PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2311
this subsection shall be equal to the hospital’s charges for each device furnished, adjusted to cost. Charges for such devices shall not be included in determining any outlier payment under this subsection.’’. (2) SPECIFICATION OF GROUPS FOR BRACHYTHERAPY DEVICES.—Section 1833(t)(2) (42 U.S.C. 1395l(t)(2)) is amended— (A) in subparagraph (F), by striking ‘‘and’’ at the end; (B) in subparagraph (G), by striking the period at the end and inserting ‘‘; and’’; and (C) by adding at the end the following new subparagraph: ‘‘(H) with respect to devices of brachytherapy consisting of a seed or seeds (or radioactive source), the Secretary shall create additional groups of covered OPD services that classify such devices separately from the other services (or group of services) paid for under this subsection in a manner reflecting the number, isotope, and radioactive intensity of such devices furnished, including separate groups for palladium-103 and iodine-125 devices.’’. (3) GAO REPORT.—The Comptroller General of the United States shall conduct a study to determine appropriate payment amounts under section 1833(t)(16)(C) of the Social Security Act, as added by paragraph (1), for devices of brachytherapy. Not later than January 1, 2005, the Comptroller General shall submit to Congress and the Secretary a report on the study conducted under this paragraph, and shall include specific recommendations for appropriate payments for such devices.
42 USC 1395l note.
Deadline.
SEC. 622. LIMITATION OF APPLICATION OF FUNCTIONAL EQUIVALENCE STANDARD.
Section 1833(t)(6) (42 U.S.C. 1395l(t)(6)) is amended by adding at the end the following new subparagraph: ‘‘(F) LIMITATION OF APPLICATION OF FUNCTIONAL EQUIVALENCE STANDARD.— ‘‘(i) IN GENERAL.—The Secretary may not publish regulations that apply a functional equivalence standard to a drug or biological under this paragraph. ‘‘(ii) APPLICATION.—Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after the date of enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 unless— ‘‘(I) such application was being made to such drug or biological prior to such date of enactment; and ‘‘(II) the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this title. ‘‘(iii) RULE OF CONSTRUCTION.—Nothing in this subparagraph shall be construed to effect the Secretary’s authority to deem a particular drug to be
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