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CurrentAetnaPolicy 0007

Erectile Dysfunction and Peyronie's Disease

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Defines Aetna's medical necessity, diagnostic workup, and coverage stance for evaluation and treatments of erectile dysfunction (ED) and Peyronie's disease for Aetna members.

Policy Summary

PayerAetna

PolicyErectile Dysfunction and Peyronie's Disease

Policy CodePolicy 0007

Change TypeNo material changes

Effective DateJul 31, 1995

Last ReviewJul 29, 2026

Next Review DateJan 14, 2027

Key ActionObtain and document required diagnostic history, physical exam, laboratory testing, and prior treatment attempts when requesting authorization for penile prosthesis or re-vascularization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiplelisted as medically necessary for ED workup

>=10specific therapies experimental/investigational

<55age limit for penile re-vascularization

12 moPeyronie's surgery duration threshold

PDE5 benefitPDE-5 inhibitors effective

9/637LI-ESWT studies pooled

Coverage Criteria and Evidence Summary

Diagnostic Workup - Medically Necessary

Diagnostic workup for erectile dysfunction is considered medically necessary when appropriate:

ED diagnostic workup - required components: Comprehensive history and physical (including medical and sexual history and psychosocial evaluation); duplexscan (Doppler and ultrasound) with intracorporeal papaverine; dynamic infusion cavernosometry and cavernosography only for members being considered for re-vascularization; pharmacological response testing using vasoactive agents (e.g., papaverine, phentolamine, prostaglandin E1); pudendal arteriography only when performed for penile re-vascularization candidates; laboratory testing including biothesiometry (integral to exam), blood glucose, CBC, creatinine, hepatic panel, lipid profile, PSA, serum testosterone with pituitary evaluation if low, thyroid function studies, and urinalysis.

Biothesiometry is considered an integral part of the comprehensive history and physical examination.

Implantable Penile Prosthesis - Medically Necessary Criteria

Implantable penile prosthesis is considered medically necessary when ALL of the following are met:

Penile prosthesis eligibility:

Policy Summary

PayerAetna

PolicyErectile Dysfunction and Peyronie's Disease

Policy CodePolicy 0007

Change TypeNo material changes

Effective DateJul 31, 1995

Last ReviewJul 29, 2026

Next Review DateJan 14, 2027

Key ActionObtain and document required diagnostic history, physical exam, laboratory testing, and prior treatment attempts when requesting authorization for penile prosthesis or re-vascularization.

SourceLink

On This Page

1) Absence of active alcohol or substance abuse; 2) Absence of drug-induced impotence related to anabolic steroids, anticholinergics, antidepressants, antipsychotics, or CNS depressants; 3) Absence of untreated depression or psychiatric illness; 4) Nonsurgical methods have proven ineffective or are contraindicated; 5) Normal prolactin and thyroid hormone levels (unless erectile dysfunction is from surgical, radiation, or traumatic cause); 6) Normal serum testosterone levels (unless surgical/radiation/traumatic cause); 7) History of organic disease including one or more of: documented perineal/genital injury, major pelvic trauma, major vascular surgery (aorta/femoral), neurologic disease (e.g., diabetic neuropathy), Peyronie's disease, renal failure, spinal cord injury, status-post prostate/bladder/bowel/spinal surgery, documented vascular insufficiency or venous incompetence by DICC, or venous leak of the penis.

Individuals with surgical, radiation, or traumatic causes do not need to document normal prolactin, thyroid, or testosterone.

Penile Re-vascularization - Medically Necessary Criteria

Penile re-vascularization is considered medically necessary only when ALL of the following are met:

Penile re-vascularization criteria: 1) Member is less than 55 years old; 2) Focal blockage of arterial inflow demonstrated by duplex Doppler ultrasonography or arteriography; 3) Diagnostic work-up demonstrates normal corporeal venous function; 4) Member is not actively smoking; 5) Member is not diabetic and has no evidence of systemic vascular occlusive disease; 6) Erectile dysfunction is the direct result of arterial injury caused by blunt pelvic and/or perineal trauma.

Re-vascularization is considered experimental for other indications and arterial reconstructive or venous procedures for arteriosclerotic disease are not recommended.

Covered with criteria

Covered when selection criteria are met for listed diagnostic tests, penile prosthesis procedures, and related services

Covered services general: CPT and HCPCS codes listed as 'covered if selection criteria are met' (examples include penile prosthesis CPT codes 54400-54417 and prosthesis HCPCS C1813/C2622, penile revascularization 37788, diagnostic vascular and laboratory tests) are covered when the policy's documented selection criteria and medical necessity requirements are satisfied.

Providers must document medical necessity and required diagnostic/laboratory results when billing covered codes.

Experimental/Investigational/Not Covered

Not covered / considered experimental, investigational, or unproven for indications listed in the CPB

Not covered interventions: Includes gene therapy, pelvic floor muscle training (for the indications listed), endovascular angioplasty/stent placement for ED, genetic polymorphism testing for PDE5 response, stem cell-derived exosome therapy, low-intensity pulsed ultrasound for ED, mesenchymal stem cell microspheres modified with BDNF, fractional CO2 laser for Peyronie's disease (no specific code), extracorporeal shock wave therapy (high energy), platelet-rich plasma injections, certain intralesional injections (e.g., nicardipine coded 11900/11901 for listed indications), penile venous occlusive procedures (37790), and enumerated CPT/HCPCS/J-codes listed as not covered for the indications in this CPB.

