Archived Policies - Surgery


Treatment of Male Sexual Dysfunction

Number:SUR717.010

Effective Date:03-01-2000

End Date:02-14-2007

Coverage:

Treatment for male sexual or erectile dysfunctions may be eligible for coverage provided the contract does not have an exclusion for any services related to sexual dysfunction.  Should the contract not contain an exclusion for any services related to sexual dysfunction, coverage may be allowed if the patient has a documented disease process resulting in impotence.  The surgical procedures, supplies, or medications used for treatment of male sexual or erectile dysfunction include, but are not limited to, the following:

  • Inflatable or Non-inflatable Penile Implants (Prostheses),
  • Vacuum Erection Devices,
  • Intracavernosal Injection Therapy,
  • (Trans)urethral Suppository Method, or
  • Oral Medication.

The use of the procedures, supplies, or medications listed below for treatment of psychologic/psychogenic male sexual or erectile dysfunction/impotence is not eligible for coverage as they are considered contract exclusion. The surgical procedures, supplies, or medications include, but are not limited to, the following: 

  • Inflatable or Non-inflatable Penile Implants (Prostheses),
  • Vacuum Erection Device, 
  • Intracavernosal Injection Therapy,
  • (Trans)urethral Suppository Method, or
  • Oral Medication.

The use of oral medication as an enhancement to sexual function and treatment of female sexual dysfunction is not eligible for coverage as it is considered investigational.

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 psychologic.  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.

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 can be broadly classified into two categories:

  • Organic or a result of a disease process (damage to the nerve pathways of the penis resulting in the absence of nocturnal penile tumescence or the inability of an erection during sleep) and
  • Psychologic/psychogenic (underlying factors such as anxiety, fatigue, interpersonal stresses, and chronic illness).

Diagnosis/treatment for male sexual or erectile dysfunctions includes:

  • Dynamic Cavernosometry, Penile Plethysmography, or Duplex Scan of penis
  • Nocturnal Penile Tumescence and/or Rigidity Test
  • Inflatable or Non-inflatable Penile Implants (prostheses)
  • Vacuum Erection Devices
  • Intracavernosal Injection Therapy
  • (Trans)urethral Suppository Method
  • Oral Medication.                 

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 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 urethral after urination, via an applicator stem, and is absorbed by the surrounding erectile tissues, creating an erection.  On November 19, 1996, the F.D.A. 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 2 to 3 physician office visits.  Dosage adjustments can be done via the elephone 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 3 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.  On March 27, 1998, the F.D.A. approved Viagra, the first oral pill to treat impotence (erectile dysfunction).  The recommended dose is 50 mg taken one hour before sexual activity.  Individuals may need more or less and dosing should be determined by a physician depending on effectiveness and side effects.  The drug should not be used more than once a day.

Rationale:

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 been previously been provided on an exception basis for the treatment of this condition, some benefit plans specifically exclude payment for the treatment of sexual dysfunction. The exclusion extends to prescriptions or medications for the treatment of sexual dysfunction as well penile prostheses.

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:

None

References:

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.

Papaverine and Phentolamine for Impotence. AMA Diagnostic And Therapeutic Technology Assessment (1990 July 30): 1-7.

Intracavernous Injection of Prostaglandin E1. AMA Diagnostic And Therapeutic Technology Assessment (1991 March 19): 1-5.

Berkow, Robert M.D., and Andrew J. Fletcher, M.B., B.Chir., eds. 1992. The Merck Manual, 17th edition. New Jersey: Merck & C., Inc.: 1573-9.

Impotence. AMA 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) Prepared by FDA (Web Site/on-line): http://www.fda.gov//bbs/topics/ANSWERS/ANS00493.html.

Organic Impotence. Medicare Part B Newsletter (on-line) (1993 December 27).

Self Administered and/or Take Home Drugs. Medicare Part B Newsletter (on-line) (1993 June 1) #128.

Olin, Bernie R., Pharm.D., ed-in-chief. Phentolamine. Drugs, Facts and Comparisons, St. Louis, 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., 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.

Olin, Bernie R., Pharm.D., ed-in-chief. Alprostadil and Prostaglandin E1 (PGE1). Drugs, Facts and Comparisons, St. Louis, Facts and Comparisons, Inc, (1995 September): 731h-l.

Caverject.Medicare Part B Policy Manual, (on-line) (1996 August 30).

Coverage 35-24 Diagnosis and Treatment of Impotence. Medicare B Coverage Issues (on-line) (1996).

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.

Garber, B.B. Inflatable penile prosthesis: results of 150 cases British Journal of Urology (1996 December) 78(6): 933-5.

Prostaglandin E1/Caverject. PDR Electronic Library (CD Rom/on-line) (1996 December 30).

Rossi, D., et al. Clinical experience with 80 inflatable penile prostheses. European Urology (1997) 31(3): 335-8.

Shafik, A. Hollow and fenestrated penile prosthesis: a new implant for treatment of impotence. Archives of Andrology (1997 January-February) 38(1): 93-8.

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., et al. The use of an external vacuum to augment a penile prosthesis. Tech Urol (1997 Summer) 3(2): 100-2.

Erectile Dysfunction. BCBSA Consortium Health Plan Medical Policy Reference Manual (1997 June 30) Medicine: 2.01.25.

Koeneman, K.S., et al. Sexual health for the man at midlife: in-office workup. Geriatrics (1997 September) 52(9): 76-8, 84-6, 87.

MUSE Urethral Suppository. PDR Electronic Library (CD Rom/on-line) (1998 May 1).

FDA Impotence Treatment Options. (1998 May 2) Prepared by Northeast Indiana Urology (Web Site/on-line): http://www.wellweb.com/impotent/chris/treatmen.htm.

FDA Penile Prostheses (Implants). (1998 May 2) Prepared by Northeast Indiana Urology (Web Site/on-line): http://www.wellweb.com/impotent/shris/penimpl.htm.

Sildenafil: An Oral Drug for Impotence.  The Medical Letter, (1998 May 8) 40(1026): 51-2.

FDA Viagra Information - FDA Announces Approval of Male Impotence Drug, Viagra (sildenafil citrate). (1998 March 27) Prepared by Center for Drug Evaluation and Research (Web Site/on-line):  http://www.fda.gov/cder/news/viagra.htm.

Policy History:

Archived Document(s):

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