RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: HEXA Gene Analysis

A53598

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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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General Information

Source Article ID
N/A
Article ID
A53598
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: HEXA Gene Analysis
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
10/24/2019
Revision Ending Date
05/08/2024
Retirement Date
05/08/2024

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CMS National Coverage Policy

Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that no Medicare payment shall be made for items or 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

Effective for dates of service on and after February 7, 2013

The clinical diagnosis of Hexosaminidase A deficiency, a disorder also known as Tay-Sachs disease characterized by progressive weakness, loss of motor skills, and increased startle reflex in infants, relies on blood tests that result in absent or near absent beta-hexosaminidase A (HEXA) enzymatic activity. Molecular genetic testing identifies HEXA gene mutation carriers at risk for conceiving offspring with the disease. Therefore, HEXA genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include the HEXA gene as a statutorily excluded service.

To receive a HEXA gene test service denial, please submit the following claim information:

    • Select the appropriate CPT® code based on type of testing
      • 81255 – HEXA, common variants
      • 81406 – HEXA, full gene sequence
      • 81412 - Ashkenazi Jewish associated disorders
      • 81443 – Genetic testing for severe inherited conditions
    • 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
    • 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

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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
05/08/2024 R8

This article is being retired because it is not supported by a Local Coverage Determination (LCD) and does not comply with current 21st Century Cures requirements.

10/24/2019 R7

This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual. 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. Under Article Title changed title from “MolDX: HEXA Gene Analysis Coding and Billing Guidelines” to “Billing and Coding: MolDX: HEXA Gene Analysis”. Under Article Text deleted the sentence “Select the appropriate diagnosis for the patient”. Under CPT/HCPCS Codes Group 1: Codes deleted CPT® codes 81406 and 81412. Under CPT/HCPCS Codes Group 2: Paragraph added verbiage “CPT® codes that are also referenced in other articles.” Under CPT/HCPCS Codes Group 2: Codes added CPT® codes 81406 and 81412. Under CPT/HCPCS Modifiers added modifiers GX and GY.

01/01/2019 R6

Added 81412 and 81443 to the article. Added 81255, 81406, 81412, and 81443 to the CPT/HCPCS Group 1 section. This is due to the 2019 Annual CPT/HCPCS Code update and is effective 1/1/19.

 

 

 

 

 

02/26/2018 R5 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.
07/06/2017 R4

Added Part A contractor number to article. Updated Part A and Part B billing instructions.

11/19/2015 R3 Changed "MolDX ID (MID) field" back to read SV101-7
11/19/2015 R2 Replace Palmetto reference with MolDX and replaced SV101-7 with MolDX ID (MID) field
10/01/2015 R1 Updated per 2015 CPT coding and completed Annual Validation.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Public Versions
Updated On Effective Dates Status
05/08/2024 10/24/2019 - 05/08/2024 Retired You are here
10/14/2019 10/24/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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