Archived Policies - Medicine


Sexual Dysfunctions, Assessment and Treatment

Number:MED201.030

Effective Date:02-15-2007

End Date:05-31-2008

Coverage:

Assessment

The following diagnostic procedures may be considered medically necessary in the assessment of sexual dysfunction:

  • Comprehensive history and physical examination.
  • Pharmacologic screening test, intracavernosal injection of Papaverine, Phentolamine, or Prostagladin E [sub 1] (PGE1).
  • Nocturnal penile tumescence (NPT) test and rigidity monitoring (Morning Sleep Nap).
  • Evaluation of penile arterial flow
    1. Penile brachial index using a Doppler signal transducer.
    2. Pudendal arteriography with intracavernosal injection (ICI) using vasodilating agents.
    3. Angiography (with ICI) using vasodilating agents.
    4. Duplex Doppler sonography or color Doppler sonography (with ICI) using vasodilating agents.
  • Veno-occlusive dysfunction testing:
    1. Cavernosography utilizing radiocontrast solution (with ICI) using vasodilating agents.
    2. Cavernosometry with simultaneous infusion of saline solution (with or without ICI) using vasodilating agents.
  • Laboratory testing
    1. Hormonal evaluation (includes testosterone, luteinzing hormone, follicle stimulating hormone, prolactin levels).
    2. Complete blood count (CBC).
    3. Urinalysis.
    4. Thyroid function studies.
    5. Creatinine.
    6. Lipid profile.
    7. Diabetes screening (includes fasting blood sugar and glucose tolerance testing).

The following diagnostic procedures and laboratory tests for the assessment of sexual dysfunction are considered experimental, investigational and unproven:

  1. Corpora cavernosal electromyography (CCEMG)
  2. Single analysis of cavernous electrical activity (SPACE)
  3. Dorsal nerve conduction latencies
  4. Evoked potential measurements
  5. Penile plethysmography
  6. Iron binding capacity
  7. Prostatic acid phosphatase

Treatment

The following therapies for the treatment of sexual dysfunction may be considered medically necessary provided the contract does not contain any exclusions for any services related to sexual dysfunction.  Should the contract not contain exclusion for any services related to sexual dysfunction, coverage may be allowed if the patient has a documented disease process  (e.g., diabetes mellitus, hypertension, blood lipid abnormalities, or peripheral vascular disease). Other causes of sexual dysfunction may be caused by penile trauma, spinal cord injuries, and abnormalities of the penis (e.g., penile fibrosis and Peyronie’s disease). 

Surgical procedures, supplies, or medications used for treatment of sexual dysfunction include, but are not limited to:

  • Medications  
    1. Injections into the corpus cavernosa to cause an erection (papaverine, asprostadol, (prostaglandin E1 or Caverject) phentoalmine), and
    2. MUSE (medicated urethral system for erection) method of treatment for erectile dysfunction that involves inserting medication through a small catheter into the urethra,
    3. (Trans) urethral suppository method,
    4. Oral medication.
  • External and Implantable Devices
    1. Inflatable or non-inflatable penile implants (prostheses),
    2. Vacuum erection devices.
  • Penile venous occlusive surgery (e.g. venous ligation, dorsal vein ligation).
  • Penile revascularization for vasculogenic erectile dysfunction may be considered medically necessary only in men less than 50 years old who meet all of the following criteria:
    1. The erectile dysfunction is the direct result of an arterial injury caused by blunt trauma to the pelvis and/or perineum; and
    2. A focal blockage of arterial inflow is demonstrated by duplex Doppler ultrasonography or arteriography; and
    3. Diagnostic work-up reveals normal corporeal venous function; and
    4. Patient is not diabetic and has no evidence of systemic vascular occlusive disease; and
    5. Patient is a non-smoker.

Surgical correction of Peyronie’s disease (e.g., plaque excisions and venous graft patching, tunica placation, Nesbit tuck procedure) may be considered medically necessary when the disease has been present for at least12 months.

