By Counterforce Health Team in Qalsody (tofersen) —

Getting Qalsody (Tofersen) Covered by Cigna in Ohio: Coding, Appeals & Documentation Guide

Answer Box: Getting Qalsody (Tofersen) Covered by Cigna in Ohio

Eligibility: Qalsody is covered by Cigna for adults with ALS and confirmed SOD1 gene mutation. Fastest path: Submit prior authorization through Express Scripts/Accredo with genetic test results, ICD-10 G12.21, HCPCS J1304, and neurologist documentation. First step today: Call Cigna at the number on your insurance card to confirm specialty pharmacy requirements and request PA forms. If denied, Ohio allows two internal appeals plus external review through the Ohio Department of Insurance within 180 days.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping and Documentation Requirements
  3. Product Coding: HCPCS, J-Code, and NDC Details
  4. Clean Prior Authorization Request Anatomy
  5. Frequent Billing Pitfalls to Avoid
  6. Verification with Cigna Resources
  7. Appeals Playbook for Ohio
  8. Quick Pre-Submission Checklist
  9. Common Denial Reasons & Solutions
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Qalsody (tofersen) typically falls under medical benefit coverage rather than pharmacy benefit because it requires intrathecal administration by a healthcare provider. This distinction affects where you submit claims and which forms you'll need.

Medical Benefit Path (most common):

  • Administered in clinical setting (hospital, infusion center, neurology clinic)
  • Billed using HCPCS J-code plus administration CPT codes
  • Prior authorization through Cigna medical management
  • Claims submitted by the administering facility

Specialty Pharmacy Path (if applicable):

  • Drug shipped to clinic through Express Scripts/Accredo
  • Facility bills for administration only
  • May require separate PA for drug acquisition and administration
Note: Confirm with Cigna which pathway applies to your specific plan, as coverage can vary between commercial, Medicare Advantage, and Medicaid managed care products.

ICD-10 Mapping and Documentation Requirements

The primary diagnosis code for Qalsody coverage is G12.21 (Amyotrophic lateral sclerosis). Your documentation must clearly support this diagnosis and the medical necessity for SOD1-targeted therapy.

Required Documentation Elements

Diagnosis Support:

SOD1 Mutation Confirmation:

  • Genetic test report showing pathogenic SOD1 mutation
  • Laboratory results must be clearly documented and attached
  • Test must be from certified genetic testing laboratory

Functional Assessment:

  • Baseline ALSFRS-R score with individual item scores documented
  • Patient must score ≥2 points on each ALSFRS-R item for initial approval
  • Assessment must be current (typically within 30 days of request)

Provider Requirements:

  • Prescription by or consultation with neurologist experienced in ALS management
  • Provider attestation of diagnosis and treatment rationale
  • Documentation that patient is not dependent on invasive ventilation

Product Coding: HCPCS, J-Code, and NDC Details

Essential Codes for Qalsody Billing

Code Type Code Description Units
HCPCS J-Code J1304 Injection, tofersen, 1 mg Per mg administered
NDC 64406-0109-01 Qalsody 100 mg/15 mL vial Per vial
ICD-10 G12.21 Amyotrophic lateral sclerosis Primary diagnosis

Dosing and Units Calculation

Standard Qalsody Dosing:

  • Loading phase: 100 mg (15 mL) every 14 days × 3 doses
  • Maintenance: 100 mg (15 mL) every 28 days
  • Each vial contains exactly 100 mg in 15 mL

Billing Units:

  • Bill 100 units of J1304 per administration (100 mg = 100 units of "1 mg")
  • Never bill for unused portions—entire vial must be discarded after single use
  • Include appropriate administration CPT codes for intrathecal injection
Important: The J1304 code became effective January 1, 2024, replacing temporary codes. Verify current codes with CMS HCPCS updates before billing.

Clean Prior Authorization Request Anatomy

A complete Cigna prior authorization for Qalsody should include:

Core Documentation Package

  1. Completed PA Form
    • Use Cigna Express Scripts specialty pharmacy form
    • Include all required fields and provider signatures
  2. Clinical Documentation
    • Neurologist consultation notes
    • ALS diagnosis confirmation with criteria used
    • ALSFRS-R assessment with individual scores
    • Treatment history and rationale
  3. Laboratory Results
    • SOD1 genetic test report
    • Any relevant biomarker results (NfL if available)
    • Supporting diagnostic tests
  4. Prescription Details
    • Exact dosing schedule (loading then maintenance)
    • Administration location and method
    • Duration of treatment requested

Sample Request Structure

Patient: [Name], DOB [Date], Member ID [Number]
Diagnosis: Amyotrophic lateral sclerosis (G12.21)
Drug: Qalsody (tofersen) - NDC 64406-0109-01
Dose: 100 mg intrathecally every 28 days (after loading)
HCPCS: J1304 (100 units per administration)

Medical Necessity: Patient has confirmed pathogenic SOD1 mutation 
[attach genetic test] with progressive ALS [attach ALSFRS-R scores]. 
Prescribed by Dr. [Name], board-certified neurologist. Patient meets 
all Cigna policy criteria per [policy reference].

