By Counterforce Health Team in Opdivo (nivolumab) —

The Requirements Checklist to Get Opdivo (Nivolumab) Covered by Humana in Florida: Forms, Appeals, and Medical Necessity

Answer Box: Getting Opdivo Covered by Humana in Florida

Eligibility: Opdivo (nivolumab) requires prior authorization for all Humana Medicare Advantage plans in Florida. Coverage falls under Part B medical benefits, not Part D pharmacy coverage.

Fastest approval path: Your oncologist submits a complete prior authorization request through Humana's provider portal or by fax to 877-486-2621, including pathology reports, biomarker testing, staging information, and a medical necessity letter referencing FDA labeling.

First step today: Contact your oncologist's office to confirm they have your complete pathology reports, prior treatment history, and current staging information ready for submission. Standard decisions take 30 days; expedited appeals (for urgent cases) receive decisions within 72 hours.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Appeals Process in Florida
  8. Common Denial Prevention Tips
  9. FAQ: Opdivo Coverage with Humana
  10. Printable Checklist

Who Should Use This Checklist

This guide is designed for cancer patients and their care teams navigating Opdivo (nivolumab) coverage through Humana Medicare Advantage plans in Florida. You'll benefit from this checklist if:

  • Your oncologist has recommended Opdivo for an FDA-approved indication
  • You have active Humana Medicare Advantage coverage
  • You're facing a prior authorization requirement or denial
  • You need to understand the appeals process specific to Florida

Expected outcome: Following this checklist improves your chances of first-time approval and provides a clear roadmap for appeals if needed. Humana has a relatively low Medicare Advantage prior authorization denial rate of approximately 3.5% (2023), but denials that occur often stem from incomplete documentation or formulary placement issues.

Member & Plan Basics

Coverage Verification

Before starting your prior authorization request, confirm these basics:

  • Active Humana Medicare Advantage enrollment in Florida
  • Part B medical coverage (Opdivo is covered under medical benefits, not Part D pharmacy)
  • Current member ID and policy information
  • Annual deductible status (you'll typically pay 20% coinsurance after meeting your deductible)

Prior Authorization Requirements

All Humana Medicare Advantage plans require prior authorization for Opdivo before treatment begins. This applies to both the standard intravenous formulation and the newer subcutaneous Opdivo Qvantig (approved December 2024).

Note: Prior authorization is mandatory—filling without approval may result in full out-of-pocket costs.

Clinical Criteria Requirements

FDA-Approved Indications

Opdivo must be prescribed for an FDA-approved indication, including:

  • Melanoma: Unresectable or metastatic disease
  • Non-small cell lung cancer (NSCLC): Advanced squamous NSCLC or resectable stages 2A-3B
  • Head and neck squamous cell carcinoma: Recurrent or metastatic disease
  • Urothelial carcinoma: Locally advanced or metastatic disease
  • Esophageal and gastroesophageal junction cancer: Various settings
  • Gastric cancer: Advanced or metastatic disease (in combination)
  • Colorectal cancer: MSI-H or dMMR tumors
  • Hepatocellular carcinoma: First-line treatment (in combination with ipilimumab)
  • Renal cell carcinoma: Various indications

Biomarker Testing Requirements

Specific biomarker testing may be required depending on your cancer type:

  • Colorectal cancer: MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient) status must be confirmed
  • NSCLC: EGFR or ALK genomic testing may be required to exclude patients with known mutations
  • Other tumor types: PD-L1 testing may be requested but isn't universally required

Step Therapy Considerations

Check Humana's 2025 Step Therapy List to determine if you must try preferred immunotherapies first unless contraindicated.

Coding & Billing Information

HCPCS Codes

  • Standard Opdivo (IV): J9299 (1 mg = 1 billing unit)
  • Opdivo Qvantig (subcutaneous): J9289 (effective July 1, 2025)

ICD-10 Diagnosis Codes

Common diagnosis codes for Opdivo indications:

  • Melanoma: C43.x (site-specific)
  • Lung cancer: C78.x (depending on staging)
  • Renal cell carcinoma: C64
  • Colorectal cancer: C18.x-C20 (site-specific)

Required Modifiers

  • JA modifier: For intravenous infusion
  • JB modifier: For subcutaneous injection (Opdivo Qvantig)

Documentation Packet Essentials

Core Medical Records

Your oncologist must submit:

  1. Complete pathology reports with specific cancer type and staging
  2. Biomarker testing results (as applicable to your cancer type)
  3. Prior treatment history with dates, outcomes, and reasons for discontinuation
  4. Current performance status (ECOG or Karnofsky scale)
  5. Imaging reports confirming current disease status

Medical Necessity Letter Components

The medical necessity letter should include:

  • Patient identification and diagnosis with ICD-10 codes
  • FDA-approved indication being treated
  • Clinical rationale for Opdivo selection
  • Prior therapies tried and failed or contraindications to alternatives
  • Treatment goals and expected outcomes
  • References to FDA labeling and NCCN guidelines
  • Dosing schedule and monitoring plan
Clinician Corner: Include specific citations from FDA labeling and major oncology society guidelines (NCCN, ASCO) to strengthen medical necessity arguments. Reference the patient's specific biomarker status and staging information.

