By Counterforce Health Team in Galafold (migalastat) —

Coding That Helps Get Galafold (Migalastat) Approved by Cigna in Virginia: ICD-10, HCPCS, and NDC Guide

Answer Box: Getting Galafold Covered by Cigna in Virginia

Getting Galafold (migalastat) approved by Cigna requires precise coding and complete documentation. Use ICD-10 code E75.21 for Fabry disease, submit through pharmacy benefit (not medical), and include genetic confirmation of amenable GLA variant. Virginia patients have strong appeal rights through the State Corporation Commission if initially denied.

First steps today:

  1. Verify genetic testing confirms amenable GLA variant
  2. Complete Cigna's prior authorization form via provider portal
  3. Include specialist letter of medical necessity with E75.21 diagnosis

Table of Contents

Coding Basics: Medical vs Pharmacy Benefit

Galafold (migalastat) is covered under the pharmacy benefit, not the medical benefit, by Cigna and Express Scripts. This oral medication for Fabry disease flows through specialty pharmacy channels like Accredo.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Galafold prescriptions Cigna provider portal Cigna PA policy
Age Restriction Adults 18+ only FDA prescribing information FDA label
Genetic Testing Amenable GLA variant required Laboratory documentation Cigna PA policy
Specialist Requirement Geneticist, nephrologist, or cardiologist Provider credentials Cigna PA policy
Annual Reauthorization Clinical assessment and labs required Cigna renewal process Cigna PA policy

ICD-10 Mapping for Fabry Disease

Primary code: E75.21 (Fabry disease/Anderson-Fabry disease)

Documentation Requirements for E75.21

Your medical records must include:

  • Definitive diagnosis confirmation: Laboratory evidence of deficient alpha-galactosidase A enzyme activity OR genetic testing showing pathogenic GLA variant
  • Clinical manifestations: Documented symptoms such as:
    • Neurological (acroparesthesias, neuropathic pain)
    • Cutaneous (angiokeratomas)
    • Renal (proteinuria, chronic kidney disease)
    • Cardiac/cerebrovascular involvement
  • Family history: X-linked inheritance pattern if available
  • Organ involvement: Specify affected systems and severity
Tip: Cigna requires genetic confirmation of an amenable GLA variant—not just any Fabry diagnosis. The variant must be proven to respond to migalastat therapy through in vitro testing.

Supporting Documentation Words

When documenting for medical necessity, include these specific terms:

  • "Confirmed amenable GLA variant per genetic testing"
  • "Progressive multisystem manifestations of Fabry disease"
  • "Failed or contraindicated for enzyme replacement therapy"
  • "Specialist-managed rare disease requiring oral chaperone therapy"

Product Coding: HCPCS, J-Codes, and NDC

Pharmacy Benefit Coding (Primary Path)

  • NDC: Use specific Galafold 123 mg capsule NDC
  • Dispensing: 14 capsules per 28 days (every other day dosing)
  • Billing channel: Specialty pharmacy (Accredo/Express Scripts)

Medical Benefit Coding (Rare)

If medical benefit billing is required:

  • HCPCS code: J8499 (prescription drug, oral, not otherwise classified)
  • NDC required: Yes, include on medical claims
  • Units: Report as prescribed (verify with payer)
Note: Galafold does not have a product-specific J-code. Most payers cover it under pharmacy benefit only.

Dosing Units and Conversion

Correct dosing: 123 mg capsule, one capsule every other day

Common unit errors to avoid:

  • Don't convert to migalastat hydrochloride (150 mg)
  • Don't list as daily dosing
  • Don't split capsules or use partial units

Clean Prior Authorization Request

Step-by-Step: Fastest Path to Approval

  1. Verify genetic testing (Patient/Clinic)
  2. Complete Cigna PA form (Clinic)
    • Access via Cigna provider portal
    • Include all required signatures
    • Timeline: Submit within 180 days of genetic testing
  3. Attach medical necessity letter (Specialist)
    • Include E75.21 diagnosis with clinical justification
    • Document failed/contraindicated alternatives
    • Timeline: Current letter (within 6 months)
  4. Submit to specialty pharmacy (Clinic)
    • Forward to Accredo or designated specialty pharmacy
    • Include prescription and all documentation
    • Timeline: 5-7 business days for initial review
  5. Follow up on status (Patient/Clinic)
    • Contact Cigna within 5 business days
    • Document all communication
    • Timeline: PA decision typically within 15 business days

Medical Necessity Letter Checklist

Your specialist's letter should include:

