Local Coverage Article Billing and Coding

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

A56104

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Contractor Information

Article Information

General Information

Article ID
A56104
Article Title
Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker Billing and Coding Guidelines for Patients with Unresectable or Metastatic Solid Tumors
Article Type
Billing and Coding
Original Effective Date
10/13/2018
Revision Effective Date
11/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
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CMS National Coverage Policy

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Article Guidance

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

 

 

Coding Information

CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
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
CodeDescription
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

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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

Group 1

Group 1 Paragraph

N/A

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.

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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

Group 1

Group 1 Paragraph

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Group 1 Codes

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
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.

Associated Documents

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L36374 - MolDX: Genetic Testing for Lynch Syndrome
Related National Coverage Documents
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Updated On Effective Dates Status
02/14/2020 11/01/2019 - N/A Currently in Effect You are here
10/31/2019 11/01/2019 - N/A Superseded View
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