Archived Policies - Medicine
Sexual Dysfunctions, Assessment and Treatment
NOTE: The use of procedures, supplies, or medications for treatment of psychological or psychogenic sexual dysfunctions may be subject to contract benefit limitations. Check contract benefits carefully.
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 Prostaglandin E [sub 1] (PGE1);
• Nocturnal penile tumescence 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);
4. Thyroid function studies;
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/or unproven:
The following therapies for the treatment of sexual dysfunction may be considered medically necessary provided the contract does not contain any exclusion for any services related to sexual dysfunction. Should the contract not contain exclusions for 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:
1. Injection into the corpus cavernosa to cause an erection (papaverine, phentolamine, alprostadil, (prostaglandin E1, Caverject));
2. Intracavernosal injection of Verapamil for treatment of Peyronie’s disease (NOTE: For additional information on Injectable Clostridial Collagenase for Fibroproliferative Disorders for the treatment of Peyronie’s Disease see Medical Policy RX501.073);
3. MUSE (medicated urethral system for erection) method of treatment for erectile dysfunction that involves inserting medication through a small catheter into the urethra;
4. Urethral suppository;
5. 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.
Perineoplasty (also known as vaginal rejuvenation or tightening) done as a “stand-alone” procedure is considered not medically necessary.
Perineoplasty (also known as vaginal rejuvenation or tightening) done as part of a cysto/rectocele repair is considered ineligible for separate reimbursement.
The following therapies for treatment of sexual dysfunction are considered experimental, investigational and/or unproven:
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 is the persistent or recurrent failure to attain or maintain the lubrication-swelling response of sexual excitement until completion of the sexual activity.
Laser vaginal Rejuvenation® (LVR®) is an outpatient surgical procedure designed to enhance sexual gratification. These procedures are reported to be a modification of a gynecological surgical procedure used for the treatment of stress urinary incontinence. LVR is claimed to effectively enhance vaginal muscle tone, strength, and control, and effectively decrease the internal and external vaginal diameters as well as build up and strengthen the perineal body.
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:
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.
A complete evaluation of sexual dysfunction includes, but is not limited to, the following tests:
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 x-rayed to visualize 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 plethysmography is used to measure physiological sexual arousal.
The nocturnal penile tumescence 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 for sexual dysfunctions includes:
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, Verapamil 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 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 Food and Drug Administration approved a medicated urethral system for erection (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 or more 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 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.
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.
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.
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.
Erectile dysfunction or impotence can be a secondary symptom of systemic diseases or their treatment, (e.g., 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. (5), 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 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 is 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.
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 Food and Drug Administration (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. (39, 40) 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.
A statement by The American College of Obstetricians and Gynecologists (ACOG) in a new Committee Opinion published in the September 2007 issue of Obstetrics & Gynecology stated: “vaginal rejuvenation," "designer vaginoplasty," "revirgination," and "G-spot amplification" procedures are not medically indicated, nor is there documentation of their safety and effectiveness. ACOG also recommends that women considering cosmetic vaginal procedures should be informed about the lack of data supporting the effectiveness of these procedures as well as their potential complications, including infection, altered sensation, dyspareunia (pain), adhesions, and scarring. (56)
Intralesional injection of verapamil weekly for three months is a potentially valuable non-toxic, non-surgical alternative to treatment of Peyronie's disease. Based on results in over 50 patients, the ideal candidate presents with pain on erection, has curvature of less than 30 degrees, has plaque volume less than 5 cubic centimeters without extensive calcification, and the patient refuses to have an invasive surgical procedure. Both subjective and objective improvement should be rapid; patients showing no response within six injections should be withdrawn from further therapy and offered surgical correction or other alternatives. Patients should be monitored for improvement in: plaque size (50% to 90% size reduction within six months for plaques 2.5 cm or smaller initially); bottle-neck or hour-glass deformity; erectile ability and/or effective coitus. Patients with significant pretreatment erectile dysfunction, larger plaques, extensive calcification, greater than 90 degree curvature or ventral curvature are least likely to respond. (8, 31)
Treatment of patients with Peyronie's disease for six months led to subjective improvement in painful erections in 10 of 11 patients with that pre-treatment complaint, decreased bottle-neck deformity in 9 of 9 patients, improved curvature deformity in 5 of 12 patients, and produced perceived improvement in sexual performance in 7 of 12. Decreased plaque volume of greater than 50% was measured in 4 of 12, while plaque-related changes in erectile function did not worsen or improved in 10 of 12.
