By Counterforce Health Team in Prolastin-C (alpha1-proteinase inhibitor) —

Complete Guide to Getting Prolastin-C Covered by Aetna in Pennsylvania: Prior Authorization, Appeals, and Success Strategies

Answer Box: Getting Prolastin-C Covered by Aetna in Pennsylvania

Yes, Aetna requires prior authorization for Prolastin-C in Pennsylvania. Success requires documented alpha-1 antitrypsin deficiency (Pi*ZZ genotype), serum AAT levels <80 mg/dL, evidence of emphysema, and FEV1 between 25-80% of predicted.

Fastest path to approval:

  1. Gather genetic testing, recent labs, and pulmonary function tests
  2. Submit Aetna's precertification form with comprehensive medical necessity letter
  3. If denied, use Pennsylvania's external review program (50% success rate)

Start today: Contact your prescriber to request Aetna's Alpha1-Antitrypsin Inhibitor Therapy Precertification Request Form and begin collecting required documentation.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Approval
  4. Coding and Billing Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: What to Expect
  9. Common Denial Reasons & Solutions
  10. Pennsylvania Appeals Process
  11. Quick Reference Checklist
  12. Frequently Asked Questions

Who Should Use This Guide

This guide helps patients with alpha-1 antitrypsin deficiency and their healthcare teams navigate Aetna's prior authorization process for Prolastin-C in Pennsylvania. You'll need this if:

  • Your doctor has prescribed Prolastin-C for alpha-1 antitrypsin deficiency
  • You have Aetna commercial insurance or Medicare coverage in Pennsylvania
  • You've received a denial and need to appeal
  • You want to prepare a strong initial submission to avoid delays

Expected outcome: With proper documentation, many patients successfully obtain coverage. Pennsylvania's new external review program has overturned approximately 50% of denied claims in 2024, providing a strong backup option if initial requests are denied.

Member & Plan Basics

Coverage Requirements

Active Aetna coverage in Pennsylvania is required. Prolastin-C coverage applies to:

  • Commercial Aetna plans
  • Aetna Medicare plans
  • CVS Health specialty pharmacy network

Key plan considerations:

  • Prior authorization is mandatory—no exceptions
  • Deductible may apply before coverage begins
  • CVS Specialty Pharmacy typically handles distribution
  • Authorization periods: 3 months initially, up to 12 months for renewals
Note: Self-funded employer plans may have different requirements. Contact your benefits administrator to confirm coverage rules.

Clinical Criteria for Approval

Aetna requires strict clinical documentation for Prolastin-C approval. All criteria must be met:

Primary Requirements

Requirement Specific Threshold Documentation Needed
Age 18+ years Date of birth verification
Diagnosis Alpha-1 antitrypsin deficiency Genetic testing showing Pi*ZZ, PiZ(null), or Pi(null,null)
Serum AAT Level <80 mg/dL (radial immunodiffusion) or <50 mg/dL (nephelometry) Recent lab report
Lung Disease Emphysema due to AAT deficiency Clinical notes, imaging, or PFT interpretation
Pulmonary Function Post-bronchodilator FEV1 25-80% of predicted Recent pulmonary function test
Smoking Status Must not be a current smoker Provider attestation

Step Therapy Requirements

Aetna considers Prolastin-C and Zemaira as preferred agents. If requesting Glassia or Aralast NP, you must document:

  • Contraindication to both preferred agents, OR
  • Intolerance/adverse reactions to both preferred agents, OR
  • Therapeutic failure with adequate trial periods

Coding and Billing Requirements

HCPCS and Billing Codes

Primary Code: J0256 - "Injection, alpha 1 proteinase inhibitor (human), not otherwise specified, 10 mg"

Billing details:

  • Bill in 10 mg increments (e.g., 1000 mg dose = 100 units)
  • Include specific NDC number for Prolastin-C
  • Use modifier JA for intravenous administration when required
  • Typical coverage limit: 2800 billable units every 28 days

ICD-10 Codes

Primary diagnosis codes for alpha-1 antitrypsin deficiency:

  • E88.01 - Alpha-1-antitrypsin deficiency
  • J43.0 - Unilateral pulmonary emphysema (MacLeod's syndrome)
  • J43.1 - Panlobular emphysema
  • J43.2 - Centrilobular emphysema

Documentation Packet

Medical Necessity Letter Components

Your prescriber's letter must address each approval criterion:

Required elements:

  1. Patient identification and insurance information
  2. Confirmed diagnosis with genetic testing results
  3. Laboratory evidence of AAT deficiency with specific values
  4. Clinical evidence of emphysema and symptoms
  5. Pulmonary function data showing FEV1 impairment
  6. Treatment rationale and expected benefits
  7. Smoking cessation confirmation

Essential Attachments

  • Genetic testing report showing Pi*ZZ genotype
  • Recent serum AAT level lab report
  • Pulmonary function test results
  • Clinical notes documenting emphysema
  • Any prior authorization forms required by Aetna
  • Documentation of previous therapy failures (if requesting non-preferred agent)
Clinician Corner: Reference FDA labeling for Prolastin-C and current guidelines from the American Thoracic Society for alpha-1 antitrypsin deficiency management. Include specific citations in your medical necessity letter to strengthen the clinical rationale.

