LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: SEPT9 Gene Test

A55206

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55206
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: SEPT9 Gene Test
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
11/30/2023
Revision Ending Date
N/A
Retirement Date
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CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Article Guidance

Article Text

The MolDX team has determined that a Septin 9 methylation analysis test for colorectal cancer detection is not a Medicare covered service. Screening in the absence of signs and symptoms of an illness or injury is not defined as a Medicare benefit. Therefore, MolDX will deny Septin 9 methylation analysis tests as a statutorily excluded service.
To receive a SEPT9 service denial, please submit the following claim information:

  • 81327- SEPT9 (Septin9) (e.g., colorectal cancer) promoter methylation analysis
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
    • For a voluntary issued ABN, append with GX modifier
    • To indicate a statutorily excluded service, append with a GY modifier
  • Enter DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Box 19 for paper claim
  • Enter 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

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

Group 1

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

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ICD-10-PCS Codes

Group 1

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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
11/30/2023 R7

Posted 11/30/2023: Biannual review completed with no change in coverage. No changes were made to the article.

11/25/2021 R6

11/25/2021- Updated CMS National Coverage Policy section. Added Title XVIII of the Social Security Act, §1862(a)(1)A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Removed 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.” Review completed 10/25/2021.

11/01/2019 R5

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 11/13/2019.

01/01/2019 R4

01/01/2019-Code update: 81327 description change.

11/01/2018 R3

11/01/2018-Annual review completed 10/10/2018.

12/01/2017 R2

 

12/01/2017-Annual review completed 11/03/2017.

02/16/2017 R1 01/01/2017-Code update-added new code -81327 & removed 81401; added DEX Z-Code™ identifier and instructions for Part A claim submission. Annual review 12/06/2016.
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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
11/20/2023 11/30/2023 - N/A Currently in Effect You are here
11/16/2021 11/25/2021 - 11/29/2023 Superseded View
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