By Counterforce Health Team in Vitrakvi (larotrectinib) —

How to Get Vitrakvi (Larotrectinib) Covered by Humana in Florida: Prior Authorization Guide and Appeal Scripts

Answer Box: Getting Vitrakvi Covered by Humana in Florida

Vitrakvi (larotrectinib) requires prior authorization from Humana Medicare Advantage plans in Florida. Your fastest path to approval: Submit complete NTRK fusion testing documentation with your PA request. If denied, you have 65 days to appeal internally, then can request external review through Florida's Department of Financial Services. Start today: Call Humana Member Services (number on your ID card) to request PA forms and confirm your plan's specific requirements. Expedited appeals are available for urgent oncology cases with 24-72 hour decisions.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana MA plans Humana provider portal Humana PA Requirements
NTRK Fusion Testing Must document positive NTRK gene fusion CLIA-certified lab report FDA Label Requirements
Formulary Status Typically Tier 5 specialty Plan formulary document Humana Formulary Search
Prescriber Requirements Oncologist or hematologist preferred PA form Humana Medical Policy
Age Restrictions Adults require full PA documentation Plan documents Medicare Part D Guidelines
Appeal Deadlines 65 days from denial notice Denial letter CMS Appeal Rights

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Caregiver)

  • Insurance card with member ID
  • Complete NTRK fusion test results from CLIA-certified lab
  • All prior cancer treatment records
  • Current oncologist contact information

2. Obtain PA Forms (Clinic Staff)

3. Complete Medical Necessity Documentation (Prescriber) Required elements for your letter:

  • Confirmed NTRK gene fusion with fusion partner details
  • Tumor histology and staging (metastatic/unresectable)
  • Prior therapies attempted and outcomes
  • Contraindications to alternative treatments
  • Dosing plan based on BSA (pediatric) or standard adult dosing

4. Submit Complete PA Request (Clinic)

  • Submit via Humana provider portal or fax
  • Include all supporting documents in single submission
  • Timeline: Humana processes 85% within 1 business day

5. Track Your Request

  • Call Humana Member Services for status updates
  • Request expedited review if medically urgent
  • Standard decision: Within 30 days for Part C, 72 hours for Part D

6. If Denied: File Internal Appeal Immediately

  • Submit within 65 days of denial notice
  • Include additional clinical documentation
  • Timeline: 30 days for standard, 72 hours for expedited

7. External Review if Needed

  • Request through Florida Department of Financial Services
  • Available after internal appeal denial
  • Timeline: 4 months to request, 72 hours for urgent cases

Florida Prior Authorization Laws and Your Rights

How Florida Rules Interact with Federal Medicare

While Humana Medicare Advantage plans follow federal Medicare rules, Florida provides additional consumer protections that can strengthen your position during appeals.

Key Florida Protections:

  • 180-day appeal window for most insurance disputes (though Medicare's 65-day rule takes precedence for MA plans)
  • Mandatory external review after internal appeals are exhausted
  • Consumer assistance through the Department of Financial Services

Turnaround Standards in Florida

Review Type Timeline Authority
Standard PA 30 days (Part C), 72 hours (Part D) Federal Medicare rules
Expedited PA 24-72 hours 42 CFR § 423.567
Internal Appeal 30-60 days standard, 72 hours expedited CMS regulations
External Review 72 hours for urgent cases Florida DFS process

Step Therapy Protections

Florida's Medicaid program has explicit medical necessity override procedures, but Medicare Advantage plans follow federal guidelines. However, oncology medications often receive special consideration:

Note: While Florida doesn't have a specific oncology carveout for step therapy, Medicare Part D plans must consider "medically accepted indications" and cannot require step therapy for drugs with no therapeutic alternatives.

Continuity of Care Rights

If you're already taking Vitrakvi and switching to a new Humana plan:

  • Transition supplies: Up to 30-day temporary coverage while PA is processed
  • Ongoing therapy: Simplified reauthorization if therapy is stable
  • Grace periods: Protection against coverage gaps during plan transitions

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
"No NTRK fusion documented" Submit complete lab report CLIA-certified NGS or RNA fusion assay results
"Tumor is resectable" Provide surgical consultation Oncology note stating unresectable/metastatic status
"Prior therapies not attempted" Document treatment history Chemotherapy records or contraindication letter
"Non-specialist prescriber" Transfer to oncologist New prescription from hematology/oncology
"Off-label use suspected" Clarify FDA indication Reference FDA label for tumor-agnostic approval
"Quantity limits exceeded" Justify dosing BSA calculation (pediatric) or standard adult dosing
From Our Advocates: "We've seen many Vitrakvi denials overturned simply by submitting the complete molecular pathology report that clearly shows the NTRK fusion partner and confirms no resistance mutations. The key is ensuring your lab report explicitly states 'NTRK gene fusion positive' rather than just listing genetic alterations."

