By Counterforce Health Team in Waylivra (volanesorsen) —

Coding That Helps Get Waylivra (volanesorsen) Approved in California with Blue Cross Blue Shield (ICD-10, HCPCS/J-Code, NDC)

Answer Box: Getting Waylivra Coded and Covered

Waylivra (volanesorsen) requires precise coding for Blue Cross Blue Shield California approval. Use ICD-10 E78.3 (Hyperchylomicronemia) for familial chylomicronemia syndrome. Bill under J3490/J3590 (miscellaneous codes) for medical benefit or NDC 72063-013-01 for pharmacy benefit. Document genetic confirmation of FCS, triglyceride levels >875 mg/dL, and failed conventional therapies. Submit through Blue Shield's AuthAccel system with complete clinical justification. California's Independent Medical Review has a 75% success rate for specialty drugs when properly documented.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit Paths

Understanding which benefit covers Waylivra determines your coding approach. Blue Cross Blue Shield California follows standard benefit structures:

Medical Benefit Coverage:

  • Physician-administered injections in clinic/hospital
  • Bill using HCPCS J-codes with procedure codes
  • Requires prior authorization through AuthAccel
  • Higher reimbursement rates but complex documentation

Pharmacy Benefit Coverage:

  • Self-administered or home health injections
  • Bill using NDC numbers through pharmacy claims
  • May require specialty pharmacy dispensing
  • Lower cost-sharing but stricter formulary controls
Tip: Most insurers prefer medical benefit for initial doses to monitor for adverse reactions, then transition to pharmacy benefit for maintenance therapy.

ICD-10 Mapping for FCS

Primary Code: E78.3 (Hyperchylomicronemia)

This billable ICD-10 code includes:

  • Familial chylomicronemia syndrome (FCS)
  • Chylomicronemia syndrome
  • Fredrickson's type I hyperlipoproteinemia
  • Fredrickson's type V hyperlipoproteinemia

Supporting Documentation Language:

  • "Genetically confirmed familial chylomicronemia syndrome"
  • "Persistent triglycerides >10 mmol/L (>875 mg/dL)"
  • "Recurrent acute pancreatitis secondary to severe hypertriglyceridemia"
  • "Biallelic pathogenic mutations in [LPL/APOC2/APOA5/LMF1/GPIHBP1]"

Additional Relevant Codes:

  • E78.1 (Pure hyperglyceridemia) - for marked triglyceride elevation
  • Z83.438 (Family history of disorder of lipoprotein metabolism) - family history
  • K85.9 (Acute pancreatitis, unspecified) - if pancreatitis episodes documented

Product Coding: HCPCS, J-Codes, and NDC

HCPCS/J-Code Information

Current Status: Waylivra lacks a permanent J-code in the US. Use miscellaneous codes:

  • J3490 (Unclassified drugs)
  • J3590 (Unclassified biologics)

Billing Units: Each unit = 1 mg

  • Standard dose = 285 mg = 285 units per injection
  • Always include drug name "Waylivra" or "volanesorsen" in claims

NDC Number

Primary NDC: 72063-013-01 (pre-filled syringe, 285 mg/1.5 mL)

Note: Verify current NDC with Blue Shield's formulary as manufacturers may update packaging.

Dosing and Administration Coding

Initial Dosing: 285 mg subcutaneous weekly Maintenance: 285 mg every 2 weeks (after 3-month assessment)

Modifiers to Consider:

  • JW - Drug amount discarded/not administered
  • GA - Waiver of liability statement on file

Clean Request Anatomy

Medical Benefit Claim Example

Diagnosis: E78.3 (Hyperchylomicronemia)
HCPCS: J3490 (285 units)
Drug Name: Waylivra (volanesorsen)
NDC: 72063-013-01
Date of Service: [Date]
Modifier: GA (if applicable)

Required Documentation Elements

Clinical Information:

  • Genetic test results confirming FCS
  • Lipid panel showing triglycerides >875 mg/dL
  • History of pancreatitis or other FCS complications
  • Failed trials of conventional therapies (fibrates, statins, niacin)

Administrative Details:

  • Patient demographics and insurance information
  • Prescriber NPI and specialty (endocrinology/lipidology preferred)
  • Site of care (clinic, hospital, home health)
  • Treatment plan and monitoring schedule

Frequent Coding Pitfalls

Unit Conversion Errors

  • Wrong: Billing 1 unit for 285 mg dose
  • Right: Billing 285 units (1 mg per unit)

