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

How to Get Prolastin-C (Alpha1-Proteinase Inhibitor) Covered by Aetna CVS Health in Michigan: Complete Coding, Prior Authorization & Appeals Guide

Answer Box: Getting Prolastin-C Covered by Aetna CVS Health in Michigan

Prolastin-C requires prior authorization from Aetna CVS Health with specific coding and documentation. Use ICD-10 code E88.01 (alpha-1 antitrypsin deficiency) with J43.9 (emphysema), HCPCS code J0256 (10mg units), and NDC 13533-0700-xx series. Submit PA forms to 888-267-3277 with AAT levels <57 mg/dL, Pi*ZZ genotype, and FEV1 30-65% predicted. If denied, you have 180 days for internal appeals and 127 days for Michigan DIFS external review. Start today: Call Aetna member services to verify coverage and request PA forms.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Prolastin-C (alpha1-proteinase inhibitor) is typically covered under the medical benefit rather than pharmacy benefit due to its infusion administration. This affects both coding and prior authorization pathways.

Medical Benefit Path (Most Common)

  • HCPCS Code: J0256 (injection, alpha 1 proteinase inhibitor, 10 mg units)
  • Administration: CPT codes for infusion services (96365-96368)
  • Site of Care: Hospital outpatient, infusion center, or home health
  • Prior Auth: Required through Aetna's medical management team

Pharmacy Benefit Considerations

Some Aetna plans may cover Prolastin-C through specialty pharmacy with different coding requirements. Verify your specific plan's pathway with CVS Caremark.

Tip: Always confirm which benefit applies to your patient's plan before submitting claims or prior authorization requests.

ICD-10 Mapping for Alpha-1 Antitrypsin Deficiency

Proper diagnosis coding is critical for Prolastin-C approval. Use these specific ICD-10 codes with supporting documentation.

Primary Diagnosis ICD-10 Code Documentation Required
Alpha-1 Antitrypsin Deficiency E88.01 Genetic testing showing Pi*ZZ or equivalent severe phenotype
Emphysema due to AATD J43.9 CT scan showing panacinar emphysema, typically lower lobe
COPD with AATD J44.1 Spirometry showing obstruction (FEV1 30-65% predicted)

Key Documentation Words

Include these specific terms in clinical notes to support coding:

  • "Severe alpha-1 antitrypsin deficiency with Pi*ZZ genotype"
  • "Emphysema secondary to genetic AAT deficiency"
  • "Serum AAT level below protective threshold (<57 mg/dL)"
  • "Progressive dyspnea and airflow limitation"

Reference: WHO ICD-10 Classification and Aetna's clinical policy bulletin.

Product Coding: HCPCS, J-Codes, and NDCs

HCPCS Code J0256 Details

J0256: Injection, alpha 1 proteinase inhibitor (human), not otherwise specified, 10 mg billable unit

NDC Codes for Prolastin-C (Grifols)

  • Powder formulations:
    • 1g/20mL: 13533-0700-xx
    • 2g/40mL: 13533-0701-xx
    • 4g/80mL: 13533-0703-xx
    • 5g/100mL: 13533-0706-xx
  • Liquid formulations:
    • 500mg/10mL: 13533-0705-xx
    • 1g/20mL: 13533-0700-xx

Units Calculation

Standard weekly dosing: 60 mg/kg body weight

  • Example: 70kg patient = 4,200 mg weekly = 420 units (4,200 ÷ 10 mg per unit)
  • Typical vial usage: 4-7 vials per week depending on patient weight and vial strength
Important: Always include the specific NDC code on claims with J0256 to distinguish Prolastin-C from other alpha-1 proteinase inhibitors.

Clean Prior Authorization Request

Required Aetna Forms

Essential Documentation Package

  1. Laboratory Results:
    • Serum AAT level <57 mg/dL (within 12 months)
    • Pi*ZZ genotype confirmation
    • Reference ranges and assay methods
  2. Pulmonary Function Tests:
    • FEV1 30-65% predicted (within 6 months)
    • Post-bronchodilator measurements
    • DLCO if available
  3. Imaging Studies:
    • Chest CT showing emphysema pattern
    • Lower lobe predominance typical of AATD
  4. Clinical Documentation:
    • Smoking cessation status and dates
    • Current COPD medications and response
    • Exacerbation history

Submission Details

  • Fax: 888-267-3277 (specialty drugs)
  • Phone: 866-752-7021 (precertification)
  • Timeline: Submit 60-90 days before treatment start
  • Decision timeframe: 14 days standard, 72 hours urgent

