How to Get Galafold (Migalastat) Covered by Cigna in Pennsylvania: Complete Guide with ICD-10, NDC Codes, and Appeal Process
Answer Box: Getting Galafold Covered by Cigna in Pennsylvania
Eligibility: Adults ≥18 with confirmed Fabry disease and an amenable GLA variant documented by genetic testing. Fastest path: Submit prior authorization through Accredo (Cigna's specialty pharmacy) with ICD-10 code E75.21, genetic test results, and specialist letter. First step today: Contact your Fabry specialist to request a medical necessity letter and genetic amenability confirmation. If denied, Pennsylvania's external review program has helped overturn roughly 50% of insurance denials in 2024.
Table of Contents
- Coverage Requirements at a Glance
- ICD-10 and Medical Coding Essentials
- NDC and Billing Code Specifications
- Step-by-Step Prior Authorization Process
- Common Denial Reasons and Solutions
- Pennsylvania Appeals Process
- Cost-Saving Resources
- Frequently Asked Questions
Coverage Requirements at a Glance
| Requirement | Details | Documentation Needed | Source |
|---|---|---|---|
| Age | ≥18 years | Birth date verification | Cigna PA Policy |
| Diagnosis | Fabry disease (ICD-10: E75.21) | Genetic testing + specialist diagnosis | ICD-10 Reference |
| Genetic Testing | Amenable GLA variant confirmed | Lab report with variant amenability | FDA Label |
| Prescriber | Genetics/nephrology/cardiology specialist | Specialist consultation note | Cigna PA Policy |
| Pharmacy | Accredo specialty pharmacy only | Prescription routed through Accredo | Express Scripts |
| Dosing | 123 mg every other day | Prescription matching FDA label | FDA Label |
ICD-10 and Medical Coding Essentials
Primary Diagnosis Code
Use ICD-10 code E75.21 for Fabry (Anderson) disease on all medical records, prior authorization forms, and claims. This billable code falls under metabolic disorders and is recognized by all major payers including Cigna.
Supporting Documentation for E75.21
Your medical records must clearly link the diagnosis to clinical findings:
- Genetic confirmation: Pathogenic or likely pathogenic GLA variant
- Enzyme activity: Reduced α-galactosidase A levels (especially in males)
- Clinical manifestations: Renal involvement, cardiac symptoms, neuropathic pain, or other Fabry-related organ damage
- Specialist evaluation: Geneticist, nephrologist, or cardiologist confirming Fabry disease
Tip: Ensure your problem list in the electronic health record uses "Fabry disease" or "Fabry (Anderson) disease" to match the ICD-10 terminology exactly.
Medical vs. Pharmacy Benefit
Galafold is covered under Cigna's pharmacy benefit, not the medical benefit. This means:
- No J-codes or HCPCS codes needed for typical billing
- Prior authorization processed through Express Scripts
- Dispensed exclusively through specialty pharmacies like Accredo
NDC and Billing Code Specifications
NDC Code and Packaging
- NDC: 68151-1230-1
- Strength: 123 mg capsule
- Package size: 14 capsules per wallet pack
- Days supply calculation: 14 capsules = 28-day supply (every other day dosing)
Quantity Limits and Dosing
Standard dosing: One 123 mg capsule every other day at the same time Monthly quantity: 15 capsules per 30-day supply 90-day quantity: 45 capsules per 90-day supply
Critical: Never dose on consecutive days. The every-other-day schedule is FDA-mandated and required for coverage.
Common Coding Errors to Avoid
- Billing 30 capsules for 30 days (implies daily dosing)
- Using incorrect days supply calculations
- Missing the 2-hour fasting requirement in counseling documentation
- Prescribing concurrent enzyme replacement therapy (contraindicated)
Step-by-Step Prior Authorization Process
Step 1: Verify Insurance and Specialty Pharmacy Benefits
Who: Patient or clinic staff
Timeline: Same day
Action: Call Cigna member services to confirm Galafold is covered under specialty pharmacy benefit and requires prior authorization.
