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

How to Get Prolastin-C Covered by Blue Cross Blue Shield in Florida: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Prolastin-C Approved by Florida Blue Cross Blue Shield

To get Prolastin-C covered by Blue Cross Blue Shield in Florida, you need prior authorization showing severe alpha-1 antitrypsin deficiency (AAT level <57 mg/dL, Pi*ZZ genotype), emphysema with FEV1 25-80% predicted, and proper ICD-10 coding (E88.01 + J43.1). Submit via Availity portal or call 1-877-719-2583. Standard approval: 7-14 days; expedited: 72 hours. If denied, file internal appeal within 180 days, then external review with Florida DFS within 4 months if needed.

Table of Contents

  1. Florida Blue Coverage Requirements
  2. ICD-10 Coding for Medical Necessity
  3. HCPCS/J-Code and NDC Billing
  4. Prior Authorization Process
  5. Common Denial Reasons & Solutions
  6. Appeals Process in Florida
  7. Cost-Saving Options
  8. Frequently Asked Questions

Florida Blue Coverage Requirements

Florida Blue requires prior authorization for Prolastin-C under medical policy 09-J0000-49 for alpha1-proteinase inhibitors. Here's what must be documented:

Core Eligibility Criteria

Requirement Documentation Needed Where to Find
Severe AAT deficiency Serum AAT <57 mg/dL (11 μM) Lab report with reference ranges
High-risk genotype PiZZ, PiZ/null, or equivalent Genetics lab report
Emphysema/COPD CT showing panlobular emphysema Radiology report
Airflow obstruction Post-bronchodilator FEV1 25-80% predicted Spirometry report
Age requirement ≥18 years Medical record
Smoking status Non-smoker or actively quitting Provider documentation

Maximum approved dose: 60 mg/kg IV once weekly, consistent with FDA labeling.

Note: Florida Blue covers Prolastin-C under the medical benefit, not pharmacy benefit, requiring HCPCS J-code billing rather than NDC-only claims.

ICD-10 Coding for Medical Necessity

Proper diagnosis coding is critical for Prolastin-C approval. Use these specific ICD-10-CM codes:

Primary Diagnosis

  • E88.01 – Alpha-1-antitrypsin deficiency (required on all claims)

Secondary Diagnoses (choose based on clinical presentation)

  • J43.1 – Panlobular emphysema (typical for AATD)
  • J43.9 – Emphysema, unspecified
  • J44.1 – COPD with acute exacerbation
  • J44.9 – COPD, unspecified

Documentation Requirements

Your pulmonologist's notes must include:

  1. Genetic confirmation: "Patient has Pi*ZZ genotype confirming severe hereditary alpha-1 antitrypsin deficiency"
  2. Quantitative levels: "Serum AAT level 35 mg/dL (normal 150-350 mg/dL), consistent with severe deficiency"
  3. Lung disease link: "Panacinar emphysema pattern on CT consistent with AATD-related lung disease"
  4. Functional impairment: "Post-bronchodilator FEV1 45% predicted, demonstrating moderate obstruction"

HCPCS/J-Code and NDC Billing

Prolastin-C billing uses medical benefit codes, not pharmacy claims.

Core Billing Information

  • HCPCS Code: J0256 (Injection, alpha-1 proteinase inhibitor, 10 mg)
  • Unit Calculation: Total mg dose ÷ 10 = J0256 units
  • Administration: 96365 (initial IV infusion, up to 1 hour)

Prolastin-C NDC Numbers

Liquid Solution:

  • 13533-705-01 (various vial sizes)
  • 13533-705-11
  • 13533-705-31

Powder (Lyophilized):

  • 13533-0700-xx (1g/20mL)
  • 13533-0701-xx (2g/40mL)
  • 13533-0703-xx (4g/80mL)

Dose Calculation Example

For an 80 kg adult:

  • Dose: 60 mg/kg × 80 kg = 4,800 mg
  • J0256 units: 4,800 mg ÷ 10 = 480 units
  • Billing: J0256 × 480 units with appropriate NDC
Tip: Always round up to the next whole unit for partial vials and document any wastage with modifier JW if required by the payer.

Prior Authorization Process

Step-by-Step Submission

  1. Verify coverage via Florida Blue provider portal or member services
  2. Gather documentation (see checklist below)
  3. Submit PA request via Availity or call 1-877-719-2583
  4. Track status using confirmation number provided

Required Documentation Checklist

  • Completed PA form with patient demographics
  • ICD-10 codes (E88.01 + appropriate lung disease code)
  • AAT serum level report
  • Genetic testing results (phenotype/genotype)
  • Recent spirometry with post-bronchodilator values
  • CT chest report showing emphysema
  • Clinical notes documenting COPD severity and symptoms
  • Smoking history and cessation documentation
  • Prior COPD treatments tried
  • Proposed dosing regimen (mg/kg/week)

