Covered drug, device, biological, or medical supply
Covered drug, device, biological, or medical supply means any drug, device, biological, or medical supply for which payment is available under Title XVIII of the Act or under a State plan under Title XIX or XXI of the Act (or a waiver of such plan), either separately (such as through a fee schedule or formulary) or as part of a bundled payment (for example, under the hospital inpatient prospective payment system or the hospital outpatient prospective payment system) and which is of the type that in the case of a -
(1) Drug or biological, by law, requires a prescription to be dispensed; or
(2) Device (including a medical supply that is a device), by law, requires premarket approval by or premarket notification to the FDA.
42 CFR § 403.902
For purposes of this subpart, the following definitions apply: