By Counterforce Health Team in Brineura (cerliponase alfa) —

How to Get Brineura (Cerliponase Alfa) Covered by Cigna in Michigan: Complete Forms Guide and Appeals Process

Answer Box: Getting Brineura (Cerliponase Alfa) Covered by Cigna in Michigan

Cigna covers Brineura for confirmed CLN2 disease with both genetic testing (biallelic TPP1 variants) and reduced enzyme activity. Use Cigna's drug-specific PA form plus Michigan's required FIS 2288 form. Standard approval takes 15 days; expedited takes 72 hours. If denied, you have 180 days for internal appeal, then 127 days for Michigan DIFS external review. Start today: Call Cigna Member Services (number on your ID card) to verify PA requirements and download forms from Cigna's provider portal.

Table of Contents

  1. Verify Your Plan and Requirements
  2. Required Forms for Brineura PA
  3. Medical Necessity Criteria
  4. Submission Portals and Methods
  5. Specialty Pharmacy Setup (Accredo)
  6. Appeals Process in Michigan
  7. Common Denial Reasons and Solutions
  8. Support Resources and Contact Information
  9. Frequently Asked Questions

Verify Your Plan and Requirements

Before submitting any paperwork, confirm these essential details with Cigna:

Call Cigna Member Services (number on back of your insurance card) and ask:

  • Is prior authorization required for Brineura (cerliponase alfa)?
  • Is it covered under pharmacy or medical benefit?
  • Which specialty pharmacy is required (typically Accredo)?
  • Are there any plan-specific forms beyond the standard PA request?
Tip: Have your member ID, patient's full name, and prescribing neurologist's information ready when you call.

Required Forms for Brineura PA

Cigna Drug-Specific Form

Cigna uses a dedicated "Brineura CCRD Prior Authorization Form" for cerliponase alfa. Download it from Cigna's Prescription Prior Authorization Forms page under drug-specific forms.

Michigan State-Required Form

Michigan law requires insurers to accept the "Michigan Prior Authorization Request Form for Prescription Drugs" (FIS 2288). Download the current version from the Michigan DIFS website.

Submit both forms together to ensure compliance with both Cigna's process and Michigan state requirements.

Medical Necessity Criteria

According to Cigna's Neurology Coverage Policy IP0175, Brineura coverage requires all of the following:

Required Documentation

Requirement What to Include Source Needed
Confirmed CLN2 diagnosis Biallelic pathogenic TPP1 variants Genetic test report
Enzyme deficiency Reduced TPP1 enzyme activity Lab report with reference ranges
Clinical phenotype Late-infantile onset symptoms Neurology consultation note
Age appropriateness FDA-approved age range Medical records

Key Changes to Note

Cigna removed the previous requirement that patients be ≥3 years old, so younger children who meet other criteria may qualify.

Medical Necessity Letter Checklist

Your neurologist should include:

  • Diagnosis confirmation: "CLN2 disease (neuronal ceroid lipofuscinosis type 2) due to biallelic pathogenic TPP1 variants"
  • Test results: Attach genetic testing showing two pathogenic TPP1 variants and enzyme assay confirming TPP1 deficiency
  • Clinical presentation: Age of onset, seizure history, motor/language regression, current functional status
  • Treatment rationale: Why enzyme replacement is medically necessary vs. symptomatic treatments only
  • Monitoring plan: How response will be assessed using CLN2 clinical rating scales

Submission Portals and Methods

Electronic Submission (Preferred)

Submit through Cigna's Provider Portal (CignaforHCP.com) when available. This provides electronic confirmation and faster processing.

