US Centers for Medicare and Medicaid Services Expands Coverage for Positron Emission Tomography Scanning in Patients with Cancer
April 7, 2009 — The US Centers for Medicare and Medicaid Services (CMS) has announced that they will expand coverage for positron emission tomography (PET) for Medicare beneficiaries who are diagnosed with cancer. CMS will now provide reimbursement for PET scans used in the initial treatment-strategy evaluation of patients with most types of solid tumors, and will allow for use of PET in subsequent treatment-strategy evaluations for an expanded number of cancer types.
This final national coverage determination from CMS removes a clinical-study requirement for PET-scan use in these patients. However, the use of PET in initial and subsequent treatment-strategy evaluations in certain other cancers will be covered by Medicare only if patients are enrolled in an approved clinical trial or registry.
Before this ruling, CMS only covered PET scanning for the initial diagnosis of 9 types of cancer: breast, cervical, colorectal, esophageal, head and neck, lymphoma, melanoma, non–small-cell lung, and thyroid. Medicare coverage has now been expanded to a total of 11 indications; both the initial diagnostic evaluation and subsequent treatment strategies for ovarian cancer and myeloma are now covered.
Several professional organizations applauded the CMS decision. "PET scans have revolutionized the diagnosis and treatment of cancer," said Ilyse Schuman, Managing Director of the Medical Imaging and Technology Alliance in Arlington, Virginia. "CMS' decision to expand PET coverage for many cancer indications gives oncologists 20/20 vision when deciding on the proper treatment for their patients. CMS' decision is a major step forward in the war on cancer."
Cara Tenenbaum, Senior Policy Director of the Ovarian Cancer National Alliance in Washington, DC, stated that "PET scans are a proven method for ovarian cancer patients when it comes to treating women who need restaging and/or monitoring for recurrence or response to treatment.
"CMS' decision will aid doctors and patients in having a full and accurate measure of ovarian cancer, not only assisting with more accurate treatments, but ultimately helping to save lives," Ms Tenenbaum said in a release.
This decision to expand coverage was largely based on compelling clinical evidence obtained from the National Oncologic PET Registry (NOPR). NOPR, which was launched in 2006, was developed in response to a CMS proposal to expand coverage for PET and include cancers and indications not presently eligible for Medicare reimbursement. Medicare reimbursement for those cancers could only be obtained if the referring physician and provider submitted data to a clinical registry to assess the impact of PET on cancer-patient management.
More than 100 000 patients have undergone PET scans under the NOPR protocol that permits Medicare coverage for these scans. The NOPR investigators have published several studies documenting the impact of PET on cancer management, as previously reported by Medscape Oncology. Researchers affiliated with NOPR asked CMS in March 2008 to reconsider its reimbursement policy for PET, based in part on their data.
"For years, physicians and researchers around the world have known that PET is an invaluable diagnostic tool for guiding management of patients with a wide range of cancers," said Barry Siegel, MD, Co-Chair of the NOPR Working Group and Chief of Nuclear Medicine at the Mallinckrodt Institute of Radiology in St. Louis, Missouri. "The evidence contained in the NOPR study proves the effectiveness of PET as an essential part of a cancer patient's treatment planning."
Medicare collects data from the NOPR under the Coverage with Evidence Development (CED) program, and this is the first time that CMS has reconsidered a coverage policy based on new evidence developed under the CED program.
"This expansion in coverage for PET scans shows that the CED program is a success," said CMS acting administrator Charlene Frizzera in a statement. "CED allowed us to cover an emerging technology, learn more about its usage in clinical practice, and adjust our coverage policies accordingly. Thanks to CED, Medicare beneficiaries have greater access to cutting-edge medical technologies and treatments."
However, in an editorial published online March 9 in the Journal of Clinical Oncology, Bruce Cheson, MD, Director of Hematology Services at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital in Washington, DC, cautioned against overuse of PET, particularly in patients with lymphoma.
"We need to examine the fine print before adopting the widespread use of PET," he wrote. Although computed tomography and PET scans clearly identify more lesions in lymphoma patients than other imaging, staging is altered in only 10% to 30% of patients, and treatment is changed in even fewer.
There are "no data to suggest that prognosis is improved based on this information," he noted.
PET scans in this population are also imperfect, with many false-negative and false-positive results, he pointed out, for a number of reasons, including technical problems, uncontrolled diabetes, inflammation, infection, tumor necrosis, and scanning too soon after chemotherapy or radiotherapy.
At this time, he concluded, 2-[18F] fluoro-2-deoxy-D-glucos-PET "should be reserved for restaging curable lymphomas, sparing other patients the expense and radiation exposure until clinical trials validate the role of this technology in other settings."
Source: Medscape Medical News
