CurrentCignaPolicy N/A

Penile Prosthesis and Surgical Treatments for Erectile Dysfunction

This Cigna Coverage Policy governs coverage criteria for devices and procedures used to treat erectile dysfunction (ED), including penile prosthesis implantation, nerve grafting, and amniotic-derived allografts; it applies to members of Cigna-administered health benefit plans where the customer's benefit plan allows coverage.

Policy Summary

PayerCigna

PolicyPenile Prosthesis and Surgical Treatments for Erectile Dysfunction

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionWhen coverage is available per the customer's benefit plan, prior authorization requires documentation that ED persisted ≥6 months and conservative therapies failed, were contraindicated, or not tolerated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsED duration threshold

2-4%Avg infection rate

71%-91%Patient satisfaction

Not CoveredAmniotic allograft stance

Coverage Criteria

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Penile Prosthesis (Medically Necessary)

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

Penile prosthesis criteria: erectile dysfunction has persisted for at least six months>= 6 months

Penile prosthesis criteria: a comprehensive history and physical exam, including appropriate laboratory testing, has been completed

Penile prosthesis criteria: 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

Not Medically Necessary Procedures

The following procedures for treatment of ED are considered not medically necessary:

Procedures considered not medically necessary: nerve grafting during or after a radical prostatectomy (e.g., sural nerve, genitofemoral nerve)

See coding note: CPT 64912, 64913, 64999 considered not medically necessary when used for this purpose

Procedures considered not medically necessary: application of amniotic-derived allografts to nerve bundles during a radical prostatectomy (e.g., AmnioFix®, BioDFence® G3)

See coding note: listed Q-codes considered not medically necessary when used for this purpose

Amniotic-derived allografts — Not Medically Necessary

The policy stance on amniotic-derived allografts during radical prostatectomy:

NMN statement: Application of amniotic-derived allograft to nerve bundles during radical prostatectomy is considered Not Medically Necessary due to insufficient evidence

Supported by clinical evidence summary (chunk 21) and coding guidance (chunk 26)

Penile Prosthesis — Medically Necessary when criteria met

Penile prosthesis coverage:

Medically necessary: Penile prosthesis (CPT 54400, 54401, 54405; HCPCS C1813, C2622) is considered medically necessary when criteria in applicable policy statements are met and benefit coverage is available

See policy for specific eligibility criteria, required documentation, and prior authorization requirements

A penile prosthesis implanted for any indication other than the treatment of erectile dysfunction is not medically necessary. Per policy, surgical implantation is considered medically necessary only when all specified ED criteria are met; outside those indications, coverage is excluded.

Application of amniotic-derived allografts to nerve bundles during a radical prostatectomy (for example, products such as AmnioFix® or BioDFence® G3) is considered not medically necessary. When billed using the listed HCPCS Q-codes for amniotic-derived products or relevant CPT codes, these procedures are excluded from coverage.

Nerve grafting performed during or after radical prostatectomy (e.g., sural nerve or genitofemoral nerve grafting) is considered not medically necessary. Codes for nerve allograft repair (CPT 64912, 64913, and unlisted nervous system code 64999) are designated Not Medically Necessary when used to report these procedures in this setting.

The evidence is insufficient to support the application of amniotic-derived allograft to nerve bundles during radical prostatectomy. Although small observational studies have reported faster time to continence and potency with dHACM nerve wraps, limitations such as retrospective design and small sample size prevent definitive conclusions; therefore application of these allografts to neurovascular bundles during radical prostatectomy is considered Not Medically Necessary and associated CPT/HCPCS codes are excluded.

Coding

Covered CPT/HCPCS for penile prosthesismixedCovered

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

Not Medically Necessary (nerve allograft codes)CPTNot 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

Not Medically Necessary (Q-codes for skin substitutes/amniotic products)HCPCSNot Covered

Q4100	Skin substitute, not otherwise specified.
Q4138	Biodfense dryflex, per square centimeter.
Q4140	Biodfense, 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

Duration of ED — minimum duration required before considering penile prosthesis

Minimum duration of ED required>= 6 months

Purpose of duration requirementED must have persisted for at least six months before considering penile prosthesis

Documentation impliedProviders must document that ED persisted >=6 months as part of prior authorization and clinical record

Provider Actions

Prior Authorization

Prior authorization & documentation required

If coverage is available under the member's benefit plan, prior authorization and supporting documentation are required for penile prosthesis placement and related items. When submitting for implantation, include comprehensive clinical documentation demonstrating medical necessity per the policy criteria (see conservative therapy and sequencing requirements below).

