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 re-
search study child participants. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Nino’s Act’’. 
SEC. 2. MEDICAID COVERAGE OF DRUGS PRESCRIBED FOR 
RESEARCH STUDY CHILD PARTICIPANTS. 
(a) MANDATORY COVERAGE
IF STATE PROVIDES 
DRUG COVERAGE.— 
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(1) 
STATE
PLAN
REQUIREMENT.—Section 
1902(a) of the Social Security Act (42 U.S.C. 
1396a(a)) is amended— 
(A) in paragraph (69), by striking ‘‘and’’ 
at the end; 
(B) in paragraph (70), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(C) by inserting after paragraph (70) the 
following new paragraph: 
‘‘(71) in the case of a State plan that provides 
medical assistance for prescribed drugs under sec-
tion 1905(a)(12), provide for such medical assist-
ance to include coverage for any drug, biological 
product, or insulin prescribed for a child (including 
any such drug, product, or insulin that is self-ad-
ministered) who— 
‘‘(A) is eligible for medical assistance 
under the State plan (including a child who is 
eligible only on the basis of paragraph 
(10)(A)(i)(VIII)); 
‘‘(B) is a current or former participant in 
a research study conducted or funded (in whole 
or in part) by the National Institutes of Health; 
and 
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‘‘(C) satisfies the requirements of subpara-
graphs (B), (C), and (D) of subsection 
(dd)(1).’’. 
(2) MANDATORY COVERAGE OF DRUGS OF RE-
SEARCH STUDY CHILD PARTICIPANTS WHO ARE NOT 
OTHERWISE ELIGIBLE FOR MEDICAID IF THE STATE 
OFFERS DRUG COVERAGE.— 
(A) 
IN
GENERAL.—Section 
1902(a)(10)(A)(i) of the Social Security Act 
(42 U.S.C. 1396b(a)(10)(A)(i)) is amended— 
(i) in subclause (VI), by striking ‘‘or’’ 
at the end; 
(ii) in subclause (VII), by adding ‘‘or’’ 
at the end; and 
(iii) by adding at the end the fol-
lowing new subclause: 
‘‘(VIII) who are research study 
child participants described in sub-
section (dd)(1), but only if the med-
ical assistance made available by the 
State includes prescribed drugs under 
section 1905(a)(12),’’. 
(B) GROUP DESCRIBED.—Section 1902 of 
the Social Security Act (42 U.S.C. 1396a) is 
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amended by adding at the end the following 
new subsection: 
‘‘(dd)(1) Research study child participants described 
in this subsection are individuals who— 
‘‘(A) are not otherwise eligible for medical as-
sistance under the State plan; 
‘‘(B) have not attained age 19; 
‘‘(C) have been certified by a physician partici-
pating in a research study conducted or funded (in 
whole or in part) by the National Institutes of 
Health to be current or former participants in such 
trial or study who have a specific disease or condi-
tion that— 
‘‘(i) is or has been successfully treated 
under such trial or study with a prescribed use 
of a drug, biological product, or insulin that is 
not approved under the Federal Food, Drug, 
and Cosmetic Act; and 
‘‘(ii) is likely to continue to be successfully 
treated with such drug, product, or insulin; and 
‘‘(D) do not have other health coverage for such 
drug, product, or insulin. 
‘‘(2) A State shall redetermine not less than every 
2 years the eligibility of an individual for medical assist-
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ance who is eligible solely on the basis of subsection 
(a)(10)(A)(i)(VIII). 
‘‘(3) For purposes of this subsection and paragraphs 
(10)(A)(i)(VIII) and (71) of subsection (a), the term ‘re-
search study’ means a clinical study, including an observa-
tional (or natural history) study, or a clinical trial, to test 
an experimental therapy.’’. 
