[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3560 Enrolled Bill (ENR)]

        S.3560

                       One Hundred Tenth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Thursday,
            the third day of January, two thousand and eight


                                 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress 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) 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 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
                ``(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) 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) 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 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) 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
                    ``(II) the amount of funds expended for each such 
                conference that were for transportation and for travel 
                expenses.''.

        (2) 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''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.