By Counterforce Health Team in Onivyde (irinotecan liposome) —

How to Get Onivyde (Irinotecan Liposome) Covered by Humana in Ohio: Complete Coding, Prior Authorization, and Appeals Guide

Quick Answer: Getting Onivyde Covered by Humana in Ohio

Onivyde (irinotecan liposome) requires prior authorization from Humana for all regimens. The fastest path: ensure your oncologist submits complete documentation with correct ICD-10 codes (C25.0-C25.9 for pancreatic cancer), HCPCS code J9205, and medical necessity justification referencing FDA approval for NALIRIFOX combination therapy. First step today: Contact your oncologist to initiate the PA request with Humana's provider portal or by calling 1-800-555-2546 (verify current number). If denied, you have 65 days to appeal and can request external review through Ohio's process within 180 days.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Pancreatic Cancer
  3. Product Coding: HCPCS, J-Code, and NDC
  4. Clean Prior Authorization Request
  5. Frequent Coding and Billing Pitfalls
  6. Verification with Humana Resources
  7. Appeals Process in Ohio
  8. Quick Pre-Submission Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Onivyde is administered as an IV infusion in clinical settings, placing it under the medical benefit rather than pharmacy benefit for most Humana plans. This affects both coverage determination and billing procedures.

Medical Benefit Coverage:

  • Requires prior authorization through Humana's medical management team
  • Billed using HCPCS J-codes by the administering facility
  • Subject to medical necessity reviews and step therapy requirements
  • Appeals follow medical benefit timelines (65 days for initial appeal)

Key Distinction: Unlike oral specialty medications that go through pharmacy benefits, Onivyde's infusion-based delivery means your oncology clinic handles the authorization and billing directly with Humana.

ICD-10 Mapping for Pancreatic Cancer

Proper diagnosis coding is critical for Onivyde approval. Use the most specific ICD-10 codes available based on pathology and imaging results.

Primary Pancreatic Cancer Codes

ICD-10 Code Description When to Use
C25.0 Malignant neoplasm of head of pancreas Tumor confirmed in pancreatic head
C25.1 Malignant neoplasm of body of pancreas Tumor confirmed in pancreatic body
C25.2 Malignant neoplasm of tail of pancreas Tumor confirmed in pancreatic tail
C25.3 Malignant neoplasm of pancreatic duct Tumor originating in main pancreatic duct
C25.8 Overlapping lesion of pancreas Tumor spans multiple pancreatic regions
C25.9 Malignant neoplasm of pancreas, unspecified Use only when location cannot be determined

Metastatic Disease Documentation

Always include secondary codes for metastatic sites:

  • C78.7 - Secondary malignant neoplasm of liver
  • C78.00 - Secondary malignant neoplasm of unspecified lung
  • C79.51 - Secondary malignant neoplasm of bone
  • C78.6 - Secondary malignant neoplasm of retroperitoneum and peritoneum
Documentation Tip: Include both primary pancreatic cancer code AND specific metastatic site codes. Vague coding like "C79.9 - Secondary malignant neoplasm, unspecified site" may trigger coverage delays.

Product Coding: HCPCS, J-Code, and NDC

Essential Billing Information

  • HCPCS J-Code: J9205 (Injection, irinotecan liposome, 1 mg)
  • NDC Number: 15054-0043-01 (43 mg/10 mL single-dose vial)
  • Billing Unit: 1 unit = 1 mg of irinotecan liposome
  • Standard Vial Size: 43 mg per vial = 43 billing units

Dosing and Unit Calculations

Standard Dosing:

  • 70 mg/m² every 14 days (or 50 mg/m² for UGT1A1*28 homozygous patients)
  • Administered over 90 minutes IV infusion
  • Always part of combination regimens (NALIRIFOX or with 5-FU/leucovorin)

Billing Example:

  • Patient BSA: 1.8 m²
  • Dose: 70 mg/m² × 1.8 m² = 126 mg
  • Vials needed: 3 vials (129 mg total)
  • Bill: 126 units of J9205 + 3 units of J9205 with JW modifier (for waste)

Required Modifiers

  • JW Modifier: Must be used for discarded drug from single-use vials
  • Revenue Code: 0636 (Pharmacy, drugs requiring detailed coding) or 025X (Pharmacy)

Clean Prior Authorization Request

Required Documentation Checklist

Clinical Information:

  • Confirmed pathology report showing pancreatic adenocarcinoma
  • Imaging confirming metastatic disease with specific sites documented
  • Current ECOG performance status (typically 0-1 required)
  • Recent laboratory values (CBC, comprehensive metabolic panel, liver function)

Treatment History:

  • Documentation of treatment-naive status for first-line NALIRIFOX
  • For second-line use: evidence of gemcitabine-based therapy failure or intolerance
  • Contraindications to alternative therapies (if applicable)

Regulatory Support:

  • Reference to FDA approval (February 2024 for first-line NALIRIFOX)
  • NCCN Guidelines citation (Category 1 recommendation)
  • Medical necessity letter from prescribing oncologist

Sample Medical Necessity Language

"Patient has metastatic pancreatic adenocarcinoma confirmed by pathology (C25.1) with hepatic metastases (C78.7). ECOG performance status 1. Treatment-naive for metastatic disease. Request approval for NALIRIFOX regimen including Onivyde per FDA approval February 13, 2024, and NCCN Category 1 recommendation. Alternative regimens contraindicated due to [specific clinical reasons]."

