PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2225
‘‘(i) shall be phased in among competitive acquisition areas in a manner so that the competition under the programs occurs in— ‘‘(I) 10 of the largest metropolitan statistical areas in 2007; ‘‘(II) 80 of the largest metropolitan statistical areas in 2009; and ‘‘(III) additional areas after 2009; and ‘‘(ii) may be phased in first among the highest cost and highest volume items and services or those items and services that the Secretary determines have the largest savings potential. ‘‘(C) WAIVER OF CERTAIN PROVISIONS.—In carrying out the programs, the Secretary may waive such provisions of the Federal Acquisition Regulation as are necessary for the efficient implementation of this section, other than provisions relating to confidentiality of information and such other provisions as the Secretary determines appropriate. ‘‘(2) ITEMS AND SERVICES DESCRIBED.—The items and services referred to in paragraph (1) are the following: ‘‘(A) DURABLE MEDICAL EQUIPMENT AND MEDICAL SUPPLIES.—Covered items (as defined in section 1834(a)(13)) for which payment would otherwise be made under section 1834(a), including items used in infusion and drugs (other than inhalation drugs) and supplies used in conjunction with durable medical equipment, but excluding class III devices under the Federal Food, Drug, and Cosmetic Act. ‘‘(B) OTHER EQUIPMENT AND SUPPLIES.—Items and services described in section 1842(s)(2)(D), other than parenteral nutrients, equipment, and supplies. ‘‘(C) OFF-THE-SHELF ORTHOTICS.—Orthotics described in section 1861(s)(9) for which payment would otherwise be made under section 1834(h) which require minimal selfadjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit to the individual. ‘‘(3) EXCEPTION AUTHORITY.—In carrying out the programs under this section, the Secretary may exempt— ‘‘(A) rural areas and areas with low population density within urban areas that are not competitive, unless there is a significant national market through mail order for a particular item or service; and ‘‘(B) items and services for which the application of competitive acquisition is not likely to result in significant savings. ‘‘(4) SPECIAL RULE FOR CERTAIN RENTED ITEMS OF DURABLE MEDICAL EQUIPMENT AND OXYGEN.—In the case of a covered item for which payment is made on a rental basis under section 1834(a) and in the case of payment for oxygen under section 1834(a)(5), the Secretary shall establish a process by which rental agreements for the covered items and supply arrangements with oxygen suppliers entered into before the application of the competitive acquisition program under this section for the item may be continued notwithstanding this section. In the case of any such continuation, the supplier involved shall
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