By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

Getting Besponsa (Inotuzumab Ozogamicin) Covered by Blue Cross Blue Shield in North Carolina: Complete Coding and Appeals Guide

Answer Box: Fast Track to Besponsa Coverage

Getting Besponsa covered by Blue Cross Blue Shield in North Carolina requires proper coding and documentation. Use ICD-10 code C91.00-C91.02 for B-cell ALL, HCPCS J9229 for billing, and ensure CD22-positive status is documented. Submit prior authorization through Blue Cross NC's provider portal with complete clinical notes showing failed prior therapies. If denied, you have 180 days to appeal internally, then 120 days for North Carolina's Smart NC external review. Start today: Verify your specific Blue Cross NC plan's formulary status and gather all clinical documentation before submitting your PA request.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for B-Cell ALL
  3. Product Coding: HCPCS, Units, and NDC
  4. Clean Request Anatomy
  5. Frequent Pitfalls to Avoid
  6. Blue Cross NC Verification Steps
  7. Appeals Playbook for North Carolina
  8. Quick Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Besponsa (inotuzumab ozogamicin) is typically covered under the medical benefit rather than pharmacy benefit because it's administered intravenously in clinical settings. Blue Cross NC requires prior authorization for specialty drugs, including injectable medications like Besponsa.

Medical Benefit Coverage:

  • Administered in oncology infusion centers
  • Billed using HCPCS J-codes
  • Requires facility and professional billing
  • Prior authorization through medical management

Key Coverage Requirements:

  • Prescription by or consultation with oncology specialist
  • Patient age ≥ 1 year
  • Confirmed CD22-positive B-cell ALL diagnosis
  • Documentation of appropriate line of therapy

ICD-10 Mapping for B-Cell ALL

Accurate diagnosis coding is critical for Besponsa approval. The primary ICD-10 codes for B-cell acute lymphoblastic leukemia are:

ICD-10 Code Description When to Use
C91.00 Acute lymphoblastic leukemia, not having achieved remission Newly diagnosed or active disease
C91.01 Acute lymphoblastic leukemia, in remission Patient currently in remission
C91.02 Acute lymphoblastic leukemia, in relapse Disease recurrence after remission

Documentation Requirements:

  • Explicit statement of remission status confirmed by clinical testing
  • Bone marrow blast percentages (>25% indicates precursor B-ALL)
  • CD22 protein confirmation on B-cell surface
  • Prior treatment history and response
Tip: Include specific language in clinical notes such as "CD22-positive B-cell precursor ALL" and "relapsed/refractory disease" to support both diagnosis coding and prior authorization approval.

Product Coding: HCPCS, Units, and NDC

HCPCS Code: J9229 - Injection, inotuzumab ozogamicin, 0.1 mg

Unit Conversion:

  • Each billable unit = 0.1 mg
  • Besponsa vial contains 0.9 mg (single-dose)
  • To calculate units: dose in mg × 10

Dosing Schedule:

  • Cycle 1: 1.8 mg/m² total (0.8 mg/m² Day 1, 0.5 mg/m² Days 8 and 15)
  • Subsequent cycles: 1.5 mg/m² total if CR/CRi achieved

Quantity Limits:

  • Maximum 63 billable units per 21-day period
  • Maximum 7 vials per cycle
  • Treatment limited to 6 cycles maximum

Example Calculation: For a 70 kg patient (BSA ~1.8 m²):

  • Day 1 dose: 0.8 mg/m² × 1.8 m² = 1.44 mg = 14.4 units (round to 14 units)
  • Days 8, 15: 0.5 mg/m² × 1.8 m² = 0.9 mg = 9 units each

Clean Request Anatomy

A complete prior authorization request should include:

Patient Information:

  • Full name, DOB, member ID
  • Blue Cross NC plan type and group number
  • Contact information

Clinical Documentation:

  • ICD-10 diagnosis code (C91.00, C91.01, or C91.02)
  • CD22-positive confirmation
  • Prior therapy failures with dates and reasons for discontinuation
  • Current performance status and lab values

Prescriber Information:

  • Oncology specialist credentials
  • NPI number and practice information
  • Prescriber attestation of medical necessity

Treatment Plan:

  • Planned number of cycles (maximum 6)
  • Dosing schedule with BSA calculations
  • Monitoring plan for hepatotoxicity and VOD
Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Frequent Pitfalls to Avoid

Common Billing Errors:

