How to Get Fintepla (Fenfluramine) Covered by Cigna in California: ICD-10 Codes, REMS Documentation, and Appeals Process
Answer Box: Getting Fintepla Covered by Cigna in California
Fast Track to Approval: Cigna requires prior authorization for Fintepla (fenfluramine) with documented Dravet syndrome (ICD-10: G40.83) or Lennox-Gastaut syndrome (G40.81), REMS enrollment with baseline echocardiogram, and failure of at least two preferred anti-seizure medications. First step today: Gather your child's diagnosis documentation, prior medication records, and schedule the required baseline echo. Submit the complete prior authorization package through your neurologist's office. If denied, California's Independent Medical Review (IMR) system offers strong patient protections with high overturn rates for medically necessary treatments.
Table of Contents
- Coding Basics: Medical vs. Pharmacy Benefit
- ICD-10 Mapping for Dravet and LGS
- Product Coding: HCPCS, NDC, and Billing Units
- Clean Prior Authorization Anatomy
- Frequent Coding Pitfalls
- Verification with Cigna Resources
- California Appeals Process
- Quick Audit Checklist
Coding Basics: Medical vs. Pharmacy Benefit
Fintepla (fenfluramine) is typically covered under Cigna's pharmacy benefit, not the medical benefit, which affects how claims are submitted and coded. Understanding this distinction is crucial for successful reimbursement.
Pharmacy Benefit Coverage:
- Uses NDC codes for billing
- Requires pharmacy prior authorization
- Processed through Express Scripts (Cigna's PBM)
- Subject to formulary tiers and step therapy
Key Documentation Requirements:
- Confirmed diagnosis with specific ICD-10 codes
- REMS program enrollment and monitoring
- Prior medication failure documentation
- Prescriber specialty requirements (neurologist/epileptologist)
Note: Unlike some specialty medications that require medical benefit coding with J-codes, Fintepla is dispensed through specialty pharmacies and billed using standard pharmacy claim formats.
ICD-10 Mapping for Dravet and LGS
Precise ICD-10 coding is essential for Cigna approval. Using the wrong or non-specific codes is a common cause of denial.
Coverage at a Glance
| Condition | ICD-10 Code | Specificity | Required Documentation |
|---|---|---|---|
| Dravet syndrome | G40.83 | General diagnosis | Genetic testing (SCN1A), seizure history |
| Dravet syndrome | G40.834 | Intractable, without status epilepticus | EEG findings, treatment resistance |
| Lennox-Gastaut syndrome | G40.81 | General diagnosis | Multiple seizure types, EEG pattern |
| Lennox-Gastaut syndrome | G40.814 | Intractable, without status epilepticus | Failed multiple ASMs |
Documentation Words That Support Coding:
- "Intractable" or "refractory" epilepsy
- "Multiple seizure types"
- "Developmental delay" (common comorbidity)
- "SCN1A mutation" (for Dravet)
- "Slow spike-and-wave pattern" (for LGS)
Tip: Always use the most specific ICD-10 code available. Dravet Foundation provides updated coding resources for healthcare providers.
Product Coding: HCPCS, NDC, and Billing Units
NDC and Billing Information
Fintepla Specifications:
- Oral solution: 2.2 mg/mL
- Available in 30 mL and 60 mL bottles
- NDC numbers vary by bottle size (verify current NDCs with UCB)
Billing Unit Calculations: For HCPCS code J1322 (fenfluramine, oral, 0.1 mg):
- 1 billing unit = 0.1 mg of fenfluramine
- Example: 6 mL daily dose = 13.2 mg daily
- 30-day supply = 396 mg total
- Billing units = 396 mg ÷ 0.1 mg = 3,960 units
REMS Program Requirements
Fintepla has mandatory REMS requirements that must be documented for Cigna approval:
Required REMS Documentation:
- Patient Enrollment Form (signed by prescriber and patient/caregiver)
- Baseline echocardiogram results
- Prescriber REMS certification
- Patient counseling documentation
Echocardiogram Specifications:
- Baseline echo before starting treatment
- Every 6 months during treatment
- 3-6 months after discontinuation
- Must include valve regurgitation assessment and pulmonary artery systolic pressure
Clean Prior Authorization Anatomy
Step-by-Step: Fastest Path to Approval
- Confirm Diagnosis (Clinic, Day 1)
- Document with specific ICD-10 code
- Include genetic testing results if available
- Submit via Cigna provider portal
- Complete REMS Enrollment (Clinic, Days 1-3)
- Register at FinteplarEMS.com
- Schedule baseline echocardiogram
- Complete prescriber certification
- Document Prior Failures (Clinic, Days 1-5)
- List at least 2 preferred ASMs tried
- Include dosages, duration, and reason for discontinuation
- Attach pharmacy records or clinic notes
- Submit Prior Authorization (Clinic, Days 5-7)
- Use Cigna's prior authorization form
- Include all REMS documentation
- Submit through Express Scripts if pharmacy benefit
- Follow Up (Clinic, Day 10)
- Check status via provider portal
- Prepare for potential peer-to-peer review
- Timeline: 5-7 business days for standard review
Frequent Coding Pitfalls
Common Errors That Cause Denials
| Pitfall | Impact | Solution |
|---|---|---|
| Non-specific ICD-10 codes | Automatic denial | Use G40.83/G40.834 for Dravet, G40.81/G40.814 for LGS |
| Incomplete REMS documentation | Processing delay | Submit all forms from FinteplarEMS.com |
| Incorrect billing units | Payment issues | Divide total mg by 0.1 mg per unit |
| Missing step therapy documentation | Coverage denial | Document 2+ prior ASM failures with details |
| Outdated NDC codes | Claim rejection | Verify current NDCs with UCB or pharmacy |
Unit Conversion Errors
Common Mistake: Billing per mL instead of per 0.1 mg
- Wrong: 6 mL daily = 6 units
- Correct: 6 mL daily × 2.2 mg/mL = 13.2 mg = 132 units daily
Verification with Cigna Resources
Pre-Submission Checklist
Before submitting your prior authorization, verify these elements:
Coverage Verification:
- Check current formulary status at Cigna.com
- Confirm prior authorization requirements
- Verify quantity limits and refill restrictions
Documentation Completeness:
- Specific ICD-10 diagnosis code
- REMS enrollment confirmation
- Baseline echocardiogram results
- Prior medication failure documentation
- Prescriber specialty verification
- Patient age confirmation (≥2 years)
Clinician Corner: For medical necessity letters, include FDA labeling information, peer-reviewed efficacy data for Dravet/LGS, and specific seizure frequency reduction goals. Counterforce Health specializes in creating evidence-backed appeals that align with payer-specific requirements.
