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

A56104

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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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General Information

Source Article ID
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Article ID
A56104
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
10/13/2018
Revision Effective Date
01/01/2024
Revision Ending Date
N/A
Retirement 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

 

 

Response To Comments

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Coding Information

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CPT/HCPCS Codes

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Code Description
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

Group 2

(1 Code)
Group 2 Paragraph

CPT® codes that are also referenced in other articles.

Group 2 Codes
Code Description
81301 MICROSATELLITE INSTABILITY ANALYSIS (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) OF MARKERS FOR MISMATCH REPAIR DEFICIENCY (EG, BAT25, BAT26), INCLUDES COMPARISON OF NEOPLASTIC AND NORMAL TISSUE, IF PERFORMED
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ICD-10-CM Codes that Support Medical Necessity

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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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Other Coding Information

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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
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/01/2024 R5

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.

11/01/2019 R4

Updated to indicate this article is an LCD Reference Article.

11/01/2019 R3

Corrected typographical error under Article Title.

11/01/2019 R2

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.

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.

11/01/2019 R1
 

As required by CR 10901 article is converted to a formal billing and coding type article.

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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
L36256 - 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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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
01/23/2024 01/01/2024 - N/A Currently in Effect You are here
11/22/2023 11/01/2019 - 12/31/2023 Superseded View
07/24/2023 11/01/2019 - N/A Superseded View
02/14/2020 11/01/2019 - N/A Superseded View
10/31/2019 11/01/2019 - N/A Superseded View
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