LCD Reference Article Billing and Coding Article

Billing and Coding: Spinraza® (nusinersen)

A58578

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A58578
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Spinraza® (nusinersen)
Article Type
Billing and Coding
Original Effective Date
11/25/2021
Revision Effective Date
11/25/2021
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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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, 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)

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
083x Ambulatory Surgery Center
085x Critical Access Hospital
N/A

Revenue Codes

Code Description
049X Ambulatory Surgical Care - General Classification
0636 Pharmacy - Drugs Requiring Detailed Coding
N/A

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
Code Description
J2326 INJECTION, NUSINERSEN, 0.1 MG
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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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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
Code Description
G12.0 Infantile spinal muscular atrophy, type I [Werdnig-Hoffman]
G12.1 Other inherited spinal muscular atrophy
N/A

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
Code Description
XX000 Not Applicable
N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 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.

Code Description
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
083x Ambulatory Surgery Center
085x Critical Access Hospital
N/A

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.


Code Description
049X Ambulatory Surgical Care - General Classification
0636 Pharmacy - Drugs Requiring Detailed Coding
N/A

Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/25/2021 R1

Updated to indicate this article is not an LCD Reference Article

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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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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Other URLs
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Public Versions
Updated On Effective Dates Status
11/16/2023 11/25/2021 - N/A Currently in Effect You are here
11/18/2021 11/25/2021 - N/A Superseded View

Keywords

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