By Counterforce Health Team in Voydeya (danicopan) —

Coding That Helps Get Voydeya (Danicopan) Approved by Blue Cross Blue Shield of Michigan (ICD-10, HCPCS/J-Code, NDC)

Answer Box: Getting Voydeya Coded Correctly for BCBSM Approval

Key codes for Voydeya (danicopan) in Michigan: Use ICD-10 D59.5 for PNH diagnosis, HCPCS J8499 for billing, and specific NDCs (25682-043-04, 25682-043-92, etc.). BCBSM requires flow cytometry confirmation, 6+ months on C5 inhibitor therapy, and recent transfusion documentation. Submit through pharmacy benefit with complete prior authorization. First step: Gather PNH diagnosis confirmation, C5 inhibitor history, and transfusion records before coding your claim.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for PNH
  3. Product Coding: HCPCS, J-Codes, and NDCs
  4. Clean Request Anatomy
  5. Frequent Coding Pitfalls
  6. BCBSM Verification Steps
  7. Pre-Submission Audit Checklist
  8. Michigan Appeals Process

Coding Basics: Medical vs. Pharmacy Benefit

Voydeya (danicopan) is an oral medication that typically falls under the pharmacy benefit rather than medical benefit coverage with Blue Cross Blue Shield of Michigan (BCBSM). This distinction matters significantly for your coding approach.

Pharmacy Benefit Path (Most Common):

  • Requires prior authorization through BCBSM's pharmacy management
  • Uses standard NDC codes for dispensing
  • Processed through specialty pharmacy networks
  • Coverage decisions based on pharmacy clinical criteria

Medical Benefit Path (Rare):

  • Only applies if administered in a provider setting
  • Uses HCPCS J-codes for billing
  • Generally not covered under medical benefit for self-administered oral drugs
Tip: Always verify with BCBSM member services which benefit applies to your specific plan, as some Medicare Advantage plans may have different pathways.

ICD-10 Mapping for PNH

The primary diagnosis code for paroxysmal nocturnal hemoglobinuria is D59.5. This code covers both intravascular and extravascular hemolysis associated with PNH.

Documentation Requirements

Your clinical documentation must support the D59.5 diagnosis with:

  • Flow cytometry results confirming PNH clone presence
  • Laboratory evidence of hemolysis (elevated LDH, low haptoglobin, elevated indirect bilirubin)
  • Clinical symptoms including fatigue, dark urine, anemia
  • Transfusion history demonstrating ongoing hemolysis despite C5 inhibitor therapy
Note: BCBSM specifically requires flow cytometry confirmation for PNH diagnosis. Generic hemolysis codes won't support Voydeya approval.

Supporting Documentation Language

Use specific terminology that aligns with coding requirements:

  • "Paroxysmal nocturnal hemoglobinuria confirmed by flow cytometry"
  • "Extravascular hemolysis despite optimized C5 inhibitor therapy"
  • "Persistent anemia requiring transfusion support"
  • "PNH clone burden documented at X% by flow cytometry"

Product Coding: HCPCS, J-Codes, and NDCs

HCPCS/J-Code Information

Voydeya currently uses J8499 ("Prescription drug, oral, non-chemotherapeutic, NOS") as it doesn't have a product-specific J-code assigned yet.

NDC Numbers for Voydeya

Common NDC codes for different strengths and packaging:

  • 25682-040-21 (verify current availability)
  • 25682-043-04
  • 25682-043-92
  • 25682-046-92
  • 25682-049-04
Important: Always verify the exact NDC matches your dispensed product strength and packaging size. Using incorrect NDCs is a common cause of claim rejections.

Units and Dosing Math

Standard dosing: 150 mg three times daily, may increase to 200 mg three times daily

  • Daily dose: 450-600 mg
  • Monthly supply calculation: 30-day supply = 90-180 tablets (depending on strength)
  • Ensure quantity limits align with prescribed frequency

Clean Request Anatomy

Example Prior Authorization Request

Patient Information:

  • Diagnosis: D59.5 (Paroxysmal nocturnal hemoglobinuria)
  • Medication: Voydeya (danicopan) 150 mg TID
  • NDC: 25682-043-04 (example - verify actual)
  • Quantity: 90 tablets per 30 days

Required Clinical Documentation:

  1. PNH confirmation: Flow cytometry report showing PNH clone presence
  2. C5 inhibitor history: Documentation of eculizumab or ravulizumab therapy ≥6 months
  3. Transfusion evidence: At least one transfusion in past 6 months despite C5 therapy
  4. Vaccination status: Required immunizations per REMS program

BCBSM-Specific Requirements:

  • Specialist prescriber (hematology/oncology)
  • Concurrent C5 inhibitor therapy confirmation
  • Laboratory monitoring plan

Frequent Coding Pitfalls

Common Errors That Cause Denials

1. Unit Conversion Mistakes

  • Billing for wrong tablet strength
  • Quantity doesn't match prescribed frequency
  • Days supply calculation errors