Common Coding Pitfalls to Avoid

Unit Conversion Errors

Mistake: Billing 1 unit per 1g vial Correct: 1g = 1,000mg ÷ 10mg per unit = 100 units per 1g vial

Mismatched Codes

Mistake: Using J0257 (Glassia-specific code) for Prolastin-C Correct: J0256 with Prolastin-C NDC specification

Missing Documentation

Mistake: Submitting PA without genotype results Correct: Include Pi typing results showing ZZ, SZ, or null variants

Incorrect Sequencing

Mistake: Using only J43.9 without E88.01 Correct: Link emphysema (J43.9) to genetic cause (E88.01)

Verification with Aetna CVS Health Resources

Before Submitting

  1. Check formulary status: Aetna Specialty Drug List
  2. Verify PA requirements: 2025 Precertification List
  3. Confirm site-of-care policies: Review plan-specific restrictions

Cross-Check Resources

  • Provider portal: Availity or Aetna provider website
  • Member services: Patient can call number on insurance card
  • CVS Caremark: 855-240-0535 for specialty drug questions

Counterforce Health helps healthcare providers navigate complex prior authorization requirements by analyzing payer policies and generating targeted appeals documentation. Their platform can identify specific coding requirements and denial patterns for specialty medications like Prolastin-C.

Quick Pre-Submission Audit Checklist

Clinical Documentation ✓

  • ICD-10 codes E88.01 + J43.9 documented
  • AAT level <57 mg/dL with lab report
  • Pi*ZZ genotype confirmation included
  • FEV1 30-65% predicted (within 6 months)
  • Smoking cessation documented with dates
  • Prior COPD treatments listed

Coding Accuracy ✓

  • J0256 HCPCS code selected
  • Correct NDC for Prolastin-C formulation
  • Units calculated accurately (mg ÷ 10)
  • Administration CPT codes if applicable
  • Site of care specified and justified

Submission Requirements ✓

  • Aetna PA form completed in full
  • Medical necessity letter attached
  • All supporting documents included
  • Fax number verified (888-267-3277)
  • Submission timeline adequate (60-90 days advance)

Appeals Process in Michigan

If Aetna CVS Health denies your Prolastin-C request, Michigan residents have specific appeal rights and timelines.

Internal Appeals with Aetna

  • Timeline: 180 days from denial date
  • Standard review: 30-45 days for decision
  • Expedited review: 72 hours for urgent cases
  • Required: Complete internal process before external review

Michigan DIFS External Review

After exhausting Aetna's internal appeals, you can request an independent external review through the Michigan Department of Insurance and Financial Services (DIFS).

Key Details:

  • Timeline: 127 days from final internal denial
  • Process: File online at DIFS website or call 877-999-6442
  • Decision timeframe: Up to 60 days (standard), 72 hours (expedited)
  • Binding decision: If approved, Aetna must comply

When to Request Expedited Review

Request expedited appeals when delays could:

  • Seriously jeopardize health or ability to regain function
  • Cause irreversible progression of alpha-1 antitrypsin deficiency
  • Result in hospitalization for COPD exacerbations
Note: Michigan's 127-day external review window is longer than the federal 120-day standard, giving patients additional time to file.

The Counterforce Health platform can help generate evidence-based appeal letters that address specific Aetna denial reasons and align with Michigan's external review requirements.

FAQ

How long does Aetna CVS Health prior authorization take for Prolastin-C in Michigan? Standard PA decisions take 14 calendar days. Urgent requests (when health is at risk) are decided within 72 hours. Submit 60-90 days before treatment start to avoid delays.

What if Prolastin-C is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Include failed trials of preferred alternatives (Zemaira, Aralast NP) and contraindications to formulary options.

Can I get an expedited appeal if Aetna denies Prolastin-C? Yes, if your physician certifies that delays would seriously jeopardize your health. Both Aetna's internal expedited review (72 hours) and Michigan DIFS expedited external review (72 hours) are available.

Do I need step therapy for Prolastin-C with Aetna CVS Health? Some Aetna plans require trials of other alpha-1 proteinase inhibitors first. Document any failures, intolerances, or contraindications to preferred alternatives in your PA request.

What's the difference between J0256 and J0257 codes? J0256 covers Prolastin-C, Aralast NP, and Zemaira (specify with NDC). J0257 is specific to Glassia. Using the wrong code can cause claim denials.

How much does Prolastin-C cost without insurance coverage? Annual costs commonly exceed $80,000-$127,000 per patient. Check with Grifols for patient assistance programs and copay support if facing coverage challenges.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with healthcare providers and insurance representatives for specific coverage decisions. Appeal rights and timelines may vary by plan type and state regulations. For personalized assistance with insurance appeals, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

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