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patients undergoing alternative cancer treatment because of a contraindication to fluoropyrimidines Comparator Included: wild-type patients or DPYD carriers with no fluoropyrimidine dose adjustment before the start of treatment Excluded: patients who had a fluoropyrimidine dose adjustment before the start of treatment OUTCOME MEASURES Clinical Validity Severe fluoropyrimidine-related toxicity, overall and by type (hematological, gastrointestinal, dermatological) Clinical sensitivity, specificity, and positive and negative predictive value of DPYD genotyping (three to four variants) for the prediction of fluoropyrimidine-associated toxicity Toxicity-related changes to fluoropyrimidine-based treatment (i.e., dose reduction or increase, treatment delay and discontinuation) Toxicity-related hospitalization Toxicity-related mortality Clinical Utility Fluoropyrimidine dose reduction, increase, discontinuation

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Based on our review, we believe this service meets step 1 of our review process because it is currently assigned status indicator A (meaning that the service is separately payable under the PFS), meets step 2 of our review process because it is a service ordinarily furnished with the furnishing practitioner and patient in the same location and therefore is subject to the provisions of section 1834(m) of the Act, and meets step 3 because that all elements of this service may be furnished using an interactive telecommunications system as defined in § 410.78(a)(3)