Medicare expands PET coverage for cervical cancer

The U.S. Centers for Medicare and Medicaid Services (CMS) said it will extend Medicare coverage for the use of an FDG-PET scan for staging newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extrapelvic metastasis.

In addition to issuing a national coverage determination (NCD) for cervical cancer staging, the agency held that PET scans for brain, pancreatic, small-cell lung cancer (SCLC), ovarian, and testicular cancers are only reasonable and necessary when the provider and patients are participating in one to two types of prospective clinical studies.

According to CMS, these are:

• "A clinical trial of FDG-PET that meets the requirements of Food and Drug Administration (FDA) category B investigational device exemption (42 CFR 405.201) or;"

• "An FDG-PET clinical study that is designed to collect additional information at the time of the scan to assist in patient management. Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the PET scan and interpret the results; participating hospitals and providers accurately report data on all enrolled patients not included in other qualifying trials through adequate auditing mechanisms; and all patient confidentiality, privacy, and other federal laws must be followed."