Page:United States Statutes at Large Volume 117.djvu/2327

 117 STAT. 2308

payment classification group (APC) has been established and that is— ‘‘(I) a radiopharmaceutical; or ‘‘(II) a drug or biological for which payment was made under paragraph (6) (relating to passthrough payments) on or before December 31, 2002. ‘‘(ii) EXCEPTION.—Such term does not include— ‘‘(I) a drug or biological for which payment is first made on or after January 1, 2003, under paragraph (6); ‘‘(II) a drug or biological for which a temporary HCPCS code has not been assigned; or ‘‘(III) during 2004 and 2005, an orphan drug (as designated by the Secretary). ‘‘(C) PAYMENT FOR DESIGNATED ORPHAN DRUGS DURING 2004 AND 2005.—The amount of payment under this subsection for an orphan drug designated by the Secretary under subparagraph (B)(ii)(III) that is furnished as part of a covered OPD service (or group of services) during 2004 and 2005 shall equal such amount as the Secretary may specify. ‘‘(D) ACQUISITION COST SURVEY FOR HOSPITAL OUTPATIENT DRUGS.— ‘‘(i) ANNUAL GAO SURVEYS IN 2004 AND 2005.— ‘‘(I) IN GENERAL.—The Comptroller General of the United States shall conduct a survey in each of 2004 and 2005 to determine the hospital acquisition cost for each specified covered outpatient drug. Not later than April 1, 2005, the Comptroller General shall furnish data from such surveys to the Secretary for use in setting the payment rates under subparagraph (A) for 2006. ‘‘(II) RECOMMENDATIONS.—Upon the completion of such surveys, the Comptroller General shall recommend to the Secretary the frequency and methodology of subsequent surveys to be conducted by the Secretary under clause (ii). ‘‘(ii) SUBSEQUENT SECRETARIAL SURVEYS.—The Secretary, taking into account such recommendations, shall conduct periodic subsequent surveys to determine the hospital acquisition cost for each specified covered outpatient drug for use in setting the payment rates under subparagraph (A). ‘‘(iii) SURVEY REQUIREMENTS.—The surveys conducted under clauses (i) and (ii) shall have a large sample of hospitals that is sufficient to generate a statistically significant estimate of the average hospital acquisition cost for each specified covered outpatient drug. With respect to the surveys conducted under clause (i), the Comptroller General shall report to Congress on the justification for the size of the sample used in order to assure the validity of such estimates. ‘‘(iv) DIFFERENTIATION IN COST.—In conducting surveys under clause (i), the Comptroller General shall determine and report to Congress if there is (and the extent of any) variation in hospital acquisition costs

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PUBLIC LAW 108–173—DEC. 8, 2003

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