[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3560 Referred in House (RFH)]







110th CONGRESS
  2d Session
                                S. 3560


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 25, 2008

            Referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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''.

            Passed the Senate September 25 (legislative day, September 
      17), 2008.

            Attest:

                                                NANCY ERICKSON,

                                                             Secretary.