Government initiates interim plan to cover PET

The federal government has initiated a temporary reimbursement scheme for PET imaging that proponents hope will translate into permanent coverage for many oncologic indications currently not funded through Medicare.

The Centers for Medicare and Medicaid Services will provide reimbursement for FDG-PET when patients and physicians either participate in clinical studies or submit information to a national PET data registry. The move will allow reimbursement for uncovered applications such as the evaluation of small-cell lung, cervical, brain, pancreatic, ovarian, and testicular cancers.

"This is a very innovative decision. In essence, CMS would be providing provisional coverage for PET in a variety of applications, with permanent coverage pending results of clinical trials and evaluation of the data registry," said Dr. Bruce Hillman, chair of the American College of Radiology Imaging Network.

CMS has approved coverage for the use of FDG-PET to diagnose, stage, and restage many oncologic indications, but has excluded reimbursement for monitoring therapeutic response (except in breast cancer). Physicians will now be able to send results from these studies to the data registry. Many imagers currently use PET to monitor therapeutic response, said Dr. R. Edward Coleman, president of the Academy of Molecular Imaging. He expects that the registry will accumulate enough evidence within a year to validate coverage for PET in monitoring response in lymphoma, lung, and colorectal cancer.

A vexing problem for PET proponents has been gathering enough data on rare cancers to satisfy CMS's stringent evidence-based criteria. The data registry could speed the process. Even among the rarer cancers, some are more prevalent than others. Small-cell lung and pancreatic cancer, for example, could be approved within a year, Coleman said. Brain, testicular, and ovarian cancers could take two to four years. CMS said the registry will be available this month, but PET proponents believe that May or June is more realistic. Many issues regarding privacy and patient consent still have to be worked out.

Not covered under this initiative are the diagnosis of breast cancer, staging of regional axillary nodes in breast cancer, and staging of regional lymph nodes in melanoma. CMS had previously reviewed these indications and concluded that PET is not useful for them. Coleman agrees with the latter two indications but believes the diagnosis of breast cancer should be open to the registry.

CMS also approved in January coverage for the initial staging of cervical cancer in a patient with a negative CT or MRI for extrapelvic metastatic disease. PET proponents are disappointed that the coverage did not include restaging, but physicians can send those exams to the data registry to be reimbursed.