Answer Box: Getting Bavencio (avelumab) Covered by Humana in North Carolina

Bavencio (avelumab) requires prior authorization from Humana but is covered for FDA-approved indications (metastatic Merkel cell carcinoma and certain urothelial carcinoma cases). Fastest path to approval: Submit complete PA with diagnosis, staging, performance status, and treatment history. First step today: Call Humana at the number on your member card to confirm your plan type and get the current PA form. If denied: You have federal Medicare appeal rights (not NC external review) with strict timelines.

Table of Contents

1. Policy Overview
2. Indication Requirements
3. Step Therapy & Exceptions
4. Required Diagnostics
5. Site of Care & Specialty Pharmacy
6. Evidence to Support Medical Necessity
7. Sample "Meets Criteria" Narrative
8. Appeals Process for North Carolina
9. Common Denial Reasons & Fixes
10. Quick Reference Table
11. FAQ

Policy Overview

Plan Types and How Policies Apply

Humana's coverage for Bavencio varies by plan type in North Carolina:

• Medicare Advantage: Covered as Part B drug (J9023) with prior authorization required
• Commercial plans: Subject to state regulations and Humana's medical policies
• Dual Medicare-Medicaid: Follow Medicare Advantage rules with potential Medicaid coordination

Bavencio appears on Humana's 2024-2025 Medicare Advantage Medication Preauthorization List under HCPCS code J9023, confirming it requires prior authorization but is not subject to step therapy restrictions.

Where to Find Official Documentation

• Humana's coverage policy for Bavencio: Search Humana's Medical and Pharmacy Coverage Policies
• Current PA forms: Available through Humana provider portal or member services
• Appeal forms: Included with denial letters or available on Humana's website

Indication Requirements

FDA-Approved Uses

Bavencio is FDA-approved for:

1. Metastatic Merkel cell carcinoma (adults and pediatric patients ≥12 years)
2. Locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy (maintenance treatment)
3. Previously treated urothelial carcinoma with disease progression during/after platinum therapy

On-Label vs. Off-Label Considerations

Humana typically covers Bavencio only for FDA-labeled indications. Off-label use may require:

• Peer-reviewed literature supporting the indication
• NCCN Compendium listing (Category 2A or higher)
• Documentation of why FDA-approved alternatives are inappropriate

Step Therapy & Exceptions

Current Step Therapy Status

Based on Humana's 2025 Part B Step Therapy Preferred Drug List, Bavencio does not appear to have formal step therapy requirements. However, clinical documentation must show:

• Appropriate diagnosis and staging
• Performance status (typically ECOG 0-2)
• For urothelial carcinoma maintenance: completion of first-line platinum chemotherapy without progression

Medical Exception Pathways

If step therapy were required, exceptions could be granted for:

• Medical contraindication to preferred agents
• Previous failure or intolerance to required first-line therapies
• Drug interaction concerns with preferred medications

Required Diagnostics

Essential Documentation

For Merkel cell carcinoma:

• Pathology report confirming MCC diagnosis
• Staging studies (CT, PET, or MRI) showing metastatic disease
• Performance status assessment (ECOG 0-2)

For urothelial carcinoma:

• Pathology confirming urothelial histology
• Documentation of first-line platinum chemotherapy (regimen, cycles, dates)
• Restaging scans showing no progression (CR, PR, or stable disease)
• ICD-10 codes: C67.x (bladder), C65.x (renal pelvis), C66.x (ureter)

Timing and Recency Requirements

• Staging studies should be within 30-60 days of PA request
• Performance status documented within 30 days
• For maintenance therapy: restaging within 4-8 weeks of platinum completion

Site of Care & Specialty Pharmacy

Humana's Site of Care Requirements

Bavencio infusions may be administered at:

• Hospital outpatient infusion centers
• Physician offices with appropriate infusion capabilities
• Freestanding infusion centers
• Home infusion (after initial doses, if clinically appropriate)

Note: First doses are often restricted to monitored outpatient settings due to infusion reaction risks.

Specialty Pharmacy Routing

Humana typically requires specialty drugs to be dispensed through CenterWell Specialty Pharmacy for:

• Home infusion services
• Site-of-care optimization programs
• Coordination with infusion centers

Contact CenterWell at the provider line listed on their website to confirm drug sourcing requirements for your specific case.

