Medicare officials are preparing to expand the coverage of positron emission tomography for initial diagnostic testing in individuals with suspected solid tumors.
Under a proposed national coverage determination issued by the Centers for Medicare and Medicaid Services, Medicare beneficiaries would be eligible for one PET scan to guide the initial treatment strategy for most cancer indications not previously covered for PET. The proposal also allows for coverage of treatment response monitoring of several cancers.
Beneficiaries would be eligible for an assessment with PET if they had a solid tumor that was biopsy proven or strongly suspected based on other diagnostic testing, according to the CMS. However, Medicare officials will not provide coverage for initial PET assessments of patients with adenocarcinoma of the prostate because the available evidence does not show that these would improve physician decision making.
Under the CMS proposal, coverage of subsequent PET scans for currently noncovered cancers would continue to fall under requirements of the CMS's Coverage with Evidence Development (CED) program, meaning that patients must be involved in an approved clinical study to gain coverage. CMS officials cited a lack of evidence to support coverage of additional scans.
The CMS is expected to issue a final coverage determination in April.
Currently, Medicare beneficiaries are covered for PET scans at various stages for nine common cancers: breast, cervical, colorectal, esophageal, head and neck, non-small cell lung, and thyroid cancers, as well as lymphoma and melanoma.
Since 2005, Medicare beneficiaries have also been covered for the use of PET scans in all other cancers under the CED program, an initiative that is designed to collect information on the utilization and impact of medical technologies. As a condition of CED, beneficiaries must be enrolled in an approved clinical study. For PET, the approved study has been the National Oncologic PET Registry (NOPR), which collects prospective data from referring physicians and participating PET facilities on PET scans that are used for diagnosis, staging, restaging, and monitoring response.
Based on data collected through the registry, researchers at the NOPR requested in March 2008 that Medicare expand coverage for PET more broadly and end the required data collection except in monitoring response to treatment.
If the coverage determination were finalized as is, it would be an improvement over the current policy, said Dr. Barry A. Siegel, cochair of the NOPR Working Group and director of nuclear medicine at Washington University in St. Louis.
However, the proposal falls short by failing to provide coverage for subsequent PET scans for many cancers, Dr. Siegel added. “In some ways, it runs counter to the evidence,” he said.
Looking either at cancers globally or at changes in intended management provides a clear picture of the benefit of PET scans for restaging and for detection of suspected recurrence, he said.
For example, a study from researchers at NOPR found a change in intended management (from treatment to nontreatment, or the reverse) in 38% of cancer cases. The study looked at more than 40,000 PET scans across 18 types of cancer. The researchers found similar overall results for initial staging, restaging, and recurrence. In initial staging, there was a change in intended management in 39.8% of cases, compared with 35.9% for restaging and 38.5% for detecting suspected recurrence (J. Nucl. Med. 2008;49:1928–35).
In addition, Dr. Siegel disagreed with the CMS's decision to allow only a single PET scan before the initiation of treatment. In practice, more than one PET scan is often used during the pretreatment phase, especially for radiation therapy planning, said Dr. Siegel, who serves on the medical advisory board and has a small equity interest in Radiology Corporation of America, which is a national provider of mobile PET/CT services.