LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Fragile X

A54264

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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.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54264
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
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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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Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

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
N/A

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

N/A

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
N/A

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
N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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
N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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
N/A
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 R13

Revision Effective: 11/16/2023

Revision Explanation: 

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.

11/16/2023 R12

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

10/31/2019 R11

Revision Effective: N/A
Revision Explanation: Annual review no changes made.

10/31/2019 R10

Revision Effective date: 10/31/2019
Revision Explanation: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.

10/03/2019 R9

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into ne billing and coding article format.

01/01/2019 R8

Revision Effective date: 01/01/2019
Revision Explanation: During annual HCPCS update new codes 81470 and 81471 ere added to this article.

04/27/2017 R7

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/01/2015 R6

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

04/27/2017 R5 Revision Effective date: 04/27/2017
Revision Explanation: Updated Part A and Part B billing instructions.
10/01/2015 R4 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36021 - 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
01/04/2024 01/01/2024 - N/A Currently in Effect You are here
11/08/2023 11/16/2023 - 12/31/2023 Superseded View
11/25/2019 10/31/2019 - 11/15/2023 Superseded View
10/23/2019 10/31/2019 - N/A Superseded View
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