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 
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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 
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‘‘(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 
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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 
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‘‘(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.