By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (Inotuzumab Ozogamicin) Covered by Blue Cross Blue Shield in New York: Coding, Appeals, and Documentation Guide

Answer Box: Getting Besponsa Covered by Blue Cross Blue Shield in New York

Besponsa (inotuzumab ozogamicin) requires prior authorization from Blue Cross Blue Shield plans in New York for relapsed/refractory CD22-positive B-cell precursor ALL. The fastest path to approval involves: (1) Submit complete PA request with ICD-10 code C91.02, documented CD22 positivity, and hepatic monitoring plan, (2) If denied, file internal appeal within plan deadlines, (3) Request external review through NY Department of Financial Services within 4 months. Success depends on proper coding (J9229 for billing), thorough clinical documentation, and understanding New York's patient-friendly external appeal process.

Start today: Call the number on your BCBS member ID card to confirm PA requirements and obtain forms.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Besponsa Coverage
  3. Product Coding: HCPCS, J-Codes, and NDCs
  4. Clean Prior Authorization Request
  5. Common Denial Reasons and Solutions
  6. New York External Appeal Process
  7. Verification Steps with BCBS
  8. Pre-Submission Audit Checklist
  9. FAQ
  10. Sources and Further Reading

Coding Basics: Medical vs. Pharmacy Benefit

Besponsa (inotuzumab ozogamicin) is always covered under the medical benefit since it's administered intravenously in clinical settings. This means your oncologist's office or hospital outpatient infusion center will handle the billing and prior authorization process, not your retail pharmacy.

Key Coverage Points:

  • Medical benefit coverage: Provider-administered infusion therapy
  • Prior authorization required: All BCBS plans require PA for Besponsa
  • Site of care: Hospital outpatient or qualified oncology clinic
  • Maximum coverage: 6 cycles over 6 months, non-renewable

Understanding this distinction helps you work with the right team—your oncologist's billing staff, not your pharmacy—to navigate the approval process.

ICD-10 Mapping for Besponsa Coverage

The correct ICD-10 code is crucial for Besponsa approval. BCBS requires specific documentation of your leukemia status and subtype.

Primary Diagnosis Code

C91.02 - Acute lymphoblastic leukemia, in relapse

This code applies to both relapsed disease (returned after remission) and refractory disease (never achieved remission or progressed during treatment).

Required Documentation Language

Your medical record must include these specific terms:

  • "Relapsed" or "refractory" B-cell precursor ALL
  • "CD22-positive" confirmed by flow cytometry or pathology
  • Prior therapy details with dates and outcomes
  • Current disease status with bone marrow or blood findings
Tip: If your records don't explicitly state "CD22-positive," ask your oncologist to add this to your chart notes. BCBS often denies requests when CD22 status isn't clearly documented.

Supporting Codes to Include

  • Z87.891 - Personal history of nicotine dependence (if applicable)
  • Z51.11 - Encounter for antineoplastic chemotherapy
  • Specific codes for complications (cytopenias, infections)

Product Coding: HCPCS, J-Codes, and NDCs

HCPCS J-Code: J9229

J9229 covers "Injection, inotuzumab ozogamicin, 0.1 mg"

Critical billing calculation: Each 0.1 mg administered equals 1 billing unit.

Example: Patient receives 0.8 mg = 8 units of J9229

NDC Numbers

Besponsa vials come in specific NDC configurations:

  • 0.9 mg single-dose vial (verify current NDC from vial packaging)
  • Always confirm NDC with your specific BCBS plan's formulary

Units and Dosing Math

Standard dosing: 1.8 mg/m² per cycle

  • Cycle 1: 0.8 mg/m² (Day 1), 0.5 mg/m² (Days 8, 15)
  • Cycles 2-6: 0.5 mg/m² (Days 1, 8, 15)

Billing example for 70 kg, 1.8 m² patient:

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

Clean Prior Authorization Request

A complete PA request includes all required elements that BCBS reviewers need to approve Besponsa coverage.

Essential Documentation Checklist

Clinical Information:

  • Pathology report confirming CD22+ B-cell precursor ALL
  • Documentation of relapsed/refractory status
  • Complete prior therapy history with dates and outcomes
  • Current performance status and treatment goals
  • Baseline hepatic function tests (ALT, AST, bilirubin)
  • Plan for hepatic monitoring and VOD surveillance

Administrative Details:

  • Patient demographics and BCBS member ID
  • Prescriber NPI and specialty (hematology/oncology)
  • Requested number of cycles (maximum 6)
  • Site of administration
  • ICD-10 diagnosis codes (C91.02)

Supporting Evidence:

  • FDA prescribing information reference
  • NCCN guidelines citation (if applicable)
  • Medical necessity letter from oncologist
Note: BCBS typically requires hepatic monitoring plans due to Besponsa's boxed warning for veno-occlusive disease. Include specific lab schedules and safety protocols.

