By Counterforce Health Team in Upstaza (eladocagene exuparvovec) —

How to Get Upstaza (Eladocagene Exuparvovec) Covered by Humana in California: Complete Coding and Appeals Guide

Answer Box: Getting Upstaza Covered by Humana in California

Upstaza (eladocagene exuparvovec) is covered under Medicare Part B as a physician-administered gene therapy. For Humana Medicare Advantage in California, you'll need prior authorization with genetic confirmation of AADC deficiency, treatment at a certified neurosurgical center, and comprehensive clinical documentation. First step today: Have your neurologist submit a prior authorization request through Humana's provider portal with genetic test results and enzyme activity levels. If denied, California's Independent Medical Review (IMR) has high success rates for rare disease appeals through the DMHC Help Center.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for AADC Deficiency
  3. Product Coding: NDC and HCPCS Details
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Verification with Humana
  7. Appeals Process in California
  8. Quick Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit

Upstaza follows the medical benefit pathway under Medicare Part B, not Part D pharmacy coverage. This gene therapy requires direct intracerebral administration by neurosurgeons, making it a physician-administered drug rather than a dispensed medication.

Key Distinction:

  • Part B (Medical): Physician-administered drugs in clinical settings
  • Part D (Pharmacy): Self-administered drugs dispensed through pharmacies

For Humana Medicare Advantage plans, Part B drugs require prior authorization and may be subject to step therapy requirements as of January 2020.

Note: Humana has committed to responding to prior authorization requests within one business day for 95% of complete electronic submissions by January 2026.

ICD-10 Mapping for AADC Deficiency

While specific ICD-10 codes for AADC deficiency weren't available in current coding resources, documentation should establish the genetic and biochemical diagnosis clearly. Your medical records must include:

Required Diagnostic Elements:

  • Genetic testing showing pathogenic DDC gene variants (homozygous or compound heterozygous)
  • At least two positive results from core diagnostic tests:
    • CSF neurotransmitter metabolite panel
    • Plasma AADC enzyme activity assay
    • Confirmatory genetic testing

Supporting Documentation Keywords:

  • "Aromatic L-amino acid decarboxylase deficiency"
  • "DDC gene pathogenic variants"
  • "Severe phenotype with motor milestone delays"
  • "Failed standard medical therapy"

Consensus guidelines require genetic testing alongside biochemical confirmation for definitive diagnosis.

Product Coding: NDC and HCPCS Details

Upstaza Product Information:

  • NDC Number: 52856-601-01
  • Concentration: 5.6 × 10¹¹ vector genomes per mL
  • Dose: Single-dose vial containing 2.8 × 10¹¹ vg in 0.5 mL
  • Administration: Four separate infusions totaling 1.8-2.4 × 10¹¹ vg

Billing Considerations:

  • Gene therapy drug cost (NDC 52856-601-01)
  • Professional charges for stereotactic neurosurgery
  • Facility charges for operative suite and monitoring
Important: A Medicare National Coverage Decision exists for this therapy. Contact your Medicare Administrative Contractor for current HCPCS J-codes, as these weren't specified in available resources.

Clean Prior Authorization Request

Essential Components for Humana Submission:

  1. Patient Demographics
    • Humana member ID
    • Date of birth
    • Treating physician information
  2. Clinical Documentation
    • Genetic test results (DDC gene variants)
    • Enzyme activity levels
    • CSF neurotransmitter metabolite results
    • Treatment history and failures
  3. Facility Verification
    • Certified neurosurgical center credentials
    • Surgeon qualifications for stereotactic procedures
  4. Medical Necessity Statement
    • Severe phenotype documentation
    • Lack of gross motor milestone achievement
    • Persistent symptoms despite standard therapy

Submit through Humana's provider portal or call 866-461-7273.

Common Coding Pitfalls

Avoid These Documentation Errors:

Pitfall Impact Solution
Incomplete genetic testing Automatic denial Include both pathogenic variants
Missing enzyme activity Insufficient diagnosis Submit plasma AADC assay results
Uncertified facility Coverage exclusion Verify center specializes in stereotactic neurosurgery
Inadequate prior therapy documentation Medical necessity failure Detail all failed treatments with dates

Unit Conversion Issues:

  • Ensure vector genome counts match product specifications
  • Verify single-dose vial coding (not per-infusion billing)
  • Include all four infusion procedures in surgical planning

Verification with Humana

Pre-Submission Checklist:

  1. Confirm Upstaza requires PA using Humana's search tool
  2. Verify treating facility is in-network
  3. Check current formulary status
  4. Review Medicare Advantage prior authorization lists

Contact Resources:

  • Provider services: Use Humana provider portal
  • Member services: 866-461-7273
  • Prior authorization status: Online tracking available

Appeals Process in California

California offers robust appeal rights through dual regulatory oversight. Most Humana Medicare Advantage plans fall under DMHC jurisdiction.

Internal Appeal (First Level):

  • Timeline: 30 days for standard grievance
  • Expedited: Available for urgent medical needs
  • Submit: Through Humana member portal or written request

Independent Medical Review (External Appeal):

  • Who: DMHC assigns independent physician experts
  • Timeline: 45 days standard, 7 days expedited
  • Cost: Free to members
  • Success Rate: High for rare disease treatments
  • Contact: DMHC Help Center at 888-466-2219
From our advocates: "Families pursuing gene therapy appeals in California often succeed when they include comprehensive genetic testing results and document the specialized center's qualifications. The state's Independent Medical Review process is particularly effective for rare disease cases where standard treatments have failed."

Required Appeal Documentation:

  • Original denial letter
  • Complete medical records
  • Genetic test results
  • Treatment center credentials
  • Medical necessity letter from neurologist

Quick Audit Checklist

Pre-Submission Review:

  • Genetic testing confirms DDC pathogenic variants
  • Enzyme activity and CSF metabolite results included
  • Treatment center certified for stereotactic neurosurgery
  • Prior therapy failures documented with dates
  • NDC 52856-601-01 correctly specified
  • Vector genome dosing matches product specifications
  • Medical necessity letter addresses severe phenotype
  • All required Humana PA forms completed
  • Supporting clinical notes attached

Post-Denial Actions:

  • Review denial reason against submission
  • Gather any missing documentation
  • File internal appeal within 30 days
  • Prepare for potential IMR if needed
  • Contact DMHC Help Center for guidance

When navigating complex gene therapy approvals, specialized support can make a significant difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Frequently Asked Questions

How long does Humana prior authorization take for gene therapy? Humana currently responds within one business day for 85% of requests, with a commitment to 95% same-day response for complete electronic submissions by January 2026.

What if Upstaza is considered experimental by Humana? California's IMR process specifically covers disputes over experimental/investigational determinations. Independent medical experts review the scientific evidence for FDA-approved therapies.

Can I request expedited review for urgent cases? Yes, both Humana internal appeals and California's IMR offer expedited timelines (typically 72 hours to 7 days) when delays could seriously jeopardize health.

What documentation proves medical necessity? Genetic confirmation of AADC deficiency, failed standard treatments, lack of motor milestones, and treatment at a certified neurosurgical center are key elements.

Does step therapy apply to gene therapies? Humana's Part B step therapy requirements may apply, but genetic diseases often qualify for exceptions when no alternative treatments exist for the specific condition.

How do I find certified treatment centers in California? Contact PTC Therapeutics directly or verify with Humana that your chosen neurosurgical center specializes in stereotactic procedures and is in-network.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan directly. For additional help with California insurance appeals, contact the DMHC Help Center at 888-466-2219.

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