[110th Congress Public Law 379]
[From the U.S. Government Printing Office]


[DOCID: f:publ379.110]

[[Page 122 STAT. 4075]]

Public Law 110-379
110th Congress

                                 An Act


 
  To amend title XIX of the Social Security Act to provide additional 
    funds for the qualifying individual (QI) program, and for other 
             purposes. <<NOTE: Oct. 8, 2008 -  [S. 3560]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: QI Program Supplemental 
Funding Act of 2008. 42 USC 1305 note.>> assembled,
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``QI Program Supplemental Funding Act 
of 2008''.
SEC. 2. FUNDING FOR THE QUALIFYING INDIVIDUAL (QI) PROGRAM.

    Section 1933(g)(2) of the Social Security Act (42 U.S.C. 1396u-
3(g)(2)), as amended by section 111(b) of the Medicare Improvements for 
Patients and Providers Act of 2008 (Public Law 110-275), is amended--
            (1) in subparagraph (I), by striking ``$300,000,000'' and 
        inserting ``$315,000,000''; and
            (2) in subparagraph (J), by striking ``$100,000,000'' and 
        inserting ``$130,000,000''.
SEC. 3. MANDATORY USE OF STATE PUBLIC ASSISTANCE REPORTING 
                    INFORMATION SYSTEM (PARIS) PROJECT.

    (a) In General.--Section 1903(r) of the Social Security Act (42 
U.S.C. 1396b(r)) is amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A), by inserting ``, in addition to meeting the requirements of 
        paragraph (3),'' after ``a State must''; and
            (2) by adding at the end the following new paragraph:

    ``(3) In order to meet the requirements of this paragraph, a State 
must have in operation an eligibility determination system which 
provides for data matching through the Public Assistance Reporting 
Information System (PARIS) facilitated by the Secretary (or any 
successor system), including matching with medical assistance programs 
operated by other States.''.
    (b) <<NOTE: 42 USC 1396b note.>> Effective Date.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by subsection (a) take effect on October 1, 
        2009.
            (2) Extension of effective date for state law amendment.--In 
        the case of a State plan under title XIX of the Social Security 
        Act (42 U.S.C. 1396 et seq.) which the Secretary of Health and 
        Human Services determines requires State legislation in order 
        for the plan to meet the additional requirements imposed by the 
        amendments made by subsection (a), the State

[[Page 122 STAT. 4076]]

        plan shall not be regarded as failing to comply with the 
        requirements of such title solely on the basis of its failure to 
        meet these additional requirements before the first day of the 
        first calendar quarter beginning after the close of the first 
        regular session of the State legislature that begins after the 
        date of enactment of this Act. For purposes of the previous 
        sentence, in the case of a State that has a 2-year legislative 
        session, each year of the session is considered to be a separate 
        regular session of the State legislature.
SEC. 4. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, CERTAIN 
                    ANTIBIOTICS.

