By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (cerliponase alfa) Covered by UnitedHealthcare in New York: Complete Appeals Guide with Forms and Deadlines

Answer Box: Getting Brineura Covered by UnitedHealthcare in New York

UnitedHealthcare requires prior authorization for Brineura (cerliponase alfa) with strict clinical criteria: confirmed CLN2 diagnosis, age ≥3 years, baseline motor/language scores ≥1, and treatment at a qualified neurosurgical center. If denied, you have 180 days for internal appeals, then 4 months for New York's binding external review through the Department of Financial Services.

Your first step today: Call UnitedHealthcare at the number on your card to request the current Brineura prior authorization form and clinical criteria. Simultaneously, contact BioMarin RareConnections at 1-866-906-6100 for coverage support and potential copay assistance.

Table of Contents

  1. Understanding UnitedHealthcare's Brineura Coverage
  2. Prior Authorization Requirements
  3. Common Denial Reasons & How to Fix Them
  4. Step-by-Step Appeals Process
  5. New York External Review Rights
  6. Medical Necessity Letter Template
  7. Cost Reduction Options
  8. When to Escalate to Regulators
  9. FAQ: Your Top Questions Answered

Understanding UnitedHealthcare's Brineura Coverage

UnitedHealthcare covers Brineura under their medical benefit (not pharmacy) for pediatric patients with late-infantile CLN2 disease. The drug is billed using HCPCS code J0567 at approximately $27,000 per biweekly infusion, with additional facility and administration costs.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all lines of business UHC Provider Portal
Age Requirement ≥3 years at treatment start UHC Brineura Policy
Diagnosis Confirmed CLN2 (TPP1 deficiency) Same policy document
Functional Status Motor + language scores 3-6, each ≥1 Same policy document
Site of Care Qualified neurosurgical center only UHC medical management
Appeals Deadline 180 days from denial date Member benefits document
Note: These criteria apply to Commercial, Medicare Advantage, and Medicaid Community Plan products unless state-specific rules override them.

Prior Authorization Requirements

Clinical Criteria You Must Meet

Based on UnitedHealthcare's current Brineura policy, all of these must be documented:

  1. Confirmed CLN2 diagnosis via:
    • Biallelic pathogenic TPP1 gene mutations, OR
    • Deficient TPP1 enzyme activity in leukocytes
  2. Age and functional requirements:
    • Pediatric patient ≥3 years old
    • Combined CLN2 motor + language score of 3-6
    • Motor domain score ≥1 (can stand/transfer)
    • Language domain score ≥1 (meaningful babbling)
  3. Prescriber qualification:
    • Ordered by pediatric neurologist, geneticist, or CLN2 specialist
  4. Safety requirements:
    • No active CNS infections
    • Surgically implanted intraventricular access device
    • Treatment at facility with neurosurgical capability

Required Documentation Checklist

Before submitting your PA request, gather:

  • Genetic testing report showing TPP1 mutations
  • Enzyme activity lab results (if genetic testing unavailable)
  • Baseline CLN2 Clinical Rating Scale scores
  • Neurologist consultation notes documenting progressive decline
  • Confirmation of intraventricular device placement
  • Hospital/center capability attestation for Brineura administration

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"Age criteria not met" Submit birth certificate + current neurologist note Age verification, specialist letter
"Diagnosis not confirmed" Provide genetic/enzyme testing Lab reports, genetic counselor summary
"Functional scores missing" Submit formal CLN2 rating scale assessment Neuropsychology evaluation, CLN2 scores
"Site of care not qualified" Document facility capabilities Hospital credentials, neurosurgery attestation
"Not medically necessary" Emphasize progressive decline without treatment Natural history data, specialist letter
From our advocates: We've seen families successfully overturn "not medically necessary" denials by submitting a detailed timeline showing their child's functional decline over 6-12 months, paired with published CLN2 natural history studies. The key is demonstrating urgency—that delays risk irreversible neurological loss.

Step-by-Step Appeals Process

Level 1: Internal Appeal (First Line)

Timeline: Must file within 180 days of denial; UnitedHealthcare has 30 days to respond (15 days for urgent appeals).

How to submit:

  1. Online: UnitedHealthcare Provider Portal (providers) or member portal (families)
  2. Fax: Use the fax number listed on your denial letter
  3. Mail: Address provided in denial notification

What to include:

  • Original denial letter
  • Completed appeal request form
  • Medical necessity letter from neurologist
  • All supporting clinical documentation
  • CLN2 natural history literature

Level 2: Second Internal Appeal

If your first appeal is denied, you have 60 days to request a second-level review. This typically involves a peer-to-peer consultation between your neurologist and UnitedHealthcare's medical director.

