By Counterforce Health Team in Raxone (idebenone) —

Getting Raxone (Idebenone) Covered by Cigna in Michigan: Prior Authorization, Appeals, and Coding Guide

Answer Box: Getting Raxone (Idebenone) Covered by Cigna in Michigan

Challenge: Raxone is not FDA-approved in the US, making coverage difficult through standard channels. Solution: Use Cigna's formulary exception process with strong medical necessity documentation. First step: Have your ophthalmologist submit a formulary exception request through CoverMyMeds or Cigna's provider portal within 72 hours of denial, including LHON genetic testing, visual field studies, and treatment timeline documentation. Michigan advantage: If denied, you have 127 days to file an external review with DIFS, which provides binding independent medical review within 60 days.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for LHON
  3. Product Coding: HCPCS, NDC, and Units
  4. Clean Request Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with Cigna Resources
  7. Appeals Playbook for Michigan
  8. Quick Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Understanding whether Raxone falls under medical or pharmacy benefits affects your coding approach and approval pathway with Cigna.

Pharmacy Benefit Path (Most Common)

  • Raxone is typically processed as a specialty pharmacy drug through Express Scripts/Accredo
  • Requires formulary exception request rather than standard prior authorization
  • Uses NDC numbers for billing and tracking
  • 72-hour review timeline for standard requests

Medical Benefit Path (Rare)

  • Only applies if administered in clinical settings
  • Would require HCPCS J-codes (currently none assigned for idebenone)
  • Processed through medical claims with CPT codes for administration
Note: Since Raxone is an oral medication for LHON, it almost always follows the pharmacy benefit pathway through Cigna's specialty pharmacy network.

ICD-10 Mapping for LHON

Accurate diagnosis coding is crucial for establishing medical necessity with Cigna.

Primary ICD-10 Code

H47.22 - Hereditary optic atrophy is the billable ICD-10-CM diagnosis code for Leber's optic atrophy, valid through September 30, 2026.

Supporting Documentation Language

Your medical records should include specific terminology that supports the H47.22 coding:

  • "Bilateral painless subacute visual loss"
  • "Central vision impairment affecting reading and driving"
  • "Pathogenic mitochondrial DNA mutation confirmed"
  • "Visual field defects consistent with LHON"
  • "Onset in young adult" (typical age range)

Additional Codes for Complications

If applicable, include secondary codes for:

  • H53.4 - Visual field defects
  • H54.0-H54.8 - Visual impairment classifications
  • Z87.891 - Personal history of nicotine dependence (LHON risk factor)

Product Coding: HCPCS, NDC, and Units

NDC Numbers and Strength

Raxone (idebenone) 150 mg tablets require specific NDC identification for Cigna processing. Since NDC numbers can vary by manufacturer and packaging, verify current numbers with your specialty pharmacy (verify with Accredo or your dispensing pharmacy).

Dosing and Units Calculation

Standard LHON Dosing: 900 mg daily (two 150 mg tablets three times daily with food)

  • Monthly supply: 180 tablets (90-day supply = 540 tablets)
  • Units per prescription: Calculate based on days supply requested

HCPCS/J-Code Status

Currently, no specific HCPCS J-code exists for idebenone in the CMS HCPCS database. For oral specialty medications like Raxone, this is typical since J-codes primarily apply to injectable/infusible drugs.

Clean Request Anatomy

A successful Cigna formulary exception request includes these components:

Required Clinical Elements

  1. Diagnosis Documentation
    • ICD-10: H47.22 (Hereditary optic atrophy)
    • Genetic testing confirming LHON mutation
    • Visual field testing results
    • Optical coherence tomography (OCT) findings
  2. Medical Necessity Justification
    • Timeline of vision loss onset and progression
    • Prior treatments attempted and outcomes
    • Why no formulary alternatives are appropriate
    • Expected treatment goals and monitoring plan
  3. Prescriber Certification
    • Written statement that formulary drugs would be "detrimental or ineffective"
    • Clinical rationale for idebenone specifically
    • Dosing justification (900 mg daily)

Submission Pathways

Submit through CoverMyMeds, Evicore ePA portal, or fax to Cigna provider services (confirm current fax with Cigna provider support: 1-800-882-4462).

