Page:United States Statutes at Large Volume 104 Part 2.djvu/557

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PUBLIC LAW 101-508—NOV. 5, 1990 104 STAT. 1388-149 "(iiXD The Secretary may exclude drugs approved by the Food and Drug Administration on or after October 1, 1990, from the calculation of weighted average manufacturer price if inclus ^^ manufacturer demonstrates through a petition, in a form and manner prescribed by the Secretary, undue hardship on such manufacturer as a result of the inclusion of such drug in such calculation).^® "(II) The Secretary may promulgate guidelines to restrict the conditions under which the Secretary may consider such petitions. "(C) For each of 8 calendar quarters beginning after December 31, 1991, the Secretary shall compare the aggregate amount of the rebates under subparagraph (A)(i) to the aggregate amount of rebates under subparagraph (A)(ii). Based on any such comparison, the Secretary may propose and utilize an alternative formula for the purpose of calculating an aggregate rebate. "(3) REBATE FOR OTHER DRUGS.—The amount of the rebate to a State for a calendar quarter (or other period specified by the Secretary) with respect to covered outpatient drugs (other than single source drugs and innovator multiple source drugs) shall be equal to the product of^ "(A) the applicable percentage (as described in paragraph (4) 3'^ of the average manufacturer price for each dosage form and strength of such drugs (after deducting customary prompt payment discounts) for the quarter (or other period), and "(B) the number of units of such form and dosage dispensed under the plan under this title in the quarter (or other period) reported by the State under subsection (b)(2). "(4) For the purposes of paragraph (3), the applicable percent- . age is— "(A) with respect to calendar quarters beginning after December 31, 1990, and ending before January 1, 1994, 10 percent; and "(B) with respect to calendar quarters beginning on or after December 31, 1993,11 percent. '(d) LIMITATIONS ON COVERAGE OF DRUGS.— "(1) PERMISSIBLE RESTRICTIONS.— (A) Except as provided in paragraph (6), a State may subject to prior authorization any covered outpatient drug. Any such prior authorization program shall comply with the requirements of paragraph (5). "(B) A State may exclude or otherwise restrict coverage of a covered outpatient drug if— "(i) the prescribed use is not for a medically accepted indication (as defined in (k)(6)); "(ii) the drug is contained in the list referred to in paragraph (2); or "(iii) the drug is subject to such restrictions pursuant to an agreement between a manufacturer and a State authorized by the Secretary under subsection (a)(1) or in effect pursuant to subsection (a)(4). "(2) LIST OF DRUGS SUBJECT TO RESTRICTION. — The following drugs or classes of drugs, or their medical uses, may be excluded from coverage or otherwise restricted: "(A) Agents when used for anorexia or weight gain. "(B) Agents when used to promote fertility. '» So in original. The "inclus" probably should be "the" '• So in original. Probably should be "calculation.". '^ So in original. Probably should be "(4))".