California Appeals Process
California offers strong patient protections through its Independent Medical Review (IMR) system, overseen by the Department of Managed Health Care (DMHC).
Appeals Playbook for Cigna in California
Level 1: Internal Appeal (Grievance)
- Timeline: File within 180 days of denial
- Response time: 30 days (expedited: 72 hours for urgent)
- How to file: Cigna member portal or written request
- Required: Denial letter, medical records, prescriber letter
Level 2: Independent Medical Review (IMR)
- When: After internal appeal denial or 30 days with no response
- Timeline: 45 days for standard, 7 days for expedited
- Cost: Free to patients
- Success rate: High for rare disease treatments with proper documentation
How to Request IMR:
- Contact DMHC Help Center: (888) 466-2219
- Submit online at healthhelp.ca.gov
- Include all medical records and denial letters
- Specify that treatment is medically necessary per FDA labeling
When to Escalate
Contact California regulators if:
- Cigna doesn't respond to appeals within required timeframes
- Prior authorization delays exceed 5 business days for urgent cases
- REMS-compliant prescriptions are denied without clinical justification
DMHC Complaint Line: (888) 466-2219 Online complaint: healthhelp.ca.gov
Quick Audit Checklist
Pre-Submission Review
Patient Information:
- Confirmed Dravet syndrome or LGS diagnosis
- Age ≥2 years documented
- Current Cigna coverage verified
Clinical Documentation:
- Specific ICD-10 code used (G40.83, G40.834, G40.81, or G40.814)
- Prior ASM failures documented (minimum 2)
- Neurologist/epileptologist prescription
- Seizure frequency and severity noted
REMS Compliance:
- Prescriber enrolled in REMS program
- Patient enrollment form completed
- Baseline echocardiogram completed and results submitted
- Cardiac monitoring plan documented
Billing Accuracy:
- Correct NDC codes used
- Billing units calculated properly (mg ÷ 0.1)
- Quantity matches prescribed dose and days supply
Common Denial Reasons & Fixes
| Denial Reason | Fix Strategy |
|---|---|
| "Diagnosis not supported" | Submit genetic testing, EEG reports, seizure logs |
| "Step therapy not met" | Provide detailed prior medication history with dates |
| "REMS documentation missing" | Submit complete enrollment forms and echo results |
| "Not medically necessary" | Include FDA labeling, clinical guidelines, seizure impact |
From our advocates: We've seen Fintepla approvals succeed when families work closely with their neurologist's office to ensure REMS compliance is documented upfront. The key is treating REMS as part of the medical necessity argument, not just a regulatory hurdle. This comprehensive approach has helped many California families avoid lengthy appeals processes.
FAQ
How long does Cigna prior authorization take for Fintepla in California? Standard review is 5-7 business days. Expedited review (for urgent cases) is 72 hours. Counterforce Health can help prepare comprehensive submissions that reduce the likelihood of delays or denials.
What if Fintepla is non-formulary on my Cigna plan? Request a formulary exception with medical necessity documentation. California law requires insurers to have an exception process for non-formulary drugs when medically necessary.
Can I request an expedited appeal in California? Yes, if delays would seriously jeopardize your health. Both Cigna and California's IMR system offer expedited pathways for urgent cases.
Does step therapy apply if my child failed medications outside California? Yes, documented failures from any provider count toward step therapy requirements. Ensure you have pharmacy records or clinic notes from previous states.
What's the success rate for Fintepla appeals in California? California's IMR system has high overturn rates for medically necessary treatments, especially for rare diseases with clear FDA indications and proper documentation.
Sources & Further Reading
- Cigna Fintepla Coverage Policy
- Fintepla REMS Program
- California DMHC Help Center
- Dravet Foundation ICD-10 Resources
- FDA Fintepla Labeling
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions. For assistance with complex appeals, California residents can contact the DMHC Help Center at (888) 466-2219 or visit healthhelp.ca.gov.
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