Page:United States Statutes at Large Volume 102 Part 1.djvu/741

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PUBLIC LAW 100-360—JULY 1, 1988

102 STAT. 703

"(iiiXD which is described in section 107(c)(3) of the Drug Amendments of 1962 and for which the Secretary has determined there is a compelling justification for its medical need, or is identical, similar, or related (within the meaning of section 310.60aXl) of title 21 of the Code of Federal R^ulations) to such a drug, and (11) for which the Secretary has not issued a notice of an opportunity for a hearing under section 505(e) of the Federal Food, Drug, and Cosmetic Act on a proposed order of the Secretary to withdraw approval of an application for such drug under such section because the Secretary has determined that the drug is less than effective for all conditions of use prescribed, recommended, or suggested in its labeling; "(B) a biol(^cal product which— "(i) may only be dispensed upon prescription, "(ii) is licensed under section 351 of the Public Health Service Act, and "(iii) is produced at an establishment licensed under such section to produce such product; and "(C) insulin certified under section 506 of the Federal Food, Drug, and Cosmetic Act. "(3)(A) The term 'covered outpatient drug* does not include any drug, biol(^cal product, or insulin provided as, as part of, or as incident to, any of the following (and for which payment may be included under this title): "(i) Inpatient hospital services (described in subsection (b)(2)). "(ii) Extended care services (described in subsection (h)(5)). "(iii) Physicians' services under subparagraph (A) or (B) of subsection (s)(2). "(iv) Dialysis supplies under subsection (s)(2)(F). "(v) Antigens under subsection (s)(2)(G). "(vi) Blood clotting factors for hemophiliacs under subsection (s)(2)(I). "(vii) Services of a physician assistant under subsection (s)(2)(K)(ii). "(viii) Pneumococcal, hepatitis B, or influenza vaccines under subsection (s)(10). "(ix) Rural health clinic services (under subsection (aaXD). "(x) Comprehensive outpatient rehabilitation facility services (under subsection (ccXD). "(xi) Hospice care (as defined in subsection (ddXD). "(xii) Certified nurse-midwife service (as defined in subsection (ggXD). "(xiii) A covered surgical procedure in an ambulatory surgical center (under section 1832(a)(2)(F)(i)). "(B) With respect to covered outpatient drugs dispensed in 1990, the term 'covered outpatient drug* is limited— "(i) to drugs described in paragraph (2)(A) used in immunosuppressive therapy, and (ii) to covered home IV drugs (as defined in paragraph (4)). "(C) The term 'covered outpatient drug* does not include a drug that is intravenously administered in a home setting unless it is a covered home IV drug. "(4)(A) The term 'covered home IV drug* means a covered outpatient drug dispensed to an individual that—

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