By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (Cerliponase Alfa) Covered by UnitedHealthcare in California: Appeals Guide with Forms and Timelines

Answer Box: Getting Brineura Covered by UnitedHealthcare in California

UnitedHealthcare requires prior authorization for Brineura (cerliponase alfa) with strict CLN2 disease criteria. If denied, California residents can file an Independent Medical Review (IMR) through the DMHC with a 55-70% overturn rate for specialty drugs. First step today: Gather CLN2 diagnosis documentation, Hamburg rating scale scores, and contact your neurologist to submit PA via the UHC Provider Portal.

Fast track: 1) Submit PA with CLN2 confirmation, 2) If denied, file internal appeal within 180 days, 3) Request IMR through dmhc.ca.gov (free, binding decision).

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all UHC plans UHC Provider Portal UHC PA Requirements
CLN2 Diagnosis Confirmed TPP1 deficiency by neurologist Medical records, genetic testing UHC Medical Policy
Age Requirement ≥3 years old Patient chart FDA Label
Hamburg Scale Score 3-6 combined motor/language, ≥1 each domain Neurologist assessment UHC Medical Policy
Specialty Pharmacy Optum Specialty, Accredo, or Amber only UHC drug chart UHC Specialty Network
Formulary Tier Tier 4-5 (20-40% coinsurance) Plan formulary UHC Formulary

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Documentation (Patient + Neurologist)

  • What you need: CLN2 genetic testing results, Hamburg CLN2 rating scale assessment
  • Timeline: Gather within 1-2 weeks
  • Submit to: Your CLN2 specialist neurologist

2. Submit Prior Authorization (Neurologist)

  • How: UHC Provider Portal at uhcprovider.com or call 800-445-1638
  • Required documents: CLN2 diagnosis (ICD-10 E75.4), genetic confirmation, Hamburg scores, treatment plan
  • Timeline: UHC has 5-14 days to respond
  • Source: UHC Provider Portal

3. If Approved: Coordinate Specialty Pharmacy (Patient + Clinic)

  • Contact: Optum Specialty Pharmacy or approved network provider
  • Process: Pharmacy obtains PA, processes insurance, coordinates delivery to infusion site
  • Timeline: 7-10 days for first delivery

4. If Denied: File Internal Appeal (Patient or Provider)

  • Deadline: 180 days from denial notice
  • How: UHC member portal, mail, or fax (verify current contact)
  • Include: Point-by-point response to denial reasons, additional clinical evidence
  • Timeline: 30 days for standard, 72 hours for expedited

5. Request California IMR (Patient)

  • When: After internal appeal denial or 30-day delay
  • How: Online at dmhc.ca.gov or call 888-466-2219
  • Cost: Free
  • Timeline: 45 days standard, 7 days expedited
  • Success rate: 55-70% overturn rate for specialty drugs
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and drafts point-by-point rebuttals aligned to your plan's specific policies, which can significantly improve your chances of approval.

Understanding Your Benefits and Costs

Specialty Tier Placement

Brineura's $702,000 annual list price places it in UHC's highest specialty tiers (Tier 4-5), meaning you'll pay coinsurance (20-40% of drug cost) rather than a flat copay.

Cost protection: UHC caps specialty drug costs at $2,000 annually (2024). After reaching this cap, additional specialty medications are covered at no cost for the remainder of the year.

Medical vs. Pharmacy Benefit

Brineura is typically covered under the medical benefit since it's an infusion therapy. This means:

  • Billed through your medical coverage, not pharmacy
  • Subject to medical deductible and out-of-pocket maximums
  • Administration costs covered separately from drug costs

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Evidence
"Not medically necessary" Submit peer-reviewed studies showing Brineura slows CLN2 progression NEJM CLN2 studies, FDA label
"Age criteria not met" Provide birth certificate, medical records confirming ≥3 years Patient chart with birthdate
"Inadequate diagnosis documentation" Submit genetic testing, TPP1 enzyme assay results Lab reports from certified facility
"Hamburg scale scores missing" Neurologist assessment with documented 3-6 combined score CLN2 specialist evaluation
"Out-of-network provider" Transfer care to in-network CLN2 center or request exception UHC provider directory

Appeals Process in California

Internal Appeals with UnitedHealthcare

Standard Appeal:

  • Deadline: 180 days from denial
  • Timeline: 30 days for UHC decision
  • Submit via: Member portal, mail, or fax (confirm current contact)

Expedited Appeal (if delay could seriously jeopardize health):

  • Timeline: 72 hours for UHC decision
  • Criteria: Progressive neurologic condition qualifies

California Independent Medical Review (IMR)

California's IMR system provides binding external review through the Department of Managed Health Care (DMHC).

