疑義解釈資料(平成28年)
Q
(問2)平成28年12月1日より、FIP1L1-PDGFRα融合遺伝子検査が保険適用となったが、どのような場合に算定できるか。
A
(答)FISH法によるFIP1L1-PDGFRα融合遺伝子検査が可能な体外診断用医薬品として薬事承認を得ているものを用いて、測定した場合に限り算定できる。
疑義解釈資料の送付について(その10)-2017.03.31-[PDF形式/184KB]
Q
(問2)平成27年4月収載予定の「Major BCR-ABL mRNA IS」について、当該項目を測定する体外診断用医薬品には、承認上の使用目的に「診断補助」が含まれるものと含まれないものがあるが、使用目的に「診断補助」が含まれない体外診断用医薬品を用いて、診断補助を目的に検査を実施した場合においても当該項目は算定できるか。
A
(答)算定できない。
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