By Counterforce Health Team in Brineura (cerliponase alfa) —

Renewing Brineura (Cerliponase Alfa) Coverage with Aetna in Michigan: Timeline, Documentation & Appeal Process

Answer Box: Renewing Brineura Coverage with Aetna in Michigan

Start your Brineura renewal 60-90 days before expiration. Aetna requires updated clinical documentation showing motor function scores ≥1 on the CLN2 Clinical Rating Scale, plus physician notes demonstrating ongoing treatment benefit. Submit renewal through your prescribing neurologist or specialty center. If authorization lapses, request expedited review (72 hours for urgent cases). Michigan residents have 127 days to file external appeals through DIFS if internal appeals fail. First step: Contact your treatment center today to check your current authorization expiration date.

Table of Contents

Renewal Triggers: When to Start

Start early. Aetna typically approves Brineura authorizations for 12-month periods, but renewal processing can take 2-4 weeks. Begin your renewal process 60-90 days before expiration to prevent treatment interruptions.

Key Timing Signals

  • 90 days out: Contact your neurologist to schedule renewal assessment
  • 60 days out: Submit complete renewal packet to Aetna
  • 30 days out: Follow up on pending decisions; prepare for potential appeals
  • Authorization expires: Emergency protocols if renewal wasn't completed
Tip: Set calendar reminders for these milestones. Treatment centers often track multiple patients' renewal dates, but you should monitor your own timeline as backup.

Evidence Update Requirements

Aetna's renewal criteria focus on demonstrating continued medical necessity and treatment response. The insurer requires specific clinical markers to justify ongoing coverage.

Required Clinical Documentation

Motor Function Assessment

  • Current CLN2 Clinical Rating Scale score (motor domain must be ≥1)
  • Comparison to baseline and previous assessments
  • Documentation that treatment continues to slow loss of ambulation

Treatment Response Documentation

  • Physician notes showing ongoing benefit from therapy
  • Any changes in neurological status since last authorization
  • Adherence to the every-other-week infusion schedule

Safety Monitoring

  • Recent laboratory results and safety assessments
  • Documentation of any adverse events and their management
  • Confirmation that intraventricular device remains functional

What Counts as Treatment Benefit

According to Aetna's renewal criteria, patients must maintain a score of at least 1 on the motor domain of the CLN2 Clinical Rating Scale. This demonstrates that Brineura continues to slow the loss of ambulation rather than simply maintaining a static condition.

Renewal Packet Essentials

Your renewal submission should include comprehensive documentation that addresses Aetna's specific requirements for continued coverage.

Core Documents Checklist

Clinical Records

  • Updated physician consultation report discussing continued medical necessity
  • Current CLN2 Clinical Rating Scale assessment
  • Chart notes from recent infusion visits
  • Laboratory results and safety monitoring data
  • Hospital or emergency room records (if any occurred since last approval)

Administrative Forms

  • Completed prior authorization renewal form
  • Copy of current insurance card
  • Statement of medical necessity from prescribing neurologist
  • ICD-10 codes for TPP1 deficiency and related conditions
Note: Incomplete submissions are a common cause of renewal delays. Use this checklist to ensure you've included all required documentation before submitting.

Timeline & Decision Windows

Understanding Aetna's review process helps you plan appropriately and know when to escalate if needed.

Standard Review Process

Timeline Action Who's Responsible
60-90 days before expiration Begin renewal preparation Patient/family + treatment center
30-60 days before expiration Submit complete renewal packet Prescribing physician
2-4 weeks Aetna reviews and makes determination Aetna utilization management
Within 72 hours Expedited review (if urgent) Aetna (with physician justification)

When Decisions Are Made

Standard renewals: Aetna typically processes specialty medication renewals within 2-4 weeks of receiving complete documentation. However, complex cases or requests requiring additional review may take longer.

Expedited reviews: Available when standard timeframes could jeopardize the patient's health. Your physician must provide written justification for expedited processing.

If Authorization Lapses

Despite careful planning, authorization lapses can occur. Here's what to do if you find yourself without active coverage for Brineura.

