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Given that devices are not cleared by FDA for use under 21 CFR 882.5801, we clarify here that this proposed coding and payment policy would apply to DMHT devices that have been cleared under section 510(k) of the Food, Drug, and Cosmetics Act (FD&C Act) or granted De Novo authorization by FDA and classified under 21 CFR 882.5801, as discussed below

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4) Blood Disorders Certain conditions affecting blood and bone marrow including some leukaemias and myeloproliferative disorders such as polycythaemia vera can cause elevated B12 due to increased production of B12binding proteins by white blood cells