CurrentCignaPolicy IP0458

Bleomycin sulfate (non-oncology) coverage

Governs medical necessity review and authorization for bleomycin sulfate used for non-oncology indications (specifically recalcitrant verruca vulgaris) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyBleomycin sulfate (non-oncology) coverage

Policy CodePolicy IP0458

Change TypeNo material change

Effective DateAug 15, 2022

Next Review DateAug 15, 2023

Key ActionObtain prior authorization demonstrating medical necessity for symptomatic recalcitrant verruca vulgaris after failure of other treatments.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1primary covered indication (recalcitrant verruca vulgaris)

12 moinitial authorization duration

J9040HCPCS code

Not coveredother non-oncology uses

Coverage Criteria

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Initial Coverage Criteria: Diagnosis of symptomatic recalcitrant verruca vulgaris

Recalcitrant verruca vulgaris = symptomatic common warts unresponsive to all other treatments (see definition).

Prior Treatment Failure: Unresponsive to all other standard treatments (i.e., prior treatment failure required)

Step requirement: must have tried and failed other treatments prior to approval.

Indication: Use is for a non-oncology indication (recalcitrant verruca vulgaris)

Policy governs non-oncology use only.

Appropriate treatment parameters: Dosage, frequency, duration of therapy, and site of care are reasonable, clinically appropriate, and supported by evidence-based literature

Should be adjusted based on severity, alternative treatments, and prior response.

inv-02: Continuation/Reauthorization

Covered when ALL of the following are met:

Reauthorization Criteria: Initial medical necessity criteria were met at the time of initiation

Documentation of initial criteria required.

Clinical response: There is documentation of beneficial response to bleomycin therapy

Reauthorization may be granted for up to 12 months.

Initial Therapy

inv-14: Initial Therapy

Initial authorization

Initial: Used for symptomatic recalcitrant verruca vulgaris unresponsive to all other treatments; provider documents diagnosis and prior treatment failures

Initial approval duration up to 12 months.

Treatment parameters: Dosage, frequency, duration, and site of care are reasonable and supported by evidence-based literature

Adjust based on severity, alternative treatments, and prior response; site of care typically office-based if appropriate.

Continuation / Reauthorization

inv-15: Reauthorization

Reauthorization

Reauthorization: Initial criteria were met AND there is documentation of beneficial response to therapy

Reauthorization approvals may be granted up to 12 months.

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required with medical necessity criteria met for bleomycin (J9040) when used for symptomatic recalcitrant verruca vulgaris. Initial and reauthorization approvals are limited to durations noted in the policy.

Affected HCPCS: J9040 — Injection, bleomycin sulfate, 15 units

Step Therapy

Step Requirement — Prior Treatment Failure

Bleomycin is indicated only for symptomatic recalcitrant verruca vulgaris unresponsive to all other treatments — prior treatment failure with alternative therapies is required before coverage.

Documentation Required

Reauthorization Documentation

For reauthorization, documentation must show the initial medical necessity criteria were met and there is documentation of a beneficial clinical response to therapy.

Documentation Required

Treatment Documentation

When coverage is available and medically necessary, the prescribed dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, supported by evidence-based literature, and adjusted based upon severity, available alternatives, and prior response.

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months

Denial Risk

Non-covered Non-oncology Uses

Coverage is denied for any non-oncology indications other than recalcitrant verruca vulgaris; other non-oncology uses are considered experimental, investigational, or unproven.

Requirement	Details
Must have tried and failed other treatments prior to approval	Bleomycin is used for symptomatic recalcitrant verruca vulgaris that is unresponsive to all other treatments; prior treatment failure is required before authorization

Site of Care

Note

Document and justify site of care (office or other appropriate setting)

Select a site of care that is reasonable and clinically appropriate and document evidence-based support for that setting (e.g., office-based intralesional administration when supported by literature).

Site of care should be supported by evidence-based literature and adjusted based on severity and prior response

Background

Bleomycin sulfate has been used off-label for cutaneous warts (verruca vulgaris) administered intralesionally or topically with scarification; however, outside the covered indication for recalcitrant verruca vulgaris, other non-oncology applications are treated as experimental, investigational, or unproven under this policy.