II 

110TH CONGRESS 

2D SESSION S. 3560 

To amend title XIX of the Social Security Act to provide additional funds 

for the qualifying individual (QI) program, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 24 (legislative day, SEPTEMBER 17), 2008 

Mr. BAUCUS (for himself and Mr. GRASSLEY) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To amend title XIX of the Social Security Act to provide 

additional funds for the qualifying individual (QI) program, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘QI Program Supple5 mental Funding Act of 2008’’. 

6 SEC. 2. FUNDING FOR THE QUALIFYING INDIVIDUAL (QI) 

7 PROGRAM. 

8 Section 1933(g)(2) of the Social Security Act (42 

9 U.S.C. 1396u–3(g)(2)), as amended by section 111(b) of 


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1 the Medicare Improvements for Patients and Providers 

2 Act of 2008 (Public Law 110–275), is amended— 

3 (1) in subparagraph (I), by striking 

4 ‘‘$300,000,000’’ and inserting ‘‘$315,000,000’’; and 

5 (2) in subparagraph (J), by striking 

6 ‘‘$100,000,000’’ and inserting ‘‘$130,000,000’’. 

7 SEC. 3. MANDATORY USE OF STATE PUBLIC ASSISTANCE 

8 REPORTING INFORMATION SYSTEM (PARIS) 

9 PROJECT. 

10 (a) IN GENERAL.—Section 1903(r) of the Social Se11 curity Act (42 U.S.C. 1396b(r)) is amended— 

12 (1) in paragraph (1), in the matter preceding 

13 subparagraph (A), by inserting ‘‘, in addition to 

14 meeting the requirements of paragraph (3),’’ after 

15 ‘‘a State must’’; and 

16 (2) by adding at the end the following new 

17 paragraph: 

18 ‘‘(3) In order to meet the requirements of this para19 graph, a State must have in operation an eligibility deter20 mination system which provides for data matching 

21 through the Public Assistance Reporting Information Sys22 tem (PARIS) facilitated by the Secretary (or any suc23 cessor system), including matching with medical assist24 ance programs operated by other States.’’. 

25 (b) EFFECTIVE DATE.— 


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1 (1) IN GENERAL.—Except as provided in para2 graph (2), the amendments made by subsection (a) 

3 take effect on October 1, 2009. 

4 (2) EXTENSION OF EFFECTIVE DATE FOR

5 STATE LAW AMENDMENT.—In the case of a State 

6 plan under title XIX of the Social Security Act (42 

7 U.S.C. 1396 et seq.) which the Secretary of Health 

8 and Human Services determines requires State legis9 lation in order for the plan to meet the additional 

10 requirements imposed by the amendments made by 

11 subsection (a), the State plan shall not be regarded 

12 as failing to comply with the requirements of such 

13 title solely on the basis of its failure to meet these 

14 additional requirements before the first day of the 

15 first calendar quarter beginning after the close of 

16 the first regular session of the State legislature that 

17 begins after the date of enactment of this Act. For 

18 purposes of the previous sentence, in the case of a 

19 State that has a 2-year legislative session, each year 

20 of the session is considered to be a separate regular 

21 session of the State legislature. 


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1 SEC. 4. INCENTIVES FOR THE DEVELOPMENT OF, AND AC2 CESS TO, CERTAIN ANTIBIOTICS. 

3 (a) IN GENERAL.—Section 505 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 

5 adding at the end the following: 

6 ‘‘(v) ANTIBIOTIC DRUGS SUBMITTED BEFORE NO7 VEMBER 21, 1997.— 

8 ‘‘(1) ANTIBIOTIC DRUGS APPROVED BEFORE

9 NOVEMBER 21, 1997.— 

10 ‘‘(A) IN GENERAL.—Notwithstanding any 

11 provision of the Food and Drug Administration 

12 Modernization Act of 1997 or any other provi13 sion of law, a sponsor of a drug that is the sub14 ject of an application described in subparagraph 

15 (B)(i) shall be eligible for, with respect to the 

16 drug, the 3-year exclusivity period referred to 

17 under clauses (iii) and (iv) of subsection 

18 (c)(3)(E) and under clauses (iii) and (iv) of 

19 subsection (j)(5)(F), subject to the require20 ments of such clauses, as applicable. 

