Page:United States Statutes at Large Volume 117.djvu/2331

 117 STAT. 2312

PUBLIC LAW 108–173—DEC. 8, 2003 identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs.’’.

SEC. 623. PAYMENT FOR RENAL DIALYSIS SERVICES.

42 USC 1395rr note.

42 USC 1395rr note.

VerDate 11-MAY-2000

13:59 Aug 30, 2004

(a) INCREASE IN RENAL DIALYSIS COMPOSITE RATE FOR SERVICES FURNISHED.—The last sentence of section 1881(b)(7) (42 U.S.C. 1395rr(b)(7)) is amended— (1) by striking ‘‘and’’ before ‘‘for such services’’ the second place it appears; (2) by inserting ‘‘and before January 1, 2005,’’ after ‘‘January 1, 2001,’’; and (3) by inserting before the period at the end the following: ‘‘, and for such services furnished on or after January 1, 2005, by 1.6 percent above such composite rate payment amounts for such services furnished on December 31, 2004’’. (b) RESTORING COMPOSITE RATE EXCEPTIONS FOR PEDIATRIC FACILITIES.— (1) IN GENERAL.—Section 422(a)(2) of BIPA is amended— (A) in subparagraph (A), by striking ‘‘and (C)’’ and inserting ‘‘, (C), and (D)’’; (B) in subparagraph (B), by striking ‘‘In the case’’ and inserting ‘‘Subject to subparagraph (D), in the case’’; and (C) by adding at the end the following new subparagraph: ‘‘(D) INAPPLICABILITY TO PEDIATRIC FACILITIES.—Subparagraphs (A) and (B) shall not apply, as of October 1, 2002, to pediatric facilities that do not have an exception rate described in subparagraph (C) in effect on such date. For purposes of this subparagraph, the term ‘pediatric facility’ means a renal facility at least 50 percent of whose patients are individuals under 18 years of age.’’. (2) CONFORMING AMENDMENT.—The fourth sentence of section 1881(b)(7) (42 U.S.C. 1395rr(b)(7)) is amended by striking ‘‘The Secretary’’ and inserting ‘‘Subject to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, the Secretary’’. (c) INSPECTOR GENERAL STUDIES ON ESRD DRUGS.— (1) IN GENERAL.—The Inspector General of the Department of Health and Human Services shall conduct two studies with respect to drugs and biologicals (including erythropoietin) furnished to end-stage renal disease patients under the medicare program which are separately billed by end stage renal disease facilities. (2) STUDIES ON ESRD DRUGS.— (A) EXISTING DRUGS.—The first study under paragraph (1) shall be conducted with respect to such drugs and biologicals for which a billing code exists prior to January 1, 2004. (B) NEW DRUGS.—The second study under paragraph (1) shall be conducted with respect to such drugs and biologicals for which a billing code does not exist prior to January 1, 2004. (3) MATTERS STUDIED.—Under each study conducted under paragraph (1), the Inspector General shall— (A) determine the difference between the amount of payment made to end stage renal disease facilities under

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