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

Aetna (CVS Health) Coverage Criteria for Prolastin-C in Florida: What Counts as "Medically Necessary"?

Answer Box

To get Prolastin-C covered by Aetna (CVS Health) in Florida, you need: 1) Confirmed severe AAT deficiency (Pi*ZZ genotype + serum AAT <57 mg/dL), 2) Post-bronchodilator FEV₁ between 25-80% predicted, and 3) Documentation of emphysema/COPD due to AAT deficiency. Submit prior authorization using Aetna's Alpha1-Proteinase Inhibitor precertification form. If denied, you have 180 days to appeal and can request external review through Florida's Department of Financial Services.

Table of Contents

  1. Policy Overview: How Aetna Handles Alpha1-Proteinase Inhibitors
  2. Core Medical Necessity Criteria
  3. Step Therapy Requirements and Exceptions
  4. Quantity Limits and Renewal Requirements
  5. Required Diagnostics and Documentation
  6. Site of Care and Specialty Pharmacy Rules
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Letter Template
  9. Common Denial Reasons and How to Fix Them
  10. Florida Appeals Process
  11. Frequently Asked Questions

Policy Overview: How Aetna Handles Alpha1-Proteinase Inhibitors

Aetna (CVS Health) requires prior authorization for all alpha1-proteinase inhibitors, including Prolastin-C, under their Clinical Policy Bulletin #0145. This applies across all plan types in Florida:

  • Commercial plans (employer and individual)
  • Aetna Better Health of Florida (Medicaid)
  • Aetna Medicare Advantage plans

The policy covers chronic augmentation therapy for adults with emphysema due to severe hereditary AAT deficiency. Coverage decisions are based on FDA labeling, ATS/ERS guidelines, and Aetna's internal medical review criteria.

Note: Self-funded employer plans may have slightly different procedures but must follow the same core clinical criteria.

Core Medical Necessity Criteria

Aetna requires all of the following criteria to be met for Prolastin-C coverage:

Diagnosis Requirements

  • Confirmed severe hereditary AAT deficiency with emphysema/COPD
  • Appropriate ICD-10 codes (typically E88.01 for AATD plus J43.x/J44.x for emphysema/COPD)

Laboratory Evidence

  • Serum AAT level below 57 mg/dL (approximately 11 μM), documented by quantitative testing
  • Severe genotype confirmation (PiZZ, PiZ null, or equivalent severe variant)

Pulmonary Function Criteria

According to Aetna's precertification form:

  • Post-bronchodilator FEV₁ between 25% and 80% predicted
  • Evidence of fixed airflow obstruction (FEV₁/FVC <0.7)
  • Spirometry performed according to ATS/ERS standards

Patient Status Requirements

  • Adult patient (≥18 years old)
  • Non-smoker or enrolled in intensive smoking cessation program
  • No contraindications to alpha1-proteinase inhibitor therapy

Step Therapy Requirements and Exceptions

Many Aetna formularies in 2024 list Prolastin-C as non-formulary, with Aralast NP or Glassia as preferred alternatives. However, you can obtain coverage through:

Formulary Exception Process

Submit documentation showing the preferred agent is inappropriate due to:

  • Previous intolerance or adverse reaction
  • Clinical contraindication (e.g., IgA deficiency with anti-IgA antibodies)
  • Inadequate response to preferred agent at appropriate dose/duration
  • Patient stability on Prolastin-C (if already established on therapy)

Medicare Part B Exception

For Aetna Medicare plans, step therapy doesn't apply if the patient received the non-preferred drug within the past 365 days.

Quantity Limits and Renewal Requirements

Initial Authorization

  • Typically approved for 3-6 months initially
  • Standard dosing: 60 mg/kg weekly IV infusion
  • May require dose justification based on patient weight

Renewal Criteria

Reauthorization (typically every 12 months) requires:

  • Updated serum AAT levels showing therapeutic response
  • Current spirometry demonstrating disease stability or slowed decline
  • Evidence of ongoing clinical benefit (stable exacerbations, preserved function)
  • Continued non-smoker status and treatment adherence
Tip: Start renewal requests 90 days before expiration to avoid treatment gaps.

Required Diagnostics and Documentation

Laboratory Requirements

Test Requirement Timing
Serum AAT level <57 mg/dL Within 12 months
Genotype/Phenotype Pi*ZZ or severe variant Any time (doesn't expire)
Spirometry FEV₁ 25-80% predicted Within 6 months

Supporting Documentation

  • Pulmonology consultation notes confirming AATD-related emphysema
  • CT chest showing panacinar/basilar emphysema pattern (supportive)
  • Smoking cessation documentation if former smoker
  • Previous alpha1-PI therapy records if applicable

Site of Care and Specialty Pharmacy Rules

Aetna has specific site of care policies for alpha1-proteinase inhibitors:

Preferred Sites

  • Home infusion (most cost-effective)
  • Physician office
  • Freestanding infusion center

Hospital Outpatient Exceptions

Hospital outpatient infusion is only approved when documented:

  • History of serious adverse events not controlled by standard interventions
  • Laboratory-confirmed IgA antibodies (anaphylaxis risk)
  • Severe venous access issues requiring specialized intervention
  • Significant behavioral/cognitive impairment without adequate caregiver support
  • Medical instability requiring immediate medical personnel/equipment

CVS Specialty Coordination

Most Aetna plans route alpha1-PI through CVS Specialty Pharmacy, which coordinates home infusion services and provides standardized administration protocols.

