Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Evaluation and Treatment of Erectile Dysfunction (ED)

Policy #:11.11.01i

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

DIAGNOSIS OF ERECTILE DYSFUNCTION (ED)

MEDICALLY NECESSARY
The following procedures are considered medically necessary and, therefore, covered for the diagnosis of erectile dysfunction (ED):
  • Comprehensive history and physical examination
  • Duplex scan
  • Dynamic infusion cavernosogram and cavernosometry
  • Laboratory testing for evaluation of hormone levels
    • Abnormal hormone levels indicate the need for further endocrine testing for pituitary, thyroid, and adrenal dysfunction
  • Nocturnal penile tumescence (NPT) test, when results from the physical examination cannot be used to distinguish between organic causes and psychogenic causes
  • Pudendal arteriography
  • Pharmacological response test for ED [Note: The drugs associated with the pharmacological response test may be available under more than one benefit category (i.e., medical, pharmacy); therefore, individual benefits must be verified.]

NOT MEDICALLY NECESSARY
Penile plethysmography is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the diagnosis of erectile dysfunction.

The following diagnostic procedures are considered not medically necessary and, therefore, not covered, because spinal cord injury and other neurological deficits that may cause erectile dysfunction are typically identified during a comprehensive history and examination. These tests do not have any therapeutic implications and are, therefore, unnecessary:
  • Corpora cavernosal electromyography
  • Dorsal nerve conduction latencies
  • Evoked potential measurements

TREATMENT OF ERECTILE DYSFUNCTION

MEDICALLY NECESSARY
The following interventions are considered medically necessary and, therefore, covered for the treatment of erectile dysfunction:
  • Vacuum constriction devices when all the following criteria are met:
    • The individual has ED secondary to organic impotence.
    • The individual has had an in-person clinical evaluation with his treating provider within six months prior to the ordering of a vacuum constriction device.
    • The individual has no evidence of symptomatic or untreated hypogonadism or hyperprolactinemia.
  • Penile prosthetic implants when the following criteria are met:
    • The individual has ED secondary to organic impotence.
    • The individual has no evidence of symptomatic or untreated hypogonadism or hyperprolactinemia.
    • Other less invasive treatment options, i.e., pharmacological therapy and/or vacuum constriction devices have been tried or considered and ruled out, and the result (if tried) or contraindication (if considered) must be clearly documented in the individual's medical record.
    • The individual receives appropriate preoperative education concerning the benefits and potential risks of the procedure, including the possibility of erosion and infection; mechanical failure, and resulting re-operation; and potential reduction of the effectiveness of other therapies if the device is subsequently removed.
  • Penile revascularization when all of the following criteria are met:
    • The individual has ED that is secondary to a focal arterial occlusion, as evidenced by arteriography or duplex ultrasonography.
      • The individual's arterial occlusion resulted directly from blunt trauma to the pelvis and/or perineum.
    • The individual has no evidence of generalized vascular disease (e.g., diabetes mellitus, hypertension, coronary artery disease), Peyronie's plaques, intracavernosal masses, nodules, or sensory neuropathy.
    • The individual has normal corporeal venous function.
    • Alternative nonsurgical treatment modalities have been fully explained to the individual, and the individual is determined to achieve spontaneous erections without the need for pharmacological, external, or internal support devices.

NOT MEDICALLY NECESSARY
Penile venous occlusive surgery is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of erectile dysfunction.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

BILLING REQUIREMENTS

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.
Guidelines

The evaluation of erectile dysfunction should begin with a thorough medical history, including, but not limited to, the following:
  • Detailed sexual history
  • Physical examination, including examination of genitals and prostate
  • Assessment of male secondary sexual characteristics
  • Palpation of femoral and lower extremity pulses
  • Focused neurological examination

The diagnostic evaluation of erectile dysfunction should only include tests that identify the treatment options available to a specific individual and should be based on the individual's clinical status and treatment preferences.

Penile revascularization is usually considered for individuals less than 55 years of age who meet all of the criteria for the procedure as outlined in the Policy section.

Vacuum constriction devices are classified as durable medical equipment (DME) (e.g., Erect Aid).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, the evaluation and treatment of erectile dysfunction is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. DME used in the treatment of erectile dysfunction may be covered under the medical benefits of the Company’s products when medical necessity criteria in the medical policy are met.