Many specific CPT/HCPCS/J-codes are enumerated as not covered for the CPB indications.

Therapy hierarchy and investigational stance

Summarized coverage-relevant clinical positions from cited guidelines and reviews:

First-line therapy: Clinicians should initiate therapy with an oral PDE-5 inhibitor for men seeking treatment for ED who have no contraindication to PDE-5 inhibitor use.

ACP and AUA guidance support PDE-5 inhibitors as initial therapy.

When to consider invasive therapies: Inflatable or semi-rigid penile prosthesis is indicated after failure of or contraindication to nonsurgical options; penile arterial reconstruction may be considered selectively in young men with focal arterial occlusion without generalized vascular disease; venous surgery is not recommended for arteriosclerotic disease.

AUA guidance and policy statements referenced.

Investigational / Experimental treatments: LI-ESWT, intracavernosal stem cell therapy, and platelet-rich plasma therapy should be regarded as investigational/experimental or unproven for routine clinical use pending higher-quality evidence; transdermal/iontophoresis verapamil has limited and inconsistent evidence.

Guideline conclusions and trial data inform investigational stance.

Evidence summaries informing coverage stance

Summaries of efficacy findings that determine clinical support:

Intralesional verapamil for Peyronie's disease: Randomized and controlled trials report no consistent significant improvement in curvature, plaque size, pain, or sexual function versus saline/placebo; evidence does not support reliable curvature correction.evidence not supportive

Multiple RCTs report non-significant differences (see verapamil trials).

Iontophoresis/transdermal verapamil + dexamethasone: Small uncontrolled studies report improvement in pain but limited or no effect on curvature; controlled trials are lacking.limited evidence

Limited clinical data exist for curvature benefit.

ESWT for Peyronie's disease: A randomized trial (n=102) showed pain reduction in a subgroup but no reduction in deviation or plaque size and potential for worsening deviation; ESWT is not recommended for deformity correction.not recommended for deformity

Placebo-controlled RCT found no curvature benefit and possible worsening.

Acoustical Wave Therapy (SwissWave) for ED: Device cleared as a soft-tissue massage device lacks evidence of effectiveness for treatment of erectile dysfunction.insufficient evidence

No quality evidence of efficacy for ED.

Adipose-derived regenerative cells (ADRC) intracavernosal injection: Phase I open-label trial (n=21) showed a safety signal and functional improvement in a subgroup (continent men) but requires phase II/III trials to establish efficacy.investigational—limited to clinical trials

Preliminary safety and efficacy signals need confirmatory trials.

LIPUS +/- biofeedback for ED: Small retrospective study (n=68) reported improvements in IIEF-5 and EHS, but design limitations and lack of RCT data require cautious interpretation.preliminary evidence—requires RCTs

Limited non-randomized data only.

Botulinum toxin intra-cavernosal injection for ED: Systematic review/meta-analysis shows some improvements in EHS and PSV but trials are limited and heterogeneous; use should be limited to clinical studies.investigational—clinical trials preferred

Authors recommend restricting to research settings.

Endovascular therapies for vasculogenic ED: Case series and meta-analyses report moderate technical and clinical success rates (VOD ~59.8%, AI ~63.2%) with heterogeneous definitions and limited long-term data; consider only for select patients with focal traumatic arterial lesions.selective use—limited evidence

Evidence limited by heterogeneity and follow-up.

LI-ESWT for vasculogenic ED: Multiple RCTs and meta-analyses report short-term improvements in IIEF and EHS for some patients (especially mild–moderate or vasculogenic ED), but protocols are heterogeneous, evidence quality is low–moderate, and long-term durability is uncertain.potential short-term benefit—evidence low to moderate

Systematic reviews and RCTs show mixed results and limited durability beyond 6–12 months.

LI-ESWT (evidence synthesis)

Summary of evidence-based coverage considerations for LI-ESWT:

LI-ESWT evidence summary: Randomized trials and meta-analyses show statistically significant short-term improvements in IIEF and EHS (typically at 3–6 months) for some patient groups (vasculogenic ED, mild–moderate ED); however, evidence quality is low, treatment protocols are heterogeneous, and durability beyond 6–12 months is inconsistent. Guideline bodies (e.g., Canadian Urological Association) have recommended against LI-ESWT due to low certainty of evidence, supporting a cautious or investigational stance by payers.

Consider limited/experimental coverage or require prior authorization with documented failed standard therapies and outcome measures.

Radial wave therapy

Radial wave therapy:

Radial wave therapy evidence: No quality human evidence demonstrates benefit of radial pressure waves for ED; pre-clinical results are contradictory. Radial wave therapy should be considered experimental or not covered pending higher-quality clinical data.

Systematic review found no differences versus placebo and contradictory animal data.

