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

A56072

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Source Article ID
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Article ID
A56072
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
08/03/2017
Revision Effective Date
01/01/2024
Revision Ending Date
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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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Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/01/2024 R3

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 88341 and 88342. This revision is due to the 2024 Annual/Q1 CPT/HCPCS Code Update and is effective 1/1/2024.

11/07/2019 R2

Due to annual review

11/07/2019 R1

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.

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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
L35025 - 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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Updated On Effective Dates Status
01/23/2024 01/01/2024 - N/A Currently in Effect You are here
08/25/2022 11/07/2019 - 12/31/2023 Superseded View
10/29/2019 11/07/2019 - N/A Superseded View
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