A proposal to expand Medicare coverage of FDG-PET studies for cancer staging and restaging has elicited mixed reactions among proponents.
Though some applaud the move, others, particularly PET researchers, say it falls short of expectations.
The Centers for Medicare and Medicaid Services proposes to cover one FDG-PET study for Medicare beneficiaries with biopsy-proven or strongly suspected solid tumors. The initial PET scan would be used for diagnosis/staging and to guide management.
The policy, based on experience from the National Oncologic PET Registry, would cover all cancers except prostate and breast cancer and the evaluation of regional lymph nodes in melanoma. The use of PET beyond the initial patient evaluation, however, will continue to require Coverage with Evidence Development (CED), most likely through the NOPR.
“(The proposed decision) is an improvement on current coverage policy,” said Dr. Barry Siegel, director of nuclear medicine at the Mallinckrodt Institute of Radiology and cochair of the NOPR Working Group, in an interview with Diagnostic Imaging.
“But it doesn't pay full credence to the evidence and really falls short of what the PET community and the oncology community likely were expecting CMS to do.”
The NOPR was established in 2005 in response to a CMS proposal to expand FDG-PET coverage to numerous evaluations that were not eligible for Medicare reimbursement. The Academy of Molecular Imaging sponsored the registry. The American College of Radiology sponsored registry- related research through the American College of Radiology Imaging Network.
In its decision memorandum released Jan. 6, CMS credited the NOPR with providing the necessary evidence to review previous national coverage determinations. According to a CMS statement, it was the first time such a measure has been taken under a CED program. The NOPR was successful in launching the process and helping the decision making. But it did not lead to the kind of coverage outcome registry researchers expected, Siegel said.
“I am not completely satisfied,” he said. “But I am hoping that the comment period will let CMS know that the radiology and nuclear medicine community and the oncology community feel that they should have gone further.”
CMS's proposal would be helpful to oncologists by improving current coverage for the initial workup of most cancer types as well as treatment monitoring for some, including colorectal, esophageal, lymphoma, and non-small cell lung cancer, said Dr. Anthony Shields, a professor of medicine and oncology at the Karmanos Cancer Institute in Detroit and cosponsor of the application that led to the CMS proposal.
CMS's plan, however, does not allow for the restaging of many cancers, such as ovarian or pancreatic. Being able to perform the initial staging and plan treatment helps greatly. But not being able to use PET for restaging when problems arise months or years down the line does not make a lot of sense, Shields said.
“That, to me, is the greatest limitation of what's been proposed so far,” he said.