Fractional CO2 laser (Peyronie's disease)

Fractional CO2 laser for Peyronie's disease:

Fractional CO2 laser PD evidence: Single small pilot (n=5) reported median curvature reduction at 52 weeks and improved PDQ scores with transient self-limited side effects; evidence is preliminary and insufficient to support routine coverage.

Larger controlled trials are needed before routine clinical adoption.

Gene therapy and stem-cell approaches

Gene and advanced cellular therapies:

Gene therapy and modified stem-cells: Pre-clinical research and early-phase work demonstrate potential mechanisms but face technical, delivery, and safety limitations. Human data are minimal or absent, and gene therapy approaches and BDNF-modified MSC microspheres remain investigational pending human trials.

Clinical translation has not been established; further human safety and efficacy trials required.

Biomarkers (MPV, melatonin, vitamin D)

Biomarkers and predictors:

Biomarker findings: Higher mean platelet volume (MPV) has been associated with vasculogenic ED in pooled analyses; lower serum melatonin and lower vitamin D levels have been reported in small studies or meta-analyses, but findings are inconsistent and not validated for diagnostic or therapeutic decision-making.

Not established for routine clinical use.

Emerging/Investigational Therapies and Diagnostic Modalities

Evidence and policy-relevant conclusions summarized from background literature in this excerpt.

Penile traction therapy (RestoreX) — evidence summary: RestoreX is an FDA-cleared mechanical penile traction device for Peyronie's-related curvature and length loss. Randomized controlled data (n=110) showed improvements in length, curvature, and erectile function versus no therapy with typical use of 30–90 minutes/day and favorable safety profile; AUA considers mechanical therapies promising but evidence insufficient for a formal recommendation.

Device data are preliminary; further studies may clarify indications.

Platelet-rich plasma (PRP): PRP has been evaluated in small pre-clinical and clinical studies for ED and PD with few major complications reported, but studies are limited by small size, short follow-up, lack of controls, and heterogeneous protocols; evidence is insufficient to recommend routine clinical use.

Recommend further standardized clinical trials and research participation.

Shear wave elastography (SWE): SWE shows preliminary promise as a noninvasive diagnostic tool to quantify corpus cavernosum rigidity changes and may assist etiologic diagnosis of ED, but findings remain preliminary.

Further validation studies needed.

Stem cell-derived exosomes and stem cell therapy: Preclinical meta-analyses suggest exosomes improve erectile function in animal models; limited human SCT trials (5 studies, 61 patients) report safety and some functional improvements but are small and largely uncontrolled, leaving clinical utility unestablished.

Further human trials required for safety, efficacy, and standardization.

Vitamin D and eNOS polymorphisms: Meta-analyses show inconsistent or preliminary associations between vitamin D levels and ED and mixed findings regarding eNOS polymorphisms; evidence is not robust enough for clinical application.

Additional large studies required.

Pelvic floor muscle training after radical prostatectomy: Systematic reviews of heterogeneous studies suggest pelvic floor muscle training may improve ED after prostatectomy, but methodological limitations and protocol variability limit definitive conclusions; further well-powered RCTs are needed.

Considered promising but not definitively proven.

Aetna identifies numerous diagnostic tests and adjunctive therapies for erectile dysfunction and Peyronie’s disease as experimental, investigational, or unproven. Examples include genetic polymorphism testing (e.g., eNOS, ACE), cavernosal nerve mapping/electrical stimulation, corpora cavernosal electromyography, dorsal nerve conduction studies, penile plethysmography, shear wave elastography, measurement of serum melatonin or vitamin D for ED, and various serum biomarker panels — all of which lack established clinical utility and are not supported as standard diagnostic procedures.

Routine nocturnal penile tumescence (NPT) and simple gauge tests are rarely necessary; NPT is considered medically necessary only when history and physical cannot distinguish psychogenic from organic impotence and when simpler tests are inconclusive. The policy lists these diagnostic and investigational modalities to clarify that they are not routine components of the medically necessary ED workup.

The policy enumerates specific CPT, HCPCS, and J-codes that are either covered when selection criteria are met or listed as not covered for the CPB indications. Examples of codes not covered include 0038U (vitamin D LC‑MS/MS microsample), 0101T (high-energy extracorporeal shock wave), 0232T (platelet-rich plasma injections), 11900–11901 (intralesional injections by lesion count), 37790 (penile venous occlusive procedure), and HCPCS E0201 (manual penile contracture device >3 lbs traction).

Covered procedure groups include diagnostic duplex scanning codes (e.g., 93975–93981) and penile prosthesis CPT ranges (54400–54417) and HCPCS prosthesis codes (e.g., C1813, C2622) when the policy's selection criteria and documentation requirements are met.

Platelet-rich plasma (PRP) injections for ED and Peyronie’s disease are considered experimental. Available human and preclinical studies are small, heterogeneous, often uncontrolled, and lack standardized protocols and adequate follow-up; therefore PRP is not supported as a routine covered therapy outside of clinical trials.

As a result, CPT 0232T (injection(s), PRP) and similar billing for PRP-based treatments may be excluded for the indications described in this CPB.