Submission Process

Step-by-Step Submission

  1. Download current forms from Aetna's provider portal (verify current link with your provider relations representative)
  2. Complete precertification form with all required fields:
    • Patient demographics and insurance information
    • Prescriber details and NPI number
    • Diagnosis codes and clinical information
    • Requested medication details and dosing
  3. Attach comprehensive documentation as listed in the Documentation Packet section
  4. Submit via preferred method:
    • Fax to Aetna's prior authorization department (confirm current fax number)
    • Upload through provider portal
    • Mail to address specified on current forms
  5. Obtain confirmation number and record submission date

Timeline expectations:

  • Standard review: 30-45 days
  • Expedited review (urgent medical need): 72 hours
  • Incomplete submissions may extend timelines

Specialty Pharmacy Coordination

CVS Specialty Pharmacy Process

Aetna typically routes Prolastin-C through CVS Specialty Pharmacy:

Steps for coordination:

  1. Authorization first - Don't transfer prescription until PA is approved
  2. Prescription transfer - Your prescriber sends prescription to CVS Specialty
  3. Patient enrollment - CVS Specialty contacts patient for enrollment and scheduling
  4. Shipment coordination - Verify delivery address and infusion scheduling
  5. Insurance verification - CVS Specialty confirms coverage and copay responsibility

Important contacts:

  • CVS Specialty Pharmacy: 1-800-237-2767
  • Patient support services available for scheduling and coordination

After Submission: What to Expect

Tracking Your Request

Record these details:

  • Confirmation/reference number
  • Submission date and method
  • Contact information for follow-up
  • Expected decision timeline

Status check schedule:

  • Week 2: Confirm receipt and completeness
  • Week 4: Request status update if no decision
  • Week 6: Escalate if approaching deadline

Possible Outcomes

Approval: Coverage authorized for specified period (typically 3-12 months) Partial approval: Coverage with modifications (dose, frequency, duration) Denial: Request denied with specific reasons provided

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient genetic testing Submit complete genotype analysis Lab report showing Pi*ZZ or equivalent
Inadequate lung disease documentation Provide comprehensive pulmonary assessment PFTs, imaging, clinical notes
Step therapy not met Document failures with preferred agents Treatment records, adverse event documentation
"Not medically necessary" Strengthen clinical rationale Guidelines citations, FDA labeling references
Missing lab values Submit recent AAT levels Lab report with specific numerical values

Pennsylvania Appeals Process

Pennsylvania offers robust appeal rights with a new external review program launched in 2024.

Internal Appeals (Required First Step)

Timeline: Must file within 180 days of denial Process: Submit appeal through Aetna's internal process Documentation: Include all supporting medical records and additional evidence

Pennsylvania External Review

If internal appeal fails, Pennsylvania's Independent External Review Program offers strong patient protections:

Success rate: Approximately 50% of appeals overturned in 2024 Eligibility: Commercial insurance plans (not self-funded employer plans) Timeline: 4 months from Final Adverse Benefit Determination to file Process: File through Pennsylvania Insurance Department

Key advantages:

  • Independent medical review by qualified physicians
  • Binding decisions on insurers
  • No cost to patients
  • Additional evidence submission allowed
From our advocates: We've seen patients successfully overturn Prolastin-C denials by submitting comprehensive genetic testing documentation and detailed pulmonary function histories during Pennsylvania's external review process. The key is thorough preparation and meeting all submission deadlines. These are composite examples based on general advocacy experience, not guaranteed outcomes for individual cases.

For assistance with appeals, contact:

Quick Reference Checklist

Before You Start

  • Confirm active Aetna coverage
  • Verify Prolastin-C is prescribed for FDA-approved indication
  • Gather all required documentation
  • Identify preferred specialty pharmacy

Required Documentation

  • Genetic testing (Pi*ZZ genotype)
  • Serum AAT levels (<80 mg/dL)
  • Pulmonary function tests (FEV1 25-80% predicted)
  • Clinical notes documenting emphysema
  • Smoking cessation confirmation
  • Completed Aetna precertification form

Submission Checklist

  • All forms completed with required signatures
  • Supporting documentation attached
  • Submission method confirmed (fax/portal/mail)
  • Confirmation number obtained
  • Follow-up schedule established

If Denied

  • Review denial letter for specific reasons
  • Gather additional supporting evidence
  • File internal appeal within 180 days
  • Consider Pennsylvania external review if internal appeal fails
  • Document all communications and deadlines

Frequently Asked Questions

How long does Aetna prior authorization take in Pennsylvania? Standard reviews typically take 30-45 days. Expedited reviews for urgent medical situations are completed within 72 hours.

What if Prolastin-C is not on Aetna's formulary? Even non-formulary drugs can be covered through the prior authorization process with appropriate medical necessity documentation.

Can I request an expedited appeal? Yes, if there's urgent medical need. Provide documentation of immediate health risks to qualify for expedited review.

Does step therapy apply if I've used other AAT inhibitors outside Pennsylvania? Yes, document any previous trials with Prolastin-C or Zemaira, including dates, outcomes, and reasons for discontinuation.

What if my doctor isn't familiar with the PA process? Counterforce Health helps clinicians and patients navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create comprehensive appeals that address payer-specific requirements.

How much does Prolastin-C cost without insurance? Annual treatment costs commonly exceed $80,000, with some analyses showing average payer spending around $127,000 per year per patient.

What manufacturer support is available? Contact Grifols patient support services for information about copay assistance programs and patient support resources.

Can I appeal to Pennsylvania state regulators? Yes, after completing internal appeals, you can file an external review through the Pennsylvania Insurance Department's Independent External Review Program.

Sources & Further Reading

Important Disclaimer

This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Insurance policies, coverage criteria, and appeal processes can change. Always consult with your healthcare provider about treatment decisions and verify current requirements with your insurance plan. Counterforce Health provides specialized support for navigating complex prior authorization and appeal processes, helping patients and clinicians prepare comprehensive, evidence-backed submissions that align with payer requirements.

For official Pennsylvania insurance regulations and consumer assistance, visit the Pennsylvania Insurance Department website or call their consumer services line at 1-877-881-6388.

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