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Notes

§427.100. Definitions.

42 C.F.R. § 427.100

As used in this subpart, the following definitions apply:

EUA Declaration means the March 27, 2020, Emergency Use Authorization (EUA) Declaration for Drugs and Biological Products under section 564 of the Food, Drug, and Cosmetic (FD&C) Act.

Individual who uses such a drug or biological means a unique Medicare Part B beneficiary who was furnished the Part B drug or biological that was covered under Part B during the applicable calendar quarter, identified using final action claims data with dates of service during the calendar year set forth in § 427.101(b)(6) and with allowed charges greater than zero.

Notes, amendments, and revision history

Authority

Authority: 42 U.S.C. 1395w-3a(i), 1302, and 1395hh.

Source

Source: 89 FR 98578, Dec. 9, 2024, unless otherwise noted.