(C) MEDICAL
ASSISTANCE
LIMITED
TO 
COVERAGE
OF
THE
RESEARCH
OR
OBSERVA-
TIONAL TRIAL DRUGS, BIOLOGICAL PRODUCT, 
OR INSULIN.—Section 1902(a)(10) of the Social 
Security Act (42 U.S.C. 1396a(a)(10)) is 
amended in the matter following subparagraph 
(G)— 
(i) by striking ‘‘and (XIV)’’ and in-
serting ‘‘(XIV)’’; and 
(ii) by inserting ‘‘, and (XV) the med-
ical assistance made available to a research 
study child participant described in sub-
section (dd)(1) who is eligible for medical 
assistance solely on the basis of subpara-
graph (A)(10)(i)(VIII) shall be limited to 
medical assistance for a drug, biological 
product, or insulin that is prescribed for 
the participant as a result of participation 
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in such trial or study (including any such 
drug, product, or insulin that is self-ad-
ministered)’’ before the semicolon. 
(D) CONFORMING
AMENDMENT.—Section 
1903(f)(4) 
of 
such 
Act 
(42 
U.S.C. 
1396b)(f)(4)) is amended in the matter pre-
ceding 
subparagraph 
(A) 
by 
inserting 
‘‘1902(a)(10)(A)(i)(VIII),’’ 
after 
‘‘1902(a)(10)(A)(i)(VII),’’. 
(b) PRESUMPTIVE ELIGIBILITY.—Section 1920B of 
the Social Security Act (42 U.S.C. 1396r–1b) is amend-
ed— 
(1) in the section heading, by inserting ‘‘OR RE-
SEARCH
STUDY
CHILD
PARTICIPANTS’’ after ‘‘PA-
TIENTS’’; 
(2) in subsection (a), by inserting ‘‘or a child 
who is eligible for medical assistance under the State 
plan (including a child who is eligible only on the 
basis of section 1902(a)(10)(A)(i)(VIII) but subject 
to the limitation on medical assistance for such a 
child under clause (XV) of the matter following sec-
tion 1902(a)(10)(G)), is a current or former partici-
pant in a research study conducted or funded (in 
whole or in part) by the National Institutes of 
Health, and satisfies the requirements of subpara-
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graphs (B), (C), and (D) of section 1902(dd)(1)’’ 
after ‘‘patients)’’; 
(3) in subsection (b)(1)(A), by inserting ‘‘or 
subsection (a)’’ after ‘‘1902(aa)’’; and 
(4) in subsection (d), in the flush language fol-
lowing paragraph (2), by striking ‘‘for purposes of 
clause (4) of the first sentence of section 1905(b)’’ 
and inserting ‘‘for purposes of the first sentence of 
section 1905(b) (and, in the case of medical assist-
ance furnished to an individual described in section 
1902(aa), for purposes of clause (4) of such sen-
tence)’’. 
(c) NOTICE OF MEDICAID COVERAGE FOR RESEARCH 
STUDY CHILD PARTICIPANTS.— 
(1) IN GENERAL.—Not later than 90 days after 
the date of enactment of this Act, the Secretary of 
Health and Human Services, in consultation with 
the Director of the Institutes of Health and State 
Medicaid Directors, shall— 
(A) develop a written notice for child par-
ticipants in research studies (as defined in sec-
tion 1902(dd)(3) of the Social Security Act, as 
added by subsection (a)(2)(B)) conducted or 
funded (in whole or in part) by the National In-
stitutes of Health who are likely to eligible for 
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medical assistance for a drug, biological prod-
uct, or insulin prescribed for such participants 
as a result of participation in such a study (in-
cluding any such drug, product, or insulin that 
is self-administered) in accordance with para-
graph (10)(A)(i)(VIII) or (71) of section 
1902(a) of the Social Security Act (42 U.S.C. 
1396a(a)) (as added by subsection (a)), of the 
availability of such assistance; and 
(B) establish procedures for making such 
notice available to the child participants 
through physicians participating in such re-
search studies or such other means as the Sec-
retary determines appropriate. 
(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated for fiscal 
year 2008 and each fiscal year thereafter such sums 
as may be necessary to carry out this subsection. 
(d) EFFECTIVE DATE.—The amendments made by 
this section apply to medical assistance for items and serv-
ices furnished on or after the date of enactment of this 
Act, without regard to whether final regulations to carry 
out such amendments have been promulgated. 
Æ 
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