By Counterforce Health Team in Zolgensma (onasemnogene abeparvovec) —

The Requirements Checklist to Get Zolgensma (onasemnogene abeparvovec) Covered by Aetna (CVS Health) in Michigan

Answer Box: Getting Zolgensma Covered by Aetna (CVS Health) in Michigan

Aetna requires prior authorization for Zolgensma (onasemnogene abeparvovec) via CVS Specialty Pharmacy. Key requirements: age under 24 months, bi-allelic SMN1 mutations, anti-AAV9 antibody titer ≤1:50, and treatment at a certified gene therapy center. Submit the Zolgensma Medication Precertification Request Form via Availity portal or fax to 888-267-3277. Standard decisions within 72 hours; expedited within 24 hours. If denied, file internal appeal within 180 days, then external review with Michigan DIFS within 127 days.

First step today: Order genetic testing (SMN1 mutations) and anti-AAV9 antibody titer from CLIA-certified lab.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet
  6. Submission Mechanics
  7. Specialty Pharmacy Routing
  8. After Submission: Tracking & Follow-up
  9. Denial-Prevention Tips
  10. Appeals Process for Michigan
  11. Printable One-Page Checklist

Who Should Use This Checklist

This guide helps families and clinicians navigate Aetna (CVS Health) prior authorization for Zolgensma in Michigan. You'll need this if:

  • Your child has spinal muscular atrophy (SMA) and you're considering gene therapy
  • You received a Zolgensma denial from Aetna and need to appeal
  • You're a clinician submitting prior authorization requests
  • You want to understand Michigan-specific appeal rights and timelines

Expected outcome: With proper documentation, most medically appropriate Zolgensma requests get approved. Michigan's external review process has helped overturn many initial denials when clinical criteria are met.

Member & Plan Basics

Verify Active Coverage

  • Confirm Aetna membership is active and includes prescription drug coverage
  • Check if CVS Caremark handles your pharmacy benefits
  • Verify in-network status of your treatment center

Plan Type Matters

Plan Type Prior Auth Required Special Notes
Commercial (employer) Yes Standard 72-hour decision
Aetna Better Health (Medicaid) Yes Follow Medicaid timelines
Medicare Advantage Yes CMS expedited rules apply

Deductible & Authorization Requirements

  • Zolgensma may apply to medical deductible (not pharmacy)
  • Prior authorization required regardless of deductible status
  • Site of care authorization also needed for infusion center

Clinical Criteria Requirements

FDA-Approved Indication

Zolgensma is approved for pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

Aetna's Core Requirements (All Must Be Met)

Age & Timing

  • Patient must be under 24 months at time of infusion
  • One-time treatment only (no repeat dosing)

Genetic Confirmation

  • Bi-allelic SMN1 gene mutations documented by CLIA-certified lab
  • SMN2 copy number may be requested for risk assessment

Clinical Status

  • Confirmed SMA diagnosis by pediatric neurologist
  • No invasive ventilatory support (tracheostomy)
  • Not requiring respiratory assistance ≥16 hours/day for ≥14 days

Laboratory Prerequisites

  • Anti-AAV9 neutralizing antibody titer ≤1:50 by ELISA
  • Baseline liver function tests within normal limits
  • Adequate platelet count and cardiac function (troponin I/T)

Safety Requirements

  • Up-to-date vaccinations prior to infusion
  • Discontinuation of concurrent SMA therapies (Spinraza, Evrysdi)
  • Treatment at Novartis-certified gene therapy center

Coding & Billing Information

Primary Codes

  • HCPCS J-code: J3399 (Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5x10¹⁵ vector genomes)
  • ICD-10 Diagnosis: G12.0 (Infantile spinal muscular atrophy), G12.1 (Other inherited spinal muscular atrophy)
  • CPT for Infusion: 96365 (initial, up to 1 hour), 96366 (each additional hour)

Units & Modifiers

  • One billable unit = one complete treatment
  • No specific modifiers required for standard administration
  • Verify NDC codes from manufacturer packaging

Documentation Packet

Provider Note Elements

Your pediatric neurologist's documentation should include:

  • Confirmed SMA diagnosis with phenotype/type
  • Genetic testing results showing bi-allelic SMN1 mutations
  • Current functional status and motor milestones
  • Prior therapy history (if any) and outcomes
  • Medical necessity for gene therapy over alternatives

Letter of Medical Necessity Components

Include these key elements in your LMN:

Patient Demographics

  • Name, DOB, Aetna member ID
  • Current age and weight
  • SMA type and symptom onset

Clinical Rationale

  • Why Zolgensma is appropriate for this patient
  • Urgency related to age cutoff (24 months)
  • Expected benefits vs. risks
  • Why alternatives are insufficient

Supporting Evidence

Required Attachments

  • Genetic testing report (bi-allelic SMN1 mutations)
  • Anti-AAV9 antibody titer results (≤1:50)
  • Baseline laboratory values (LFTs, platelets, troponin)
  • Vaccination records
  • Prior therapy documentation (if applicable)
  • Treatment center certification verification

Submission Mechanics

Correct Form Version

Use the current Zolgensma Medication Precertification Request Form. Verify you have the latest version from Aetna's website.

