Patisiran Lipid Complex Injection, for Intravenous Use (Onpattro™) HCPCS Code J3490: Billing Guidelines

Effective with date of service Sept. 5, 2018, the Medicaid and NC Health Choice programs cover patisiran lipid complex injection, for intravenous use (Onpattro) for use in the Physicians Drug Program (PDP) when billed with HCPCS code J3490 - Unclassified drugs. Onpattro is commercially available as 10 mg/5 mL in a single-dose vial.

Onpattro is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

Recommended Dose

For patients weighing less than 100 kg, the recommended dosage is 0.3 mg/kg every 3 weeks by intravenous infusion. For patients weighing 100 kg or more, the recommended dosage is 30 mg every 3 weeks by intravenous infusion. Premedicate with a corticosteroid, acetaminophen and antihistamines. See full prescribing information for further detail.

For Medicaid and NCHC Billing

• The ICD-10-CM diagnosis code required for billing is E85.1 - Neuropathic heredofamilial amyloidosis.
• Providers must bill with HCPCS code J3490-Unclassified drugs.
• One Medicaid and NC Health Choice unit of coverage is 1 mg.
• The maximum reimbursement rate per unit is $1026.00.
• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is 71336-1000-01.
• 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 PDP, refer to the PDP Clinical Coverage Policy No. 1B, Attachment A, H.7 on the NC Medicaid website.
• Providers shall bill their usual and customary charge for non-340B drugs.
• PDP reimburses for drugs billed for Medicaid and NC 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 Physician's Drug Program is available on the NC Medicaid website’s PDP web page.