Evidence to Support Medical Necessity

Clinical Guidelines to Reference

  • FDA labeling for Prolastin-C (chronic augmentation therapy indication)
  • ATS/ERS Alpha-1 Antitrypsin Deficiency Guidelines
  • Alpha-1 Foundation clinical recommendations

Key Supporting Data Points

  • Disease progression evidence (declining FEV₁, increasing exacerbations)
  • Functional impact (mMRC dyspnea score, 6-minute walk distance)
  • Quality of life measures when available
  • Previous response to other COPD therapies

Sample "Meets Criteria" Letter Template

This 45-year-old patient meets all Aetna Clinical Policy Bulletin #0145 criteria for alpha1-proteinase inhibitor therapy: Diagnosis: Severe hereditary AAT deficiency (Pi*ZZ genotype) with emphysema (ICD-10: E88.01, J43.9). Laboratory: Serum AAT 32 mg/dL (<57 mg/dL threshold). Pulmonary Function: Post-bronchodilator FEV₁ 42% predicted (within required 25-80% range), FEV₁/FVC 0.58 confirming obstruction. Clinical Status: Never-smoker with progressive dyspnea and recurrent exacerbations despite optimal COPD therapy. CT chest shows panacinar emphysema consistent with AATD. Patient requires chronic augmentation therapy per FDA indication and ATS/ERS guidelines to slow disease progression.

Common Denial Reasons and How to Fix Them

Denial Reason Solution Documentation Needed
Insufficient genotype documentation Submit SERPINA1 genetic testing Lab report showing Pi*ZZ or equivalent
FEV₁ outside range Retest or provide trend data Recent spirometry with post-bronchodilator values
Missing smoking status Document cessation or never-smoker Clinic notes with smoking history
Non-formulary status Request formulary exception Letter explaining why preferred agents inappropriate
Site of care denial Document medical necessity for setting Evidence of complications requiring specific site
Inadequate prior authorization Resubmit with complete documentation All required forms and supporting records

Florida Appeals Process

Internal Appeal Timeline

  • Filing deadline: 180 days from denial notice
  • Standard decision: 30 days
  • Expedited decision: 72 hours (for urgent cases)

External Review Options

After exhausting internal appeals:

Commercial Plans:

  • File with Florida Department of Financial Services
  • Deadline: 4 months after final internal denial
  • Decision timeframe: 60 days
  • Cost: Free to consumer

Aetna Better Health Florida (Medicaid):

  • Request state fair hearing through Florida AHCA
  • Deadline: 120 days after appeal decision
  • Process: Independent state review
Important: Document all correspondence and submit appeals well before deadlines.

When working with patients who face coverage challenges for expensive specialty medications like Prolastin-C, Counterforce Health helps transform insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each payer's own rules, significantly improving approval odds for complex cases like alpha1-antitrypsin deficiency.

Maximizing Appeal Success

  • Include treating specialist's detailed medical necessity letter
  • Provide comprehensive medical records documenting disease progression
  • Reference specific policy language and criteria
  • Consider requesting peer-to-peer review with Aetna medical director
  • Submit additional clinical evidence if initial documentation was incomplete

Frequently Asked Questions

How long does Aetna prior authorization take in Florida? Standard PA decisions typically take 3-15 business days. Expedited reviews for urgent cases are decided within 72 hours.

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

Can I get coverage for home infusion? Yes, Aetna prefers home infusion when clinically appropriate. Hospital outpatient requires specific medical justification.

Do I need a pulmonologist to prescribe Prolastin-C? While not always required, specialist involvement strengthens the case and may be necessary for complex appeals.

What happens if my appeal is denied? You can request external review through Florida's Department of Financial Services (commercial) or state fair hearing (Medicaid).

Does step therapy apply if I'm stable on Prolastin-C? Generally no - continuation of effective therapy is typically approved, especially if switching could cause clinical deterioration.

How often do I need lab monitoring? Serum AAT levels and spirometry are typically required every 6-12 months for renewals.

Can I appeal if Aetna requires a different infusion site? Yes, if you can document medical necessity for your preferred site of care based on safety or access considerations.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and review your specific insurance policy. For assistance with insurance appeals in Florida, contact the Florida Department of Financial Services at 1-877-693-5236.

Sources & Further Reading

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