The policy lists multiple treatments lacking Level 1 or Level 2 supportive evidence or cleared indications and classifies them as not medically necessary or investigational. Examples include transdermal/iontophoresis verapamil for Peyronie’s disease (randomized trials showing non-significant curvature improvement), extracorporeal shock wave therapy for PD (RCT showing pain reduction but no curvature or plaque benefit and potential worsening of deviation), and acoustical wave therapies cleared only as soft-tissue massage devices without ED efficacy data.

The document emphasizes that interventions with mixed or negative RCT results, inconsistent outcomes across trials, or insufficient randomized evidence should not be considered proven therapies for routine coverage.

Radial pressure wave therapy is not supported by quality human evidence. Systematic review findings indicate no meaningful differences between radial wave therapy and placebo on mean IIEF score, EHS, or penile Doppler parameters, and preclinical results are contradictory. Therefore radial pressure wave therapy is considered unsupported and may be classified as experimental or not covered for ED.

RestoreX is an FDA‑cleared, reusable penile traction device indicated for Peyronie’s disease deformity and length loss. Clinical trial protocols and manufacturer guidance describe typical use of two 30‑minute sessions per day (totaling 30–90 minutes/day) with minimum treatment durations commonly reported at 12 weeks and some studies extending to 24 weeks. The manufacturer notes no evidence to recommend RestoreX for congenital penile curvature.

Stem cell therapy (SCT) for erectile dysfunction remains investigational. Most evidence comprises preclinical rodent studies and a very small number of human phase I/II trials (totaling limited patient counts), which report preliminary safety signals and some functional improvements but are constrained by small cohorts, short follow-up, and few controlled trials. Routine coverage is not supported pending larger, standardized trials addressing safety, efficacy, and reproducibility.

A randomized, double‑blind trial of oral tacrolimus after nerve‑sparing radical prostatectomy failed to demonstrate a statistically significant benefit in erectile function recovery versus placebo. Tacrolimus did not improve IIEF‑EFD outcomes or rates of return to spontaneous erectile function in the reported trial and therefore is not supported as an effective therapy for this indication based on current evidence.

Clinical Policy Bulletins (CPBs) are administrative guidance to assist in applying plan benefits and do not constitute a contract or guarantee of coverage. Specific coverage decisions, prior authorization requirements, and exclusions depend on the member’s benefit plan and program provisions; providers should follow plan-specific rules and document required clinical information when requesting authorization.

Routine nocturnal penile tumescence (NPT) testing and simple gauge methods are rarely medically necessary. NPT testing (postage stamp or snap gauge) is only considered when history and physical exam cannot reliably distinguish psychogenic from organic erectile dysfunction and when simpler assessments are inconclusive; RigiScan is reserved for cases where NPT testing is indicated and less‑complex tests produce equivocal results.

The policy references ICD‑10 codes used for Peyronie’s disease and erectile dysfunction and identifies certain diagnoses not covered for the listed indications. Examples include N48.6 (Peyronie’s disease) and the N52.* series for organic male erectile dysfunction as codes that may be covered when selection criteria are met, whereas diabetes mellitus codes (E08.69–E13.69) and several psychosexual disorder codes (F52.*) are listed among codes not covered for the CPB indications.

Transdermal verapamil delivered via electromotive drug administration or iontophoresis has not demonstrated consistent, significant reductions in penile curvature versus placebo in clinical trials. Randomized and small uncontrolled studies report limited or non‑significant curvature improvement, with some benefit noted for pain in uncontrolled series; overall evidence does not support verapamil transdermal therapy as an effective curvature‑reducing treatment.

Extracorporeal shock wave therapy (ESWT/LI‑ESWT) for Peyronie’s disease is not recommended for reducing curvature or plaque size. A randomized trial (n=102) showed pain improvement in a subgroup but no benefit for deviation or plaque size and some instances of worsened deviation; guideline summaries and systematic reviews report mixed or insufficient evidence to support ESWT for deformity correction.

Interventions that lack standardized clinical translation or reproducible RCT evidence are considered investigational or not medically necessary. This includes heterogeneous LI‑ESWT protocols without consistent durable benefit, radial wave therapy with no quality human evidence, fractional CO2 laser for Peyronie’s disease (pilot data only), and gene therapies that remain at preclinical or early‑phase stages.

PRP, stem cell injections, and exosome therapies share common evidence limitations: small, heterogeneous studies, short follow‑up, lack of standardized preparations or dosing, and few controlled trials. While preclinical data and early human reports suggest possible biologic effects and safety signals, these modalities remain investigational and are not supported for routine coverage outside of well‑designed clinical trials.

Several emerging therapies are supported only by preclinical or small early‑phase human data. Examples include stem cell‑derived exosomes (animal meta‑analyses showing improvements in ICP/MAP and microstructure), intracavernous stem cell injections (limited human phase I/II trials), and gene therapy approaches — all of which require further clinical investigation before consideration as standard care.

Coding and Billing Guidance

Covered CPT Codes (selection shown)CPTCovered

37788	Penile revascularization, artery, with or without vein graft.
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).
54360	Plastic operation on penis to correct angulation.
54400-54417	Penile prosthesis procedures.
74445	Corpora cavernosography, radiological supervision and interpretation.
78012	Thyroid uptake, single or multiple quantitative measurement(s).

