The Health Care Financing Administration in December approved the use of positron emission tomography scans for Medicare beneficiaries for any clinically appropriate use for six cancer types.
Previously, Medicare restricted the oncologic use of PET to characterize solitary pulmonary nodules, stage non-small cell lung cancer, detect and localize recurrent colorectal cancer after a rise in carcinoembryonic antigen, stage both Hodgkins and non-Hodgkins lymphoma, and detect recurrent melanoma.
The HCFA decision means that Medicare, starting later this year, will pay for PET scans when they are used more broadly to diagnose, stage, and restage these four cancers as well as esophageal and head and neck cancers (excluding brain and thyroid tumors). These malignancies account for about 38% of all cancers in the Medicare population, which is people age 65 and over.
For primary cancer diagnosis, PET will be covered if used to potentially avoid or direct an invasive diagnostic procedure, such as biopsy. For staging or restaging of disease, PET is covered only if the stage of the cancer remains unclear after a conventional imaging work-up and if treatment would change depending on the stage of disease. Medicare will not cover the use of PET for screening.
The approval was requested by scientists at the University of California at Los Angeles, including the inventor of the PET technology, and supported by industry and congressional members.
HCFA approved PET for use with the six cancers, although it reviewed its use with about 20 cancers. HCFA decided if a rigorous study showed that PET was useful in one clinical situation for a specific cancer, then it was reasonable to conclude the technology would be useful for other clinical applications within the same cancer type.
"The metabolic abnormality associated with a particular cancer type does not vary depending on the specific diagnostic purpose for which the test is being used," wrote HCFA analysts Mary Stojak and Samantha Richardson in the memo summarizing the scientific evidence behind the decision to expand coverage. Requests for Medicare coverage for the non-approved cancers must be made anew. But, the application for breast cancer is being separately evaluated by the Medicare Coverage Advisory Committee, a panel of private sector experts created to advise HCFA on important coverage issues. The committee also participated in the current decision to expand coverage.
PET is a diagnostic imaging technique that most commonly utilizes fluorodeoxyglucose (FDG), a radiopharmaceutical, to detect the increased metabolism of tumor cells. Because malignancies can cause abnormal metabolism before structural alterations are apparent, PET can detect tumors when conventional imaging techniques, such as computed tomography and magnetic resonance imaging, cannot. In addition, when compared to CT and MRI, PET shows improved sensitivity, specificity, and diagnostic accuracy for several types of cancer.
"As PET has been incorporated into the evaluation of patients with cancer, evidence has accumulated that it has significant impact on patient management," said Ellen Feigal, M.D., deputy director of the Divison of Cancer Treatment and Diagnosis at the National Cancer Institute. She said that PET is more accurate in the diagnosis and staging of many types of cancers.
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