Alpha Proteinase Inhibitors (Medical)
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Prior authorization policy for intravenous alpha-1 antitrypsin (AAT) augmentation therapy (Aralast NP, Glassia, Prolastin-C, Zemaira) including initial and continuation authorization clinical criteria, quantity limits (NDCs/HCPCS units), and administrative submission requirements for AvMed members.
No material clinical or coverage changes.
Coverage Summary
This AvMed prior authorization policy applies to intravenous alpha-1 antitrypsin (AAT) augmentation therapy (products listed: Aralast NP, Glassia, Prolastin-C, Zemaira) and covers both initial and continuation authorizations for members receiving IV AAT for congenital AAT deficiency with emphysema. The policy defines clinical criteria that must be met for approval, quantity limits and unit billing per vial (NDC/HCPCS), and administrative submission requirements for prior authorization.
The policy specifically addresses prior authorization requirements for initiation and continuation (each authorized for up to 12 months), including the clinical criteria and documentation that must be submitted to support approval.
Medical Necessity Criteria
Not Covered / Experimental
No explicit exclusions or experimental uses are listed in the brief beyond general risk of denial if required documentation is incomplete, illegible, or missing.
Coding
| 00944-2815-01 | Aralast NP 1000 mg (1 vial) = 100 billable units |
| 00944-2814-01 | Aralast NP 500 mg (1 vial) = 50 billable units |
| 00944-2884-XX | Glassia 1,000 mg/50 mL (1 vial) = 100 billable units |
| 13533-0705-XX | Prolastin-C 1,000 mg/20 mL (1 vial) = 100 billable units |
| 13533-0700-02 | Prolastin-C 1,000 mg (1 vial) = 100 billable units |
| 13533-0703-10 | Prolastin-C 1,000 mg (1 vial) = 100 billable units |
| 00053-7201-02 | Zemaira 1,000 mg (1 vial) = 100 billable units |
Provider Actions
Prior authorization required
Prescribers must complete and sign the AvMed medical prior authorization form and fax it with all required documentation to 1-877-535-1391. The prescribing physician must sign and clearly print their name (preprinted stamps not valid).
Submit phenotype and lab results
Specify the member's AAT phenotype (e.g., PiZ, PiZ (null), Pi (null,null), PiMZ, PIMS). Submit serum AAT level with the date obtained and pulmonary function test results documenting FEV1 values and the documented rate of decline.
Initial and continuation authorization durations
Initial authorization and continuation approvals are authorized for up to 12 months.
Continuation from another plan
For continuation of therapy from another plan, submit the prior plan's initial authorization information along with required labs and chart notes to establish continuity of care.
Failure to provide documentation may result in denial
Requests may be denied if required documentation (labs, diagnostics, chart notes) is not provided, incomplete, illegible, or missing.
Administration site reporting
Provide the location/site of drug administration and the NPI or DEA number of the administering location, or indicate that the medication is provided via the specialty pharmacy (Proprium Rx).
Background
The policy requires documentation to support each listed criterion; incomplete or missing documentation may delay or result in denial of authorization. Prescribers must complete and sign the AvMed prior authorization form and fax all required documentation (labs, pulmonary function tests, chart notes) to 1-877-535-1391.
For initial authorization (up to 12 months), all of the following must be met and documented: diagnosis of congenital alpha-antitrypsin deficiency with emphysema; specification of the member's AAT phenotype (examples include PiZ, PiZ (null), Pi (null, null), PiMZ, PIMS); clinical evidence of progressive panacinar emphysema; member is a current non-smoker; documented rate of decline in FEV1 between 30 and 65% (submit pulmonary function test results); and a submitted serum AAT level (with result and date) that meets one of the following thresholds: < 11 µmol/L, < 80 mg/dL if measured by radial immunodiffusion, or < 57 mg/dL if measured by nephelometry.
For continuation of therapy while insured with AvMed (up to 12 months), all of the following must be documented: member compliance with medication, demonstrated clinical improvement in the past 3 months, and submission of a serum AAT level with date and value. For continuation from another plan, initial authorization information plus required labs and chart notes must be submitted to establish continuity of care.
Quantity limits and unit billing instructions require billing per listed billable units per vial (examples: 100 billable units per 1000 mg vial for most products) and use of the corresponding NDC when applicable.
Medicare Determinations
| Name | Type/Number/Effective Date |
|---|---|
| Medicare Coverage for outpatient (Part B) drugs | |
| Type: NCD (National Coverage Determination) — Number: (not specified) — Effective date: (not specified) |
Revision History
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