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

Do You Qualify for Prolastin-C Coverage by Blue Cross Blue Shield in New York? Decision Tree & Next Steps

Answer Box: Getting Prolastin-C Covered in New York

To get Prolastin-C covered by Blue Cross Blue Shield in New York, you need: (1) Confirmed severe alpha-1 antitrypsin deficiency (Pi*ZZ genotype), (2) FEV1 between 30-65% predicted, and (3) clinical evidence of emphysema. First step today: Contact your pulmonologist to order genetic testing if not already done, and request a medical necessity letter citing BCBS criteria. Most approvals require prior authorization through your plan's provider portal within 72 hours for urgent cases.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If You're Likely Eligible
  4. If You're Possibly Eligible
  5. If You're Not Yet Eligible
  6. If Your Claim Gets Denied
  7. Coverage Requirements at a Glance
  8. Appeals Playbook for New York
  9. Common Denial Reasons & How to Fix Them
  10. FAQ
  11. Sources & Further Reading

How to Use This Decision Tree

This guide walks you through Blue Cross Blue Shield's specific requirements for Prolastin-C coverage in New York. Start with the eligibility triage below to determine your approval likelihood, then follow the appropriate pathway.

Before you begin, gather these documents:

  • Insurance card and member ID
  • Complete medical records showing alpha-1 antitrypsin deficiency diagnosis
  • Recent pulmonary function tests (within 12 months)
  • Lab results showing AAT levels and genotype
  • List of previous treatments tried and failed
Note: BCBS New York includes multiple plans (Empire BlueCross BlueShield, Excellus, etc.). Requirements are generally consistent, but verify with your specific plan's formulary.

Eligibility Triage: Do You Qualify?

Step 1: Age and Diagnosis

  • Are you 18 or older? ✓ Required
  • Do you have confirmed alpha-1 antitrypsin deficiency? Must be documented by genetic testing

Step 2: Severity Assessment

What's your genotype?

  • PiZZ, PiZ(null), or Pi*(null,null) → Continue to Step 3
  • Pi*MZ or other heterozygote → Skip to "Not Yet Eligible"
  • Unknown/not tested → Skip to "Possibly Eligible"

Step 3: Clinical Requirements

  • FEV1 between 30-65% of predicted? Required range
  • Clinical evidence of emphysema? CT scan or clinical notes required
  • No significant IgA deficiency with anti-IgA antibodies? Contraindication for Prolastin-C

Step 4: Current Status

  • Are you a non-smoker or former smoker? Active smoking may disqualify
  • AAT level <11 μmol/L (57 mg/dL)? Confirms severe deficiency

Results:

  • All "yes" answers → Likely Eligible
  • Missing 1-2 requirements → Possibly Eligible
  • Missing 3+ requirements → Not Yet Eligible

If You're Likely Eligible

Congratulations! You meet BCBS's standard criteria. Here's your approval checklist:

Document Checklist

  • Genetic test results confirming Pi*ZZ or equivalent severe genotype
  • Quantitative AAT level <11 μmol/L
  • Pulmonary function test showing FEV1 30-65% predicted
  • CT scan or clinical notes documenting emphysema
  • Smoking status documentation (non-smoker/former smoker)
  • IgA level results (to rule out contraindication)

Submission Path

  1. Provider submits prior authorization through BCBS provider portal
  2. Include medical necessity letter addressing all criteria above
  3. Specify dosing: Maximum 7 vials per week (700 billable units every 7 days)
  4. Request 12-month approval with renewal option
Tip: Ask your provider to reference BCBS policy number (verify with current formulary) and cite FDA labeling for Prolastin-C in the medical necessity letter.

Expected timeline: 72 hours for standard review, 24 hours for urgent requests.

If You're Possibly Eligible

You're close but missing some documentation. Here's what to request:

Tests to Order

If genotype unknown:

  • Request genetic testing for alpha-1 antitrypsin deficiency
  • Insurance typically covers testing once per lifetime when medically indicated

If lung function unclear:

  • Schedule pulmonary function testing
  • Request high-resolution CT chest if emphysema not yet documented

If AAT level missing:

  • Order quantitative alpha-1 antitrypsin level by nephelometry
  • Ensure test is recent (within 12 months)

Timeline to Reapply

  • Genetic testing results: 2-4 weeks
  • Pulmonary function tests: Can often be scheduled within 1-2 weeks
  • AAT levels: Results typically available within 3-5 business days

Track your results and resubmit once you have complete documentation.

