Getting Vitrakvi (Larotrectinib) Covered by Humana in Ohio: Complete Coding, PA, and Appeals Guide
Answer Box: Your Fastest Path to Vitrakvi Coverage
Getting Vitrakvi (larotrectinib) covered by Humana in Ohio requires proper NTRK gene fusion documentation, correct ICD-10 coding, and meeting prior authorization requirements. Most approvals happen within 1-2 business days when submitted electronically with complete documentation.
Your 3-step action plan:
- Confirm NTRK fusion status with validated molecular testing (NGS, FISH, or RT-PCR)
- Submit prior authorization via Humana's provider portal with pathology report and clinical notes
- Use correct ICD-10 codes for your tumor site (C50.x for breast, C34.x for lung, etc.) plus metastatic/unresectable documentation
If denied, Ohio residents have 65 days to appeal and can request external review through the Ohio Department of Insurance.
Table of Contents
- Coding Basics: Medical vs. Pharmacy Benefit
- ICD-10 Mapping for NTRK-Positive Tumors
- Product Coding: NDCs and Units
- Clean Request Anatomy
- Frequent Coding Pitfalls
- Humana Verification Steps
- Pre-Submission Audit Checklist
- Appeals Playbook for Ohio
- FAQ
Coding Basics: Medical vs. Pharmacy Benefit
Vitrakvi (larotrectinib) is an oral targeted cancer therapy that falls under Medicare Part D pharmacy benefits, not Part B medical benefits. This distinction affects how you code and bill for coverage.
Key coding points:
- No J-code exists for oral Vitrakvi since J-codes apply to injectable/infusible drugs
- Use NDC billing for pharmacy claims through Part D
- Prior authorization required for most Humana Medicare Advantage plans
- Specialist prescriber (oncologist/hematologist) typically required
Note: Unlike injectable cancer drugs that may be covered under Part B, oral medications like Vitrakvi require Part D coverage and pharmacy benefit determination.
ICD-10 Mapping for NTRK-Positive Tumors
There's no specific ICD-10 code for "NTRK gene fusion positive tumor." Instead, use the site-specific malignant neoplasm code for the primary tumor location.
Common ICD-10 Codes for NTRK-Positive Tumors
| Primary Site | ICD-10 Code | Example |
|---|---|---|
| Breast | C50.911 | Malignant neoplasm of unspecified site of right female breast |
| Lung | C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| Colon | C18.9 | Malignant neoplasm of colon, unspecified |
| Thyroid | C73 | Malignant neoplasm of thyroid gland |
| Soft tissue sarcoma | C49.9 | Malignant neoplasm of connective and soft tissue, unspecified |
| Unknown primary | C80.1 | Malignant (primary) neoplasm, unspecified |
Documentation Words That Support Coding
Your clinical notes should include specific language that supports the ICD-10 code and medical necessity:
- NTRK fusion status: "NTRK gene fusion detected by [NGS/FISH/RT-PCR]"
- Disease stage: "metastatic," "unresectable," "locally advanced"
- Prior therapies: "progressed following [specific treatments]"
- Treatment rationale: "candidate for TRK inhibitor therapy"
Product Coding: NDCs and Units
Vitrakvi comes in two formulations, each with specific NDC codes and dosing considerations.
NDC Codes and Strengths
| Formulation | Strength | NDC | Package Size |
|---|---|---|---|
| Capsules | 25 mg | 50419-0188-56 | 56 capsules |
| Capsules | 100 mg | 50419-0189-56 | 56 capsules |
| Oral Solution | 20 mg/mL | 50419-0190-01 | 100 mL bottle |
Dosing and Units Math
Adult dosing (BSA ≥1.0 m²): 100 mg orally twice daily
- Monthly supply: 60 × 100 mg capsules = 6,000 mg total
- Alternative: 240 × 25 mg capsules = 6,000 mg total
Pediatric dosing (BSA <1.0 m²): 100 mg/m² orally twice daily
- Calculate: BSA × 100 mg × 2 doses × 30 days
- Maximum: 100 mg per dose (same as adult)
Oral solution conversions:
- 1 mL = 20 mg larotrectinib base
- For 50 mg dose: 2.5 mL twice daily
- Monthly volume: 150 mL (1.5 bottles)
Important: Always specify dosing in mg of larotrectinib base, not sulfate salt equivalent. The 100 mg base equals 123 mg sulfate, but billing should use base measurements.
Clean Request Anatomy
A successful prior authorization request includes these essential components:
Patient Information Section
- Name, DOB, Humana ID number
- Prescribing physician (board-certified oncologist preferred)
- ICD-10 diagnosis code with site-specific malignancy
- Date of diagnosis and staging information
Clinical Documentation
- Pathology report confirming NTRK gene fusion
- Molecular test details: assay method, fusion partner, laboratory
- Disease status: metastatic, unresectable, or locally advanced
- Prior therapy history: treatments tried, dates, outcomes
- Contraindications to alternative therapies if applicable
Prescription Details
- Drug name: Vitrakvi (larotrectinib)
- Strength and formulation: 25 mg or 100 mg capsules, or 20 mg/mL solution
- Dosing: mg amount, frequency, duration
- NDC code matching the prescribed strength
- Quantity: 30-day or 90-day supply as appropriate
Supporting Evidence
- FDA labeling reference for tissue-agnostic indication
- Clinical guidelines supporting use (NCCN, ASCO if applicable)
- Literature citations for rare tumor types if needed
Frequent Coding Pitfalls
Avoid these common errors that lead to denials or billing problems:
Unit Conversion Errors
- Wrong: Prescribing 100 mg/m² for adults (pediatric dosing)
- Right: 100 mg twice daily for BSA ≥1.0 m²
- Wrong: Billing oral solution in mL instead of mg
- Right: Convert volume to mg base (1 mL = 20 mg)
Missing Documentation
- Wrong: Submitting PA without molecular test results
- Right: Include complete pathology report with NTRK fusion confirmation
- Wrong: Using generic "cancer" diagnosis
- Right: Site-specific ICD-10 code (C50.x, C34.x, etc.)
