By Counterforce Health Team in Evkeeza (evinacumab-dgnb) —

How to Get Evkeeza (Evinacumab) Covered by Blue Cross Blue Shield in New York: Coding, Appeals, and PA Requirements 2025

Answer Box: Quick Path to Evkeeza Coverage

Getting Evkeeza (evinacumab-dgnb) covered by Blue Cross Blue Shield in New York requires three key steps: 1) Confirm your HoFH diagnosis with ICD-10 code E78.010 and genetic/clinical documentation, 2) Document failure or intolerance of maximum-dose statins, ezetimibe, and PCSK9 inhibitors, and 3) Submit prior authorization through your provider using HCPCS code J1305 for billing. If denied, New York's external review through DFS offers strong patient protections with binding decisions. Start by gathering your lipid panels, genetic testing results, and prior therapy records—most approvals take 14-30 days with complete documentation.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for HoFH Documentation
  3. Product Coding: HCPCS, NDC, and Units Calculation
  4. Clean Prior Authorization Request Anatomy
  5. Frequent Coding and Billing Pitfalls
  6. BCBS New York Verification Steps
  7. Pre-Submission Audit Checklist
  8. Appeals Playbook for New York
  9. Common Denial Reasons & Solutions
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Evkeeza (evinacumab-dgnb) is typically processed under the medical benefit rather than pharmacy benefit for Blue Cross Blue Shield plans in New York. This distinction affects everything from prior authorization forms to billing procedures.

Medical Benefit Coverage:

  • Administered in healthcare facilities (infusion centers, hospitals, clinics)
  • Requires HCPCS J-code billing (J1305)
  • Prior authorization through medical management departments
  • Claims submitted via CMS-1500 or UB-04 forms

Key Advantage: Medical benefit coverage often provides better access to specialty infusion drugs, especially for rare conditions like homozygous familial hypercholesterolemia (HoFH).

Note: Always verify with your specific BCBS plan, as some may have hybrid coverage models or special pharmacy benefit pathways for certain specialty drugs.

ICD-10 Mapping for HoFH Documentation

Primary Diagnosis Code: E78.010

As of October 2025, the specific ICD-10-CM code for homozygous familial hypercholesterolemia is E78.010. This updated coding structure requires precise documentation to avoid claim denials.

Documentation Requirements for E78.010

Documentation Element Required Details Supporting Evidence
Genetic Confirmation Bi-allelic pathogenic variants in LDLR, APOB, or PCSK9 genes Genetic testing report
Clinical Phenotype LDL-C >400 mg/dL (untreated) or family history Lipid panels, pedigree
Physical Findings Xanthomas, corneal arcus (if present) Clinical examination notes
Treatment Response Minimal response to standard lipid-lowering therapy Prior therapy documentation

Avoid These Common Coding Errors:

  • Using E78.019 (familial hypercholesterolemia, unspecified)
  • Mixing HoFH with heterozygous FH codes (E78.011)
  • Insufficient documentation to support homozygous diagnosis

Product Coding: HCPCS, NDC, and Units Calculation

HCPCS Code: J1305

Definition: Injection, evinacumab-dgnb, 5 mg

Critical Calculation: Each billing unit = 5 mg of Evkeeza

NDC Numbers by Vial Size

  • 345 mg/2.3 mL vial: NDC 61755-078-01
  • 1,200 mg/8 mL vial: NDC 61755-079-01

Dosing and Units Math

Standard HoFH Dose: 15 mg/kg every 4 weeks

Example Calculation for 75 kg patient:

  • Dose needed: 75 kg × 15 mg/kg = 1,125 mg
  • Billing units: 1,125 mg ÷ 5 mg per unit = 225 units of J1305

Required Modifiers

  • JW modifier: Report discarded drug amounts
  • JZ modifier: Report when no drug is discarded (required since July 2023)

Infusion Administration Codes

  • CPT 96413: First hour of IV infusion
  • CPT 96415: Each additional hour beyond the first

