Local Coverage Article Billing and Coding

Billing and Coding: Eculizumab


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Contractor Information

Article Information

General Information

Article ID
Article Title
Billing and Coding: Eculizumab
Article Type
Billing and Coding
Original Effective Date
Revision Effective Date
Revision Ending Date
Retirement Date
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CMS National Coverage Policy


Article Guidance

Article Text

This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.

Utilization Guidelines:

Dose and frequency should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Documentation Requirements:

Clinical records should document either immunization with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of eculizumab or that the risks of delaying eculizumab outweighed the risk of meningococcal infection.
When used for the treatment of an individual with PNH, the following should be documented at initiation of therapy:

  • Flow cytometry confirming the diagnosis of PNH and either of the following (a or b)
    1. Evidence of clinically significant hemolysis; or
    2. Documented history of a major adverse vascular event (MAVE) from thromboembolism.

Note: for individuals with confirmed PNH who do not meet the documentation requirements above and who were started on a course of eculizumab prior to the effective date of this document, continuation of therapy may be allowed based on the potential risk of adverse events which may occur upon discontinuation or interruption of therapy.

When given as an initial trial (generally 6-12 weeks) for the treatment of aHUS, the individual was assessed and both:

  • Had no signs of Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); and
  • Thrombotic thrombocytopenic purpura (TTP) was ruled out (for example, normal ADAMTS 13 activity and no evidence of an ADAMTS 13 inhibitor), or if TTP could not be ruled out by laboratory and clinical evaluation, a trial of plasma exchange did not result in clinical improvement

When eculizumab is continued following an initial trial for aHUS, the records should reflect that there had been clinical improvement (for example, increased platelet count or laboratory evidence of reduced hemolysis).

When eculizumab is given for biopsy proven dense deposit disease, elevated serum levels of sC5b-9 (serum Membrane Attack Complex (sMAC) must be documented.

FDA and Compendia Review:

Clinical Pharmacology website http://www.clinicalpharmacology.com/. Accessed 09/08/2022.
FDA label for Soliris (eculizumab). FDA website http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Lexi-Drugs Web site. http://online.lexi.com. Accessed 09/08/2022.
Micromedex DrugDex®. http://www.thomsonhc.com/home/dispatch. Accessed 09/08/2022.
National Comprehensive Cancer Network website http://www.nccn.org/index.asp. Accessed 09/08/2022.

Coding Information


Group 1

(1 Code)
Group 1 Paragraph

HCPCS code J1300 should be used to report eculizumab.

Effective for dates of service on or after 05/01/2021, the administration of eculizumab should be billed using the intravenous infusion administration codes (Refer to article A58620 - Billing and Coding: Complex Drug Administration Coding).

For dates of service prior to 05/01/2021, administration of eculizumab may be billed using the chemotherapy administration code 96413 - Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug and 96415 - Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure) when required due to infusion related adverse reactions in adults (up to 2 hours total) or when used in pediatric or aged Medicare beneficiaries (up to 4 hours total).

Group 1 Codes

CPT/HCPCS Modifiers


ICD-10-CM Codes that Support Medical Necessity

Group 1

(14 Codes)
Group 1 Paragraph


Group 1 Codes
D59.31 Infection-associated hemolytic-uremic syndrome
D59.32 Hereditary hemolytic-uremic syndrome
D59.39 Other hemolytic-uremic syndrome
D59.5 Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli]
G36.0 Neuromyelitis optica [Devic]
G70.00 Myasthenia gravis without (acute) exacerbation
G70.01 Myasthenia gravis with (acute) exacerbation
N00.6 Acute nephritic syndrome with dense deposit disease
N01.6 Rapidly progressive nephritic syndrome with dense deposit disease
N02.6 Recurrent and persistent hematuria with dense deposit disease
N03.6 Chronic nephritic syndrome with dense deposit disease
N04.6 Nephrotic syndrome with dense deposit disease
N07.6 Hereditary nephropathy, not elsewhere classified with dense deposit disease
T86.19 Other complication of kidney transplant

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


ICD-10-PCS Codes


Additional ICD-10 Information


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.


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.


Other Coding Information


Revision History Information

Revision History DateRevision History NumberRevision History Explanation
10/01/2022 R5

Based on the annual ICD-10 code update, ICD-10 code D59.3 has been deleted and replaced by D59.31, D59.32 and D59.39.

07/01/2021 R4

The administration of eculizumab has been updated in the CPT/HCPCS Paragraph section to indicate that intravenous infusion administration codes should be used, effective for dates of service on or after 05/01/2021. (Refer to article A58620 - Billing and Coding: Complex Drug Administration Coding).

11/07/2019 R3

This article was converted to the new Billing and Coding Article format and the brand name, Soliris® has been removed. The Article Text section has been revised to remove the indications and limitations which can be found on the FDA Web site and in the approved compendia. The “Sources of Information” has been revised to “FDA and Compendia Review.” Sources of information other than the FDA and compendia have been moved to a PDF file attached to LCD L33394. The Bill type codes have been removed from this article. Guidance on these codes is available in the Bill type code section.

10/01/2019 R2

An indication for neuromyelitis optica spectrum disorder (NMOSD) has been added based on FDA approval. ICD-10-CM code G36.0 has been added to the “ICD-10 Codes that are Covered” section effective for dates of service on or after 06/27/2019.

12/01/2017 R1

Based on a reconsideration request, biopsy proven dense deposit disease has been added as an indication expanded by this article. ICD-10-CM codes N00.6, N01.6, N02.6, N03.6, N04.6, N07.6 and T86.19 have been added effective for dates of service on or after 12/01/2017. References have been added to the “Sources of Information” section of the article.

Treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive (Effective October 23, 2017 based on FDA approval) has been added to the “Indications” section of the article.  ICD-10-CM codes G70.00 and G70.01 have been added to the Group 1 code section effective for dates of service on or after 10/23/2017. The first paragraph in the "Indications" section of the article has been revised to include Lexi-Drug compendium. Lexi-Drug Web site has been added to the “Sources of Information” section of the article.  

Associated Documents

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Public Versions
Updated On Effective Dates Status
09/09/2022 10/01/2022 - N/A Currently in Effect You are here
06/25/2021 07/01/2021 - 09/30/2022 Superseded View
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