    (a) In General.--Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the following:
    ``(v) Antibiotic Drugs Submitted Before November 21, 1997.--
            ``(1) Antibiotic drugs approved before november 21, 1997.--
                    ``(A) In general.--Notwithstanding any provision of 
                the Food and Drug Administration Modernization Act of 
                1997 or any other provision of law, a sponsor of a drug 
                that is the subject of an application described in 
                subparagraph (B)(i) shall be eligible for, with respect 
                to the drug, the 3-year exclusivity period referred to 
                under clauses (iii) and (iv) of subsection (c)(3)(E) and 
                under clauses (iii) and (iv) of subsection (j)(5)(F), 
                subject to the requirements of such clauses, as 
                applicable.
                    ``(B) Application; antibiotic drug described.--
                          ``(i) Application.--An application described 
                      in this clause is an application for marketing 
                      submitted under this section after the date of the 
                      enactment of this subsection in which the drug 
                      that is the subject of the application contains an 
                      antibiotic drug described in clause (ii).
                          ``(ii) Antibiotic drug.--An antibiotic drug 
                      described in this clause is an antibiotic drug 
                      that was the subject of an application approved by 
                      the Secretary under section 507 of this Act (as in 
                      effect before November 21, 1997).
            ``(2) Antibiotic drugs submitted before november 21, 1997, 
        but not approved.--
                    ``(A) In general.--Notwithstanding any provision of 
                the Food and Drug Administration Modernization Act of 
                1997 or any other provision of law, a sponsor of a drug 
                that is the subject of an application described in 
                subparagraph (B)(i) may elect to be eligible for, with 
                respect to the drug--
                          ``(i)(I) the 3-year exclusivity period 
                      referred to under clauses (iii) and (iv) of 
                      subsection (c)(3)(E) and under clauses (iii) and 
                      (iv) of subsection (j)(5)(F), subject to the 
                      requirements of such clauses, as applicable; and
                          ``(II) the 5-year exclusivity period referred 
                      to under clause (ii) of subsection (c)(3)(E) and 
                      under clause (ii) of subsection (j)(5)(F), subject 
                      to the requirements of such clauses, as 
                      applicable; or

[[Page 122 STAT. 4077]]

                          ``(ii) a patent term extension under section 
                      156 of title 35, United States Code, subject to 
                      the requirements of such section.
                    ``(B) Application; antibiotic drug described.--
                          ``(i) Application.--An application described 
                      in this clause is an application for marketing 
                      submitted under this section after the date of the 
                      enactment of this subsection in which the drug 
                      that is the subject of the application contains an 
                      antibiotic drug described in clause (ii).
                          ``(ii) Antibiotic drug.--An antibiotic drug 
                      described in this clause is an antibiotic drug 
                      that was the subject of 1 or more applications 
                      received by the Secretary under section 507 of 
                      this Act (as in effect before November 21, 1997), 
                      none of which was approved by the Secretary under 
                      such section.
            ``(3) Limitations.--
                    ``(A) Exclusivities and extensions.--Paragraphs 
                (1)(A) and (2)(A) shall not be construed to entitle a 
                drug that is the subject of an approved application 
                described in subparagraphs (1)(B)(i) or (2)(B)(i), as 
                applicable, to any market exclusivities or patent 
                extensions other than those exclusivities or extensions 
                described in paragraph (1)(A) or (2)(A).
                    ``(B) Conditions of use.--Paragraphs (1)(A) and 
                (2)(A)(i) shall not apply to any condition of use for 
                which the drug referred to in subparagraph (1)(B)(i) or 
                (2)(B)(i), as applicable, was approved before the date 
                of the enactment of this subsection.
            ``(4) Application of certain provisions.--Notwithstanding 
        section 125, or any other provision, of the Food and Drug 
        Administration Modernization Act of 1997, or any other provision 
        of law, and subject to the limitations in paragraphs (1), (2), 
        and (3), the provisions of the Drug Price Competition and Patent 
        Term Restoration Act of 1984 shall apply to any drug subject to 
        paragraph (1) or any drug with respect to which an election is 
        made under paragraph (2)(A).''.

    (b) <<NOTE: Deadline. 21 USC 355 note.>> Transitional Rules.--
            (1) With respect to a patent issued on or before the date of 
        the enactment of this Act, any patent information required to be 
        filed with the Secretary of Health and Human Services under 
        subsection (b)(1) or (c)(2) of section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355) to be listed on a drug to 
        which subsection (v)(1) of such section 505 (as added by this 
        section) applies shall be filed with the Secretary not later 
        than 60 days after the date of the enactment of this Act.
            (2) <<NOTE: Publication.>> With respect to any patent 
        information referred to in paragraph (1) of this subsection that 
        is filed with the Secretary within the 60-day period after the 
        date of the enactment of this Act, the Secretary shall publish 
        such information in the electronic version of the list referred 
        to at section 505(j)(7) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(j)(7)) as soon as it is received, but in no 
        event later than the date that is 90 days after the enactment of 
        this Act.
            (3) With respect to any patent information referred to in 
        paragraph (1) that is filed with the Secretary within the