The following therapies for treatment of sexual dysfunction are considered experimental, investigational and unproven:

  1. Arterial reconstructive procedures, dorsal vein arterialization procedures, or penile venous occlusive surgery (e.g., venous ligation, dorsal vein ligation) in men with erectile dysfunction secondary to arteriosclerotic occlusive disease.
  2. Vacuum therapy as a treatment of female sexual dysfunction.
  3. Oral medication as an enhancement to sexual function and treatment of female sexual dysfunction.
  4. Topical cream or gel containing vasodilators, such as verapamil cream.
  5. Exogenous testosterone replacement therapy, including transdermal preparations for the treatment of non-hypogonadal sexual dysfunction.
  6. Extracorporeal shock wave therapy for Peyronie’ disease.
  7. Oral drug therapy using Yohimbine.
  8. Temporary or permanent ganglionic block or sympathectomy for erectile dysfunction secondary to cavernous adrenergic hypertone.

The use of procedures, supplies, or medications for treatment of psychological or psychogenic sexual dysfunctions may be contract exclusions.

Description:

Most sexual dysfunctions are related to disturbances in one or more phases of the sexual response cycle.  The disturbance may be physiologic/organic or psychological.  This dysfunction is usually chronic and perceived by the patient as a change in the sense of sexual pleasure as well as in performance. 

For women, female sexual dysfunction (FSD) is the persistent or recurrent failure to attain or maintain the lubrication-swelling response of sexual excitement until completion of the sexual activity.

Male sexual dysfunction or erectile dysfunction is the inability to attain or sustain an erection satisfactory for normal intercourse.  Causes contributing to male sexual or erectile dysfunction include, but are not limited to:

  1. Organic as a result of or secondary to a disease process or treatment (e.g., diabetes mellitus, hypertension, blood lipid abnormalities, or peripheral vascular disease), 
  2. Penile trauma,
  3. Spinal cord injuries,
  4. Abnormalities of the penis (e.g. penile fibrosis and Peyronie’s disease),
  5. Veno-occlusive dysfunction,
  6. As a result of radical pelvic surgery (e.g. radical prostatectomy or cystectomy),
  7. Alcohol and/or drugs,
  8. Smoking,
  9. Psychological/psychogenic factors such as anxiety, fatigue, interpersonal stresses, and chronic illness.

Assessment

The evaluation of sexual dysfunction begins with a comprehensive history and physical examination.  A careful sexual history and knowledge of concurrent illnesses and medications are essential. 

Laboratory Studies including Hormonal Assessment and Diabetes Screening,

  1. Morning sleep nap/Nocturnal penile tumescence testing;
  2. Pharmacologic screening testing including administering vascular dilating agents testing the penile erection process;
  3. Dynamic cavernosometry, penile and vaginal plethysmography, or duplex scan of penis;  
  4. Nocturnal penile tumescence and/or rigidity test;
  5. Evaluation of penile arterial flow including doppler studies, Angiography or Arteriography;
  6. Veno-occlusive dysfunction testing to include cavernosography and cavernosometry.

Dynamic infusion cavernosometry is a technique in which fluid is pumped into the penis at a known rate and pressure. It gives a measurement of the vascular pressure in the corpus cavernosum during an erection. To do this test a vasodilator like prostaglandin E-1 is injected to measure the rate of infusion required to get a rigid erection and to help find how severe the venous leak is. The cavernosography is an adjunct to this procedure, where a contrast material is injected and then it is x-rayed to visualize any leakage.

A plethysmograph is an instrument that measures variations in the size of an organ or body part on the basis of the amount of blood passing through or present in the part. Penile or vaginal pethysmography is used to measure physiological sexual arousal. 

The nocturnal penile tumescence (NPT) test determines whether a man is having normal erections during sleep.  The presence of normal erections during rapid eye movement (REM) sleep indicates that no organic etiology is present.

Treatment

Treatment for sexual dysfunctions includes:

  1. Inflatable or non-inflatable penile implants (prostheses);
  2. Vacuum erection devices;
  3. Intracavernosal injection therapy;
  4. (Trans)urethral suppository method;
  5. Oral Medication; 
  6. Vacuum therapy as a treatment of female sexual dysfunction;
  7. Arterial reconstructive procedures;
  8. Penile revascularization for vasculogenic erectile dysfunction;        
  9. Dorsal vein arterialization procedures;
  10. Penile venous occlusive surgery (e.g., venous ligation, dorsal vein ligation).

Inflatable or non-inflatable penile implants (prostheses) are devices that provide an erection on demand.  The inflatable penile implants are made of silicone rubber or polyurethane rubber.  The multi-component inflatable prostheses consist of two inflatable cylinders implanted in the penis.  These are connected to a reservoir filled with fluid implanted in the abdomen and a manual pump implanted in the scrotum.  In order to get an erection, the pump must be squeezed.  The non-inflatable prostheses are rigid, semi-rigid and malleable rods that produce varying degrees of penile rigidity to allow for vaginal penetration.

