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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.
Content provided on this page contains outdated information and instruction and should not be considered current. CGS is providing this archived information for research purposes only. This archived section contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

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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