[United States Statutes at Large, Volume 122, 110th Congress, 2nd Session]
[From the U.S. Government Printing Office, www.gpo.gov]

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 4076]]
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 4077]]
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 4078]]
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 4079]]
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:
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CONGRESSIONAL RECORD, Vol. 154 (2008):
Sept. 25, considered and passed Senate.
Sept. 27, considered and passed House.