I 

110TH CONGRESS 

2D SESSION H. R. 5468 

To amend title XIX of the Social Security Act to provide Medicaid coverage 

of drugs prescribed for certain research study child participants. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 14, 2008 

Mr. SHUSTER (for himself and Mr. PLATTS) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend title XIX of the Social Security Act to provide 

Medicaid coverage of drugs prescribed for certain research study child participants. 

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 ‘‘Nino’s Act’’. 

5 SEC. 2. MEDICAID COVERAGE OF DRUGS PRESCRIBED FOR 

6 RESEARCH STUDY CHILD PARTICIPANTS. 

7 (a) MANDATORY COVERAGE IF STATE PROVIDES

8 DRUG COVERAGE.— 

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1 (1) STATE PLAN REQUIREMENT.—Section 

2 1902(a) of the Social Security Act (42 U.S.C. 

3 1396a(a)) is amended— 

4 (A) in paragraph (69), by striking ‘‘and’’ 

5 at the end; 

6 (B) in paragraph (70), by striking the pe7 riod at the end and inserting ‘‘; and’’; and 

8 (C) by inserting after paragraph (70) the 

9 following new paragraph: 

10 ‘‘(71) in the case of a State plan that provides 

11 medical assistance for prescribed drugs under sec12 tion 1905(a)(12), provide for such medical assist13 ance to include coverage for any drug, biological 

14 product, or insulin prescribed for a child (including 

15 any such drug, product, or insulin that is self-ad16 ministered) who— 

17 ‘‘(A) is eligible for medical assistance 

18 under the State plan (including a child who is 

19 eligible only on the basis of paragraph 

20 (10)(A)(i)(VIII)); 

21 ‘‘(B) is a current or former participant in 

22 a research study conducted or funded (in whole 

23 or in part) by the National Institutes of Health; 

24 and 

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1 ‘‘(C) satisfies the requirements of subpara2 graphs (B), (C), and (D) of subsection 

3 (dd)(1).’’. 

4 (2) MANDATORY COVERAGE OF DRUGS OF RE5 SEARCH STUDY CHILD PARTICIPANTS WHO ARE NOT

6 OTHERWISE ELIGIBLE FOR MEDICAID IF THE STATE

7 OFFERS DRUG COVERAGE.— 

8 (A) IN GENERAL.—Section 

9 1902(a)(10)(A)(i) of the Social Security Act 

10 (42 U.S.C. 1396b(a)(10)(A)(i)) is amended— 

11 (i) in subclause (VI), by striking ‘‘or’’ 

12 at the end; 

13 (ii) in subclause (VII), by adding ‘‘or’’ 

14 at the end; and 

15 (iii) by adding at the end the fol16 lowing new subclause: 

17 ‘‘(VIII) who are research study 

18 child participants described in sub19 section (dd)(1), but only if the med20 ical assistance made available by the 

21 State includes prescribed drugs under 

22 section 1905(a)(12),’’. 

23 (B) GROUP DESCRIBED.—Section 1902 of 

24 the Social Security Act (42 U.S.C. 1396a) is 

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1 amended by adding at the end the following 

2 new subsection: 

3 ‘‘(dd)(1) Research study child participants described 

4 in this subsection are individuals who— 

5 ‘‘(A) are not otherwise eligible for medical as6 sistance under the State plan; 

7 ‘‘(B) have not attained age 19; 

8 ‘‘(C) have been certified by a physician partici9 pating in a research study conducted or funded (in 

10 whole or in part) by the National Institutes of 

11 Health to be current or former participants in such 

12 trial or study who have a specific disease or condi13 tion that— 

14 ‘‘(i) is or has been successfully treated 

15 under such trial or study with a prescribed use 

16 of a drug, biological product, or insulin that is 

17 not approved under the Federal Food, Drug, 

18 and Cosmetic Act; and 

19 ‘‘(ii) is likely to continue to be successfully 

20 treated with such drug, product, or insulin; and 

21 ‘‘(D) do not have other health coverage for such 

22 drug, product, or insulin. 

23 ‘‘(2) A State shall redetermine not less than every 

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1 ance who is eligible solely on the basis of subsection 

2 (a)(10)(A)(i)(VIII). 

3 ‘‘(3) For purposes of this subsection and paragraphs 

4 (10)(A)(i)(VIII) and (71) of subsection (a), the term ‘re5 search study’ means a clinical study, including an observa6 tional (or natural history) study, or a clinical trial, to test 

7 an experimental therapy.’’. 

