By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (tofersen) Covered by Blue Cross Blue Shield in New York: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Qalsody (tofersen) Covered by Blue Cross Blue Shield in New York

Quick Path to Approval: Blue Cross Blue Shield in New York requires prior authorization for Qalsody with documented SOD1 mutation, ALS diagnosis by a neurologist, and ALSFRS-R/NfL baseline data. If denied, file internal appeal within 60 days, then external appeal through NY Department of Financial Services within 4 months. Start today: Verify your genetic testing results show pathogenic SOD1 mutation and request prior authorization through your BCBS provider portal or member services.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must get approval before treatment BCBS provider portal or member services BCBS NY PA Requirements
SOD1 Mutation Genetic test showing pathogenic SOD1 variant Laboratory report from certified genetic testing FDA Label Requirements
ALS Diagnosis ICD-10 G12.21 by neurologist Clinical notes and diagnostic workup Clinical Guidelines
ALSFRS-R Score Baseline functional assessment Neurologist's clinical documentation Biogen Resource Guide
Appeal Deadline 60 days for internal, 4 months for external Denial letter instructions NY DFS External Appeals

Step-by-Step: Fastest Path to Approval

1. Confirm SOD1 Mutation Status

Who: Patient with neurologist
Document needed: Genetic testing report showing pathogenic SOD1 mutation
Timeline: If not done, 2-4 weeks for results
Next step: Share results with treating neurologist

2. Gather Required Clinical Documentation

Who: Neurologist's office
Documents needed:

  • ALS diagnosis confirmation (ICD-10: G12.21)
  • Baseline ALSFRS-R functional rating
  • Neurofilament light chain (NfL) levels if available
  • Treatment history and contraindications to alternatives

3. Submit Prior Authorization Request

Who: Prescribing neurologist
How to submit: BCBS provider portal or fax
Expected timeline: 72 hours standard, 24 hours if urgent
What happens next: BCBS reviews and issues determination

4. If Denied: Immediate Internal Appeal

Who: Patient or authorized representative
Timeline: Within 60 days of denial notice
Documents to include: Medical necessity letter, genetic testing, clinical notes
How to submit: Follow instructions in denial letter

5. External Appeal Through New York State

Who: Patient after internal appeal denial
Timeline: Within 4 months of final adverse determination
Cost: $25 (waived for Medicaid, refunded if successful)
Submit via: NY DFS Portal

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"No documented SOD1 mutation" Submit certified genetic testing report Laboratory report with pathogenic variant confirmation
"Experimental/investigational" Reference FDA approval and CMS coverage directive FDA approval letter, CMS Medicare Advantage directive
"Not prescribed by specialist" Ensure neurologist is prescriber Neurologist's credentials and ALS experience documentation
"Missing baseline assessments" Complete ALSFRS-R and NfL testing Clinical notes with functional ratings and biomarker levels
"Concurrent therapy restrictions" Document medication reconciliation Current medication list and interaction analysis
From Our Advocates: We've seen BCBS denials overturned when families included the December 2024 CMS directive requiring Medicare Advantage plans to cover FDA-approved Qalsody for SOD1-ALS. This regulatory guidance strengthens appeals for all BCBS plans, not just Medicare. Always reference current regulatory support in your appeal letters.

Appeals Playbook for BCBS in New York

Internal Appeal Process

  • Timeline: Must file within 60 days of denial
  • Decision deadline: 30 days for standard, 72 hours for expedited
  • How to request expedited: Doctor must attest that delay would seriously jeopardize health
  • Required elements: Written appeal, medical records, prescriber statement

External Appeal Through NY DFS

  • Eligibility: After receiving final internal denial
  • Timeline to file: 4 months from final adverse determination
  • Decision timeline: 30 days standard, 72 hours expedited, 24 hours for urgent formulary exceptions
  • Cost: $25 fee (waived for Medicaid enrollees and financial hardship cases)
  • Binding outcome: Decision is final and binding on insurer

Getting Help with Appeals

Community Health Advocates: Free assistance at 888-614-5400, Monday-Friday 9am-4pm. They help New Yorkers navigate insurance denials and can assist with both internal and external appeals.

Medical Necessity Letter Template

When appealing a Qalsody denial, your neurologist should include these key elements:

Patient Information & Diagnosis

  • Confirmed ALS diagnosis (ICD-10: G12.21) with date of diagnosis
  • Genetic testing results showing pathogenic SOD1 mutation
  • Current ALSFRS-R functional rating score

Clinical Justification

  • Disease progression despite standard ALS therapies (riluzole, edaravone if tried)
  • Contraindications or failures with alternative treatments
  • Expected benefit based on clinical trial data showing slowed functional decline

Regulatory Support

  • FDA approval for SOD1-ALS (April 2023)
  • CMS directive requiring Medicare Advantage coverage (December 2024)
  • Published clinical guidelines supporting use

Monitoring Plan

  • Planned ALSFRS-R assessments every 3 months
  • NfL biomarker monitoring if available
  • Safety monitoring for intrathecal administration

Costs & Patient Assistance Options

List Price: Approximately $14,230-$14,754 per vial
Annual Cost: $200,000-$220,000 first year, $170,000-$180,000 ongoing

Patient Assistance Programs

  • Biogen Support Services: Coverage verification, prior authorization assistance, and appeals support
  • Copay Assistance: May be available for commercially insured patients (verify eligibility)
  • Foundation Grants: Patient Advocate Foundation, HealthWell Foundation for qualifying patients

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using FDA labeling, peer-reviewed studies, and payer-specific requirements—exactly what's needed for complex cases like Qalsody approvals.

When to Escalate Beyond BCBS

File a Complaint with New York Regulators

If BCBS isn't following proper procedures or timelines:

  • NY Department of Financial Services: File complaints about insurance practices
  • Required documentation: All correspondence, denial letters, appeal submissions, timeline violations

Consider consulting with a healthcare attorney if:

  • BCBS violates New York appeal timelines
  • External appeal is wrongfully denied
  • Pattern of improper denials affects multiple patients

FAQ: Qalsody Coverage in New York

How long does BCBS prior authorization take in New York?
Standard PA decisions within 72 hours, expedited within 24 hours if medical urgency is documented by your neurologist.

What if Qalsody isn't on my BCBS formulary?
Request a formulary exception with medical necessity documentation. BCBS must respond within 72 hours for standard requests, 24 hours for urgent cases.

Can I get expedited appeals for Qalsody?
Yes, if your neurologist documents that delay would seriously jeopardize your health. Expedited external appeals through NY DFS are decided within 72 hours.

Does step therapy apply if I haven't tried riluzole or edaravone?
BCBS may require trial of standard ALS therapies first, unless contraindicated. Document any adverse reactions or medical reasons why alternatives aren't appropriate.

What happens if my external appeal is denied?
NY DFS external appeal decisions are final and binding. At that point, consider legal consultation or exploring manufacturer assistance programs.

How much does it cost to appeal in New York?
Internal appeals with BCBS are free. External appeals through NY DFS cost $25, waived for Medicaid enrollees and financial hardship cases, and refunded if you win.

Can Community Health Advocates help with BCBS appeals?
Yes, Community Health Advocates at 888-614-5400 provides free assistance to all New Yorkers with insurance appeals, including specialty drug denials.

What if I'm switching from another insurance plan?
If you were previously approved for Qalsody under another plan, BCBS generally honors that authorization for 90 days to ensure care continuity, effective January 2026 for many plans.

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 plan for specific coverage decisions. Appeal rights and timelines may vary by individual plan. For personalized assistance with insurance appeals, contact Counterforce Health or Community Health Advocates at 888-614-5400.

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