By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (Natalizumab) Covered by Cigna in Florida: Prior Authorization, Appeals, and State Protections

Answer Box: Get Tysabri Covered by Cigna in Florida

Cigna requires prior authorization for Tysabri (natalizumab) with strict TOUCH program enrollment and medical necessity documentation. In Florida, you have enhanced protections including step therapy exemptions and external review rights. First step: Ensure your prescriber, infusion site, pharmacy, and you are all enrolled in the TOUCH program before submitting a prior authorization request. If denied, Florida law gives you 180 days to appeal internally, followed by external review through the Florida Department of Financial Services. Expedited reviews (24-72 hours) are available for urgent cases.

Table of Contents

Why Florida State Rules Matter

Florida's insurance regulations provide important protections that work alongside Cigna's coverage policies. Since July 2022, Florida law requires insurers to publish clear step therapy exemption procedures and respond to medical necessity requests within specific timeframes. These rules apply to most individual and group plans regulated by Florida (though not self-insured ERISA employer plans).

For Tysabri patients, this means you have legal backing when challenging denials based on step therapy requirements or medical necessity determinations. Florida's external review process also provides binding oversight when internal appeals fail.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Tysabri prescriptions Cigna Provider Portal
TOUCH Enrollment All parties must be registered TOUCH Program Website
Formulary Status Specialty tier with quantity limits Your plan's Prescription Drug List
Site of Care Infusion centers or buy-and-bill Accredo Specialty Pharmacy
Appeals Deadline 180 days from denial notice Florida Insurance Law

TOUCH Program Requirements

Before Cigna will consider covering Tysabri, everyone involved must be enrolled in the TOUCH Prescribing Program due to the risk of progressive multifocal leukoencephalopathy (PML):

Required Enrollments:

  • Prescribing physician
  • Infusion site or clinic
  • Dispensing pharmacy
  • Patient

Ongoing Requirements:

  • Patient must have "Authorized" status before each infusion
  • Pre-infusion checklist completed within 1 business day
  • JCV antibody testing and documentation
  • Regular MRI monitoring for PML surveillance
  • Longitudinal safety tracking
Note: Missing TOUCH enrollment is the most common reason for Tysabri denials. Verify all parties are registered before submitting your prior authorization.

Step-by-Step: Fastest Path to Approval

  1. Enroll in TOUCH (All parties)
    • Visit touchprogram.com
    • Complete enrollment for prescriber, site, pharmacy, and patient
    • Timeline: 1-3 business days
  2. Gather Medical Documentation
    • MS diagnosis with ICD-10 codes
    • Prior DMT trials and failures/intolerances
    • JCV antibody test results
    • Recent MRI reports
    • Timeline: Varies by clinic
  3. Submit Prior Authorization
    • Prescriber submits via Cigna provider portal
    • Include TOUCH confirmation and medical necessity letter
    • Timeline: Standard 30 days, expedited 24-72 hours
  4. Verify Authorized Status
    • Check TOUCH Online before each infusion
    • Submit pre-infusion checklist
    • Timeline: Real-time verification
  5. Coordinate with Accredo
    • Cigna's specialty pharmacy for Tysabri
    • Arrange delivery to infusion site
    • Timeline: 3-5 business days

Florida's Step Therapy Protections

Florida law requires Cigna to allow step therapy exemptions when medically appropriate. You can request an exemption if:

  • Previous step therapy was completed under another plan within 90 days
  • Alternative drugs are contraindicated or likely to cause adverse reactions
  • Alternative drugs are expected to be ineffective based on clinical history
  • You're stable on current therapy after completing step therapy

Process:

  • Prescriber submits exemption request with medical justification
  • Cigna must respond within 72 hours (24 hours for urgent cases)
  • If approved, coverage guaranteed for the entire plan year without tier changes

Appeals Process and Timelines

Internal Appeals

Standard Timeline: 30 days from receipt Expedited Timeline: 24-72 hours for urgent cases Deadline to File: 180 days from denial notice

