PET imaging is approved for use by Medicare for:

1. Lung Cancer (SPN) - PET imaging regional or whole body; solitary pulmonary nodule
2. Diagnosis, Staging and Re-staging (see text and chart below)
   - Lung Cancer (NSCLC)
   - Colorectal
   - Melanoma
   - Lymphoma
   - Head and Neck, excluding CNS and thyroid
   - Esophogeal
3. Breast Cancer - Staging, Re-staging and Treatment Follow-up
4. FDG cardiac scans for the evaluation of myocardial viability
5. Neurological scans for the pre-surgical evaluation of refractory seizures.

In addition to the Medicare approved indications for PET imaging, the following types of cancer are approved by the FDA.

1. Hepatocellular (liver)
2. Brain
3. Ovarian
4. Pancreatic

As a general rule, PET imaging for these latter indications is considered on a case-by-case basis by the patient's insurance carrier.

Medicare's Definition of Diagnosis, Staging, and Restaging

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 the tissue diagnosis are performed for the purpose of staging, not diagnosis. Therefore, the use of PET in the initial diagnosis of lymphoma, esophageal and colorectal cancers as well as in melanoma, should be rare.

Note: PET is not covered for other diagnostic uses, and is NOT covered for screening (testing of patients without specific signs of a disease).

Staging and/or Restaging:
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 (CT, MRI, 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. 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 patients.

The 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. Restaging only occurs after a course of treatment is completed, and this is covered subject to the conditions above.

Medicare's Approved PET Indications (effective October 1, 2002)