By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (Tofersen) Covered by UnitedHealthcare in New York: Complete Coding, Appeals & Forms Guide

Answer Box: Getting Qalsody Covered by UnitedHealthcare in New York

Qalsody (tofersen) requires prior authorization from UnitedHealthcare and is covered under the medical benefit using J-code J1304. Key requirements: confirmed SOD1 gene mutation, ALS diagnosis (ICD-10: G12.21), baseline neurofilament light chain (NfL) levels, and ALSFRS-R score ≥24. If denied, you have 180 days for internal appeals and 4 months for New York's external review through DFS. Start today: Gather genetic testing results, baseline NfL labs, and have your neurologist submit a comprehensive medical necessity letter through the UnitedHealthcare Provider Portal.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for ALS Documentation
  3. Product Coding: HCPCS, J-Code, and NDC
  4. Clean Request Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with UnitedHealthcare Resources
  7. Quick Audit Checklist
  8. Common Denial Reasons & Solutions
  9. New York Appeals Process
  10. Cost Support Options
  11. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Qalsody (tofersen) is exclusively covered under the medical benefit, not pharmacy benefits, across all major insurers including UnitedHealthcare. This means:

  • Billing location: Hospital outpatient departments, infusion centers, or specialty clinics
  • Administration codes required: CPT codes for intrathecal injection (96450) and spinal procedures
  • Prior authorization pathway: Medical benefit PA, not pharmacy PA
  • Claims processing: Through medical claims, not pharmacy claims

Understanding this distinction is crucial because submitting to the wrong benefit will result in automatic denials.

ICD-10 Mapping for ALS Documentation

Primary Diagnosis Code

ICD-10: G12.21 (Amyotrophic lateral sclerosis) is the required diagnosis code for all Qalsody-related claims and prior authorizations.

Documentation Requirements for G12.21

Your medical records must clearly demonstrate:

  • Upper motor neuron signs: Spastic gait, hyperreflexia, pathological reflexes
  • Lower motor neuron signs: Muscle atrophy, fasciculations, weakness
  • Electromyography (EMG) findings: Acute denervation and motor neuron loss
  • El Escorial criteria: Clinical evidence supporting ALS diagnosis
  • SOD1 mutation confirmation: Genetic testing results documenting specific mutation
Tip: Include the phrase "clinically definite ALS per El Escorial revised criteria" in your documentation to strengthen the diagnosis coding.

Product Coding: HCPCS, J-Code, and NDC

Essential Codes for Qalsody

Code Type Code Description Units
HCPCS J-Code J1304 Injection, tofersen, 1 mg Per mg
NDC 64406-0109-01 Qalsody 100 mg/15 mL solution Per vial
Administration 96450 Chemotherapy administration, intrathecal Per session
Spinal Procedure 62272 Spinal puncture, therapeutic If applicable

Units Calculation

  • Each Qalsody vial contains 100 mg
  • Bill 100 units of J1304 per vial administered
  • Standard dosing: 100 mg (1 vial) per intrathecal injection

Required Modifiers

For facilities participating in the 340B program, add:

  • TB modifier: Required starting January 1, 2025
  • JG modifier: May be required depending on your 340B status

Clean Request Anatomy

Prior Authorization Request Components

Patient Information Block:

  • Member ID and group number
  • ICD-10: G12.21
  • Prescribing neurologist NPI and credentials

Clinical Justification Section:

Diagnosis: Amyotrophic lateral sclerosis with confirmed SOD1 gene mutation
Genetic Testing: [Include specific mutation and lab report]
Baseline Assessments:
- ALSFRS-R Score: [Must be ≥24 with score ≥2 on each item]
- Slow Vital Capacity: [Must be ≥65%]
- Plasma NfL Level: [Baseline measurement required]
Treatment Plan: Intrathecal tofersen 100 mg every 28 days

Supporting Documentation:

  • Genetic testing confirming SOD1 mutation
  • Baseline NfL laboratory results
  • ALSFRS-R assessment
  • Pulmonary function tests
  • Neurologist consultation notes

Frequent Coding Pitfalls

Unit Conversion Errors

❌ Wrong: Billing 1 unit of J1304 for 100 mg dose ✅ Correct: Billing 100 units of J1304 for 100 mg dose

Missing Documentation

❌ Wrong: Submitting PA without genetic testing results ✅ Correct: Including comprehensive SOD1 mutation documentation

