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

How to Get Prolastin-C (Alpha1-Proteinase Inhibitor) Covered by Cigna in Michigan: Complete PA Guide and Appeals Process

Answer Box: Getting Prolastin-C Covered by Cigna in Michigan

Cigna requires prior authorization for Prolastin-C (alpha1-proteinase inhibitor) with step therapy preference over Zemaira. Key requirements: severe AAT deficiency (genotype Pi*ZZ or equivalent), serum AAT <80 mg/dL, emphysema documentation, and non-smoker status. First step today: Have your pulmonologist submit a PA request through CoverMyMeds or Cigna's provider portal with complete genotype, PFT results, and smoking cessation documentation. If denied, Michigan patients have 180 days for internal appeals and 127 days for DIFS external review after final denial.

Table of Contents

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans Complete PA form via CoverMyMeds Cigna PA Policy
Step Therapy Prolastin-C preferred over Zemaira Prior trial documentation if requesting non-preferred Cigna Medicare Criteria
AAT Level <80 mg/dL or <11 µmol/L Lab report with reference ranges Cigna Coverage Policy
Genotype Pi*ZZ or severe variant Genetic testing results Cigna Coverage Policy
Emphysema Evidence COPD with airflow obstruction PFTs, chest CT, clinical notes Cigna Coverage Policy
Smoking Status Non-smoker ≥6 months Cotinine test, attestation Cigna Coverage Policy

Step-by-Step: Fastest Path to Approval

1. Confirm Your Cigna Plan Type and Benefits

Who: Patient or clinic staff
Action: Call the member services number on your insurance card to verify:

  • Whether Prolastin-C requires medical benefit or pharmacy benefit authorization
  • Your specific plan's formulary status
  • Current deductible and coinsurance amounts
    Timeline: 15-30 minutes
    Tip: Ask specifically about "alpha-1 proteinase inhibitor coverage requirements"

2. Gather Required Clinical Documentation

Who: Patient and healthcare team
Documents needed:

  • AAT serum level (with date and reference range)
  • Genetic testing showing Pi*ZZ or equivalent severe genotype
  • Recent pulmonary function tests (within 12 months)
  • Chest CT or X-ray showing emphysema
  • Smoking cessation documentation (cotinine test if available)
  • Current medication list and COPD treatment history
    Timeline: 1-2 weeks to collect

3. Submit Prior Authorization Request

Who: Prescribing physician or clinic staff
Method: CoverMyMeds portal or Cigna Provider Portal
Required form: Cigna Alpha-1 Proteinase Inhibitor PA Form
Timeline: Cigna responds within 72 hours for standard requests, 24 hours for expedited
Key: Include ICD-10 code E88.01 (Alpha-1 antitrypsin deficiency) plus emphysema codes

4. Request Expedited Review if Appropriate

When to use: If standard timeline would seriously jeopardize health
Requirements: Physician letter stating medical urgency
Benefit: 24-hour decision timeline instead of 72 hours
Submit: Check "expedited" on PA form and attach urgency letter

5. Monitor Decision and Prepare for Potential Appeal

Track: PA decision through Cigna provider portal
If approved: Coordinate with specialty pharmacy or infusion center
If denied: Review denial reason and gather additional documentation for appeal
Important: Note the 180-day internal appeal deadline from denial date

Clinician Corner: Medical Necessity Documentation

Essential Elements for Prolastin-C PA Success

Diagnosis Documentation:

  • ICD-10: E88.01 (Alpha-1 antitrypsin deficiency) + J43.1 (Panacinar emphysema) or appropriate COPD code
  • Phenotype: PiZZ, PiZ(null), Pi*(null)(null), or equivalent severe genotype
  • AAT serum concentration: <80 mg/dL (1.45 g/L) or <11 µmol/L with lab reference ranges

Clinical Evidence Required:

  • Post-bronchodilator FEV₁ 30-65% predicted (moderate to severe airflow obstruction)
  • FEV₁/FVC ratio <70%
  • High-resolution chest CT showing basilar-predominant emphysema
  • Documentation of symptoms (dyspnea, exercise limitation, quality of life impact)

Treatment History:

  • Current COPD medications (bronchodilators, inhaled corticosteroids)
  • Smoking cessation status with timeline
  • Previous alpha-1 augmentation therapy (if any) with response documentation
  • Pulmonary rehabilitation participation
Medical Necessity Letter Template Points:"Patient has confirmed severe hereditary alpha-1 antitrypsin deficiency with genotype [Pi*ZZ] and serum AAT level [X mg/dL], well below normal range""Clinical presentation includes early-onset panacinar emphysema with FEV₁ of [X]% predicted, consistent with AAT deficiency-related lung disease""Patient is a committed non-smoker [X months/years] and adherent to optimal COPD therapy""Augmentation therapy with Prolastin-C at 60 mg/kg weekly is FDA-approved and guideline-recommended to slow lung function decline""Delay in treatment risks irreversible lung damage and progression to respiratory failure"

