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Positron emission tomography (PET) has been used for almost 30 years to quantify normal physiology and metabolism, to characterize disease, and to evaluate the changes resulting from disease processes. The data that have been developed from these research applications have led to the clinical applications. Clinical PET is one of the many uses of PET, including clinical care, and it is reimbursed by insurance companies. Clinical PET became a reality only after widespread reimbursement became available for the procedure. Rapid growth in the utilization of PET is directly related to changes in radiopharmaceutical regulation and reimbursement. In the Food and Drug Administration (FDA) Modernization and Accountability Act passed by Congress in 1997, it was stated that PET radiopharmaceuticals have the equivalence of FDA approval until a new process for regulating PET radiopharmaceuticals is developed. In 1998, the Health Care Financing Administration (HCFA) began covering fluorodeoxyglucose (FDG)-PET for the evaluation of solitary pulmonary nodules (G code 0125), initial staging of lung cancer (G0126), detection of recurrent colorectal cancer with rising carcinoembryonic antigens (G0163), staging of lymphoma (G0164), and detection of recurrent malignant melanoma (G0165). The HCFAapproved indications were paid using G codes, and hospital outpatients have been reimbursed using the Ambulatory Payment Classification (APC). The PET imaging devices, both dedicated and hybrid systems, have been also covered.1 The growing recognition of the cost-effectiveness of FDG-PET in cancer management has made oncology the focus for most clinical PET studies.2 |