Fax Submission

  • Standard medication PA fax: 855-840-1678
  • Urgent/expedited requests: Call 800-882-4462 (800.88.CIGNA) first, then fax

Michigan-Specific Deadlines

Under Michigan law:

  • Standard requests: Cigna must respond within 15 days or the PA is considered granted
  • Expedited requests: Response required within 72 hours or deemed approved
  • Mark requests as expedited when delay could harm the patient's neurological function

Specialty Pharmacy Setup (Accredo)

Most Cigna plans route Brineura through Accredo Specialty Pharmacy. Here's how the process works:

For Patients and Caregivers

  1. Initial setup: Call Accredo at 877-826-7657 to begin enrollment
  2. Required information: Insurance details, prescriber information, delivery address
  3. Delivery coordination: Accredo ships to approved locations (home vs. infusion center depends on state law and facility policies)

For Providers

  • Accredo Provider Portal: Register at MyAccredoPatients.com to track patient orders and PA status
  • Provider line: 844-516-3319 for prescription coordination
  • Fax: 888-302-1028 for enrollment documents
Note: Brineura requires specialized handling due to intracerebroventricular administration, so coordinate delivery timing with your infusion center.

Appeals Process in Michigan

If Cigna denies your Brineura request, Michigan provides strong appeal protections:

Level 1: Cigna Internal Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30 days (pre-service) or 60 days (post-service) for decision; 72 hours for expedited
  • Submission: Via provider portal, fax to 877-815-4827, or mail to address in denial letter
  • Include: Original denial letter, updated medical records, physician letter addressing denial reasons

Level 2: Michigan External Review

After exhausting Cigna's internal process:

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to draft evidence-backed rebuttals. The platform identifies specific denial reasons and creates targeted appeals using FDA labeling, peer-reviewed studies, and specialty guidelines tailored to each payer's requirements.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Incomplete genetic testing Provide both genetic and enzyme results Biallelic TPP1 variants + reduced enzyme activity
Age restrictions Reference updated Cigna policy Medical records showing appropriate use per FDA labeling
Lack of specialist care Confirm neurologist involvement Consultation note from pediatric neurologist
Site of care issues Verify infusion center requirements Facility credentials and administration plan
Non-formulary status Request formulary exception Letter explaining no therapeutic alternatives exist

Support Resources and Contact Information

Cigna Contacts

  • Member Services: Number on back of insurance card
  • Provider Appeals: 800-882-4462
  • Specialty Support: 800-351-3606
  • Urgent PA requests: 800-882-4462

Michigan Resources

Manufacturer Support

  • BioMarin Rare Connections: Coverage authorization guides and patient support
  • Coverage Authorization Guide: Available to healthcare providers for PA preparation

For families navigating the complex world of rare disease coverage, Counterforce Health offers specialized support in converting insurance denials into successful appeals through systematic analysis of payer policies and evidence-based rebuttals.

Frequently Asked Questions

How long does Cigna take to approve Brineura PA in Michigan?
Standard requests: up to 15 days under Michigan law. Expedited requests: 72 hours. If Cigna doesn't respond by these deadlines, the PA is considered approved.

What if Brineura isn't on my Cigna formulary?
Request a formulary exception using Cigna's exception forms. Emphasize that no therapeutic alternatives exist for TPP1 enzyme replacement in CLN2 disease.

Can I appeal if my child is under 3 years old?
Yes. Cigna removed the age restriction from their policy. Focus on FDA labeling and medical necessity for your child's specific clinical situation.

What counts as "expedited" for a Brineura request?
When delay could worsen neurological function or cause irreversible decline. Include a physician letter stating urgency to qualify for 72-hour review.

How much does the external review cost in Michigan?
External reviews through Michigan DIFS are free to patients. The state covers all costs of the independent medical review.

What if I miss the appeal deadline?
Michigan's 127-day external review deadline is strict. If you miss it, you may need to resubmit a new PA request or explore other coverage options.

Does step therapy apply to Brineura?
Typically no, since there are no alternative enzyme replacement therapies for CLN2. If step therapy is required, request an exception based on lack of therapeutic alternatives.

Can my doctor file appeals for me?
Yes. Michigan law allows physicians or authorized representatives to file appeals on your behalf with written consent.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always verify current requirements with your insurer and consult healthcare providers for medical decisions. For personalized assistance with insurance appeals, contact Michigan DIFS at 877-999-6442 or visit michigan.gov/difs.

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