Billing and Coding: Spinraza (nusinersen)

Noridian 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 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 _must_ 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

Should 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 provider _must_ bill 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 Noridian's expectation that the appropriate primary
ICD-10-CM Diagnosis Code _must_ be billed, as 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 atrophy



**_Frequency 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.3

For 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:_**

  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)