US · guidance
CMS Pub. 100-04, ch. 32, § 250.1
Coverage Requirements
Effective August 3, 2009, pharmacogenomic testing to predict warfarin responsiveness is
covered only when provided to Medicare beneficiaries who are candidates for anticoagulation
therapy with warfarin; i.e., have not been previously tested for CYP2C9 or VKORC1 alleles;
and have received fewer than five days of warfarin in the anticoagulation regimen for which
the testing is ordered; and only then in the context of a prospective, randomized, controlled
clinical study when that study meets certain criteria as outlined in Pub 100-03, section 90.1,
of the NCD Manual.
NOTE: A new temporary HCPCS Level II code effective August 3, 2009, G9143, warfarin
responsiveness testing by genetic technique using any method, any number of specimen(s),
was developed to enable implementation of CED for this purpose.
History
(Rev. 1889, Issued: 01-08-10; Effective Date: 08-03-09; Implementation Date: 04-05- 10)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
be6e0cb7c7246e1e6db6a2b2932a16f6a66d2b84f5f22d45a8bffbc4a1ef34a8
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