PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2229
‘‘(iv) The development of proposals for efficient interaction among manufacturers, providers of services, suppliers (as defined in section 1861(d)), and individuals. ‘‘(v) The establishment of quality standards under section 1834(a)(20). ‘‘(B) ADDITIONAL DUTIES.—The Committee shall perform such additional functions to assist the Secretary in carrying out this section as the Secretary may specify. ‘‘(4) INAPPLICABILITY OF FACA.—The provisions of the Federal Advisory Committee Act (5 U.S.C. App.) shall not apply. ‘‘(5) TERMINATION.—The Committee shall terminate on December 31, 2009. ‘‘(d) REPORT.—Not later than July 1, 2009, the Secretary shall submit to Congress a report on the programs under this section. The report shall include information on savings, reductions in costsharing, access to and quality of items and services, and satisfaction of individuals. ‘‘(e) DEMONSTRATION PROJECT FOR CLINICAL LABORATORY SERVICES.— ‘‘(1) IN GENERAL.—The Secretary shall conduct a demonstration project on the application of competitive acquisition under this section to clinical diagnostic laboratory tests— ‘‘(A) for which payment would otherwise be made under section 1833(h) (other than for pap smear laboratory tests under paragraph (7) of such section) or section 1834(d)(1) (relating to colorectal cancer screening tests); and ‘‘(B) which are furnished by entities that did not have a face-to-face encounter with the individual. ‘‘(2) TERMS AND CONDITIONS.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), such project shall be under the same conditions as are applicable to items and services described in subsection (a)(2), excluding subsection (b)(5)(B) and other conditions as the Secretary determines to be appropriate. ‘‘(B) APPLICATION OF CLIA QUALITY STANDARDS.—The quality standards established by the Secretary under section 353 of the Public Health Service Act for clinical diagnostic laboratory tests shall apply to such tests under the demonstration project under this section in lieu of quality standards described in subsection (b)(2)(A)(i). ‘‘(3) REPORT.—The Secretary shall submit to Congress— ‘‘(A) an initial report on the project not later than December 31, 2005; and ‘‘(B) such progress and final reports on the project after such date as the Secretary determines appropriate.’’. (2) CONFORMING AMENDMENTS.—Section 1833(a)(1) (42 U.S.C. 1395l(a)(1)) is amended— (A) by striking ‘‘and (U)’’ and inserting ‘‘(U)’’; (B) by inserting before the semicolon at the end the following: ‘‘, and (V) notwithstanding subparagraphs (I) (relating to durable medical equipment), (M) (relating to prosthetic devices and orthotics and prosthetics), and (Q) (relating to 1842(s) items), with respect to competitively priced items and services (described in section 1847(a)(2)) that are furnished in a competitive area, the amounts
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