By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (Eculizumab) Covered by Aetna (CVS Health) in Florida: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Soliris Covered by Aetna (CVS Health) in Florida

Step 1: Submit prior authorization through CVS Specialty Pharmacy with lab-confirmed diagnosis, meningococcal vaccination records, and REMS enrollment. Step 2: If denied, file internal appeal within 180 days using clinical documentation and medical necessity letter. Step 3: Request external review through Florida Department of Financial Services if internal appeal fails. Florida law provides binding independent review with 4-month filing deadline and no patient cost. Most denials involve incomplete vaccination records or insufficient diagnostic proof.

Table of Contents

Why Florida State Rules Matter

Florida's insurance regulations work alongside Aetna (CVS Health) policies to protect patients seeking expensive specialty medications like Soliris (eculizumab). While Aetna sets its own prior authorization criteria, Florida law establishes minimum turnaround times, appeal rights, and external review procedures that can overturn insurer denials.

For rare disease treatments, these state protections are crucial. Florida's external review process allows independent medical experts to override insurance denials when they conflict with medical evidence—and these decisions are legally binding on insurers.

Line-of-business differences matter: Commercial Aetna plans follow Florida's 180-day appeal deadline and 45-day external review timeline. Medicare Advantage plans must follow federal timelines (60 days for appeals, 72 hours for expedited reviews). Self-funded employer plans may have different procedures under ERISA.

Aetna (CVS Health) Prior Authorization Requirements

Soliris requires strict prior authorization for all covered indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), anti-AChR antibody-positive generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

Key requirements include:

  • Lab-confirmed diagnosis with appropriate testing (flow cytometry for PNH, complement studies for aHUS, antibody testing for gMG/NMOSD)
  • Meningococcal vaccination (MenACWY and MenB) completed at least 2 weeks before first infusion
  • Prescriber enrolled in Soliris REMS program
  • Dispensing through CVS Specialty Pharmacy
  • Preferred administration in home, office, or infusion center (hospital requires additional justification)

Coverage at a Glance

Requirement Details Where to Find It Source
Prior Authorization Required for all indications CVS Specialty Pharmacy Aetna Policy
Formulary Status Specialty tier (high copay) Plan formulary document Member portal
Step Therapy May apply; medical exceptions available Florida HB 459 (2022) Florida Statutes
Site of Care Home/office/infusion preferred Aetna policy Site of Care Policy
Appeals Deadline 180 days (commercial), 60 days (Medicare) Plan documents Florida DFS
External Review 4 months after final denial Florida law DFS Consumer Services

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Lab Results (Patient + Clinician)

Gather lab confirmation appropriate to your condition. For PNH, you'll need flow cytometry showing PNH clone size. For aHUS, complement studies and TMA evidence. Timeline: Usually available from recent testing.

2. Complete Meningococcal Vaccination (Patient)

Schedule MenACWY and MenB vaccines at least 2 weeks before planned Soliris start. If urgent treatment needed, antibiotic prophylaxis can substitute temporarily. Timeline: 2-3 weeks minimum.

3. Prescriber REMS Enrollment (Clinician)

Your doctor must enroll in the Soliris REMS program before prescribing. This includes safety training and ongoing monitoring requirements. Timeline: 1-2 business days online.

4. Submit Prior Authorization (Clinician)

Complete Aetna's Soliris PA form through CVS Specialty Pharmacy with all supporting documentation. Timeline: Same day submission possible.

5. CVS Specialty Pharmacy Coordination (Patient + Pharmacy)

CVS Specialty will contact you to arrange delivery and infusion scheduling once approved. They handle insurance billing and copay assistance enrollment. Timeline: 2-3 business days after approval.

6. Monitor for Decision (Patient)

Standard review takes 30-45 days. Expedited review available for urgent medical need (≤72 hours). Track status through member portal or by calling customer service.

7. Appeal if Denied (Patient + Clinician)

If denied, immediately request written denial reason and file internal appeal within 180 days. Include additional clinical documentation and medical necessity letter. Timeline: Internal appeal decision within 30 days.

Florida Turnaround Standards

Florida requires specific response times for prior authorization and appeals:

Standard Prior Authorization: 30-45 business days maximum for commercial plans. Medicare Advantage must respond within 14 days (72 hours if expedited).

Urgent/Expedited Requests: 72 hours maximum when delay could seriously jeopardize health. Document urgency in submission.

Appeal Timelines: Internal appeals must be decided within 30 days for prospective services, 60 days for services already received. Expedited appeals: 72 hours.

Note: Business days exclude weekends and holidays. Calendar days run continuously. Verify which standard applies to your specific request.

Step Therapy Protections in Florida

Florida HB 459 (2022) restricts step therapy protocols and requires clear exemption procedures. For Soliris, this means:

Medical Exception Criteria:

  • Previous completion of step therapy protocol under different plan (with documentation)
  • Contraindication to required first-line therapy
  • Drug interaction with required medication
  • Previous adverse reaction or treatment failure

Documentation that Helps:

  • "Patient has documented intolerance to [specific medication] as evidenced by [specific adverse event]"
  • "Prior authorization requested under Florida step therapy exception due to contraindication with current medications"
  • "Patient previously completed step therapy protocol under [previous insurer] with documented failure"

Insurers must provide step therapy exception forms and decision timelines. Keep records of all prior treatments and outcomes.

