Billing and Coding: MolDX: Fragile X (A55241)



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: A55241 Status: A-Approved

Article Title: Billing and Coding: MolDX: Fragile X

Original Article Effective Date: 10/31/2016

Revision Effective Date: 01/01/2024

Article Text:

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
    • Item 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.

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:
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


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
01/01/2024
R6

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.

12/17/2021
R5

Updated to indicate this article is not an LCD Reference Article.

12/17/2021
R4

Noridian has modified certain language in this article to mirror the language used presently by the MolDX team at Palmetto GBA as part of an annual review. Revision history dates and language may not exactly match the MolDX PGBA revision history. However, these revision do not change coverage or guidance.

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: 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: 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.

12/01/2019
R3

As required by CR 10901, article is converted to a formal billing and coding type article. There is no change in coverage. References were added to the CMS National Coverage Policy Section.

01/01/2019
R2

Article is revised to add CPT codes 81470 and 81471 per the 2019 Annual CPT Code Update. 81244 short/long descriptor was changed in Group 1.

10/31/2016
R1

Added Part A claim filing information.