Proponents call CMS proposed PET coverage decision ‘bittersweet’

A proposal by the Centers for Medicare and Medicaid Services to expand coverage of FDG-PET studies elicited mixed reactions among proponents. Though some applauded the move, others, particularly PET researchers, felt that it fell short of expectations.

CMS proposes to cover one FDG-PET study for Medicare beneficiaries with biopsy-proven or strongly suspected solid tumors based on other diagnostic exams. The initial PET scan would be used for diagnostic or staging purposes and to guide management.

The policy will cover all cancers except prostate and breast cancer and the evaluation of regional lymph nodes in melanoma. The uses of PET beyond the initial patient evaluation, however, will continue to require Coverage with Evidence Development (CED).

"(The proposed decision) is an improvement in current coverage policy," said Dr. Barry Siegel, director of nuclear medicine at the Mallinckrodt Institute of Radiology and cochair of the National Oncology PET Registry (NOPR) working group in an interview with Diagnostic Imaging. "But it doesn't really 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."

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 is appropriately concerned about overuse and abuse of PET, and NOPR investigators have encouraged cracking down on practices at odds with the rules, Siegel said. But he thought CMS should apply the same standards to every imaging modality, not just PET.

What remains to be seen is whether the CED program will be a continuation of the NOPR as it exists, a revised version of the registry that researchers have already dubbed "NOPR II," or another, much higher level of study such as randomized controlled trials. It is not yet clear what CMS has in mind, Siegel said.

The proposal seems reasonable based on current knowledge, with the recognition that new data or therapeutic alternatives may require a reassessment, said Dr. Steven T. Rosen, director of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago.

"However, I would want to see the tumor-specific exceptions, which, I presume, would include follow-up imaging in some instances," Rosen said.

A number of proponents, including nuclear physicians and the Medical Imaging & Technology Alliance, a division of the National Electrical Manufacturers Association, welcomed CMS's decision.

"We are pleased by the decision, which would expand coverage for initial diagnostic testing with PET for many seniors undergoing cancer treatment," said Ilyse Schuman, MITA's managing director.

Should the coverage decision become final, MITA members hope it will provide greater access for patients. That will help cancer patients beat their disease and reduce healthcare expenditures by informing doctors about what is the most effective treatment possible, said Schuman, who is also NEMA's vice president.

The SNM echoed MITA's praise.

"SNM is pleased with CMS's proposed national coverage determination," said SNM president Dr. Robert Atcher. "This is a positive first step toward improving coverage for patients to allow them access to molecular imaging tests critical to better diagnosis, staging, and restaging of many types of cancer.

Recent studies have shown PET has a clinically significant impact on cancer management, resulting in a change in treatment in more than one out of three cases, across all types of cancer, Atcher said.

Nuclear physicians believe CMS's approach will lead to greater access and better management among patients, according to Atcher.

"We applaud CMS for their cooperative approach in working with the various professional societies -- AMI, ACRIN, ACR, ASCO, and SNM -- to improve this coverage," he said.

CMS will accept public comments concerning proposed decision until Feb. 5. It will issue a final national coverage determination in April.

For more information from the Diagnostic Imaging archives:

Medicare proposes expanded coverage for cancer-related FDG PET

PET's impact on intended management shows consistency across indications

Panel pans clinical trails justifying PET coverage

PET registry study authors ask Medicare to expand coverage