Timeline Expectations

  • Standard review: 7-14 business days
  • Expedited review: 72 hours (for urgent cases)
  • Peer-to-peer: Available within 72 hours if initially denied

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing genotype Submit genetic testing PiZZ, PiZ/null confirmation
AAT level too high Verify lab methodology Quantitative nephelometry preferred
FEV1 outside range Document disease progression Serial PFTs showing decline
Smoking history Provide cessation proof Counseling notes, nicotine testing
Non-preferred product Request formulary exception Medical necessity for Prolastin-C specifically
Dosing exceeded Recalculate based on current weight Weight-based calculation documentation

Medical Necessity Letter Template

When appealing or requesting exceptions, your pulmonologist should include:

"This 45-year-old patient has severe alpha-1 antitrypsin deficiency (Pi*ZZ genotype, serum AAT 32 mg/dL) with progressive panacinar emphysema. Despite optimal bronchodilator therapy, the patient experiences frequent exacerbations and declining FEV1 (currently 38% predicted). Prolastin-C augmentation therapy at 60 mg/kg weekly is medically necessary to slow lung function decline per American Thoracic Society guidelines for severe AATD."

Appeals Process in Florida

If your Prolastin-C request is denied, Florida provides a structured appeals pathway.

Internal Appeals (First Level)

Timeline: Must file within 180 days of denial notice

How to submit:

  • Online via Florida Blue member portal
  • Phone: Number on your ID card
  • Written request with denial letter attached

Decision timeframe:

  • Standard: 30 days
  • Expedited: 72 hours (if delay could harm your health)

External Review (Independent)

Eligibility: Must complete internal appeal first (except urgent cases)

Timeline: File within 4 months of final internal denial

Process:

  1. Contact Florida Department of Financial Services at 1-877-693-5236
  2. Submit external review request form
  3. Include all prior documentation and denial letters
  4. Independent medical reviewer makes binding decision

Cost: Free to consumers

Decision timeframe:

  • Standard: 45 days
  • Expedited: 72 hours

When to Request Expedited Review

Request fast-track appeals if:

  • You're currently on Prolastin-C and facing interruption
  • Severe exacerbations without treatment
  • Rapid lung function decline documented

Cost-Saving Options

Even with insurance coverage, Prolastin-C can have significant out-of-pocket costs.

Manufacturer Support

  • Grifols Patient Assistance Program: Income-based support for eligible patients
  • Commercial copay assistance: Up to $15,000/year for non-Medicare patients
  • Contact: 1-800-520-2807

Foundation Grants

  • Alpha-1 Foundation: Emergency assistance for AAT therapy
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Access Network (PAN): Alpha-1 antitrypsin deficiency fund

State Resources

  • Florida Catastrophic Care Program: For high-cost medical needs
  • 211 Florida: Dial 2-1-1 for local assistance programs

At Counterforce Health, we help patients navigate complex insurance appeals for specialty medications like Prolastin-C. Our platform analyzes denial letters and creates evidence-based appeals that align with payer-specific policies, helping improve approval rates for life-changing treatments.

Frequently Asked Questions

Q: How long does Florida Blue prior authorization take for Prolastin-C? A: Standard review is 7-14 business days. Expedited review for urgent cases takes 72 hours. You can track status via the Availity portal or by calling 1-877-719-2583.

Q: What if Prolastin-C is non-formulary on my Florida Blue plan? A: Request a formulary exception through the prior authorization process. Your doctor must document why covered alternatives (like Aralast or Glassia) would be less effective or cause adverse effects.

Q: Can I appeal if I'm denied for not meeting FEV1 requirements? A: Yes. Submit serial pulmonary function tests showing disease progression, exacerbation history, and specialist notes explaining why augmentation therapy is needed despite current FEV1 levels.

Q: Does step therapy apply to alpha-1 antitrypsin inhibitors? A: Some Florida Blue plans require trying a preferred AAT product first. If you've already failed another AAT therapy or have contraindications, document this in your exception request.

Q: What happens if my appeal is denied? A: You can request external review through the Florida Department of Financial Services within 4 months. This independent review is binding on Florida Blue if decided in your favor.

Q: Are there age restrictions for Prolastin-C coverage? A: Florida Blue typically requires patients to be 18 years or older for augmentation therapy, consistent with FDA labeling for adult use.

Q: How do I prove medical necessity for Prolastin-C specifically vs. other AAT products? A: Document any prior reactions to other products, differences in infusion requirements, or clinical stability on Prolastin-C if switching from another therapy.

Q: Can I get temporary coverage while my appeal is pending? A: For urgent situations, request expedited review and ask about emergency supplies through manufacturer programs or your specialty pharmacy while the appeal processes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always consult your healthcare provider for medical decisions and verify current policy details with Florida Blue directly. For personalized assistance with insurance appeals, Counterforce Health provides evidence-based support to help patients access needed specialty medications.

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