By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (Cerliponase Alfa) Covered by Blue Cross Blue Shield in Georgia: Complete Prior Authorization and Appeals Guide

Answer Box: Fast Track to Brineura Coverage

Getting Brineura (cerliponase alfa) covered by Blue Cross Blue Shield of Georgia requires prior authorization with confirmed CLN2 diagnosis, pediatric neurology specialist oversight, and administration at an approved infusion center. Submit PA through your neurologist with genetic testing results, CLN2 Clinical Rating Scale scores, and facility credentials. If denied, you have 60 days to file external review with Georgia Department of Insurance. First step today: Call BCBS Georgia at the number on your insurance card to request current PA forms and verify network infusion centers.

Table of Contents

Who Should Use This Guide

This guide is for Georgia families with children diagnosed with CLN2 disease (late infantile neuronal ceroid lipofuscinosis type 2) who need Brineura coverage through Blue Cross Blue Shield of Georgia. You'll also find this helpful if you're a pediatric neurologist, metabolic specialist, or care coordinator working with CLN2 patients.

Expected outcome: With complete documentation meeting BCBS criteria, most Brineura prior authorizations are approved within 14-30 days. If initially denied, Georgia's external review process provides a second opinion that's binding on your insurer.

Member & Plan Basics

Before starting your prior authorization, verify these basics:

  • Active BCBS Georgia coverage with your member ID card current
  • Medical benefit coverage (Brineura is typically covered under medical, not pharmacy benefits)
  • Deductible status and any out-of-pocket maximums that may apply
  • Network status of your pediatric neurologist and intended infusion center
Tip: Call the customer service number on your BCBS Georgia ID card to confirm these details and request current prior authorization forms.

Clinical Criteria Requirements

BCBS plans, including Georgia, require all of the following criteria for Brineura approval:

Primary Requirements

Requirement Documentation Needed Source
Confirmed CLN2 Diagnosis TPP1 gene mutations via genetic testing AND enzyme assay confirming TPP1 deficiency FDA Access Data
Age Eligibility Pediatric patient ≥3 years (FDA approved for all ages, but most policies specify ≥3) FDA Label
Functional Assessment CLN2 Clinical Rating Scale scores (motor and language domains) Clinical documentation
Specialist Oversight Pediatric neurology or metabolic specialist consultation Provider notes
Qualified Facility Center with pediatric neurosurgery and intraventricular infusion capabilities Facility credentials

Clinical Progression Documentation

Your neurologist must document:

  • Current motor function and ambulatory status
  • Evidence of disease progression or risk of ambulation loss
  • Previous treatments attempted (if any)
  • Treatment goals and monitoring plan

Medical Coding & Documentation

Accurate coding is essential for approval:

Primary Diagnosis Code

  • ICD-10: E75.4 (Neuronal ceroid lipofuscinosis) - required for medical necessity

Billing Codes

  • HCPCS J-code: J0567 (Injection, cerliponase alfa, 1 mg)
  • NDC: 68682-0520-01 (Brineura 150 mg/5 mL vial)
  • Units: Bill 300 units per 300 mg dose (standard dosing)

Administration Requirements

  • Intraventricular administration only via surgically implanted reservoir
  • 300 mg every 2 weeks (biweekly infusions)
  • 4.5-hour infusion protocol with continuous monitoring

Documentation Packet Essentials

Medical Necessity Letter Components

Your pediatric neurologist should include:

  1. Patient identification and confirmed CLN2 diagnosis
  2. Clinical presentation with current CLN2 Scale scores
  3. Disease prognosis without treatment (typically fatal by age 8-12)
  4. Treatment rationale - why Brineura is medically necessary
  5. Monitoring plan and expected outcomes
  6. Facility qualifications for safe administration

Required Attachments

  • Genetic test results confirming TPP1 mutations
  • TPP1 enzyme assay results
  • Recent CLN2 Clinical Rating Scale assessment
  • Neurological examination notes
  • MRI/EEG results (if available)
  • Infusion center credentials and network verification
Clinician Corner: Include specific CLN2 Scale motor domain scores and document the natural history of rapid decline without treatment. Reference FDA approval data showing slowed ambulation loss in clinical trials.