CPT Codes Not Covered for Indications Listed in the CPB (selection shown)CPTNot Covered

0038U	Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative.
0101T	Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy.
0232T	Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed.
11900-11901	Injection, intralesional; up to and including 7 lesions / more than 7 lesions.
37790	Penile venous occlusive procedure.
38240-38242	Hematopoietic progenitor cell transplantation codes (allogeneic/autologous).
51792	Stimulus evoked response (e.g., measurement of bulbocavernosus reflex latency time).
54110-54112	Excision of penile plaque (Peyronie disease).

Covered HCPCS Codes (selection shown)HCPCSCovered

C1813	Prosthesis, penile, inflatable.
C2622	Prosthesis, penile, non-inflatable.
J0270	Injection, alprostadil, 1.25 mcg.
J0275	Alprostadil urethral suppository.
J0775	Injection, collagenase, clostridium histolyticum, 0.01 mg.
L7900	Male vacuum erection system.
L7902	Tension ring, for vacuum erection device, replacement only.

HCPCS Codes Not Covered for Indications Listed in the CPB (selection shown)HCPCSNot Covered

E0201	Penile contracture device, manual, greater than 3 lbs traction force.
J0585-J0588	Various botulinum toxin injection codes.
J1071-J3145	Various testosterone injection codes.
J9213-J9215	Interferon alpha injection codes.
S0090	Sildenafil citrate, 25 mg.

ICD-10 Codes (covered and not covered groups)ICD-10

N48.6	Induration of penis plastica [Peyronie's disease].
N52.01-N52.1	Male erectile dysfunction [impotence of organic origin].
F52.0-F52.4	Sexual dysfunction and related psychosexual disorders.
E08.69-E13.69	Diabetes mellitus codes listed as not covered for indications in CPB.

inv-35: Age threshold for penile re-vascularization

Age thresholdMember must be less than 55 years old for penile re-vascularization to be considered medically necessary

Required vascular demonstrationFocal arterial inflow blockage must be demonstrated by duplex Doppler ultrasonography or arteriography

Venous functionDiagnostic work-up must reveal normal corporeal venous function

inv-36: Duration threshold for Peyronie's surgical correction

Minimum disease duration>= 12 months of Peyronie's disease with significant morbidity before surgical correction is considered medically necessary

Failure of conservative therapySurgical correction indicated only after failure of conservative medical treatment

Procedures coveredIncludes plaque excisions, venous graft patching, tunica plication, Nesbit tuck procedure when criteria met

inv-37: Lesion count for intralesional injection coding

Intralesional injection codingCPT 11900 covers injection for up to and including 7 lesions; CPT 11901 covers more than 7 lesions

Associated codesRelated Peyronie’s injection/excision codes referenced in code list (e.g., 54200-54205, 54110-54112)

DocumentationRecord lesion count and procedure details to support correct CPT selection

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization for surgical interventions

Prior authorization is implied for implantable penile prostheses and penile re-vascularization because specific medical necessity criteria and documentation must be met before these surgical interventions are covered.

Prior Authorization

Prior authorization for prosthesis and surgical procedures

Certain penile prosthesis procedures and related prosthesis HCPCS codes are covered only when the policy's selection criteria are met; prior authorization may be required when billing CPT 54400–54417 or HCPCS C1813/C2622.

Document that all medical criteria for implantation are satisfied (see policy selection criteria).

Prior Authorization

Prior authorization for surgical/device therapies

Surgical interventions and device implants (for example inflatable penile prosthesis or penile revascularization) typically require documentation of prior treatment attempts and indications consistent with guideline recommendations when requesting authorization.

Include evidence of nonsurgical therapy failure or contraindication.
Provide relevant guideline-based indications and counseling documentation.

Prior Authorization

Endovascular therapy — prior authorization considerations

Endovascular therapies for vasculogenic ED have limited, heterogeneous evidence; prior authorization should require documentation of a focal vascular lesion, prior conservative therapy failure, and discussion of limited long-term data.

Document diagnostic imaging confirming focal arterial lesion or venous pathology.
Provide record of prior medical management and counseling regarding limited durability.

Prior Authorization

Prior authorization for LI-ESWT

Prior authorization may be required for low-intensity extracorporeal shock wave therapy (LI-ESWT); when requested include the indication (e.g., vasculogenic ED, post-prostatectomy, diabetic ED), prior treatments tried, and objective outcome measures (IIEF, EHS) documented before and after therapy.

Specify LI-ESWT protocol used and prior response to PDE5 inhibitors or other therapies.

Note

PTT (RestoreX) authorization note

RestoreX is FDA-cleared and trial evidence describes typical home use (30–90 minutes/day), but the policy text does not define payer prior authorization requirements for this device; include device usage instruction and documented patient use if submitting for review.

Document patient instruction and recorded daily use (minutes/day) and treatment duration in the medical record.

Prior Authorization

Prior authorization for stem cell or experimental biologic treatments

Prior authorization requests for stem cell therapy or other novel biologic injections should include clinical trial phase, safety data, validated outcome measures (IIEF/EHS), and supporting human evidence because current data are limited.

