The Centers for Medicare & Medicaid Services (CMS) yesterday proposed a national coverage determination (NCD) to expand coverage for initial diagnostic testing with PET for many Medicare beneficiaries who are being treated for cancer.
The agency said that the “test may provide important clinical information to guide the initial treatment approach for many tumors. The additional information may help physicians to distinguish benign from cancerous lesions and better determine the extent of a tumor’s growth or metastasis.”
Under the coverage with evidence development (CED) program, CMS had issued an NCD in 2005 that tied Medicare coverage of PET scans to the collection of clinical information about the effect of the test on the beneficiary’s cancer care. The information was obtained through the National Oncologic PET Registry ( NOPR) observational study. Without CED, the tests would not have been reimbursed by Medicare.
The purpose of CED is to develop evidence on the utilization and impact of the item or service evaluated in an NCD, so that Medicare can:
- Document the appropriateness of use of that item or service in Medicare beneficiaries under current coverage;
- Consider future changes in coverage for the item or service; and
- Generate clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding the item or service.
The sponsors of NOPR—the American College of Radiology Imaging Network (ACRIN), the American College of Radiology (ACR), and the Academy of Molecular Imaging (AMI)—submitted a written request in September 2008 to reconsider the 2005 coverage determination to CMS, based on the evidence they had collected and published. Medicare uses a formal evidence based process when it reconsiders past NCDs. This proposed expansion in coverage is the first time that CMS has reviewed medical evidence arising from its CED program, according to the agency.
Diagnostic findings from FDG-PET imaging changed the intended care of more than one in three cancer patients, according to a study of first-year data from the NOPR published in the May issue of the Journal of Clinical Oncology. NOPR was launched in May 2006 in response to the CMS Coverage with Evidence policy to collect data through a clinical registry to inform the Center’s FDG-PET coverage determination decisions for currently non-covered cancer indications. The study analyzed data regarding nearly 23,000 patients contributed to NOPR by more than 1,200 facilities in the United States that provide PET scans.
Analysis of data collected found that FDG-PET utilization is associated with a 36.5 percent change in the decision of whether or how to treat a patient’s cancer. The NOPR study also found that PET is associated with a management change in almost 75 percent of patients when the addition or deletion to specific modes of therapy was included. In addition, the NOPR data revealed that for patients with a pre-PET plan of biopsy, the post-PET plan had a significant impact on care, with these patients avoiding biopsy in about 75 percent of the cases analyzed.
The proposed decision would remove a significant part of the CED requirement for PET scans in cancer and allow coverage for one PET scan to guide the initial treatment strategy. CED will still be required for PET scans for subsequent treatment strategies, as CMS said it “believes that the current evidence is not adequate to provide coverage for PET scans in guiding subsequent treatment.”
CMS proposed some cancer-specific exceptions to the broad requirements, which are listed in the proposed decision.
CMS will accept public comments on the entire proposed decision through February 5, 2009 and will issue a final national coverage determination in April 2009. Instructions on how to submit comments are found at www.cms.hhs.gov/InfoExchange/02_publiccomments.asp.