Table Of Contents of the INDEX

 

Biological
Sec 1310. -- Expanding Access To Vaccines.
(2) TREATMENT OF CERTAIN MANUFACTURERS.
DIVISION B TITLE III SEC 1310. (c) (7) (C) Quoted: (2)
Automated Concept:

BIOLOGICAL described in subparagraphs ;   Case of manufacturer of drug or

Index of Sec 1310. ...

Drug
Sec 1310. -- Expanding Access To Vaccines.
(2) TREATMENT OF CERTAIN MANUFACTURERS.
DIVISION B TITLE III SEC 1310. (c) (7) (C) Quoted: (2)
Automated Concept:

DRUG or biological if manufacturer not submitting information described in section 1927(b)(3)(a)( iii in same manner ;   No payment to be made under part for

Index of Sec 1310. ...

Drug: manufacturer of
Sec 1310. -- Expanding Access To Vaccines.
(2) TREATMENT OF CERTAIN MANUFACTURERS.
DIVISION B TITLE III SEC 1310. (c) (7) (C) Quoted: (2)
Automated Concept:

BIOLOGICAL described in subparagraphs ;   Case of manufacturer of drug or

Index of Sec 1310. ...

Implementation of section: purposes of
Sec 1310. -- Expanding Access To Vaccines.
(H) IMPLEMENTATION.
DIVISION B TITLE III SEC 1310. (c) (3) (B) Quoted: (H)
Automated Concept:

IMPLEMENTATION of section ;   Chapter 35 of title 44, United States Code not applying to manufacturer provision of information pursuant to section 1927(b)(3)(a)( iii or subsection for purposes of

Index of Sec 1310. ...

Influenza and hepatitis B vaccine and administration
Sec 1310. -- Expanding Access To Vaccines.
(c) CONFORMING AMENDMENTS. - paragraph (5)
DIVISION B TITLE III SEC 1310. (c) (5)
Automated Concept:

HEPATITIS B vaccine and administration and inserting federally approved or authorized vaccines and respective administration ;   Influenza and

Index of Sec 1310. ...

Information
Sec 1310. -- Expanding Access To Vaccines.
(2) TREATMENT OF CERTAIN MANUFACTURERS.
DIVISION B TITLE III SEC 1310. (c) (7) (C) Quoted: (2)
Automated Concept:

INFORMATION described in section 1927(b)(3)(a)( iii in same manner ;   No payment to be made under part for drug or biological if manufacturer not submitting

Index of Sec 1310. ...

Information: manufacturer provision of
Sec 1310. -- Expanding Access To Vaccines.
(H) IMPLEMENTATION.
DIVISION B TITLE III SEC 1310. (c) (3) (B) Quoted: (H)
Automated Concept:

IMPLEMENTATION of section ;   Chapter 35 of title 44, United States Code not applying to manufacturer provision of information pursuant to section 1927(b)(3)(a)( iii or subsection for purposes of

Index of Sec 1310. ...

Payment: no
Sec 1310. -- Expanding Access To Vaccines.
(2) TREATMENT OF CERTAIN MANUFACTURERS.
DIVISION B TITLE III SEC 1310. (c) (7) (C) Quoted: (2)
Automated Concept:

DRUG or biological if manufacturer not submitting information described in section 1927(b)(3)(a)( iii in same manner ;   No payment to be made under part for

Index of Sec 1310. ...

Pursuant
Sec 1310. -- Expanding Access To Vaccines.
(H) IMPLEMENTATION.
DIVISION B TITLE III SEC 1310. (c) (3) (B) Quoted: (H)
Automated Concept:

IMPLEMENTATION of section ;   Chapter 35 of title 44, United States Code not applying to manufacturer provision of information pursuant to section 1927(b)(3)(a)( iii or subsection for purposes of

Index of Sec 1310. ...
(2) TREATMENT OF CERTAIN MANUFACTURERS.
DIVISION B TITLE III SEC 1310. (c) (7) (C) Quoted: (2)
Automated Concept:

INFORMATION reported pursuant to section ;   Subparagraphs and section 1927(b)(3) applying to information reported pursuant to previous sentence in same manner as subparagraphs applying with respect to

Index of Sec 1310. ...

Title 44: chapter 35 of
Sec 1310. -- Expanding Access To Vaccines.
(H) IMPLEMENTATION.
DIVISION B TITLE III SEC 1310. (c) (3) (B) Quoted: (H)
Automated Concept:

IMPLEMENTATION of section ;   Chapter 35 of title 44, United States Code not applying to manufacturer provision of information pursuant to section 1927(b)(3)(a)( iii or subsection for purposes of

Index of Sec 1310. ...

Vaccine
Sec 1310. -- Expanding Access To Vaccines.
(lll) FEDERALLY RECOMMENDED VACCINES.
DIVISION B TITLE III SEC 1310. (b) Quoted: (lll)
Automated Concept:

VACCINE meaning vaccine ;   Term federally approved and recommended

Index of Sec 1310. ...
(c) CONFORMING AMENDMENTS. - paragraph (4)
DIVISION B TITLE III SEC 1310. (c) (4)
Automated Concept:

VACCINE and following through administration ;   Section 1860d-2(e)(1) of Act 42 USC 1395w-102(e)(1) amended by striking term including

Index of Sec 1310. ...


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111th CONGRESS
1st Session


    To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.


IN THE HOUSE OF REPRESENTATIVES

July 14, 2009

    Mr. Dingell (for himself, Mr. Rangel, Mr. Waxman, Mr. George Miller of California, Mr. Stark, Mr. Pallone, and Mr. Andrews) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, and the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned


A BILL

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SEC. 1310. Expanding access to vaccines.

(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:

“(10) federally approved and recommended vaccines (as defined in subsection (lll)) and their respective administration;”.

(b) Federally approved and recommended vaccines defined.—Section 1861 of such Act is further amended by adding at the end the following new subsection:

“Federally Approved And Recommended Vaccines

“(lll) The term ‘federally approved and recommended vaccine’ means a vaccine that—

“(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

“(2) is recommended by the Director of the Centers for Disease Control and Prevention.”.

(c) Conforming amendments.—

(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.

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

(A) by striking “subparagraph (A) or (B) of”; and

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

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

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

(B) by the following new paragraph:

“(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.”.

(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”.

(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 (lll)) and their respective administration”.

(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”.

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

(A) by striking “For” and inserting “(1) In general.—For”;

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

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

“(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.”.”.

(d) Effective dates.—The amendments made—

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

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


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