Submission Process

Submission Methods

Healthcare Provider Submission (Recommended):

  • Online through Humana's provider portal
  • Fax to 877-486-2621
  • Phone: 800-555-CLIN (2546) (Monday-Friday, 8 a.m.-8 p.m. local time)

Member Direct Submission:

Required Forms

Download the "Request for Medicare Prescription Drug Coverage Determination Form" from Humana's forms page (available in English and Spanish).

Timeline Expectations

  • Standard decisions: 30 calendar days for Part B medical services
  • Expedited appeals: 72 hours if delay could harm your health
  • Confirmation: You'll receive a determination letter by mail

Appeals Process in Florida

Internal Appeal Timeline

If your initial request is denied, you have 65 days from the denial notice to file an appeal with Humana.

Appeal Submission Options

  • Online: Through Humana's member portal
  • Mail/Fax: Using the Appeal, Complaint or Grievance Form
  • Phone: 800-867-6601 for expedited appeals

External Review in Florida

If Humana's internal appeal is unsuccessful, Florida law provides external review rights:

  1. Timeline: You have 4 months after final internal denial to request external review
  2. Process: Submit request through Florida Department of Financial Services
  3. Cost: No charge to consumers for external review
  4. Decision: External reviewer decisions are binding on Humana
Florida-Specific Resource: Contact Florida's Insurance Consumer Helpline at 1-877-MY-FL-CFO (877-693-5236) for assistance with appeals.

For urgent cases involving life-threatening conditions, you can request expedited internal and external review simultaneously, with decisions possible within 72 hours.

Common Denial Prevention Tips

Five Key Pitfalls to Avoid

  1. Incomplete biomarker testing: Ensure all required testing (MSI-H, dMMR, PD-L1) is completed and documented
  2. Missing prior therapy documentation: Include detailed records of previous treatments, dates, and outcomes
  3. Inadequate staging information: Provide complete TNM staging and current imaging reports
  4. Generic medical necessity letters: Customize letters with patient-specific clinical details and guideline references
  5. Wrong billing codes: Verify correct HCPCS codes (J9299 for IV, J9289 for subcutaneous)

Pro Tips for Success

  • Submit requests early in your treatment planning process
  • Include all supporting documentation in the initial submission
  • Keep detailed records of all communications and confirmation numbers
  • Follow up within 5-7 business days if you haven't received confirmation

FAQ: Opdivo Coverage with Humana

Q: How long does Humana prior authorization take in Florida? A: Standard decisions take 30 calendar days for Part B medical services. Expedited appeals for urgent cases receive decisions within 72 hours.

Q: What if Opdivo is not on Humana's formulary? A: Opdivo products were updated on Humana's formulary effective January 1, 2025. You can also request a formulary exception if coverage issues arise.

Q: Can I get expedited approval for Opdivo? A: Yes, if you or your provider believe waiting could seriously harm your health, request an expedited appeal by calling 800-867-6601.

Q: What are my out-of-pocket costs with Humana Medicare Advantage? A: You typically pay 20% coinsurance after meeting your annual deductible. For a $7,943 vial, this equals approximately $1,589 per dose.

Q: Does step therapy apply to Opdivo in Florida? A: Check Humana's 2025 Step Therapy List to determine if you must try preferred alternatives first, unless contraindicated.

Printable Checklist

Before Submission ✓

  • Confirm active Humana Medicare Advantage coverage
  • Verify FDA-approved indication for your cancer type
  • Complete all required biomarker testing
  • Gather complete pathology and staging reports
  • Document prior therapy history with outcomes
  • Obtain current performance status assessment

Documentation Package ✓

  • Medical necessity letter with guideline references
  • Complete pathology reports
  • Biomarker testing results
  • Prior treatment records
  • Current imaging/staging information
  • ICD-10 diagnosis codes included
  • Correct HCPCS codes verified (J9299 or J9289)

Submission ✓

  • Submit via provider portal or fax to 877-486-2621
  • Keep confirmation number
  • Schedule follow-up in 5-7 business days
  • Prepare appeal documentation if needed

If Denied ✓

  • File internal appeal within 65 days
  • Include additional clinical evidence
  • Consider peer-to-peer review request
  • Prepare for external review if needed (within 4 months)

From our advocates: "The most successful Opdivo approvals we see include comprehensive biomarker testing results and detailed prior therapy documentation in the initial submission. Taking time to gather complete clinical records upfront often prevents delays and denials later in the process."

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for cancer patients and their care teams. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals that align with each payer's requirements. For complex cases like Opdivo prior authorizations, we help clinicians craft targeted medical necessity arguments using the right clinical evidence and payer-specific language.

Whether you're facing a Humana denial or need help navigating prior authorization requirements, Counterforce Health provides the tools and expertise to improve your chances of coverage approval while reducing administrative burden on your care team.

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 guidance specific to your situation. Appeal rights and processes may vary by plan type and state regulations.

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