Clean Prior Authorization Request Anatomy

A successful Evkeeza prior authorization for BCBS New York requires these essential components:

Patient Information Section

✓ Member ID and demographics
✓ ICD-10 code: E78.010 (HoFH)
✓ Prescribing physician details
✓ Requested drug: Evkeeza (evinacumab-dgnb)
✓ Dose: 15 mg/kg every 4 weeks
✓ HCPCS code: J1305

Medical Necessity Documentation

  1. HoFH Diagnosis Confirmation
    • Genetic testing results showing bi-allelic mutations
    • Clinical phenotype documentation
    • Family history of premature cardiovascular disease
  2. Prior Therapy Failures
    • Maximum-tolerated statin therapy (document specific drug, dose, duration)
    • Ezetimibe trial results
    • PCSK9 inhibitor experience (evolocumab or alirocumab)
    • Reasons for discontinuation (inefficacy, intolerance, contraindications)
  3. Current Clinical Status
    • Recent lipid panel (within 3 months)
    • LDL-C levels despite maximum therapy
    • Cardiovascular risk assessment

Supporting Attachments

  • Laboratory results
  • Genetic testing report
  • Prior authorization forms from previous therapies
  • Physician attestation letter

When patients and providers work with specialized platforms like Counterforce Health, these complex prior authorization requests are systematically organized to address each payer's specific requirements, reducing the likelihood of denials and appeals.

Frequent Coding and Billing Pitfalls

Unit Conversion Errors

Common Mistake: Billing 1,125 mg as 1,125 units instead of 225 units Correct Approach: Always divide total mg by 5 to get J1305 units

Mismatched Diagnosis Codes

Problem: Using unspecified FH codes (E78.019) when HoFH is documented Solution: Ensure E78.010 matches clinical documentation exactly

Missing Start Dates

Issue: Omitting therapy start dates or duration of prior treatments Fix: Document exact dates, doses, and outcomes for all prior lipid-lowering therapies

Modifier Oversights

Problem: Forgetting JW/JZ modifiers for drug wastage Impact: Claim delays or denials from Medicare and commercial payers

Site of Care Confusion

Issue: Billing for home administration when drug requires clinical supervision Correction: Evkeeza must be administered in healthcare facilities with infusion capabilities

BCBS New York Verification Steps

Pre-Submission Verification Checklist

  1. Confirm Plan Type
    • Individual/family plan
    • Employer-sponsored coverage
    • Medicare Advantage
    • Medicaid managed care
  2. Check Current Formulary Status
    • Visit your BCBS plan's online formulary tool
    • Verify tier placement and restrictions
    • Note any quantity limits or step therapy requirements
  3. Verify Prior Authorization Requirements
    • Access provider portal for current PA forms
    • Review medical policy for Evkeeza (policy numbers vary by plan)
    • Confirm submission methods (online portal, fax, mail)
  4. Cross-Reference Billing Codes
    • Ensure J1305 is recognized for your specific BCBS plan
    • Verify NDC numbers are current and accepted
    • Check for any plan-specific billing requirements

BCBS New York Contact Resources

  • Provider Services: Available through Availity portal
  • Prior Authorization Status: Online provider dashboard
  • Appeals Department: Plan-specific contact information on member ID card

Pre-Submission Audit Checklist

Before submitting your Evkeeza prior authorization:

Clinical Documentation ✓

  • HoFH diagnosis confirmed with E78.010 coding
  • Genetic testing results attached
  • Recent lipid panels (within 90 days)
  • Complete prior therapy documentation
  • Physician attestation of medical necessity

Coding Accuracy ✓

  • J1305 units calculated correctly (mg ÷ 5)
  • Appropriate NDC for vial size selected
  • JW or JZ modifier applied as needed
  • CPT codes for infusion administration included

Administrative Requirements ✓

  • Current BCBS member ID verified
  • Provider NPI and taxonomy codes correct
  • Prior authorization form completed entirely
  • All required signatures obtained

Submission Method ✓

  • Correct portal or fax number confirmed
  • All attachments properly labeled
  • Submission receipt or confirmation number saved

Appeals Playbook for New York

New York offers robust patient protections for insurance denials, including specialty drug coverage disputes.