Appeals Playbook for Humana in Florida

Level 1: Internal Appeal (Reconsideration)

Who Can File: Member, prescriber, or authorized representative Deadline: 65 days from denial notice How to Submit:

Required Documents:

  • Original denial letter
  • Updated medical necessity letter
  • Additional clinical evidence
  • Peer-reviewed studies supporting use

Level 2: Independent Review (External)

Trigger: After internal appeal denial Deadline: 60 days from internal denial Process: Automatically forwarded to Maximus Federal (CMS contractor) Timeline: 72 hours for expedited cases

Level 3: Administrative Law Judge

Eligibility: If dispute value ≥$170 (2024 threshold) Timeline: 90 days for decision Representation: Legal counsel recommended

Scripts and Templates

Patient Phone Script for Humana Member Services

"Hello, I'm calling about prior authorization for Vitrakvi, also called larotrectinib, for my NTRK fusion-positive cancer. My member ID is [ID number]. Can you tell me the specific PA requirements and forms needed? I also want to confirm if this requires expedited review given the urgency of my cancer treatment."

Clinic Staff Script for Peer-to-Peer Review

"I'm requesting a peer-to-peer review for [Patient Name] regarding the Vitrakvi denial. The patient has a confirmed NTRK gene fusion-positive solid tumor with no satisfactory treatment alternatives. The denial appears to be based on [specific reason from denial letter]. When can we schedule this review with one of your oncology medical directors?"

Medical Necessity Letter Template

Key paragraphs to include:

"This patient has a histologically confirmed [tumor type] with documented NTRK gene fusion as demonstrated by [specific assay method]. Vitrakvi (larotrectinib) is FDA-approved for this exact indication and represents the only targeted therapy available for this molecular alteration."
"Prior treatments including [list specific therapies] have [failed/are contraindicated/caused intolerable side effects]. Given the rarity of NTRK fusions (occurring in <1% of solid tumors) and the high response rates seen with larotrectinib across multiple histologies, this therapy is not only medically necessary but represents the standard of care for this molecular subtype."

Costs and Financial Assistance

Manufacturer Support Programs

Bayer's TRAK Assist Program:

  • Copay assistance for eligible commercial patients
  • Free drug program for uninsured/underinsured
  • Prior authorization support services
  • Contact: 1-833-TRAK-411

Foundation Resources

  • Patient Access Network Foundation: NTRK-positive cancer fund
  • CancerCare: Financial assistance and copay relief
  • American Cancer Society: Transportation and lodging assistance

Estimated Costs

  • Wholesale Acquisition Cost: ~$32,800 per 30-day supply
  • With Insurance: Varies by plan design and tier placement
  • Patient Assistance: May reduce copay to $0 for eligible patients

When to Escalate: State Resources

Florida Department of Financial Services

When to Contact:

  • Humana delays processing beyond required timelines
  • Denial appears to contradict plan documents
  • Communication problems with member services

How to File Complaint:

Required Information:

  • Humana policy/member number
  • Timeline of events and correspondence
  • Specific complaint about process or decision
  • Desired resolution

External Review Process

Florida contracts with independent review organizations to conduct external appeals. After exhausting Humana's internal appeals:

  1. Request external review within 4 months of final denial
  2. Submit through DFS or request form from Humana
  3. Include all medical records and correspondence
  4. Decision is binding on Humana if overturned

Frequently Asked Questions

Q: How long does Humana prior authorization take for Vitrakvi in Florida? A: Humana processes 85% of PA requests within one business day when complete documentation is submitted. Complex cases may take up to 30 days for Part C coverage.

Q: What if Vitrakvi is non-formulary on my Humana plan? A: You can request a formulary exception by demonstrating that covered alternatives are not medically appropriate. Submit evidence that Vitrakvi is medically necessary for your specific NTRK fusion.

Q: Can I request an expedited appeal for cancer treatment? A: Yes. If waiting for a standard decision could seriously jeopardize your health, request expedited review. Humana must decide within 24-72 hours for urgent cases.

Q: Does Florida's step therapy law apply to Medicare Advantage? A: Federal Medicare rules supersede state step therapy laws. However, oncology medications often receive exceptions, especially for rare molecular subtypes like NTRK fusions.

Q: What happens if I move to Florida while taking Vitrakvi? A: Contact Humana immediately to ensure continuity of coverage. You may be eligible for transition supplies while your PA is processed in the new state.

Q: Who can help me navigate the appeal process in Florida? A: Contact Florida's Insurance Consumer Helpline at 1-877-MY-FL-CFO for free assistance with insurance disputes and appeals.

Q: What documentation do I need for an NTRK fusion test? A: You need results from a CLIA-certified laboratory showing the specific NTRK gene fusion (NTRK1, NTRK2, or NTRK3), fusion partner, and confirmation that the kinase domain is retained.

Q: How much will Vitrakvi cost with Humana coverage? A: Costs vary by plan design, but manufacturer copay assistance may reduce out-of-pocket expenses to $0 for eligible commercial patients. Contact Bayer's TRAK Assist program for specific assistance.

Counterforce Health specializes in helping patients and providers navigate complex prior authorization requirements for specialty medications like Vitrakvi. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with payer-specific requirements and maximize approval rates.

For additional support with your Vitrakvi appeal, Counterforce Health can help identify the specific denial basis and draft point-by-point rebuttals using the right clinical evidence and procedural requirements for Humana Medicare Advantage plans in Florida.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Prior authorization requirements and appeal procedures may change. Always consult your healthcare provider for medical decisions and verify current requirements with Humana and Florida regulatory authorities.

Sources & Further Reading

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