Warfarin Response Testing Covered Under CED

August of last year, the Centers for Medicare & Medicaid Services (CMS) rendered a final National Coverage Determination (NCD) for warfarin responsiveness via pharmacogenomic testing. The news was not good. In short, CMS said there was insufficient evidence to support such testing improves health outcomes. The agency also said, however, that there was evidence to support pharmacogenomic testing for warfarin responsiveness under coverage with evidence development (CED). Medicare participating practitioners can, in fact, claim reimbursement for such services—providing they play by the rules.

Warfarin is an orally administered anticoagulent or “blood thinner” drug most commonly marketed as Coumadin®.

Billing requirements for practitioners vary slightly from those for facilities. A physician’s claim for pharmacogenomic testing for warfarin responsiveness should include:

  • Eight-digit clinical trial number;
  • ICD-9 diagnosis code V70.7 Examination of participant in clinical trial;
  • HCPCS Level II code G9143 Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s) (for dates of service on or after Aug. 3, 2009 on claims processed prior to Jan. 1, 2011); and
  • HCPCS Level II modifier Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

“Investigational” clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) by Medicare.

Of course, other restrictions apply. First, pharmacogenomic testing for warfarin response is a once-in-a-lifetime Medicare benefit.  You cannot report code G9143 more than once per a Medicare patient’s lifetime. Second, Medicare patients may not receive more than five days of warfarin in the anticoagulation regimen for which testing is ordered. And as we said before, this benefit is covered only in the context of a prospective, randomized, controlled clinical study.

See Pub. 100-03, section 90.1 of the NCD Manual and the Medicare Claims Processing Manual, chapter 32, section 250 for complete details. See also CMS Transmittal 1889 and MLN Matters 6715.

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