By Counterforce Health Team in Tegsedi (inotersen) —

How to Get Tegsedi (inotersen) Covered by Humana in Florida: Prior Authorization, Appeals & REMS Requirements

Answer Box: Getting Tegsedi (inotersen) Covered by Humana in Florida

Tegsedi (inotersen) requires prior authorization from Humana Medicare Advantage plans in Florida. Your prescriber must submit documentation proving hATTR polyneuropathy diagnosis, complete REMS program enrollment, and arrange specialty pharmacy dispensing through CenterWell. If denied, you have 65 days to appeal with expedited review available within 24 hours for urgent cases.

First steps today:

  1. Confirm your prescriber is REMS-certified at tegsedirems.com
  2. Gather genetic testing or biopsy confirming hATTR diagnosis
  3. Have your doctor submit prior authorization through Humana's provider portal

Table of Contents

Plan Types & Coverage Implications

Humana operates primarily Medicare Advantage and Medicare Part D plans in Florida. For Tegsedi (inotersen), coverage flows through the prescription drug benefit, which means:

  • Medicare Advantage plans with integrated Part D coverage handle both medical and pharmacy benefits
  • Stand-alone Part D plans focus solely on prescription coverage
  • Network restrictions apply—you'll need to use Humana's designated specialty pharmacy network
Note: Humana's Medicare Advantage denial rate is approximately 3.5% (2023), among the lowest of major insurers, but denials often occur due to incomplete documentation or formulary placement issues.

Formulary Status & Tier Placement

Tegsedi is covered by Humana Medicare Advantage plans but requires prior authorization. Based on current Humana policies, the medication appears on specialty drug lists with specific access controls.

Coverage Requirements:

  • Prior Authorization (PA): Required before dispensing
  • Limited Access (LA): Must use designated specialty pharmacies
  • REMS Enrollment: Both prescriber and patient must be certified
  • Regular Monitoring: Weekly platelet counts and monthly kidney function tests

Prior Authorization Requirements

Essential Documentation Checklist

Your prescriber must submit comprehensive documentation proving medical necessity:

Diagnosis Confirmation (choose one):

  • Genetic testing showing pathogenic TTR variant
  • Tissue biopsy with amyloid deposits confirmed by mass spectrometry
  • Technetium bone scan showing ATTR involvement

Clinical Documentation:

  • Detailed chart notes outlining symptoms and progression
  • Polyneuropathy Disability (PND) score or neurological assessment
  • Evidence of symptomatic polyneuropathy affecting daily function
  • Confirmation patient is ≥18 years old

Specialist Involvement:

  • Prescription from neurologist, cardiologist, or geneticist with amyloidosis expertise
  • Letter of medical necessity citing clinical guidelines

Medical Necessity Criteria

Based on standard payer requirements, Humana typically requires:

  • Confirmed hATTR polyneuropathy diagnosis
  • Symptomatic disease impacting daily activities
  • No concurrent use of other hATTR therapies (patisiran, vutrisiran, etc.)
  • Exclusion of light chain amyloidosis
  • Appropriate baseline lab values (platelets ≥100×10⁹/L)

REMS Program Enrollment

Tegsedi requires mandatory FDA Risk Evaluation and Mitigation Strategy (REMS) enrollment due to risks of severe thrombocytopenia and glomerulonephritis.

REMS Requirements:

  1. Prescriber Certification: Must complete training at tegsedirems.com
  2. Patient Enrollment: Required safety monitoring agreement
  3. Pharmacy Certification: Only REMS-certified pharmacies can dispense

Monitoring Schedule:

  • Weekly: Platelet count monitoring throughout treatment
  • Monthly: Kidney function (creatinine, urinalysis)
  • Baseline: Complete lab panel before starting therapy
Important: REMS enrollment documentation must be submitted with your prior authorization request. Missing REMS certification is a common denial reason.

Specialty Pharmacy Requirements

Humana requires Tegsedi to be dispensed through CenterWell Specialty Pharmacy or other designated network partners.

Patient Enrollment Process:

  1. Provider submits prescription to CenterWell
  2. Specialty pharmacy contacts patient for enrollment
  3. Pharmacy verifies insurance, collects shipping details
  4. Patient counseling on administration and safety monitoring
  5. Medication shipped to home or provider office
  6. Ongoing monitoring and refill coordination

Contact CenterWell: Available through Humana's specialty pharmacy portal or provider resources.