Description

Erectile dysfunction (ED) is defined as the inability to achieve a sufficient erection for satisfactory sexual performance. Erectile function requires competent arterial blood inflow as well as a reduction of venous blood outflow. Disease and other risk factors may affect the arterial and venous systems in a manner that impedes erectile function and may lead to ED. The causes of ED are divided into the following categories:
  • Psychogenic etiology (originating from the mind or psyche): Caused by factors that include performance anxiety, disaffection with the current sexual partner, or some other emotional problem
  • Organic etiology, which includes the following causes:
    • Neurogenic: These causes may be central (e.g., spinal cord injury, multiple sclerosis) or peripheral (diabetic polyneuropathy, sacral cord and nerve root compression or trauma)
    • Vasculogenic: Encompasses arterial insufficiency related to arteriosclerosis, tobacco use, or trauma and venocclusive efficiency due to trauma, congenital anomalies, and Peyronie's disease
    • Myogenic: Conditions such as hypertension, benign prostatic hypertrophy, and radiation injury may cause dysfunction of the intrinsic smooth muscle cells of the erectile tissues
    • Hormonal: Hormones have an influence on both central proerectile pathways and end organ cavernosal tissues. However, hypogonadism is not considered to be a principal cause of ED in the majority of patients.
  • Mixed etiology (combination of psychogenic and organic causes)

The diagnosis of ED requires a detailed sexual, psychosocial, and medical history, physical examination, and laboratory tests. In addition, diagnostic testing may be needed to support the diagnosis of ED. Examples of this testing include nocturnal penile tumescence testing and pudendal arteriography. Based on a review of available published literature, there is limited support for use of the following tests for the diagnosis of ED:
  • Penile plethysmography
  • Corpora cavernosal electromyography
  • Dorsal nerve conduction latencies
  • Evoked potential measurements

The primary goal of treatment for ED is to restore satisfactory erections with minimal adverse effects. Treatment options for ED include oral medications (phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil citrate [Viagra®], vardenafil [Levitra®], tadalafil [Cialis®]); intraurethral insertion of prostaglandin E1 (alprostadil); intracavernosal vasoactive drug injection therapy with a combination of papaverine, phentolamine, alprostadil, and atropine [Quad-Mix®] or papaverine, phentolamine, and/or prostaglandin E1 (alprostadil); psychological counseling; vacuum constriction devices (also known as vacuum erection devices); and surgery, including penile revascularization procedures and penile implants. Penile venous occlusive surgery has been investigated as a treatment option for men with ED and had promising early results; however, its effectiveness beyond six months was minimal. Also, this type of procedure has been abandoned in favor of other therapies.
References


Agency for Healthcare Research and Quality (AHRQ). Diagnosis and management of erectile dysfunction. [AHRQ Web site]. 06/09. Available at: http://www.ahrq.gov/research/findings/evidence-based-reports/erecdystp.html. Accessed May 4, 2018.

American Association of Clinical Endocrinologists (AACE) Sexual Dysfunction Task Force. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Male Sexual Dysfunction: A Couple's Problem--2003 Update. [AACE Web site]. Available at: https://www.aace.com/files/sexdysguid.pdf. Accessed May 4, 2018.

American College of Physicians (ACP). Clinical Practice Guidelines. Hormonal testing and pharmacologic treatment of erectile dysfunction: A clinical practice guideline from the American College of Physicians. [AAFP Web site]. 11/09. Available at:http://www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/acp-hormonaltest-ed.pdf. Accessed May 4, 2018.

American Urological Association (AUA). Guideline for the diagnosis and treatment of erectile dysfunction. 2018. Available at: https://www.auanet.org/guidelines/erectile-dysfunction-aua-guideline-(2018). Accessed May 30, 2018.

Bacon CG, Mittleman MA, Kawachi I, et al. A prospective study of risk factors for erectile dysfunction. J Urol.2006;176(1):217-221.

Canguven O, Bailen J, Fredriksson W, et al. Combination of vacuum erection device and PDE5 inhibitors as salvage therapy in PDE5 inhibitor nonresponders with erectile dysfunction. J Sexual Med.2009;6(39):2561-2567.

