By Counterforce Health Team in Opfolda (miglustat) —

How to Get Opfolda (miglustat) Covered by Aetna CVS Health in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Opfolda Covered by Aetna CVS Health in Virginia

Opfolda (miglustat) requires prior authorization from Aetna CVS Health and must be prescribed with Pombiliti for adults (≥18 years, ≥40 kg) with late-onset Pompe disease who aren't improving on current enzyme replacement therapy. Submit requests via Aetna's Availity portal or fax to 1-877-269-9916. If denied, Virginia residents can appeal internally (180 days) then file external review using SCC Form 216-A within 120 days. Key documentation: confirmed LOPD diagnosis, ERT failure evidence, and specialist evaluation.

First step today: Verify your Aetna plan covers specialty drugs and download the medical exception form from Aetna's provider portal.

Table of Contents

  1. Verify Your Plan and Find the Right Policy
  2. Required Forms for Prior Authorization
  3. Submission Portals and Electronic Options
  4. Fax Numbers and Mailing Addresses
  5. CVS Specialty Pharmacy Enrollment
  6. Support Phone Lines and Contact Information
  7. Virginia External Review and Consumer Protection
  8. When to Update Your Resources
  9. Step-by-Step: Fastest Path to Approval
  10. Common Denial Reasons and Solutions
  11. Appeals Process in Virginia
  12. FAQ

1. Verify Your Plan and Find the Right Policy

Before starting your Opfolda prior authorization, confirm these basics:

Check Your Coverage

  • Log into your Aetna member portal or call Member Services at 1-855-463-0933
  • Verify you have prescription drug coverage that includes specialty medications
  • Confirm Opfolda appears on your plan's specialty drug list

Find Your Specific Policy Aetna's requirements vary by plan type:

  • Commercial plans: Standard prior authorization through CVS Caremark
  • Medicare Part D: May have different timelines and appeal rights
  • Medicaid managed care: Check Virginia-specific formulary requirements
Tip: Aetna lists Opfolda as non-formulary with prior authorization required in their 2025 drug guides.

2. Required Forms for Prior Authorization

Primary Form: Aetna Medical Exception/Prior Authorization Form

  • Download from Aetna's provider forms page
  • Complete sections for patient details, medication specifics, and medical justification
  • Include ICD-10 code E74.02 for late-onset Pompe disease

Supporting Documentation Checklist

  • Confirmed LOPD diagnosis (genetic testing or enzyme assay)
  • Evidence of inadequate response to current ERT (Lumizyme, Nexviazyme)
  • Patient age ≥18 years and weight ≥40 kg verification
  • Prescription for both Opfolda AND Pombiliti (combination required)
  • Specialist evaluation from metabolic or neuromuscular expert
  • Functional assessments (6-minute walk test, pulmonary function tests)

Medical Necessity Letter Requirements Your prescriber should include:

  • Detailed ERT history with dates, doses, and duration
  • Objective evidence of treatment failure (declining FVC, reduced 6MWT)
  • Clinical rationale for Opfolda + Pombiliti combination therapy
  • Treatment goals and monitoring plan

3. Submission Portals and Electronic Options

Primary Electronic Submission

Portal Access Requirements

  • Providers must register with NPI and practice information
  • Secure login credentials required for HIPAA compliance
  • Upload capability for clinical notes, lab results, and imaging
Note: Electronic submissions typically process faster than fax or mail submissions.

4. Fax Numbers and Mailing Addresses

Prior Authorization Fax Numbers

  • General PA requests: 1-877-269-9916
  • Specialty drug precertification: 1-855-330-1716
  • Expedited/urgent requests: Same numbers, mark "URGENT" on cover sheet

Mailing Address

Aetna Prior Authorization
CVS Caremark
P.O. Box 52136
Phoenix, AZ 85072-2136

Cover Sheet Best Practices

  • Include patient name, Aetna ID, and prescriber NPI
  • List total pages being faxed
  • Mark "EXPEDITED" if clinically urgent
  • Include callback number for questions

5. CVS Specialty Pharmacy Enrollment

Enrollment Process

  1. Download the CVS Specialty enrollment form for Pombiliti + Opfolda
  2. Complete patient demographics and insurance information
  3. Submit prescription and clinical documentation
  4. CVS Specialty coordinates with Aetna for prior authorization

Transfer Instructions If transferring from another specialty pharmacy:

  • Provide current prescription details and refill information
  • Include prior authorization approval letter
  • Coordinate timing to avoid therapy interruption

Patient Portal Access Patients can track orders and schedule deliveries through the CVS Specialty patient portal after enrollment.

