Improving Access to Clinical Trials Act of 2009
PL 111-255 (S.1674), enacted 10/05/2010

124 STAT. 2640 
PUBLIC LAW 111–255—OCT. 5, 2010 
Public Law 111–255 
111th Congress 
An Act 
To provide for an exclusion under the Supplemental Security Income program 
and the Medicaid program for compensation provided to individuals who partici-
pate in clinical trials for rare diseases or conditions. 
Be it enacted by the Senate and House of Representatives of 
the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Improving Access to Clinical 
Trials Act of 2009’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Advances in medicine depend on clinical trial research 
conducted at public and private research institutions across 
the United States. 
(2) The challenges associated with enrolling participants 
in clinical research studies are especially difficult for studies 
that evaluate treatments for rare diseases and conditions 
(defined by the Orphan Drug Act as a disease or condition 
affecting fewer than 200,000 Americans), where the available 
number of willing and able research participants may be very 
small. 
(3) In accordance with ethical standards established by 
the National Institutes of Health, sponsors of clinical research 
may provide payments to trial participants for out-of-pocket 
costs associated with trial enrollment and for the time and 
commitment demanded by those who participate in a study. 
When offering compensation, clinical trial sponsors are required 
to provide such payments to all participants. 
(4) The offer of payment for research participation may 
pose a barrier to trial enrollment when such payments threaten 
the eligibility of clinical trial participants for Supplemental 
Security Income and Medicaid benefits. 
(5) With a small number of potential trial participants 
and the possible loss of Supplemental Security Income and 
Medicaid benefits for many who wish to participate, clinical 
trial research for rare diseases and conditions becomes 
exceptionally difficult and may hinder research on new treat-
ments and potential cures for these rare diseases and condi-
tions. 
42 USC 1382a 
note. 
42 USC 1305 
note. 
Improving Access 
to Clinical Trials 
Act of 2009. 
Oct. 5, 2010 
[S. 1674] 
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124 STAT. 2641 
PUBLIC LAW 111–255—OCT. 5, 2010 
SEC. 3. EXCLUSION FOR COMPENSATION FOR PARTICIPATION IN CLIN-
ICAL TRIALS FOR RARE DISEASES OR CONDITIONS. 
(a) EXCLUSION FROM INCOME.—Section 1612(b) of the Social 
Security Act (42 U.S.C. 1382a(b)) is amended— 
(1) by striking ‘‘and’’ at the end of paragraph (24); 
(2) by striking the period at the end of paragraph (25) 
and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(26) the first $2,000 received during a calendar year by 
such individual (or such spouse) as compensation for participa-
tion in a clinical trial involving research and testing of treat-
ments for a rare disease or condition (as defined in section 
5(b)(2) of the Orphan Drug Act), but only if the clinical trial— 
‘‘(A) has been reviewed and approved by an institu-
tional review board that is established— 
‘‘(i) to protect the rights and welfare of human 
subjects participating in scientific research; and 
‘‘(ii) in accord with the requirements under part 
46 of title 45, Code of Federal Regulations; and 
‘‘(B) meets the standards for protection of human sub-
jects as provided under part 46 of title 45, Code of Federal 
Regulations.’’. 
(b) EXCLUSION FROM RESOURCES.—Section 1613(a) of the Social 
Security Act (42 U.S.C. 1382b(a)) is amended— 
(1) by striking ‘‘and’’ at the end of paragraph (15); 
(2) by striking the period at the end of paragraph (16) 
and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (16) the following: 
‘‘(17) any amount received by such individual (or such 
spouse) which is excluded from income under section 
1612(b)(26) (relating to compensation for participation in a 
clinical trial involving research and testing of treatments for 
a rare disease or condition).’’. 
(c) MEDICAID EXCLUSION.— 
(1) IN
GENERAL.—Section 1902(e) of the Social Security 
Act (42 U.S.C. 1396a(e)), is amended by adding at the end 
the following: 
‘‘(14) EXCLUSION OF COMPENSATION FOR PARTICIPATION IN 
A CLINICAL TRIAL FOR TESTING OF TREATMENTS FOR A RARE 
DISEASE OR CONDITION.—The first $2,000 received by an indi-
vidual (who has attained 19 years of age) as compensation 
for participation in a clinical trial meeting the requirements 
of section 1612(b)(26) shall be disregarded for purposes of deter-
mining the income eligibility of such individual for medical 
assistance under the State plan or any waiver of such plan.’’. 
(2) CONFORMING AMENDMENT.—Section 1902(a)(17) of such 
Act (42 U.S.C. 1396a(a)(17)) is amended by inserting ‘‘(e)(14),’’ 
before ‘‘(l)(3)’’. 
(d) EFFECTIVE DATE.—The amendments made by this section 
shall take effect on the date that is the earlier of— 
(1) the effective date of final regulations promulgated by 
the Commissioner of Social Security to carry out this section 
and such amendments; or 
(2) 180 days after the date of enactment of this Act. 
(e) SUNSET PROVISION.—This Act and the amendments made 
by this Act are repealed on the date that is 5 years after the 
date of the enactment of this Act. 
42 USC 1382a 
note, 1305 note, 
1382a, 1382b, 
1396a. 
Regulations. 
42 USC 1382a 
note. 
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124 STAT. 2642 
PUBLIC LAW 111–255—OCT. 5, 2010 
LEGISLATIVE HISTORY—S. 1674: 
CONGRESSIONAL RECORD, Vol. 156 (2010): 
Aug. 5, considered and passed Senate. 
Sept. 23, considered and passed House. 
SEC. 4. STUDY AND REPORT. 
(a) STUDY.—Not later than 36 months after the effective date 
of this Act, the Comptroller General of the United States shall 
conduct a study to evaluate the impact of this Act on enrollment 
of individuals who receive Supplemental Security Income benefits 
under title XVI of the Social Security Act (referred to in this 
section as ‘‘SSI beneficiaries’’) in clinical trials for rare diseases 
or conditions. Such study shall include an analysis of the following: 
(1) The percentage of enrollees in clinical trials for rare 
diseases or conditions who were SSI beneficiaries during the 
3-year period prior to the effective date of this Act as compared 
to such percentage during the 3-year period after the effective 
date of this Act. 
(2) The range and average amount of compensation pro-
vided to SSI beneficiaries who participated in clinical trials 
for rare diseases or conditions. 
(3) The overall ability of SSI beneficiaries to participate 
in clinical trials. 
(4) Any additional related matters that the Comptroller 
General determines appropriate. 
(b) REPORT.—Not later than 12 months after completion of 
the study conducted under subsection (a), the Comptroller General 
shall submit to Congress a report containing the results of such 
study, together with recommendations for such legislation and 
administrative action as the Comptroller General determines appro-
priate. 
Approved October 5, 2010. 
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