PUBLIC LAW 106-554—APPENDIX F 114 STAT. 2763A-505 "(II) the device is described by a category established and in effect under clause (ii) and an application under section 515 of the Federal Food, Drug, and Cosmetic Act has been approved with respect to the device, or the device has been cleared for market under section 510(k) of such Act, or the device is exempt from the requirements of section 510(k) of such Act pursuant to subsection (1) or (m) of section 510 of such Act or section 520(g) of such Act. Nothing in this clause shall be construed as requiring an application or prior approval (other than that described in subclause (II)) in order for a covered device described by a category to qualify for payment under this paragraph. "(C) LIMITED PERIOD OF PAYMENT. — "(i) DRUGS AND BIOLOGICALS.—The payment under this paragraph with respect to a drug or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins— "(I) on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or "(II) in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service, "(ii) MEDICAL DEVICES. —Pajment shall be made under this paragraph with respect to a medical device only if such device— "(I) is described by a category of medical devices established and in effect under subparagraph (B); and "(II) is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph.". (b) CONFORMING AMENDMENTS.— Section 1833(t) (42 U.S.C. 13951(t)) is further amended— (1) in paragraph (6)(A)(iv)(II), by striking "the cost of the device, drug, or biological" and inserting "the cost of the drug or biological or the average cost of the category of devices"; (2) in paragraph (6)(D) (as redesignated by subsection (a)(1)), by striking "subparagraph (D)(iii)" in the matter preceding clause (i) and inserting "subparagraph (E)(iii)"; and (3) in paragraph (12)(E), by striking "additional pa5mfients (consistent with paragraph (6)(B))" and inserting "additional pa3mients, the determination and deletion of initial and new categories (consistent with subparagraphs (B) and (C) of paragraph (6))" (c) EFFECTIVE DATE.— The amendments made by this section take effect on the date of the enactment of this Act. 7&-194O-00 -18:QL3Part5
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