Implications of the recent CMS PET coverage decision

By Johannes Czernin, MD
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Dr. Czernin is Chief of Nuclear Medicine, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine, University of California, Los Angeles.

Positron emission tomography/computed tomography (PET-CT) scanners using the radioisotope 18F-fluorodeoxyglucose (FDG) have been used with increasing frequency and with great success in the care of cancer patients. However, increasing healthcare expenditures in the United States over the last 2 decades, have limited the reimbursement for PET imaging by various health care agencies. Some of the reasons for the limited coverage were acceptable (e.g., lack of convincing, well designed studies) while other reasons for limited coverage were increasingly difficult to understand. For instance, FDG-PET imaging is used all over the world for monitoring lymphoma treatments, yet, coverage for this indication was not available until now.

The Centers for Medicare & Medicaid Services (CMS) has recently announced a plan to expand coverage for PET imaging in cancer. Without any doubt, this is a major success for everyone who practices PET imaging. More importantly, it is a major milestone for cancer patients who historically had limited access to PET imaging. CMS decided that PET reimbursement will now be approved for developing the initial treatment strategy in all cancers with two exceptions, prostate and breast cancer. In addition, PET is now approved for subsequent treatment-strategy evaluations in lung cancer, breast cancer, melanoma, lymphoma, head and neck cancer, esophageal cancer, colorectal cancer, cervical cancer, myeloma, thyroid cancer and ovarian cancer. This expanded coverage will have a major impact on managing patients with cancer. It removes barriersfor many patients who were unable to get the most advanced diagnostic cancer tests.

This great success should be attributed to a few leaders in the field who initiated the National Oncology PET Registry (NOPR) several years ago. NOPR is a prospective data registry that collects data from PET imaging facilities and from physicians requesting the PET scan. The data derived from simple questionnaires were used to evaluate the impact of PET on intended patient management. The design of the study (by Bruce Hillner, MD, of Virginia Commonwealth University; R. Edward Coleman, MD, Duke; Barry Siegel, MD, Washington University; Anthony Shields, MD, Wayne State University; and many others) met the CMS requirements of "Coverage with Evidence Development," or CED. It is a concept that limits CMS coverage to those diagnostic or therapeutic modalities/ interventions for which sufficient scientific evidence for cost-effectiveness has been developed. The NOPR investigators worked with CMS in a productive, collaborative way to design and establish the registry.

The NOPR was funded by the Academy of Molecular Imaging (AMI) and was supported, among others, by the American College of Radiology (ACR) and the Society of Nuclear Medicine (SNM). More than 100,000 patients have been enrolled in the registry to date. The data have been analyzed and have been published, and these reports (appearing in such journals as the Journal of Clinical Oncology in 2008 and in Cancer in 2009) demonstrated that FDG-PET imaging impacts the management of 30% to 40% of all cancer patients. This high impact was evident across all cancers and across most study indications, such as staging or treatment monitoring.

While the CMS coverage proposal reflects significant progress, the mission of imaging specialists (diagnostic oncologists) is still not accomplished. For instance, monitoring the effects of treatments (chemotherapy, targeted cancer treatments and radiation treatment) is still not covered for many cancers including prostate cancer, sarcoma, pancreatic cancer, endometrial cancer and others. Therefore, professional organizations such as AMI, ACR and SNM will continue to collect data to eventually achieve broad coverage for PET imaging. For the time being, every effort will be made to continue the NOPR so that patients can undergo PET scans even if they suffer from "noncovered" cancers.

It is hoped that the continuation of the NOPR will eventually lead to broad CMS coverage of FDG-PET imaging for all cancer patients.

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Implications of the recent CMS PET coverage decision.  Appl Radiol. 

May 19, 2009
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