Cemiplimab-rwlc Injection, for Intravenous Use (Libtayo®) HCPCS Code J9999: Billing Guidelines

Tuesday, December 4, 2018

Effective with date of service Oct. 8, 2018, North Carolina Medicaid and NC Health Choice programs cover cemiplimab-rwlc injection, for intravenous use (Libtayo) for use in the Physician Administered Drug Program when billed with HCPCS code J9999 - Not Otherwise Classified, Antineoplastic Drugs.

Libtayo is available as a single-dose vial containing 350 mg per 7 mL. It is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

Recommended Dose

350 mg as an intravenous infusion over 30 minutes every 3 weeks

See full prescribing information for further detail.

For Medicaid and NCHC Billing

• Providers must bill with HCPCS code: J9999 - Not Otherwise Classified, Antineoplastic Drugs

• One Medicaid and NC Health Choice unit of coverage is 1 mg

• Maximum reimbursement rate per unit is $28.08

• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is 61755-0008-01

• 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 No. 1B, Attachment A, H.7 on DMA's website.

• Providers shall bill their usual and customary charge for non-340B drugs.

• PDP reimburses for drugs billed for Medicaid and NCHC 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 Physician Administered Drug Program is available on the Medicaid website PADP page.

• Information current as of 10/24/2018 and is not a substitute for professional judgment. For full prescribing information, please refer to current package insert or other appropriate sources prior to making clinical judgments.

GDIT, (800) 688-6696