CMS Declines to Cover NaF-18 PET Outside of Trials

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To help address delays in nuclear imaging procedures caused by an isotope shortage that resulted when two Canadian reactors went offline in 2009, the Academy of Molecular Imaging and other professional societies urged CMS to grant coverage for the use of sodium fluoride-18 positron emission tomography (NaF-18 PET) in diagnosing bone metastases in patients with cancer. At present, CMS covers only technetium-99m (99mTc) for bone scintigraphy. CMS agreed to consider the request.

After receiving 33 public comments—all favoring coverage of NaF-18 PET to diagnose bone metastases—and conducting a literature review with the National Institutes of Health, CMS issued a “Decision Memo for Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer” on February 26, 2010. CMS said it found insufficient evidence that using NaF-18 PET to identify bone metastases sufficiently altered treatment strategies to improve health outcomes in patients with cancer. The agency said the use of NaF-18 PET, therefore, was not “reasonable and necessary” under the Social Security Act.

CMS did agree to cover NaF-18 PET to identify bone metastases under the Coverage with Evidence Development (CED) provision but with several limitations. Medicare will cover the procedure when there is strong suspicion that the patient has bone metastases; when the physician feels it is needed to guide an initial treatment strategy or determine subsequent treatment after completion of initial treatment; and when the imaging is administered as part of a clinical study investigating the usefulness of NaF-18 PET.

In its Decision Memo, CMS said qualified trials must be designed to “answer one or more of the following questions” about NaF-18 PET imaging:

• Will it change patient management to more appropriate care?

• Will it change patient management to more appropriate curative care?

• Will it improve quality of life?

• Will it improve survival?

CMS said it is particularly interested in the effect of NaF-18 PET on the use of surgical procedures, including biopsies; the selection of an anticancer chemotherapy regimen; radiotherapy use; hospitalization; and mortality rates. Although the literature demonstrated that NaF-18 PET has a high level of sensitivity for metastatic bone lesions that some studies said exceeded that of 99mTc scans, CMS expressed concern about the rate of false positives identified in several reports. The articles that did show using NaF-18 PET changed patient management strategies failed to provide data on patient outcomes. CMS concluded there was insufficient evidence to suggest that NaF-18 PET could improve outcomes when used for routine follow-up or to monitor suspected bone metastases.

This decision is not likely to help alleviate delays due to the isotope shortage, which some anticipate will worsen once a plant in the Netherlands goes offline for 6 months of maintenance over the next several weeks. Even though one of the inoperational Canadian reactors plans to resume activity this April, worldwide isotope production is expected to decline further, to 30% to 40% of normal. The full Decision Memo is available at the CMS Website (http:// bit.ly/9D9ygW).