Retired Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Minimal Residual Disease Testing for Colorectal Cancer

A58449

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Contractor Information

Article Information

General Information

Article ID
A58449
Article Title
Billing and Coding: MolDX: Minimal Residual Disease Testing for Colorectal Cancer
Article Type
Billing and Coding
Original Effective Date
10/18/2020
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
01/26/2022
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CMS National Coverage Policy

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Article Guidance

Article Text

This Medicare contractor will provide limited coverage for ctDNA tests that detect minimum residual disease (MRD) in patients with a personal history of colorectal cancer.

Specifically, the enclosed evidentiary review is focused on the Signatera molecular residual disease assessment test, from here on called “Signatera,” (Natera, Inc, San Carlos, CA). Other tests that demonstrate equivalent analytical and clinical validity as part of a comprehensive technical assessment (TA) will similarly attain coverage for indications that are supported by the evidence and intended use within scope of this policy.

This Contractor provides limited coverage for MRD testing in colorectal cancer when:

  1. The conditions set by NCD 90.2 are fulfilled if NGS methodology is utilized (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously been tested with the same test for the same genetic content) or are not applicable (the patient does not have cancer as defined below);
  2. The patient has a personal history of colorectal cancer, the type and staging of which is within the intended use of the MRD test;
  3. The identification of recurrence or progression of disease within the intended use population of the test is identified in the NCCN Guidelines as a condition that requires a definitive change in patient management;
  4. The test is demonstrated to identify recurrence or progression before there is clinical or radiographical evidence of recurrence or progression; and demonstrates sensitivity and specificity comparable with radiographical evidence of recurrence. For colorectal cancer, it must have a sensitivity at least equivalent to and specificity that is significantly better than serial CEA monitoring OR demonstrate equivalence with another ctDNA MRD test that has demonstrated this measuring the same analytes. Test performance must be similar to established MRD tests including Signatera
  5. The test satisfactorily completes a technical assessment that will review and confirm the analytical and clinical validity of the test.

MRD testing often requires two types of assays to be performed as part of the service. First, a sample is taken from tumor diagnostic material to establish a baseline tumor signature as defined by the test methodology. This is followed by a series assays run on blood to detect the presence or recurrence of tumor based on the measured biomarkers, expression, or other analytes over various timepoints. This series of assays comprises a single test when the patient is known to have cancer.

When the patient is NOT known to have cancer (specifically when there is no clinical, radiographical, or other biological evidence that tumor cells remain post treatment and subsequently the patient is no longer being subjected to therapeutic interventions for cancer), a second kind of test may exist wherein a single additional timepoint may constitute a single test.

The evidentiary review is available upon request.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE

CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(13 Codes)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.1 Malignant neoplasm of anal canal

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.

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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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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
01/27/2022 R1

This article is being retired because the information in this article has been incorporated within the Billing and Coding: MolDX: Minimal Residual Disease Testing for Solid Tumor Cancers A58456 article.

Associated Documents

Related Local Coverage Documents
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Related National Coverage Documents
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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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Other URLs
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Public Versions
Updated On Effective Dates Status
01/27/2022 10/18/2020 - 01/26/2022 Retired You are here
09/04/2020 10/18/2020 - N/A Superseded View

Keywords

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