GroundRules
42 CFR 427.100: Definitions.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—MEDICARE PROGRAM
- PART 427—MEDICARE PART B DRUG INFLATION REBATE PROGRAM
- Subpart B—Determination of Part B Rebatable Drugs
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.
Collected 2026-08-27T02:26:11Z. Source file · JSON