The vacuum erection device is a plastic cylinder that is placed around the penis.  When negative pressure is applied, the penis becomes rigid.  A rubber ring traps the blood in the penis and keeps the penis rigid until ejaculation.  These devices are made by a number of manufacturers and have very variable levels of sophistication, from manual pumps to battery operated devices.  The devices are reusable.

Intracavernosal injection therapy is the direct introduction of vasodilator substances into the corpora cavernosa of the penis via syringe and needle, creating an erection.  The most effective and well-studied agents are Papaverine, Phentolamine, and Prostaglandin E [sub 1] (PGE1).  These have been used either singly (such as Caverject that contains Alprostadil as the naturally occurring form of PGE1) or in combination.

The (trans) urethral suppository method introduces the medication into the urethra after urination, via an applicator stem, and is absorbed by the surrounding erectile tissues, creating an erection.  On November 19, 1996, the FDA approved MUSE, the first and only non-injectable, transurethral delivery system of Alprostadil.

To ensure safe and effective use of these substances, the patient should be thoroughly instructed and trained in the self-injection technique and solution preparation or the self-insertion before urethral suppository. 

The desirable dose should be initially established in the physician's office, known as titration.  This may require two to physician office visits.  Dosage adjustments can be done via the telephone with the physician once self-injection training has been completed.  The patient will have periodic routine follow-up visits and long-term therapy management, as often as in three month intervals.

Oral medication acts by enhancing the smooth muscle relaxant effects of nitric oxide, a substance that is normally released locally in response to sexual stimulation.  The medication does not directly cause penile erections, but the smooth muscle relaxation allows blood to enter and pool leading to an erection. 

The arterial revascularization procedure usually involves taking an artery from a leg and then surgically connecting it to the arteries at the back of the penis, bypassing the blockages and restoring blood flow. In a related procedure called deep dorsal vein arterialization, a penile vein is used for the bypass. Young men with local sites of arterial blockage or those with pelvic injuries generally achieve the best results. In studies of selected patients there was improvement in erectile dysfunction in 50% to 75% of men after five years.

Penile revascularization is vascular reconstructive surgery to improve blood flow to the penis. Revascularization involves bypassing blocked veins or arteries by transferring a vein from the leg and attaching it so that it creates a path to the penis that bypasses the area of blockage. Young men with only local arterial blockage are the best candidates for this procedure.

Venous ligation is performed when the penis is unable to store a sufficient amount of blood to maintain an erection. This operation ties off or removes veins that are causing an excessive amount of blood to drain from the erection chambers. The success rate is estimated at between 40% and 50% initially, but drops to 15% over the long term. It is important to find a surgeon experienced in this surgery. In a variation of this technique called venous ablation, ethanol is injected into the deep dorsal vein, the main vein that drains blood from the penis. The ethanol causes scarring that closes off smaller veins and prevents blood leakage, thereby bolstering erectile function.

Rationale:

Erectile dysfunction or impotence can be a secondary symptom of systemic diseases or their treatment, such as diabetes mellitus, hypertension, blood lipid abnormalities, or peripheral vascular disease.  Evaluation of impotence should include detailed medical and sexual history, physical examination, and basic lab studies.  Further diagnostic studies may be required to assess:

  • Erectile responses to medications,
  • Abnormalities in vascular flow, and/or
  • Absence of erections during sleep.

Considerable attention has been paid to the evaluation and treatment of sexual dysfunction due to the development of new drugs and procedures.  While benefits may have been previously provided on an exception basis for the treatment of this condition, some benefit plans specifically exclude payment for the treatment of sexual dysfunction.  This exclusion extends to prescriptions or medications for the treatment of sexual dysfunction as well as penile prostheses.

Penile revascularization surgery was first reported in the literature in 1972.  Significant complications resulted and subsequently the procedure has undergone several modifications.  The approach, which remains in use today, is a technique using a side-to-side anastomosis between the dorsal artery and vein covered by a spatulated epigastric artery.  The overall long-term efficacy of penile revascularization surgery is approximately 60%.

Laparoscopy was introduced in the mid-1990s as a minimally invasive approach to penile revascularization in order to reduce postoperative morbidity.

