The National Oncologic PET Registry: expanded medicare coverage for PET under coverage with evidence development.

OBJECTIVE: The purpose of this article is to review the recent expansion of Medicare coverage for 18F-FDG PET for certain cancer indications under the Centers for Medicare & Medicaid Services' new Coverage with Evidence Development (CED) policy and to describe the specific operational mechanics of the National Oncologic PET Registry (NOPR). CONCLUSION: The NOPR will make possible a more accurate assessment of the actual influence of PET on patient management across a wide spectrum of cancer indications. By linking access to PET for virtually all Medicare beneficiaries to the collection of clinically valuable evidence, the NOPR represents the cutting edge of the CED approach.

Medicare coverage of PET for cervical cancer.

Positron emission tomography (PET) with 2-[(18)F]fluoro-2-deoxyglucose (FDG) has had a major impact on the initial evaluation and follow-up of patients with cancer. Yet because Medicare coverage standards differ from the US Food and Drug Administration's approval requirements, FDG-PET has not been covered by the Centers for Medicare and Medicaid Service (CMS) for general oncologic indications. Instead, starting in 1995, CMS began to cover FDG-PET for specific cancers and indications after an individualized review of the evidence of benefit in the scientific literature. The CMS limited coverage to circumstances in which results could be expected to change patient outcomes and in which FDG-PET could either help avoid an invasive procedure or would replace other imaging studies or when the results of prior conventional imaging were inconclusive. To expand the coverage of FDG-PET for cancer imaging, the Academy of Molecular Imaging began working with various organizations to submit applications for coverage of several additional cancers. In 2003, Washington University investigators requested FDG-PET coverage for the staging and restaging of cervical cancer. In January 2005, CMS issued a decision memorandum covering FDG-PET for patients with newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extrapelvic metastasis. The CMS also announced a new approach for evaluating new technology and indicated its intent to cover FDG-PET for all oncologic indications as part of a national PET data registry. With this approach, FDG-PET for a presently noncovered indication will now be covered, if an attending physician completes a brief case report both before and after the PET study. The CMS is attempting to implement the registry by late 2005.