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October 30, 2015 - Revised: 05.17.17

Fragile X Coding and Billing Guidelines (CM00083, V2)

Effective for dates of service (DOS) on and after January 1, 2013.

MolDX 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:
    • CPT code 81243- FMR1
    • CPT code 81244- FMR1, methylation analysis
  • An Advance Beneficiary Notice of Non-Coverage (ABN)External website is not required for statutorily excluded services.
    • For a voluntary issued ABN, append with HCPCS modifier GX
    • To indicate a valid ABN is on file for a known statutorily excluded service, append with HCPCS modifier GY
  • Select the appropriate diagnosis for the patient
  • 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

Reference: Sec. 1862 (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,…"

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