RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: ApoE Genotype

A55141

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55141
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: ApoE Genotype
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
08/31/2023
Revision Ending Date
10/31/2024
Retirement Date
10/31/2024

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(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".

Article Guidance

Article Text

The MolDX Team has determined Apolipoprotein (Apo) E genotype testing, developed to assess the risk of cardiovascular disease, has insufficient evidence to support the required clinical utility for the established Medicare benefit category.

As reviewed, the developers described the indication to perform an Apolipoprotein (Apo) E genotype test as a risk assessment for developing a disease or condition. Risk assessment for developing a disease or condition in the absence of signs and symptoms of an illness or injury is also not defined as a Medicare benefit. Therefore, Apolipoprotein (Apo) E genotype tests used for that purpose would continue to be statutory excluded tests.

To receive an ApoE service denial, please submit the following claim information:

  • CPT code 81401- APOE, common variant 
  • 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
  • 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 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 

Response To Comments

Number Comment Response
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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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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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Group 1 Codes

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

Group 1

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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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.

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
10/31/2024 R9

Posted 10/31/2024: Billing and Coding: MolDX: ApoE Genotype A55141 will be retiring 10/03/2024. The information in this article has been incorporated within the Billing and Coding: MolDX: Pharmacogenomics Testing A58395.

08/31/2023 R8

Posted 08/31/2023: Under Article Text first paragraph deleted the 2nd sentence. Revised 2nd paragraph 3rd sentence to add “used for that purpose”. Revised the 5th and 8th bullets to remove “DEX Z-Code™” and replaced with “DEX Z-Code®”.

11/25/2021 R7

11/25/2021-Review completed 10/08/2021; no changes made.

11/01/2019 R6

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 11/19/2019.

01/01/2019 R5

01/01/2019-Code update: 81401 long description changes.

06/01/2018 R4

 

06/01/2018-Annual review completed 05/02/2018.

01/01/2018 R3

01/01/2018- Code update-81401 description change.

07/01/2017 R2

07/01/2017- Annual review completed 06/08/2017; Updated billing instructions, added Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information & added Part A billing instructions and updated Part B instructions.

02/16/2017 R1 01/01/2017- Code update-81401 description change.
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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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Other URLs
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Public Versions
Updated On Effective Dates Status
10/31/2024 08/31/2023 - 10/31/2024 Retired You are here
08/23/2023 08/31/2023 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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