Alpha-1 Proteinase Inhibitors
Customize your policy alerts
Sign up for Aloha Care Policy RXMP-01 alerts
Get alerted when Policy RXMP-01 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization, coverage criteria, and billing/coding guidance for alpha-1 proteinase inhibitor products (Aralast NP, Glassia, Prolastin-C, Zemaira) under Aloha Care; applies to Medicare/Medicaid lines of business and affected providers who request reimbursement.
Continuity of Care requirement was added in the 4/2/2025 review.
Coverage and Medical Necessity Criteria
Approval criteria and renewals
Covered when ALL of the following initial clinical and laboratory criteria are met. Prior authorization is required; initial approvals are for 6 months. Renewal approvals require documentation of benefit and are granted for 1 year.
ALL of the following
- Diagnosis of congenital alpha-1 antitrypsin (AAT) deficiency (ICD-10: E88.01)
- Diagnosis of emphysema (ICD-10: J43.0-J43.9)
ONE of
- Protein phenotypes Pi*ZZ, Pi*Z(null) or Pi*(null)(null) (homozygous)
- Other rare AAT genotypes associated with pre-treatment serum AAT <11 micromole/L (e.g., Pi(Malton), Pi(SZ))
ALL of the following
ONE of
- Circulating pre-treatment serum alpha1-antitrypsin (AAT) level <11 micromole per liter (corresponds to <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry)
- Member has a concomitant diagnosis of necrotizing panniculitis
ALL of the following
- Continued optimal conventional treatment for emphysema (e.g., bronchodilators)
ONE of
- FEV1 ≤ 65% of predicted
- Rapid decline in FEV1 (reduction >120 mL/year) that warrants treatment
ALL of the following
- Member is NOT a current smoker
Prior authorization and duration
- Prior authorization required for medical benefit; initial approval length 6 months
- Renewal requires documentation of positive clinical response to therapy and continued optimal conventional treatment; renewal approval length 1 year
Medicare Part B transition
- For new Medicare members, a 90-day transition period applies during which coverage and step therapy do not apply for members currently on active treatment; after 90 days coverage criteria must be met
Exclusions
DO NOT APPROVE for
- Individual who is IgA deficient and has IgA antibodies
- Requests that do not meet the above criteria or other non-supported indications
Billing Codes and Laboratory Thresholds
Prior Authorization, Transition, and Denial Guidance
Prior authorization required; initial 6-month approval, renewals 1 year
Prior authorization is required for alpha-1 proteinase inhibitor therapy when billed as a medical benefit; the pharmacy benefit is not covered. Initial approvals are granted for 6 months; renewal approvals are granted for 1 year.
- Medical benefit: Authorization required; Pharmacy benefit: Not covered.
- Initial approval length: 6 months.
- Renewal approval length: 1 year.
Medicare Part B 90-day transition for members on active treatment
For new Medicare members there is a 90-day transition period during which coverage and step therapy requirements do not apply if the member is currently on an active course of the requested treatment (including when furnished by an out-of-network provider). After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage.
- Transition period length: 90 days from Medicare enrollment.
- Applies when member is currently on active treatment; includes out-of-network care.
- After 90 days, standard coverage and step therapy criteria apply.
Denial risk and exclusions (IgA deficiency, unmet criteria)
Requests may be denied for members who do not meet the policy criteria or who meet listed exclusions; specifically, therapy may not be approved for individuals who are IgA deficient and have IgA antibodies.
- Denial risk if criteria (diagnoses, genotype or low serum AAT, lung-function and treatment requirements) are not met.
- Exclusion: Individual who is IgA deficient and has IgA antibodies.
Diagnostic Definitions and Codes
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.