Provide trial phase, sample size, follow-up duration, and safety outcomes.
Document prior conventional therapy failure and inclusion criteria if part of a trial.

Prior Authorization

Follow plan-specific prior authorization

Follow the member's plan-specific prior authorization rules and program provisions; Clinical Policy Bulletins do not replace plan requirements and prior authorization may be required per plan rules.

Verify member benefits and obtain any plan-required authorizations before scheduling procedures.

Step Therapy

Step requirement before implantable devices

Penile prosthesis implantation is covered only after nonsurgical methods have proven ineffective or are contraindicated; failure to document prior therapy attempts may lead to noncoverage.

Document trials of PDE5 inhibitors, vacuum devices, injections, or contraindications to these therapies.

Step Therapy

First-line PDE-5 inhibitor therapy

Guideline-supported first-line therapy for ED is initiation of an oral PDE-5 inhibitor when not contraindicated; document use and response to PDE-5 inhibitors when relevant to authorization of advanced therapies.

Record which PDE-5 inhibitor was used, dose, duration, and clinical response.

Step Therapy

Step: start with PDE-5 inhibitors

When escalating therapy, start with a PDE-5 inhibitor in men without contraindications; authorization for invasive or device therapies should reflect documented trial and response to PDE-5 inhibitors.

Include documentation of contraindications if PDE-5 inhibitors were not used.

Step Therapy

Step considerations around bariatric surgery

When bariatric surgery is reported as a management option for ED, ensure prior optimization of medical management of ED and document obesity-related comorbidities and prior ED therapy attempts.

Provide records of medical optimization and objective ED assessments pre- and post-intervention when available.

Step Therapy

Adjunct use after PDE5i

For post-prostatectomy ED, LI-ESWT is often studied as an adjunct to PDE-5 inhibitors; consider documenting a trial of PDE5i and response status prior to authorization of LI-ESWT.

Document timing of LI-ESWT relative to surgery and prior PDE5i therapy details.

Note

No explicit step therapy sequences given

The policy excerpt provides no explicit step therapy sequences for devices or biologics; when seeking authorization, include documented prior treatments and clinical rationale even though no formal sequence is defined here.

Step Therapy

Surgical approach guided by SUI severity

For synchronous surgical management of ED with stress urinary incontinence, surgical severity (e.g., severe SUI >4 pads/day) should guide choice of combined procedures; document SUI severity and rationale for combined approach.

Record pad counts/day, urodynamic findings if available, and surgical plan justification.

Documentation Required

Required diagnostic documentation

Providers must document a comprehensive history and physical, specified laboratory testing (including serum testosterone, prolactin, and thyroid studies when indicated), and appropriate diagnostic studies (e.g., duplexscan with intracorporeal papaverine) to support medical necessity.

Include biothesiometry as part of the exam when performed.
Provide results of duplex Doppler, cavernosometry/cavernosography when relevant.

Documentation Required

Document selection criteria for covered codes

When billing CPT and HCPCS codes listed as 'covered if selection criteria are met' (for example CPT 54400–54417 or HCPCS C1813/C2622), document the medical necessity and the specific selection criteria used to justify coverage.

Attach the policy selection criteria text or cite the clinical findings that meet each required element.

Documentation Required

Testing and counseling documentation

Document morning serum total testosterone levels for men diagnosed with ED when indicated, and counsel patients about FDA‑approved PDE5 inhibitors and other options per AUA guidance; include counseling notes in the record.

Record testosterone level values, date/time (morning sample), and any subsequent endocrine evaluation.

Documentation Required

Documentation for investigational biologic therapy

For investigational biologic treatments (e.g., adipose-derived regenerative cells), document trial phase, inclusion/exclusion criteria, prior conventional therapy failure, and safety monitoring results when submitting for review.

Include study identifiers (e.g., ClinicalTrials.gov number) if treatment is part of a clinical trial.

Documentation Required

Documentation for investigational therapies

For investigational therapies such as fractional CO2 laser for Peyronie's disease, document the device used, treatment protocol (number and timing of sessions), concomitant topical/adjunct treatments, baseline and follow-up curvature measurements, validated questionnaires (IIEF, PDQ), and adverse events.

Provide objective curvature measurements and dates of each treatment session.

Documentation Required

PTT (RestoreX) usage documentation

Manufacturer and trial guidance report typical RestoreX use of about 30–90 minutes/day (commonly two 30‑minute sessions) with minimum 12 weeks and up to 24 weeks in some studies; document patient instruction and device usage time in records.

Record daily minutes of device use and total weeks of therapy in the chart.

Documentation Required

Required evidence details for experimental therapies

When submitting experimental therapies for review, include trial phase, sample size, follow-up duration, safety outcomes, and objective erectile function measures (e.g., IIEF, EHS) because the cited literature emphasizes limited cohorts and heterogeneous endpoints.

Provide published study references and any available comparative data.

Documentation Required

Documentation and plan provisions

Clinical Policy Bulletins are partial descriptions of plan benefits and not contracts; participating providers remain responsible for following plan-specific program provisions and disclosures when seeking authorization or billing.