Common Denial Reasons & How to Fix Them

Denial Reason Solution Strategy Required Documentation
"Step therapy not met" Document medical necessity for Prolastin-C over alternatives Allergy history, prior intolerance, or clinical rationale letter
"Not medically necessary" Strengthen clinical evidence Updated PFTs, specialist consultation, exacerbation history
"Insufficient genotype documentation" Provide complete genetic testing Full phenotype report showing Pi*ZZ or equivalent
"Missing AAT serum level" Submit recent lab work AAT level <80 mg/dL with lab reference ranges
"Active smoker" Document smoking cessation Cotinine test, smoking cessation program enrollment
"Quantity/dosing exceeded" Justify weight-based dosing Current weight, dose calculation (60 mg/kg weekly)

Appeals Process for Michigan Cigna Members

Internal Appeals with Cigna

Level 1 Internal Appeal:

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard review, 24-48 hours if expedited
  • Submit to: Cigna appeals department (address on denial letter)
  • Include: Original denial, medical records, specialist letter, new clinical evidence

Level 2 Internal Appeal:

  • Available if Level 1 denied
  • Same timeline and submission process
  • Consider requesting peer-to-peer review with Cigna medical director

Michigan DIFS External Review

When to use: After exhausting Cigna internal appeals
Deadline: 127 days from Cigna's final adverse determination
How to file:

Required for external review:

  • Cigna's final denial letter
  • Complete medical records
  • Physician letter explaining medical necessity
  • Any relevant clinical guidelines or studies

Timeline:

  • Standard review: 60 days maximum
  • Expedited review: 72 hours (requires physician certification of urgency)

Key advantage: Independent medical experts with alpha-1 antitrypsin deficiency expertise review your case

Coding and Billing Essentials

HCPCS and Billing Codes

Primary drug code: J0256 - Injection, alpha 1-proteinase inhibitor (human), not otherwise specified, 10 mg
Unit calculation: Total prescribed mg ÷ 10, rounded up
Example: 4,200 mg dose = 420 billing units of J0256

NDC codes for Prolastin-C:

  • 13533-705-01 (1,000 mg vial)
  • 13533-705-11, 13533-705-31, 13533-705-32 (various strengths)

Administration codes:

  • 96365/96366 (IV infusion) or 96413/96415 (therapeutic infusion)
  • Place of service: 12 (home), 11 (office), 22 (hospital outpatient)

Documentation for Clean Claims

Required elements:

  • ICD-10: E88.01 + appropriate emphysema/COPD codes
  • Patient weight for dose calculation
  • Exact NDC with 11-digit format
  • Units calculated correctly (total mg ÷ 10)
  • Prior authorization number
Billing Tip: Always include both the J-code and specific NDC on medical claims. J-code alone often results in denial for alpha-1 products.

When to Escalate to Michigan DIFS

Contact Michigan Department of Insurance and Financial Services when:

  • Cigna delays exceed published timelines
  • Internal appeals are wrongfully denied
  • You need assistance with external review process
  • Cigna fails to comply with external review decision

Michigan DIFS Contact:

  • Phone: 877-999-6442
  • Website: Michigan.gov/DIFS (verify with source linked below)
  • Services: External review coordination, consumer assistance, regulatory oversight

Cost Assistance Options

Manufacturer Support:

  • Grifols Patient Assistance Program (verify with source linked below)
  • Copay assistance for eligible commercially insured patients
  • Patient support services and nursing education

Foundation Resources:

  • Alpha-1 Foundation patient assistance programs
  • State pharmaceutical assistance programs for Michigan residents
  • Medicare Extra Help for Part D coverage

Financial Planning:

  • Annual costs typically >$80,000 without insurance
  • Understand your plan's out-of-pocket maximum
  • Consider supplemental insurance during open enrollment

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Prolastin-C?
A: Standard PA decisions are made within 72 hours. Expedited requests (when medically urgent) are decided within 24 hours. Submit complete documentation to avoid delays.

Q: What if Prolastin-C is non-formulary on my Cigna plan?
A: Request a formulary exception through your prescriber. Cigna must consider exceptions when covered alternatives are ineffective, contraindicated, or cause adverse effects.

Q: Does step therapy apply if I've used Prolastin-C successfully before?
A: Prior successful use typically satisfies step therapy requirements. Include documentation of previous therapy and clinical response in your PA request.

Q: Can I appeal a Cigna denial in Michigan?
A: Yes. You have 180 days for internal appeals with Cigna, followed by 127 days for external review through Michigan DIFS after final denial.

Q: What makes an appeal expedited in Michigan?
A: When standard timelines would seriously jeopardize life, health, or ability to regain maximum function. Requires physician certification of urgency.

Q: Are there alternatives if Prolastin-C is denied?
A: Other alpha-1 augmentation therapies include Zemaira, Glassia, and Aralast NP. However, Cigna typically requires Prolastin-C trial first due to step therapy requirements.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-based advocacy. Our platform analyzes denial letters, identifies specific denial reasons, and generates targeted appeals aligned with payer policies and clinical guidelines. For complex cases like alpha-1 antitrypsin deficiency, we provide specialized support that combines clinical expertise with deep knowledge of insurance coverage requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions. For assistance with insurance appeals in Michigan, contact the Department of Insurance and Financial Services at 877-999-6442.

Last updated based on 2025 Cigna policies and Michigan insurance regulations. Policies may vary by plan type and employer group.

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