The Centers for Medicare & Medicaid Services (CMS), in a Nov. 30 draft memorandum, has proposed that “the evidence is not sufficient” to determine that the results of NaF-18 PET imaging to identify bone metastases improve health outcomes of beneficiaries with cancer, and therefore, is looking to stop reimbursements for the procedure.
On June 4, CMS opened a reconsideration of Section 220.6 of the National Coverage Determinations Manual to review evidence on the use of NaF-18 (sodium fluoride-18) imaging to identify bone metastasis of cancer.
However, the agency also proposed that the available evidence is sufficient to determine that NaF-18 PET imaging to identify bone metastasis of cancer to inform the “initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment is reasonable and necessary through coverage with evidence development.”
The memo said that the clinical studies for which Medicare will provide coverage must answer one or more of the following questions: “Does the addition of NaF-18 PET imaging lead to a change in the likelihood of appropriate referrals for palliative care; improved quality of life; or improved survival?”
CMS is soliciting public comment on the proposed decision through Dec. 30. The decision should be finalized by Feb. 28, 2010.