Controversy persists concerning the use of penile revascularization surgery.  Sharlip et al., in a report to the International Society for Impotence Research summarized the problems and weaknesses of the available studies

  • Imprecise patient selection criteria,
  • The lack of objective standardized follow-up,
  • The lack of rational physiologic surgical concepts,
  • Sham or placebo effects, and
  • Potential surgeon prejudice.

Although 15 years have passed since Sharlip’s critique, these key issues continue.

Although revascularization may increase arterial flow into the corporal bodies, this change alone does not guarantee the restoration of erectile function. Impaired neuronal and endothelium-dependent corporal smooth muscle relaxation, corporal fibrosis owing to hypertensive effects, or diabetes-induced connective tissue damage leading to veno-occlusive dysfunction are among the reasons why surgery fails despite a patent postoperative anastomosis. End-organ damage at the cellular level may be the overriding factor in a significant number of men with erectile dysfunction. Penile revascularization has proven efficacy in young men with arterial insufficiency secondary to pelvic trauma, which are a small subset of men for whom erectile dysfunction is an issue.

The 1992 National Institutes of Health Consensus Development Conference on Impotence stated that "penile revascularization should have a very limited role and probably should be restricted to the clinical investigation setting in medical centers with experienced personnel."

Several approaches to penile vein ligation have been used. The initial approach of single-vessel ligation of the dorsal vein was expanded due to poor results. A range of ligation procedures varied in their aggressiveness have emerged and range from dorsal and accessory vein ligation to complete ligation and excision of the dorsal, cavernous, and crural veins.  More recently dorsal vein embolization has been used alone or in combination with surgery to decrease the invasiveness of therapy. Two small case series have published promising short term results.  Deep dorsal vein arterialization has been proposed to increase venous outflow pressures and compensating for veno-occlusive dysfunction. Preliminary evidence indicates promise in treating mixed arterial and veno-occlusive disease.

Success rates for surgical procedures for veno-occlusive disease generally have been poor. Success rates within the first year range from 23% to 80% and consistently decrease with longer-term follow-up (14% to 77% at one year). Reasons proposed for the inadequate long-term results include inadequate surgical ligation of veins, the development of collateral bypasses, especially spongiosal leaks, corporal myopathy, and neurotransmitter deficiencies. Diseases such as diabetes and hypertension along with substances such as nicotine can cause damage to corporal smooth muscle cells. Damage at the cellular level produces deficits in erectile physiology that is not compensated for directly by venous ligation. Surgery may address a symptom of the disease but not the disease process, accounting for the poor results seen over the long-term in patients with smooth muscle dysfunction.

There is no published scientific literature in which Yohimbine or topical vasodilators are investigated as treatments of erectile dysfunction; therefore, it is not possible to reach conclusions concerning the efficacy or health outcome effects of these treatments.

Published data regarding vacuum therapy for female sexual dysfunction are limited. The Eros™ clitoral therapy device received FDA clearance for marketing under a 510(k) process. As such, the device was not presented to an FDA advisory committee for review and discussion; therefore, the clinical data presented to the FDA are not publicly available. However, an FDA Talk Paper announcing approval of the device states that the data presented to the FDA consisted of 25 patients, fifteen of whom had female sexual dysfunction and ten who did not.  A literature search identified two published peer-reviewed articles.  Both articles are authored by the same investigator using a similar study design, and thus likely consist of overlapping patient populations. Therefore, the study with the largest number of patients is reviewed here. A total of 32 patients participated in the clinical trial; 20 patients (nine premenopausal and eleven postmenopausal) reported female sexual dysfunction, while 12 patients (ten premenopausal and two postmenopausal) reported no sexual dysfunction. During the first three home uses of the device, patients were asked to note any change in sexual pleasure, including clitoral and labial engorgement, orgasm, and vaginal lubrications. Each patient then completed a questionnaire, the Female Intervention Efficacy Index. With patients serving as their own control, 90% of the 20 patients with sexual dysfunction reported increased sensation; 80% reported increased lubrication; 45% reported an increased ability to achieve orgasm; and 80% reported increased sexual satisfaction. This uncontrolled trial of a small sample of self-selected patients of limited duration is not adequate to validate the long-term efficacy of vacuum therapy as a treatment of female sexual dysfunction.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

Medicare (CMS) does not have a national position on this service. It is subject to local carrier discretion. Please refer to the local carrier for more information.

The information contained in this section is for informational purposes only.  HCSC makes no representation as to the accuracy of this information.  It is not to be used for claims adjudication for HCSC plans.

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