QI Program Supplemental Funding Act of 2008
PL 110-379 (S.3560), enacted 10/08/2008

122 STAT. 4075 
PUBLIC LAW 110–379—OCT. 8, 2008 
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. 
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 assist-
ance 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 AMEND-
MENT.—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 legis-
lation in order for the plan to meet the additional requirements 
imposed by the amendments made by subsection (a), the State 
42 USC 1396b 
note. 
QI Program 
Supplemental 
Funding Act 
of 2008. 
42 USC 1305 
note. 
Oct. 8, 2008 
[S. 3560] 
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122 STAT. 4076 
PUBLIC LAW 110–379—OCT. 8, 2008 
plan shall not be regarded as failing to comply with the require-
ments 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 subpara-
graph (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 subpara-
graph (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), sub-
ject 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 
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122 STAT. 4077 
PUBLIC LAW 110–379—OCT. 8, 2008 
‘‘(ii) a patent term extension under section 156 
of title 35, United States Code, subject to the require-
ments 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 enact-
ment of this subsection. 
‘‘(4) 
APPLICATION
OF
CERTAIN
PROVISIONS.—Notwith-
standing 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 Sec-
retary 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 
Publication. 
Deadline. 
21 USC 355 note. 
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122 STAT. 4078 
PUBLIC LAW 110–379—OCT. 8, 2008 
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 sec-
tion 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 INTEG-
RITY 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 estab-
lish, of State or local officers, employees, or independent 
contractors responsible for the administration or the super-
vision 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
TRANSPOR-
TATION
AND
TRAVEL
EXPENSES
FOR
ATTENDEES
AT
EDU-
CATION, 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 Medi-
care & 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 
42 USC 1396u–6 
note. 
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122 STAT. 4079 
PUBLIC LAW 110–379—OCT. 8, 2008 
LEGISLATIVE HISTORY—S. 3560: 
CONGRESSIONAL RECORD, Vol. 154 (2008): 
Sept. 25, considered and passed Senate. 
Sept. 27, considered and passed House. 
‘‘(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’’. 
Approved October 8, 2008. 
42 USC 1396u–6 
note. 
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