Noridian has received numerous billing and coding queries regarding J2326, Nusinersen, (brand name SPINRAZA®). This code became effective 01/01/2018.

The purpose of this article is to offer 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 requirement when used for indications specified on the labeling. Therefore, the program may pay 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."¹

When provided in accordance with FDA indications and subsequently billing for Medicare reimbursement, use J-code J2326 along with the appropriate billable units.

The medication is injected intrathecally. Therefore, it is expected that this medication would be billed in conjunction with CPT procedure code 96450 [chemotherapy administration, into central nervous system (CNS) (e.g. intrathecal), requiring spinal puncture] on the same date of service.²

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, it is expected that the provider would code with the appropriate primary ICD-10-CM code that the Medicare beneficiary has been fully evaluated and diagnosed with.

FDA labeling includes the approved dosage of 12 mg (5mL) per administration with specific loading dose instructions, followed by a maintenance dose every 4 months thereafter.³

Any use outside FDA indications would need to meet Medicare Reasonable and Necessary requirements as well as Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1.^1,4

Resources

1. Internet Only Manual (IOM), Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 50.4.1
2. CPT Assistant-Reporting Intrathecal Injection of Nusinersen (March 2021, Volume 31, Issue 3, page 3)
3. FDA Label SPINRAZA® (nusinersen)
4. Internet Only Manual (IOM), Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2