The Centers for Medicare and Medicaid Services proposed Tuesday to grant routine Medicare payment for numerous cancer-related FDG-PET applications evaluated by the National Oncology PET Registry, a program managed by the American College of Radiology Imaging Network.
The proposed coverage determination potentially eliminates the currently rigorous reporting requirements for use of FDG-PET for the initial postdiagnostic evaluation of numerous types of cancer. As part of a 2005 compromise between CMS and PET advocates, Medicare reimbursement was granted for the staging, restaging, and evaluation of the therapeutic response of cancers as part of CMS's Coverage with Evidence Development (CED) program.
The policy covered the following solid tumors:
- breast cancer
- colorectal cancer
- esophageal cancer
- head and neck cancers
- lung cancer
- lymphoma
- melanoma
- thyroid cancer
- soft tissue sarcoma
- and brain, ovarian, pancreatic, small cell lung, and testicular cancer.
The NOPR program measured the impact of FDG-PET on clinical patient management. Imaging services were required to participate in the NOPR to qualify for Medicare reimbursement. The NOPR managed a complex electronic survey that required ordering physicians to report their clinical management plans for patients before and again after receiving FDG-PET findings.
CMS noted in the announcement Tuesday that the FDG-PET applications would not have been covered by Medicare without the CED requirement.
Preliminary results published by the NOPR in March 2008 in the Journal of Clinical Oncology indicated that FDG-PET led referring physicians to alter their intended clinical management for more than one-third of nearly 23,000 cancer patients who had been enrolled in the program up to that point.
Nearly two and a half years after the registry's creation, NOPR data from more than 40,000 PET studies performed at 1368 centers suggest that the impact of PET on physicians' intended patient management is similar across cancer types, according to lead investigator Dr. Bruce E. Hillner, associate chair of internal medicine at Virginia Commonwealth University.
The study included 18 different individual cancer types and looked at PET's impact on intended management for patients with known cancers of these types for staging, restaging, and suspected recurrence.
Sponsors of the NOPR asked CMS in April 2008 to reconsider its 2005 coverage determination, based on the evidence they had collected and published. The sponsors included Dr. R. Edward Coleman, director of nuclear medicine at Duke University, Dr. Anthony Shields, a professor of medicine and oncology at Karmanos Center Institute in Detroit, Dr. Barry Siegel, chief of nuclear medicine at Washington University in St. Louis, and Hillner.
Medicare uses a formal evidence-based process when it reconsiders past national coverage determinations. According to the CMS release, this proposed expansion in coverage is the first time that CMS has reviewed medical evidence arising from its CED program.
"We are pleased with these first results of the Coverage with Evidence Development program and look forward to patients gaining greater access to new technologies while enhancing the evidence physicians use to make treatment recommendations," said CMS acting administrator Kerry Weems in a news release.
The proposed decision would grant one FDG-PET study for Medicare beneficiaries who have biopsy-proven or strongly suspected solid tumors. Imaging would be used to determine the location and/or extent of the tumors to guide initial therapy planning, according to CMS.
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, according to CMS. A CED will still be required for PET scans for subsequent treatment strategies, because CMS believes that the current evidence is not adequate to provide coverage for PET scans in guiding subsequent treatment.
The proposal specifically excludes payment for FDG-PET to determine initial antitumor treatment of patients with adenocarcinoma of the prostate, breast cancer, or for imaging the lymph nodes of melanoma patients.
CMS will accept public comments concerning its proposed decision until Feb. 5. It will issue a final national coverage determination in April.
For more information from the Diagnostic Imaging archives:
Panel pans clinical trails justifying PET coverage
PET's impact on intended management shows consistency across indications
PET registry study authors ask Medicare to expand coverage