21 ‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE22 SCRIBED.— 

23 ‘‘(i) APPLICATION.—An application 

24 described in this clause is an application 

25 for marketing submitted under this section 

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1 section in which the drug that is the sub2 ject of the application contains an anti3 biotic drug described in clause (ii). 

4 ‘‘(ii) ANTIBIOTIC DRUG.—An anti5 biotic drug described in this clause is an 

6 antibiotic drug that was the subject of an 

7 application approved by the Secretary 

8 under section 507 of this Act (as in effect 

9 before November 21, 1997). 

10 ‘‘(2) ANTIBIOTIC DRUGS SUBMITTED BEFORE

11 NOVEMBER 21, 1997, BUT NOT APPROVED.— 

12 ‘‘(A) IN GENERAL.—Notwithstanding any 

13 provision of the Food and Drug Administration 

14 Modernization Act of 1997 or any other provi15 sion of law, a sponsor of a drug that is the sub16 ject of an application described in subparagraph 

17 (B)(i) may elect to be eligible for, with respect 

18 to the drug— 

19 ‘‘(i)(I) the 3-year exclusivity period re20 ferred to under clauses (iii) and (iv) of 

21 subsection (c)(3)(E) and under clauses (iii) 

22 and (iv) of subsection (j)(5)(F), subject to 

23 the requirements of such clauses, as appli24 cable; and 


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1 ‘‘(II) the 5-year exclusivity period re2 ferred to under clause (ii) of subsection 

3 (c)(3)(E) and under clause (ii) of sub4 section (j)(5)(F), subject to the require5 ments of such clauses, as applicable; or 

6 ‘‘(ii) a patent term extension under 

7 section 156 of title 35, United States 

8 Code, subject to the requirements of such 

9 section. 

10 ‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE11 SCRIBED.— 

12 ‘‘(i) APPLICATION.—An application 

13 described in this clause is an application 

14 for marketing submitted under this section 

15 after the date of the enactment of this sub16 section in which the drug that is the sub17 ject of the application contains an anti18 biotic drug described in clause (ii). 

19 ‘‘(ii) ANTIBIOTIC DRUG.—An anti20 biotic drug described in this clause is an 

21 antibiotic drug that was the subject of 1 or 

22 more applications received by the Secretary 

23 under section 507 of this Act (as in effect 

24 before November 21, 1997), none of which 


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1 was approved by the Secretary under such 

2 section. 

3 ‘‘(3) LIMITATIONS.— 

4 ‘‘(A) EXCLUSIVITIES AND EXTENSIONS.— 

5 Paragraphs (1)(A) and (2)(A) shall not be con6 strued to entitle a drug that is the subject of 

7 an approved application described in subpara8 graphs (1)(B)(i) or (2)(B)(i), as applicable, to 

9 any market exclusivities or patent extensions 

10 other than those exclusivities or extensions de11 scribed in paragraph (1)(A) or (2)(A). 

12 ‘‘(B) CONDITIONS OF USE.—Paragraphs 

13 (1)(A) and (2)(A)(i) shall not apply to any con14 dition of use for which the drug referred to in 

15 subparagraph (1)(B)(i) or (2)(B)(i), as applica16 ble, was approved before the date of the enact17 ment of this subsection. 

18 ‘‘(4) APPLICATION OF CERTAIN PROVISIONS.— 

19 Notwithstanding section 125, or any other provision, 

20 of the Food and Drug Administration Modernization 

21 Act of 1997, or any other provision of law, and sub22 ject to the limitations in paragraphs (1), (2), and 

23 (3), the provisions of the Drug Price Competition 

24 and Patent Term Restoration Act of 1984 shall 

25 apply to any drug subject to paragraph (1) or any 


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1 drug with respect to which an election is made under 

2 paragraph (2)(A).’’. 

3 (b) TRANSITIONAL RULES.— 

4 (1) With respect to a patent issued on or before 

5 the date of the enactment of this Act, any patent in6 formation required to be filed with the Secretary of 

7 Health and Human Services under subsection (b)(1) 

8 or (c)(2) of section 505 of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 355) to be listed on a 

10 drug to which subsection (v)(1) of such section 505 

11 (as added by this section) applies shall be filed with 

12 the Secretary not later than 60 days after the date 

13 of the enactment of this Act. 