Prescriber Issues
- Wrong: Primary care physician prescribing
- Right: Board-certified oncologist or hematologist
- Wrong: Missing NPI or DEA information
- Right: Complete prescriber credentials
Timing Problems
- Wrong: Requesting coverage before molecular testing
- Right: Confirm NTRK fusion before PA submission
- Wrong: Missing start date or duration
- Right: Specific treatment timeline with monitoring plan
Humana Verification Steps
Before submitting your prior authorization, verify these details through Humana's systems:
Check Formulary Status
- Visit Humana's drug lookup tool
- Search "larotrectinib" or "Vitrakvi"
- Note formulary tier and restrictions
- Review quantity limits and step therapy requirements
Confirm PA Requirements
- Access Humana's PA search tool
- Look up current criteria for larotrectinib
- Download the most recent PA form
- Review clinical criteria and documentation requirements
Submission Methods
- Fastest: Electronic submission via provider portal (85%+ decided within 1 business day)
- Fax: 877-486-2621 (verify current number)
- Phone: 800-555-CLIN (2546) for Clinical Pharmacy team
Pre-Submission Audit Checklist
Use this checklist to review your PA request before submission:
Documentation Complete?
- NTRK gene fusion test report attached
- Site-specific ICD-10 diagnosis code used
- Metastatic/unresectable status documented
- Prior therapy history included
- Board-certified oncologist prescribing
Prescription Accurate?
- Correct NDC for prescribed strength
- Dosing in mg larotrectinib base (not sulfate)
- Appropriate quantity for supply period
- BSA calculation included for pediatric patients
Forms and Process?
- Most current Humana PA form used
- All required fields completed
- Supporting documents attached
- Submission method confirmed (portal preferred)
Appeals Playbook for Ohio
If your initial prior authorization is denied, Ohio residents have specific appeal rights and timelines.
Humana Internal Appeals
Timeline: 65 days from denial notice Process:
- Call Humana Member Services: 1-800-833-2364
- Request internal appeal in writing
- Submit additional documentation if available
- Response within 30 days for standard appeals, 72 hours for expedited
Ohio External Review
Timeline: 180 days from final internal denial Process:
- Request external review through your health plan
- Plan notifies Ohio Department of Insurance
- Independent Review Organization (IRO) assigned
- Decision within 30 days (72 hours if expedited)
- IRO decision is binding on Humana
When to Request Expedited Review
- Delay would seriously jeopardize your health
- Cancer progression without treatment
- Standard timeline would reduce treatment effectiveness
Ohio-Specific Advantage: Even if Humana claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility and order a review.
Counterforce Health helps patients and clinicians navigate complex prior authorization denials by turning insurance rejections 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 payer's own rules. For medications like Vitrakvi, we pull the right evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals with required clinical facts like NTRK fusion documentation and prior therapy history. Learn more about our coverage appeal services.
Getting Help in Ohio
- Ohio Department of Insurance Consumer Hotline: 1-800-686-1526
- OSHIIP (Medicare issues): Ohio Senior Health Insurance Information Program
- UHCAN Ohio: Universal Health Care Action Network for consumer assistance
FAQ
How long does Humana prior authorization take for Vitrakvi in Ohio? Electronic submissions through Humana's provider portal receive decisions within 1 business day for 85%+ of cases. Fax submissions typically take 2-5 business days. Expedited reviews are completed within 72 hours when medically urgent.
What if Vitrakvi is non-formulary on my Humana plan? You can request a formulary exception if alternative drugs wouldn't be as effective for your condition. Include documentation showing why covered alternatives aren't appropriate, such as contraindications or prior treatment failures.
Can I request an expedited appeal in Ohio? Yes, if a delay would seriously endanger your health or reduce treatment effectiveness. Both Humana internal appeals and Ohio external reviews offer expedited timelines (72 hours vs. 30 days).
Does step therapy apply if I've already tried treatments outside Ohio? Step therapy requirements typically apply regardless of where prior treatments occurred. Document all previous therapies with dates, outcomes, and reasons for discontinuation to support your request.
What counts as medical necessity for Vitrakvi? Medical necessity requires: confirmed NTRK gene fusion by validated testing, metastatic or unresectable solid tumor, and either no satisfactory alternatives or progression following prior treatment per FDA labeling.
How do I get help with my Humana appeal in Ohio? Contact the Ohio Department of Insurance Consumer Hotline at 1-800-686-1526 for assistance with appeals. Counterforce Health also provides specialized support for complex prior authorization denials and appeals.
What if my tumor type is very rare? NTRK fusions occur across many tumor types. Include relevant literature citations and specialty guidelines supporting Vitrakvi use in your specific histology. The FDA's tissue-agnostic approval covers solid tumors regardless of site.
Can my primary care doctor prescribe Vitrakvi? Most payers, including Humana, require prescribing by a board-certified oncologist or hematologist due to the drug's specialty nature and need for molecular testing interpretation.
Sources & Further Reading
- Humana Prior Authorization Portal
- Ohio Department of Insurance Appeals
- FDA Vitrakvi Prescribing Information
- Humana Drug Formulary Lookup
- Bayer Vitrakvi Access Services
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with your insurance plan and consult healthcare professionals for medical decisions. For official guidance on Ohio insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.