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

How to Get Prolastin-C Covered by Aetna CVS Health in Virginia: Appeal Process, Forms & Timelines

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

Prolastin-C is non-formulary for most Aetna commercial plans but may be covered for Medicare members with prior authorization. Your fastest path: 1) Check if you qualify for preferred alternatives (Aralast NP, Glassia), 2) Submit a formulary exception request with documented severe AAT deficiency (Pi*ZZ genotype, serum AAT <57 mg/dL), and 3) If denied, file an internal appeal within 180 days. Virginia residents have external review rights through the State Corporation Commission Bureau of Insurance after completing internal appeals.

Table of Contents

  1. Understanding Your Denial Letter
  2. Coverage Requirements at a Glance
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process for Aetna CVS Health in Virginia
  6. Medical Necessity Letter Checklist
  7. Virginia External Review Process
  8. Cost Support Options
  9. Frequently Asked Questions

Understanding Your Denial Letter

When Aetna CVS Health denies Prolastin-C, your denial letter will include specific reason codes. The most common reasons are:

  • Non-formulary status: Prolastin-C is excluded from most Aetna commercial formularies for 2024
  • Step therapy required: Must try preferred alternatives (Aralast NP, Glassia) first
  • Missing documentation: Inadequate proof of severe AAT deficiency or clinical need
  • Site of care restrictions: Home infusion may require special authorization
Tip: Look for the "determination date" on your denial letter—this starts your 180-day internal appeal clock in Virginia.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all alpha1-proteinase inhibitors Aetna provider portal or fax Aetna PA Policy
Formulary Status Non-formulary (commercial); may be preferred (Medicare) Plan drug guide 2024 Exclusions List
Step Therapy Try Aralast NP/Glassia first (commercial plans) Coverage policy Step Therapy Requirements
Diagnosis Requirements Severe AAT deficiency with Pi*ZZ genotype Lab reports, genetic testing Clinical Criteria
Site of Care Home infusion through CVS Specialty Specialty pharmacy enrollment CVS Specialty Forms

Step-by-Step: Fastest Path to Approval

1. Verify Your Plan Type and Formulary Status

Who does it: Patient or clinic staff
Timeline: 15 minutes
Action: Call Aetna member services at 1-800-872-3862 or check your plan's drug formulary online. Medicare members may have different coverage than commercial plan holders.

2. Gather Required Documentation

Who does it: Prescriber and patient
Timeline: 1-2 days
Documents needed:

  • Lab results showing serum AAT level <57 mg/dL
  • Genetic testing confirming Pi*ZZ genotype
  • Pulmonary function tests showing fixed airflow obstruction
  • Documentation of emphysema diagnosis (ICD-10 codes J43.0-J43.9)

3. Submit Prior Authorization Request

Who does it: Prescriber
Timeline: 3-5 business days for standard review
How to submit: Use Aetna's Medicare PA form or commercial PA portal

4. If Denied: Request Formulary Exception (Commercial Plans)

Who does it: Prescriber
Timeline: 15 business days for standard determination
Required: Medical necessity letter explaining why preferred alternatives are inappropriate

5. File Internal Appeal if Exception Denied

Who does it: Patient or authorized representative
Timeline: Must file within 180 days of denial
Submit to: Aetna appeals department via member portal or certified mail

6. Request Peer-to-Peer Review

Who does it: Prescriber
Timeline: Can request during or after PA process
Action: Call Aetna provider services to schedule discussion with medical director

7. Virginia External Review (If Internal Appeals Fail)

Who does it: Patient
Timeline: Must request within 120 days of final internal denial
Submit: Form 216-A to Virginia Bureau of Insurance

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Non-formulary drug" Submit formulary exception with medical necessity Letter explaining why Aralast NP/Glassia are inappropriate; clinical evidence
"Step therapy not completed" Document contraindications or failures with preferred agents Adverse event reports, intolerance documentation, efficacy failures
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label, ATS/ERS guidelines
"Not medically necessary" Strengthen clinical justification Exacerbation history, functional decline, quality of life impact
"Inadequate trial of alternatives" Provide detailed trial history Pharmacy records, clinical notes documenting previous therapies

Appeals Process for Aetna CVS Health in Virginia

Internal Appeals Timeline

  • Standard appeal: 30 days for medical necessity determinations
  • Expedited appeal: 72 hours if urgent medical need
  • Pre-service appeals: 15 days for prior authorization denials

Required Information for Appeals

  1. Patient Information: Name, member ID, date of birth
  2. Denial Details: Original denial letter, determination date, reason codes
  3. Clinical Support: Updated medical records, lab results, specialist notes
  4. Medical Necessity Statement: Why Prolastin-C is specifically required
From our advocates: We've seen the strongest appeals include a timeline showing disease progression despite standard treatments, plus specific contraindications to formulary alternatives. One case succeeded after documenting severe infusion reactions to Glassia that didn't occur with Prolastin-C.