These findings were later confirmed in a larger series of 46 men, 60% of whom had failed previous treatment (vitamin E, potassium aminobenzoate, radiation, intralesional steroids). (22) Based on plaque size (less than two centimeters, 2 to 4, over four) and curvature (less than 30 degrees, 30 to 60, over 60), patients were stratified by severity as Grade 1 (n=8), 2 (n=20), or 3 (n=28). Results characterized both objective and subjective assessments of pain, curvature, deformity, and erectile responses before and after treatment which ranged from 8 to 38 months. Pain relief was rapid, resolving completely within four injections in 97%. Subjective assessment of improvement in curvature was more optimistic (70% or more of patients regardless of baseline severity) than objective measures (50%); worsening of curvature was noted in 30%, but only in Grade 2 patients. Improved sexual function was claimed by 70% to 75% of patients in each severity stage; 66% with disease duration less than 12 months and 82% of those with late-stage disease. Eight patients withdrew from the study, two each with no response or pain relief only. Four, however, were impotent or had extensive plaque calcification and were advised to stop further treatment. Mild side effects noted in some patients included transient decreased penile shaft sensation, hematoma, and ecchymosis; no adverse cardiovascular effects occurred.
In a long-term single-blind study of 14 patients, intralesional verapamil was effective treatment for Peyronie's disease in patients with a noncalcified plaque and penile angulation of less than 30 degrees. Patients received local anesthesia with 2% lidocaine, followed by intralesional injection of either verapamil in isotonic saline or saline alone. The dose of verapamil ranged from 10 milligrams (mg) to 27 milligrams (mg) and was based upon plaque volume. Injections were performed weekly for six months. Plaque length, width, and volume were all significantly reduced (p less than 0.05 for all measures) in the verapamil treatment group compared to patients treated with saline alone. Significant subjective improvement in plaque-associated quality of erections was observed in 42% of patients receiving verapamil compared to 0% of patients in the control group. The benefits of verapamil injections were noted within the first three months of therapy. The authors stated that patients failing to respond or patients who present with penile angulation of more than 30 degrees should be considered candidates for surgery. (22)
A search of peer reviewed literature through October 2014 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.
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.
Disclaimer for coding information on Medical Policies
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.
Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.
The following codes may be applicable to this Medical policy and may not be all inclusive.
37788, 37790, 54200, 54205, 54235, 54240, 54400, 54401, 54405, 54406, 54408, 54410, 54411, 54415, 54416, 54417, 56810, 54230, 54231, 58999, 74445, 76870, 80061, 81002, 81003, 81005, 82540, 82550, 82552, 82553, 82554, 82565, 82570, 82575, 82951, 83001, 84146, 84402, 84403, 93980, 93981
J0270, J0275, J2440, J2760, L7900, S0090
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
64.94, 64.95, 64.97
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
0VUS7Z, 0VUSJZ, 0VUSKZ, 0VS0JZ, 0VS4JZ
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.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position on one or more of the topics addressed in this document.
A national coverage position for Medicare may have been developed or changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov.
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|5/15/2015||Reviewed. No changes.|
|12/15/2014||Document updated with literature review. Coverage unchanged.|
|6/1/2012||Document updated with literature review. The following was added to Coverage: Intracavernosal injection of Verapamil for treatment of Peyronie’s disease was added to the list that may be considered medically necessary. References and rationale updated.|
|12/15/2010||CPT/HCPCS code(s) updated.|
|2/15/2007||New Medical Document|
|Title:||Effective Date:||End Date:|
|Sexual Dysfunctions, Assessment and Treatment||06-01-2017||06-14-2018|
|Sexual Dysfunctions, Assessment and Treatment||03-15-2016||05-31-2017|
|Sexual Dysfunctions, Assessment and Treatment||05-15-2015||03-14-2016|
|Sexual Dysfunctions, Assessment and Treatment||12-15-2014||05-14-2015|
|Sexual Dysfunctions, Assessment and Treatment||06-01-2012||12-14-2014|
|Sexual Dysfunctions, Assessment and Treatment||12-15-2010||05-31-2012|
|Sexual Dysfunctions, Assessment and Treatment||06-01-2008||12-14-2010|
|Sexual Dysfunctions, Assessment and Treatment||02-15-2007||05-31-2008|
|Treatment of Male Sexual Dysfunction||03-01-2000||02-14-2007|
|Evaluation of Impotence||09-01-1999||02-14-2007|