SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Fragile X

A53638

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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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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A53638
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Fragile X
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2024
Revision Ending Date
N/A
Retirement Date
N/A

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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

Effective for dates of service on and after 01/1/2013

The MolDX Team has determined that Fragile X testing 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 testing for Fragile X as a statutorily excluded service.

To receive a Fragile X service denial, please submit the following claim information:

  • Select the appropriate CPT® code:
    • 81243- FMR1
    • 81244- FMR1, methylation analysis
    • 81470 – X-linked intellectual disability genomic sequence analysis panel
    • 81471 – X-linked intellectual disability genomic sequence analysis panel duplication / deletion
  • 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

For CPT® non-NOC codes, 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 field for the following 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

NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.

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

Group 1 Paragraph

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Group 1 Codes

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

Group 1

Group 1 Paragraph

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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
N/A N/A
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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
01/01/2024 R10

Under CPT/HCPCS Group 1: Codes the description was revised for 81243 and 81244. This revision is due to the 2024 Annual/Q1 CPT/HCPCS Code Update and is effective 1/1/2024.

Under Article Text revised the 9th and 12th bullets to remove “DEX Z-Code™” and replaced with “DEX Z-Code®”. Added “NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line”. This revision is effective 1/1/2024.

10/24/2019 R9

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: Fragile X Coding and Billing Guidelines Update” to “Billing and Coding: MolDX: Fragile X”. 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 Modifiers Group 1: Codes added modifiers GX and GY. CPT® was inserted throughout the article where applicable.

01/01/2019 R8

Added 81470 and 81471 to the article. Added 81243, 81244, 81470, and 81471 to the CPT/HCPCS Group 1 section. This is due to the 2019 Annual CPT/HCPCS Code update and is effective 1/1/19.

 

 

 

04/12/2018 R7

Conducted annual validation and removed an extraneous bullet that did not contain content.

02/26/2018 R6 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.
04/27/2017 R5 Annual review completed. Updated Part-A & Part B billing instructions.
11/19/2015 R4 Changed "MolDX ID (MID) field" back to read SV101-7
11/19/2015 R3 Removed Palmetto GBA reference
11/19/2015 R2 Replace Palmetto reference with MolDX and replaced SV101-7 with MolDX ID (MID) field
10/01/2015 R1 Added Annual Review Date.
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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
05/23/2024 01/01/2024 - 05/23/2024 Retired View
01/03/2024 01/01/2024 - N/A Superseded You are here
10/15/2019 10/24/2019 - 12/31/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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