How to Submit Internal Appeals

  • Online: Aetna member portal (fastest method)
  • Phone: 1-800-872-3862 for member services
  • Mail: Send certified mail to address on denial letter
  • Fax: Use fax number provided in denial notice

Medical Necessity Letter Checklist

Essential Elements Your Prescriber Should Include:

Patient's Clinical History:

  • Confirmed alpha1-antitrypsin deficiency with Pi*ZZ genotype
  • Serum AAT level (typically <57 mg/dL)
  • Current emphysema severity and symptoms
  • Exacerbation frequency and hospitalizations

Prior Treatment Attempts:

  • Documentation of trials with preferred formulary alternatives
  • Specific adverse events or contraindications
  • Lack of efficacy with other agents
  • Reasons why step therapy requirements cannot be met

Clinical Rationale for Prolastin-C:

  • Evidence supporting this specific brand
  • Expected clinical outcomes
  • Monitoring plan and safety considerations
  • References to published guidelines

Supporting Evidence:

  • FDA-approved indication for chronic augmentation therapy
  • American Thoracic Society/European Respiratory Society guidelines
  • Peer-reviewed literature on AAT augmentation therapy

Virginia External Review Process

If Aetna CVS Health upholds their denial through internal appeals, Virginia residents can request an independent external review through the State Corporation Commission Bureau of Insurance.

Eligibility Requirements

  • Completed all internal appeal levels with your insurer
  • Denial based on medical necessity, experimental treatment, or similar clinical judgment
  • Virginia-issued health plan or self-funded plan that opted into Virginia's process

How to Request External Review

  1. Download Form 216-A from the Virginia SCC website
  2. Submit within 120 days of your final internal appeal denial
  3. Include all documentation: Denial letters, medical records, supporting evidence
  4. No cost to you: Virginia provides free external review services

Timeline for External Review

  • Standard review: 30 working days from receipt of complete information
  • Expedited review: 5 working days for urgent medical situations
  • Decision is binding: If overturned, Aetna must provide coverage within 1-3 days

Contact Information

Virginia Bureau of Insurance Consumer Services:

Cost Support Options

Manufacturer Support Programs

PROLASTIN DIRECT® Program:

  • Provides insurance navigation support
  • Coordinates with CVS Specialty Pharmacy for home infusion
  • Offers copay assistance for eligible patients
  • Contact: prolastin.com

Patient Assistance Foundations

  • Alpha-1 Foundation: Provides grants and resources for AAT deficiency patients
  • HealthWell Foundation: Offers copay assistance for chronic conditions
  • Patient Access Network Foundation: Helps with insurance premium and copay costs

State Resources

Virginia's Medicaid expansion (2019) has improved access to specialty medications for eligible residents. Contact Virginia Department of Medical Assistance Services for eligibility information.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Virginia? Standard PA decisions are made within 15 business days for pre-service requests. Expedited reviews for urgent medical needs are completed within 72 hours.

What if Prolastin-C is completely non-formulary on my plan? You can request a formulary exception by having your prescriber submit a medical necessity letter explaining why preferred alternatives are inappropriate for your specific condition.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that waiting for a standard appeal timeline could seriously jeopardize your health. Expedited appeals are decided within 72 hours.

Does step therapy apply if I've tried alternatives outside Virginia? Yes, documented trials from any location count toward step therapy requirements. Provide pharmacy records and clinical notes from previous treatment attempts.

What happens if external review upholds the denial? The decision is final and binding. However, you retain rights to pursue other legal options or work with your employer if you have a self-funded plan.

How can Counterforce Health help with my appeal? Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, pulling appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines to strengthen your case.

When navigating Prolastin-C coverage with Aetna CVS Health in Virginia, persistence and proper documentation are key. The state's robust external review process provides an important safety net when internal appeals fail. Remember that Counterforce Health can help streamline the appeal process by creating targeted, evidence-backed responses to denials.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For additional help with health insurance appeals in Virginia, contact the Virginia State Corporation Commission Bureau of Insurance at 1-877-310-6560.

Sources & Further Reading

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