6. Support Phone Lines and Contact Information

For Members

  • Aetna Member Services: 1-855-463-0933
  • CVS Specialty Patient Care: 1-800-237-2767
  • Prior Authorization Status: Available through member portal or by phone

For Providers

  • Aetna Provider Services: 1-855-240-0535 (Mon-Fri, 8 a.m.-6 p.m. CT)
  • Specialty Precertification: 1-866-814-5506
  • Peer-to-peer review requests: Request through provider portal or call main line

What to Ask When Calling

  • Current status of your prior authorization request
  • Specific denial reasons if applicable
  • Required additional documentation
  • Timeline for decision
  • Appeal rights and deadlines

7. Virginia External Review and Consumer Protection

Virginia State Corporation Commission Bureau of Insurance If Aetna denies your internal appeal, Virginia law provides independent external review:

External Review Process

  • File within 120 days of final Aetna denial
  • Independent Review Organization (IRO) makes binding decision
  • Standard review: 45 days
  • Expedited review: 72 hours (with physician certification)

Virginia Managed Care Ombudsman The SCC also provides a Managed Care Ombudsman to help with health plan issues:

  • Same phone number: 1-877-310-6560
  • Can assist with understanding appeal rights
  • May help resolve issues informally
Note: Virginia's external review is free to consumers and decisions are binding on Aetna.

8. When to Update Your Resources

Quarterly Checks

Annual Updates

  • Download new prior authorization forms (usually updated January 1)
  • Review plan benefits and coverage changes
  • Confirm specialty pharmacy network requirements

Trigger Events for Immediate Updates

  • Plan changes or renewals
  • Moving to different Aetna product
  • Changes in Virginia insurance regulations

Step-by-Step: Fastest Path to Approval

  1. Prescriber verifies eligibility (same day)
    • Confirm LOPD diagnosis and patient meets age/weight criteria
    • Document ERT failure with objective measures
  2. Submit complete PA package (1-2 business days)
    • Use Availity portal for fastest processing
    • Include all required documentation in initial submission
  3. Aetna reviews request (15 business days standard)
    • May request additional information
    • Expedited review available for urgent cases (72 hours)
  4. If approved: CVS Specialty coordinates delivery (2-5 business days)
  5. If denied: Request specific denial reasons and missing documentation
  6. Internal appeal (within 180 days)
    • Address denial reasons with additional evidence
    • Consider peer-to-peer review with Aetna medical director
  7. External review if needed (within 120 days of final denial)
    • File SCC Form 216-A with Virginia Bureau of Insurance

Common Denial Reasons and Solutions

Denial Reason How to Overturn
Insufficient ERT failure documentation Submit detailed treatment history with objective measures (FVC decline, 6MWT reduction)
Missing combination therapy requirement Ensure both Opfolda AND Pombiliti are prescribed together
Age/weight criteria not met Provide documentation showing patient ≥18 years and ≥40 kg
Not medically necessary Submit specialist letter citing FDA indication for LOPD patients not improving on ERT
Experimental/investigational Reference FDA approval and published clinical trial data

Appeals Process in Virginia

Internal Appeals with Aetna

  • Timeline: 180 days from denial notice
  • Standard decision: 30 days (pre-service) or 60 days (post-service)
  • Expedited: 72 hours with physician certification
  • Submit via: Availity portal, fax, or mail with additional evidence

Virginia External Review After exhausting internal appeals:

  • File: SCC Form 216-A within 120 days
  • Cost: Free to consumers
  • Decision: Binding on Aetna
  • Timeline: 45 days standard, 72 hours expedited

Required for External Review

  • Copy of final Aetna denial letter
  • Insurance card copy
  • Supporting medical records
  • Physician certification for expedited review (if applicable)

FAQ

How long does Aetna CVS Health prior authorization take in Virginia? Standard PA decisions take up to 15 business days. Expedited reviews for urgent cases are completed within 72 hours when physician certification is provided.

What if Opfolda is non-formulary on my plan? You can request a formulary exception by documenting medical necessity and failure of formulary alternatives. Include evidence of inadequate response to standard ERTs.

Can I request an expedited appeal? Yes, if your physician certifies that delay would seriously jeopardize your health or ability to regain function. Submit physician certification with your appeal.

Does step therapy apply if I failed ERT outside Virginia? Prior therapy from other states or insurers should count toward step therapy requirements. Include complete documentation of previous treatments and outcomes.

What counts as ERT failure for Opfolda approval? Objective evidence of inadequate response typically includes declining pulmonary function (FVC), reduced exercise capacity (6MWT), or worsening muscle strength despite 12-18 months of compliant ERT.

Can my doctor request a peer-to-peer review? Yes, request through the Aetna provider portal or by calling 1-855-240-0535. This allows your specialist to discuss the case directly with an Aetna medical director.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients seeking coverage of specialty medications like Opfolda. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer requirements. We help patients, clinicians, and specialty pharmacies navigate complex prior authorization processes with documentation that meets medical necessity standards and procedural requirements.

From our advocates: We've seen many Opfolda appeals succeed when providers include quantitative data showing ERT failure—specific FVC percentages, 6MWT distances, and muscle strength scores over time. Payers respond well to objective measures rather than subjective symptom descriptions.

For complex cases involving multiple denials or urgent clinical needs, consider working with specialized advocacy services that understand payer-specific requirements and can help craft compelling appeals using the right evidence and language.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult your healthcare provider and insurance plan documents for specific guidance. For personalized help with appeals or complex coverage issues, contact the Virginia State Corporation Commission Bureau of Insurance or consider working with a qualified patient advocate.

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