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Evaluation and Treatment of Erectile Dysfunction (ED)
11.11.01k

Policy

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 (e.g., serum testosterone, prolactin)
    • 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.
Pharmacological therapy for the treatment of ED may be covered under the prescription plan when the member has a pharmacy benefit. Individual benefits must be verified.​

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.

EXPERIMENTAL/INVESTIGATIONAL
Other treatments for ED including extracorporeal shock wave therapy (ESWT), intracavernosal stem cell therapy, ​are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.​

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.

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written 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 standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY REQUIREMENTS
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 (WHEN APPLICABLE)
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.

For specified DME items, documentation of a face-to-face encounter between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.

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.​

Guidelines

The evaluation of erectile dysfunction (ED) 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 ED 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 ED 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.

The Company has delegated the responsibility for utilization management activities for professional behavioral health services for ED to the contracted behavioral health vendor.

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, lack of sexual arousability, and overt psychiatric disorders such as depression and schizophrenia.
  • 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). Mixed etiologies for ED are the most common.
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®], avanafil [Stendra®]); 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. 

As reported by the American Urological Association (AUA), penile venous surgery is not recommended because of the lack of evidence that it constitutes an effective ED management strategy for most individuals. The available data for penile venous occlusive surgery were contributed by observational designs; most studies were retrospective. Limited information was reported regarding individual characteristics such as the presence of comorbidities, particularly those that contribute to vascular integrity. There was considerable variability in participant types, with some individuals diagnosed with one vascular condition (i.e., veno-occlusive dysfunction or arterial disease) and some diagnosed with both conditions. Furthermore, there was considerable variability in surgical technique across studies, making findings interpretation challenging, and follow-up durations were generally short. Finally, most studies did not use validated questionnaires and relied on the individual's reports or medical chart review. Furthermore, this type of procedure has been abandoned in favor of other therapies. 

Among the studies reviewed for treatments for ED, the AUA's Erectile Dysfunction Guideline (2018)​ reported on ​findings from randomized sham-controlled trials that have evaluated low-intensity extracorporeal shockwave therapy (ESWT) which were inconsistent and do not clearly indicate that benefits reliably outweigh risks/burdens for individuals with ED. In particular, the treatment's ability to restore normal erectile function remains in question, the duration of treatment effects beyond possible short-term efficacy is not well-established. Consideration is given to the availability of other treatments that are less burdensome and known to be effective. Furthermore, ESWT is not FDA-approved to treat ED. Four published systematic reviews with meta-analyses evaluated the use of ESWT. These papers are compromised by the failure to address substantial heterogeneity that suggests flawed conclusions, the pooling of trials across non-comparable individual groups (i.e., ED, chronic pelvic pain); the pooling of trials that measured unassisted erectile function with trials that measured erectile function in response to oral phosphodiesterase type 5 inhibitor (PDE5i), and the use of non-standard data analytic procedures (i.e., separate analyses for active and sham-treated groups). The evidence is insufficient to determine the effects of the technology on health outcomes.

In addition, the AUA concluded that ​findings from studies that have evaluated intracavernosal stem cell therapy do not indicate that benefits reliably outweigh risks/burdens for individuals with ED. In particular, the treatment's ability to restore normal erectile function in various populations with ED has not been convincingly demonstrated. Moreover, neither the most effective source and dose of stem cells nor the duration of treatment effects has been established. Given the paucity of data obtained in human participants, the risks of treatment also are not well established. Other treatments are well-characterized in terms of benefits and risks/burdens are available. The literature consists primarily of observational designs with extremely small sample sizes (less than 50 individuals in total). The stem cell source and dose varied across studies, making it unclear which protocols might be effective. Individual populations also differed substantially across studies, including individuals with diabetes, individuals post-RP, and individuals from the general ED population. The safety profile of this therapy is unclear given the limited number of human participants. Overall, confidence in reliable outcomes without significant risks is compromised by an inadequate body of evidence comprised of robustly designed studies with sufficient sample sizes for a particular stem cell methodology in a particular group. The evidence is insufficient to determine the effects of the technology on health outcomes.​

References

Agency for Healthcare Research and Quality (AHRQ). Diagnosis and management of erectile dysfunction. [AHRQ Web site]. 06/09. Available at: https://www.ahrq.gov/downloads/pub/evidence/pdf/erectiledys/erecdys.pdf . Accessed December 16, 2025.

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. [AACE Web site]. 2003. Available at: https://pro.aace.com/sites/default/files/2019-06/sexdysguid.pdf. Accessed December 16, 2025.

