Article - Billing and Coding: Spinraza® (Nusinersen) (A58579)

CMS National Coverage PolicyN/AArticle TextNoridian has received numerous billing and coding queries regarding J2326, Nusinersen, (Brand name SPINRAZA). This code became effective 01/01/2018.This article is not a coverage determination, but rather guidance on the appropriate billing and coding when utilizing this medication.As a reminder, the Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1 Approved Use of Drug states,"Use of the drug or biological must be safe and effective and otherwise reasonable and necessary. Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirementwhen used for indications specified on the labeling.Therefore, the programmaypay for the use of an FDA approved drug or biological, if:it was injected on or after the date of the FDA's approval;it is reasonable and necessary for the individual patient and,all other applicable coverage requirements are met."1When provided in accordance with FDA indications and subsequently billing for Medicare reimbursement, use J-codeJ2326along with the appropriate billable units.The medication is injected intrathecally. Therefore, it is expected that this medicationmustbe billed in conjunction with CPT procedure code96450[chemotherapy administration, into central nervous system (CNS) (e.g. intrathecal), requiring spinal puncture] on the same date of service.2Should the provider and facility bill separately for procedure and medication respectively, the facility must bill the administration code as a no pay service and the drug as the presumed covered service.Noridian recognizes the importance of the provider coding to the highest level of specificity. As this medication is clinically indicated for the most specific of diagnoses, the providermustbill with the appropriate primary ICD -10-CM code that identifies the type of Spinal Muscular Atrophy that the Medicare beneficiary has been fully evaluated and diagnosed with.Consequently, it is Noridians expectation that the appropriate primary ICD-10-CM Diagnosis Codemustbe billed, which includes either:G12.0(Infantile spinal muscular atrophy, type I; Werdnig-Hoffman)or,G12.1(Other inherited spinal muscular atrophy) to include:-Adult form spinal muscular atrophy-Childhood form, type II spinal muscular atrophy-Distal spinal muscular atrophy-Juvenile form, type III spinal muscular atrophy (Kugelberg-Welander)-Progressive bulbar palsy of childhood (Fazio-Londe)-Scapuloperoneal from spinal muscular atrophyFrequency Limitations:The drug SPINRAZA (nusinersen) is also FDA indicated for a specific dosing requirement.Currently, FDA has approved the dosage of 12 mg (5mL) per administration.3For the first 12 months of treatment, no more than six (6) intrathecal injections of (SPINRAZA) nusinersen(HCPCS code J2326) may be reported.After the first 12 months of treatment, no more than three (3) intrathecal injections of (SPINRAZA) nusinersen(HCPCS code J2326) may be reported in a rolling 12-month period of time.Any other associated primary ICD 10 diagnosis code billed, or any dosage or frequency other than what is FDA approved, will be reviewed on a claim by claim basis for medical necessity and payment.References:Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1CPT Assistant-Reporting Intrathecal Injection of Nusinersen (March 2021, Volume 31, Issue 3, page 3)FDA Label SPINRAZA (nusinersen)