102 STAT. 702
PUBLIC LAW 100-360—JULY 1, 1988 (b)
LIMITATION
ON
CHARGES
WHEN
CATASTROPHIC
LIMIT
REACHED.—Section 1866(a)(2)(A) (42 U.S.C. 1395cc(a)(2)(A)) is amended by adding at the end the following new sentence: "A provider of services may not impose a charge under the first sentence of this subparagraph for services for which payment is made to the provider pursuant to section 1833(c) (relating to catastrophic benefits).". (c) NoncE FOR BENEFICIARIES REACHING CATASTROPHIC LIMIT.— Section 1842(b)(3) (42 U.S.C. 1395u(b)(3)) is amended— (1) by striking "and" at the end of subparagraph (G), (2) by insert^ig "and" at the end of subparagraph (H), and (3) by inserting after subparagraph (H) the following new subparagraph: "(I) will provide each individual, who is determined to have incurred (or has had paid on the individual's behalf) suifficient outK>f-pocket part B cost sharing in a calend^u* year to qualify for payment for additional incuired expenses to be made pursuant to section 1833(c), with a notice that states that the individual has reached the part B catastrophic limit on out-of-pocket cost sharing for the year;". (d) CONFORMING AM^^IMENT.—The second sentence of section 1866(a)(2)(A) (42 U.S.C. 1395cc(a)(2)(A)) is amended by striking "1833(c)" and inserting "1833(d)(l)". SEC. 202. COVERAGE OF CATASTROPHIC EXPENSES FOR PRESCRIPTION DRUGS AND INSULIN. (a) DESCRIPTION OF COVERED OUTPATIENT DRUGS.—Section 1861 (42
U.S.C. 1395x) is amended— (1) by amending subparagraph (J) of subsection (s)(2) to read as follows: "(J) covered outpatient drugs (as defined in subsection (t)); and", and (2) in subsection (t)— (A) by inserting "and paragraph (2)" after "subsection (m)(5)", (B) by inserting "(1)" after "(t)", and (C) by adding at the end the following new paragraphs: "(2) Subject to paragraph (3), the term 'covered outpatient drug* means— "(A) a drug which may be dispensed only upon prescription and— "(i) which is approved for safety and effectiveness as a prescription drug under section 506 or 507 of the Federal Food, Drug, and C!osmetic Act or which is approved under section 505(j) of such Act; "(ii)(1) which was commercially used or sold in the United States before the date of the enactment of the Drug Amendments of 1962 or which is identical, similar, or related (within the meaning of section 310.6(b)(l) of title 21 of the Code of Federal R^ulations) to such a drug, and (II) which has not been the subject of a final determination by the Secretary that it is a 'new drug* (within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act) or an action brought by the Secretary under section 301, 302(a), or 304(a) of such Act to enforce section 502(f) or 505(a) of such Act; or
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