[[Page 122 STAT. 4078]]

        60-day period after the date of enactment of this Act, each 
        applicant that, not later than 120 days after the date of the 
        enactment of this Act, amends an application that is, on or 
        before the date of the enactment of this Act, a substantially 
        complete application (as defined in paragraph (5)(B)(iv) of 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j))) to contain a certification described in 
        paragraph (2)(A)(vii)(IV) of such section 505(j) with respect to 
        that patent shall be deemed to be a first applicant (as defined 
        in paragraph (5)(B)(iv) of such section 505(j)).
SEC. 5. CLARIFICATION OF AUTHORITY FOR USE OF MEDICAID INTEGRITY 
                    PROGRAM FUNDS.

    (a) Clarification of Authority for Use of Funds.--
            (1) In general.--Section 1936 of the Social Security Act (42 
        U.S.C. 1396u-6) is amended--
                    (A) in subsection (b)(4), by striking ``Education 
                of'' and inserting ``Education or training, including at 
                such national, State, or regional conferences as the 
                Secretary may establish, of State or local officers, 
                employees, or independent contractors responsible for 
                the administration or the supervision of the 
                administration of the State plan under this title,''; 
                and
                    (B) in subsection (e), by striking paragraph (2) and 
                inserting the following:
            ``(2) Availability; authority for use of funds.--
                    ``(A) Availability.--Amounts appropriated pursuant 
                to paragraph (1) shall remain available until expended.
                    ``(B) Authority for use of funds for transportation 
                and travel expenses for attendees at education, 
                training, or consultative activities.--
                          ``(i) In general.--The Secretary may use 
                      amounts appropriated pursuant to paragraph (1) to 
                      pay for transportation and the travel expenses, 
                      including per diem in lieu of subsistence, at 
                      rates authorized for employees of agencies under 
                      subchapter I of chapter 57 of title 5, United 
                      States Code, while away from their homes or 
                      regular places of business, of individuals 
                      described in subsection (b)(4) who attend 
                      education, training, or consultative activities 
                      conducted under the authority of that 
                      subsection.''.
            (2) <<NOTE: 42 USC 1396u-6 note.>> Effective date.--The 
        amendments made by paragraph (1) shall take effect as if 
        included in the enactment of section 1936 of the Social Security 
        Act, as added by section 6034(a) of the Deficit Reduction Act of 
        2005 (Public Law 109-171).

    (b) Public Disclosure.--
            (1) In general.--Section 1936(e)(2)(B) of such Act (42 
        U.S.C. 1396u-6(e)(2)(B)), as added by subsection (a) of this 
        section, is amended by adding at the end the following:
                          ``(ii) Public disclosure.--The Secretary shall 
                      make available on a website of the Centers for 
                      Medicare & Medicaid Services that is accessible to 
                      the public--
                                    ``(I) the total amount of funds 
                                expended for each conference conducted 
                                under the authority of subsection 
                                (b)(4); and

[[Page 122 STAT. 4079]]

                                    ``(II) the amount of funds expended 
                                for each such conference that were for 
                                transportation and for travel 
                                expenses.''.
            (2) <<NOTE: 42 USC 1396u-6 note.>> Effective date.--The 
        amendment made by paragraph (1) shall apply to conferences 
        conducted under the authority of section 1936(b)(4) of the 
        Social Security Act (42 U.S.C. 1396u-6(b)(4)) after the date of 
        enactment of this Act.
SEC. 6. FUNDING FOR THE MEDICARE IMPROVEMENT FUND.

    Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)) is amended by striking ``$2,220,000,000'' and inserting 
``$2,290,000,000''.

    Approved October 8, 2008.

LEGISLATIVE HISTORY--S. 3560:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 154 (2008):
            Sept. 25, considered and passed Senate.
            Sept. 27, considered and passed House.

                                  <all>