PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2243
they do present such a problem, they are shown to meet an appropriate standard of bioequivalence. ‘‘(G) INCLUSION OF VACCINES.—In applying provisions of section 1927 under this section, ‘other than a vaccine’ is deemed deleted from section 1927(k)(2)(B). ‘‘(d) MONITORING OF MARKET PRICES.— ‘‘(1) IN GENERAL.—The Inspector General of the Department of Health and Human Services shall conduct studies, which may include surveys, to determine the widely available market prices of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate. ‘‘(2) COMPARISON OF PRICES.—Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the average sales price under this section for drugs and biologicals with— ‘‘(A) the widely available market price for such drugs and biologicals (if any); and ‘‘(B) the average manufacturer price (as determined under section 1927(k)(1)) for such drugs and biologicals. ‘‘(3) LIMITATION ON AVERAGE SALES PRICE.— ‘‘(A) IN GENERAL.—The Secretary may disregard the average sales price for a drug or biological that exceeds the widely available market price or the average manufacturer price for such drug or biological by the applicable threshold percentage (as defined in subparagraph (B)). ‘‘(B) APPLICABLE THRESHOLD PERCENTAGE DEFINED.— In this paragraph, the term ‘applicable threshold percentage’ means— ‘‘(i) in 2005, in the case of an average sales price for a drug or biological that exceeds widely available market price or the average manufacturer price, 5 percent; and ‘‘(ii) in 2006 and subsequent years, the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both. ‘‘(C) AUTHORITY TO ADJUST AVERAGE SALES PRICE.— If the Inspector General finds that the average sales price for a drug or biological exceeds such widely available market price or average manufacturer price for such drug or biological by the applicable threshold percentage, the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this subparagraph) and the Secretary shall, effective as of the next quarter, substitute for the amount of payment otherwise determined under this section for such drug or biological the lesser of— ‘‘(i) the widely available market price for the drug or biological (if any); or ‘‘(ii) 103 percent of the average manufacturer price (as determined under section 1927(k)(1)) for the drug or biological. ‘‘(4) CIVIL MONEY PENALTY.— ‘‘(A) IN GENERAL.—If the Secretary determines that a manufacturer has made a misrepresentation in the
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