By Counterforce Health Team in Qalsody (tofersen) —

How to Get Qalsody (tofersen) Covered by Humana in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Qalsody (tofersen) Covered by Humana in Virginia

Yes, Humana covers Qalsody for SOD1-ALS patients in Virginia under Medicare Part B. Following CMS's December 2024 directive, Medicare Advantage plans must cover Qalsody when medically necessary. Your fastest path to approval: Have your neurologist submit prior authorization with confirmed SOD1 mutation testing, ALS diagnosis documentation, and medical necessity letter through Humana's provider portal. Start today: Contact your ALS specialist to order SOD1 genetic testing if not already done, as this is required for coverage.

Table of Contents

  1. Coverage Basics: Is Qalsody Covered by Humana?
  2. Prior Authorization Process: Who Submits and How
  3. Timing: How Long Does Approval Take?
  4. Medical Necessity Criteria: What Documentation is Required
  5. Costs: Understanding Your Out-of-Pocket Expenses
  6. Denials and Appeals: Your Rights in Virginia
  7. Specialty Pharmacy and Administration
  8. Troubleshooting Common Issues
  9. Frequently Asked Questions

Coverage Basics: Is Qalsody Covered by Humana?

Qalsody (tofersen) is covered by Humana Medicare Advantage plans in Virginia under Medicare Part B, not Part D, because it's administered via intrathecal injection. This is crucial—Qalsody won't appear on pharmacy formularies since it's a medical benefit.

Coverage at a Glance

Requirement What It Means Source
Prior Authorization Required for all Humana Medicare plans Humana PA Lists
SOD1 Mutation Documented positive test required FDA Qalsody Label
Neurologist Prescription Must be prescribed by neurologist Humana Clinical Guidelines
ALS Diagnosis Confirmed via El Escorial or Awaji criteria ALS Association Guidelines
Part B Coverage Medical benefit, not pharmacy CMS HPMS Memo
Important Update: In December 2024, CMS directed all Medicare Advantage plans to stop blanket denials of Qalsody as "experimental." If you were previously denied on these grounds, contact Humana for retroactive coverage consideration.

Prior Authorization Process: Who Submits and How

Step-by-Step: Fastest Path to Approval

  1. Order SOD1 Genetic Testing (Patient + Neurologist)
    • Who: Your neurologist orders the test
    • What: ALS gene panel including SOD1, C9orf72, FUS, TARDBP
    • Timeline: 21-28 days for results
    • Cost: Usually covered by insurance with proper diagnosis codes
  2. Gather Required Documentation (Clinic Staff)
    • SOD1 mutation test results (positive)
    • ALS diagnosis confirmation (El Escorial/Awaji criteria)
    • ALSFRS-R baseline scores
    • Prior treatment history (riluzole, edaravone if applicable)
  3. Submit Prior Authorization (Neurologist's Office)
    • Where: Humana Provider Portal
    • Timeline: Submit 5-7 business days before planned start
    • Decision: 72 hours for standard requests, within 24 hours for expedited
  4. Schedule Administration (After Approval)
    • Coordinate with approved infusion center
    • Verify Part B benefits and copay responsibilities
    • Plan for loading doses (3 doses, 14 days apart)

Required Documentation Checklist

For the Neurologist's Medical Necessity Letter:

  • Confirmed ALS diagnosis with supporting EMG/nerve conduction studies
  • Documented SOD1 mutation (specific variant and laboratory)
  • Current ALSFRS-R score and functional status
  • Prior treatments attempted (riluzole, edaravone) and responses
  • Treatment goals and monitoring plan
  • Contraindications to alternative therapies

Timing: How Long Does Approval Take?

Standard Timeline

  • Prior Authorization Decision: 72 hours from complete submission
  • Expedited Requests: 24 hours when medical urgency documented
  • Appeals (if denied): 30 days for standard, 72 hours for expedited

When to Request Expedited Review

Contact Humana immediately for expedited processing if:

  • Patient shows rapid functional decline (ALSFRS-R dropping >1 point/month)
  • Risk of respiratory compromise
  • Delay would compromise safety or treatment effectiveness

Script for Expedited Request: "This is a request for expedited prior authorization review for Qalsody (tofersen) due to rapid ALS progression. Delay in treatment initiation poses serious risk to the patient's neurological function and safety."

