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

Getting Prolastin-C Covered by Blue Cross Blue Shield in Virginia: Complete Guide to Prior Authorization, Appeals, and State External Review

Answer Box: Prolastin-C Coverage with Blue Cross Blue Shield in Virginia

Blue Cross Blue Shield Virginia requires prior authorization for Prolastin-C (alpha1-proteinase inhibitor) for alpha-1 antitrypsin deficiency. Coverage requires documented severe AATD (like Pi*ZZ genotype), clinical evidence of emphysema, and lung function tests showing moderate impairment (typically FEV1 35-60% predicted). If denied, Virginia's State Corporation Commission Bureau of Insurance provides external review within 120 days. First step: Have your doctor submit a complete prior authorization request with genotype results, pulmonary function tests, and clinical documentation through your plan's provider portal.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Financial Support
  6. Denials and Appeals
  7. Specialty Pharmacy Requirements
  8. Virginia External Review Process
  9. Common Questions

Coverage Basics

Is Prolastin-C Covered by Blue Cross Blue Shield Virginia?

Yes, Prolastin-C is typically covered by Blue Cross Blue Shield plans in Virginia when medically necessary for adults with severe alpha-1 antitrypsin deficiency and clinical evidence of emphysema. However, coverage requires prior authorization and adherence to specific medical criteria.

Which Blue Cross Blue Shield Plans Cover Prolastin-C?

Coverage applies to most BCBS Virginia commercial plans, including Anthem Blue Cross Blue Shield Virginia (the dominant carrier with ~43% market share). Requirements may vary slightly between plan types:

  • Commercial plans: Standard prior authorization required
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Subject to Virginia Medicaid guidelines
Note: Always verify coverage with your specific plan, as formulary status can change quarterly.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm diagnosis - Your doctor documents severe AATD with lab results showing low serum alpha1-PI levels and genotyping (Pi*ZZ or equivalent)
  2. Document lung impairment - Complete pulmonary function tests showing FEV1 typically 35-60% predicted with obstructive pattern
  3. Submit prior authorization - Provider submits PA request through Anthem's provider portal with all required documentation
  4. Include smoking status - Document non-smoking status or smoking cessation efforts (required by most plans)
  5. Attach supporting evidence - Clinical notes, chest imaging, and treatment history
  6. Follow up - Check status within 5-7 business days and respond promptly to any requests for additional information

Required Documentation Checklist

  • ✅ Confirmed severe AATD diagnosis (lab results and genotype)
  • ✅ Pulmonary function tests showing moderate impairment
  • ✅ Clinical notes documenting emphysema symptoms
  • ✅ Chest imaging (CT or X-ray) if available
  • ✅ Smoking history and current status
  • ✅ Prior treatment attempts (if applicable)
  • ✅ IgA antibody testing results (some plans require)

Timing and Deadlines

Process Stage Timeline Notes
Prior Authorization Decision 5-15 business days Standard review
Expedited PA (if urgent) 72 hours Requires physician certification
Internal Appeal 30 days After denial
External Review Filing 120 days From final denial notice
External Review Decision 45 days (standard) / 72 hours (expedited) Virginia SCC process

Medical Necessity Criteria

Blue Cross Blue Shield Virginia typically requires all of the following for Prolastin-C coverage:

Essential Requirements

  1. Confirmed severe AATD: Pi*ZZ genotype or equivalent severe deficiency alleles
  2. Low serum levels: Alpha1-PI levels below normal range
  3. Clinical emphysema: Documented symptoms and clinical evidence
  4. Lung function impairment: FEV1 typically 35-60% predicted on pulmonary function tests
  5. Non-smoking status: Current non-smoker or documented cessation efforts

Common Denial Reasons and Solutions

Denial Reason How to Address
Normal or near-normal lung function Provide recent PFTs showing moderate impairment; consider repeat testing
Missing genotype confirmation Submit lab results confirming Pi*ZZ or severe deficiency
Inadequate clinical documentation Provide detailed notes on emphysema symptoms and functional impact
Active smoking Document cessation efforts or current non-smoking status
Non-preferred brand Request formulary exception with clinical justification

Costs and Financial Support

Insurance Coverage

  • Formulary tier: Typically Tier 3 (specialty) or Tier 4 (high-cost specialty)
  • Prior authorization: Required for all plans
  • Quantity limits: Usually aligned with FDA dosing (60 mg/kg weekly)

Financial Assistance Options

Prolastin-C Quick Start Program: Provides up to 8 weeks of no-cost medication for commercially insured patients during insurance review (not available for Medicare/Medicaid patients).

