Retifanlimab-dlwr Injection, for Intravenous Use (Zynyz™) HCPCS Code J9999 - Not Otherwise Classified, Antineoplastic Drugs: Billing Guidelines

Effective with date of service April 5, 2023, NC Medicaid covers retifanlimab-dlwr injection, for intravenous use (Zynyz)

Effective with date of service April 5, 2023, the NC Medicaid program covers retifanlimab-dlwr injection, for intravenous use (Zynyz) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.

Strength/Package Size: Injection: 500 mg/20 mL (25 mg/mL) solution in a single-dose vial.

Indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

Recommended Dose: 500 mg as an intravenous infusion over 30 minutes every 4 weeks. See full prescribing information for further detail. 

For Medicaid Billing

The ICD-10-CM diagnosis codes required for billing are:
Merkel Cell Carcinoma: 
C4A.0 – Merkel cell carcinoma of lip; 
C4A.111 – Merkel cell carcinoma of right upper eyelid, including canthus; 
C4A.112 – Merkel cell carcinoma of right lower eyelid, including canthus; 
C4A.121 – Merkel cell carcinoma of left upper eyelid, including canthus; 
C4A.122 – Merkel cell carcinoma of left lower eyelid, including canthus; 
C4A.21 – Merkel cell carcinoma of right ear and external auricular canal; 
C4A.22 – Merkel cell carcinoma of left ear and external auricular canal; 
C4A.31 – Merkel cell carcinoma of nose; 
C4A.39 – Merkel cell carcinoma of other parts of face; 
C4A.4 – Merkel cell carcinoma of scalp and neck; 
C4A.51 – Merkel cell carcinoma of anal skin; 
C4A.52 – Merkel cell carcinoma of skin of breast; 
C4A.59 – Merkel cell carcinoma of other part of trunk; 
C4A.61 – Merkel cell carcinoma of right upper limb, including shoulder; 
C4A.62 – Merkel cell carcinoma of left upper limb, including shoulder; 
C4A.71 – Merkel cell carcinoma of right lower limb, including hip; 
C4A.72 – Merkel cell carcinoma of left lower limb, including hip; 
C4A.8 – Merkel cell carcinoma of overlapping sites; 
C7B.1 – Secondary Merkel cell carcinoma 

  • Providers must bill with HCPCS code: J9999 - Not otherwise classified, antineoplastic drugs
  • One Medicaid unit of coverage is: 1 mg  
  • The maximum reimbursement rate per unit is: $30.75840  
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 50881-0006-03
  • The NDC units should be reported as "UN1." 
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and 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 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 the NC Medicaid Fee Schedule & Covered Code portal

Contact

NCTracks Call Center: 800-688-6696

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