Confirm member eligibility and any plan-specific prior authorization or coverage limitations before treatment.

Denial Risk

Penile prosthesis prerequisites (denial risk)

Failure to document that nonsurgical methods were ineffective or contraindicated, or failure to provide required lab documentation (normal prolactin, thyroid, and testosterone when indicated) may lead to denial of coverage for penile prosthesis implantation.

Ensure labs and prior therapy attempts are in the medical record prior to submission for authorization.

Billing Rule

Billing non-covered codes may be denied

Use of CPT/HCPCS codes listed as 'not covered for indications listed in the CPB' (for example 0038U, 0101T, 0232T, 11900–11901, 37790, or HCPCS E0201) may trigger claim denial when billed for the policy's stated indications.

Avoid billing these codes for indications listed in the CPB unless plan exceptions or prior approvals are documented.

Denial Risk

Investigational therapy denial risk

Therapies described as investigational or experimental such as platelet-rich plasma, intracavernosal stem cell injections, or some ESWT applications may be denied if billed as medically necessary without robust supporting evidence.

If provided in research context, include trial documentation; otherwise expect coverage denial risk.

Denial Risk

Risk for denial when using treatments lacking Level 1/2 support

Use of treatments with mixed or negative Level 1/2 evidence (e.g., iontophoresis/transdermal verapamil, certain oral therapies, ESWT for Peyronie's, intralesional verapamil/nicardipine) may be unsupported and could risk denial if billed as proven treatments.

Document trial results and rationale when considering these therapies; preferentially enroll patients in trials.

Denial Risk

Radial wave therapy unsupported — denial risk

Radial pressure wave therapy has no quality human evidence demonstrating benefit for ED; claims for this treatment may be denied or considered experimental based on lack of supporting data.

Do not bill radial wave therapy for ED as standard care for indications listed in the CPB.

Note

AUA states penile traction is promising

The AUA states penile traction is promising but evidence is insufficient for a formal recommendation; until larger rigorous trials are available, use may be considered unproven and could be subject to investigational coverage decisions.

Document clinical rationale and device usage if seeking coverage consideration.

Denial Risk

Investigational therapies may be denied

Treatments described as investigational or lacking robust human evidence (for example stem cell therapy for ED) may trigger coverage denial or require further evidence before authorization.

Submit comprehensive human trial data, safety outcomes, and objective measures when requesting review.

Note

Policy administrative note

Clinical Policy Bulletins do not constitute coverage guarantees; providers must follow plan-specific provisions and authorizations to avoid denials related to nonconformance with plan rules.

Confirm benefit limitations and obtain required prior authorizations per the member's plan.

Note

Background and Rationale

Background: Erectile dysfunction (ED) and Peyronie’s disease (PD) require a structured diagnostic evaluation including history, physical examination, and targeted testing. Oral phosphodiesterase‑5 inhibitors are first‑line therapy when not contraindicated. Mechanical and surgical options — such as penile traction devices (RestoreX) and implantable penile prostheses — are described as promising or indicated in select situations, but many novel regenerative and device therapies (LI‑ESWT, PRP, stem cell therapies) remain investigational pending higher‑quality and longer‑term evidence.

The policy notes that penile arterial reconstruction may be considered in select young men with focal traumatic arterial lesions, whereas venous surgery is not recommended. It further highlights that mechanical traction (RestoreX) is FDA‑cleared for PD with trial evidence of benefit but that AUA guidance regards mechanical therapies as promising yet unsupported for a formal recommendation until larger rigorous trials are available.

Definitions and Terms

inv-71: NPT definition

DefinitionNocturnal penile tumescence (NPT) testing — measurement of nocturnal erections (e.g., RigiScan) as part of ED evaluation; generally of limited routine value

Use guidanceRigiScan or NPT used selectively when differentiating psychogenic vs organic ED after history and exam

Policy stanceRoutine NPT testing has no proven value; simpler methods rarely necessary

inv-72: Erectile dysfunction (ED) definition

DefinitionErectile dysfunction (ED) — persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance

EtiologyAssociated with vascular, neurogenic, hormonal, or psychological factors and comorbidities such as diabetes and cardiovascular disease

Evaluation componentsDiagnosis includes comprehensive history, physical, laboratory tests, and vascular studies as appropriate

inv-73: Peyronie's disease (PD) definition

DefinitionPeyronie's disease (PD) — a fibrotic disorder of the tunica albuginea characterized by penile curvature, pain, and sometimes erectile dysfunction due to plaque formation

Clinical courseOften related to microvascular trauma and may cause cosmetic and functional morbidity

Treatment thresholdSurgical correction considered for PD of 12+ months with significant morbidity after failed conservative therapy

inv-74: Neurogenic erectile dysfunction (NED) definition

DefinitionNeurogenic erectile dysfunction (NED) — ED resulting from neurologic causes, including autonomic and small-fiber neuropathies

Diagnostic noteEvaluation may require specialized testing beyond conventional neurophysiology (e.g., small-fiber assessment, autonomic testing)

