Page:United States Statutes at Large Volume 114 Part 5.djvu/544

 114 STAT. 2763A-504 PUBLIC LAW 106-554—APPENDIX F on the basis of the program memoranda issued before such date. " (II) AUTHORIZATION OF IMPLEMENTATION OTHER THAN THROUGH REGULATIONS.— The categories may be established under this clause by program memorandum or otherwise, after consultation with groups representing hospitals, manufacturers of medical devices, and other affected parties. "(ii) ESTABLISHING CRITERIA FOR ADDITIONAL CAT- EGORIES.— "(I) IN GENERAL.—The Secretary shall establish criteria that will be used for creation of additional categories (other than those established under clause (i)) through rulemaking (which may include use of an interim final rule with comment period). "(II) STANDARD.— Such categories shall be established under this clause in a manner such that no medical device is described by more than one category. Such criteria shall include a test of whether the average cost of devices that would be included in a category and are in use at the time the category is established is not insignificant, as described in subparagraph (A)(iv)(II). "(Ill) DEADLINE. —Criteria shall first be established under this clause by July 1, 2001. The Secretary may establish in compelling circumstances categories under this clause before the date such criteria are established. "(IV) ADDING CATEGORIES. —The Secretary shall promptly establish a new category of medical devices under this clause for any medical device that meets the requirements of subparagraph (A)(iv) and for which none of the categories in effect (or that were previously in effect) is appropriate. "(iii) PERIOD FOR WHICH CATEGORY IS IN EFFECT, — A category of medical devices established under clause (i) or (ii) shall be in effect for a period of at least 2 years, but not more than 3 years, that begins— "(I) in the case of a category established under clause (i), on the first date on which pa3niient was made under this paragraph for any device described by such category (including payments made during the period before April 1, 2001); and "(II) in the case of any other category, on the first date on which payment is made under this paragraph for any medical device that is described by such category. " (iv) REQUIREMENTS TREATED AS MET. —^A medical device shall be treated as meeting the requirements of subparagraph (A)(iv), regardless of whether the device meets the requirement of subclause (I) of such subparagraph, if— "(I) the device is described by a category established and in effect under clause (i); or

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