Billing and Coding: MolDX: ApoE Genotype (A55094)


Related Local Coverage Determination (LCD)
L35160-MolDX: Molecular Diagnostic Tests (MDT)
L36358-MolDX: Biomarkers in Cardiovascular Risk Assessment


Contractor NameContract NumberStates
Noridian Healthcare Solutions, LLC 01111 - A and B MAC California - Entire State
01112 - A and B MAC California - Northern
01182 - A and B MAC California - Southern
01211 - A and B MAC American Samoa
Guam
Hawaii
Northern Mariana Islands
01212 - A and B MAC American Samoa
Guam
Hawaii
Northern Mariana Islands
01311 - A and B MAC Nevada
01312 - A and B MAC Nevada
01911 - A and B MAC American Samoa
California - Entire State
Guam
Hawaii
Nevada
Northern Mariana Islands

Article Information

Article ID Number: A55094 Status: A-Approved

Article Title: Billing and Coding: MolDX: ApoE Genotype

Original Article Effective Date: 10/10/2016

Revision Effective Date: 08/31/2023

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
    • Item 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

Coding Information
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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.


CPT/HCPCS Codes:

Group 1 Paragraph:

N/A



Group 1 CPT Codes:
81401 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 2 (EG, 2-10 SNPS, 1 METHYLATED VARIANT, OR 1 SOMATIC VARIANT [TYPICALLY USING NONSEQUENCING TARGET VARIANT ANALYSIS], OR DETECTION OF A DYNAMIC MUTATION DISORDER/TRIPLET REPEAT)


ICD-10 Codes That Are Covered

N/A

ICD-10 Codes That Are Not Covered

N/A


Revision History Information
Revision History DateRevision History NumberRevision History Explanation
08/31/2023
R4

Updated Related Local Coverage Documents link. 

08/31/2023
R3

Updated to indicate this article is an LCD Reference Article.

08/31/2023
R2

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®”.

12/01/2019
R1

12/01/2019: 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.