Page:United States Statutes at Large Volume 106 Part 6.djvu/405

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PUBLIC LAW 102-585—NOV. 4, 1992 106 STAT. 4963 "(i) ENTITIES.— Each covered entity shall inform the single State agency under section 1902(a)(5) when it is seeking reimbursement from the State plan for medical assistance described in section 1905(a)(12) with respect to a unit of any covered outpatient drug which is subject to an agreement under section 340B(a) of such Act. "(ii) STATE AGENCY.— Each such single State agency shall provide a means by which a covered entity shall mdicatci on any drug reimbursement claims form (or format, where electronic claims management is used) that a unit of the drug that is the subject of the form is subject to an agreement under section 340B of such Act, and not submit to any manufacturer a cl€dm for a rebate payment under subsection (b) with respect to such a drug. "(D) EFFECT OF SUBSEQUENT AMENDMENTS. —In determining whether an agreement under subparagraph (A) meets the requirements of section 340B of the Public Health Service Act, the Secretary shall not take into account any amendments to such section that are enacted after the enactment of title VI of the Veterans Health Care Act of 1992. "(E) DETERMINATION OF COMPLIANCE.— A manufacturer is deemed to meet the requirements of this paragraph if the manufacturer establishes to the satisfaction of the Secretary that the manvifacturer would comply (and has offered to comply) with the provisions of section 340B of the Public Health Service Act (as in effect inmiediately after the enactment of this paragraph) and would have entered into an agreement under such section (as such section was in effect at such time), but for a legislative change in such section after the date of the enactment of this paragraph. " (6) REQUIREMENTS RELATING TO MASTER AGREEMENTS FOR DRUGS PROCURED BY DEPARTMENT OF VETERANS AFFAIRS AND CERTAIN OTHER FEDERAL AGENCIES. — "(A) IN GENERAL.—A manufacturer meets the requirements of this paragraph if the manufacturer complies with the provisions of section 8126 of title 38, United States Code, including the requirement of entering into a master agreement wiui the Secretary of Veterans Affairs under such section.

    • (B) EFFECT OP SUBSEQUENT AMENDMENTS.—In determining whether a master agreement described in subparagraph (A) meeti} the requirements of section 8126 of title

38, United States Code, the Secretary shall not take into account any amendments to such section that are enacted after the enactment of title VI of the Veterans Health Care Act of 1992. "(C) DETERMINATION OF COMPLIANCE.— A manufacturer is deemed to meet the requiremente of this paragraph if the manufactiirer estoblishes to the satisfaction of the Secretary that the manufacturer would comply (and has offered to comply) with the provisions of section 8126 of title 38, United States Code (as in effect immediately after the enactment of this paragraph) and would have entered