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

How to Get Prolastin-C Covered by Aetna in New York: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Prolastin-C Covered by Aetna in New York

Prolastin-C requires prior authorization from Aetna in New York. To get approved: (1) Have your pulmonologist complete Aetna's Alpha-1 Proteinase Inhibitors PA form with severe genotype (Pi*ZZ), FEV1 30-65% predicted, and non-smoking status, (2) Submit via phone 866-752-7021 or fax 888-267-3277, and (3) If denied, file internal appeal within 180 days, then external review with New York DFS within 4 months.

Table of Contents

  1. Aetna Coverage Requirements for Prolastin-C
  2. Step-by-Step: Fastest Path to Approval
  3. Required Documentation Package
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in New York
  6. Site of Care Considerations
  7. Patient Scripts & Templates
  8. When to Escalate to New York State
  9. Frequently Asked Questions

Aetna Coverage Requirements for Prolastin-C

Aetna requires prior authorization for all alpha1-proteinase inhibitors, including Prolastin-C, across commercial and Medicare plans in 2024-2025. Here's what you need to qualify:

Core Clinical Criteria

Requirement Details Documentation Needed
Severe AAT Deficiency Serum AAT level <57 mg/dL Lab report with reference range
High-Risk Genotype Pi*ZZ or equivalent severe phenotype Genetic test results
Emphysema Diagnosis COPD due to AAT deficiency ICD-10 J43.0-J43.9, imaging reports
Moderate Airflow Obstruction FEV1 30-65% predicted Recent pulmonary function tests
Non-Smoking Status Current non-smoker or ≥6 months quit Provider documentation, possible cotinine test
Note: Aetna's clinical policy considers augmentation therapy medically necessary when all criteria are met and the patient derives clinical benefit.

Step-by-Step: Fastest Path to Approval

Step 1: Verify Your Plan Coverage (Patient)

  • Check if Prolastin-C is on your formulary or marked "PA" (prior authorization required)
  • Call Aetna member services to confirm precertification requirements
  • Timeline: 15-30 minutes

Step 2: Gather Required Labs and Tests (Clinic)

  • Order AAT serum level if not done within 12 months
  • Obtain genetic testing for Pi*ZZ if not available
  • Complete spirometry showing FEV1 % predicted
  • Timeline: 1-2 weeks for results

Step 3: Complete PA Documentation (Provider)

  • Fill out Aetna's Alpha-1 PA form
  • Write medical necessity letter citing ATS/ERS guidelines
  • Attach all supporting labs and imaging
  • Timeline: 2-3 business days

Step 4: Submit Authorization Request

  • Phone: 866-752-7021 (Aetna Specialty Pharmacy)
  • Fax: 888-267-3277
  • Include all documentation in single submission
  • Timeline: Same day submission

Step 5: Track Decision Timeline

  • Standard review: 14-15 business days
  • Expedited review: 72 hours (if urgent medical need)
  • Decision notification: Via provider portal and phone

Step 6: If Approved - Coordinate Infusion

  • Verify approved site of care (home vs. clinic)
  • Coordinate with Aetna's specialty pharmacy network
  • Schedule first infusion within authorization window

Step 7: If Denied - File Appeal Immediately

  • Request internal appeal within 180 days
  • Gather additional clinical evidence
  • Consider peer-to-peer review

Required Documentation Package

Your submission must include these elements to avoid automatic denial:

Clinical Documentation

  • Provider letter stating diagnosis of severe AATD with emphysema
  • Smoking history and current cessation status with dates
  • Symptom assessment including dyspnea scale and exacerbation history
  • Current COPD medications and pulmonary rehabilitation status

Laboratory Evidence

  • AAT serum level <57 mg/dL with assay method noted
  • Genetic testing confirming Pi*ZZ or equivalent severe genotype
  • Recent spirometry (within 6 months) showing obstructive pattern

Supporting Records

  • Chest imaging (CT or X-ray) showing lower-lobe emphysema
  • Medication trial history if step therapy applies
  • Specialist consultation notes from pulmonologist
Tip: Start gathering documentation 90 days before current authorization expires to allow time for missing tests or records.

