Page:United States Statutes at Large Volume 117.djvu/2328

 PUBLIC LAW 108–173—DEC. 8, 2003

117 STAT. 2309

for drugs among hospitals based on the volume of covered OPD services performed by such hospitals or other relevant characteristics of such hospitals (as defined by the Comptroller General). ‘‘(v) COMMENT ON PROPOSED RATES.—Not later than 30 days after the date the Secretary promulgated proposed rules setting forth the payment rates under subparagraph (A) for 2006, the Comptroller General shall evaluate such proposed rates and submit to Congress a report regarding the appropriateness of such rates based on the surveys the Comptroller General has conducted under clause (i). ‘‘(E) ADJUSTMENT IN PAYMENT RATES FOR OVERHEAD COSTS.— ‘‘(i) MEDPAC REPORT ON DRUG APC DESIGN.—The Medicare Payment Advisory Commission shall submit to the Secretary, not later than July 1, 2005, a report on adjustment of payment for ambulatory payment classifications for specified covered outpatient drugs to take into account overhead and related expenses, such as pharmacy services and handling costs. Such report shall include— ‘‘(I) a description and analysis of the data available with regard to such expenses; ‘‘(II) a recommendation as to whether such a payment adjustment should be made; and ‘‘(III) if such adjustment should be made, a recommendation regarding the methodology for making such an adjustment. ‘‘(ii) ADJUSTMENT AUTHORIZED.—The Secretary may adjust the weights for ambulatory payment classifications for specified covered outpatient drugs to take into account the recommendations contained in the report submitted under clause (i). ‘‘(F) CLASSES OF DRUGS.—For purposes of this paragraph: ‘‘(i) SOLE SOURCE DRUGS.—The term ‘sole source drug’ means— ‘‘(I) a biological product (as defined under section 1861(t)(1)); or ‘‘(II) a single source drug (as defined in section 1927(k)(7)(A)(iv)). ‘‘(ii) INNOVATOR MULTIPLE SOURCE DRUGS.—The term ‘innovator multiple source drug’ has the meaning given such term in section 1927(k)(7)(A)(ii). ‘‘(iii) NONINNOVATOR MULTIPLE SOURCE DRUGS.— The term ‘noninnovator multiple source drug’ has the meaning given such term in section 1927(k)(7)(A)(iii). ‘‘(G) REFERENCE AVERAGE WHOLESALE PRICE.—The term ‘reference average wholesale price’ means, with respect to a specified covered outpatient drug, the average wholesale price for the drug as determined under section 1842(o) as of May 1, 2003. ‘‘(H) INAPPLICABILITY OF EXPENDITURES IN DETERMINING CONVERSION, WEIGHTING, AND OTHER ADJUSTMENT FACTORS.—Additional expenditures resulting from this paragraph shall not be taken into account in establishing

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