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]. 11/03/2009. Available at:http://www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/acp-hormonaltest-ed.pdf. Accessed December 16, 2025.

American Urological Association (AUA). Guideline for the diagnosis and treatment of erectile dysfunction. 2018. Available at: https://www.auanet.org/guidelines-and-quality/guidelines/erectile-dysfunction-(ed)-guideline. Accessed December 16, 2025​.


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 December 16, 2025​​.

Chiles KA, Staff I, Johnson-Arbor K, et al.  A double-blind, randomized trial on the efficacy and safety of hyperbaric oxygenation therapy in the preservation of erectile function after radical prostatectomy. J Urol. 2018;199(3):805. 

Dong L, Chang D, Zhang X, et al. Effect of low-Intensity extracorporeal shock wave on the treatment of erectile dysfunction: A systematic review and meta-analysis. Am J Mens Health. 2019;13(2):1557988319846749.

 

Fojecki GL, Tiessen S, Osther PJ. Effect of low-energy linear shockwave therapy on erectile dysfunction-A double-blinded, sham-controlled, randomized clinical trial. J Sex Med. 2017;14(1):106. 

 

Hadanny A, Lang E, Copel L, et al. Hyperbaric oxygen can induce angiogenesis and recover erectile function. Int J Impot Res. 2018;30(6):292. 

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.

 

Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015;12(5):1105. 

 

Khera M. Treatment of male sexual dysfunction. UpToDate. [UpToDate Web site]. 10/04/23.  Available at: http://www.uptodate.com [via subscription only]. Accessed December 16, 2025​​.

Mayo Clinic. Penile Implants. [Mayo Clinic Web site]. Available at: https://www.mayoclinic.org/tests-procedures/penile-implants/about/pac-20384916. Accessed December 16, 2025.

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: https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction. Accessed December 16, 2025​.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD).L34824: Vacuum Erection Devices (VED). [Noridian Healthcare Solutions Web site]. Original: 10/01/15. (Revised: 01/01/2020). Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active. Accessed December 16, 2025​.


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.

 

Sahin MO, Sen V, Eser E, et al. The effect of hyperbaric oxygen therapy on erectile functions: A prospective clinical study. Urol Int. 2018;101(2):206-211.

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

 

Rosen R, O'Leary M. Epidemiology and etiologies of male sexual dysfunction. UpToDate. [UpToDate Web site]. 10/31/2024. Available at: http://www.uptodate.com [via subscription only]. Accessed December 16, 2025.​

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

THE FOLLOWING CODES ARE MEDICALLY NECESSARY FOR THE EVALUATION AND TREATMENT OF ERECTILE DYSFUNCTION:

 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

THE FOLLOWING CODES ARE NOT MEDICALLY NECESSARY FOR THE EVALUATION AND TREATMENT OF ERECTILE DYSFUNCTION:

37790, 51792, 54240, 95870, 95907, 95908, 95909, 95910, 95911, 95912, 95913

EXPERIMENTAL/INVESTIGATIONAL

0864T

ICD - 10 Procedure Code Number(s)
N/A
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

THE FOLLOWING CODES ARE MEDICALLY NECESSARY FOR THE TREATMENT OF ERECTILE DYSFUNCTION:

C1813 Prosthesis, penile, inflatable

C2622 Prosthesis, penile, noninflatable​
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

Policy History

Revisions From 11.11.01k:
​01/21/2026
​​The policy has been reviewed and reissued to communicate the Company’s continuing position on Evaluation and Treatment of Erectile Dysfunction (ED)​.​
​07/09/2025
This policy has been reissued in accordance with the Company's annual review process.​​​

0​5/29/202​4

​This policy has been reissued in accordance with the Company's annual review process.​

01/02/2024This policy has been identified for a CPT code update, effective 01/02/2024.

The following CPT code has been added to this policy: 0864T 

Revisions From 11.11.01j:
​05/31/2023​

​This policy has been reissued in accordance with the Company's annual review process.​
06/15/2022This policy has been reissued in accordance with the Company's annual review process.
​09/13/2021

​This version of the policy will become effective 09/13/2021. 
The policy has been updated to address ​Experimental/Investigational treatments for erectile dysfunction 

The following HCPCS codes have been added to this policy:
C1813 Prosthesis, penile, inflatable
C2622 Prosthesis, penile, noninflatable​

Revisions From 11.11.01i:
03/25/2020This policy has been reissued in accordance with the Company's annual review process.
04/24/2019This policy has been reissued in accordance with the Company's annual review process.
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.
1/2/2024
1/3/2024
1/21/2026
11.11.01
Medical Policy Bulletin
Commercial
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.