CMS is proposing not to offer lenience on its reimbursement constraints around a sodium-fluoride PET agent, NaF-18, which is used in finding metastasized cancer cells in bones.
In a proposed decision memo released Sept. 16, the agency said it will nevertheless continue paying for NaF-18 PET under coverage with evidence development (CED) conditions, by which CMS reimburses for new drugs and devices while gathering further evidence on clinical efficacy.
CMS began reviewing NaF-PET reimbursement last March in response to requests for full reimbursement without the CED limitation.
CMS proposes continuing the CED reimbursements for 12 months from the date of final decision on NaF-18.
According to the memo, this time window will allow for evidence and analysis pointing to a conclusive answer on whether or not NaF-18 PET imaging leads to:
- A change in patient management to more appropriate palliative care;
- A change in patient management to more appropriate curative care;
- Improved quality of life; or
- Improved survival.
The FDA approved Sodium Fluoride F18 injection for diagnostic PET imaging of bone to define areas of altered osteogenic activity in 2011, the memo notes.
CMS says it will reconsider the National Coverage Determinations “at such time when the evidence has been published in a peer-reviewed journal,” the memo states.
CMS is seeking comments on this proposed decision.