2. Mismatched Codes

  • Using wrong NDC for actual product dispensed
  • ICD-10 code doesn't support medical necessity
  • Missing or incorrect HCPCS modifier

3. Missing Documentation Elements

  • No flow cytometry confirmation of PNH
  • Insufficient C5 inhibitor therapy history
  • Missing vaccination documentation
  • No evidence of extravascular hemolysis

4. Timing Issues

  • Request submitted before completing 6 months of C5 therapy
  • Missing recent transfusion within 6-month window
  • Vaccination requirements not met before therapy start

BCBSM Verification Steps

Pre-Submission Checklist

1. Confirm Current Formulary Status

  • Check BCBSM formulary for tier placement
  • Verify prior authorization requirements
  • Confirm quantity limits

2. Validate Coding Elements

  • Cross-reference NDC with FDA database
  • Confirm ICD-10 code supports indication
  • Verify HCPCS code for billing pathway

3. Review Documentation Completeness

  • All BCBSM-specific criteria addressed
  • Supporting labs and imaging included
  • Specialist attestation present

BCBSM Resources for Verification

  • Provider Portal: Access current PA forms and criteria
  • Member Services: Confirm benefit coverage pathway
  • Pharmacy Help Desk: Verify NDC and quantity limits
  • Prior Authorization Department: Clarify specific requirements

Pre-Submission Audit Checklist

Clinical Documentation Review

  • PNH diagnosis confirmed by flow cytometry (D59.5)
  • C5 inhibitor therapy documented ≥6 months
  • Recent transfusion within past 6 months
  • Extravascular hemolysis evidence (labs, symptoms)
  • Required vaccinations completed and documented
  • Specialist prescriber credentials verified

Coding Accuracy Check

  • Correct NDC for dispensed strength/packaging
  • ICD-10 D59.5 properly documented
  • HCPCS J8499 if billing medical benefit
  • Quantity calculation matches prescribed frequency
  • Days supply accurate for billing period

BCBSM-Specific Requirements

  • Prior authorization form completed
  • All supporting documents attached
  • Submission through correct channel (pharmacy vs. medical)
  • Timeline requirements met (6+ months C5 therapy)

Michigan Appeals Process

If your initial request is denied, Michigan provides robust appeal rights through the Department of Insurance and Financial Services (DIFS).

Internal Appeal Timeline

  • Standard: 5-7 business days for BCBSM decision
  • Expedited: 24-48 hours with medical urgency attestation

External Review Process

  • Deadline: 127 days after final internal denial
  • Timeline: 60 days maximum for standard review, 72 hours for expedited
  • Submission: DIFS External Review form
From our advocates: We've seen successful appeals when providers clearly document the progression from intravascular to extravascular hemolysis despite optimized C5 therapy. Include specific hemoglobin trends and transfusion dates to strengthen your case. Remember, this represents a composite of experiences, not a guarantee of outcomes.

Required Appeal Documentation

  • Copy of original denial letter
  • Updated clinical notes supporting medical necessity
  • Any new laboratory or imaging results
  • Physician statement of urgency (if expedited)

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to payer policies. Our platform helps identify the specific denial basis and pulls the right clinical evidence to support your Voydeya appeal with BCBSM.

For urgent appeals, contact DIFS at 877-999-6442 to ensure proper expedited processing.

Coverage at a Glance

Requirement What It Means Where to Find It
ICD-10 D59.5 PNH diagnosis by flow cytometry Clinical notes, lab reports
C5 inhibitor ≥6 months Established therapy with eculizumab/ravulizumab Treatment history, pharmacy records
Recent transfusion Blood transfusion within past 6 months Hospital records, transfusion logs
Vaccination status Required immunizations per REMS Immunization records, provider notes
Specialist prescriber Hematology/oncology provider Provider credentials, referral

FAQ

How long does BCBSM prior authorization take for Voydeya? Standard requests: 5-7 business days. Expedited requests with medical urgency: 24-48 hours.

What if Voydeya isn't on the BCBSM formulary? Submit a formulary exception request with medical necessity documentation showing why alternatives don't meet clinical needs.

Can I appeal if my Voydeya request is denied? Yes. Michigan residents have 127 days to file an external review with DIFS after exhausting BCBSM's internal appeal process.

Does step therapy apply to Voydeya coverage? Voydeya requires concurrent C5 inhibitor therapy, so traditional step therapy doesn't apply. However, you must demonstrate inadequate response to optimized C5 therapy alone.

What's the difference between pharmacy and medical benefit coverage? Voydeya typically falls under pharmacy benefit as an oral self-administered medication. Medical benefit coverage is rare and usually only applies to provider-administered drugs.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical advice. Always consult with your healthcare provider and verify current requirements with BCBSM and Michigan DIFS. Insurance policies and procedures may change. For personalized assistance with complex denials and appeals, Counterforce Health provides specialized support in turning insurance denials into successful approvals.

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