  1. Unit Conversion Mistakes
    • Incorrect: Billing 1.44 mg as 1.44 units
    • Correct: Billing 1.44 mg as 14 units (1.44 × 10)
  2. Exceeding Quantity Limits
    • Error: Requesting >63 units per 21-day period
    • Solution: Verify total units don't exceed plan limits
  3. Missing CD22 Documentation
    • Error: Submitting without CD22-positive confirmation
    • Solution: Include flow cytometry or immunohistochemistry results
  4. Inappropriate Line of Therapy
    • Error: First-line use without proper justification
    • Solution: Document failed standard therapies or contraindications
  5. Incomplete Hepatic Monitoring Plan
    • Error: No mention of VOD risk assessment
    • Solution: Include hepatic function monitoring protocol

Blue Cross NC Verification Steps

Before submitting your prior authorization:

  1. Check Formulary Status
  2. Verify Patient Eligibility
    • Confirm active coverage and benefits
    • Check for any plan-specific exclusions
    • Verify prior authorization requirements
  3. Review Medical Necessity Criteria
    • Download current Besponsa policy (if available)
    • Cross-reference with clinical documentation
    • Ensure all criteria are addressed
  4. Submit Through Correct Channel
    • Use Availity portal for electronic submission
    • Include all required attachments
    • Follow up within 5-7 business days

Appeals Playbook for North Carolina

Internal Appeals Process

Level 1 Internal Appeal:

  • Timeline: 180 days from denial notice
  • Review Time: 7 calendar days (standard), 72 hours (expedited)
  • Submission: Mail to Blue Cross NC Medicare Provider Appeal Department, P.O. Box 1291, Durham, NC 27702-1291
  • Fax: 888-375-8836
  • Email: [email protected]

Required Information:

  • Member name, ID, DOB, phone number
  • Drug name and prescriber information
  • Detailed reason for believing coverage should be approved
  • Supporting clinical documentation

Smart NC External Review

If internal appeals fail, North Carolina's Smart NC program offers independent external review:

Key Details:

  • Filing Deadline: 120 days from final internal denial
  • Success Rate: Approximately 43% for pharmacy-related appeals
  • Cost: Free to consumers
  • Timeline: 45 days (standard), 72 hours (expedited)
  • Contact: 1-855-408-1212

Filing Process:

  1. Complete Smart NC external review form
  2. Submit within 120 days of final internal denial
  3. Include all relevant medical documentation
  4. Request expedited review if medically urgent
From our advocates: We've seen cases where initial denials for specialty oncology drugs like Besponsa were overturned at the Smart NC level when the appeal included comprehensive documentation of failed prior therapies and clear evidence of CD22-positive disease status. The key is presenting a complete clinical picture that demonstrates medical necessity according to FDA-approved indications.

Quick Audit Checklist

Before submitting your Besponsa prior authorization or appeal:

Clinical Documentation:

  • ICD-10 code matches disease status (C91.00, C91.01, or C91.02)
  • CD22-positive status confirmed and documented
  • Prior therapy failures detailed with dates and reasons
  • Oncology specialist involvement documented
  • Hepatic function baseline established

Coding Accuracy:

  • HCPCS J9229 used correctly
  • Units calculated properly (mg dose × 10)
  • Quantity limits not exceeded (≤63 units per 21 days)
  • Treatment duration ≤6 cycles

Administrative Details:

  • Patient eligibility verified
  • Correct Blue Cross NC plan identified
  • All required forms completed
  • Supporting documentation attached
  • Submission deadline met

Appeal Preparation (if needed):

  • Internal appeal filed within 180 days
  • All clinical evidence included
  • Point-by-point response to denial reasons
  • Smart NC external review option preserved

Frequently Asked Questions

How long does Blue Cross NC prior authorization take? Standard reviews typically take 5-15 business days, though complex cases may take longer. Expedited reviews are completed within 72 hours when medically urgent.

What if Besponsa is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and providing evidence that preferred alternatives are inappropriate or have failed.

Can I request an expedited appeal? Yes, if delaying treatment would seriously jeopardize your health. Both internal appeals and Smart NC external reviews offer expedited options.

What happens if I exceed the 6-cycle limit? Coverage beyond 6 cycles requires exceptional circumstances documentation and may need external review approval.

Does step therapy apply to Besponsa? Many plans require documentation of failed conventional therapies before approving Besponsa, though specific requirements vary by plan.

Cost-Saving Resources

Pfizer Oncology Together:

Patient Assistance Programs:

  • Income-based free drug programs
  • Foundation grants for eligible patients
  • State pharmaceutical assistance programs

When to Escalate

Contact the North Carolina Department of Insurance if:

  • Appeals processes aren't followed properly
  • Unreasonable delays in review
  • Violations of state insurance laws
  • Need assistance with Smart NC process

Contact: 1-855-408-1212 (Smart NC helpline)

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting comprehensive rebuttals aligned to each plan's specific requirements.

Sources & Further Reading

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