C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM › Subpart B—Determination of Part D Rebatable Drugs

42 C.F.R. § 428.100

Definitions

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As used in this subpart, the following definitions apply:

Individual who uses such a drug or biological means a unique Medicare Part D beneficiary who was dispensed the Part D drug or biological that was covered by their Part D plan sponsor during the applicable period, identified using Prescription Drug Event (PDE) data with dates of service during the applicable period and with gross covered prescription drug costs greater than zero.

Gross covered prescription drug costs has the meaning set forth in § 423.308 of this chapter.

Notes of Decisions
Cited in 1 case, 2016–2016 · leading case: United States ex rel. Brown v. Celgene Corp., 226 F. Supp. 3d 1032 (C.D. Cal. 2016).
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United States ex rel. Brown v. Celgene Corp., 226 F. Supp. 3d 1032 (C.D. Cal. 2016). “42 C.F.R. § 428.100 . There was no judicial authority to the contrary.”
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