CurrentAvMedPolicy N/A

Amphotericin B liposome (AmBisome) prior authorization

Defines AvMed medical prior authorization and step-edit criteria for amphotericin B liposome (AmBisome) for outpatient medical administration, including required documentation, eligible diagnoses, prescriber requirements, and reauthorization conditions for members.

Policy Summary

PayerAvMed

PolicyAmphotericin B liposome (AmBisome) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the medical prior authorization request and submit supporting documentation including chart notes, lab results, diagnostics, and pharmacy paid claims.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsInitial authorization duration

3 monthsReauthorization duration

J0289HCPCS code listed for AmBisome

RequiredSpecialist prescriber

Coverage Criteria for Amphotericin B Liposome (AmBisome)

Initial Authorization

Covered when ALL of the following are met

Prescriber and diagnosis requirements: Prescribed by or in consultation with an infectious disease and/or transplant specialist AND member has one of the listed diagnoses (cryptococcal meningitis in patients with HIV; febrile neutropenic patients with presumed fungal infection; systemic infections caused by Aspergillus, Candida, and/or Cryptococcus; visceral leishmaniasis)

Must be verified by documentation.

Justification for liposomal formulation: Member must meet ONE of the following: refractory to conventional amphotericin B deoxycholate therapy OR has renal impairment or unacceptable toxicity that precludes use of the deoxycholate formulation OR has tried and failed ONE of the specified first-line therapies when applicable (flucytosine, voriconazole, posaconazole, caspofungin IV)

Prior therapies and refractoriness/intolerance must be verified by chart notes or pharmacy paid claims; some listed agents require prior authorization themselves (e.g., flucytosine, posaconazole).

Reauthorization

Policy Summary

PayerAvMed

PolicyAmphotericin B liposome (AmBisome) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the medical prior authorization request and submit supporting documentation including chart notes, lab results, diagnostics, and pharmacy paid claims.

SourceLink

On This Page

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Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Amphotericin B liposome (J0289). The prescribing physician must complete and sign the medical prior authorization form (preprinted stamps are not valid) and fax to 1-877-535-1391. If the information provided is not complete, correct, or legible, authorization can be delayed or denied.

Code: J0289 (Amphotericin B liposome)
Form must be signed by prescribing physician (no preprinted stamps)
Fax completed form to 1-877-535-1391

Documentation Required

Clinical Prerequisites

All clinical criteria must be met for approval. Member must have one of the listed diagnoses and must be refractory to conventional amphotericin B deoxycholate therapy, have renal impairment or unacceptable toxicity that precludes deoxycholate, or have tried and failed an applicable first-line therapy (verified by chart notes or pharmacy paid claims).

Member must have ONE qualifying diagnosis (e.g., cryptococcal meningitis with HIV; febrile neutropenia with presumed fungal infection; systemic Aspergillus/Candida/Cryptococcus infections; visceral leishmaniasis).
Member must meet ONE of the following: refractory to amphotericin B deoxycholate; renal impairment or unacceptable toxicity to deoxycholate; or tried and failed an applicable first-line therapy (e.g., flucytosine, voriconazole, posaconazole, caspofungin IV) verified by chart notes or pharmacy paid claims.

Documentation Required

Documentation to Provide

Provide all supporting documentation with the request. Authorization may be delayed or denied if documentation is incomplete.

Chart notes supporting diagnosis and clinical course
Relevant lab results (including renal function) and date obtained
Diagnostic test results
Pharmacy paid claims or medication history verifying prior therapies or failures
Weight (if applicable) and date weight obtained
Provider attestation that renal function is being monitored for reauthorization requests

Denial Risk

Incomplete Information Risks

Incomplete, incorrect, or illegible information can delay or result in denial of the authorization. Missing required documentation — such as lab results, diagnostics, chart notes, or evidence of prior therapies/paid claims — may lead to denial.

Ensure all fields on the prior authorization form are complete and legible
Missing lab results, diagnostics, chart notes, or paid-claim evidence may result in denial
For Medicare members, ensure compliance with applicable NCDs/LCDs

Definitions

Refractory to deoxycholate — definition

DefinitionFailure to respond to conventional amphotericin B deoxycholate therapy as verified by chart notes or pharmacy paid claims.

Verification sourcesChart notes documenting lack of clinical response to amphotericin B deoxycholate.

Alternate verificationPharmacy paid claims showing prior dispensing of amphotericin B deoxycholate without clinical improvement.

Context of useUsed to justify step-up to amphotericin B liposome when member meets eligible diagnoses (e.g., cryptococcal meningitis, systemic Aspergillus/Candida/Cryptococcus infections, febrile neutropenia, visceral leishmaniasis).

Reauthorization documentation

Provider attestation requirementProvider attests renal function is being monitored and no preclusions due to toxicity have been observed.

Documentation to submitDocumentation confirming the member's condition has improved or stabilized, or that continued therapy is medically necessary and benefits outweigh risks (e.g., in HIV).

Reauthorization periodReauthorization may be granted for 3 months when requirements are met.

Evidence acceptableClinical progress notes and relevant laboratory results demonstrating renal monitoring and clinical course.

OpenPayer

Amphotericin B liposome (AmBisome) prior authorization

Coverage Criteria for Amphotericin B Liposome (AmBisome)

Coding

Provider Actions and Documentation Requirements

Definitions

Background