Incorrect Benefit Submission

❌ Wrong: Submitting to pharmacy benefit ✅ Correct: Submitting to medical benefit with proper J-code

Administration Code Omissions

❌ Wrong: Billing only the drug code J1304 ✅ Correct: Including both J1304 and administration code 96450

Verification with UnitedHealthcare Resources

Online Verification Tools

  1. UnitedHealthcare Provider Portal: Check real-time PA status and requirements
  2. OptumRx PreCheck MyScript: Verify coverage details and PA requirements
  3. Provider Services: Call 800-657-8205 for urgent clarifications

Coverage Confirmation Steps

Before submitting your request:

  • Verify member eligibility and active coverage
  • Confirm medical benefit covers intrathecal therapies
  • Check for any plan-specific SOD1-ALS coverage criteria
  • Review current PA requirements (may change quarterly)

Quick Audit Checklist

Before Submission:

  • ICD-10 G12.21 documented with supporting clinical findings
  • SOD1 genetic testing results attached
  • Baseline NfL measurement included
  • ALSFRS-R score ≥24 documented
  • Slow vital capacity ≥65% confirmed
  • J1304 units calculated correctly (100 units per vial)
  • NDC 64406-0109-01 specified
  • Administration code 96450 included
  • 340B modifiers added if applicable
  • Neurologist credentials verified

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
No SOD1 mutation documented Submit genetic testing results Laboratory report with specific mutation identified
Insufficient baseline assessments Provide comprehensive baseline data NfL levels, ALSFRS-R scores, pulmonary function
Non-neurologist prescriber Transfer prescription to neurologist Board-certified neurologist consultation
Missing medical necessity Submit detailed clinical justification Treatment history, disease progression, monitoring plan
Experimental/investigational Reference CMS December 2024 guidance CMS directive requiring MA coverage

New York Appeals Process

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial date Method: UnitedHealthcare Provider Portal or written submission Required: All supporting clinical documentation

New York External Review

If internal appeals fail, New York offers robust external review rights:

Filing Deadline: 4 months from final internal denial Filing Method: New York DFS External Appeal Portal Review Timeline:

  • Standard: 30 days
  • Expedited: 72 hours (24 hours for non-formulary drugs) Fee: $25 (waived for Medicaid/hardship)

Expedited Appeals for Urgent Cases

For patients requiring immediate treatment continuation:

  • Request expedited internal and external review simultaneously
  • Emphasize time-sensitive nature of ALS progression
  • Include physician statement on urgency
From our advocates: We've seen successful appeals where families combined strong genetic testing documentation with detailed progression notes showing rapid decline. The key was demonstrating that standard ALS therapies weren't sufficient for this specific SOD1 mutation subtype, making Qalsody medically necessary rather than experimental.

Cost Support Options

Manufacturer Support

  • Biogen Support Program: Patient assistance and copay support
  • Prior Authorization Support: Biogen provides PA assistance through specialty pharmacies

State and Federal Programs

  • New York Medicaid: Covers Qalsody with proper PA approval
  • Medicare Part B: Medical benefit coverage for intrathecal administration

Foundation Grants

  • ALS Association: Financial assistance programs
  • Patient Access Network Foundation: Copay assistance for qualifying patients

FAQ

How long does UnitedHealthcare PA take in New York? Standard PA decisions are typically issued within 15 business days. Expedited reviews for urgent cases can be completed within 72 hours.

What if Qalsody is non-formulary on my plan? Non-formulary status doesn't prevent coverage if medical necessity is established. Use the appeals process and reference the FDA approval and CMS guidance requiring coverage.

Can I request an expedited appeal? Yes, both internal and external appeals can be expedited in New York if delay would seriously jeopardize your health. Include physician documentation of urgency.

Does step therapy apply to Qalsody? Step therapy requirements vary by plan, but SOD1-specific ALS typically qualifies for exceptions since no other SOD1-targeted therapies exist.

What happens if I'm denied after external review? New York's external review decisions are binding on insurers. If denied, consider working with Counterforce Health to identify additional appeal strategies or coverage pathways.

How do I prove medical necessity for SOD1-ALS? Document the specific SOD1 mutation, demonstrate ALS progression despite standard therapies, and show baseline functional status meeting coverage criteria (ALSFRS-R ≥24, SVC ≥65%).

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance approvals for specialty medications like Qalsody. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that turn denials into approvals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For additional support navigating insurance approvals, consider consulting with Counterforce Health or other patient advocacy services.

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