Common Denial Reasons and Solutions

Denial Reason How to Fix Required Documentation
CD22 status not documented Request pathology addendum Flow cytometry or IHC results showing CD22+
Insufficient prior therapy Document treatment history Dates, drugs, doses, and outcomes of prior regimens
Hepatic risk concerns Submit monitoring plan Baseline labs, frequency of monitoring, VOD protocols
Dosing exceeds guidelines Verify BSA calculations Height, weight, BSA calculation, dose justification
Not relapsed/refractory Clarify disease status Bone marrow results, treatment response data

Most Effective Appeal Strategies

For medical necessity denials:

  1. Peer-to-peer review: Request oncologist speak directly with BCBS medical director
  2. Literature support: Include recent studies on Besponsa efficacy in your specific situation
  3. Alternative analysis: Document why other treatments are inappropriate

For formulary denials:

  1. Step therapy exception: Prove medical necessity despite formulary placement
  2. Contraindication documentation: Show why preferred alternatives can't be used

New York External Appeal Process

New York offers one of the most patient-friendly external appeal systems in the country. If BCBS denies your Besponsa coverage after internal appeals, you have strong rights under New York law.

External Appeal Timeline

Standard Process:

  1. Internal appeal with BCBS (required first step)
  2. Final denial received from BCBS
  3. 4 months to file external appeal with NY Department of Financial Services
  4. 30 days for standard external review decision
  5. Binding decision on BCBS

Expedited Process for Urgent Cases:

  • 24-48 hours for urgent drug appeals
  • Available when delay could seriously jeopardize health

How to File

Contact: New York Department of Financial Services

Required Documents:

  • Final BCBS denial letter
  • All medical records supporting Besponsa need
  • Physician letter of medical necessity
  • Completed DFS external appeal application

Success Rates

New York external appeals overturn 35-50% of specialty drug denials, particularly when supported by strong clinical evidence and proper documentation.

From our advocates: We've seen cases where BCBS initially denied Besponsa due to "experimental" concerns, but New York external reviewers approved coverage after reviewing FDA labeling and clinical guidelines. The key was submitting comprehensive documentation showing the drug's established role in relapsed/refractory ALL treatment protocols.

Verification Steps with BCBS

Before submitting your PA request, verify these details with your specific BCBS plan:

Plan-Specific Requirements

Call the provider services number on your BCBS card to confirm:

  • Current PA form version and submission method
  • Specific clinical criteria for your plan year
  • Required supporting documentation
  • Processing timelines and expedited options

Online Resources

BCBS Plan Websites:

  • Medical policy databases
  • Formulary lookup tools
  • PA form downloads
  • Provider portal access

Key verification points:

  • Is Besponsa on formulary or requires exception?
  • Are there quantity limits per cycle?
  • What site-of-care restrictions apply?
  • Are there age or diagnosis-specific requirements?

Pre-Submission Audit Checklist

Use this checklist to review your PA request before submission:

Clinical Documentation Review

  • ICD-10 code C91.02 documented in chart
  • CD22 positivity explicitly stated
  • Relapsed/refractory status clearly defined
  • Prior therapies listed with dates and outcomes
  • Current labs and imaging results included
  • Hepatic monitoring plan detailed

Coding and Billing Accuracy

  • J9229 units calculated correctly
  • NDC numbers match plan formulary
  • Dosing aligns with FDA labeling
  • BSA calculations documented
  • Site of care appropriate for plan

Administrative Completeness

  • All required forms completed
  • Provider NPI and credentials verified
  • Member ID and demographics accurate
  • Submission method confirmed (portal, fax, mail)
  • Timeline allows for processing before treatment start

FAQ

Q: How long does BCBS prior authorization take for Besponsa in New York? A: Standard PA reviews take 3-5 business days. Expedited reviews for urgent cases are completed within 24-72 hours. Always request expedited review if treatment delay could harm your health.

Q: What if Besponsa isn't on my BCBS formulary? A: You can request a formulary exception by demonstrating medical necessity. Include documentation showing why formulary alternatives are inappropriate or contraindicated.

Q: Can I appeal if BCBS says Besponsa is experimental? A: Yes. Besponsa has full FDA approval for relapsed/refractory B-cell precursor ALL. Include FDA labeling and NCCN guidelines in your appeal to counter "experimental" denials.

Q: Does step therapy apply to Besponsa? A: Most BCBS plans require documentation of prior therapy failures, but formal step therapy protocols vary. Check your specific plan's medical policy.

Q: What's the cost if BCBS covers Besponsa? A: Your out-of-pocket cost depends on your plan's coinsurance and out-of-pocket maximum. Pfizer offers patient assistance programs that may help with copays.

Q: Can I get Besponsa covered for off-label use? A: Coverage for off-label indications requires extensive documentation of medical necessity, published literature support, and often external appeals. Success rates are lower than for FDA-approved indications.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-based advocacy. Our platform analyzes denial letters and plan policies to create targeted rebuttals that address specific payer concerns, increasing approval rates for complex specialty medications like Besponsa.

Sources and 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 plan for specific coverage decisions. Coverage policies vary by plan and may change over time.

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