Page:United States Statutes at Large Volume 113 Part 2.djvu/855

 PUBLIC LAW 106-113—APPENDIX F 113 STAT. 1501A-337 "(B) AMOUNT OF ADJUSTMENT. — The amount of the additional payment under subparagraph (A) shall be determined by the Secretary and shall approximate the marginal cost of care beyond the applicable cutoff point under such subparagraph. "(C) LIMIT ON AGGREGATE OUTLIER ADJUSTMENTS.— "(i) IN GENERAL. —The total of the additional pay- ments made under this paragraph for covered OPD services furnished in a year (as estimated by the Secretary before the beginning of the year) may not exceed the applicable percentage (specified in clause (ii)) of the total program pa5nnents estimated to be made under this subsection for all covered OPD services furnished in that year. If this paragraph is first applied to less than a full year, the previous sentence shall apply only to the portion of such year. " (ii) APPLICABLE PERCENTAGE. —For purposes of clause (i), the term 'applicable percentage' means a percentage specified by the Secretary up to (but not to exceed)— "(I) for a year (or portion of a year) before 2004, 2.5 percent; and "(II) for 2004 and thereafter, 3.0 percent. "(D) TRANSITIONAL AUTHORITY.— In applying subparagraph (A) for covered OPD services furnished before January 1, 2002, the Secretary may— "(i) apply such subparagraph to a bill for such services related to an outpatient encounter (rather than for a specific service or group of services) using OPD fee schedule amounts and transitional passthrough payments covered under the bill; and "(ii) use an appropriate cost-to-charge ratio for the hospital involved (as determined by the Secretary), rather than for specific departments within the hospital.", (b) TRANSITIONAL PASS-THROUGH FOR AIDDITIONAL COSTS OF INNOVATIVE MEDICAL DEVICES, DRUGS, AND BIOLOGICALS.— Such section is further amended by inserting after paragraph (5) the following new paragraph: " (6) TRANSITIONAL PASS-THROUGH FOR ADDITIONAL COSTS OF INNOVATIVE MEDICAL DEVICES, DRUGS, AND BIOLOGICALS. — "(A) IN GENERAL.— The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services): "(i) CURRENT ORPHAN DRUGS.—^A drug or biological that is used for a rare disease or condition with respect to which the drug or biological has been designated as an orphan drug under section 526 of the Federal Food, Drug and Cosmetic Act if pa5niient for the drug or biological as an outpatient hospital service under this part was being made on the first date that the system under this subsection is implemented. "(ii) CURRENT CANCER THERAPY DRUGS AND BIOLOGICALS AND BRACHYTHERAPY. —A drug or biological that is used in cancer therapy, including (but not limited to) a chemotherapeutic agent, an

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