LCD Reference Article Billing and Coding Article

Billing and Coding: Instructions for Lemtrada® (alemtuzumab) When Used in the Treatment of Relapsing Multiple Sclerosis

A55310

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55310
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Instructions for Lemtrada® (alemtuzumab) When Used in the Treatment of Relapsing Multiple Sclerosis
Article Type
Billing and Coding
Original Effective Date
09/18/2016
Revision Effective Date
10/01/2025
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

Lemtrada® is indicated in the treatment of patients with relapsing forms of multiple sclerosis. The dosage of Lemtrada® when used for this indication is 12mg/day infused for 5 consecutive days, then 12mg/day infused for 3 consecutive days at one interval, one year from the first course of treatment.

To submit a claim for Lemtrada® in Part B of A (hospital outpatient) on a UB-04 claim form, the following information must appear on the form:

Diagnosis-(Box 66)

ICD-10-CM G35.A or G35.C1 (for claims with date of service (DOS) from 10/01/2015 forward)

HCPCS drug code-(Field 44)
 
J0202 Injection, alemtuzumab 1mg (DOS 01/01/2016 forward)

Narrative (Remarks) in (Field 80) (or electronic equivalent)

National Drug Code (NDC)- 58468-0200-1 or 58468-0200-01 Single use vial 12mg/1.2 ml (10mg/ml)
Name of Drug (trade and generic)
Dose of drug administered
Route of administration

To submit a claim for Lemtrada® in Part B on a CMS-1500 claim form, the following information must appear on the form:

Diagnosis-(Box 21)

ICD-10-CM G35.A or G35.C1 (for claims with DOS from 10/01/2015 forward)

HCPCS drug code- (Box 24D)

J0202 Injection, alemtuzumab 1mg (DOS 01/01/2016 forward)

Narrative- (Box 19) (or electronic equivalent)

NDC- 58468-0200-1 or 58468-0200-01 Single use vial 12mg/1.2 ml (10mg/ml)
Name of Drug (trade and generic)
Dose of drug administered
Route of administration

Note: This drug is supplied in a single use vial that contains 12mg of alemtuzumab. Per Food and Drug Administration (FDA) labeling, the dose of this drug is 12mg per day, therefore claims reflecting administered dosages other than 12mg per DOS or claims reporting wastage or product NDC numbers other than those listed above will be rejected.

Response To Comments

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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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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

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Group 1 Codes
Code Description
G35.A Relapsing-remitting multiple sclerosis
G35.C1 Active secondary progressive multiple sclerosis
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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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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

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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.

Code Description

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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
10/01/2025 R5

Under Article Text under subheading Diagnosis-(Box 66) removed “G35 Multiple Sclerosis” and replaced with “G35.A or G35.C1”. Under subheading Diagnosis-(Box 21) removed “G35 Multiple Sclerosis” and replaced with “G35.A or G35.C1”. Under ICD-10-CM Codes that Support Medical Necessity Group 1: Paragraph deleted G35. Under ICD-10-CM Codes that Support Medical Necessity Group 1: Codes added G35.A and G35.C1. This revision is due to the Annual ICD-10-CM Update and will become effective on 10/1/25.

10/24/2019 R4

This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Under Article Title added a colon after the word “Coding”. Formatting, punctuation and typographical errors were corrected throughout the article.

04/01/2018 R3

Under CPT/HCPCS Group 1: Codes, added HCPCS J0202.

02/26/2018 R2 The Jurisdiction "J" Part A and Part B Contracts for Alabama (10111/10112), Georgia (10211/10212) and Tennessee (10311/10312) are now being serviced by Palmetto GBA. Effective 02/26/18, these 6 contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 6 Part A and B contract numbers) have been completed in this revision.
08/03/2017 R1

Under Article Text second sentence added the word “consecutive” after the number “3”, under Diagnosis-(Box 66) deleted the verbiage “ICD-9 340 Multiple Sclerosis (for claims with DOS from 11/14/2014 to 9/30/2015)”, under HCPCS drug code-(Field 44) deleted the verbiage “C9399 Unclassified drugs or biologics (DOS from 11/14/2014 to 9/30/2015)” and “Q9979 Injection, alemtuzumab 1mg (DOS from 10/01/2015 to 12/31/2015)” under Diagnosis-(Box 21) deleted the verbiage “ICD-9 340 Multiple Sclerosis (for claims with DOS from 11/14/2014 to 9/30/2015)” and under HCPCS drug code-(Box 24D) deleted the verbiage “J3490 Unclassified drugs or J3590 unclassified biologics (DOS from 11/14/2014 to 9/30/2015)” and  “Q9979 Injection, alemtuzumab 1mg (DOS from 10/01/2015 to 12/31/2015)”.

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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
NCDs
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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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Public Versions
Updated On Effective Dates Status
08/28/2025 10/01/2025 - N/A Currently in Effect You are here
10/14/2019 10/24/2019 - 09/30/2025 Superseded View
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Keywords

  • Alemtuzumab