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CurrentExcellus Health Plan IncPolicy 7.01.30

Erectile Dysfunction

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This policy governs the medical appropriateness of diagnostic procedures and treatment modalities for individuals with erectile dysfunction, including appropriate diagnostic testing, non-covered services, and treatment coverage requirements.

Policy Summary

PayerExcellus Health Plan Inc

PolicyErectile Dysfunction

Policy CodePolicy 7.01.30

Change TypeAnnual review — policy intent unchanged

Effective DateOctober 16, 2025

Next Review DateOctober 1, 2026

Key ActionUse the least invasive procedure as first-line treatment; if oral therapy fails, generally use a durable medical equipment modality next.

SourceLink

POLICY UPDATE CHANGES

The policy history identifies the 2025 review as an annual review with policy intent unchanged.

>6 monthsRequired symptom duration

6Appropriate diagnostic procedures

5Non-medically necessary diagnostic procedures

6Appropriate ED treatment modalities

5Non-medically necessary ED treatments

15CPT codes listed

Medical Necessity and Coverage Criteria

Medically Appropriate Diagnostic Evaluation

Diagnosing erectile dysfunction (ED) with ANY of the following procedures is considered medically appropriate:

ANY of the following diagnostic procedures

Nocturnal penile tumescence (NPT) test, only when the clinical evaluation is unable to distinguish psychogenic from organic impotence.
Duplex scan in conjunction with intracorporeal papaverine.
Pharmacological response test (PRT) using vasoactive medications such as papaverine HCL or prostaglandin E1.
Dynamic infusion cavernosonogram and cavernosometry, for patients who meet the criteria for penile revascularization.

Policy Summary

PayerExcellus Health Plan Inc

PolicyErectile Dysfunction

Policy CodePolicy 7.01.30

Change TypeAnnual review — policy intent unchanged

Effective DateOctober 16, 2025

Next Review DateOctober 1, 2026

Key ActionUse the least invasive procedure as first-line treatment; if oral therapy fails, generally use a durable medical equipment modality next.

SourceLink

On This Page

Pudendal arteriography/angiography, for patients who meet the criteria for penile revascularization.

Penile biothesiometry, considered an integral part of evaluation and management during an office visit.

Treatment Eligibility

Treatment modalities for individuals with known ED are considered medically appropriate when ALL of the following criteria are met:

ALL criteria required

Symptoms have lasted more than six (6) months.
Treatment may be initiated before six months under the acute-event exceptions described in the treatment sequencing and medical-necessity criteria.
ONE of the following treatment modalities
- Oral drug therapy, including sildenafil citrate (Viagra), vardenafil (Levitra, Staxyn), avanafil (Stendra), or tadalafil (Cialis).
- Intracavernous injection therapy, such as Caverject or Edex.

Pharmacologic and Device-Based Therapy

Covered treatment modalities include the following, subject to applicable benefit limitations and medical-necessity requirements:

Covered pharmacologic and device-based modalities

Oral drug therapy: sildenafil citrate (Viagra), vardenafil (Levitra, Staxyn), avanafil (Stendra), or tadalafil (Cialis).
Intracavernous injection therapy, such as Caverject or Edex.
Transurethral delivery system, such as the Medicated Urethral System for Erection (MUSE).
Vacuum constriction devices, such as ErecAid.

Penile Prosthetic Implants

Penile prosthetic implants, including semi-rigid, malleable, and inflatable prostheses, are medically appropriate only when the applicable conditions are met:

ALL conditions required

The patient has failed or refused other forms of therapy.
The patient does not have psychogenic ED, unless a psychiatrist or psychologist participates in the preoperative evaluation and concurs with the need for prosthesis implantation.

Arterial Revascularization

Arterial revascularization is medically appropriate only when ALL of the following conditions are met:

ALL conditions required

The patient has normal corporeal venous function.
The patient has arteriogenic ED secondary to pelvic or perineal trauma.

Electroejaculation

Electroejaculation is medically appropriate for ANY of the following indications:

ANY of the following indications

The man has a spinal cord injury and desires to become a biological father.
The inability to ejaculate is a consequence of retroperitoneal lymph node dissection (REPLND).
Insulin-dependent diabetes.
Multiple sclerosis (MS).
Spina bifida or another neural tube deficit; complications due to bladder or rectal surgery; or idiopathic anejaculation, whether neurogenic, psychogenic, or a combination of both.

