I 

110TH CONGRESS 

2D SESSION S. 3560 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 25, 2008 

Referred to the Committee on Energy and Commerce 

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. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘QI Program Supple3 mental Funding Act of 2008’’. 

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

5 PROGRAM. 

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

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

8 the Medicare Improvements for Patients and Providers 

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

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

11 ‘‘$300,000,000’’ and inserting ‘‘$315,000,000’’; and 

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

13 ‘‘$100,000,000’’ and inserting ‘‘$130,000,000’’. 

14 SEC. 3. MANDATORY USE OF STATE PUBLIC ASSISTANCE 

15 REPORTING INFORMATION SYSTEM (PARIS) 

16 PROJECT. 

17 (a) IN GENERAL.—Section 1903(r) of the Social Se18 curity Act (42 U.S.C. 1396b(r)) is amended— 

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

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

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

22 ‘‘a State must’’; and 

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

24 paragraph: 

25 ‘‘(3) In order to meet the requirements of this para26 graph, a State must have in operation an eligibility deterVerDate Aug 31 2005 22:15 Sep 30, 2008 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3560.RFH S3560

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1 mination system which provides for data matching 

2 through the Public Assistance Reporting Information Sys3 tem (PARIS) facilitated by the Secretary (or any suc4 cessor system), including matching with medical assist5 ance programs operated by other States.’’. 

6 (b) EFFECTIVE DATE.— 

7 (1) IN GENERAL.—Except as provided in para8 graph (2), the amendments made by subsection (a) 

9 take effect on October 1, 2009. 

10 (2) EXTENSION OF EFFECTIVE DATE FOR

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

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

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

14 and Human Services determines requires State legis15 lation in order for the plan to meet the additional 

16 requirements imposed by the amendments made by 

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

18 as failing to comply with the requirements of such 

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

20 additional requirements before the first day of the 

21 first calendar quarter beginning after the close of 

22 the first regular session of the State legislature that 

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

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

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


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1 of the session is considered to be a separate regular 

2 session of the State legislature. 

3 SEC. 4. INCENTIVES FOR THE DEVELOPMENT OF, AND AC4 CESS TO, CERTAIN ANTIBIOTICS. 

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

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

7 adding at the end the following: 

8 ‘‘(v) ANTIBIOTIC DRUGS SUBMITTED BEFORE NO9 VEMBER 21, 1997.— 

10 ‘‘(1) ANTIBIOTIC DRUGS APPROVED BEFORE

11 NOVEMBER 21, 1997.— 

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) shall be eligible for, with respect to the 

18 drug, the 3-year exclusivity period referred to 

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

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

21 subsection (j)(5)(F), subject to the require22 ments of such clauses, as applicable. 

23 ‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE24 SCRIBED.— 


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1 ‘‘(i) APPLICATION.—An application 

2 described in this clause is an application 

3 for marketing submitted under this section 

4 after the date of the enactment of this sub5 section in which the drug that is the sub6 ject of the application contains an anti7 biotic drug described in clause (ii). 

8 ‘‘(ii) ANTIBIOTIC DRUG.—An anti9 biotic drug described in this clause is an 

10 antibiotic drug that was the subject of an 

11 application approved by the Secretary 

12 under section 507 of this Act (as in effect 

13 before November 21, 1997). 

14 ‘‘(2) ANTIBIOTIC DRUGS SUBMITTED BEFORE

15 NOVEMBER 21, 1997, BUT NOT APPROVED.— 

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

17 provision of the Food and Drug Administration 

18 Modernization Act of 1997 or any other provi19 sion of law, a sponsor of a drug that is the sub20 ject of an application described in subparagraph 

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

22 to the drug— 

23 ‘‘(i)(I) the 3-year exclusivity period re24 ferred to under clauses (iii) and (iv) of 

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


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

2 the requirements of such clauses, as appli3 cable; and 

4 ‘‘(II) the 5-year exclusivity period re5 ferred to under clause (ii) of subsection 

6 (c)(3)(E) and under clause (ii) of sub7 section (j)(5)(F), subject to the require8 ments of such clauses, as applicable; or 

9 ‘‘(ii) a patent term extension under 

10 section 156 of title 35, United States 

11 Code, subject to the requirements of such 

12 section. 

13 ‘‘(B) APPLICATION; ANTIBIOTIC DRUG DE14 SCRIBED.— 

15 ‘‘(i) APPLICATION.—An application 

16 described in this clause is an application 

17 for marketing submitted under this section 

18 after the date of the enactment of this sub19 section in which the drug that is the sub20 ject of the application contains an anti21 biotic drug described in clause (ii). 

22 ‘‘(ii) ANTIBIOTIC DRUG.—An anti23 biotic drug described in this clause is an 

24 antibiotic drug that was the subject of 1 or 

25 more applications received by the Secretary 


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1 under section 507 of this Act (as in effect 

2 before November 21, 1997), none of which 

3 was approved by the Secretary under such 

4 section. 

