1.This Act may be cited as the
QI Program Supplemental Funding Act of
2008
.
2.Funding for the Qualifying Individual (QI)
programSection 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
.
3.Mandatory use of State public assistance
reporting information system (PARIS) project
(a)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)
(1)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
amendmentIn 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.
4.Incentives for the development of, and
access to, certain antibiotics
(a)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)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)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)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)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)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)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)
(A)Exclusivities and extensionsParagraphs (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)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
provisionsNotwithstanding
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)
(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)).
5. Clarification of authority for use of
Medicaid Integrity Program funds
(a)Clarification of authority for use of
funds
(1)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)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)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)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)
(1)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)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)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.
6.Funding for the Medicare Improvement
FundSection 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