If You're Not Yet Eligible

Don't give up. Here are alternatives to discuss with your provider:

Alternative Approaches

If you have Pi*MZ genotype:

  • Discuss with pulmonologist whether severe lung disease warrants exception request
  • Document any unusual clinical circumstances
  • Consider genetic counseling for family members

If FEV1 is outside 30-65% range:

  • Document disease progression if FEV1 has declined
  • Consider whether other alpha-1 proteinase inhibitors have different criteria
  • Explore compassionate use programs

Prepare for Exception Requests

  1. Document failed alternative therapies (bronchodilators, corticosteroids, etc.)
  2. Gather supporting literature showing benefit in your specific situation
  3. Request peer-to-peer review with BCBS medical director

If Your Claim Gets Denied

New York has strong appeal rights. Here's your pathway:

Level 1: Internal Appeal

  • Deadline: File within 180 days of denial notice
  • How: Submit through BCBS member portal or by mail
  • Include: Original denial letter, medical necessity letter, and supporting documentation
  • Timeline: Decision within 30 days (72 hours for urgent)

Level 2: External Review

If internal appeal fails, you have the right to external review through the New York State Department of Financial Services.

  • Deadline: 4 months after final internal denial
  • Cost: Maximum $25 (waived for financial hardship/Medicaid)
  • Process: Independent medical expert reviews your case
  • Timeline: Standard cases within 45 days; urgent within 72 hours
Help Available: Community Health Advocates provides free assistance at 888-614-5400. They can help you navigate the appeals process and file paperwork correctly.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Age 18+ Adult indication only Birth certificate/ID FDA Label
Pi*ZZ genotype Severe AAT deficiency Genetic test report BCBS Policy
FEV1 30-65% Moderate lung impairment Pulmonary function test BCBS Policy
No IgA deficiency Safety contraindication Lab results FDA Label
Prior authorization Required for coverage Provider submission BCBS NY Updates

Appeals Playbook for New York

New York residents have robust appeal rights under state law. Here's how to use them effectively:

Internal Appeal Process

  1. File within 180 days of denial notice
  2. Submit complete package: denial letter, medical records, provider letter
  3. Request expedited review if urgent (72-hour decision)
  4. Track your submission - keep confirmation numbers

External Review Rights

New York's external review program is binding on insurers:

  • Independent medical review by qualified specialists
  • Decisions based on medical literature and clinical guidelines
  • Searchable database of past decisions available through DFS External Appeals Database
  • Success stories exist for specialty drug approvals
From our advocates: "We've seen Prolastin-C denials overturned on external review when patients submitted comprehensive genetic testing, clear documentation of lung disease progression, and evidence that they met all clinical criteria. The key is thorough documentation and persistence through the process."

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"Missing genetic testing" Submit Pi*ZZ genotype confirmation from certified lab
"FEV1 outside range" Provide recent PFT showing 30-65% predicted value
"Not medically necessary" Medical necessity letter citing BCBS criteria and FDA indication
"Non-formulary drug" Request formulary exception with clinical justification
"Quantity exceeded" Verify dosing at 60 mg/kg weekly (max 7 vials/week)
"Site of care denied" Document medical necessity for specific infusion setting

FAQ

How long does BCBS prior authorization take in New York? Standard review takes up to 72 hours. Urgent requests are processed within 24 hours if medical necessity is documented.

What if Prolastin-C is non-formulary on my plan? You can request a formulary exception. Document why preferred alternatives (Glassia, Aralast NP) are inappropriate or have failed.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. New York allows 72-hour expedited external appeals for urgent drug denials.

Does step therapy apply if I've tried alternatives outside New York? Yes, document all prior alpha-1 proteinase inhibitor trials regardless of where they occurred. Include dates, dosing, and reasons for discontinuation.

What's the success rate for appeals? Success rates vary, but thorough documentation significantly improves outcomes. New York's external review database shows some specialty drug approvals after initial denials.

Are there patient assistance programs available? Yes, Grifols (Prolastin-C manufacturer) offers patient support programs. Check eligibility at their official website or ask your provider.

When navigating complex insurance approvals like Prolastin-C coverage, having expert support can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.

The platform helps clinicians save time with medical necessity templates while ensuring patients get clear next steps throughout the appeals process. For complex cases like alpha-1 antitrypsin deficiency treatments, having the right evidence and documentation strategy is crucial for success.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria can change. Always consult with your healthcare provider and verify current requirements with your specific Blue Cross Blue Shield plan. For personalized assistance with appeals, contact Community Health Advocates at 888-614-5400 or visit Counterforce Health for professional appeal support.

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