Peer-to-Peer Preparation:

  • Schedule through UHC medical management
  • Prepare 3-5 key talking points about medical necessity
  • Have patient chart and CLN2 guidelines readily available
  • Request specific denial rationale during the call

Medical Necessity Letter Template

Your neurologist should include these elements:

Patient: [Name], DOB: [Date]
Diagnosis: Late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2)

CLINICAL SUMMARY:
[Patient] has confirmed CLN2 disease with [genetic/enzyme testing details]. 
Current functional status: CLN2 motor score [X], language score [Y], 
combined score [Z]. Without disease-modifying therapy, natural history 
shows rapid decline in ambulation and cognitive function.

MEDICAL NECESSITY RATIONALE:
1. FDA-approved indication: Brineura is the only approved therapy to slow 
   loss of ambulation in CLN2 patients ≥3 years
2. Progressive decline: Patient demonstrates ongoing neurological 
   deterioration consistent with CLN2 natural history
3. Functional preservation: Patient retains ambulatory function 
   (motor score ≥1) necessary for treatment benefit
4. No alternatives: No other disease-modifying therapies exist for CLN2

CLINICAL REFERENCES:
- FDA Brineura prescribing information
- Schulz et al. CLN2 natural history study (Neurology 2013)
- [Additional peer-reviewed literature]

REQUEST: Immediate approval for Brineura 300mg every 2 weeks via 
intraventricular infusion at [qualified facility].

New York External Review Rights

New York offers one of the strongest external appeal systems in the nation. After exhausting UnitedHealthcare's internal appeals, you can request an independent external review through the New York Department of Financial Services (DFS).

External Review Process

Eligibility:

  • Final adverse determination from UnitedHealthcare
  • Request filed within 4 months of denial
  • Denial based on medical necessity, experimental treatment, or out-of-network coverage

How to file:

Timeline:

  • Standard: Decision within 30 days
  • Expedited: 72 hours for urgent cases (24 hours for non-formulary drugs)

Cost: Maximum $25 filing fee (waived for Medicaid enrollees and financial hardship)

Tip: New York's external reviewers have overturned many denials for rare disease treatments. Search the DFS External Appeals Database for similar CLN2 or enzyme replacement therapy cases to strengthen your appeal.

Additional New York Resources

Community Health Advocates: Free insurance counseling at 888-614-5400 for help filing appeals and understanding your rights.

Cost Reduction Options

Even with UnitedHealthcare coverage, your out-of-pocket costs for Brineura can be substantial. Here's how to minimize them:

BioMarin Financial Support

RareConnections Program:

  • Phone: 1-866-906-6100 (Mon-Fri, 8 AM-8 PM ET)
  • Services: Coverage verification, PA support, appeals assistance
  • Eligibility: All patients prescribed Brineura

Copay Assistance Program:

  • For commercial insurance: Can cover copays, coinsurance, and deductibles
  • Not available for: Medicare, Medicaid, or other government programs
  • New York status: No state-specific restrictions (unlike MA, RI, MI, MN)

UnitedHealthcare-Specific Benefits

Some UnitedHealthcare commercial plans include a $2,000 annual specialty medication cap. Once reached, additional copayments for covered specialty drugs are waived for the remainder of the year.

When to Escalate to Regulators

If UnitedHealthcare continues denying coverage despite strong clinical evidence, file complaints with:

New York Department of Financial Services

  • Website: www.dfs.ny.gov
  • Phone: Consumer Hotline for insurance complaints
  • When to file: Unreasonable delays, failure to follow appeal timelines, or suspected bad faith denials

Federal Options (for Medicare Advantage):

  • Centers for Medicare & Medicaid Services: 1-800-MEDICARE
  • Medicare.gov complaints portal for MA plan issues

FAQ: Your Top Questions Answered

Q: How long does UnitedHealthcare prior authorization take for Brineura in New York? A: Standard PA decisions are made within 14 days. Urgent requests (when delay could jeopardize health) are decided within 72 hours.

Q: What if Brineura is non-formulary on my UnitedHealthcare plan? A: Request a formulary exception with medical necessity documentation. Non-formulary appeals can be expedited if clinically urgent.

Q: Can I request an expedited appeal for Brineura? A: Yes, if your neurologist attests that delays could worsen your child's condition or cause irreversible neurological decline.

Q: Does step therapy apply if we've tried treatments outside New York? A: Document all prior treatments and failures. UnitedHealthcare should accept out-of-state medical records as evidence of step therapy completion.

Q: What happens if the external review also denies coverage? A: External review decisions are binding on UnitedHealthcare. If approved, they must cover the treatment and refund your appeal filing fee.

Q: Can we use multiple appeal levels simultaneously? A: No, you must complete UnitedHealthcare's internal appeals before filing external review. However, you can file urgent external appeals simultaneously with internal appeals in some circumstances.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify the specific reasons for rejection, then drafts point-by-point rebuttals aligned to the payer's own rules. For complex cases like Brineura appeals, we pull the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals that meet UnitedHealthcare's procedural requirements while tracking deadlines and required documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400 or visit the New York Department of Financial Services website.

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