Evidence to Support Medical Necessity

Required Clinical Elements

Your medical necessity letter should include:

1. Patient demographics and diagnosis
2. Disease staging and extent
3. Performance status (ECOG scale)
4. Prior treatments and responses/failures
5. Planned dosing: 800 mg IV every 2 weeks
6. Treatment goals and expected duration

Guideline Citations

Reference these in your PA request:

• FDA labeling for metastatic MCC or maintenance UC therapy
• NCCN Guidelines listing avelumab as preferred regimen for advanced MCC
• NCCN Compendium Category 2A recommendation for single-agent avelumab in MCC

Sample "Meets Criteria" Narrative

"This 68-year-old patient with biopsy-proven metastatic Merkel cell carcinoma (stage IV, multiple liver and lung metastases on CT chest/abdomen/pelvis dated [date]) has an ECOG performance status of 1 and is appropriate for systemic immunotherapy. Bavencio (avelumab) 800 mg IV every 2 weeks is requested per FDA labeling for metastatic MCC in adults. This represents first-line systemic therapy for metastatic disease. NCCN Guidelines v1.2024 list avelumab as a Preferred Regimen for disseminated MCC. The patient has no contraindications to PD-L1 inhibitor therapy and will be monitored for immune-mediated adverse events per standard protocols."

Appeals Process for North Carolina

Important Distinction: Medicare vs. Commercial

For Humana Medicare Advantage: You cannot use North Carolina's Smart NC external review. Medicare Advantage appeals follow federal rules with these levels:

1. Plan reconsideration (Level 1)
2. Independent Review Entity (Level 2 - automatic if plan upholds denial)
3. Administrative Law Judge (if amount threshold met)

For Commercial Humana plans: You may be eligible for North Carolina's external review process through Smart NC.

Appeal Timeline for Medicare Advantage

• Standard appeals: Submit within 60 days of denial notice
• Expedited appeals: Available when delay would seriously jeopardize life or health
• Part D drug appeals: 7 days for standard, 72 hours for expedited decisions

How to File an Appeal

1. Call Humana at the appeals number on your denial letter
2. Submit in writing within required timeframes
3. Include additional evidence: Updated clinical notes, peer-reviewed studies, specialist letters
4. Request peer-to-peer review with Humana's medical director

Tip: For urgent cancer cases, always request expedited handling and have your oncologist provide written support for the expedited request.

Common Denial Reasons & Fixes

Denial Reason	How to Overturn
"Not FDA-approved for indication"	Submit FDA label excerpt showing approved indication; verify ICD-10 codes match
"Insufficient clinical documentation"	Provide complete staging studies, pathology report, performance status assessment
"Alternative therapy should be tried first"	Document contraindications or prior failures; cite NCCN preferred status
"Site of care not appropriate"	Submit facility accreditation; request home infusion if clinically stable

Quick Reference Table

Requirement	What It Means	Where to Find It	Source
Prior Authorization	Required for all Bavencio uses	Humana PA list	Medicare PA List
HCPCS Code	J9023 for billing	Medicare fee schedule	CMS
Dosing	800 mg IV every 2 weeks	FDA prescribing information	Bavencio PI
Age Limit	≥12 years for MCC	FDA label	Bavencio PI
Appeal Deadline	60 days from denial	Medicare rules	CMS

Frequently Asked Questions

Q: How long does Humana prior authorization take in North Carolina? A: Standard PA decisions are typically made within 72 hours for Part D drugs, 14 days for Part B services. Expedited requests are processed within 24-72 hours.

Q: What if Bavencio is denied as "not medically necessary"? A: Request the specific clinical criteria used for the denial, then submit additional documentation addressing each criterion. Consider requesting a peer-to-peer review with the medical director.

Q: Can I get financial assistance for Bavencio? A: Yes, the manufacturer offers CoverOne patient assistance which may provide coverage support and patient assistance programs.

Q: Does North Carolina's external review apply to Medicare Advantage denials? A: No, Medicare Advantage appeals follow federal Medicare rules, not state external review processes. Contact Smart NC for guidance, but formal external review won't be available.

Q: What happens if I need Bavencio urgently? A: Request an expedited prior authorization and appeal process. Your oncologist should document that delay would seriously jeopardize your life or health.

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Sources & Further Reading

• Humana Medicare Advantage PA List 2024-2025
• Bavencio FDA Prescribing Information
• North Carolina External Review Process
• CenterWell Specialty Pharmacy
• Bavencio Patient Resources

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Disclaimer: This guide is for informational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider about treatment options and contact your insurance company directly for coverage determinations. For personalized assistance with North Carolina insurance issues, contact Health Insurance Smart NC at 1-855-408-1212.

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