Submission Options

Primary Method: Aetna provider portal via Availity

  • Log in with your provider credentials
  • Navigate to prior authorization section
  • Upload completed form and attachments

Alternative Method: Fax submission

  • Fax to: 888-267-3277 (CVS Specialty)
  • Call 855-582-2025 to confirm receipt
  • Retain fax confirmation for records

Required Fields That Commonly Cause Rejections

  • Complete member information (ID, plan type, group number)
  • Prescriber NPI and specialty designation
  • Detailed diagnosis with ICD-10 codes
  • Specific treatment center name and NPI
  • All laboratory values with reference ranges
  • Clear statement of medical necessity

Specialty Pharmacy Routing

CVS Specialty Pharmacy

Aetna routes most Zolgensma cases through CVS Specialty:

  • Phone: 855-582-2025
  • Fax: 888-267-3277
  • Online portal access through CVS Caremark

Transfer Steps

  1. Prior authorization approval from Aetna
  2. Prescription sent to CVS Specialty
  3. Benefit verification and copay calculation
  4. Coordination with treatment center for delivery
  5. Cold-chain shipping arrangement

Shipment Verification

  • Confirm delivery date with treatment center
  • Verify proper temperature maintenance
  • Check product integrity before administration

After Submission: Tracking & Follow-up

Confirmation Numbers

  • Record your submission confirmation number
  • Note the date and time of submission
  • Keep copies of all submitted documents

Status Check Schedule

  • Day 1-2: Confirm receipt via phone or portal
  • Day 3: Check for any requests for additional information
  • Day 5: Follow up if no decision received (standard 72-hour timeline)

What to Record

  • All communication dates and reference numbers
  • Names of representatives you speak with
  • Any additional documentation requests
  • Decision dates and outcomes
From Our Advocates: "We've seen cases where families thought their submission was complete, but missing vaccination records caused a 2-week delay. Always double-check that every required document is included before submitting, especially when you're approaching the 24-month age cutoff."

Denial-Prevention Tips

Five Common Pitfalls and How to Avoid Them

  1. Incomplete Genetic Testing
    • Problem: Lab report doesn't specify bi-allelic mutations
    • Solution: Request comprehensive SMN1 analysis from CLIA-certified lab
  2. High Anti-AAV9 Titer
    • Problem: Antibody level above 1:50 threshold
    • Solution: Retest after interval; consider clinical exception with strong rationale
  3. Age Documentation Issues
    • Problem: Unclear if patient will be under 24 months at infusion
    • Solution: Provide clear timeline with birth certificate and planned infusion date
  4. Site of Care Problems
    • Problem: Chosen center not certified or in-network
    • Solution: Verify both Novartis certification and Aetna network status before submission
  5. Concurrent Therapy Confusion
    • Problem: Patient still receiving Spinraza or Evrysdi
    • Solution: Document clear discontinuation plan before Zolgensma administration

Appeals Process for Michigan

Internal Appeal with Aetna

Timeline: File within 180 days of denial notice Decision: 30 days standard, 72 hours for urgent cases How to Submit:

  • Online through Aetna member portal
  • Mail to address on denial letter
  • Include denial letter, new documentation, updated medical necessity letter

External Review with Michigan DIFS

Timeline: File within 127 days of final internal denial Decision: Up to 60 days (72 hours for expedited) How to Submit:

Expedited Review: Available when delay would seriously jeopardize patient's health. Requires physician letter stating urgency.

Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted, evidence-backed submissions that address each payer's specific criteria. Their platform helps families and clinicians navigate complex prior authorization requirements and appeal processes for specialty medications like Zolgensma.

Printable One-Page Checklist

Before You Start

  • Confirm Aetna membership and CVS Specialty coverage
  • Verify patient age (must be <24 months at infusion)
  • Identify certified gene therapy center in Aetna network

Required Testing

  • SMN1 genetic testing showing bi-allelic mutations
  • Anti-AAV9 antibody titer ≤1:50 by ELISA
  • Baseline labs: LFTs, platelets, troponin I/T
  • Current vaccination records

Documentation

  • Complete Zolgensma Precertification Request Form
  • Medical necessity letter from pediatric neurologist
  • All laboratory reports with reference ranges
  • Prior therapy records (if applicable)
  • Treatment center verification

Submission

  • Submit via Availity portal or fax to 888-267-3277
  • Call 855-582-2025 to confirm receipt
  • Record confirmation number and submission date
  • Set calendar reminder for 72-hour follow-up

If Denied

  • File internal appeal within 180 days
  • Gather additional supporting documentation
  • Consider peer-to-peer review request
  • Prepare for external review with Michigan DIFS if needed

FAQ

Q: How long does Aetna prior authorization take for Zolgensma in Michigan? A: Standard decisions within 72 hours; expedited/urgent cases within 24 hours per Michigan requirements.

Q: What if Zolgensma is not on Aetna's formulary? A: Submit a formulary exception request with the prior authorization, emphasizing FDA approval and medical necessity.

Q: Can I request an expedited appeal in Michigan? A: Yes, both Aetna internal appeals and Michigan DIFS external reviews offer expedited options when delay would harm the patient.

Q: Does step therapy apply if my child tried Spinraza outside Michigan? A: Prior therapy records from any state are acceptable. Document the treatment history and outcomes clearly.

Q: What happens if my child turns 24 months during the appeal process? A: Age at infusion matters, not age at appeal. However, expedited processing becomes critical to meet FDA labeling requirements.

Q: Who pays for the required genetic testing? A: Most Aetna plans cover medically necessary genetic testing with appropriate prior authorization through eviCore.

For additional support with complex prior authorizations and appeals, Counterforce Health offers specialized assistance in creating evidence-based submissions that align with payer-specific requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance company for specific guidance. For official Michigan insurance appeals information, visit the Michigan Department of Insurance and Financial Services.

Sources & Further Reading

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