PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2245
‘‘(2) the identification of units (and package size) under subsection (b)(2); ‘‘(3) the method to allocate rebates, chargebacks, and other price concessions to a quarter if specified by the Secretary; ‘‘(4) the manufacturer’s average sales price when it is used for the determination of a payment amount under this section; and ‘‘(5) the disclosure of the average manufacturer price by reason of an adjustment under subsection (d)(3)(C) or (e).’’. (2) REPORT ON SALES TO PHARMACY BENEFIT MANAGERS.— (A) STUDY.—The Secretary shall conduct a study on sales of drugs and biologicals to large volume purchasers, such as pharmacy benefit managers and health maintenance organizations, for purposes of determining whether the price at which such drugs and biologicals are sold to such purchasers does not represent the price such drugs and biologicals are made available for purchase to prudent physicians. (B) REPORT.—Not later than January 1, 2006, the Secretary shall submit to Congress a report on the study conducted under paragraph (1), and shall include recommendations on whether such sales to large volume purchasers should be excluded from the computation of a manufacturer’s average sales price under section 1847A of the Social Security Act, as added by paragraph (1). (3) INSPECTOR GENERAL REPORT ON ADEQUACY OF REIMBURSEMENT RATE UNDER AVERAGE SALES PRICE METHODOLOGY.— (A) STUDY.—The Inspector General of the Department of Health and Human Services shall conduct a study on the ability of physician practices in the specialties of hematology, hematology/oncology, and medical oncology of different sizes, especially particularly large practices, to obtain drugs and biologicals for the treatment of cancer patients at 106 percent of the average sales price for the drugs and biologicals. In conducting the study, the Inspector General shall conduct an audit of a representative sample of such practices to determine the adequacy of reimbursement under section 1847A of the Social Security Act, as added by paragraph (1). (B) REPORT.—Not later October 1, 2005, the Inspector General shall submit to Congress a report on the study conducted under subparagraph (A), and shall include recommendations on the adequacy of reimbursement for such drugs and biologicals under such section 1847A. (d) PAYMENT BASED ON COMPETITION.— (1) IN GENERAL.—Title XVIII is amended by inserting after section 1847A, as added by subsection (c), the following new section: ‘‘COMPETITIVE
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42 USC 1395w–3a note.
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ACQUISITION OF OUTPATIENT DRUGS AND BIOLOGICALS
‘‘SEC. 1847B. (a) IMPLEMENTATION OF COMPETITIVE ACQUISITION.— ‘‘(1) IMPLEMENTATION OF PROGRAM.— ‘‘(A) IN GENERAL.—The Secretary shall establish and implement a competitive acquisition program under which—
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