Immediate Actions

  1. Contact Aetna immediately at the member services number on your insurance card
  2. Request expedited review of a new authorization, emphasizing the urgent medical need
  3. Notify your treatment center so they can coordinate with the specialty pharmacy
  4. Document the lapse and any resulting delays in treatment

Emergency Supply Options

Unlike oral medications, Brineura doesn't have formal emergency supply protocols through CVS Caremark because it's administered in clinical settings. However, you can:

  • Request your treatment center contact Aetna's pharmacy services directly
  • Ask for a case manager assignment to expedite resolution
  • Consider temporary self-pay while pursuing expedited authorization (though costs exceed $27,000 per infusion)
Important: There's no guarantee of retroactive coverage for unauthorized treatments, so work urgently to restore authorization rather than proceeding without coverage.

Annual Plan Changes to Monitor

Insurance plans update their formularies and policies annually, which can affect your Brineura coverage even if you've had prior approvals.

What Changes to Watch For

Formulary Updates

  • Movement between coverage tiers
  • Addition of new prior authorization requirements
  • Changes to preferred specialty pharmacies

Policy Modifications

  • Updated clinical criteria for approval
  • New requirements for treatment centers or providers
  • Changes to renewal timeframes or documentation requirements

Based on recent Aetna formulary changes, specialty medications can see tier adjustments or new restrictions. Review your plan's Summary of Changes each year during open enrollment.

Personal Renewal Tracker

Use this template to track your Brineura renewal progress:

Key Dates to Monitor

  • Current authorization expires: ___________
  • Start renewal prep (90 days prior): ___________
  • Submit renewal packet (60 days prior): ___________
  • Follow up if no decision (30 days prior): ___________

Contact Information

  • Treatment center coordinator: ___________
  • Prescribing neurologist office: ___________
  • Aetna member services: ___________
  • CVS Caremark Specialty: ___________

Documentation Status

  • Recent CLN2 scale assessment completed
  • Physician renewal visit scheduled
  • Prior authorization form obtained
  • Previous year's approval letter located

Michigan-Specific Appeal Rights

If Aetna denies your Brineura renewal, Michigan law provides specific appeal rights that differ from federal minimums.

Internal Appeal Process

  • Timeline: File within 60 days of denial notice
  • Decision timeframe: Up to 30 days for standard appeals, 72 hours for expedited
  • Required elements: Written request, supporting clinical documentation, physician statement

External Review Through DIFS

Michigan's Department of Insurance and Financial Services offers independent external review after internal appeals are exhausted.

Key Details:

  • Timeline to file: 127 days after final internal denial
  • Review timeframe: Up to 60 days for standard cases, 72 hours for expedited
  • Filing options: Online form, email, fax, or mail to DIFS
  • Decision binding: Yes, Aetna must comply with favorable external review decisions

Contact DIFS at 877-999-6442 for assistance with the external review process or to request forms.

FAQ: Common Renewal Questions

How long does Aetna take to process Brineura renewals? Standard renewals typically take 2-4 weeks once complete documentation is received. Expedited reviews can be completed within 72 hours if medical urgency is documented.

What if my CLN2 scores have declined since last approval? Slight declines may still qualify for renewal if the rate of decline is slower than expected without treatment. Your neurologist should document how Brineura continues to provide benefit compared to natural disease progression.

Can I switch treatment centers during renewal? Yes, but the new center must meet Aetna's requirements for administering intraventricular therapies. Coordinate the transition carefully to avoid authorization gaps.

What happens if Aetna changes its Brineura policy mid-year? Existing authorizations typically remain valid until their expiration date. However, renewals will be subject to new criteria. Monitor plan communications for policy updates.

Does Michigan Medicaid cover Brineura if I lose commercial coverage? Michigan Medicaid may cover Brineura for eligible patients, but the approval process and criteria may differ from commercial insurance. Contact your local Medicaid office for specific information.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-based advocacy. Our platform analyzes denial letters and plan policies to create targeted rebuttals that align with insurers' own criteria, improving approval rates for complex treatments like Brineura.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always consult with your healthcare providers and insurance plan directly for the most current information regarding your specific situation.

Sources & Further Reading

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