8 (C) MEDICAL ASSISTANCE LIMITED TO

9 COVERAGE OF THE RESEARCH OR OBSERVA10 TIONAL TRIAL DRUGS, BIOLOGICAL PRODUCT, 

11 OR INSULIN.—Section 1902(a)(10) of the Social 

12 Security Act (42 U.S.C. 1396a(a)(10)) is 

13 amended in the matter following subparagraph 

14 (G)— 

15 (i) by striking ‘‘and (XIV)’’ and in16 serting ‘‘(XIV)’’; and 

17 (ii) by inserting ‘‘, and (XV) the med18 ical assistance made available to a research 

19 study child participant described in sub20 section (dd)(1) who is eligible for medical 

21 assistance solely on the basis of subpara22 graph (A)(10)(i)(VIII) shall be limited to 

23 medical assistance for a drug, biological 

24 product, or insulin that is prescribed for 

25 the participant as a result of participation 

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1 in such trial or study (including any such 

2 drug, product, or insulin that is self-ad3 ministered)’’ before the semicolon. 

4 (D) CONFORMING AMENDMENT.—Section 

5 1903(f)(4) of such Act (42 U.S.C. 

6 1396b)(f)(4)) is amended in the matter pre7 ceding subparagraph (A) by inserting 

8 ‘‘1902(a)(10)(A)(i)(VIII),’’ after 

9 ‘‘1902(a)(10)(A)(i)(VII),’’. 

10 (b) PRESUMPTIVE ELIGIBILITY.—Section 1920B of 

11 the Social Security Act (42 U.S.C. 1396r–1b) is amend12 ed— 

13 (1) in the section heading, by inserting ‘‘OR RE14 SEARCH STUDY CHILD PARTICIPANTS’’ after ‘‘PA15 TIENTS’’; 

16 (2) in subsection (a), by inserting ‘‘or a child 

17 who is eligible for medical assistance under the State 

18 plan (including a child who is eligible only on the 

19 basis of section 1902(a)(10)(A)(i)(VIII) but subject 

20 to the limitation on medical assistance for such a 

21 child under clause (XV) of the matter following sec22 tion 1902(a)(10)(G)), is a current or former partici23 pant in a research study conducted or funded (in 

24 whole or in part) by the National Institutes of 

25 Health, and satisfies the requirements of subparamstockstill on PROD1PC66 with BILLS

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1 graphs (B), (C), and (D) of section 1902(dd)(1)’’ 

2 after ‘‘patients)’’; 

3 (3) in subsection (b)(1)(A), by inserting ‘‘or 

4 subsection (a)’’ after ‘‘1902(aa)’’; and 

5 (4) in subsection (d), in the flush language fol6 lowing paragraph (2), by striking ‘‘for purposes of 

7 clause (4) of the first sentence of section 1905(b)’’ 

8 and inserting ‘‘for purposes of the first sentence of 

9 section 1905(b) (and, in the case of medical assist10 ance furnished to an individual described in section 

11 1902(aa), for purposes of clause (4) of such sen12 tence)’’. 

13 (c) NOTICE OF MEDICAID COVERAGE FOR RESEARCH

14 STUDY CHILD PARTICIPANTS.— 

15 (1) IN GENERAL.—Not later than 90 days after 

16 the date of enactment of this Act, the Secretary of 

17 Health and Human Services, in consultation with 

18 the Director of the Institutes of Health and State 

19 Medicaid Directors, shall— 

20 (A) develop a written notice for child par21 ticipants in research studies (as defined in sec22 tion 1902(dd)(3) of the Social Security Act, as 

23 added by subsection (a)(2)(B)) conducted or 

24 funded (in whole or in part) by the National In25 stitutes of Health who are likely to eligible for 

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1 medical assistance for a drug, biological prod2 uct, or insulin prescribed for such participants 

3 as a result of participation in such a study (in4 cluding any such drug, product, or insulin that 

5 is self-administered) in accordance with para6 graph (10)(A)(i)(VIII) or (71) of section 

7 1902(a) of the Social Security Act (42 U.S.C. 

8 1396a(a)) (as added by subsection (a)), of the 

9 availability of such assistance; and 

10 (B) establish procedures for making such 

11 notice available to the child participants 

12 through physicians participating in such re13 search studies or such other means as the Sec14 retary determines appropriate. 

15 (2) AUTHORIZATION OF APPROPRIATIONS.— 

16 There is authorized to be appropriated for fiscal 

17 year 2008 and each fiscal year thereafter such sums 

18 as may be necessary to carry out this subsection. 

19 (d) EFFECTIVE DATE.—The amendments made by 

20 this section apply to medical assistance for items and serv21 ices furnished on or after the date of enactment of this 

22 Act, without regard to whether final regulations to carry 

23 out such amendments have been promulgated. 

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