Frequent Billing Pitfalls to Avoid

Common Unit Conversion Errors

Mistake: Billing 15 units (confusing mL with mg) Correct: Bill 100 units of J1304 (100 mg dose)

Mistake: Attempting to bill partial vials Correct: Bill only for administered dose; document waste appropriately

Timing and Interval Issues

  • Loading doses must be 14 days apart (±2 days typically acceptable)
  • Maintenance doses every 28 days (±3 days usually allowed)
  • Document any missed or delayed doses with clinical rationale

Documentation Gaps

Common oversights:

  • Missing provider signatures or credentials
  • Incomplete ALSFRS-R scoring (need individual item scores)
  • Generic ALS diagnosis without SOD1 mutation confirmation
  • Outdated functional assessments

Verification with Cigna Resources

Before submitting your request, verify current requirements through official Cigna channels:

Provider Resources:

  • Cigna Provider Portal - current PA forms and policies
  • Express Scripts specialty pharmacy guidelines
  • Provider services: 1-800-88-CIGNA

Policy Verification:

  • Search for "tofersen" or "Qalsody" in Cigna's coverage policy database
  • Confirm current HCPCS codes and billing requirements
  • Check for any recent policy updates or restrictions
Tip: Cigna policies can change quarterly. Always verify the policy effective date matches your submission timeframe.

Appeals Playbook for Ohio

If Cigna denies your Qalsody prior authorization, Ohio provides a structured appeals process with specific timelines and requirements.

Internal Appeals with Cigna

Level 1 - Standard Internal Appeal:

  • Deadline: 180 days from denial date
  • Timeline: 15 days for urgent, 30 days for standard review
  • Submit: Written appeal with additional documentation

Level 2 - Internal Appeal:

  • Automatic if Level 1 is denied
  • Timeline: 15-30 days depending on urgency
  • May include peer-to-peer review opportunity

Ohio External Review Process

If internal appeals are unsuccessful, Ohio law provides an independent external review:

Eligibility:

  • Must complete all internal Cigna appeals first
  • Denial must involve medical necessity or experimental treatment determination
  • Request must be filed within 180 days of final internal denial

Process:

  • Submit request through your health plan (they forward to Ohio Department of Insurance)
  • Independent Review Organization (IRO) assigned
  • Decision typically within 30 days (72 hours for expedited)
  • Decision is binding on Cigna

Ohio Department of Insurance Contact:

From our advocates: In our experience with rare disease appeals, success often hinges on providing the exact clinical evidence that addresses the specific denial reason. Don't just resubmit the same documentation—identify what the reviewer found insufficient and provide targeted additional evidence.

Quick Pre-Submission Checklist

Before submitting your Cigna prior authorization:

Documentation Review:

  • SOD1 genetic test results attached and clearly referenced
  • Complete ALSFRS-R with individual item scores ≥2
  • Neurologist consultation notes with ALS diagnosis confirmation
  • Provider signatures and credentials on all forms
  • Current contact information for all providers

Coding Verification:

  • ICD-10 G12.21 used for primary diagnosis
  • HCPCS J1304 with correct unit calculation (100 units per dose)
  • NDC 64406-0109-01 specified
  • Administration CPT codes included if billing facility

Policy Compliance:

  • Patient meets age requirement (18+ years)
  • No invasive ventilation dependency documented
  • Dosing schedule matches FDA labeling
  • All Cigna-specific requirements addressed

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
No SOD1 mutation documented Submit genetic test report Certified laboratory results with pathogenic variant
Insufficient functional assessment Provide complete ALSFRS-R Individual item scores with provider interpretation
Non-specialist prescriber Obtain neurologist consultation Board-certified neurologist evaluation and recommendation
Experimental/investigational Reference FDA approval status FDA label, CMS guidance on accelerated approval drugs
Missing baseline documentation Submit comprehensive clinical notes Diagnosis confirmation, disease progression, treatment history

Leveraging Recent CMS Guidance

In December 2024, CMS directed Medicare Advantage plans to cover Qalsody for on-label SOD1-ALS use. While this doesn't directly apply to commercial Cigna plans, it provides strong precedent for medical necessity arguments in appeals.

Appeal Language: "CMS has confirmed that Qalsody meets medical necessity standards for SOD1-ALS, contradicting any 'experimental' designation for FDA-approved, on-label use."

FAQ

How long does Cigna prior authorization take for Qalsody in Ohio? Standard review is typically 15 business days, though complex cases may take up to 30 days. Urgent/expedited reviews are completed within 72 hours if clinical urgency is documented.

What if Qalsody is non-formulary on my Cigna plan? Request a formulary exception through the standard PA process. Provide documentation that no formulary alternatives are appropriate for SOD1-ALS treatment.

Can I request an expedited appeal in Ohio? Yes, if delays would seriously jeopardize your health. Submit expedited appeal request with physician attestation of medical urgency.

Does step therapy apply to Qalsody? Most Cigna policies don't require step therapy for SOD1-ALS since Qalsody is the only FDA-approved SOD1-targeted therapy. However, documentation of standard ALS treatments (riluzole, edaravone) may strengthen your case.

What happens if I miss a scheduled dose? Document the reason and clinical plan in medical records. Most policies allow flexibility for missed doses due to medical reasons, but chronic non-adherence may affect continued coverage.

How much will Qalsody cost with Cigna coverage? Costs vary by plan design. With coverage, expect specialty drug copays ($100-500+ per administration). Check your specific benefit summary or contact Cigna member services.

Can I appeal to Ohio regulators if Cigna denies coverage? Yes, after completing internal appeals, you can request external review through the Ohio Department of Insurance. This provides an independent medical review of your case.

What if I have both Medicare and Cigna coverage? Coordination of benefits rules apply. Medicare may be primary for the drug cost, with Cigna covering remaining portions. Verify with both payers before treatment initiation.

Getting Additional Help

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Qalsody. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer-specific requirements, potentially saving weeks of back-and-forth documentation requests.

For additional Ohio-specific assistance:

  • Ohio Department of Insurance: 1-800-686-1526
  • UHCAN Ohio (consumer advocacy): Provides guidance on insurance appeals
  • ALS Association: Offers resources for navigating insurance coverage

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage determinations. Coverage policies and procedures may change; verify current requirements before submitting requests.

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