117 STAT. 2246
PUBLIC LAW 108–173—DEC. 8, 2003 ‘‘(i) competitive acquisition areas are established for contract award purposes for acquisition of and payment for categories of competitively biddable drugs and biologicals (as defined in paragraph (2)) under this part; ‘‘(ii) each physician is given the opportunity annually to elect to obtain drugs and biologicals under the program, rather than under section 1847A; and ‘‘(iii) each physician who elects to obtain drugs and biologicals under the program makes an annual selection under paragraph (5) of the contractor through which drugs and biologicals within a category of drugs and biologicals will be acquired and delivered to the physician under this part. This section shall not apply in the case of a physician who elects section 1847A to apply. ‘‘(B) IMPLEMENTATION.—For purposes of implementing the program, the Secretary shall establish categories of competitively biddable drugs and biologicals. The Secretary shall phase in the program with respect to those categories beginning in 2006 in such manner as the Secretary determines to be appropriate. ‘‘(C) WAIVER OF CERTAIN PROVISIONS.—In order to promote competition, in carrying out the program 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. ‘‘(D) EXCLUSION AUTHORITY.—The Secretary may exclude competitively biddable drugs and biologicals (including a class of such drugs and biologicals) from the competitive bidding system under this section if the application of competitive bidding to such drugs or biologicals— ‘‘(i) is not likely to result in significant savings; or ‘‘(ii) is likely to have an adverse impact on access to such drugs or biologicals. ‘‘(2) COMPETITIVELY BIDDABLE DRUGS AND BIOLOGICALS AND PROGRAM DEFINED.—For purposes of this section— ‘‘(A) COMPETITIVELY BIDDABLE DRUGS AND BIOLOGICALS DEFINED.—The term ‘competitively biddable drugs and biologicals’ means a drug or biological described in section 1842(o)(1)(C) and furnished on or after January 1, 2006. ‘‘(B) PROGRAM.—The term ‘program’ means the competitive acquisition program under this section. ‘‘(C) COMPETITIVE ACQUISITION AREA; AREA.—The terms ‘competitive acquisition area’ and ‘area’ mean an appropriate geographic region established by the Secretary under the program. ‘‘(D) CONTRACTOR.—The term ‘contractor’ means an entity that has entered into a contract with the Secretary under this section. ‘‘(3) APPLICATION OF PROGRAM PAYMENT METHODOLOGY.— ‘‘(A) IN GENERAL.—With respect to competitively biddable drugs and biologicals which are supplied under the
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