Affected CPT: 54400, 54401, 54405
Affected HCPCS: C1813, C2622

Step Therapy

Conservative therapy requirement

Surgical implantation of a penile prosthesis is considered medically necessary only after documented failure, contraindication, or intolerance to conservative medical management. At minimum, the medical record must show: a comprehensive history and physical exam (including relevant labs such as serum testosterone and glucose/A1c), ED duration ≥ 6 months, and clear documentation of trials of conservative therapies. Provide documentation of patient counseling about risks/benefits and alternative therapies.

Minimum conservative therapy trials: oral PDE5 inhibitors, intracavernosal injection and/or intraurethral medication, and/or vacuum erection device
Document reason if any conservative therapy was not tried (e.g., contraindication, intolerance)

Note

ED treatment sequencing per professional societies

Clinical management should follow professional society guidance: oral PDE5 inhibitors are first‑line therapy; second‑line options include alprostadil (intracavernosal or intraurethral) and vacuum erection devices. Surgically implanted penile prostheses are appropriate when less invasive treatments are ineffective, contraindicated, or not tolerated. Document sequencing of therapies and rationale for proceeding to surgery in the medical record.

Professional guidance sources: AAFP, AUA, NCCN

Denial Risk

Denial risk — amniotic‑derived allograft application to nerve bundles

Do not report or bill nerve allograft/related or listed Q‑codes to justify amniotic‑derived allograft application to nerve bundles or sural nerve grafting during radical prostatectomy. Use of codes 64912, 64913, 64999 or the listed Q‑codes for amniotic‑derived allograft applications to nerves is considered not medically necessary and is subject to denial.

Not medically necessary / denial risk codes: 64912, 64913, 64999, Q4100, Q4138, Q4140, Q4145, Q4148, Q4156

Documentation Required

Required coding and documentation for penile prosthesis and related products

Codes to report for covered penile prosthesis implantation and expectations for documentation: submit the appropriate CPT for the procedure (54400, 54401, 54405) and the corresponding HCPCS device supply codes (e.g., C1813, C2622) when covered by the member's benefit. Include in the record: indication, duration of ED, prior conservative therapy trials (or documented contraindications/intolerance), comprehensive history and physical, pertinent labs, and documentation of informed consent and counseling.

Covered procedure CPTs: 54400, 54401, 54405
Covered HCPCS: C1813, C2622
Include: ED duration ≥ 6 months, prior therapy trials or reasons therapy not tried, physical exam, relevant labs, informed consent

Definitions

Erectile dysfunction (ED) — definition

DefinitionThe inability to achieve or maintain an erection sufficient for satisfactory sexual performance.

Clinical contextED prevalence increases with age and can have vascular, neurologic, hormonal, traumatic, medication-related, or psychological causes.

Role in policyED must be documented and persist ≥6 months to meet penile prosthesis criteria.

Penile prosthesis types — noninflatable and inflatable device classifications

Noninflatable (semirigid) devicesPair of semi-rigid rods or cylinders surgically implanted in the corpora cavernosa; FDA Class II (rod, malleable, single- or multiple-hinged designs).

Inflatable devicesPaired cylinders with reservoir and scrotal pump, expanded using pressurized fluid; FDA Class III (single- or multi-component inflatable systems).

ExamplesRigid examples: Spectra™ and Genesis®; Inflatable examples: AMS 700™ and Titan®.

Dehydrated human amnion/chorion membrane allograft (dHACM) used as a nerve wrap — definition/example (AmnioFix)

Definition/exampleDehydrated human amnion/chorion membrane (dHACM) allograft used as a nerve wrap (e.g., AmnioFix®/AmnioFix™) is a biologic graft placed around neurovascular bundles during prostatectomy to potentially accelerate return of potency.

Reported study findingsStudies reported faster return to potency and shorter time to potency in cohorts receiving dHACM, but were limited by non-randomized or retrospective designs and need randomized trials.

Common product nameAmnioFix (MiMedx) — example of dHACM product used as a nerve wrap in reported studies.

OpenPayer

Penile Prosthesis and Surgical Treatments for Erectile Dysfunction

Coverage Criteria

Coding

Provider Actions

Background

Definitions