Step-by-Step: Fastest Path to Approval

1. Verify REMS Certification (Week 1)

Who: Prescriber
Action: Complete training at tegsedirems.com
Timeline: 1-2 business days

2. Gather Diagnostic Documentation (Week 1)

Who: Patient/Clinic
Documents: Genetic test results, biopsy report, or bone scan
Source: Medical records department

3. Complete Prior Authorization (Week 1-2)

Who: Prescriber
Action: Submit PA through Humana provider portal
Timeline: Standard review 30 days, expedited 24 hours

4. Enroll Patient in REMS (Week 2)

Who: Prescriber and Patient
Action: Complete patient enrollment at tegsedirems.com
Requirements: Signed monitoring agreement

5. Coordinate Specialty Pharmacy (Week 2-3)

Who: Provider
Action: Send prescription to CenterWell Specialty Pharmacy
Timeline: 3-5 business days for patient outreach

6. Schedule Monitoring Labs (Week 2-3)

Who: Patient
Action: Arrange weekly platelet and monthly kidney function tests
Timeline: Must be in place before first dose

7. Receive Medication (Week 3-4)

Who: Patient
Action: Complete CenterWell enrollment and arrange delivery
Timeline: 5-7 days after all approvals received

Common Denial Reasons & Solutions

Denial Reason How to Fix Documentation Needed
Missing REMS enrollment Complete prescriber and patient certification REMS confirmation numbers
Insufficient diagnosis proof Submit genetic testing or biopsy results Pathology report with TTR confirmation
No specialist involvement Get referral to amyloidosis expert Consultation note from neurologist/cardiologist
Incomplete lab monitoring plan Establish monitoring schedule Lab requisitions for weekly/monthly tests
Medical necessity unclear Strengthen clinical justification Detailed symptom documentation, PND score

Appeals Process in Florida

If Humana denies your Tegsedi prior authorization, you have multiple appeal levels available under Florida and federal Medicare rules.

Internal Appeals (Redetermination)

  • Deadline: 65 days from denial notice
  • Standard timeline: 7 days for decision
  • Expedited timeline: 24 hours if delay could jeopardize health
  • How to file: Call 800-867-6601 or submit appeal form

External Review

If internal appeal fails, Florida contracts with independent review organizations for external appeals.

  • Deadline: 4 months after final internal denial
  • Process: Submit request to Florida Department of Financial Services
  • Cost: Free to consumer
  • Timeline: Standard review within 30 days, expedited within 72 hours
Tip: For rare disease treatments like Tegsedi, expedited reviews are often successful when supported by strong clinical documentation and specialist letters.

Cost-Share Considerations

Tegsedi is a high-cost specialty medication. Your out-of-pocket costs depend on:

  • Plan tier placement (typically specialty tier)
  • Deductible status (may need to meet annual deductible first)
  • Coinsurance rates (often 25-50% for specialty drugs)

Potential Cost Support:

  • Manufacturer assistance programs (verify current availability)
  • Medicare Extra Help for low-income beneficiaries
  • State pharmaceutical assistance programs

Note: This information is educational only. Consult your plan documents for specific cost-sharing details.

When to Escalate

Contact Florida insurance regulators if you experience:

  • Repeated inappropriate denials
  • Failure to meet appeal timelines
  • Lack of response from Humana

Florida Department of Financial Services
Insurance Consumer Helpline: 1-877-693-5236
Online complaint system

FAQ

How long does Humana prior authorization take for Tegsedi in Florida?
Standard review takes up to 30 days. Expedited review for urgent cases provides decisions within 24 hours when supported by prescriber documentation.

What if Tegsedi is non-formulary on my Humana plan?
You can request a formulary exception by demonstrating medical necessity and that covered alternatives are inappropriate or ineffective.

Can I appeal if I live in Florida but have coverage from another state?
Yes, but follow your plan's specific procedures. Florida residents with out-of-state plans may still access Florida's consumer assistance resources.

Does step therapy apply to Tegsedi?
Humana may require trying other hATTR treatments first. However, contraindications or prior failures can support step therapy exceptions.

What happens if my REMS enrollment expires?
Treatment must stop until re-enrollment is complete. Work with your prescriber to maintain current REMS status.

Are there alternatives if Tegsedi is denied?
Other FDA-approved hATTR treatments include Amvuttra (vutrisiran), Onpattro (patisiran), and Wainua (eplontersen). Each has similar prior authorization requirements.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies, then drafts evidence-backed rebuttals that address specific payer requirements—like Humana's REMS and specialty pharmacy protocols for medications like Tegsedi.

When navigating complex prior authorizations for rare disease treatments, having the right documentation and understanding payer-specific workflows can make the difference between approval and denial. Counterforce Health specializes in these targeted, evidence-based approaches that align with each plan's own rules and requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Humana directly and consult with your healthcare provider about treatment decisions. For assistance with insurance complaints in Florida, contact the Department of Financial Services at 1-877-693-5236.

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