ALS Treatment Insurance Denied? How to Appeal

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with no cure, and the treatments that slow progression or manage symptoms are frequently denied by insurers as experimental, not medically necessary, or subject to excessive Prior Authorization Denied: How to Appeal" class="auto-link">prior authorization requirements. When you or a loved one is facing ALS (ICD-10 code G12.21), fighting an insurance denial is an urgent matter. Under the ACA Essential Health Benefits framework, FDA-approved ALS medications, respiratory support, and rehabilitation therapy are covered services. Under ERISA for employer plans, you have the right to appeal, access the complete claims file, and pursue federal court review. This guide covers the most common ALS denial reasons, your legal rights, and the step-by-step process to appeal.

Why Insurers Deny ALS Treatment Claims

ALS claims face specific denial patterns across treatment categories:

• Riluzole (Rilutek/generic) denials — Despite being the oldest FDA-approved ALS treatment, insurers sometimes deny riluzole on formulary grounds, requiring generic substitution when the patient has demonstrated intolerance, or through incorrect tier placement
• Edaravone (Radicava) or Relyvrio denials — These expensive ALS medications ($145,000–$158,000 per year) are frequently denied as "not medically necessary," requiring documentation of the clinical decision-making for each patient
• Tofersen (Qalsody) for SOD1-ALS — An RNA-targeted therapy approved in 2023 for SOD1 gene mutation-related ALS, commonly denied pending genetic testing results or on "experimental" grounds despite FDA approval
• Non-invasive ventilation (NIV/BiPAP) denied — Respiratory support is denied as "not medically necessary" when pulmonary function thresholds are not yet fully documented
• Feeding tube (PEG) placement denied — Percutaneous endoscopic gastrostomy is denied as "elective" or timing-related
• Multidisciplinary ALS clinic visits denied — Some insurers deny these visits as not separately billable
• Physical, occupational, and speech therapy denied — Denied as "maintenance care" during ALS plateau periods, incorrectly characterizing ongoing therapy as custodial

How to Appeal an ALS Treatment Denial

Step 1: Understand the Denial Type and Request the Full Claims File

Read the denial letter carefully to identify whether the denial is based on medical necessity, formulary or tier placement, "experimental" classification despite FDA approval, documentation insufficiency, or prior authorization gap. Request the complete claims file and the insurer's clinical policy bulletin for ALS treatment. Knowing their exact criteria allows you to directly contradict each point of their denial with targeted evidence.

Step 2: Document ALS Diagnosis and Functional Status Comprehensively

Your neurologist should provide comprehensive documentation including the confirmed ALS diagnosis with ICD-10 code G12.21, current ALSFRS-R (ALS Functional Rating Scale – Revised) score documenting functional impairment level, rate of functional decline over recent months, pulmonary function test results (FVC%) if respiratory support is at issue, and SOD1 gene test results for tofersen cases. These objective measures directly satisfy prior authorization requirements.

Step 3: Obtain an ALS Specialist Medical Necessity Letter Citing AAN Guidelines

Request a detailed letter from your ALS specialist — ideally a neurologist at an ALS multidisciplinary clinic — that states the ALS diagnosis, type, and current progression stage, explains the specific treatment requested and its clinical rationale, references the American Academy of Neurology (AAN) ALS Practice Parameter and ALS Association treatment guidance, addresses the insurer's specific denial grounds, and explains why alternative or delayed treatment is clinically harmful given ALS progression rate.

Step 4: Cite FDA Approvals and Challenge "Experimental" Classifications

For any FDA-approved medication (riluzole, edaravone, Relyvrio, tofersen), an insurer cannot categorize it as "experimental" — cite the FDA approval date and specific indication directly. Under ACA provisions and ERISA standards, medical necessity must be assessed against recognized clinical standards, not arbitrary internal criteria. If the denial uses "experimental" language for an FDA-approved drug, it is an error of fact that substantially strengthens your appeal.

Step 5: Address DME and Equipment Denials with Functional Documentation

For durable medical equipment denials (power wheelchair, AAC communication device, home ventilator), provide a detailed physician order explaining the functional need, occupational therapy or speech therapy assessment documenting capabilities and limitations, CMS DME coverage criteria (which commercial insurers routinely follow), and for power wheelchairs, documentation that the patient cannot self-propel a manual chair.

Step 6: File the Internal Appeal and Request Expedited Review if Urgent

Submit your complete appeal package to the insurer's appeals department within the deadline (typically 180 days for commercial plans). For urgent ALS cases — where delayed treatment would cause irreversible harm — request an expedited appeal, which must be decided within 72 hours. If the internal appeal is denied, immediately request External Independent Review: Complete Guide" class="auto-link">external review by an IRO — this is free under the ACA and binding on the insurer.

What to Include in Your ALS Appeal

• Written denial letter with specific reason code, policy provision, and clinical criteria used, plus ALS diagnosis documentation including EMG and nerve conduction studies
• Neurologist or ALS specialist letter confirming diagnosis (ICD-10: G12.21), ALSFRS-R score, and medical necessity with AAN guideline citations
• Pulmonary function tests (FVC%) for respiratory support denials, SOD1 genetic testing results for tofersen cases, and DME prescriptions with detailed clinical justification
• Clinical guidelines supporting the treatment from AAN and ALS Association, FDA approval documentation for any medication being denied as experimental
• Prior authorization records and correspondence history with the insurer

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Related Reading

• How to Write an Insurance Appeal Letter
• What Is Medical Necessity?
• Internal vs External Insurance Appeal