Evinacumab-dgnb Injection, for Intravenous Use (Evkeeza™) HCPCS Code J3590: Billing Guidelines

Tuesday, May 4, 2021

Effective with date of service Feb. 19, 2021, the North Carolina Medicaid and NC Health Choice programs cover evinacumab-dgnb injection for intravenous use (Evkeeza) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

Evkeeza is available as an injection: 345 mg/2.3 mL (150 mg/mL) and 1,200 mg/8 mL (150 mg/mL) solution in single-dose vials. It is indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH). 

Limitations of Use:

  • The safety and effectiveness of Evkeeza have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
  • The effects of Evkeeza on cardiovascular morbidity and mortality have not been determined.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing are: E78.01 - Familial hypercholesterolemia
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid and Health Choice unit of coverage is: 1 mg 
  • The maximum reimbursement rate per unit is: $33.75
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 61755-0010-01, 61755-0013-01
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012 Special Bulletin National Drug Code Implementation Update
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website
  • Providers shall bill their usual and customary charge for non-340B drugs
  • PADP reimburses for drugs billed for Medicaid and Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PADP is available on Medicaid's PADP web page


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