Treatment Sequencing and Medical Necessity

Treatment coverage and medical necessity are subject to the following clinical, sequencing, documentation, and benefit conditions:

Applicable treatment conditions

Treatment may be initiated before six months when the ED follows an acute event such as penile trauma or radical pelvic surgery, including prostatectomy or cystectomy, or when drug-induced ED is caused by treatment of a comorbid condition.
The least invasive procedure should be the first line of treatment.
If oral therapy fails, a durable medical equipment (DME) modality should generally be the next treatment step.
Coverage of oral drug therapy, intracavernous injection therapy, and transurethral delivery systems depends on the member's subscriber contract with a prescription drug benefit; refer to Pharmacy Management for oral drug therapy coverage information.
Except for oral drug therapy, the urologist must provide a statement of medical necessity documenting the results of the clinical evaluation and any diagnostic test results.

PDE5 Inhibitor Safety

PDE5 inhibitors must be prescribed and used subject to the following safety conditions:

Safety conditions

PDE5 inhibitors should not be used in combination with other ED treatment modalities.
PDE5 inhibitors are contraindicated when the patient is actively taking nitrates in any form.
PDE5 inhibitors should be used with caution in patients who take alpha-blockers.
Vardenafil should be used with caution if the patient, or a patient's family member, has a rare heart condition known as prolongation of the QT interval.

AUA Guideline Treatment Positions

The AUA 2018 guideline positions summarized in this policy include the following:

Guideline positions

Low-intensity extracorporeal shock wave therapy (ESWT) for ED should be considered investigational (Conditional Recommendation; Evidence Level: Grade C).
Intracavernosal stem cell therapy for ED should be considered investigational (Conditional Recommendation; Evidence Level: Grade C).
Platelet-rich plasma (PRP) therapy for ED should be considered experimental (Expert Opinion).
For young men with ED and focal pelvic or penile arterial occlusion, without documented generalized vascular disease or veno-occlusive dysfunction, penile arterial reconstruction may be considered (Conditional Recommendation; Evidence Level: Grade C).
Penile venous surgery is not recommended for men with ED (Moderate Recommendation; Evidence Level: Grade C).

Emerging and Restorative Therapies

The following emerging or restorative therapies are investigational, experimental, or insufficiently validated for routine coverage:

Emerging or restorative approaches with insufficient evidence

Low-intensity shock wave therapy (LiSWT/ESWT) for ED; available studies show potential benefit, but limitations include small samples, variable protocols, limited follow-up, and the need for further comparative evidence.
Intracavernosal botulinum toxin (BoNT-A); reported improvements in some outcomes, but evidence is limited by small sample sizes, heterogeneity, and potential bias, and use should remain within clinical research settings until further evidence supports broader application.
Penile traction or contracture devices for ED or Peyronie's disease; available studies report possible improvements, but limited clinical trials and external validation do not establish sufficient evidence for routine use.
Intracavernosal stem cell therapy, considered investigational under the AUA guideline.
Platelet-rich plasma (PRP) therapy, considered experimental under the AUA guideline.
Nerve grafting to replace resected nerves after radical prostatectomy; NCCN guidance states that it has not been shown to be beneficial.

The following diagnostic procedures are considered not medically necessary for diagnosing ED: dorsal nerve conduction latencies; penile plethysmography; cavernosal nerve mapping; evoked potential measurements; and corpora cavernosal electromyography.

Arterial or penile revascularization is not medically necessary except for the specified indication: men with normal corporeal venous function who have arteriogenic ED secondary to pelvic or perineal trauma.

PDE5 inhibitors are contraindicated if the patient is actively taking nitrates in any form.

PDE5 inhibitors should not be combined with other ED treatment modalities.

New York State-regulated Medicaid, Family Health Plus, Healthy New York, and standardized HMO and HMO/POS direct payment policies exclude coverage of drugs, procedures, and supplies for ED when provided to, or prescribed for use by, a person who is required to register as a sex offender under state law.

Federal law excludes coverage of drugs to treat ED for all Family Health Plus enrollees.

Penile venous surgery is not recommended for men with ED.

Dorsal nerve conduction latencies are not medically necessary for diagnosing ED.

Penile plethysmography is not medically necessary for diagnosing ED.

