SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors

A56106

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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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Source Article ID
N/A
Article ID
A56106
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors
Article Type
Billing and Coding
Original Effective Date
08/15/2018
Revision Effective Date
02/02/2023
Revision Ending Date
11/21/2023
Retirement Date
N/A
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Article Text

 

In May, 2017, the FDA granted accelerated approval for the use of Keytruda for treatment of patients with unresectable or metastatic solid tumors having either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or metastatic head and neck squamous cancer, advanced/metastatic urothelial cancer and classical Hodgkin’s lymphoma.

This contractor will allow one of the following:

  • dMMR by immunohistochemistry (IHC), or
  • MSI by PCR, or
  • Multi-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genes

Testing by one of the above methodologies is reasonable and necessary if testing for dMMR or MSI has not previously been performed on the patient’s tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS panel and separate MSI by PCR will be denied as not reasonable and necessary. If testing is performed by NGS, the test must be a properly designed and appropriately validated assay demonstrating 95% concordance to the reference method (MSI by PCR).

To report a dMMR service, please submit the following claim information:

  • CPT® code 88342 – One (1) unit of service
  • CPT® code 88341 – Three (3) units of service

To report a MSI service, please submit the following claim information:

  • CPT® code 81301 – One (1) unit of service

To report by NGS, please submit the following claim information:

  • CPT® code 81479 – One (1) unit of service

 

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Coding Information

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81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
88341 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; EACH ADDITIONAL SINGLE ANTIBODY STAIN PROCEDURE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
88342 IMMUNOHISTOCHEMISTRY OR IMMUNOCYTOCHEMISTRY, PER SPECIMEN; INITIAL SINGLE ANTIBODY STAIN PROCEDURE
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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.

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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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Revision History Information

Revision History Date Revision History Number Revision History Explanation
02/02/2023 R7

Revision Effective date: 02/02/2023
Revision Explanation: Annual review, no changes were made.

07/08/2021 R6

Revision Effective date: 07/08/2021
Revision Explanation: Annual review, no changes were made.

11/14/2019 R5

Revision Effective date: N/A
Revision Explanation: Annual review no changes were made.

11/14/2019 R4

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

11/14/2019 R3

Revision Effective date: 11/14/2019
Revision Explanation: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual. Under Article Title changed title from “MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker Coding and Billing Guidelines for Patients with Unresectable or Metastatic Solid Tumors” to “Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors”. Under Article Text deleted statement, “ICD10 – appropriate for the tumor type and location”. Under CPT/HCPCS Codes Group 1: Codes deleted CPT® code 81301. Under CPT/HCPCS Codes Group 2: Paragraph added verbiage, “CPT® codes that are also referenced in other articles”. Under CPT/HCPCS Group 2: Codes added CPT® code 81301. CPT® was inserted throughout the article where applicable.

10/03/2019 R2

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

08/15/2018 R1

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

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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
L36021 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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Updated On Effective Dates Status
01/30/2024 01/01/2024 - N/A Currently in Effect View
11/15/2023 11/22/2023 - 12/31/2023 Superseded View
01/27/2023 02/02/2023 - 11/21/2023 Superseded You are here
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