By Counterforce Health Team in Opdivo (nivolumab) —

How to Get Opdivo (Nivolumab) Covered by Humana in New York: Prior Authorization Guide, Appeals Process, and Step Therapy Requirements

Answer Box: Getting Opdivo (Nivolumab) Covered by Humana in New York

Opdivo (nivolumab) requires prior authorization from Humana Medicare Advantage plans and may be subject to step therapy requirements, especially for lung cancer starting in 2025. The fastest path to approval: 1) Verify your specific plan covers Opdivo using Humana's Drug List tool, 2) Have your oncologist submit prior authorization through Humana's provider portal with complete clinical documentation, and 3) If denied, file an internal appeal within 65 days and consider New York's external review process through the Department of Financial Services. Expedited reviews are available for urgent oncology cases with 72-hour decision timelines.

Table of Contents

Coverage Basics: Is Opdivo Covered by Humana?

Opdivo (nivolumab) coverage under Humana depends on your specific plan type and location. Here's what New York patients need to know:

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Opdivo uses Provider portal submission Humana PA Requirements
Formulary Status Specialty oncology tier Plan-specific drug list Humana Drug List Tool
Part B vs Part D Covered under Part B (medical) Administered in clinical setting Humana Medicare Coverage
Step Therapy May apply (especially NSCLC 2025+) Step therapy preferred drug list Humana Step Therapy List

Which Humana Plans Cover Opdivo?

Opdivo is typically covered under Humana Medicare Advantage plans as a Part B medical benefit, not through Part D prescription coverage. This means the drug must be administered by a healthcare provider in an approved clinical setting—you cannot fill a prescription for Opdivo at a retail or specialty pharmacy for home use.

To confirm coverage for your specific plan, use Humana's Drug List search tool or call the member services number on your ID card.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Network Status (Patient/Clinic Staff)
    • Confirm your oncologist and infusion center are in-network with Humana
    • Document: Provider NPI numbers and facility contracts
    • Timeline: Same day verification
  2. Gather Clinical Documentation (Oncologist's Office)
    • Complete pathology reports with cancer staging
    • Prior treatment history and outcomes/failures
    • Current performance status and treatment goals
    • Document: Medical records, lab results, imaging
    • Timeline: 1-2 business days to compile
  3. Submit Prior Authorization (Provider)
    • Use Humana's provider portal or fax submission
    • Include ICD-10 diagnosis codes and HCPCS code J9299 for billing
    • Timeline: Same day electronic submission
  4. Track Authorization Status (Patient/Provider)
    • Monitor through provider portal or call Humana
    • Standard decision: 14 days for Part B medical benefits
    • Expedited: 72 hours if urgent medical need documented
  5. Schedule Treatment (Upon Approval)
    • Coordinate with infusion center scheduling
    • Verify prior authorization number with facility
    • Timeline: Within authorization validity period
Clinician Corner: Medical Necessity Documentation

Your medical necessity letter should include: specific cancer diagnosis with staging, FDA-approved indication for Opdivo, prior therapies tried and outcomes (including toxicities or contraindications), current performance status, treatment goals, and relevant biomarker results if applicable. For lung cancer cases starting in 2025, document any contraindications to Libtayo (cemiplimab) due to new step therapy requirements.

Timing and Urgency

Standard Timelines

  • Prior Authorization Decision: Up to 14 days for Part B medical benefits
  • Appeal Submission Deadline: 65 days from denial notice date
  • Standard Appeal Decision: 30 days for pre-service, 60 days for post-service

Expedited Review Process If waiting for a standard decision could seriously jeopardize your health, you or your prescriber can request expedited review:

  • Decision Timeline: 72 hours for expedited appeals
  • How to Request: Clearly state "expedited review requested" and document urgent medical need
  • Who Can Request: Patient, appointed representative, or prescribing physician
  • Required Documentation: Clinical rationale for urgency (disease progression, treatment delays)

Contact Humana's expedited review line or submit through the provider portal with urgent designation.

Step Therapy and Clinical Criteria

New 2025 Step Therapy Requirements

Starting January 1, 2025, Humana Medicare Part B requires step therapy for frontline metastatic non-small cell lung cancer (NSCLC):

  • Preferred Agent: Libtayo (cemiplimab)
  • Non-Preferred Agents Requiring Step Through: Opdivo, Keytruda, Tecentriq, Imfinzi, Imjudo, Yervoy
  • Grandfathering: Current users of non-preferred agents may continue therapy
  • Exception Process: Document contraindications or clinical reasons Libtayo is inappropriate

Common Clinical Criteria

  • FDA-approved cancer indication
  • Appropriate line of therapy per NCCN guidelines
  • Adequate performance status (typically ECOG 0-2)
  • Required biomarker testing where indicated by label
  • Documentation of prior therapy failures where applicable

Biomarker Testing Requirements For NSCLC, document PD-L1 expression status when relevant to treatment selection. While not always a coverage requirement, including biomarker results strengthens prior authorization requests and aligns with standard oncology practice.