Submission Process

Step-by-Step Submission

  1. Obtain current PA forms from BCBS Georgia provider portal or customer service
  2. Complete clinical documentation with your pediatric neurologist
  3. Verify infusion center is in-network or request network exception
  4. Submit complete packet via provider portal (preferred) or fax
  5. Request expedited review if clinical situation is urgent
  6. Track submission with confirmation number

Timeline Expectations

  • Standard review: 14-30 days
  • Expedited review: 72 hours (for urgent cases)
  • Incomplete submissions: May add 7-14 days for additional information requests

Specialty Pharmacy & Infusion Centers

Brineura requires administration at specialized facilities with:

  • Pediatric neurosurgery capabilities for reservoir placement
  • Intraventricular infusion experience
  • Infection control protocols
  • Emergency resuscitation equipment

Georgia Infusion Centers

Contact these types of facilities and verify BCBS Georgia network status:

  • Children's Healthcare of Atlanta (multiple locations)
  • Augusta University Medical Center (pediatric neurology)
  • Emory University Hospital (pediatric specialists)
Note: Verify current network status directly with BCBS Georgia, as contracts can change.

After Submission: What to Expect

Tracking Your Request

  1. Save confirmation number from submission
  2. Check status weekly via provider portal or phone
  3. Respond quickly to any requests for additional information
  4. Document all communications with dates and reference numbers

Potential Outcomes

  • Approved: Authorization letter with effective dates and any limitations
  • Denied: Detailed denial letter with specific reasons and appeal rights
  • Pending: Request for additional clinical information

Appeals Process for Georgia

If your initial request is denied, Georgia law provides strong appeal rights:

Internal Appeal (First Step)

  • Deadline: 60-180 days from denial notice (check your specific denial letter)
  • Process: Submit written appeal with additional clinical evidence
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Who can appeal: Patient, authorized representative, or prescribing physician

External Review (Second Step)

If internal appeal is denied:

  • Deadline: 60 days from final internal denial
  • Cost: Free to consumers
  • Process: File with Georgia Department of Insurance
  • Contact: 1-800-656-2298 or www.oci.ga.gov
  • Timeline: 30 business days standard, 72 hours expedited
  • Outcome: Binding on BCBS Georgia if approved
Important: Georgia's 60-day external review deadline is stricter than federal requirements. Don't wait - file promptly after internal denial.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Lack of specialist oversight Obtain consultation from pediatric neurologist or metabolic specialist
Insufficient diagnostic evidence Submit complete genetic testing and enzyme assay results
Facility not qualified Provide infusion center credentials or request network exception
Missing functional assessment Include current CLN2 Clinical Rating Scale scores
Age restrictions Document FDA approval and medical necessity for specific age

Prevention Tips

  1. Submit complete packets - missing documents cause automatic denials
  2. Use board-certified specialists for all clinical documentation
  3. Verify network status of all providers and facilities before submission
  4. Include natural history data showing disease progression without treatment
  5. Reference FDA approval and clinical trial data supporting efficacy

Cost Support Options

Even with insurance approval, families may face significant costs:

Manufacturer Support

  • BioMarin RareConnections patient support program
  • Copay assistance for eligible patients
  • Prior authorization support services

Additional Resources

  • National Organization for Rare Disorders (NORD) patient assistance
  • HealthWell Foundation grants for rare diseases
  • State pharmaceutical assistance programs (verify Georgia eligibility)

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes for specialty medications like Brineura. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that align with each payer's specific requirements.

FAQ

How long does BCBS Georgia prior authorization take for Brineura? Standard reviews take 14-30 days. Expedited reviews for urgent cases are completed within 72 hours.

What if my infusion center isn't in the BCBS Georgia network? Request a network exception by documenting the lack of in-network alternatives with appropriate capabilities.

Can I appeal if Brineura isn't on the formulary? Yes, you can request a formulary exception with medical necessity documentation showing why Brineura is required.

What counts as urgent for expedited review? Rapid CLN2 disease progression where delays in treatment could result in irreversible neurological decline.

How do I know if my appeal was successful? You'll receive a written decision letter. Approvals include authorization numbers and effective dates.

What if I disagree with the external review decision? External review decisions are binding on insurers. Further disputes would require legal action.

Does step therapy apply to Brineura? Typically no, as there are no alternative disease-modifying treatments for CLN2 disease.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and should not be considered medical or legal advice. Coverage policies vary by plan and can change. Always verify current requirements with your insurance company and consult with qualified healthcare providers for medical decisions. For personalized assistance with complex prior authorizations and appeals, consider working with specialized services like Counterforce Health that understand the intricacies of rare disease coverage.

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