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October 12, 2015 - Revised 05.17.17

CYP2C9 and/or VKORC1 Gene Testing for Warfarin Response Coding and Billing Guidelines (CM00033, V2)

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

Based on NCD 90.1 - Pharmacogenomic Testing for Warfarin Response, gene testing on CYP2C9 and/or VKORC1 will only be covered through coverage with evidence development (CED). Testing will be limited to once in a lifetime per beneficiary. MolDX will reimburse ONLY genetic testing services for beneficiaries who meet the NCD criteria and are enrolled in a clinical trial.

Lab providers that perform services on eligible beneficiaries and described by CPT codes 81227 and 81355 must submit the following claim items:

  • HCPCS code: G9143- warfarin responsiveness testing
  • ICD-10-CM code Z00.6-Encounter for examination for normal comparison and control in lcincal research program
  • HCPCS modifier QO - Investigational clinical service provided in a clinical research study that is in an approved clinical research study
  • 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:

  1. Report only HCPCS code G9143 and 1 UOS. Do NOT report CPT codes 81227 and/or 81355 on the claim
  2. Report only 1 ID on the claim
  3. To facilitate payment, please add the voluntarily reported 8-digit clinical trial number

References:

  • Pub 100-04 Medicare Claims Processing, CR#6715 and 7806
  • NCD 90.1 - Pharmacogenomic Testing for Warfarin Response

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