Cavernosal nerve mapping is not medically necessary for diagnosing ED.

Evoked potential measurements are not medically necessary for diagnosing ED.

Corpora cavernosal electromyography is not medically necessary for diagnosing ED.

Topical medications containing vasodilators are not medically necessary for ED treatment.

Arterial or penile revascularization is not medically necessary except for the specified indication described in the policy.

Venous ligation for venous leak impotency is not medically necessary.

Crural ligation for primary venous leakage ED is not medically necessary.

Temporary or permanent lumbar ganglionic block or sympathectomy for ED secondary to cavernous adrenergic hypertone is not medically necessary.

CPT 37790, penile venous occlusive procedure, is marked not medically necessary/appropriate.

CPT 54240, penile plethysmography, is marked not medically necessary/appropriate.

Applicable Procedure and Diagnosis Codes

Covered CPT CodesCPTCovered

37788	Penile revascularization, artery, with or without vein graft.
54220	Irrigation of corpora cavernosa for priapism.
54230	Injection procedure for corpora cavernosography.
54231	Dynamic cavernosometry, including intracavernosal injection of vasoactive drugs (e.g., papaverine, phentolamine).
54235	Injection of corpora cavernosa with pharmacologic agent(s) (e.g., papaverine, phentolamine).
54250	Nocturnal penile tumescence and/or rigidity test.
54400	Insertion of penile prosthesis; non-inflatable (semi-rigid).

Not Medically Necessary CPT CodesCPTNot Covered

37790	Penile venous occlusive procedure.
54240	Penile plethysmography.

Covered CPT CodesCPTCovered

54401	Insertion of penile prosthesis; inflatable (self-contained).
54405	Insertion of multi-component, inflatable penile prosthesis, including placement of pump, cylinders, and reservoir.
54406	Removal of all components of a multi-component, inflatable penile prosthesis without replacement of prosthesis.
54408	Repair of component(s) of a multi-component, inflatable penile prosthesis.
54410	Removal and replacement of all component(s) of a multi-component, inflatable penile prosthesis at the same operative session.
54411	Removal and replacement of all components of a multi-component, inflatable penile prosthesis through an infected field at the same operative session, including irrigation and debridement of infected tissue.
54415	Removal of non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis, without replacement of prosthesis.
54416	Removal and replacement of non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis at the same operative session.
54417	Removal and replacement of non-inflatable (semi-rigid) or inflatable (self-contained) penile prosthesis through an infected field at the same operative session, including irrigation and debridement of infected tissue.
55870	Electroejaculation.

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Experimental CPT CodesCPTExperimental

0864T

Low-intensity extracorporeal shock wave therapy involving corpus cavernosum, low energy.

Covered HCPCS CodesHCPCSCovered

C1813	Prosthesis, penile, inflatable.
C2622	Prosthesis, penile, non-inflatable.
J0270	Injection, alprostadil, per 1.25 mcg (Code may be used for Medicare when drug administered under direct supervision of a physician, not for use when drug is self-administered).
J0275	Alprostadil urethral suppository (Code may be used for Medicare when a drug administered under direct supervision of a physician, not for use when drug is self-administered).
J2440	Injection, papaverine HCL, up to 60 mg.
J2760	Injection, phentolamine mesylate, up to 5 mg.
L7900	Male vacuum erection system.
L7902	Tension ring, for vacuum erection device, any type, replacement only, each.

Experimental HCPCS CodesHCPCSExperimental

E0201	Tension ring, for vacuum erection device, any type, replacement only, each.
S4988	Penile contracture device, manual, greater than 3 lbs. traction force.

ICD-10 Diagnosis CodesICD-10

E01.8	Other iodine-deficiency related thyroid disorders and allied conditions.
E02	Subclinical iodine-deficiency hypothyroidism.
E03.2-E03.9	Other hypothyroidism, other (code range).
E05.00-E05.91	Thyrotoxicosis [hyperthyroidism] (code range).
E10.40-E10.59; E10.69	Type 1 diabetes mellitus with complications (code range).
E11.40-E11.59; E11.69	Diabetes mellitus with complications (code range; description truncated in source).
E13.40-E13.59; E13.69	Other specified diabetes mellitus with complications (code range; description truncated in source).
E22.1-E23.7	Disorders of pituitary gland (code range).
E24.1	Nelson's syndrome.
E27.0-E27.9	Other disorders of adrenal gland (code range).