Manufacturer Support: Grifols offers patient assistance programs - contact through Prolastin Direct for eligibility screening.

Denials and Appeals

Internal Appeals with Blue Cross Blue Shield

If your prior authorization is denied:

  1. File within 30 days of denial notice
  2. Submit through member portal or provider portal
  3. Include new evidence not in original request
  4. Request peer-to-peer review if appropriate

Medical Necessity Letter Template

Your doctor should address:

  • Specific AATD genotype and lab values
  • Current lung function measurements
  • Symptom severity and functional impact
  • Why Prolastin-C is medically necessary
  • Citations to FDA labeling and clinical guidelines
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific criteria.

Specialty Pharmacy Requirements

Prolastin-C typically requires dispensing through specialty pharmacies:

  • Accredo: Primary specialty pharmacy for many BCBS plans
  • CVS Specialty: Alternative specialty pharmacy option
  • Home infusion: Available through contracted providers
  • Clinic administration: Covered at approved infusion centers

Site of Care Considerations

Coverage may vary by administration site:

  • Home infusion: Often preferred by plans for cost containment
  • Outpatient infusion center: Requires prior authorization
  • Hospital outpatient: May require additional justification

Virginia External Review Process

If your internal appeals are unsuccessful, Virginia provides robust external review rights through the State Corporation Commission Bureau of Insurance.

How to File External Review

  1. Timing: File within 120 days of final denial
  2. Forms: Complete Form 216-A (External Review Request)
  3. Submit via:
    • Fax: (804) 371-9915
    • Email: [email protected]
    • Mail: SCC Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218

Required Documents

  • Completed Form 216-A
  • Copy of final denial letter
  • Insurance card copy
  • Medical records release form
  • Any new supporting documentation

Timeline

  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours (requires physician certification)
Virginia Advantage: The state provides free external review and has special provisions allowing expedited review for cancer treatments without exhausting internal appeals.

For guidance, contact the Virginia SCC Consumer Services at 1-877-310-6560.

Common Questions

Q: How long does BCBS Virginia prior authorization take for Prolastin-C? A: Standard prior authorization decisions are typically made within 5-15 business days. Expedited review (72 hours) is available when medically urgent.

Q: What if Prolastin-C is not on my formulary? A: Your doctor can request a formulary exception by demonstrating medical necessity and providing clinical justification for why covered alternatives are inappropriate.

Q: Can I appeal if I have the Pi*ZZ genotype but normal lung function? A: Appeals are challenging without documented lung impairment, as BCBS policies require clinical evidence of emphysema. Consider monitoring and repeat testing if symptoms develop.

Q: Does step therapy apply to alpha-1 antitrypsin replacement? A: Step therapy requirements vary by plan. Some may require trial of other AAT products (Glassia, Zemaira) before approving Prolastin-C.

Q: What if my doctor recommends home infusion but BCBS prefers clinic administration? A: Request a site-of-care exception with documentation of why home infusion is medically necessary or more appropriate for your situation.

Q: How often do I need to renew prior authorization? A: Most plans require reauthorization every 6-12 months with documentation of continued clinical benefit and stable or improved lung function.

Specialty Resources

When navigating complex coverage challenges, specialized support can make the difference. Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by analyzing denial letters, identifying specific coverage criteria, and crafting evidence-backed responses that address each payer's unique requirements. Their platform ingests denial letters and clinical documentation to produce targeted rebuttals that significantly improve approval rates.

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 verify current requirements with your insurance provider and consult your healthcare team for medical decisions. For personalized assistance with coverage challenges, consider consulting with healthcare coverage advocates or legal professionals specializing in insurance appeals.

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