Understanding Your Costs

Medicare Part B Cost Structure

  • Annual Deductible: Standard Medicare Part B deductible applies
  • Coinsurance: Typically 20% after deductible for in-network providers
  • Out-of-Pocket Maximum: Varies by specific Humana Medicare Advantage plan

Manufacturer Support Programs Bristol Myers Squibb offers patient assistance through:

  • Access Support: Coverage verification and prior authorization assistance
  • Co-pay Programs: May help reduce out-of-pocket costs for eligible patients
  • Patient Assistance Programs: Income-based free drug programs

Contact Bristol Myers Squibb Access Support at 1-855-4-OPDIVO (1-855-467-3486) to explore available programs.

Denials and Appeals Process

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Not medically necessary Submit peer-reviewed evidence supporting use Clinical studies, FDA label, NCCN guidelines
Wrong line of therapy Document prior treatment failures/contraindications Treatment history, toxicity records
Missing biomarker data Provide required lab results Pathology reports, PD-L1 testing
Step therapy not completed Request exception or document contraindications Medical records showing inability to use preferred agent

Appeals Playbook for Humana in New York

Level 1: Internal Appeal (Reconsideration)

  • Deadline: 65 days from denial notice
  • Decision Timeline: 30 days (pre-service) or 60 days (post-service)
  • How to File: Humana member portal or written request
  • Required: Appeal form, supporting clinical documentation

Level 2: Independent Review

  • When Available: After internal appeal denial
  • Timeline: Varies by specific circumstances
  • Process: Automatic referral or patient-initiated

Expedited Appeals

  • Available For: Urgent medical situations where delays could harm health
  • Decision Timeline: 72 hours
  • Documentation: Clinical urgency justification required

New York External Review Rights

New York residents have strong additional appeal rights through the state's external review process.

When to Use External Review After exhausting Humana's internal appeals, you can file an external appeal with the New York Department of Financial Services (DFS) if your denial was based on:

  • Treatment deemed not medically necessary
  • Experimental/investigational designation
  • Out-of-network service denial

External Review Process

  • Filing Deadline: 4 months after final internal denial
  • Cost: Maximum $25 filing fee (waived for financial hardship/Medicaid)
  • Decision Authority: Independent medical experts assigned by DFS
  • Binding: Decision is final and binding on Humana

How to File External Appeal

  1. Download application from NY DFS External Appeals
  2. Submit completed form with supporting documentation
  3. Include all denial letters and medical records
  4. Track status through DFS portal

Expedited External Review Available for urgent situations with decisions within 72 hours (24 hours for urgent drug denials).

From Our Advocates

We've seen New York patients successfully overturn Humana denials for specialty oncology drugs by thoroughly documenting clinical necessity and utilizing the state's external review process. The key is gathering comprehensive medical records and citing relevant medical literature. While outcomes vary by individual case, New York's independent review system provides an important safety net for patients facing coverage denials.

Additional New York Resources

  • Community Health Advocates: Free counseling at 888-614-5400
  • NY SHIP Program: Medicare-specific assistance
  • DFS Consumer Assistance: General insurance help and complaint filing

For comprehensive guidance on using New York's external appeal system, visit Community Health Advocates' database to review similar case outcomes.

Renewal and Ongoing Authorization

When to Renew Authorization

  • Typical Duration: 6-12 months for ongoing cancer treatment
  • Renewal Timing: Submit 30 days before expiration
  • Required Updates: Current imaging, lab results, treatment response documentation

What Changes Trigger New Authorization

  • Dose modifications
  • Treatment schedule changes
  • Addition of combination therapies
  • Disease progression requiring continued treatment

Renewal Documentation Your oncologist should include updated treatment response assessments, current performance status, and rationale for continuing therapy.

Common Issues and Troubleshooting

Portal and System Issues

  • Provider Portal Down: Call Humana provider services for alternative submission methods
  • Missing Forms: Download current forms from Humana provider resources
  • Status Tracking Problems: Contact member services with prior authorization reference number

Communication Breakdowns

  • Delayed Responses: Follow up within 5 business days of submission
  • Missing Information Requests: Respond promptly to avoid automatic denials
  • Peer-to-Peer Reviews: Schedule when requested to discuss clinical rationale directly

Documentation Issues

  • Incomplete Medical Records: Ensure all prior therapies and outcomes are documented
  • Missing Lab Results: Include all relevant biomarker and staging information
  • Unclear Clinical Rationale: Provide specific medical necessity justification

Glossary of Terms

Prior Authorization (PA): Requirement to get insurer approval before receiving a covered service or medication

Step Therapy (ST): Requirement to try preferred treatments before covering non-preferred options

Quantity Limit (QL): Restrictions on the amount of medication covered per time period

Peer-to-Peer Review (P2P): Direct conversation between prescribing physician and insurer's medical director

Letter of Medical Necessity (LMN): Detailed clinical documentation supporting treatment need

Formulary: List of covered medications organized by coverage tiers

HCPCS Code: Healthcare procedure coding system for billing (J9299 for nivolumab)

External Review: Independent evaluation of coverage denials by state-appointed medical experts

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules, pulling the right citations and weaving them into appeals with required clinical facts.

For more information about getting complex prior authorizations approved, visit Counterforce Health.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider regarding treatment decisions and contact Humana directly for the most current coverage information. For personalized assistance with insurance appeals and coverage issues in New York, contact Community Health Advocates at 888-614-5400 or visit the NY Department of Financial Services website.

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