Archived Policies - Medicine
Sexual Dysfunctions, Assessment and Treatment
The following diagnostic procedures may be considered medically necessary in the assessment of sexual dysfunction:
The following diagnostic procedures and laboratory tests for the assessment of sexual dysfunction are considered experimental, investigational and unproven:
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:
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:
The use of procedures, supplies, or medications for treatment of psychological or psychogenic sexual dysfunctions may be contract exclusions.
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:
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,
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 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, 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.
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:
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
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.
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.
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.
Goldman, Howard H., M.D., M.P.H., PhD. 1988 Review of General Psychiatry, 2nd edition. Norwalk: Appleton & Lange: 425-41.
Olin, Bernie R., Pharm.D, ed-in-chief. Papaverine HCL. Drugs, Facts and Comparisons, St. Louis, Facts and Comparisons, Inc, (1989 May): 150f-h.
Lue, T.F. Penile venous surgery. Urology Clinics of North America (1989) 16(3):607-11
Papaverine and Phentolamine for Impotence. American Medical Association. Diagnostic and Therapeutic Technology Assessment (1990 July 30): 1-7.
Intracavernous Injection of Prostaglandin E1. American Medical Association Diagnostic and Therapeutic Technology Assessment (1991 March 19): 1-5.
Sharlip, I.D. The incredible results of penile vascular surgery. International Journal of Impotence Research (1991) 3:1.
Berkow, Robert M.D., and Andrew J. Fletcher, eds. The Merck Manual, 17th edition. New Jersey: Merck & Co., Inc. (1992) 1573-9.
Impotence. American Medical Association. Practice Parameters (CD Rom/on-line) National Institutes of Health Consensus Development Conference (1992 December) 10(4): 1-31.
FDA - "FDA Proposes to Review Penile Implants." (1993 April 27) Food and Drug Administration (Web Site/on-line). <http://www.fda.gov>.
Goldstein, I. and D. Hatzichristou. Penile microvascular arterial bypass: indications and surgical considerations. Surgical Annals (1993) 25(Pt 2):207-29.
National Institute of Health (NIH) Consensus Conference, NIH Consensus Development Panel on Impotence (1993 July 7) 270(1): 83-90.
Fowlis, G.A., Sidhu, P.S., et al. Preliminary report: combined surgical and radiological penile vein occlusion for the management of impotence caused by venous-sinusoidal incompetence. British Journal of Urology (1994) 74(4):492-6.
Olin, Bernie R., Pharm.D, ed-in-chief. Phentolamine. Drugs, Facts and Comparisons, St. Louis, Missouri: Facts and Comparisons, Inc, (1994 July) 166.
The Testis. 1995 Scientific American Medicine (CD Rom/on-line) Chapter II (1995 January): 1-22.
Bosshardt, R.J., Farwerk, R., et al. Objective measurement of the effectiveness, therapeutic success and dynamic mechanisms of the vacuum device. British Journal of Urology (1995 June) 75(6): 786-91.
Hassan, A.A., Hassouna, M.M., et al. Long-term results of penile venous ligation for corporeal venous occlusive dysfunction. Canadian Journal of Surgery (1995 December) 38(6): 537-41.
Olin, Bernie R., Pharm.D, ed-in-chief. Alprostadil and Prostaglandin E1 (PGE1). Drugs, Facts and Comparisons, St. Louis, Missouri: Facts and Comparisons, Inc, (1995 September): 731h-l.
Caverject.Medicare Part B Policy Manual, (on-line) (1996 August 30).
DeWire, D.M. Evaluation and treatment of erectile dysfunction. American Family Physician (1996 May 1) 53(6): 2101-8.
MUSE." VIVUS, Inc., (1996 November) Product Information.
Connolly, J.A., Borirakchanyavat, S., et al. Journal of Clinical Ultrasound (1996 October) 24(8): 481-6.
Garber, B.B. Inflatable penile prosthesis: results of 150 cases British Journal of Urology (1996 December) 78(6): 933-5.
Prostaglandin E1/Caverject. Physicians Desk Reference Electronic Library (CD Rom/on-line) (1996 December 30).
Sarramon, J.P., Bertrand, N., et al. Microrevascularization of the penis in vascular impotence. International Journal of Impotence Research (1997) 9(3): 127-35.
Rossi, D., Ayuso, D., et al. Clinical experience with 80 inflatable penile prostheses. European Urology (1997) 31(3): 335-8.
Borirakchanyavat, S. and Tom F. Lue. Evaluation of Impotence. Infectious Urology (1997) 10(1): 12-5, 18-23, 29.
Shafik, A. Hollow and fenestrated penile prosthesis: a new implant for treatment of impotence. Archives of Andrology (1997 January-February) 38(1): 93-8.
Soderdahl, D.W., Petroski, R.A., et al. The use of an external vacuum to augment a penile prosthesis. Technical Urology (1997 Summer) 3(2): 100-2.
Erectile Dysfunction. Chicago, Illinois: Blue Cross Blue Shield Association Consortium Health Plan Medical Policy Reference Manual (1997 June 30) Medicine: 2.01.25.
