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

How to Get Evkeeza (evinacumab-dgnb) Covered by Cigna in New York: Complete Coding & Prior Authorization Guide

Answer Box: Getting Evkeeza Covered by Cigna in New York

Evkeeza (evinacumab-dgnb) requires prior authorization from Cigna for homozygous familial hypercholesterolemia (HoFH). Key steps: 1) Confirm HoFH diagnosis with genetic testing or clinical criteria, 2) Document failed trials of maximum statin, ezetimibe, and PCSK9 inhibitor therapy, 3) Submit complete prior authorization with recent LDL-C levels ≥70 mg/dL. Use ICD-10 code E78.010 and J-code J1305 for billing. If denied, New York offers external appeals through the Department of Financial Services with 72-hour expedited decisions. Start with Cigna's prior authorization form.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for HoFH Documentation
  3. Product Coding: HCPCS, J-Code, and NDC Overview
  4. Clean Request Anatomy: Building Your Prior Authorization
  5. Frequent Pitfalls and How to Avoid Them
  6. Verification Step: Cross-Checking with Cigna
  7. Appeals Playbook for New York
  8. Quick Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Understanding whether Evkeeza falls under medical or pharmacy benefits affects your prior authorization approach, copay structure, and billing procedures with Cigna.

Medical Benefit Coverage

When Evkeeza is administered in a clinic, hospital outpatient facility, or physician's office, it typically falls under medical benefits. This pathway uses:

  • Medical claim forms (CMS-1500 or UB-04)
  • J-code billing (J1305)
  • Prior authorization through Cigna's clinical networks program

Pharmacy Benefit Coverage

Home infusion delivery through specialty pharmacy falls under pharmacy benefits. Cigna's designated partner is Accredo specialty pharmacy, which handles:

  • Specialty pharmacy dispensing
  • Home infusion coordination
  • Pharmacy benefit prior authorization
Tip: Regardless of benefit type, prior authorization is required for all Evkeeza coverage with Cigna.

ICD-10 Mapping for HoFH Documentation

Accurate diagnosis coding is critical for Evkeeza approval. The specific ICD-10 code for homozygous familial hypercholesterolemia is E78.010, which became effective in October 2025.

Documentation Requirements

Your medical records must clearly distinguish HoFH from other lipid disorders:

Code Description Documentation Needed
E78.010 Homozygous familial hypercholesterolemia Genetic testing OR clinical phenotype with LDL-C ≥400 mg/dL
E78.011 Heterozygous familial hypercholesterolemia Single-gene variant, moderate LDL-C elevation
E78.019 Familial hypercholesterolemia, unspecified Avoid when specific type is known

Supporting Documentation Words

Include these clinical terms in your records to support E78.010 coding:

  • "Homozygous familial hypercholesterolemia confirmed by genetic testing"
  • "Pathogenic variants in LDLR/APOB/PCSK9/LDLRAP1 genes"
  • "Severe hypercholesterolemia with LDL-C >400 mg/dL"
  • "Family history consistent with HoFH inheritance pattern"

Source: Lipid.org ICD-10 Guidelines

Product Coding: HCPCS, J-Code, and NDC Overview

J-Code and Billing Units

The HCPCS J-code for Evkeeza is J1305: "Injection, evinacumab-dgnb, 5 mg" where 1 billing unit = 5 mg.

NDC Numbers

Two NDC codes are mapped to J1305:

  • 61755-0010-01: 240 billing units (1200 mg/8 mL)
  • 61755-0013-01: 69 billing units (345 mg/2.3 mL)

Dosing and Units Calculation

Evkeeza is dosed at 15 mg/kg IV every 4 weeks with a maximum of 345 billing units (1,725 mg) every 28 days.

Example calculation:

  • Patient weight: 70 kg
  • Dose needed: 70 kg × 15 mg/kg = 1,050 mg
  • Billing units: 1,050 mg ÷ 5 mg = 210 units

Administration Coding

Use these CPT codes for IV administration:

  • 96413: Chemotherapy administration, IV infusion, up to 1 hour
  • 96365: IV infusion for therapy, initial, up to 1 hour

Required modifiers:

  • JZ modifier: No discarded drug (required by Medicare since July 2023)
  • JW modifier: Report discarded amounts when applicable

Source: Buy and Bill Evkeeza J1305 Guide

Clean Request Anatomy: Building Your Prior Authorization

Complete Documentation Package

Submit these elements together for fastest approval:

1. Cigna HoFH-Specific Form

2. Diagnosis Confirmation

  • Genetic testing results showing pathogenic variants, OR
  • Clinical phenotype documentation with LDL-C ≥400 mg/dL and family history

3. Laboratory Results

  • Lipid panel within past 3 months
  • LDL-C levels ≥70 mg/dL despite maximum therapy
  • Patient weight for dosage calculations

4. Background Therapy Documentation Required step therapy trials with specific dates and dosages:

  • High-intensity statin (atorvastatin 80mg or rosuvastatin 40mg equivalent)
  • Ezetimibe 10mg daily
  • PCSK9 inhibitor trial (for patients ≥10 years) with 8+ weeks documentation

