Nusinersen injection, for intrathecal use (Spinraza) HCPCS code J2326 - Unclassified Drugs: Billing Guidelines and Change in Coverage
Author: CSRA, 1-800-688-6696
Effective July 1, 2018, the North Carolina Medicaid and N.C. Health Choice (NCHC) programs will cover nusinersen injection, for intrathecal use (Spinraza) for use only in the Physician's Drug Program (PDP). The HCPCS code is J2326 – Injection, nusinersen.
Effective June 30, 2018, Spinraza coverage through outpatient specialty pharmacy and via the prior authorization method will terminate and outpatient pharmacy claims submitted for Spinraza initial treatment or continuation of treatment will be denied. Providers will need to submit claims for Spinraza as per the requirements on Centers for Medicare and Medicaid Services (CMS) 1500/837P form for professional claims.
Spinraza is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. It is available as 12 mg/5 mL (2.4 mg/mL) in a single-dose vial for intrathecal administration.
The recommended dosage is 12 mg (5 mL) per administration. Initiate Spinraza treatment with four loading doses; the first three loading doses should be administered at 14-day intervals; the fourth loading dose should be administered 30 days after the third dose; a maintenance dose should be administered once every four months thereafter. See full prescribing information for further detail.
Note: All the information mentioned in this article will need to be carefully followed to minimize the possibility of a claim denial. As with all PDP drug products, the cost of drug acquisition is the responsibility of the provider until the claim is processed.
For Medicaid and NCHC Billing
- The ICD-10-CM diagnosis code required for billing are G12.0 Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]; G12.1 Other inherited spinal muscular atrophy; G12.8 Other spinal muscular atrophies and related syndromes and G12.9 Spinal muscular atrophy, unspecified.
- Providers must bill with HCPCS code J2326 - Injection, nusinersen.
- One Medicaid unit of coverage is 12 mg. NCHC bills according to Medicaid units.
- The maximum reimbursement rate per unit is $135,000.
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is 64406-0058-01.
- 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 Medicaid website.
- Providers shall bill their usual and customary charge for non-340-B drugs.
- PDP reimburses for drugs billed for Medicaid and NCHC beneficiaries by 340-B 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 PDP is available on Medicaid’s PDP web page.