102 STAT. 712 Federal Register, publication.
PUBLIC LAW 100-360—JULY 1, 1988 "(iii) EFFESCTIVKNESS OP REGULATORY CHANGES.—If proposed regulations are published under clause (iiXn) in 1992 or 1993, during the last 3 days of September of such year, the Secretary shall pubuish in the Federal Register a final regulation to implement the changes described in such clause. Notwiuistanding any other provision of this part, but subject to subparagraph (E) and unless otherwise provided by law, such cmmges shall become effective on January 1 of the succeeding year and shall apply only during that succeeding year. Such final regulation may not revise the proposed ren^lation in a manner that would result in a greater reduction in outlays than would have been the case under the proposed regulation. "(E) LIMITATION ON CHANGES.—In making r^ulatory changes under subparagraph (D), the Secretary may not— "(i) provide for a formulary (in violation of paragraph (5)(C)); "(ii) change the methodology for determining whether for a year an individual has met the catastrophic drug deductible established under paragraph (l)(A);or "(iii) increase the coinsurance percent under paragraph (2)(C) for a year above the coinsurance percent in effect during the previous year. Clause (ii) shall not be construed as prohibiting the Secretary from increasing the amount of the catastrophic drug deductible under paragraph (I)(A). "(F) MINIMUM CONTINGENCY MARGIN DEFINED.—In this paragraph, the term ^minimum contingency margin' means— "(i) for 1993,50 percent, and "(ii) for 1994,25 percent. Such margin shall be determined as of the close of each calendar year and shall be determined based on the total outlays from the Trust Fund during the year.
- (9) DEFINITIONS.—In this subsection:
"(A) MULTIPLE SOURCE DRUG.—
"(i) IN GENERAL.—The term 'multiple source drug* means, with respect to a payment calculation period, a covered outpatient drug for which there are 2 or more drug products which— "(I) are rated as therapeutically equivalent (under the Food and Drug Administration's most recent publication of 'Approved Drug Products with Therapeutic Equivalence Evaluations'), "(ID except as provided in clause (ii), are pharmaceutically equivalent and bioequivalent, as defined in clause (iii) and as determined by the Food and Drug Administration, and "(HI) are sold or marketed during the period. "(ii) EXCEPTION.—Subclause (II) of clause (i) shall not apply if the Food and Drug Administration changes by r^ulation (after an opportunity for public comment of 90 days) the requirement that, for purposes of the publication described in clause (i)(D, in order for drug products to be rated as therapeutically equivalent
�
