(1) 
STATE
PLAN
REQUIREMENT.—Section 
1902(a) of the Social Security Act (42 U.S.C. 
1396a(a)) is amended— 
(A) in paragraph (72), by striking ‘‘and’’ 
at the end; 
(B) in paragraph (73), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(C) by inserting after paragraph (73) the 
following new paragraph: 
‘‘(74) 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 
(gg)(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 (gg)(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: 
‘‘(gg)(1) Research study child participants described 
in this subsection are individuals who— 
‘‘(A) are not otherwise eligible for medical 
assistance under the State plan; 
‘‘(B) have not attained age 19; 
‘‘(C) have been certified by a physician 
participating in a research study conducted or 
funded (in whole or in part) by the National In-
stitutes of Health to be current or former par-
ticipants in such trial or study who have a spe-
cific disease or condition 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 suc-
cessfully 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 (74) 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 (gg)(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 
such Act (42 U.S.C. 1396r–1b) is amended— 
(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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