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Erectile Dysfunction (ED) What is it? # 01056 CPTS and HCPCS Codes – C1813, C2622, J0270, J0275, J2440, J2760, L7900, S0090, 37788, 54400 – 54417 Experimental Codes – J1070, J1080, J3120, J3130, J3140, J3150. 51792, 54240, 54250, 83550, 84066, 95900 – 95904, 95925, 95927 Erectile dysfunction (ED) (such as impotence) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. ED affects between 15 and 30 million American men. There are multiple causes of ED including disease processes, psychological conditions, trauma, drug and alcohol use/abuse, as well as smoking. ED may occur as a result of an underlying medical condition, such as diabetes, kidney disease, hormonal imbalance, multiple sclerosis, atherosclerosis, vascular disease or neurological disease. Injury to the penis, spinal cord, prostate, bladder, and pelvis may also cause ED. Surgery, especially radical prostate or bladder surgery can injure the nerves and arteries near the penis resulting in ED. Many medications have ED as a side effect and include: antihypertensive drugs, antihistamines, antidepressants, tranquilizers, opiates, and appetite suppressants. Psychological factors (such as stress, anxiety, depression, and low selfesteem) cause 10–20% of ED cases. Note: The treatment of male sexual dysfunction, including ED, is specifically excluded under some benefit plans; therefore, penile prostheses and other treatments may not be covered or limited. When coverage is available it is subject to the terms, conditions and limitations of the applicable benefit plan. Criteria Diagnosis of ED There are a variety of diagnostic tests that are considered medically necessary in order to diagnose ED including – serum testosterone, pharmacological response testing using vasoactive drugs and thyroid function studies. However, the following tests for diagnosis of ED are considered experimental and investigational: • Dorsal nerve conduction latencies – 95900 - 95904 • Evoked potential measurements – 95925 - 95927 • Iron binding capacity - 83550 • Nocturnal penile tumescence (NPT) or rigidity testing – 54250 - using postage stamp or snap gauge test unless clinical evaluation including history and physical exam are unable to distinguish psychogenic from organic impotence and any identified medical factors have been corrected. RigiScan is considered medically necessary only when postage stamp or snap gauge testing are inconclusive. • Penile plethysmography - 54240 • Prostatic acid phosphatase - 84066 • Stimulus evoked response (measurement of bulbocavernosus reflex latency time) 51792 1 Treatment of ED Once ED has been diagnosed and documented, treatment is considered medically necessary only when the condition is the result of or related to an organic disease or injury (not psychological in nature – Diagnoses Codes 302.70 – 302.79). Therapy should be applied in a stepwise fashion with increasing invasiveness and risk balanced against the likelihood of efficacy. Injectable and oral agents have become the first line treatment option for ED. The following therapies for the treatment of ED are considered medically necessary: z Injectable Medications given into the corpus cavernosa or through a small catheter into the urethra. The latter procedure is known as MUSE – Medicated Urethral System for Erection. Medications include: 1) Papaverine – J2440; 2) Alprostadil (prostaglandin E1 or Caverject) – J0270, J0275; and, 3) Phentolamine – J2760. z Oral Medications. However many benefit plans exclude coverage for drugs for lifestyle enhancement or performance. Medications include: 1) Viagra® - sildenafil citrate (S0090); 2) Levitra® - vardenafil hydrochloride; and, 3) Cialis® - tadalafil. z Testosterone replacement therapy (J1070, J1080, J3120, J3130, J3140, J3150) including transdermal preparations are considered experimental and investigational for the treatment of nonhypogonadal impotence because effectiveness has not been established. Topical creams or gels containing vasodilators (such as Verapamil cream) are experimental and investigational for treatment of ED because their effectiveness has not been established. External Devices or vacuum constriction devices (such as Osbon ErecAid™ and Rejoyn Vacuum Therapy System – L7900) are considered medically necessary when prescribed by a physician as an alternative to medication therapies for ED. z external devices are considered experimental and investigational for all other indications including for the prevention of erectile dysfunction following prostatectomy. Implantable Devices or semi-rigid (AMS Malleable 650 and Mentor Genesis™ C2622) or inflatable (AMS 700 CXM and Mentor Alpha 1® - C1813) implantable penile prostheses (54400 – 54417) are considered medically necessary after failure or contraindication to medical therapies. Removal of internal penile prosthesis is considered medically necessary for any of the following indications: 1) infection; or, 2) mechanical failure; or, 3) urinary obstruction; or, 2 4) intractable pain. z Implantable penile prostheses are considered experimental and investigational for all other indications. As surgery destroys the corpus cavernosus of the penis, this procedure precludes any future pharmacological treatment. Surgical Penile Revascularization (37788) for vasculogenic ED is considered medically necessary for members who meet all of the following criteria: 1) Member is less than 55 years old; and, 2) ED is direct result of an arterial injury caused by blunt trauma to the pelvis and/or perineum (902.50, 902.54, 902.59); and, 3) Blockage of arterial inflow is demonstrated by duplex Doppler ultrasound or arteriography (440.8 – 440.9, 607.82); and, 4) Diagnostic testing reveals normal corporeal venous function; and, 5) Member is not diabetic (250.00 – 250.93) and has no systemic vascular occlusive disease; and, 6) Member does not actively smoke. Notice Penile revascularization is considered experimental and investigational for other indications. Arterial reconstructive procedures – dorsal vein arterialization procedures or penile venous occlusive surgery (venous ligation or dorsal vein ligation – 37790) in men with ED secondary to arteriosclerotic occlusive disease is experimental and investigational because it has not been proven to be effective. Policies are designed to provide medical guidelines that are applicable for the majority of individuals with a particular disease, illness, or condition. In addition, policies are designed to supplement the medical necessity terms as defined in the member's Policy or Benefit Plan. Therefore, policies alone can not override specific Policy or Benefit plan language regarding coverage, limitations and exclusions. In the event of conflict, the Policy or Benefit Plan shall govern. Any policies included herein do not constitute medical advice or the practice of policy to medicine. Rather, they are intended only to establish general guidelines. Application of a determine medical necessity in an individual instance is not intended, implied or construed to take priority over the professional judgment of a treating provider. In all situations, the treating provider must use professional judgment to provide the care believed to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions. Sentinel retains the right to review and update policies at its sole discretion. Policies are proprietary information of Sentinel. Any sale, copying or dissemination is prohibited; however, limited copying is permitted for individual use. 3