[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3560 Engrossed in Senate (ES)]
110th CONGRESS
2d Session
S. 3560
_______________________________________________________________________
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:
Secretary.
110th CONGRESS
2d Session
S. 3560
_______________________________________________________________________
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.