1. (a) General rule. CMS provides for an additional payment beyond the standard payment to a hospital for a dose of Tc-99m derived from Mo-99, if at least 50 percent of the Mo-99 in the Tc-99m generator that produced the dose was both irradiated and processed in the United States.

   1. (1) Domestically produced Mo-99 refers to Mo-99 that was both irradiated and processed in the United States.
   2. (2) Irradiated refers to the process of bombarding a uranium or molybdenum target with radiation in order to produce Mo-99. Irradiation is typically performed with a nuclear reactor or particle accelerator.
   3. (3) Processed refers to the purification of Mo-99 from irradiated material.

2. (b) Exclusions. A dose of Tc-99m does not qualify for the add-on payment if more than 50 percent of the Mo-99 in the Tc-99m generator was irradiated or processed outside the United States, even if the Mo-99 has been loaded into a Tc-99m generator in the United States or if the Tc-99m has been eluted at a radiopharmacy in the United States.

   1. (1) Eluted refers to the process by which Tc-99m is chemically separated from Mo-99 within the generator and collected in an elution vial.
   2. (2) [Reserved]

[90 FR 54086, Nov. 25, 2025]