PUBLIC LAW 111–255—OCT. 5, 2010 

IMPROVING ACCESS TO CLINICAL TRIALS 

ACT OF 2009 


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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 participate 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 treatments and potential cures for these rare diseases and conditions. 

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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PUBLIC LAW 111–255—OCT. 5, 2010 124 STAT. 2641 

SEC. 3. EXCLUSION FOR COMPENSATION FOR PARTICIPATION IN CLINICAL 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 participation in a clinical trial involving research and testing of treatments 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 institutional 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 subjects 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 individual (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 determining 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. 

Æ 

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 provided 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 appropriate. 

Approved October 5, 2010. 


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