CurrentCignaPolicy 0403

Male Sexual Dysfunction Treatment: Nonpharmacologic

Cigna medical coverage policy 0403 governs nonpharmacologic treatments for male sexual dysfunction (erectile dysfunction), specifying medical necessity criteria for penile prosthesis implantation, and listing procedures considered not medically necessary (nerve grafting and application of amniotic-derived allografts to nerve bundles during radical prostatectomy). It also provides coding guidance and references.

Policy Summary

PayerCigna

PolicyMale Sexual Dysfunction Treatment: Nonpharmacologic

Policy CodePolicy 0403

Change TypeAnnual Review (revisions)

Effective DateAug 15, 2025

Next Review DateAug 15, 2026

Key ActionConfirm benefit coverage and document that all medical necessity criteria are met before approving penile prosthesis (ED ≥6 months, comprehensive history/physical with labs, and failure/contraindication/intolerance to conservative treatments).

SourceLink

POLICY UPDATE CHANGES

Annual Review removed the policy statements for vacuum erection devices and extracorporeal shock wave therapy.

Annual Review removed the policy statement for venous occlusive surgery.

1Covered Primary Procedure Type (Penile Prosthesis)

2Procedures Not Medically Necessary (nerve grafting, amniotic allografts)

5+CPT/HCPCS codes listed

Scope: This policy (0403) covers nonpharmacologic treatments for male sexual dysfunction (erectile dysfunction). Coverage stance: mixed — penile prosthesis implantation is covered (medically necessary) when ALL specified criteria are met (ED duration ≥ 6 months, comprehensive history/physical with appropriate labs, and failure/contraindication/intolerance to conservative medical management); certain procedures are not medically necessary (nerve grafting and application of amniotic-derived allografts to nerve bundles during radical prostatectomy). Subject: Male Sexual Dysfunction Treatment — Nonpharmacologic (Penile Prosthesis, Nerve Grafting, Amniotic-Derived Allografts). Status: CURRENT. Effective date: 8/15/2025; Last review: 8/15/2025; Next review: 8/15/2026.

Key thresholds and quick facts

Duration of erectile dysfunction (threshold)>= 6 months

Covered primary procedure typePenile prosthesis (1)

Procedures considered not medically necessaryNerve grafting and amniotic-derived allografts (2)

CPT/HCPCS codes listed5+ codes included (e.g., 54400, 54401, 54405, C1813, C2622; 64912, 64913, Q4100, etc.)

Policy number0403

Payer / Effective dateCigna — Effective 8/15/2025

Effective / Next reviewEffective 8/15/2025; Next review 8/15/2026

Medical Necessity Criteria

Penile Prosthesis - Medically Necessary

Surgical implantation of a penile prosthesis is considered medically necessary when ALL of the following criteria are met:

ALL of the following

erectile dysfunction has persisted for at least six months>= 6 months
a comprehensive history and physical exam, including appropriate laboratory testing, has been completed
there is failure, contraindication or intolerance to conservative medical management including FDA pharmacological therapy (e.g., oral PDE5 inhibitors, intracavernosal injection, intraurethral medication) and/or a vacuum erection device

Penile Prosthesis - Not Medically Necessary (Other Indications)

A penile prosthesis for any other indication is considered not medically necessary.

Any indication for penile prosthesis other than treatment of erectile dysfunction meeting the medical necessity criteria above

Procedures Considered Not Medically Necessary

Each of the following procedures for the treatment of erectile dysfunction is considered not medically necessary:

Coding

Considered Medically Necessary (when criteria met and benefit coverage available)CPT|HCPCSCovered

54400	Insertion of penile prosthesis; non-inflatable (semi-rigid).
54401	Insertion of penile prosthesis; inflatable (self-contained).
54405	Insertion of multi-component, inflatable penile prosthesis, including placement of pump, cylinders, and reservoir
C1813	Prosthesis, penile, inflatable.
C2622	Prosthesis, penile, non-inflatable

Considered Not Medically Necessary - Nerve Grafting / AllograftsCPT|HCPCSNot Covered

64912	Nerve repair; with nerve allograft, each nerve, first strand (cable).
64913	Nerve repair; with nerve allograft, each additional strand (List separately in addition to code for primary procedure).
64999	Unlisted procedure, nervous system
Q4100	Skin substitute, not otherwise specified.
Q4138	Biodfence dryflex, per square centimeter.
Q4140	Biodfence, per square centimeter.
Q4145	Epifix, injectable, 1 mg.
Q4148	Neox cord 1K, Neox cord rt, or clarix cord 1K, per square centimeter.
Q4156	Neox 100 or clarix 100, per sq cm, per square centimeter

Provider Actions

Prior Authorization

Confirm benefit coverage and meet criteria for penile prosthesis

Providers must ensure the member's benefit plan covers treatment for male sexual dysfunction; penile prosthesis is covered only when the policy's ALL medical necessity criteria are documented (ED ≥6 months, comprehensive history/physical with appropriate labs, and failure/contraindication/intolerance to conservative medical management).

54400
54401
54405
C1813
C2622

Denial Risk

Claims denial for not medically necessary procedures

Claims submitted for nerve grafting or application of amniotic-derived allografts to nerve bundles during radical prostatectomy will be denied as not medically necessary.

64912
64913
64999
Q4100
Q4138
Q4140
Q4145
Q4148
Q4156

Documentation Required

Clinical documentation required

Documentation of duration of ED, results of comprehensive history/physical and lab testing, and documentation of failure, contraindication, or intolerance to conservative medical treatments (including PDE5 inhibitors, intracavernosal/intraurethral meds, vacuum device) must be available to support medical necessity.

Duration of erectile dysfunction (≥ 6 months)
Comprehensive history and physical exam with appropriate laboratory testing (e.g., testosterone, glucose/A1c, lipids as indicated)
Documentation of failure, contraindication, or intolerance to conservative medical management (oral PDE5 inhibitors, intracavernosal/intraurethral agents, and/or vacuum erection device)

Background & Evidence

Background: The policy addresses devices and procedures used to treat erectile dysfunction. When nonsurgical therapies fail, a penile prosthesis (either noninflatable/semirigid or inflatable) may be implanted; these devices are FDA-classified (noninflatable/semirigid devices as Class II and inflatable devices as Class III) and have evidence supporting improved patient satisfaction and erectile function in selected patients who have failed conservative measures. Published literature reports patient satisfaction ranging roughly 71%–91% and device survival metrics improving with newer devices.

Policy stance on other procedures: The policy considers nerve grafting (e.g., sural, genitofemoral nerve grafts) during or after radical prostatectomy to be not medically necessary because randomized and nonrandomized studies provide limited and inconsistent evidence (an RCT showed no significant difference in return of erectile function at 24 months). Similarly, the application of amniotic-derived allografts (e.g., dehydrated human amnion/chorion membrane products such as AmnioFix®/BioDFence® G3) wrapped around neurovascular bundles during radical prostatectomy is considered not medically necessary due to primarily nonrandomized observational data that are limited by retrospective designs and inconsistent long‑term evidence.

Key Evidence

Definitions

Erectile dysfunction (ED)The inability to achieve or maintain an erection sufficient for satisfactory sexual performance.

dHACMDehydrated human amnion/chorion membrane, an amniotic-derived allograft.

Determination Name	Number	Effective Date/Notes
Diagnosis and Treatment of Impotence	230.4	longstanding (no specific date provided). See policy Effective Date 8/15/2025 for current policy version.