LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)

A55711

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Noridian Healthcare Solutions, LLC	A and B MAC	01111 - MAC A	J - E	California - Entire State
Noridian Healthcare Solutions, LLC	A and B MAC	01112 - MAC B	J - E	California - Northern
Noridian Healthcare Solutions, LLC	A and B MAC	01182 - MAC B	J - E	California - Southern
Noridian Healthcare Solutions, LLC	A and B MAC	01211 - MAC A	J - E	American Samoa Guam Hawaii Northern Mariana Islands
Noridian Healthcare Solutions, LLC	A and B MAC	01212 - MAC B	J - E	American Samoa Guam Hawaii Northern Mariana Islands
Noridian Healthcare Solutions, LLC	A and B MAC	01311 - MAC A	J - E	Nevada
Noridian Healthcare Solutions, LLC	A and B MAC	01312 - MAC B	J - E	Nevada
Noridian Healthcare Solutions, LLC	A and B MAC	01911 - MAC A	J - E	American Samoa California - Entire State Guam Hawaii Nevada Northern Mariana Islands

Article Information

General Information

Article ID
A55711

Article Title
Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)

Article Type
Billing and Coding

Original Effective Date
10/15/2017

Revision Effective Date
06/01/2023

Revision Ending Date
N/A

Retirement Date
N/A

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

The Abbott RealTime IDH1 by Abbott Molecular is the only test that has received FDA approval to be used as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1 (IDH1) mutation for treatment with TIBSOVO^® (ivosidenib).

TIBSOVO^®is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

Abbott RealTime IDH1 by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 7/20/2018.

The Abbott RealTime IDH2 by Abbott Molecular is the only test that has received FDA approval to be used as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for treatment with enasidenib (IDHIFA^®).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

Abbott RealTime IDH2 by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 8/1/2017.

To report an Abbott RealTime IDH1 service, please submit the following claim information:

Select the CPT 81120 for claims on or after 7/20/2018.

To report an Abbott RealTime IDH2 service, please submit the following claim information:

Select the CPT code 81121 for claims on or after 1/1/2018.
Enter 1 unit of service (UOS)
Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:

Loop 2400 or SV101-7 for the 5010A1 837P
Item 19 for paper claim

Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:

Line SV202-7 for 837I electronic claim
Block 80 for the UB04 claim form

Select the appropriate ICD-10-CM code

Note: This MolDX coverage determination and coding guideline ONLY applies to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment, outlined in the MolDx section on www.PalmettoGBA.com/medicare, must be submitted and a determination assessed prior to claims submission.

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

Response To Comments

Number	Comment	Response
1

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

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

(2 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code	Description
C92.00	Acute myeloblastic leukemia, not having achieved remission
C92.02	Acute myeloblastic leukemia, in relapse

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

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Group 1 Codes

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ICD-10-PCS Codes

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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.

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Code	Description
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Other Coding Information

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Group 1 Paragraph

N/A

Group 1 Codes

N/A

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
			N/A	N/A

Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation
06/01/2023	R6	Updated to indicate this article is an LCD Reference Article.
06/01/2023	R5	Under *CMS National Coverage Policy* added regulations, Title XVIII of the Social Security Act, §1833(e), CMS Internet-Only Manuals, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.1.2 A/B MAC (B) Contacts With Independent Clinical Laboratories, CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.1 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance, and CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes.
11/01/2019	R4	11/01/2019: 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 changed title from MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML) Coding and Billing Guidelines to MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)
11/01/2019	R3	As required by CR 10901, article is converted to a formal billing and coding type article. There is no change in coverage.
07/20/2018	R2	Added Abbott RealTime IDH1 (81120) coverage information to the article, effective 7/20/18.
01/01/2018	R1	Article is revised to replace 81403 with 81121, effective 1/1/2018.

Associated Documents

Related Local Coverage Documents
LCDs
L35160 - MolDX: Molecular Diagnostic Tests (MDT)

Updated On	Effective Dates	Status
11/22/2023	06/01/2023 - N/A	Currently in Effect	You are here
06/21/2023	06/01/2023 - N/A	Superseded	View
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Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML)

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CMS National Coverage Policy

Article Guidance

Response To Comments

Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

ICD-10-CM Codes that Support Medical Necessity

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

Group 1

ICD-10-PCS Codes

Group 1

Additional ICD-10 Information

Bill Type Codes

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Other Coding Information

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