Positron Emission Tomography (PET) Scans – General Information

60 - Positron Emission Tomography (PET) Scans – General Information (Rev. 1833; Issued: 10-16-09; Effective Date: 04-03-09; Implementation Date: 10-30-09) Positron emission tomography (PET) is a noninvasive imaging procedure that assesses perfusion and the level of metabolic activity in various organ systems of the human body. A positron camera (tomograph) is used to produce cross-sectional tomographic images which are obtained by detecting radioactivity from a radioactive tracer substance (radiopharmaceutical) that emits a radioactive tracer substance (radiopharmaceutical FDG) such as 2 –[F-18] flouro-D-glucose FDG, that is administered intravenously to the patient. The Medicare National Coverage Determinations (NCD) Manual, chapter 1, §220.6, contains additional coverage instructions to indicate the conditions under which a PET scan is performed. A. Definitions For all uses of PET, excluding Rubidium 82 for perfusion of the heart, myocardial viability and refractory seizures, the following definitions apply: • Diagnosis: PET is covered only in clinical situations in which the PET results may assist in avoiding an invasive diagnostic procedure, or in which the PET results may assist in determining the optimal anatomical location to perform an invasive diagnostic procedure. In general, for most solid tumors, a tissue diagnosis is made prior to the performance of PET scanning. PET scans following a tissue diagnosis are generally performed for the purpose of staging, rather than diagnosis. Therefore, the use of PET in the diagnosis of lymphoma, esophageal and colorectal cancers, as well as in melanoma, should be rare. PET is not covered for other diagnostic uses, and is not covered for screening (testing of patients without specific signs and symptoms of disease). • Staging: PET is covered in clinical situations in which (1) (a) the stage of the cancer remains in doubt after completion of a standard diagnostic workup, including conventional imaging (computed tomography, magnetic resonance imaging, or ultrasound) or, (b) the use of PET would also be considered reasonable and necessary if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient and, (2) clinical management of the patient would differ depending on the stage of the cancer identified. NOTE: Effective for services on or after April 3, 2009, the terms “diagnosis” and “staging” will be replaced with “Initial Treatment Strategy.” For further information on this new term, refer to Pub. 100- 03, NCD Manual, section 220.6.17. • Restaging: PET will be covered for restaging: (1) after the completion of treatment for the purpose of detecting residual disease, (2) for detecting suspected recurrence, or metastasis, (3) to determine the extent of a known recurrence, or (4) if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is to determine the extent of a known recurrence, or if study information is insufficient for the clinical management of the patient. Restaging applies to testing after a course of treatment is completed and is covered subject to the conditions above. • Monitoring: Use of PET to monitor tumor response to treatment during the planned course of therapy (i.e., when a change in therapy is anticipated). NOTE: Effective for services on or after April 3, 2009, the terms “restaging” and “monitoring” will be replaced with “Subsequent Treatment Strategy.” For further information on this new term, refer to Pub. 100-03, NCD Manual, section 220.6.17. B. Limitations For staging and restaging: PET is covered in either/or both of the following circumstances: • The stage of the cancer remains in doubt after completion of a standard diagnostic workup, including conventional imaging (computed tomography, magnetic resonance imaging, or ultrasound); and/or • The clinical management of the patient would differ depending on the stage of the cancer identified. PET will be covered for restaging after the completion of treatment for the purpose of detecting residual disease, for detecting suspected recurrence, or to determine the extent of a known recurrence. Use of PET would also be considered reasonable and necessary if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient. The PET is not covered for other diagnostic uses, and is not covered for screening (testing of patients without specific symptoms). Use of PET to monitor tumor response during the planned course of therapy (i.e., when no change in therapy is being contemplated) is not covered.