Wahl, S.I., Rubin, M.B., et al. Radiologic evaluation of penile arterial anatomy in arteriogenic impotence. International Journal of Impotence Research (1997 June) 9(2): 93-7.
Koeneman, K.S., Mulhal, J.P., et al. Sexual health for the man at midlife: in-office workup. Geriatrics (1997 September) 52(9): 76-8, 84-6, 87.
Aggour, A., Mostafa, H., et al. Endoscopic management of ejaculatory duct obstruction. International Urology and Nephrology (1998) 30)(4): 481-5.
FDA - Penile Prostheses (Implants). (1998 May 2) Prepared by Northeast Indiana Urology (Web Site/on-line): <http://www.wellweb.com/impotent/shris/penimpl.htm>
Timmermans, L. Methodology of penile isotope imaging. Evaluation ACTA Urologcia Belgicia (1998 March) 66(1): 13-7.
Sildenafil: An Oral Drug for Impotence. The Medical Letter, (1998 May 8) 40(1026): 51-2.
Hauri, D. Penile revascularization surgery in erectile dysfunction. Andrology (1999) 31(S1): 65-76.
Nakata, M., Takashima, S., et al. Embolotherapy for venous impotence: use of ethanol. Journal of Vascular Interventional Radiology (2000 September) 11(8): 1052-7.
Da Ros, C.T., Teloken, C., et al. Long-term results of penile vein ligation for erectile dysfunction due to caverno-venous disease. Technical Urology (2000 September) 6(3): 172-4.
Billips, K.L., Berman, L., et al. A new non-pharmacological vacuum therapy for female sexual dysfunction. Journal for Sexual and Marital Therapy (2001) 27(5): 435-41.
Wilson, S.K., Delk, J.R., et al. Treating symptoms of female sexual arousal disorder with the Eros-Clitoral Therapy Device. Journal of Gender Specific Medicine (2001) 4(2): 54-8.
Anastasiadia, A.G., Wilson, S.K., et al. Long-term outcomes of inflatable penile implants: reliability, patient satisfaction and complication management. Current Opinions in Urology (2001 November) 11(6): 619-23.
Erectile dysfunction. Chicago, Illinois: Blue Cross Blue Shield Association Policy Reference Manual (2002 April) Medicine 2.01.25.
Billips, K.L. The role of mechanical devices in treating female sexual dysfunction and enhancing the female sexual response. World Journal of Urology (2002 June) 20(2): 137-41.
Berman J. R., and J. Bassuk. Physiology and pathophysioclogy of female sexual function and dysfunction. World Journal of Urology (2002 June) 20(2): 111-8.
Wespes, E., Wildschutz, T., et al. The place of surgery for vascular impotence in the third millennium. Journal of Urology (2003 October) 170(4 Pt 1): 1284-6.
Moncada, I., Martinez-Salamanca, J.I., et al. Current role of penile implants for erectile dysfunction. (2004 November) 14(6): 375-80.
Vacuum therapy as a treatment for female sexual dysfunction. Chicago, Illinois: Blue Cross Blue Shield Association Policy Reference Manual (2005 January) Medicine 2.01.46.
Gheiler, J., and I. Sharpe. Improving the quality of life of erectile dysfunction (ED) patients through penile implants. Ethnicity and Disease (2005 Summer) 15(3 Suppl 4): S4-41-2.
Althor, S.E., Dean, J., et al. Current perspectives on the clinical assessment and diagnosis of female sexual dysfunction and clinical studies of potential therapies: a statement of concern.
Journal of Sexual Medicine (2005 September) 3:146-53.
Viswaroop, B. B. A., and G. Gopalakrishnan. Evaluating erectile dysfunction: oral sildenafil versus intracavernosal injection injection of papaverine. National Medical Journal of India (2005 November-December) 18(6): 299-301.
Goldstein, I., Fisher, W.A., et al. Women’s sexual function improves when partners are administered vardenafil for erectile dysfunction: a prospective, randomized double-blind, placebo-controlled trial. Journal of Sexual Medicine (2005 November) 2(6): 819-32.
Salonia, A., Lanzi, R., et al. Sexual function and endocrine profile in fertile women with type l diabetes. Diabetes Care (2006 February) 29(2): 312-6.
Clayton, A.N., Segraves, R.T., et al. Reliability and validity of the Sexual Interest and Desire Inventory-Female (SIDI-F), a scale designed to measure severity of female hypoactive sexual disorder. Journal of Sex and Marital Therapy (2006 March-April) 32(2): 115-35.
Basson, R. Clinical practice. Sexual desires and arousal disorders in women. New England Journal of Medicine (2006 April 6) 354(14): 1497-506.
Davis, S.R., van der Mooren, M.J., et al. Efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo controlled trial. Menopause (2006 May-June) 13(3): 387-96.
Caruso, S., Rugolo, S., et al. Changes in clitoral blood flow in premenopausal women affected by type 1 diabetes after single 100-mg administration of Sildenafil. Urology (2006 July) 68(1): 161-5.
|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|