Step 2: Gather Required Documentation
Who: Patient and specialist
Timeline: 1-2 weeks
Required documents:
- Genetic testing report showing amenable GLA variant
- Specialist consultation note with Fabry diagnosis
- Current prescription for 123 mg every other day
- Insurance card and prior authorization form
Step 3: Submit Prior Authorization Through Accredo
Who: Prescriber or clinic
Timeline: 1-2 business days to submit
Process: Submit complete PA packet to Accredo, who will forward to Cigna for review Expected decision time: 10-15 business days
Step 4: Follow Up and Track Status
Who: Patient or clinic
Timeline: Weekly check-ins
Action: Monitor PA status through Cigna provider portal or by calling Accredo
Clinician Corner: Medical Necessity Letter Checklist
Your specialist should include these elements in the medical necessity letter:
✓ Patient demographics and confirmed Fabry disease diagnosis
✓ Genetic testing results with specific amenable GLA variant
✓ Clinical manifestations of Fabry disease (renal, cardiac, neurologic)
✓ Prior treatments and their outcomes or contraindications
✓ Specific dosing request: 123 mg every other day
✓ Monitoring plan for treatment response and safety
✓ FDA approval citation and clinical guideline references
Common Denial Reasons and Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Non-amenable GLA variant | Submit amenability database confirmation | Amicus amenability table |
| Insufficient genetic testing | Provide complete genetic report | CLIA-certified lab results with variant classification |
| Non-specialist prescriber | Obtain specialist consultation | Genetics/nephrology/cardiology referral note |
| Incorrect dosing | Submit corrected prescription | 123 mg every other day prescription |
| Missing clinical severity | Document organ involvement | Lab values, imaging, or biopsy results |
| Concurrent ERT therapy | Confirm ERT discontinuation | Specialist note stating ERT has been stopped |
Pennsylvania Appeals Process
Internal Appeals with Cigna
First-level appeal deadline: 180 days from denial
Timeline: 15-30 business days for decision
How to file: Cigna member portal or written appeal with supporting documentation
Pennsylvania External Review
If Cigna's internal appeal is unsuccessful, Pennsylvania residents can use the state's Independent External Review program, which launched in January 2024.
Eligibility: Must have Final Adverse Benefit Determination from Cigna
Deadline: 4 months from final denial letter
Success rate: Approximately 50% of appeals overturned in 2024
How to file: PA Insurance Department website or fax to 717-231-7960
Required documents for external review:
- Final denial letter from Cigna
- Insurance card copy
- Medical records supporting medical necessity
- Completed external review application
Timeline: 45 days for standard review, 72 hours for expedited urgent cases
Note: Pennsylvania's external review program is free to patients, and if successful, Cigna must immediately provide coverage, including retroactive coverage if you paid out-of-pocket.
Cost-Saving Resources
Manufacturer Support
Amicus Assist Program: Provides copay assistance and patient support services
Eligibility: Commercial insurance patients
Website: AmicusAssist.com
Foundation Assistance
Patient Access Network (PAN) Foundation: Provides copay assistance for rare disease medications
National Organization for Rare Disorders (NORD): Offers patient assistance programs
State Resources
Pennsylvania Health Law Project: Free legal assistance for insurance appeals
Contact: Available through pa.gov consumer assistance programs
From Our Advocates
We've seen Galafold approvals move faster when the genetic testing report explicitly states the variant is "amenable to migalastat treatment" rather than just listing the mutation. If your lab report doesn't include this language, ask your geneticist to provide a brief addendum confirming amenability based on the manufacturer's database.
Frequently Asked Questions
How long does Cigna prior authorization take for Galafold?
Typically 10-15 business days through Accredo. Expedited reviews may be available for urgent medical situations.
What if Galafold is not on Cigna's formulary?
Request a formulary exception with medical necessity documentation. Galafold is often covered under specialty tiers even if not explicitly listed.
Can I appeal if I'm denied for a non-amenable variant?
Yes, but success depends on providing strong clinical evidence. Consider genetic counseling to confirm variant classification and amenability.
Does step therapy apply to Galafold in Pennsylvania?
Some Cigna plans may require trial of enzyme replacement therapy first. Document any contraindications or failures with ERT to support step therapy exceptions.
What happens if I move to Pennsylvania from another state?
Your prior authorization may need renewal. Contact Cigna to confirm coverage continuity and any state-specific requirements.
Can I get emergency supplies while waiting for approval?
Ask your prescriber about emergency supply options through Accredo. Some situations may qualify for temporary coverage pending PA approval.
About Counterforce Health
Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Galafold. Our platform analyzes denial letters, identifies specific policy criteria, and generates evidence-backed appeals that align with each payer's requirements. We help patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and improve approval rates for life-changing treatments.
Sources & Further Reading
- Cigna Galafold Coverage Policy
- FDA Galafold Prescribing Information
- Pennsylvania External Review Program
- ICD-10 Code E75.21 Reference
- Amicus Therapeutics Patient Support
This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for the most current coverage information. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department or visit Counterforce Health for specialized appeal assistance.
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