effectiveness in treatment

Limitations:

1. ED medication coverage is determined by Pharmacy formulary and/or plan documents. Coverage, if any, is governed by plan documents.
2. If coverage is excluded, payment will not be made for the services, even if they are considered medically necessary.