5 ‘‘(3) LIMITATIONS.— 

6 ‘‘(A) EXCLUSIVITIES AND EXTENSIONS.— 

7 Paragraphs (1)(A) and (2)(A) shall not be con8 strued to entitle a drug that is the subject of 

9 an approved application described in subpara10 graphs (1)(B)(i) or (2)(B)(i), as applicable, to 

11 any market exclusivities or patent extensions 

12 other than those exclusivities or extensions de13 scribed in paragraph (1)(A) or (2)(A). 

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

15 (1)(A) and (2)(A)(i) shall not apply to any con16 dition of use for which the drug referred to in 

17 subparagraph (1)(B)(i) or (2)(B)(i), as applica18 ble, was approved before the date of the enact19 ment of this subsection. 

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

21 Notwithstanding section 125, or any other provision, 

22 of the Food and Drug Administration Modernization 

23 Act of 1997, or any other provision of law, and sub24 ject to the limitations in paragraphs (1), (2), and 

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


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1 and Patent Term Restoration Act of 1984 shall 

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

3 drug with respect to which an election is made under 

4 paragraph (2)(A).’’. 

5 (b) TRANSITIONAL RULES.— 

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

7 the date of the enactment of this Act, any patent in8 formation required to be filed with the Secretary of 

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

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

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

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

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

14 the Secretary not later than 60 days after the date 

15 of the enactment of this Act. 

16 (2) With respect to any patent information re17 ferred to in paragraph (1) of this subsection that is 

18 filed with the Secretary within the 60-day period 

19 after the date of the enactment of this Act, the Sec20 retary shall publish such information in the elec21 tronic version of the list referred to at section 

22 505(j)(7) of the Federal Food, Drug, and Cosmetic 

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

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

25 after the enactment of this Act. 


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1 (3) With respect to any patent information re2 ferred to in paragraph (1) that is filed with the Sec3 retary within the 60-day period after the date of en4 actment of this Act, each applicant that, not later 

5 than 120 days after the date of the enactment of 

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

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

8 complete application (as defined in paragraph 

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

10 Drug, and Cosmetic Act (21 U.S.C. 355(j))) to con11 tain a certification described in paragraph 

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

13 that patent shall be deemed to be a first applicant 

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

15 505(j)). 

16 SEC. 5. CLARIFICATION OF AUTHORITY FOR USE OF MED17 ICAID INTEGRITY PROGRAM FUNDS. 

18 (a) CLARIFICATION OF AUTHORITY FOR USE OF

19 FUNDS.— 

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

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

22 (A) in subsection (b)(4), by striking ‘‘Edu23 cation of’’ and inserting ‘‘Education or training, 

24 including at such national, State, or regional 

25 conferences as the Secretary may establish, of 


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1 State or local officers, employees, or inde2 pendent contractors responsible for the adminis3 tration or the supervision of the administration 

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

5 (B) in subsection (e), by striking para6 graph (2) and inserting the following: 

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

8 FUNDS.— 

9 ‘‘(A) AVAILABILITY.—Amounts appro10 priated pursuant to paragraph (1) shall remain 

11 available until expended. 

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

13 TRANSPORTATION AND TRAVEL EXPENSES FOR

14 ATTENDEES AT EDUCATION, TRAINING, OR CON15 SULTATIVE ACTIVITIES.— 

16 ‘‘(i) IN GENERAL.—The Secretary 

17 may use amounts appropriated pursuant to 

18 paragraph (1) to pay for transportation 

19 and the travel expenses, including per diem 

20 in lieu of subsistence, at rates authorized 

21 for employees of agencies under subchapter 

22 I of chapter 57 of title 5, United States 

23 Code, while away from their homes or reg24 ular places of business, of individuals de25 scribed in subsection (b)(4) who attend 


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1 education, training, or consultative activi2 ties conducted under the authority of that 

3 subsection.’’. 

4 (2) EFFECTIVE DATE.—The amendments made 

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

6 the enactment of section 1936 of the Social Security 

7 Act, as added by section 6034(a) of the Deficit Re8 duction Act of 2005 (Public Law 109–171). 

9 (b) PUBLIC DISCLOSURE.— 

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

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

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

13 at the end the following: 

14 ‘‘(ii) PUBLIC DISCLOSURE.—The Sec15 retary shall make available on a website of 

16 the Centers for Medicare & Medicaid Serv17 ices that is accessible to the public— 

18 ‘‘(I) the total amount of funds 

19 expended for each conference con20 ducted under the authority of sub21 section (b)(4); and 

22 ‘‘(II) the amount of funds ex23 pended for each such conference that 

24 were for transportation and for travel 

25 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’’. 

Passed the Senate September 25 (legislative day, 

September 17), 2008. 

Attest: NANCY ERICKSON, 

Secretary. 


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