Clinical implicationNED may show different response to therapies and guide consideration of neuromodulative approaches

inv-75: Low-intensity extracorporeal shock wave therapy definition

DefinitionLow-intensity extracorporeal shock wave therapy (LI-ESWT) — noninvasive delivery of low-energy shock waves to penile tissue intended to stimulate angiogenesis and tissue remodeling for ED

Evidence summaryPreliminary evidence suggests short-term improvements in erectile function for some patients, but protocols are heterogeneous and long-term durability is unclear

Policy stanceLI-ESWT considered investigational in many contexts pending higher-quality trials

inv-76: ESWT / LI-ESWT / LISWT definition

Term equivalenceESWT / LI-ESWT / LISWT — terms referring to extracorporeal shock wave therapy or low-intensity shock wave therapy applying acoustic pulses to penile tissue

Mechanism hypothesisHypothesized to induce angiogenesis, recruit progenitor cells, improve microcirculation and nerve regeneration

Evidence limitationsHeterogeneous treatment protocols and low-quality evidence limit definitive conclusions about effectiveness

inv-77: Intralesional verapamil definition

DefinitionIntralesional verapamil — direct injection of the calcium-channel blocker verapamil into Peyronie's plaques

Evidence summaryRandomized trials report inconsistent results versus saline/placebo with no consistent significant improvement in curvature or plaque size

Policy stanceConsidered experimental/investigational or unproven for PD due to insufficient randomized controlled evidence

inv-78: LI-ESWT (duplicate definition entry)

Definition (duplicate)LI-ESWT — application of low-energy shock waves to penile tissue hypothesized to induce angiogenesis and improve erectile function; term duplicates ESWT/LI-ESWT definitions

Evidence noteRCTs and meta-analyses show mixed short-term benefit; evidence quality is variable

Policy implicationRegarded as investigational for many indications pending better-quality, standardized trials

inv-79: Fractional CO2 laser (for PD) definition

DefinitionFractional CO2 laser (for PD) — a minimally invasive laser applied to penile plaque/skin, evaluated in pilot studies combined with topical triamcinolone and penile modeling

EvidenceSingle small pilot (n=5) reported median curvature reduction at 52 weeks; evidence is preliminary and insufficient for routine coverage

SafetyReported transient, self-limited side effects in pilot study; further investigation needed before adoption

inv-80: RestoreX definition

DefinitionRestoreX — an FDA-cleared mechanical penile traction therapy device for correcting curvature and length loss from Peyronie's disease; reusable for at-home use

UsageTypical therapy sessions include two 30-minute treatments per day; manufacturer and trials report 30–90 minutes/day total use

LimitationsManufacturer does not recommend RestoreX for congenital penile curvature; evidence described as preliminary

inv-81: Platelet-rich plasma (PRP) definition

DefinitionPlatelet-rich plasma (PRP) — autologous concentrated plasma containing growth factors proposed for tissue regeneration and investigated for ED and PD

Study limitationsClinical and preclinical studies are small, short-term, often uncontrolled, and lack standardized PRP protocols

Policy stanceConsidered experimental/investigational for ED and PD pending higher-quality evidence

inv-82: Stem cell therapy (SCT) definition

DefinitionStem cell therapy (SCT) — injection of mesenchymal stem cells or stromal vascular fractions from adipose, bone marrow, or other sources, commonly delivered via intracavernous injection for ED studies

EvidenceMostly preclinical rodent studies and a few small human phase I/II trials (total ~61 patients); human data limited in size and controls

Policy stanceConsidered investigational/experimental pending further safety, efficacy, and standardization data

inv-83: Synchronous surgical management definition

DefinitionSynchronous surgical management — single-session combined surgical implantation addressing both erectile dysfunction (e.g., inflatable penile prosthesis) and stress urinary incontinence (e.g., artificial urinary sphincter, sling)

Indication guidanceSeverity of SUI guides choice of combined procedure (e.g., AUS for severe SUI >4 pads/day) and synchronous approaches may offer cost/time advantages

Evidence noteEvidence suggests similar safety/effectiveness to staged procedures but further prospective studies are needed

inv-84: RestoreX (manufacturer reference)

ManufacturerRestoreX (PathRight Medical, Inc.) — FDA-cleared penile traction device referenced by manufacturer in policy and trials

Clinical trialManufacturer-sponsored and independent trials (including a Mayo Clinic trial) reported device usage protocols and preliminary efficacy

LimitationsManufacturer does not recommend RestoreX for congenital curvature due to lack of studies

inv-85: LI-ESWT (additional refs)

Definition and refsLI-ESWT — low-intensity extracorporeal shockwave therapy referenced in multiple studies and systematic reviews for ED and Peyronie's disease; mechanism and protocols remain under investigation

Evidence synthesisScoping reviews and RCTs show potential short-term benefit but heterogeneous protocols and low-certainty evidence limit definitive recommendations

Guideline contextSome guideline bodies regard LI-ESWT as investigational or recommend against routine use due to low certainty

Policy Revision History

1995-07-31effective_date

Policy originally became effective.

2026-07-29last_reviewLatest

Policy underwent most recent clinical and administrative review.

2027-01-14next_review_scheduled

Next scheduled policy review date.