By the remarkable development of recent molecular biology and genetic technology, the molecular diagnostic tests had put into practice as the routine test in the field of the clinical laboratory examinations. For molecular diagnostic tests, there are mainly infectious disease, hematological malignancies, hereditary disease, cancers, etc. In especially infectious disease and hematological malignancies, the adaptation of health insurance are examined in the facilities.
It is usefully utilized for early detection, early diagnosis, selection of the treatment, follow-up, especially in the hematological malignancies such as leukemia and malignant lymphoma. It is possible to determine the clonal origin of malignant cells, and to detect minimal residual disease(MRD) after achieving complete remission.
The usage of the molecular diagnostic tests is variable in infectious disease and hematological malignancies on the medical reimbursement, and there are restrictions like the following ; in the case of any tests of the infectious disease, only which or main test can be calculated, facilities standards are necessary in order to calculate the health insurance treatment cost of the once in 6 months.
In this article, we describe utilization and restrictions of the medical reimbursement for molecular diagnostic tests, focusing on the fiscal 2002 revision of the medical service fee schedule implemented in April.