Superseded Local Coverage Article Billing and Coding

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

A55711

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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.
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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55711
Original ICD-9 Article ID
Not Applicable
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
11/01/2019
Revision Ending Date
05/31/2023
Retirement Date
N/A
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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

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
    • Box 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

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Coding Information

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Revenue Codes

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CPT/HCPCS Codes

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(2 Codes)
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Group 1 Codes
Code Description
81120 IDH1 (ISOCITRATE DEHYDROGENASE 1 [NADP+], SOLUBLE) (EG, GLIOMA), COMMON VARIANTS (EG, R132H, R132C)
81121 IDH2 (ISOCITRATE DEHYDROGENASE 2 [NADP+], MITOCHONDRIAL) (EG, GLIOMA), COMMON VARIANTS (EG, R140W, R172M)
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CPT/HCPCS Modifiers

Group 1

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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
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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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.

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

Group 1

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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
11/01/2019 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.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L35160 - MolDX: Molecular Diagnostic Tests (MDT)
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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Public Versions
Updated On Effective Dates Status
06/21/2023 06/01/2023 - N/A Currently in Effect View
12/04/2019 11/01/2019 - 05/31/2023 Superseded You are here
10/16/2019 11/01/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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