LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Fragile X

A55163

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55163
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Fragile X
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
01/01/2024
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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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 or information on the line.

Response To Comments

Number Comment Response
1
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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

Group 1

(4 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
81243 FMR1 (FRAGILE X MESSENGER RIBONUCLEOPROTEIN 1) (EG, FRAGILE X SYNDROME, X-LINKED INTELLECTUAL DISABILITY [XLID]) GENE ANALYSIS; EVALUATION TO DETECT ABNORMAL (EG, EXPANDED) ALLELES
81244 FMR1 (FRAGILE X MESSENGER RIBONUCLEOPROTEIN 1) (EG, FRAGILE X SYNDROME, X-LINKED INTELLECTUAL DISABILITY [XLID]) GENE ANALYSIS; CHARACTERIZATION OF ALLELES (EG, EXPANDED SIZE AND PROMOTER METHYLATION STATUS)
81470 X-LINKED INTELLECTUAL DISABILITY (XLID) (EG, SYNDROMIC AND NON-SYNDROMIC XLID); GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 60 GENES, INCLUDING ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, AND SLC16A2
81471 X-LINKED INTELLECTUAL DISABILITY (XLID) (EG, SYNDROMIC AND NON-SYNDROMIC XLID); DUPLICATION/DELETION GENE ANALYSIS, MUST INCLUDE ANALYSIS OF AT LEAST 60 GENES, INCLUDING ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, AND SLC16A2
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CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

N/A

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

N/A

Group 1 Codes

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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Additional ICD-10 Information

N/A

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
N/A

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
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/01/2024 R7

Posted 02/01/2024 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 01/01/2024.

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 01/01/2024. Review completed.

11/25/2021 R6

11/25/2021-Review completed 10/12/2021; no changes made.

11/01/2019 R5

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 11/01/2019.

01/01/2019 R4

02/01/2019-Code update: added 81470, 81471.

01/01/2019 R3

01/01/2019-Code update: 81244 description change.

05/01/2018 R2

05/01/2018- Annual review completed 04/04/2018.

06/01/2017 R1 06/01/2017-Annual review completed 05/02/2017; Updated billing instructions, added 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. Added Part A billing instructions & updated Part B instructions.
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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
01/23/2024 01/01/2024 - N/A Currently in Effect You are here
11/16/2021 11/25/2021 - 12/31/2023 Superseded View
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Keywords

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