5. Medical Necessity Letter Include these key elements:

  • HoFH diagnosis confirmation
  • Current LDL-C levels and cardiovascular risk
  • Prior therapy failures or contraindications
  • Clinical rationale for Evkeeza
  • Treatment goals and monitoring plan

Source: Cigna Coverage Policy

Frequent Pitfalls and How to Avoid Them

Unit Conversion Errors

Pitfall: Calculating billing units incorrectly Fix: Always divide total dose (mg) by 5 to get billing units for J1305

Mismatched Codes

Pitfall: Using general familial hypercholesterolemia codes Fix: Use specific E78.010 for HoFH; avoid E78.019 (unspecified)

Missing Start Dates

Pitfall: Incomplete background therapy documentation Fix: Provide exact start/stop dates for all prior medications with pharmacy records

Insufficient LDL-C Documentation

Pitfall: Using outdated lipid panels Fix: Submit lipid results within 3 months showing inadequate control (LDL-C ≥70 mg/dL)

Pitfall: Missing PCSK9 inhibitor trials for older patients Fix: Document 8+ weeks of PCSK9 inhibitor therapy for patients ≥10 years

Verification Step: Cross-Checking with Cigna

Before submitting your prior authorization, verify these elements:

Coverage Verification

  • Call Cigna member services (number on insurance card) to confirm:
    • Prior authorization requirement
    • Preferred specialty pharmacy (typically Accredo)
    • Medical vs. pharmacy benefit coverage

Form Currency

  • Check that you're using the current Cigna form
  • Verify submission methods (portal, fax, phone)

Billing Code Confirmation

  • Confirm J1305 is covered under the patient's specific plan
  • Verify any plan-specific quantity limits or billing requirements

Appeals Playbook for New York

If Cigna denies your Evkeeza prior authorization, New York offers robust appeal protections through the Department of Financial Services.

Internal Appeals with Cigna

Timeline: File within 180 days of denial Process:

  1. Submit written appeal to Cigna with supporting documentation
  2. Standard review: 30 days
  3. Expedited review: 72 hours for urgent cases

External Appeals (New York DFS)

Timeline: File within 4 months of Cigna's final internal denial Decisions:

  • Standard: 30 days
  • Expedited: 72 hours
  • Non-formulary drugs: 24 hours (expedited)

Filing Requirements:

Submit to: NY Department of Financial Services 99 Washington Avenue, Albany, NY 12210 Fax: 800-332-2729

Cost: $25 filing fee (waived for Medicaid or financial hardship)

Note: External appeal decisions are binding on Cigna—they must comply if you win.

Free Help Available

Community Health Advocates provides free assistance at 888-614-5400 for New York residents navigating insurance appeals.

Source: NY DFS External Appeals

Quick Audit Checklist

Before submitting your Evkeeza prior authorization, verify:

Diagnosis & Coding:

  • ICD-10 code E78.010 documented in medical records
  • HoFH confirmed by genetic testing OR clinical criteria
  • J-code J1305 calculated correctly (dose in mg ÷ 5 = billing units)

Clinical Documentation:

  • Recent lipid panel (within 3 months) showing LDL-C ≥70 mg/dL
  • Maximum statin therapy documented with dates
  • Ezetimibe trial documented
  • PCSK9 inhibitor trial documented (if patient ≥10 years)
  • Patient weight recorded for dosing calculations

Submission Requirements:

  • Complete Cigna HoFH-specific form
  • Medical necessity letter from prescriber
  • All supporting lab results and pharmacy records attached
  • Submission method confirmed (portal, fax, or phone)

Appeal Preparation:

  • Copy of all submitted documents retained
  • Cigna denial letter (if applicable) saved for potential appeal
  • NY external appeal timeline noted (4 months from final denial)

When to Contact Counterforce Health

Navigating prior authorization for specialty medications like Evkeeza can be complex, especially when dealing with step therapy requirements and potential appeals. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer rules.

Their platform pulls the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—and weaves them into appeals with required clinical facts like diagnosis codes, prior therapy documentation, and treatment goals. For New York patients facing Cigna denials, this targeted approach can significantly improve appeal success rates.

FAQ

How long does Cigna prior authorization take for Evkeeza in New York? Standard review takes 72 hours from complete submission. Expedited review is available for urgent cases with 24-hour decisions.

What if Evkeeza is non-formulary on my Cigna plan? You can request a formulary exception with clinical justification. If denied, New York's external appeal process offers 24-hour expedited decisions for non-formulary drugs.

Can I request an expedited appeal if my doctor says it's urgent? Yes. If your physician certifies that delay poses an "imminent or serious health threat," you can get expedited review within 72 hours through Cigna or 24-72 hours through NY external appeals.

Does step therapy apply if I failed treatments outside New York? Yes. Document all prior therapy trials regardless of where they occurred. Cigna requires evidence of failed statin, ezetimibe, and PCSK9 inhibitor trials.

What happens if I win my external appeal? The decision is binding on Cigna—they must cover the treatment. They'll also refund your $25 appeal filing fee if you paid one.

How much does Evkeeza cost without insurance? The average wholesale acquisition cost is approximately $450,000 per year, making prior authorization and appeals critical for access.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Cigna and consult with your healthcare provider and insurance specialist. For official guidance on New York insurance appeals, contact the NY Department of Financial Services or Community Health Advocates at 888-614-5400.

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