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§419.49. Additional payment for technetium-99m (Tc-99m) derived from domestically produced molybdenum-99 (Mo-99).

42 C.F.R. § 419.49

(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)
Domestically produced Mo-99 refers to Mo-99 that was both irradiated and processed in the United States.
(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)
Processed refers to the purification of Mo-99 from irradiated material.
(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)
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)
[Reserved]
Notes, amendments, and revision history

Amendments

[90 FR 54086, Nov. 25, 2025]

Authority

Authority: 42 U.S.C. 1302, 1395l(t), and 1395hh.

Source

Source: 65 FR 18542, Apr. 7, 2000, unless otherwise noted.

Amendments

[90 FR 54086, Nov. 25, 2025]