Medical Necessity Criteria: What Documentation is Required

SOD1 Testing Requirements

Humana follows eviCore guidelines requiring comprehensive ALS gene panel testing. Key requirements:

  • Specimen: 8 mL whole blood in EDTA tube with two patient identifiers
  • Testing Method: NGS/PCR/Sanger sequencing (CPT code 81404)
  • Required Genes: Minimum panel must include SOD1, C9orf72, FUS, TARDBP
  • Physician Attestation: Informed consent documentation in certain states
  • Stability: Ambient <24 hours preferred, refrigerated <24 hours acceptable

Clinical Documentation Standards

Diagnosis Requirements:

  • Definite or probable ALS per revised El Escorial criteria
  • Supporting electrodiagnostic studies (EMG/NCS)
  • Exclusion of ALS mimics
  • ICD-10 code G12.21 (Motor neuron disease)

Functional Assessment:

  • Baseline ALSFRS-R score documented
  • Respiratory function tests if indicated
  • Nutritional status assessment
  • Mobility and independence measures

Costs: Understanding Your Out-of-Pocket Expenses

Medicare Part B Coverage

  • Standard Copay: 20% of Medicare-approved amount after Part B deductible
  • Annual Cost: Approximately $200,000-$220,000 in year one (15 doses)
  • Ongoing: ~$170,000-$180,000 annually thereafter (12 maintenance doses)

Financial Assistance Options

Note: Actual costs vary by specific Humana plan. Verify your exact copay and deductible with Humana member services at 1-800-HUMANA (1-800-486-2621).

Denials and Appeals: Your Rights in Virginia

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
No SOD1 mutation documented Submit genetic test results Laboratory report with positive SOD1 variant
Non-neurologist prescriber Transfer care to neurologist New prescription from board-certified neurologist
Lack of baseline assessments Complete required testing ALSFRS-R scores, EMG studies, respiratory function
"Experimental" designation Cite CMS directive Reference December 2024 CMS memo

Virginia Appeals Process

Internal Appeals with Humana:

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for standard, 72 hours for expedited
  • How to File: Submit via Humana member portal or mail to address on denial letter

External Review in Virginia: After exhausting Humana's internal appeals, you can request external review through the Virginia State Corporation Commission Bureau of Insurance.

Key Steps:

  1. File within 120 days of Humana's final denial
  2. Complete Form 216-A (External Review Request)
  3. Submit to: Virginia SCC Bureau of Insurance (verify address at scc.virginia.gov)
  4. Timeline: 45 days for standard review, 72 hours for expedited
  5. Cost: Free to consumers
Virginia Advantage: The state's external review process has a strong track record for specialty drug appeals when proper medical documentation is provided.

Counterforce Health: Expert Appeals Support

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Qalsody. Their platform analyzes denial letters, identifies the specific denial basis, and drafts evidence-backed appeals that address payer requirements point-by-point. For patients facing Humana denials in Virginia, Counterforce Health can help navigate both the internal appeals process and prepare documentation for external review with the Virginia Bureau of Insurance.

Specialty Pharmacy and Administration

Administration Requirements

  • Setting: Hospital outpatient or specialty clinic with intrathecal capabilities
  • Frequency: 3 loading doses (14 days apart), then monthly maintenance
  • Monitoring: Baseline and periodic cerebrospinal fluid (CSF) assessments
  • Staff: Trained in intrathecal administration techniques

Approved Administration Sites

Verify your chosen facility is in-network with Humana and has experience with intrathecal biologics. The facility should coordinate prior authorization for the administration procedure separately from the drug authorization.

Troubleshooting Common Issues

Portal and Submission Problems

  • Provider Portal Down: Call Humana provider services at 1-800-HUMANA for alternative submission methods
  • Missing Forms: Download current PA forms from provider.humana.com
  • Incomplete Submissions: Humana will notify of missing information within 24-48 hours

Communication Issues

Patient Phone Script for Humana: "I'm calling about prior authorization status for Qalsody (tofersen) for SOD1-ALS. My member ID is [X]. Can you confirm if the request was received and provide the expected decision timeline? If denied, I'd like to understand the specific reason and appeal options."

Clinic Staff Script for Peer-to-Peer: "I'm requesting a peer-to-peer review for a Qalsody (tofersen) prior authorization denial. The prescribing physician needs to discuss the medical necessity with your medical director. The patient has confirmed SOD1-ALS and meets all FDA criteria."

Frequently Asked Questions

Q: How long does Humana prior authorization take for Qalsody in Virginia? A: Standard decisions within 72 hours of complete submission. Expedited requests are decided within 24 hours when medical urgency is documented.

Q: What if Qalsody is non-formulary on my Humana plan? A: Qalsody is covered under Part B medical benefits, not pharmacy formularies. Coverage follows medical necessity criteria rather than formulary placement.

Q: Can I request an expedited appeal if my initial PA is denied? A: Yes, if your physician certifies that delay could seriously jeopardize your health or ability to regain function. Submit expedited appeal requests with supporting clinical documentation.

Q: Does step therapy apply to Qalsody for SOD1-ALS? A: Typically no, as Qalsody is the only FDA-approved SOD1-targeted therapy. However, documentation of riluzole or edaravone trials may be required as background therapy.

Q: What happens if I move out of Virginia during treatment? A: Your Humana coverage continues, but appeal rights may change based on your new state's regulations. Contact Humana to confirm coverage continuity.

Q: Can family members help with the appeals process? A: Yes, with proper authorization. Complete Humana's authorized representative form to allow family members to speak on your behalf.

This guide provides educational information about insurance coverage and is not medical advice. Coverage decisions depend on individual circumstances and plan specifics. For personalized guidance, consult your healthcare provider and contact Humana directly.

Virginia Resources:

Sources & Further Reading:

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