Page:United States Statutes at Large Volume 124.djvu/493

 124 STAT. 467 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(A) with respect to claims for reimbursement sub- mitted electronically, 14 days; and ‘‘(B) with respect to claims for reimbursement sub- mitted otherwise, 30 days. ‘‘(4) DISCOUNTED PRICE.— ‘‘(A) IN GENERAL.—The term ‘discounted price’ means 50 percent of the negotiated price of the applicable drug of a manufacturer. ‘‘(B) CLARIFICATION.—Nothing in this section shall be construed as affecting the responsibility of an applicable beneficiary for payment of a dispensing fee for an applicable drug. ‘‘(C) SPECIAL CASE FOR CERTAIN CLAIMS.—In the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall at or above the initial coverage limit under section 1860D–2(b)(3) and below the annual out-of-pocket threshold specified in sec- tion 1860D–2(b)(4)(B) for the year, the manufacturer of the applicable drug shall provide the discounted price under this section on only the portion of the negotiated price of the applicable drug that falls at or above such initial coverage limit and below such annual out-of-pocket threshold. ‘‘(5) MANUFACTURER.—The term ‘manufacturer’ means any entity which is engaged in the production, preparation, propaga- tion, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chem- ical synthesis. Such term does not include a wholesale dis- tributor of drugs or a retail pharmacy licensed under State law. ‘‘(6) NEGOTIATED PRICE.—The term ‘negotiated price’ has the meaning given such term in section 423.100 of title 42, Code of Federal Regulations (as in effect on the date of enact- ment of this section), except that such negotiated price shall not include any dispensing fee for the applicable drug. ‘‘(7) QUALIFIED RETIREE PRESCRIPTION DRUG PLAN.—The term ‘qualified retiree prescription drug plan’ has the meaning given such term in section 1860D–22(a)(2).’’. (c) INCLUSION IN INCURRED COSTS.— (1) IN GENERAL.—Section 1860D–2(b)(4) of the Social Secu- rity Act (42 U.S.C. 1395w–102(b)(4)) is amended— (A) in subparagraph (C), in the matter preceding clause (i), by striking ‘‘In applying’’ and inserting ‘‘Except as pro- vided in subparagraph (E), in applying’’; and (B) by adding at the end the following new subpara- graph: ‘‘(E) INCLUSION OF COSTS OF APPLICABLE DRUGS UNDER MEDICARE COVERAGE GAP DISCOUNT PROGRAM.—In applying subparagraph (A), incurred costs shall include the nego- tiated price (as defined in paragraph (6) of section 1860D– 14A(g)) of an applicable drug (as defined in paragraph (2) of such section) of a manufacturer that is furnished to an applicable beneficiary (as defined in paragraph (1) of such section) under the Medicare coverage gap discount