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Evidence
Non-formulary status Request formulary exception Document failure/intolerance of preferred alternatives
Step therapy required Provide trial history Detailed records of Aralast NP or Glassia failures
Insufficient lung disease Strengthen clinical documentation Serial PFTs showing decline, exacerbation history
Site of care restriction Justify medical necessity Document why home infusion is unsafe or inappropriate
"Not medically necessary" Cite clinical guidelines Reference ATS/ERS standards and FDA labeling

Appeals Process in New York

New York offers robust appeal rights through the Department of Financial Services (DFS):

Internal Appeal (Required First Step)

  • Deadline: 180 days from denial
  • Timeline: 30 days for pre-service appeals
  • Submit to: Aetna appeals department via member portal
  • Include: New clinical evidence, provider letter, guideline citations

External Review (New York DFS)

  • Deadline: 4 months after final internal denial
  • Timeline: Standard 30 days; expedited 72 hours
  • Cost: $25 maximum (waived for financial hardship)
  • Decision: Binding on Aetna
Important: New York's external appeal database shows mixed results for Prolastin-C cases. Strengthen your appeal with robust clinical documentation and guideline citations.

Filing External Appeal

  1. Complete DFS external appeal form
  2. Attach Aetna's final denial letter
  3. Include medical records or provider authorization
  4. Submit online via DFS portal or by mail

Counterforce Health helps patients navigate complex insurance denials by analyzing denial letters, plan policies, and clinical notes to draft targeted appeals that address specific denial reasons with evidence-backed rebuttals.

Site of Care Considerations

Aetna applies site-of-care policies to control costs for specialty infusions:

Home Infusion

  • Advantages: Often lower copays, convenient scheduling
  • Requirements: Clinical stability, no severe reaction history
  • Network: Must use Aetna-contracted home infusion providers

Clinic/Hospital Infusion

  • When covered: Medical necessity documented (complex comorbidities, reaction risk)
  • Higher costs: Facility fees and coinsurance may apply
  • Prior auth: May require separate justification

Patient Scripts & Templates

Calling Aetna Member Services

"Hi, I need to check prior authorization requirements for Prolastin-C under my plan. My member ID is [number]. Can you tell me if it requires PA, what the approval criteria are, and which specialty pharmacies are in-network for home infusion?"

Requesting Expedited Review

"My patient requires urgent approval for Prolastin-C due to [specific medical reason]. This delay could seriously jeopardize their health. I'm requesting expedited review under the 72-hour timeline."

When to Escalate to New York State

Contact New York regulators if:

  • Aetna fails to meet decision timelines
  • Claims are processed incorrectly
  • You suspect bad faith denial practices

New York Department of Financial Services

Community Health Advocates (Free Help)

  • Phone: 888-614-5400
  • Services: Free counseling on insurance denials and appeals

Frequently Asked Questions

Q: How long does Aetna prior authorization take in New York? A: Standard review takes 14-15 business days. Expedited review for urgent medical needs takes up to 72 hours.

Q: What if Prolastin-C is excluded from my formulary? A: Request a formulary exception with documentation showing medical necessity and failure/intolerance of preferred alternatives like Aralast NP or Glassia.

Q: Can I appeal if I have a PiMZ genotype instead of PiZZ? A: Pi*MZ typically doesn't qualify for augmentation therapy under standard criteria. You'd need exceptional clinical circumstances and strong provider advocacy.

Q: Does step therapy apply if I'm switching from another alpha-1 product? A: Possibly. Document any failures, intolerances, or clinical reasons why Prolastin-C specifically is needed over Aetna's preferred alternatives.

Q: What's the difference between internal and external appeals in New York? A: Internal appeals are reviewed by Aetna. External appeals are reviewed by independent medical experts assigned by New York DFS, and their decisions are binding on the insurer.

Q: How much does Prolastin-C cost without insurance? A: Annual costs commonly exceed $80,000. Check with Grifols patient support for assistance programs and copay cards.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. Counterforce Health provides specialized support for navigating prescription drug appeals but does not guarantee coverage outcomes.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.