Frequent Coding Pitfalls

Common Mistakes to Avoid

Incorrect ICD-10 Usage

  • ❌ Using H47.21 (Congenital optic atrophy) instead of H47.22
  • ❌ Omitting laterality when required by payer
  • ✅ Use H47.22 with supporting documentation of hereditary nature

Unit Conversion Errors

  • ❌ Requesting 90 tablets for 90-day supply (should be 540 tablets)
  • ❌ Miscalculating daily dose requirements
  • ✅ Verify: 6 tablets daily × 90 days = 540 tablets per quarter

Missing Documentation

  • ❌ Submitting without genetic testing confirmation
  • ❌ Lacking visual field or OCT studies
  • ✅ Include complete LHON diagnostic workup

Timing Issues

  • ❌ Submitting requests without clear onset timeline
  • ❌ Missing optimal treatment window documentation
  • ✅ Specify time from symptom onset to treatment initiation

Verification with Cigna Resources

Pre-Submission Verification Steps

  1. Confirm Current Formulary Status
  2. Validate Submission Method
  3. Cross-Check Requirements

Contact Points for Verification

Appeals Playbook for Michigan

Internal Appeals with Cigna

First-Level Internal Appeal

Required Documentation

  • Original denial letter
  • Additional medical records not previously submitted
  • Peer-reviewed literature supporting idebenone for LHON
  • Updated clinical notes showing progression or urgency

Michigan External Review Process

Eligibility: After completing Cigna's internal appeals process

Timeline: 127 days from final internal denial to file with DIFS

Review Period:

  • Standard: Up to 60 days
  • Expedited: 72 hours (requires physician letter stating urgency)

Filing Process:

Michigan Advantage: DIFS external reviews are binding on insurers, and Michigan's 127-day filing window is longer than the federal 120-day standard.

Quick Audit Checklist

Pre-Submission Review

Clinical Documentation ✓

  • H47.22 ICD-10 code with supporting diagnosis
  • Genetic testing confirming LHON mutation
  • Visual field studies and OCT results
  • Timeline from symptom onset to treatment request
  • Prior treatment attempts and outcomes documented

Prescription Details ✓

  • Correct NDC number for idebenone 150 mg
  • Accurate quantity calculation (6 tablets daily)
  • Appropriate days supply (30, 60, or 90 days)
  • Prescriber DEA and NPI numbers included

Formulary Exception Requirements ✓

  • Written physician certification of medical necessity
  • Explanation why formulary alternatives inappropriate
  • Clinical rationale for idebenone specifically
  • Expected treatment outcomes and monitoring plan

Submission Pathway ✓

  • Correct portal or fax number verified
  • All required forms completed
  • Supporting documentation attached
  • Submission confirmation received

Counterforce Health: Specialized Support for Complex Appeals

Getting rare disease medications like Raxone approved often requires navigating complex payer policies and building evidence-backed appeals. Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and craft point-by-point rebuttals aligned to each payer's own rules.

For medications like idebenone that lack FDA approval, Counterforce Health helps gather the right evidence—peer-reviewed studies, specialty guidelines, and recognized drug compendia—and weaves them into appeals with all required clinical facts, from diagnosis codes to prior treatment failures and contraindications.

Costs & Savings Options

Manufacturer Support Programs

Contact Santhera Pharmaceuticals directly for any available patient assistance programs (verify current programs with manufacturer).

Michigan State Resources

  • Michigan Medicaid: May cover through prior authorization if eligible
  • Healthy Michigan Plan: Medicaid expansion coverage with specialty drug benefits
  • DIFS Consumer Assistance: 877-999-6442 for insurance questions

FAQ

How long does Cigna prior authorization take for Raxone in Michigan? Standard formulary exceptions are reviewed within 72 hours, with expedited reviews completed in 24 hours for urgent cases.

What if Raxone is completely non-formulary with Cigna? Use Cigna's formulary exception process, which allows coverage for non-formulary drugs when medically necessary and formulary alternatives are inappropriate.

Can I request expedited review if my vision is worsening? Yes, if your physician certifies that waiting would jeopardize your health or ability to regain function, request expedited review for 24-hour turnaround.

Does step therapy apply to Raxone since there are no alternatives? Step therapy typically doesn't apply when no formulary alternatives exist for the specific condition, but document this clearly in your exception request.

What happens if Cigna denies my appeal in Michigan? You have 127 days to file an external review with Michigan DIFS, which provides binding independent medical review within 60 days.

Can my doctor submit the appeal for me? Yes, your physician can file appeals on your behalf with your written consent, and this is often more effective than patient-initiated appeals.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Cigna plan and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals in Michigan, contact DIFS at 877-999-6442.

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