S.Amdt. 2990

1. Adds SEC. __. EXPANDING ACCESS TO VACCINES wherever appropriate

   Adds a section

   Inserted: SEC. __. EXPANDING ACCESS TO VACCINES.

   Inserted: (a) In General.--Paragraph (10) of section 1861(s) of the Social Security Act (42 U.S.C. 1395w(s)) is amended to read as follows:

   Inserted: "(10) federally approved and recommended vaccines (as defined in subsection (hhh)) and their respective administration;".

   Inserted: (b) Federally Approved and Recommended Vaccines Defined.--Section 1861 of such Act is amended by adding at the end the following new subsection:

   Inserted: "Federally Approved and Recommended Vaccines

   Inserted: "(hhh) The term 'federally approved and recommended vaccine' means a vaccine that--

   Inserted: "(1) is licensed under section 351 of the Public Health Service Act, approved under the Federal Food, Drug, and Cosmetic Act, or authorized for emergency use under section 564 of the Federal, Food, Drug, and Cosmetic Act; and

   Inserted: "(2) is recommended by the Director of the Centers for Disease Control and Prevention.".

   Inserted: (c) Conforming Amendments.--

   Inserted: (1) Section 1833 of such Act (42 U.S.C. 1395l) is amended, in each of subsections (a)(1)(B), (a)(2)(G), and (a)(3)(A), by striking "1861(s)(10)(A)" and inserting "1861(s)(10)" each place it appears.

   Inserted: (2) Section 1842(o)(1)(A)(iv) of such Act (42 U.S.C. 1395u(o)(1)(A)(iv)) is amended--

   Inserted: (A) by striking "subparagraph (A) or (B) of"; and

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   Inserted: (B) by inserting before the period the following: "and before January 1, 2011, and influenza vaccines furnished on or after January 1, 2011".

   Inserted: (3) Section 1847A(c)(6) of such Act (42 U.S.C. 1395w-3a(c)(6)) is amended--

   Inserted: (A) in subparagraph (D)(i), by inserting ", including a vaccine furnished on or after January 1, 2010"; and

   Inserted: (B) by the following new paragraph:

   Inserted: "(H) Implementation.--Chapter 35 of title 44, United States Code shall not apply to manufacturer provision of information pursuant to section 1927(b)(3)(A)(iii) or subsection (f)(2) for purposes of implementation of this section.".

   Inserted: (4) Section 1860D-2(e)(1) of such Act (42 U.S.C. 1395w-102(e)(1)) is amended by striking "such term includes a vaccine" and all that follows through "its administration) and".

   Inserted: (5) Section 1861(ww)(2)(A) of such Act (42 U.S.C. 1395x(ww)(2)(A))) is amended by striking "Pneumococcal, influenza, and hepatitis B vaccine and administration" and inserting "federally approved or authorized vaccines (as defined in subsection (hhh)) and their respective administration".

   Inserted: (6) Section 1927(b)(3)(A)(iii) of such Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is amended, in the matter following subclause (III), by inserting "(A)(iv) (including influenza vaccines furnished on or after January 1, 2011)," after "described in subparagraph".

   Inserted: (7) Section 1847A(f) of such Act (42 U.S.C. 1395w-3a(f)) is amended--

   Inserted: (A) by striking "For" and inserting "(1) In general.--For";

   Inserted: (B) by indenting paragraph (1), as redesignated in subparagraph (A), 2 ems to the left; and--

   Inserted: (C) by adding at the end the following new paragraph:

   Inserted: "(2) Treatment of certain manufacturers.--In the case of a manufacturer of a drug or biological described in subparagraphs (A)(iv), (C), (D), (E), or (G) of section 1842(o)(1) that does not have a rebate agreement under section 1927(a), no payment may be made under this part for such drug or biological if such manufacturer does not submit the information described in section 1927(b)(3)(A)(iii) in the same manner as if the manufacturer had such a rebate agreement in effect. Subparagraphs (C) and (D) of section 1927(b)(3) shall apply to information reported pursuant to the previous sentence in the same manner as such subparagraphs apply with respect to information reported pursuant to such section.".".

   Inserted: (d) Effective Dates.--The amendments made--

   Inserted: (1) by this section (other than by subsection (c)(6)) shall apply to vaccines administered on or after January 1, 2011; and

   Inserted: (2) by subsection (c)(6) shall apply to calendar quarters beginning on or after January 1, 2010.

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   Original wording

   At the appropriate place, insert the following:

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As printed