Required Documents:

  • Written appeal letter stating why Tysabri should be covered
  • Medical records supporting necessity
  • Documentation of prior treatment failures
  • Prescriber attestation letter

Submit To: Cigna member services (number on insurance card) or provider portal

Expedited Reviews

Available when delay could seriously jeopardize your health. Common scenarios include:

  • Disease progression while awaiting treatment
  • Intolerance to current therapy requiring immediate switch
  • Risk of permanent disability without prompt treatment

External Review Rights

If Cigna denies your internal appeal, Florida law provides binding external review through the Department of Financial Services.

Timeline: Request within 4 months of final internal denial Process: Independent medical expert reviews your case Cost: Free to consumers Decision: Binding on Cigna if favorable

Contact: Florida Department of Financial Services

Common Denial Reasons & Solutions

Denial Reason Solution
Missing TOUCH enrollment Complete enrollment for all parties before resubmitting
Inadequate medical necessity Provide detailed treatment history and guideline references
Step therapy not completed Request medical exemption with contraindication documentation
Missing JCV antibody results Submit current STRATIFY JCV test results
Incomplete MRI documentation Provide baseline and monitoring MRI reports

Costs and Financial Assistance

Manufacturer Support:

  • Biogen offers patient assistance programs
  • Copay support may be available for eligible patients
  • Visit tysabri.com for current programs

Cigna Resources:

  • Accredo's copay assistance teams helped connect customers with $2.3 billion in financial assistance in 2022
  • 24/7 access to condition-focused pharmacists
  • Care management services for complex cases
From our advocates: One patient's neurologist successfully appealed a Tysabri denial by documenting three failed DMTs with specific adverse events and including recent MRI showing new lesions. The key was providing timeline evidence that step therapy alternatives had been thoroughly tried over 18 months with clear documentation of failure or intolerance.

When to Contact State Regulators

Contact the Florida Office of Insurance Regulation if:

  • Cigna fails to respond within required timeframes
  • Appeal procedures aren't clearly explained
  • You suspect systematic denial patterns
  • External review rights are denied

Florida Department of Financial Services Consumer Services:

  • File complaints online or call 877-693-5236
  • Division specialists can facilitate insurer communications
  • Insurance Consumer Advocate addresses systemic issues

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's requirements, helping patients and clinicians navigate complex prior authorization challenges more effectively.

FAQ

How long does Cigna prior authorization take for Tysabri in Florida? Standard reviews take up to 30 days, but expedited reviews are completed within 24-72 hours for urgent cases. TOUCH enrollment adds 1-3 business days to the initial process.

What if Tysabri is non-formulary on my Cigna plan? You can request a formulary exception with medical necessity documentation. Florida law requires clear exception procedures and reasonable response times.

Can I request an expedited appeal if my MS is worsening? Yes, expedited appeals are available when delay could seriously jeopardize your health. Provide documentation of disease progression or urgent medical need.

Does step therapy apply if I've already tried other DMTs? If you completed step therapy under another plan within 90 days, Florida law requires automatic exemption with proper documentation.

What counts as medical necessity for Tysabri? Treatment must be appropriate for your diagnosis, clinically effective, and not solely for convenience. Include failed prior therapies and contraindications to alternatives.

How do I file an external review in Florida? Submit a request to the Florida Department of Financial Services within 4 months of your final internal denial. The review is conducted by independent medical experts and is binding if favorable.

What if my employer plan is self-insured? Self-insured ERISA plans aren't subject to Florida state laws but must follow federal appeal requirements. Check your plan documents for specific procedures.

Can Counterforce Health help with my Tysabri appeal? Yes, our platform specializes in analyzing denial letters and drafting evidence-backed appeals that address specific payer requirements, including Cigna's policies and Florida's regulatory protections.

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 terms and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For regulatory questions, contact the Florida Department of Financial Services at 877-693-5236.

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