Page:United States Statutes at Large Volume 124.djvu/721

 124 STAT. 695 PUBLIC LAW 111–148—MAR. 23, 2010 purchasing organization (as defined by the Secretary) that pur- chases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or common- wealth of the United States. ‘‘(2) APPLICABLE MANUFACTURER.—The term ‘applicable manufacturer’ means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States. ‘‘(3) CLINICAL INVESTIGATION.—The term ‘clinical investiga- tion’ means any experiment involving 1 or more human sub- jects, or materials derived from human subjects, in which a drug or device is administered, dispensed, or used. ‘‘(4) COVERED DEVICE.—The term ‘covered device’ means any device for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan). ‘‘(5) COVERED DRUG, DEVICE, BIOLOGICAL, OR MEDICAL SUPPLY.—The term ‘covered drug, device, biological, or medical supply’ means any drug, biological product, device, or medical supply for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan). ‘‘(6) COVERED RECIPIENT.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), the term ‘covered recipient’ means the following: ‘‘(i) A physician. ‘‘(ii) A teaching hospital. ‘‘(B) EXCLUSION.—Such term does not include a physi- cian who is an employee of the applicable manufacturer that is required to submit information under subsection (a). ‘‘(7) EMPLOYEE.—The term ‘employee’ has the meaning given such term in section 1877(h)(2). ‘‘(8) KNOWINGLY.—The term ‘knowingly’ has the meaning given such term in section 3729(b) of title 31, United States Code. ‘‘(9) MANUFACTURER OF A COVERED DRUG, DEVICE, BIOLOGICAL, OR MEDICAL SUPPLY.—The term ‘manufacturer of a covered drug, device, biological, or medical supply’ means any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply). ‘‘(10) PAYMENT OR OTHER TRANSFER OF VALUE.— ‘‘(A) IN GENERAL.—The term ‘payment or other transfer of value’ means a transfer of anything of value. Such term does not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient.