CurrentAvMedPolicy N/A

Alpha Proteinase Inhibitors (Medical)

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.

Policy Summary

PayerAvMed

PolicyAlpha Proteinase Inhibitors (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescribers must complete and sign the AvMed medical prior authorization form and fax with all required documentation (labs, PFTs, chart notes) to 1-877-535-1391; incomplete information may delay or deny authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

4Products listed

3Serum AAT threshold options

12Authorization length (months)

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.

Key thresholds and facts

FEV1 declineRate of decline in FEV1 documented between 30 and 65%

Serum AAT level optionsOne of: < 11 µmol/L OR < 80 mg/dL (radial immunodiffusion) OR < 57 mg/dL (nephelometry)

Authorization lengthInitial and continuation authorizations are for 12 months

Products listedAralast NP, Glassia, Prolastin-C, Zemaira (4 products)

Coding

HCPCS codes listed for productsHCPCS

J0256	ARALAST NP, PROLASTIN-C, ZEMAIRA (listed for multiple products on form)
J0257	GLASSIA

NDCs and unit billing per vialNDC

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

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).

Documentation Required

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.

Billing Rule

Quantity limits and unit billing

Bill per the listed billable units per vial (e.g., 100 units per 1000 mg vial; 50 units per 500 mg vial) and use the corresponding NDC when applicable.

00944-2815-01
00944-2814-01
00944-2884-XX
13533-0705-XX
13533-0700-02
13533-0703-10
00053-7201-02

Prior Authorization

Initial and continuation authorization durations

Initial authorization and continuation approvals are authorized for up to 12 months.

Documentation Required

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.

Denial Risk

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.

Billing Rule

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.

Definitions

AATAlpha-1 antitrypsin (requires serum level submission)

FEV1Forced expiratory volume in 1 second (rate of decline in FEV1 must be documented)

Name	Type/Number/Effective Date
Medicare Coverage for outpatient (Part B) drugs
Type: NCD (National Coverage Determination) — Number: (not specified) — Effective date: (not specified)

Policy Summary

PayerAvMed

PolicyAlpha Proteinase Inhibitors (Medical)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Alpha Proteinase Inhibitors (Medical)

Coverage Summary

Medical Necessity Criteria

Not Covered / Experimental

Coding

Provider Actions

Background

Medicare Determinations

Revision History