14 (2) With respect to any patent information re15 ferred to in paragraph (1) of this subsection that is 

16 filed with the Secretary within the 60-day period 

17 after the date of the enactment of this Act, the Sec18 retary shall publish such information in the elec19 tronic version of the list referred to at section 

20 505(j)(7) of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 355(j)(7)) as soon as it is received, 

22 but in no event later than the date that is 90 days 

23 after the enactment of this Act. 

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1 retary within the 60-day period after the date of en2 actment of this Act, each applicant that, not later 

3 than 120 days after the date of the enactment of 

4 this Act, amends an application that is, on or before 

5 the date of the enactment of this Act, a substantially 

6 complete application (as defined in paragraph 

7 (5)(B)(iv) of section 505(j) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 355(j))) to con9 tain a certification described in paragraph 

10 (2)(A)(vii)(IV) of such section 505(j) with respect to 

11 that patent shall be deemed to be a first applicant 

12 (as defined in paragraph (5)(B)(iv) of such section 

13 505(j)). 

14 SEC. 5. CLARIFICATION OF AUTHORITY FOR USE OF MED15 ICAID INTEGRITY PROGRAM FUNDS. 

16 (a) CLARIFICATION OF AUTHORITY FOR USE OF

17 FUNDS.— 

18 (1) IN GENERAL.—Section 1936 of the Social 

19 Security Act (42 U.S.C. 1396u–6) is amended— 

20 (A) in subsection (b)(4), by striking ‘‘Edu21 cation of’’ and inserting ‘‘Education or training, 

22 including at such national, State, or regional 

23 conferences as the Secretary may establish, of 

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1 tration or the supervision of the administration 

2 of the State plan under this title,’’; and 

3 (B) in subsection (e), by striking para4 graph (2) and inserting the following: 

5 ‘‘(2) AVAILABILITY; AUTHORITY FOR USE OF

6 FUNDS.— 

7 ‘‘(A) AVAILABILITY.—Amounts appro8 priated pursuant to paragraph (1) shall remain 

9 available until expended. 

10 ‘‘(B) AUTHORITY FOR USE OF FUNDS FOR

11 TRANSPORTATION AND TRAVEL EXPENSES FOR

12 ATTENDEES AT EDUCATION, TRAINING, OR CON13 SULTATIVE ACTIVITIES.— 

14 ‘‘(i) IN GENERAL.—The Secretary 

15 may use amounts appropriated pursuant to 

16 paragraph (1) to pay for transportation 

17 and the travel expenses, including per diem 

18 in lieu of subsistence, at rates authorized 

19 for employees of agencies under subchapter 

20 I of chapter 57 of title 5, United States 

21 Code, while away from their homes or reg22 ular places of business, of individuals de23 scribed in subsection (b)(4) who attend 

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1 ties conducted under the authority of that 

2 subsection.’’. 

3 (2) EFFECTIVE DATE.—The amendments made 

4 by paragraph (1) shall take effect as if included in 

5 the enactment of section 1936 of the Social Security 

6 Act, as added by section 6034(a) of the Deficit Re7 duction Act of 2005 (Public Law 109–171). 

8 (b) PUBLIC DISCLOSURE.— 

9 (1) IN GENERAL.—Section 1936(e)(2)(B) of 

10 such Act (42 U.S.C. 1396u–6(e)(2)(B)), as added by 

11 subsection (a) of this section, is amended by adding 

12 at the end the following: 

13 ‘‘(ii) PUBLIC DISCLOSURE.—The Sec14 retary shall make available on a website of 

15 the Centers for Medicare & Medicaid Serv16 ices that is accessible to the public— 

17 ‘‘(I) the total amount of funds 

18 expended for each conference con19 ducted under the authority of sub20 section (b)(4); and 

21 ‘‘(II) the amount of funds ex22 pended for each such conference that 

23 were for transportation and for travel 

24 expenses.’’. 


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1 (2) EFFECTIVE DATE.—The amendment made 

2 by paragraph (1) shall apply to conferences con3 ducted under the authority of section 1936(b)(4) of 

4 the Social Security Act (42 U.S.C. 1396u–6(b)(4)) 

5 after the date of enactment of this Act. 

6 SEC. 6. FUNDING FOR THE MEDICARE IMPROVEMENT 

7 FUND. 

8 Section 1898(b)(1) of the Social Security Act (42 

9 U.S.C. 1395iii(b)(1)) is amended by striking 

10 ‘‘$2,220,000,000’’ and inserting ‘‘$2,290,000,000’’. 

Æ 


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