Internal Appeal (Level 1)

Timeline: Must file within 60-65 calendar days of denial Process: Submit through BCBS member/provider portal or by mail Decision Timeline:

  • Standard review: 30 calendar days
  • Expedited review: 72 hours (for urgent cases)

External Review through DFS (Level 2)

New York's External Appeal Program provides independent review of insurance denials.

Eligibility: Available after internal appeal denial Timeline: File within 4 months of internal appeal decision Process: Submit application through New York State Department of Financial Services Cost: Maximum $25 filing fee (waived for financial hardship)

Key Advantage: DFS decisions are binding on insurers and often favor patients when medical necessity is well-documented.

Expedited Appeals for Urgent Cases

If delaying Evkeeza treatment poses serious health risks:

  • Request expedited internal review (72-hour decision)
  • Expedited external review available (24-48 hours for urgent drug denials)
  • Requires physician certification of urgency

Organizations like Counterforce Health specialize in transforming insurance denials into evidence-backed appeals, using payer-specific knowledge and clinical expertise to improve success rates in complex cases like HoFH treatment approvals.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Insufficient HoFH documentation Submit comprehensive genetic and clinical evidence Genetic testing, lipid panels, family history
Step therapy not completed Document all prior lipid-lowering therapy trials Pharmacy records, physician notes, intolerance documentation
Not medically necessary Provide evidence-based medical necessity letter Clinical guidelines, FDA labeling, peer-reviewed studies
Experimental/investigational Reference FDA approval and established guidelines FDA label, specialty society recommendations
Site of care issues Confirm appropriate infusion facility Facility credentials, administration protocols

Medical Necessity Letter Template Elements

  1. Patient-specific clinical presentation
  2. HoFH diagnosis with supporting evidence
  3. Prior therapy failures with specific details
  4. Clinical rationale for Evkeeza therapy
  5. Expected outcomes and monitoring plan
  6. References to FDA labeling and clinical guidelines

FAQ

Q: How long does BCBS prior authorization take in New York? A: Standard reviews typically take 14-30 days with complete documentation. Expedited reviews for urgent cases are decided within 72 hours.

Q: What if Evkeeza is non-formulary on my BCBS plan? A: You can request a formulary exception by demonstrating medical necessity and providing evidence that formulary alternatives are inappropriate or ineffective.

Q: Can I request an expedited appeal if my initial PA is denied? A: Yes, if your physician certifies that delaying treatment poses serious health risks, you can request expedited internal and external appeals.

Q: Does step therapy apply if I failed these drugs outside New York? A: Previous therapy failures from other states are generally accepted with proper documentation, including pharmacy records and physician attestations.

Q: What happens if both internal and external appeals are denied? A: You may have additional options through state insurance commissioner complaints or legal advocacy, particularly for rare diseases like HoFH.

Q: Are there financial assistance programs for Evkeeza? A: Regeneron offers patient support programs, and various foundations provide assistance for rare disease treatments. Check eligibility requirements and income limits.

Q: How do I find a qualified infusion center for Evkeeza? A: Contact your BCBS plan's provider directory or ask your prescribing physician for in-network specialty pharmacies and infusion centers.

Q: What documentation should I keep during the appeals process? A: Maintain copies of all correspondence, denial letters, medical records, appeal submissions, and confirmation numbers for tracking purposes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and should not replace professional medical or legal advice. Insurance coverage policies vary by plan and are subject to change. Always verify current requirements with your specific BCBS plan and consult with healthcare providers for medical decisions. For personalized assistance with complex prior authorizations and appeals, consider consulting with specialized advocacy services.

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