Treatment of male sexual dysfunction with an internal or external penile prosthesis is eligible, according to the terms of the member’s contract, when either of the following medical necessity criteria is met:

• erectile dysfunction is due to an organic disease or injury and is not psychological in nature
• there is failure, contraindication or intolerance to pharmacological therapy

Diagnosis
The following diagnostic work-up for the diagnosis of erectile dysfunction is considered medically necessary:

• Comprehensive history and physical examination (including medical and sexual history and psychosocial evaluation)
• Duplexscan (doppler and ultrasound) in conjunction with intracorporeal papaverine
• Dynamic infusion cavernosometry and cavernosography only for individuals who are to undergo revascularization procedures and meet medical necessity criteria for penile revascularization
• Pharmacological response test for erectile dysfunction (using vasoactive drugs, e.g., papaverine HCl, phentolamine mesylate, prostaglandin E1)
• Pudendal arteriography (angiography) only for members who are to undergo penile revascularization and meet the medical necessity criteria for penile revascularization
• Lab tests for hormone levels of testosterone
  • Abnormal hormone levels indicate further endocrine testing for pituitary, thyroid, and adrenal dysfunction

The following laboratory tests are considered medically necessary for the diagnosis of erectile dysfunction:

• Biothesiometry (biothesiometry is considered an integral part of the comprehensive history and physical examination)
• Blood glucose
• Complete blood count
• Creatinine
• Hepatic panel
• Lipid panel
• Prostatic specific antigen
• Serum testosterone
  • Tests for evaluation of pituitary dysfunction (e.g., measurement of lutenizing hormone, follicle-stimulating hormone, and prolactin levels) if serum testosterone level is below normal
• Thyroid function studies
• Urinalysis

Routine nocturnal penile tumescence (NPT) and/or rigidity testing has no proven value. Nocturnal penile tumescence testing using the postage stamp test or the snap gauge test is rarely medically necessary. NPT is considered medically necessary where clinical evaluation, including history and physical examination, is unable to distinguish psychogenic from organic impotence and any identified medical factors have been corrected. NPT testing using the RigiScan is considered medically necessary only where NPT testing is indicated, and the results of postage stamp or snap gauge testing are equivocal or inconclusive.  All other indications for NPT are considered not medically necessary.

The following diagnostic procedures are considered not medically necessary, and therefore are not covered, because spinal cord injury and other neurological deficits that may cause erectile dysfunction are typically identified during a comprehensive history and examination. These tests do not have any therapeutic implications and are, therefore, not medically necessary:

• Corpora cavernosal electromyography
• Dorsal nerve conduction latencies
• Evoked potential measurements

Treatment
The surgical implantation of an internal penile prosthesis is considered medically necessary when the above criteria have been met and consideration has been given to a vacuum constriction device.

The removal of an internal penile prosthesis is considered medically necessary for any of the following indications:

• Infection, or
• Mechanical failure, or
• Urinary obstruction, or
• Intractable pain

Following the medically necessary removal of an internal penile prosthesis, when benefit coverage is available for the internal penile prosthetic device, the surgical re-implantation of a medically necessary internal penile prosthetic device is covered.

Penile revascularization, artery, with or without vein graft, is considered medically necessary for the treatment of erectile dysfunction when all of the following criteria are met:

• The individual presents with erectile dysfunction preceded by blunt perineal or pelvic trauma, and
• The individual has erectile dysfunction that is secondary to a focal arterial occlusion, as evidenced by an arteriogram or duplex ultrasonography conclusive for focal arterial obstruction, and
• There is no evidence of generalized vascular disease (e.g., diabetes mellitus, hypertension, coronary artery disease), Peyronie’s plaques, intracavernosal masses, nodules, or sensory neuropathy, and
• There is evidence of normal corporeal venous function, and
• Alternative nonsurgical treatment modalities have been fully explained to the individual, and the individual is determined to achieve spontaneous erections without the need for pharmacological, external, or internal support devices, and
• The individual is not actively smoking.

An external or internal penile prosthesis is considered not medically necessary for any other indication.

Venous ligation is performed as a treatment for patients with failure to store blood in the cavernosa. Venous ligation is considered not medically necessary.

Services that do not meet the medical necessity criteria will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Coverage for hormone injections (e.g., testosterone), the Snap-Gauge device (A4649), and vacuum constriction devices (e.g., ErecAid)(code L7900) is determined according to individual or group customer benefits.

Description

Erectile dysfunction is defined as the inability to achieve a sufficient erection for satisfactory sexual performance. Erectile function requires competent arterial blood inflow as well as a reduction of venous blood outflow. Disease and other risk factors may affect the arterial and venous systems in a manner that impedes erectile function and may lead to erectile dysfunction.

NOTE:

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.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Qaseem A, Snow V, Denberg T, et al. Hormonal testing and pharmacologic treatment of erectile dysfunction; A clinical practice guideline from the American College of Physicians. Ann Intern Med. 2009;151:639-649.

Tsertsvadze A, Fink H, Yazdi F, et al. Oral phosphodiesterase-5 inhibitors and hormonal treatments for erectile dysfunction: A systematic review and meta-analysis. Ann Intern Med. 2009;151:650-661.

Chung E, Brock GB. Emerging and novel therapeutic approaches in the treatment of male erectile dysfunction. Curr Urolo Rep. 2011. Epub ahead of print.

Selph JP, Carson CC. Penile prosthesis infection: approaches to prevention and treatment. Urol Clin North Am. 2011;38(22):227-235.

Montague DK. Penile prosthesis implantation in the era of medical treatment for erectile dysfunction. Urol Clin North Am. 2011;38(2):217-225.