Local Coverage Article Billing and Coding

Billing and Coding: Spinraza® (Nusinersen)

A58579

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Contractor Information

Article Information

General Information

Article ID
A58579
Article Title
Billing and Coding: Spinraza® (Nusinersen)
Article Type
Billing and Coding
Original Effective Date
11/25/2021
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
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CMS National Coverage Policy

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Article Guidance

Article Text

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, 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 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)

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book.

 

Group 1 Codes
CodeDescription
J2326 INJECTION, NUSINERSEN, 0.1 MG

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(2 Codes)
Group 1 Paragraph

It is the provider's responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

Medicare is establishing the following limited coverage for CPT/HCPCS code: J2326

Group 1 Codes
CodeDescription
G12.0 Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]
G12.1 Other inherited spinal muscular atrophy

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

(1 Code)
Group 1 Paragraph

All those not listed under the "ICD-10 Codes that Support Medical Necessity" section of this article.

Group 1 Codes
CodeDescription
XX000 Not Applicable

ICD-10-PCS Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

CodeDescription
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
083x Ambulatory Surgery Center
085x Critical Access Hospital

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Note: The contractor has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this article. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Publication 100-04, Medicare Claims Processing Manual, for further guidance.


CodeDescription
049X Ambulatory Surgical Care - General Classification
0636 Pharmacy - Drugs Requiring Detailed Coding

Other Coding Information

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Revision History Information

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Associated Documents

Related Local Coverage Documents
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
11/18/2021 11/25/2021 - N/A Currently in Effect You are here

Keywords

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