FUTURE RETIREMENT LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: ApoE Genotype

A53652

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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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Article Information

General Information

Source Article ID
N/A
Article ID
A53652
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: ApoE Genotype
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
08/31/2023
Revision Ending Date
N/A
Retirement Date
ANTICIPATED 10/03/2024

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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
  • Enter 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 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

Code Description

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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

Group 1

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ICD-10-PCS Codes

Group 1

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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
08/31/2023 R6

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®”.

10/24/2019 R5

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 the title from “MolDX: ApoE Genotype Coding and Billing Guidelines” to “Billing and Coding: MolDX: ApoE Genotype”. 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. Under Article Text deleted the bullet point “Select the appropriate diagnosis for the patient”. Under CPT/HCPCS Codes Group 1: Codes added 81401. Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and GY. CPT® was inserted throughout the article where applicable.

02/26/2018 R4 The Jurisdiction "J" Part A and Part B Contracts for Alabama (10111/10112), Georgia (10211/10212) and Tennessee (10311/10312) are now being serviced by Palmetto GBA. Effective 02/26/18, these 6 contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 6 Part A and B contract numbers) have been completed in this revision.
10/26/2017 R3

Annual review completed. Added Part A contract and DEX Z-Code identifier information.

10/29/2015 R2 Annual review completed. No changes needed.
10/01/2015 R1 Replaced Palmetto references to MolDX
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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
L35025 - 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
08/23/2023 08/31/2023 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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