Eligibility: Available after internal appeal denial for medical necessity disputes

Process:

  1. File online at dmhc.ca.gov or call 888-466-2219
  2. DMHC assigns independent medical experts in CLN2/rare diseases
  3. Expert reviews all medical records and plan policies
  4. Decision is binding on UnitedHealthcare

Success rates: DMHC data shows 55-70% overturn rates for specialty drug denials, with particularly high success for rare disease medications like Brineura.

Note: California recently fined UnitedHealthcare $475,000 for delaying care and payments, indicating increased regulatory scrutiny on denial practices.

Cost Assistance and Savings Options

BioMarin Co-Pay Assistance Program

Eligibility:

  • Commercially insured patients only (not Medicare/Medicaid)
  • U.S. residents (including Puerto Rico)
  • Prescribed for on-label CLN2 use

Coverage: Covers copays, coinsurance, and deductibles for both drug and administration costs

Enrollment: Call 1-866-906-6100 or visit BioMarin RareConnections

State restrictions: Massachusetts and Rhode Island residents eligible for drug costs only, not administration. Michigan, Minnesota, and Rhode Island residents ineligible for lab services.

Additional Resources

Patient advocacy organizations: The Batten Disease Support and Research Association provides guidance and support for families navigating insurance coverage.

Legal assistance: California's Health Consumer Alliance offers free help with complex insurance appeals.

When working with insurance appeals, Counterforce Health helps patients and clinicians turn denials into targeted appeals by analyzing your specific plan's policies and crafting evidence-backed responses that address each denial reason point-by-point.

Specialty Pharmacy Requirements

UnitedHealthcare requires Brineura to be sourced through approved specialty pharmacies:

Approved Network:

  • Optum Specialty Pharmacy (primary)
  • Accredo Specialty Pharmacy
  • Amber Specialty Pharmacy

Important: Using out-of-network pharmacies typically results in coverage denial. The specialty pharmacy handles prior authorization, insurance processing, and coordinates delivery to your infusion site.

Process:

  1. Neurologist sends prescription to approved specialty pharmacy
  2. Pharmacy obtains PA and processes insurance
  3. Pharmacy coordinates with infusion center for delivery and administration

When to Escalate to State Regulators

File a DMHC Complaint

Contact the DMHC Help Center if:

  • UHC isn't following appeal timelines
  • You need assistance filing an IMR
  • There are procedural violations

Contact: 888-466-2219 or dmhc.ca.gov

California Department of Insurance

For plans regulated by CDI (some PPO plans), contact the Consumer Hotline at 800-927-4357 for external review guidance.

FAQ: Most Common Questions

Q: How long does UnitedHealthcare prior authorization take? A: Standard PA decisions are made within 5-14 business days. Expedited requests (for urgent medical needs) are decided within 72 hours.

Q: What if Brineura isn't on my formulary? A: UHC typically places Brineura on specialty tiers. If truly non-formulary, request a formulary exception with medical necessity documentation from your neurologist.

Q: Can I get expedited appeals for CLN2 disease? A: Yes. CLN2 is a progressive neurologic condition, so delays in treatment can qualify for expedited review (72-hour decisions).

Q: What happens if my internal appeal is denied? A: You can immediately file for Independent Medical Review (IMR) through the DMHC. This is free and binding on UnitedHealthcare.

Q: Does step therapy apply to Brineura? A: UHC policy documents don't specify step therapy requirements for CLN2 disease, as there are no alternative disease-modifying treatments available.

Q: How much will I pay out-of-pocket? A: With specialty tier coinsurance of 20-40%, costs vary but are capped at $2,000 annually for specialty drugs. BioMarin's copay assistance can cover remaining costs for commercially insured patients.

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. For personalized assistance with insurance appeals, contact the California DMHC Help Center at 888-466-2219.

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