Amphotericin B liposome (AmBisome) prior authorization
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Amphotericin B Liposome (AmBisome)
Initial Authorization
Covered when ALL of the following are met
Must be verified by documentation.
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
Covered when ALL of the following are met
Reauthorization period is 3 months.
Use of manufacturer or office samples to initiate amphotericin B liposome therapy does not meet step edit/preauthorization criteria and therefore cannot be used in lieu of prior authorization requirements.
Amphotericin B liposome (AmBisome) is not covered when the member does not meet the specified eligible diagnoses (cryptococcal meningitis in patients with HIV; febrile neutropenia with presumed fungal infection; systemic infections caused by Aspergillus, Candida, and/or Cryptococcus; or visceral leishmaniasis) or when there is no documentation of refractoriness to conventional amphotericin B deoxycholate, no renal impairment/unacceptable toxicity precluding deoxycholate use, and no evidence of failure of listed alternative therapies (e.g., flucytosine, voriconazole, posaconazole, caspofungin) as verified by chart notes or pharmacy paid claims.
Coding
| J0289 | Injection, amphotericin B liposomal, 1 mg |
Provider Actions and Documentation Requirements
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
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 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
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
Background
Amphotericin B liposome (AmBisome) is used for serious systemic fungal infections and for visceral leishmaniasis and is generally reserved when conventional amphotericin B deoxycholate is not tolerated or is contraindicated. The policy requires that a specialist (infectious disease and/or transplant) prescribe or consult, and that prior therapies, refractoriness to deoxycholate, or renal impairment/toxicity be documented via chart notes or pharmacy paid claims to justify use of the liposomal formulation.
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