[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.