The Centers for Medicare and Medicaid Services (CMS) has released a Proposed Decision Memo on Medicare coverage for NaF-18 Positron Emission Tomography (PET) scans used in diagnosis or treatment of bone metastasis of cancer.

In June of this year, the agency had opened reconsideration of Section 220.6 of the National Coverage Determinations Manual to review evidence on the use of NaF-18 PET scans to identify bone metastasis of cancer. All uses of NaF-18 PET are currently nationally non-covered by Medicare.

CMS now says that current evidence is not sufficient to determine that NaF-18 PET imaging used to diagnose bone metastases improves health outcomes of beneficiaries with cancer. In its Memo, CMS said that based on review of published clinical studies, it found no conclusive evidence of improved patient-oriented health outcomes related to NaF-18 PET studies for routine follow-up or monitoring of suspected bone metastases, except for the diagnosis of bone metastases in patients with symptomatic evidence of bone pain with no other imaging findings of bone metastasis. Therefore use of NaF-18 PET scans for diagnosis is not "reasonable and necessary" to be covered under Medicare.
Guiding Treatment Strategy in Trials

However, CMS did find sufficient evidence to determine that NaF-18 PET imaging is reasonable and necessary for the purpose of identifying bone metastasis of cancer which can inform the initial anti-tumor treatment strategy, or guide subsequent anti-tumor treatment strategy after the completion of initial treatment. CMS proposes to cover NaF-18 PET imaging when a beneficiary's treating physician determines that the NaF-18 PET study is needed under those circumstances, and the beneficiary is enrolled in (and the NaF-18 PET provider is participating in) a prospective clinical study to determine if the addition of NaF-18 PET imaging leads to: a. change in the likelihood of appropriate referrals for palliative care; b. improved quality of life; or c. improved survival.

The CMS Proposed Decision Memo has information on the standards of scientific integrity and relevance necessary for any such study and the general methodological principles of study design.

CMS is soliciting public comments on the proposed decision until December 30. The proposal is scheduled to be final by the end of February 2010. Comments may be submitted on the CMS webpage with the Proposed Decision Memo: http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=233&

and also:
http://www.cms.hhs.gov/mcd/public_comment.asp?nca_id=233&basketitem=

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