By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (Inotuzumab Ozogamicin) Covered by Humana in North Carolina: Complete Guide to Prior Authorization, Appeals, and Billing Codes

Answer Box: Getting Besponsa Covered by Humana in North Carolina

Besponsa (inotuzumab ozogamicin) requires prior authorization through Evolent/New Century Health for all Humana Medicare Advantage plans. Submit requests via their portal at my.newcenturyhealth.com or call 844-926-4528 (option 5). Required documentation includes CD22-positive B-cell ALL diagnosis (ICD-10: C91.02), prior therapy history, hepatic function tests, and VOD monitoring plan. Medicare appeals follow federal timelines (not North Carolina's Smart NC process): 60 days to file, 7-day standard or 72-hour expedited decisions. Start with clinical documentation proving relapsed/refractory status and CD22 positivity—these are the most common denial triggers.

Table of Contents

Understanding Humana's Prior Authorization Process

Humana Medicare Advantage plans require mandatory prior authorization for Besponsa through their specialty oncology vendor, Evolent (formerly New Century Health). This isn't optional—coverage will be denied without explicit approval before administration.

Key Requirements at a Glance

Requirement Details Where to Submit Timeline
Prior Authorization Mandatory for all oncology specialty drugs Evolent Portal or 844-926-4528 Before administration
Documentation CD22+ status, relapse/refractory history, hepatic monitoring eFax: 213-596-3783 Submit complete package
New Member Exception First 90 days may have temporary coverage Same portal with active treatment proof Reviewed retrospectively
Failure Consequences Full financial responsibility for drug costs N/A Immediate
Important: For new Humana members already receiving Besponsa, you still need to submit prior authorization within the first 90 days, but temporary coverage may apply while the request is processed.

Essential Coding and Billing Information

Medical Benefit vs. Pharmacy Benefit

Besponsa is covered under the medical benefit, not pharmacy benefit. This means it's billed through the physician's office or infusion center, not a retail or specialty pharmacy.

Required Billing Codes

HCPCS J-Code: J9229 (Injection, inotuzumab ozogamicin, 0.1 mg)

  • Each billable unit = 0.1 mg
  • Standard 0.9 mg vial = 9 billable units
  • Maximum authorization: 63 units (6.3 mg) every 21 days

ICD-10 Diagnosis Codes:

  • C91.02 - Acute lymphoblastic leukemia, in relapse (most common)
  • C91.00 - Acute lymphoblastic leukemia, not having achieved remission
  • C91.01 - Acute lymphoblastic leukemia, in remission

NDC Numbers: Use the current NDC from the actual vial being administered. Always verify the NDC matches your product packaging, as these can change with manufacturing updates.

Units Calculation Example

For a patient receiving 1.8 mg of Besponsa:

  • 1.8 mg ÷ 0.1 mg per unit = 18 billable units (J9229 x 18)
  • This would typically use 2 vials of the 0.9 mg strength

Documentation Requirements for Approval

Clinical Documentation Checklist

Diagnosis Requirements:

  • Confirmed B-cell precursor acute lymphoblastic leukemia
  • CD22-positive status (flow cytometry or immunophenotyping results showing ≥70% positivity)
  • Relapsed or refractory disease with specific dates and prior therapy details

Prior Therapy Documentation:

  • Complete list of previous chemotherapy regimens
  • Dates of treatment and response/failure outcomes
  • Reason for discontinuation of each prior therapy
  • Philadelphia chromosome status (if positive, include tyrosine kinase inhibitor history)

Safety Monitoring Plan:

  • Baseline liver function tests (AST, ALT, bilirubin)
  • Plan for monitoring hepatotoxicity and veno-occlusive disease (VOD)
  • Baseline ECG results
  • Documentation that patient is ≥18 years old (or ≥1 year for pediatric indication)
From our advocates: One common approval delay we see is when oncologists submit "CD22-positive ALL" without the actual flow cytometry percentages. Including the specific test results showing CD22 expression levels (typically >70%) significantly speeds up the review process and reduces back-and-forth requests for additional information.

Step-by-Step: Fastest Path to Approval

1. Gather Complete Documentation (Clinic Staff)

Collect all required clinical documents before starting the PA process. Missing pieces cause delays and potential denials.

2. Submit via Evolent Portal (Provider)

  • Log into my.newcenturyhealth.com
  • Upload all documentation as a complete package
  • Alternative: Call 844-926-4528 (option 5) or eFax to 213-596-3783

3. Include Specific Clinical Language (Provider)

Use exact terminology: "relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia" with supporting test results.

4. Monitor for Response (Clinic/Patient)

Standard review timeline varies, but expedited reviews are available for urgent cases. Track your submission through the portal.

5. Prepare for Potential Peer-to-Peer (Provider)

If initially denied, Evolent may request a peer-to-peer review. Have your clinical rationale and guidelines ready.

6. Schedule Administration Only After Approval (Clinic)

Do not order or administer Besponsa until you receive explicit written approval. Verbal approvals aren't sufficient for financial protection.

7. Submit Claims with Proper Coding (Billing Staff)

Use J9229 with correct unit calculations, appropriate ICD-10 codes, and include the authorization number on all claims.

