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Additionally, we finalized corresponding modifications to the regulation text at 419.2(b)(15) and 419.41 to codify our finalized payment policy for diagnostic radiopharmaceuticals and our existing policy for therapeutic radiopharmaceuticals

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Mass spectrometry identity confirmation: Molecular weight must be verified via LC-MS to confirm the 16-amino acid sequence and the intramolecular disulfide bond, both critical structural features of this compound

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