Cabotegravir and Rilpivirine Co-Packaged for IM Use (Cabenuva™) HCPCS Code J3490: Billing Guidelines

Tuesday, March 30, 2021

Effective with date of service Feb. 1, 2021, the Medicaid and NC Health Choice programs cover cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension, co-packaged for intramuscular use (Cabenuva™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.

Cabotegravir extended-release injectable suspension and rilpivirine extended release injectable suspension is co-packaged as follows:

Cabenuva™ 400-mg/600-mg Kit:

  • single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir
  • single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine

Cabenuva™ 600-mg/900-mg Kit:

  • single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir
  • single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirine

Cabenuva™ is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

Recommended Dose: 600 mg of cabotegravir and 900 mg of rilpivirine on the last day of oral lead-in and continue with injections of 400 mg of cabotegravir and 600 mg of rilpivirine every month thereafter. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis codes required for billing are: 
    • B20 - Human immunodeficiency virus (HIV) disease
    • Z21 - Asymptomatic human immunodeficiency virus [HIV] infection status
  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid and NC Health Choice unit of coverage is: 1 mL
  • The maximum reimbursement rate per unit is: $1,069.20
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 49702-0253-15 and 49702-0240-15
  • 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

Contact

NCTracks Contact Center: 800-688-6696