applicable percentage
(ii)For purposes of clause (i), the term “applicable percentage” means— (I)for a year (or portion of a year) before 2004, 2.5 percent; and (II)for 2004 and thereafter, a percentage specified by the Secretary up to (but not to exceed) 2.0 percent. (iii)If the Secretary estimates before the beginning of a year that the amount of the additional payments under this paragraph for the year (or portion thereof) as determined under clause (i) without regard to this clause will exceed the limit established under such clause, the Secretary shall reduce pro rata the amount of each of the additional payments under this paragraph for that year (or portion thereof) in order to ensure that the aggregate additional payments under this paragraph (as so estimated) do not exceed such limit. (F) (i)The Secretary may not publish regulations that apply a functional equivalence standard to a drug or biological under this paragraph. (ii)Clause (i) shall apply to the application of a functional equivalence standard to a drug or biological on or after, unless— (I)such application was being made to such drug or biological prior to; and (II)the Secretary applies such standard to such drug or biological only for the purpose of determining eligibility of such drug or biological for additional payments under this paragraph and not for the purpose of any other payments under this subchapter. (iii)Nothing in this subparagraph shall be construed to effect the Secretary’s authority to deem a particular drug to be identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs. (G)In the case of a drug or biological whose period of pass-through status under this paragraph ended on, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning, such pass-through status shall be extended for a 2-year period beginning on. (H)In the case of a drug or biological whose period of pass-through status under this paragraph ended on, and for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) furnished beginning, the payment amount for such drug or biological under this subsection that is furnished during the period beginning on, and ending on, shall be the greater of— (i)the payment amount that would otherwise apply under subparagraph (D)(i) for such drug or biological during such period; or (ii)the payment amount that applied under such subparagraph (D)(i) for such drug or biological on. (I)In the case of a drug or biological whose period of pass-through status under this paragraph ended on, and for which payment under this subsection was packaged into a payment amount for a covered OPD service (or group of services) beginning, the following rules shall apply with respect to payment amounts under this subsection for covered a OPD service (or group of services) furnished during the period beginning on, and ending on: (i)The Secretary shall remove the packaged costs of such drug or biological (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged. (ii)The Secretary shall not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under clause (i).