Centers for Medicare & Medicaid Services (CMS). National coverage determination (NCD) for diagnosis and treatment of impotence (230.4). [CMS Web site]. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=32&ncdver=1&bc=AAAAQAAAAAAA&. Accessed May 4, 2018.

Cunningham GR, Rosen RC. Overview of male sexual dysfunction. Up to Date. [Up to Date Web site]. 06/22/11. Available at: http://www.uptodate.com [via subscription only]. Accessed May 4, 2018.

Kawanishi Y, Kimura K, Nakanishi R, et al. Penile revascularization surgery for arteriogenic erectile dysfunction: the long-tern efficacy rate calculated by survival analysis. BJU Int. 2004;94(3):361-368.

Lazarou S. Surgical treatment of erectile dysfunction. Up to Date. [Up to Date Web site]. 02/07/11. Available at: http://www.uptodate.com [via subscription only]. Accessed May 4, 2018.

Martin KA. Treatment of male sexual dysfunction. Up to Date. [Up to Date Web site]. 10/04/10. Available at: http://www.uptodate.com [via subscription only]. Accessed May 4, 2018.

Mayo Clinic. Penile Implants--Tests and Procedures. Available at: http://www.mayoclinic.org/tests-procedures/penile-implants/basics/risks/prc-20013140 Accessed May 4, 2018.

Müller A, Mulhall JP. Cardiovascular disease, metabolic syndrome and erectile dysfunction. Curr Opin Urol. 2006;16(6):435-443.

National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC). Erectile dysfunction. [NKUDIC Web site]. June 2009. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/ED/ErectileDysfunction_508.pdf. Accessed May 4, 2018.

Qaseem A, Snow V, Denberg TD, et al. Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Ann Int Med. 2009;151(9):1-11.

Reproductive and sexual function. In: Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA. Campbell-Walsh Urology. 9th edition. Philadelphia, PA: WB Saunders; 2007.

Shabsigh R, Stone B. Understanding the needs and objectives of erectile dysfunction patients. World J Urol. 2006;24(6):618-622.

Wessells H, Joyce GF, Wise M, Wilt TJ. Erectile dysfunction and Peyronie's disease. In: Litwin MS, Saigal CS, editors. Urologic Diseases in America. US Department of Health and Human Services, Public Health Service, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Washington, DC: US Government Printing Office, 2007; NIH Publication No. 07-5512 [pp.485-528]. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/peyronie/. Accessed May 4, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY
36245, 36246, 36247, 36248, 37788, 54115, 54230, 54231, 54235, 54250, 54400, 54401, 54405, 54406, 54408, 54410, 54411, 54415, 54416, 54417, 54437, 54438, 74445, 75736, 93975, 93976, 93978, 93979, 93980, 93981

NOT MEDICALLY NECESSARY
37790, 51792, 54240, 95870, 95907, 95908, 95909, 95910, 95911, 95912, 95913,


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

F52.21 Male erectile disorder

N52.01 Erectile dysfunction due to arterial insufficiency

N52.02 Corporo-venous occlusive erectile dysfunction

N52.03 Combined arterial insufficiency and corporo-venous occlusive erectile dysfunction

N52.1 Erectile dysfunction due to diseases classified elsewhere

N52.2 Drug-induced erectile dysfunction

N52.31 Erectile dysfunction following radical prostatectomy

N52.32 Erectile dysfunction following radical cystectomy

N52.33 Erectile dysfunction following urethral surgery

N52.34 Erectile dysfunction following simple prostatectomy

N52.35 Erectile dysfunction following radiation therapy

N52.36 Erectile dysfunction following interstitial seed therapy

N52.37 Erectile dysfunction following prostate ablative therapy

N52.39 Other and unspecified postprocedural erectile dysfunction

N52.8 Other male erectile dysfunction

N52.9 Male erectile dysfunction, unspecified



HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

L7900 Male vacuum erection system

L7902 Tension ring, for vacuum erection device, any type, replacement only, each



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Related Documents


Policy History

Revisions from 11.11.01i
06/20/2018Effective 6/20/18, this policy has been reviewed and reissued to communicate the Company’s continuing position on the Evaluation and Treatment of Erectile Dysfunction (ED).


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 10/01/2016
Version Issued Date: 09/30/2016
Version Reissued Date: 06/20/2018

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