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Provider Documentation and Coverage Actions

Billing Rule

Confirm Benefit-Specific Coverage

Verify the member’s subscriber contract and prescription drug benefit before providing or billing oral drug therapy, intracavernous injection therapy, or a transurethral delivery system. Oral drug coverage information should be confirmed through Pharmacy Management.

Affected modalities: oral drug therapy, intracavernous injection therapy, and transurethral delivery systems.

Step Therapy

Follow Least-Invasive Sequencing

Use the least invasive treatment first. When oral therapy fails, a durable medical equipment (DME) modality should generally be the next treatment step; vacuum constriction devices are DME.

Document oral-therapy failure before progressing to a DME modality.
Vacuum constriction devices are considered DME.

Documentation Required

Document Early-Treatment Exceptions

Treatment may begin before symptoms have continued for six months when the member has a qualifying exception.

Acute event such as penile trauma.
Radical pelvic surgery, including prostatectomy or cystectomy.
Drug-induced ED caused by treatment of a comorbid condition.

Documentation Required

Support Medical Necessity for NPT

Order nocturnal penile tumescence (NPT) only when the clinical evaluation cannot distinguish psychogenic from organic impotence. Document that limitation in the clinical record.

NPT is medically appropriate only when clinical evaluation is unable to distinguish psychogenic from organic impotence.

Documentation Required

Document Revascularization Eligibility

Before pursuing diagnostic evaluation for penile revascularization, document the findings establishing that the member meets revascularization criteria.

Dynamic infusion cavernosonography and cavernosometry require documentation that the patient meets penile-revascularization criteria.
Pudendal arteriography/angiography requires documentation that the patient meets penile-revascularization criteria.

Prior Authorization

Obtain the Urologist’s Medical-Necessity Statement

For treatments other than oral drug therapy, obtain a statement of medical necessity from the urologist documenting the clinical evaluation results and any diagnostic test results.

The urologist statement is not required for oral drug therapy.
Include relevant clinical evaluation and diagnostic test results.

Documentation Required

Provide Priapism Counseling

Counsel patients receiving vasoactive injection therapy that a prolonged erection can occur and instruct them to seek treatment if the erection lasts longer than four hours.

Applies to agents such as papaverine, phentolamine, and/or prostaglandin E1 (alprostadil).
Document counseling about priapism and the need for urgent treatment after four hours.

Denial Risk

Avoid Non-Covered Diagnostic Tests

Do not rely on the following tests to establish medically necessary ED diagnosis or treatment; diagnostic evaluation using these procedures may be denied as not medically necessary.

Dorsal nerve conduction latencies.
Penile plethysmography.
Cavernosal nerve mapping.
Evoked potential measurements.
Corpora cavernosal electromyography.

Denial Risk

Document Sufficient Symptom Duration

Treatment may be denied when ED symptoms have not lasted more than six months unless a qualifying early-treatment exception applies.

Confirm and document symptom duration of more than six months.
Exceptions include penile trauma, radical pelvic surgery, and drug-induced ED related to treatment of a comorbid condition.

Denial Risk

Watch for Not-Medically-Necessary Treatments

Do not submit the following ED treatments as medically necessary under this policy, except for an otherwise specified covered indication.

Topical medications containing vasodilators.
Arterial penile revascularization, except for the indication identified in the policy statement.
Venous ligation for venous-leak impotence.
Crural ligation for primary venous-leak ED.
Temporary or permanent lumbar ganglionic block or sympathectomy for ED secondary to cavernous adrenergic hypertone.

Denial Risk

Flag Investigational Treatments

Treatments for ED or Peyronie’s disease listed below are considered investigational and may be denied.

Extracorporeal shock wave therapy (ESWT).
Penile contracture devices, such as RestoreX.

Prior Authorization

Apply PDE5 Inhibitor Safety Restrictions

Before prescribing a PDE5 inhibitor, review concurrent ED treatments and relevant cardiovascular medications and conditions.

Do not use PDE5 inhibitors in combination with other ED treatment modalities.
PDE5 inhibitors are contraindicated with nitrates in any form.
Use caution with alpha-blockers.
Use vardenafil with caution when the patient or a family member has a rare heart condition involving QT-interval prolongation.