Code Mismatches

  • Wrong: Using permanent J-code (doesn't exist yet)
  • Right: J3490/J3590 with drug name specified

Missing Documentation

  • Wrong: Submitting without genetic confirmation
  • Right: Including molecular diagnosis report

Incorrect Benefit Selection

  • Wrong: Pharmacy claim for provider-administered dose
  • Right: Medical benefit for clinic administration

Verification with Blue Shield Resources

Pre-Submission Checklist

  1. Check Prior Authorization Requirements
  2. Verify Coding Requirements
    • Confirm J-code acceptance for miscellaneous drugs
    • Check NDC coverage in formulary
    • Validate unit calculations
  3. Documentation Review
    • Ensure ICD-10 E78.3 supports medical necessity
    • Verify genetic test results are included
    • Confirm failed therapy documentation

Blue Shield Contact Points

  • Provider Services: Check current phone number via provider portal
  • Prior Authorization: Submit through AuthAccel system
  • Appeals: Use same portal for internal appeals

Quick Audit Checklist

Before Submission:

  • ICD-10 E78.3 documented with supporting clinical notes
  • J3490/J3590 with 285 units for medical benefit OR NDC for pharmacy
  • Genetic confirmation of FCS included
  • Triglyceride levels >875 mg/dL documented
  • Failed conventional therapy trials detailed
  • Prescriber specialty appropriate (endocrinology/lipidology)
  • Prior authorization submitted if required
  • Patient consent and liability waivers on file

Documentation Strength Indicators:

  • Molecular diagnosis report from certified lab
  • Multiple triglyceride readings showing persistent elevation
  • Detailed treatment history with specific drug names, doses, duration
  • Specialist consultation notes supporting diagnosis
  • Evidence of pancreatitis or other FCS complications

California Appeals Success Rates

California's Independent Medical Review (IMR) system provides exceptional outcomes for specialty drug appeals:

Success Rates by Plan:

  • Blue Shield of California: 80.8% combined success rate (55.3% overturned + 25.5% reversed by plan)
  • Anthem Blue Cross: 76.4% combined success rate (57.9% overturned + 18.5% reversed by plan)
  • Specialty Drugs Overall: ~75% success rate for rare disease medications

Key Success Factors:

  • Complete genetic documentation for FCS
  • Detailed treatment failure history
  • Specialist prescriber involvement
  • Proper ICD-10 coding supporting medical necessity
From our advocates: "We've seen Waylivra approvals increase dramatically when genetic test results clearly document FCS and the medical necessity letter details specific triglyceride levels before and after conventional therapy failures. The key is painting a complete clinical picture that leaves no doubt about the diagnosis."

When Coding Issues Arise

If your initial request faces coding-related denials, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and creates point-by-point rebuttals using the right medical coding and clinical evidence for each payer's specific requirements.

For complex cases involving rare disease medications like Waylivra, having expert support in navigating Blue Cross Blue Shield's specific coding requirements can significantly improve approval odds, especially given California's favorable appeal environment.

FAQ

Q: How long does Blue Cross Blue Shield prior authorization take in California? A: Standard PA requests take up to 14 business days. Expedited requests for urgent cases are processed within 72 hours. Use AuthAccel to track status.

Q: What if Waylivra isn't on the formulary? A: Request a formulary exception through Blue Shield's exception process. Include genetic confirmation of FCS and failed conventional therapies.

Q: Can I bill both medical and pharmacy benefits? A: No. Choose based on administration site: medical benefit for provider-administered, pharmacy benefit for self-administered.

Q: What happens if my ICD-10 code is rejected? A: E78.3 is the standard code for FCS. If rejected, provide additional documentation linking genetic results to the hyperchylomicronemia diagnosis.

Q: Does step therapy apply to Waylivra? A: Possibly. Document trials and failures of fibrates, statins, and other triglyceride-lowering therapies to support step therapy override requests.

Q: How do I calculate billing units correctly? A: Each billing unit equals 1 mg. Standard 285 mg dose = 285 units. Never bill as 1 unit regardless of dose strength.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical advice. Coverage decisions depend on individual circumstances and plan benefits. Always verify current coding requirements with Blue Cross Blue Shield California and consult with qualified healthcare professionals for medical decisions. For additional help with insurance appeals in California, contact the DMHC Help Center at 888-466-2219.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.