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Tissue-level deficiency of cobalamin is associated with an increase in the urinary and serum concentrations of an organic acid called methylmalonic acid, which is an alternative product of a cobalamin dependent pathway within the mitochondria

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Specifically, for CY 2026, we proposed to continue our established policy of assigning comment indicator N1 in Addendum B to this final rule with comment period to the new HCPCS codes that will be effective January 1, 2026, to indicate that we are assigning them an interim status indicator, which is subject to public comment

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As previously stated, we have concerns regarding a potential lack of consensus among interested parties, given the significant number of negative public comments received during the comment period opposing the adoption of this measure for the ASCQR Program