Denial Risk

Apply the Sex-Offender Status Exclusion

For New York products subject to the statutory restriction, exclude coverage of ED drugs, procedures, and supplies when provided to or prescribed for a person required to register as a sex offender under state law.

Restriction applies to New York Medicaid, Family Health Plus, Healthy New York, and standardized HMO and HMO/POS direct-payment policies.
Verify product and member eligibility before authorizing or billing ED treatment.

Denial Risk

Apply the Family Health Plus Drug Exclusion

Do not provide coverage for drugs to treat erectile dysfunction for Family Health Plus enrollees under the federal exclusion.

Federal exclusion applies to all Family Health Plus enrollees.

Denial Risk

Review Experimental and Non-Medically-Necessary Services

Treat the identified services as experimental or not medically necessary as applicable, and review the associated code entries before billing. Low-intensity extracorporeal shock wave therapy is considered investigational under the policy and professional guidelines.

Professional-guideline services considered investigational or experimental include low-intensity ESWT, intracavernosal stem cell therapy, and platelet-rich plasma therapy; penile venous surgery is not recommended.
CPT entries: 54401, 54405, 54406, 54408, 54410, 54411, 54415, 54416, 54417, 55870, 93980, 93981, and 0864T (E/I).
HCPCS entries: C1813, C2622, J0270, J0275, J2440, J2760, L7900, L7902, E0201, and S4988 (E/I).
S4988 (E/I), penile contracture device, was termed effective 03/31/25; E0201 is associated with the tension ring for a vacuum erection device.

Policy Background

The policy addresses multiple erectile dysfunction treatment approaches, including oral drug therapy, intracavernous injections, transurethral delivery systems, vacuum constriction devices, penile prostheses, and arterial revascularization. Coverage and medical appropriateness vary by the treatment modality and the applicable clinical criteria.

Terms and Treatment Definitions

Venous ligation

TermVenous ligation

Treatment purposeAttempts to close off the natural drainage of the penis to maintain blood in the penis during an erection.

Policy statusConsidered not medically necessary for treatment of venous leak impotency.

Erectile dysfunction (ED)

Policy definitionThe inability, over time, to consistently achieve or maintain an erection of sufficient rigidity for sexual penetration.

ConsistencyED involves the inability to achieve or maintain an erection and have sexual activity 80% of the time it is attempted.

Duration conceptThe definition describes a condition occurring over time; brief, sporadic episodes of erectile failure are common occurrences and are often related to psychological stress.

RigidityThe erection must have sufficient rigidity for sexual penetration; inability to achieve or maintain that rigidity is part of the definition.

Peyronie’s disease (PD)

ConditionA localized connective tissue disorder of unknown cause.

PlaquesCharacterized by the formation of inelastic fibrous plaques.

LocationThe plaques occur within the tunica albuginea or erectile tissue of the penis.

Sexual impactMay cause sexual problems through difficulty attaining and/or maintaining erections.

Vacuum constriction device

ClassificationA durable medical equipment modality.

MechanismUses a hand pump and cylindrical component to create a vacuum around the penis.

EffectThe vacuum draws blood into the penis, resulting in an erection.

Medicated Urethral System for Erection (MUSE)

Full nameMedicated Urethral System for Erection (MUSE).

MedicationAlprostadil, also known as prostaglandin E1.

AdministrationGiven transurethrally to treat erectile dysfunction.

Intracavernous injection therapy

Therapy typeIntracavernous injection therapy.

AgentsUses vasodilating agents such as papaverine, phentolamine, and/or prostaglandin E1 (alprostadil).

Administration siteThe agents are injected into the corpora of the penis.

Treatment effectThe injections produce an erection.

(E/I)

AbbreviationE/I

EExperimental.

IInvestigational.

(NMN)

AbbreviationNMN

MeaningNot medically necessary/appropriate.

Use in policyIdentifies services considered not medically necessary or not medically appropriate.

PDE5 inhibitors

DefinitionPhosphodiesterase type 5 inhibitors.

FDA-approved oral therapyThe policy identifies these as the only oral therapies approved by the FDA for the treatment of erectile dysfunction.

SildenafilSildenafil citrate (Viagra).

VardenafilVardenafil (Levitra, Staxyn).

AvanafilAvanafil (Stendra).

TadalafilTadalafil (Cialis).