Common Denial Reasons and How to Fix Them

Denial Reason How to Fix Required Documentation
Missing CD22+ status Submit flow cytometry results Lab report showing CD22 expression ≥70%
Insufficient relapse documentation Provide detailed treatment history Prior therapy dates, responses, failure reasons
Inadequate hepatic monitoring plan Submit comprehensive safety protocol Baseline LFTs, VOD monitoring schedule, ECG
Wrong line of therapy Clarify relapsed/refractory status Timeline showing failed prior therapies
Missing age documentation Confirm patient age ≥18 years Date of birth or age verification
Incomplete dosing rationale Justify dose and frequency Clinical rationale based on FDA labeling

Most Critical Fix: CD22 Positivity Documentation

The most common denial reason is insufficient proof of CD22-positive disease. Ensure your submission includes:

  • Specific flow cytometry or immunophenotyping report
  • Percentage of blasts expressing CD22 (not just "positive")
  • Date of testing and laboratory performing the analysis

Appeals Process for North Carolina Residents

Important: Medicare Appeals Only

North Carolina's Smart NC external review process does NOT apply to Humana Medicare plans. You must use the federal Medicare appeals system.

Medicare Appeal Timeline

Appeal Level Timeline How to File Contact
Reconsideration (Internal) 60 days to file Humana member portal or phone Humana Customer Service
Independent Review Entity After internal denial Automatic escalation Medicare-contracted IRE
Administrative Law Judge After IRE denial Written request Office of Medicare Hearings
Medicare Appeals Council After ALJ decision Written request Departmental Appeals Board

Expedited Appeals

For urgent situations where delay could seriously jeopardize your health:

  • Timeline: 72 hours for expedited decisions
  • Requirements: Doctor's statement supporting urgency
  • Process: Request expedited review when filing your appeal

Appeal Documentation Tips

  • Include all original prior authorization documentation
  • Add any new clinical information supporting medical necessity
  • Provide peer-reviewed literature supporting off-label use (if applicable)
  • Submit treating physician's letter explaining why Besponsa is the best treatment option

Cost Assistance and Patient Support

Manufacturer Support Programs

Pfizer Oncology Together: Provides financial assistance for eligible patients

  • Copay assistance for commercially insured patients
  • Patient assistance program for uninsured/underinsured
  • Contact: Visit PfizerOncologyTogether.com or call 1-877-744-5675

Additional Resources

Medicare Extra Help: Low-income subsidy program that can reduce prescription drug costs for Medicare beneficiaries. Contact Social Security Administration at 1-800-772-1213.

North Carolina Cancer Fund: State-based assistance for cancer patients. Contact the North Carolina Division of Public Health for current programs and eligibility.

Foundation Grants

  • Leukemia & Lymphoma Society: Patient aid programs for blood cancer treatments
  • CancerCare: Financial assistance and copay assistance programs
  • HealthWell Foundation: Disease-specific funds for acute lymphoblastic leukemia

Frequently Asked Questions

Q: How long does Humana's prior authorization take in North Carolina? A: Standard review timelines vary, but Evolent typically processes complete submissions within 3-5 business days. Expedited reviews for urgent cases can be completed within 24-72 hours with proper clinical justification.

Q: What if Besponsa is not on Humana's formulary? A: Besponsa requires prior authorization regardless of formulary status. Non-formulary medications can still be covered through the medical exception process if medically necessary and properly documented.

Q: Can I request an expedited appeal if my initial prior authorization is denied? A: Yes, if your doctor determines that any delay in treatment would seriously jeopardize your life or health, you can request an expedited appeal with a 72-hour decision timeline.

Q: Does step therapy apply to Besponsa in North Carolina? A: Step therapy requirements depend on your specific Humana plan, but given Besponsa's indication for relapsed/refractory disease, most plans recognize that patients have already failed multiple prior therapies.

Q: What happens if I move to North Carolina from another state while on Besponsa? A: Contact Humana immediately to ensure continuity of coverage. You may qualify for the 90-day new member exception while your prior authorization is processed.

Q: How many cycles of Besponsa will Humana typically approve? A: Most payers, including Humana, approve up to 6 cycles within 6 months. Additional cycles beyond this limit are rarely approved due to safety concerns and FDA guidance.

Q: What if my doctor wants to use Besponsa off-label? A: Off-label use requires additional documentation including peer-reviewed literature, clinical guidelines, and a detailed medical necessity rationale. The approval rate for off-label indications is generally lower.

Q: Can I appeal to North Carolina's insurance commissioner if Humana denies coverage? A: No, Medicare plans are federally regulated and not subject to state insurance commissioner oversight. You must use the Medicare appeals process described above.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Besponsa. Our platform analyzes denial letters, identifies the specific coverage gaps, and generates evidence-backed appeals that address each payer's unique requirements. For patients and providers dealing with Humana prior authorization challenges, we provide targeted support that significantly improves approval rates while reducing administrative burden.

When navigating Besponsa coverage with Humana, having the right documentation and understanding payer-specific requirements can make the difference between approval and denial. Counterforce Health helps streamline this process by ensuring your appeal addresses Humana's exact coverage criteria with the clinical evidence they require.

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 and insurance company for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with official sources.

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