Frequent Coding and Billing Pitfalls

Common Errors That Cause Denials

  1. Unit Conversion Mistakes
    • ❌ Billing 1 unit per 43 mg vial
    • ✅ Billing 43 units per vial (1 unit = 1 mg)
  2. Wrong HCPCS Code
    • ❌ Using non-liposomal irinotecan codes
    • ✅ Always use J9205 for Onivyde specifically
  3. Missing Waste Documentation
    • ❌ Not using JW modifier for discarded portions
    • ✅ Separate line items: used dose + waste with JW modifier
  4. Incomplete Diagnosis Coding
    • ❌ Using only C25.9 (unspecified pancreatic cancer)
    • ✅ Most specific primary code + all metastatic sites
  5. BSA Documentation Gaps
    • ❌ No height/weight or BSA calculation documented
    • ✅ Clear BSA calculation justifying total mg dose

Verification with Humana Resources

Before Submitting Your Request

Check Current Requirements:

  1. Humana Provider Portal: Log in to verify current PA forms and submission methods
  2. Medical Policy Search: Look up Onivyde-specific coverage criteria at Humana's medical policies portal
  3. Formulary Status: Confirm Onivyde's tier placement and any quantity limits

Contact Information Verification:

  • Provider Services: 1-800-555-2546 (verify current number)
  • Prior Authorization Fax: Check current PA form for updated fax number
  • Online Submission: Use Humana provider portal for fastest processing
Important: Always verify contact information and forms with current Humana resources, as these change annually and vary by plan type.

Appeals Process in Ohio

Internal Appeals with Humana

Timeline: 65 days from denial date to file appeal

Required Documents:

  • Original denial letter
  • Updated medical necessity letter addressing specific denial reasons
  • Additional clinical documentation (labs, imaging, treatment history)
  • Peer-reviewed literature supporting Onivyde use (if applicable)

Ohio External Review Process

If Humana upholds the denial, Ohio residents can request external review:

Timeline: 180 days from final internal denial Process: File with Humana, who notifies Ohio Department of Insurance Decision Timeline:

  • Standard review: 30 days
  • Expedited review: 72 hours (for urgent cases)

Ohio Department of Insurance Contact:

When to Request Expedited Review

Request expedited appeals when:

  • Delay would seriously jeopardize health
  • Disease progression is rapid
  • Treatment timing is critical for optimal outcomes

Quick Pre-Submission Audit Checklist

Before submitting any Onivyde request:

Clinical Documentation

  • Most specific ICD-10 codes for primary cancer and all metastatic sites
  • Current pathology and imaging reports attached
  • ECOG performance status documented
  • Recent labs within 30 days

Coding Accuracy

  • HCPCS J9205 used (not other irinotecan codes)
  • NDC 15054-0043-01 specified
  • Units calculated as mg administered (not per vial)
  • JW modifier applied to any wasted drug

Regulatory Compliance

  • FDA indication referenced (NALIRIFOX first-line or combination second-line)
  • NCCN Guidelines cited
  • Medical necessity clearly stated
  • Alternative therapy contraindications documented

Submission Details

  • Current Humana PA form used
  • All required attachments included
  • Prescriber attestation signed
  • Patient demographics and insurance information verified

From Our Advocates: We've seen Onivyde approvals expedited when oncology practices submit complete documentation packages upfront, including BSA calculations, specific metastatic site imaging, and clear medical necessity letters referencing the 2024 FDA approval. Taking time to address potential denial reasons proactively often prevents the need for appeals altogether.

Counterforce Health: Streamlining Complex Appeals

When facing Onivyde denials or navigating complex prior authorization requirements, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, plan policies, and clinical notes to identify specific denial reasons—whether PA criteria, step therapy, non-formulary status, or medical necessity challenges—then drafts point-by-point rebuttals aligned to each payer's requirements.

For Onivyde cases specifically, Counterforce Health pulls relevant citations from FDA labeling, peer-reviewed studies, and NCCN guidelines, weaving them into appeals with required clinical facts like diagnosis codes, prior treatment failures, contraindications, and dosing justifications. The system produces letters that meet Humana's procedural requirements while tracking deadlines and ensuring proper documentation attachment.

FAQ

How long does Humana prior authorization take for Onivyde in Ohio? Standard PA decisions typically take 14-30 days. Expedited requests (for urgent cases) are processed within 72 hours.

What if Onivyde is non-formulary on my Humana plan? You can request a formulary exception through the standard PA process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I appeal if my oncologist is out-of-network? For HMO plans, out-of-network providers typically aren't covered except in emergencies. PPO plans may cover out-of-network care but at higher cost-sharing.

Does step therapy apply to Onivyde? Step therapy requirements vary by indication. First-line NALIRIFOX may require documentation that other first-line options are inappropriate. Second-line use requires evidence of gemcitabine-based therapy failure.

What counts as medical necessity for Onivyde? Medical necessity includes: confirmed metastatic pancreatic adenocarcinoma, appropriate performance status, FDA-approved indication (NALIRIFOX or post-gemcitabine combination), and contraindications or failures of alternative therapies.

How do I request a peer-to-peer review with Humana? Your oncologist can request peer-to-peer review through Humana provider services. This allows direct discussion with Humana's medical director about clinical rationale.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan details, and clinical factors. Always consult with your healthcare provider and insurance plan directly for coverage determinations. For additional help with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.