  • Problem: Confirmed Fabry disease with amenable GLA variant
  • Prior treatments: ERT trials, outcomes, or contraindications
  • Clinical rationale: Why migalastat is medically necessary
  • Guidelines: Reference to FDA approval and clinical evidence
  • Dosing: 123 mg every other day per FDA labeling
  • Monitoring: Plan for ongoing assessment and reauthorization

Frequent Coding Pitfalls

Common Error Why It Happens How to Fix
Using daily dosing frequency Misunderstanding EOD schedule Specify "every other day" or "123 mg capsule, 14 caps per 28 days"
Wrong strength conversion Converting to hydrochloride salt Always use 123 mg migalastat base
Missing genetic documentation Assuming Fabry diagnosis is sufficient Include amenable variant confirmation
Incorrect benefit type Submitting as medical benefit Route through pharmacy benefit/specialty pharmacy
Incomplete PA forms Rushing submission Use Cigna's specific forms with all signatures
Outdated medical records Using old clinic notes Ensure documentation is current (within 6 months)

Verification with Cigna Resources

Before submitting your request:

  1. Check formulary status: Verify Galafold coverage through Cigna formulary lookup (confirm current link)
  2. Confirm PA requirements: Review current Cigna PA policy
  3. Validate specialty pharmacy network: Confirm Accredo or designated pharmacy
  4. Verify provider credentials: Ensure prescriber meets specialist requirements

Cross-Check Resources

  • Cigna provider portal for current forms and submission process
  • FDA prescribing information for dosing and indications
  • Laboratory for genetic testing methodology and reporting

Pre-Submission Audit Checklist

Required Documentation:

  • Completed Cigna PA form with all signatures
  • ICD-10 code E75.21 documented in medical records
  • Genetic testing report confirming amenable GLA variant
  • Specialist letter of medical necessity
  • Current prescription for 123 mg every other day
  • Patient age verification (18+ years)
  • Insurance eligibility and specialty pharmacy benefits confirmed

Coding Verification:

  • Correct dosing units (123 mg capsule, not hydrochloride conversion)
  • Proper frequency (every other day, not daily)
  • Pharmacy benefit pathway selected
  • NDC and strength match prescription exactly

Timeline Compliance:

  • PA submitted within 180 days of genetic testing
  • Medical records current (within 6 months)
  • All documentation dated and signed appropriately

Virginia Appeal Rights

If Cigna denies your Galafold request, Virginia provides strong patient protections through the State Corporation Commission Bureau of Insurance.

Internal Appeal Process

  1. Submit to Cigna within 180 days of denial
  2. Include denial letter and all supporting documentation
  3. Expect decision within 45-60 days

External Review (Virginia SCC)

If internal appeal fails:

  • File within 4 months of final denial
  • Virginia SCC assigns Independent Review Organization (IRO)
  • Decision within 45 days (expedited available for urgent cases)
  • Success rate: 30-50% of external reviews overturn insurer denials
Virginia Advantage: The State Corporation Commission provides free external review services and has a track record of supporting medically necessary rare disease treatments when properly documented.

For assistance, contact Virginia SCC Bureau of Insurance at 1-877-310-6560 or visit their external review page (verify current link).

FAQ

How long does Cigna PA take in Virginia? Typically 15 business days for standard review. Expedited review available for urgent medical situations.

What if Galafold is non-formulary on my plan? Submit a formulary exception request with medical necessity documentation. Virginia external review is available if denied.

Can I request an expedited appeal? Yes, if your physician certifies that waiting could jeopardize your health. Virginia offers 72-hour expedited external review for urgent cases.

Does step therapy apply to Galafold? Cigna may require documentation of ERT failure or contraindication before approving migalastat therapy.

What genetic testing is required? Laboratory confirmation of an amenable GLA variant using in vitro assay methodology. Not all Fabry variants respond to migalastat.

How often do I need reauthorization? Annual reauthorization with updated clinical assessment, laboratory results, and demonstration of continued benefit.

Getting complex medications approved shouldn't feel impossible. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific denial basis, and drafts point-by-point rebuttals aligned to each payer's own rules—taking the guesswork out of prior authorization and appeals.

When navigating Cigna's requirements for Galafold, having the right documentation and coding from the start significantly improves your chances of approval. Counterforce Health's approach focuses on meeting payer-specific criteria while ensuring all procedural requirements are satisfied—exactly what's needed for complex rare disease medications like migalastat.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and is not medical advice. Coverage decisions depend on individual circumstances, plan benefits, and clinical factors. Always consult with your healthcare provider and insurance plan for specific guidance. For additional support with Virginia insurance issues, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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