Continuity of Care Laws

Florida's Prescription Drug Reform Act provides a 60-day continuity of care period when formulary changes affect your current medications. This applies to:

  • Mid-year formulary changes affecting Soliris coverage
  • Transitions between insurance plans
  • Changes in preferred pharmacy networks

For Medicaid patients: Beginning February 2025, enhanced continuity protections ensure ongoing Soliris treatment when transitioning between managed care plans. The 60-day grace period applies while working with the new plan for continued coverage.

Actionable steps: If your plan changes Soliris coverage mid-year, you have 60 days of continued access while appealing the change or transitioning to covered alternatives.

Appeals Playbook for Florida

Internal Appeal Process

Timeline: 180 days from denial notice to file How to File: Submit through Aetna member portal, mail, or fax (verify current submission method) Required Documents:

  • Written denial letter
  • Medical necessity letter from prescriber
  • Supporting clinical documentation
  • Lab results and diagnostic testing
  • Prior therapy documentation

Expedited Internal Appeal

When Available: Serious health jeopardy from delay Timeline: 72 hours for decision Documentation: Physician attestation of urgency required

External Review (Independent Review)

Eligibility: After exhausting internal appeals Timeline: 4 months from final denial to request Process: File with Florida Department of Financial Services Cost: No charge to patient Decision: Binding on insurer within 45 days (72 hours if expedited)

External Review & Complaints

Florida's external review process provides powerful protection for rare disease drug denials. An independent medical expert—often a specialist in your specific condition—reviews your case without insurer involvement.

What to Include in External Review Request:

  • Complete medical records and diagnostic testing
  • Prescriber's detailed medical necessity letter
  • Evidence of prior therapy failures or contraindications
  • Published clinical guidelines supporting Soliris use
  • Documentation of insurer's denial reasoning

Consumer Assistance Available:

  • Florida Insurance Consumer Helpline: 1-877-693-5236
  • Email: [email protected]
  • Online Complaint System: Available through Florida DFS website

For urgent cases involving rare diseases, emphasize the time-sensitive nature and potential for irreversible harm from treatment delays.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Incomplete vaccination records Submit proof of meningococcal vaccination Vaccination certificate or physician attestation
Insufficient diagnostic proof Provide lab confirmation of diagnosis Flow cytometry (PNH), complement studies (aHUS), antibody tests (gMG/NMOSD)
Non-REMS enrolled prescriber Ensure prescriber completes REMS training REMS enrollment confirmation
Incorrect site of care Justify hospital use or change to preferred site Medical necessity for hospital administration
Step therapy not completed Request medical exception or document prior failures Previous therapy records and outcomes
"Experimental" designation Cite FDA approval and clinical guidelines FDA labeling, specialty society recommendations

When to Escalate

Contact Florida regulators when:

  • Aetna fails to meet response deadlines
  • Denial appears to violate Florida insurance laws
  • You need help navigating the appeals process
  • External review decision is not implemented

Florida Department of Financial Services Division of Consumer Services:

  • Phone: 1-877-693-5236
  • Out of state: 850-413-3089
  • Online complaint system available

Document all interactions with dates, reference numbers, and outcomes. Florida consumer specialists can facilitate communications and ensure you receive full appeal rights.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals with the right clinical evidence and procedural requirements. By understanding exactly why Soliris was denied and what documentation Aetna requires, we help create appeals that address each specific concern while meeting Florida's regulatory standards.

FAQ

How long does Aetna (CVS Health) prior authorization take in Florida? Standard review: 30-45 days. Expedited review for urgent need: 72 hours maximum. Medicare Advantage plans must respond within 14 days (72 hours if expedited).

What if Soliris is non-formulary on my plan? Request formulary exception with medical necessity documentation. Florida law requires coverage of medically necessary treatments even if non-formulary, though higher copays may apply.

Can I request expedited appeal if I'm already on Soliris? Yes, if treatment interruption would cause serious health jeopardy. Provide physician documentation of medical urgency and potential harm from delay.

Does step therapy apply if I've previously failed alternatives? Florida HB 459 provides exceptions for documented prior failures. Submit records of previous therapies tried and outcomes to qualify for step therapy override.

What happens if Aetna doesn't respond within required timeframes? File complaint with Florida DFS Consumer Services. Late responses may constitute grounds for automatic approval or expedited external review.

Are there cost assistance programs for Soliris copays? Yes, manufacturer copay assistance and patient assistance programs available. CVS Specialty Pharmacy can help with enrollment during prior authorization process.

Can self-funded employer plans follow different rules? Yes, ERISA plans may have different appeal procedures. Check your Summary Plan Description for specific requirements, though many voluntarily follow state timelines.

What if I need Soliris while traveling outside Florida? Coordinate with CVS Specialty for out-of-state infusion arrangements. Counterforce Health can help ensure continuity of coverage across state lines.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage requirements and Florida regulations may change. Always verify current policies with your insurer and consult healthcare providers for medical decisions. For personalized assistance with Soliris appeals and prior authorization, visit Counterforce Health.

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