RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: CDH1 Genetic Testing

A55622

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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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Article Information

General Information

Source Article ID
N/A
Article ID
A55622
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: CDH1 Genetic Testing
Article Type
Billing and Coding
Original Effective Date
08/15/2017
Revision Effective Date
09/28/2023
Revision Ending Date
06/27/2024
Retirement Date
06/27/2024

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CMS National Coverage Policy

Title XVIII of the Social Security Act, Sec. 1862 (1)(A) Statutory Exclusion covers diagnostic testing “except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

CDH1 testing is utilized in patients with specified cancers as an adjunctive test.  CDH1 testing has also been recommended as a screening test for other cancers. However, screening for individuals at risk for cancer is not a Medicare benefit and is statutorily excluded.

  • CPT 81406-CDH1, full gene sequence.
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.
    • For a voluntary issued ABN, append with GX modifier
    • To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  • Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Box 19 for paper claim
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form

In rare cases in which Hereditary Diffuse Gastric Cancer (HDGC) is suspected in a Medicare beneficiary, MolDX will review the documentation on a case-by-case basis.

Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
GX NOTICE OF LIABILITY ISSUED, VOLUNTARY UNDER PAYER POLICY
GY ITEM OR SERVICE STATUTORILY EXCLUDED, DOES NOT MEET THE DEFINITION OF ANY MEDICARE BENEFIT OR, FOR NON-MEDICARE INSURERS, IS NOT A CONTRACT BENEFIT
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ICD-10-CM Codes that Support Medical Necessity

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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.

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.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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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
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
06/27/2024 R6

Posted 06/27/2024. This article is being retired because the service is not relevant to the general Medicare population and it does not comply with current 21st Century Cures requirements.

09/28/2023 R5

Posted 09/28/2023: Review completed 08/31/2023. No changes were made to the article.

10/28/2021 R4

10/28/2021-Review completed 09/20/2021. Updated CMS National Coverage Policy section.

11/01/2019 R3

Content moved to the new template. Under Article Text deleted the statement “Select the appropriate diagnosis for the patient” & Title XVIII of the Social Security Act, §1862(a)(1)(A) has been added to the CMS National Coverage Policy section and removed from the Article Text section. Added GX & GY modifiers to the modifier table. Review completed 11/06/2019.

07/01/2018 R2

07/01/2018- Information on the incidence of Hereditary Diffuse Gastric Cancer has been removed from the introductory paragraph. Added CDH1 testing is utilized in patients with specified cancers as an adjunctive test.  CDH1 testing has also been recommended as a screening test for other cancers. However, screening for individuals at risk for cancer is not a Medicare benefit and is statutorily excluded.

06/01/2018 R1

06/01/2018-Annual review completed 05/01/2018. Added “gene” to 81406 CDH1, full gene sequence.

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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
L36807 - 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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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
06/27/2024 09/28/2023 - 06/27/2024 Retired You are here
09/19/2023 09/28/2023 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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