I 
111TH CONGRESS 
1ST SESSION H. R. 2866 
To provide for a disregard under the Supplemental Security Income program 
of compensation for participation in clinical trials for rare diseases or 
conditions. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 15, 2009 
Mr. MARKEY of Massachusetts (for himself, Mr. STEARNS, Mr. BERRY, Mr. 
BOUSTANY, Ms. GINNY BROWN-WAITE of Florida, Mr. COHEN, Mr. 
CONAWAY, Ms. DEGETTE, Ms. DELAURO, Mr. DICKS, Mr. DOYLE, Mr. 
GORDON of Tennessee, Mr. GENE GREEN of Texas, Ms. JENKINS, Mr. 
KING of New York, Mr. LEWIS of Georgia, Mr. MCGOVERN, Mr. MEEK 
of Florida, Mr. MORAN of Virginia, Mr. MURPHY of Connecticut, Mr. 
OLVER, Mr. PAUL, Mr. ROGERS
of Alabama, Mr. ROSS, Ms. 
SCHAKOWSKY, Ms. SCHWARTZ, Mr. STARK, Mr. WAXMAN, Mr. WEXLER, 
and Mr. WHITFIELD) introduced the following bill; which was referred to 
the Committee on Ways and Means 
A BILL 
To provide for a disregard under the Supplemental Security 
Income program of compensation for participation in 
clinical trials for rare diseases or conditions. 
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 ‘‘Improving Access to 
Clinical Trials Act of 2009’’. 
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SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) Advances in medicine depend on clinical 
trial research conducted at public and private re-
search institutions across the United States. 
(2) The challenges associated with enrolling 
participants in clinical research studies are especially 
severe for studies evaluating treatments for rare dis-
eases and conditions—those diseases and conditions 
defined by the Orphan Drug Act of 1983 as affect-
ing fewer than 200,000 Americans—where the avail-
able number of willing and able research partici-
pants may be very small. 
(3) In accordance with ethical standards of the 
National Institutes of Health, sponsors of clinical 
trial research may provide payments to trial partici-
pants for the out-of-pocket costs associated with 
trial enrollment and for the time and commitment 
demanded by enrolling in a study. Such financial in-
centives aid the recruitment of trial participants. 
(4) The offer of payment for trial participation 
may also pose a barrier to trial enrollment since 
such payments threaten the eligibility of clinical trial 
participants for Supplemental Security Income and 
Medicaid benefits. 
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(5) The small numbers of potential trial partici-
pants and the possible loss of Supplemental Security 
Income and Medicaid benefits make clinical trial re-
search for rare diseases and conditions exceptionally 
difficult and may hinder research on new treatments 
and potential cures for these rare diseases and con-
ditions. 
(6) Individuals with rare diseases and condi-
tions may suffer a severe negative effect if trials on 
new therapies are delayed or abandoned because of 
the inability to enroll sufficient numbers of trial par-
ticipants. 
(7) A change in the Supplemental Security In-
come program rules affecting payments for trial par-
ticipation would help ensure that clinical studies on 
rare diseases and conditions proceed without delay. 
SEC. 3. DISREGARD UNDER THE SUPPLEMENTAL SECURITY 
INCOME PROGRAM OF COMPENSATION FOR 
PARTICIPATION IN CLINICAL TRIALS FOR 
RARE DISEASES OR CONDITIONS. 
(a) INCOME DISREGARD.—Section 1612(b) of the So-
cial Security Act (42 U.S.C. 1382a(b)) is amended— 
(1) by striking ‘‘and’’ at the end of paragraph 
(24); 
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(2) by striking the period at the end of para-
graph (25) and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(26) the first $2,000 per year received by such 
individual (or such spouse) for participation in a 
clinical trial to test a treatment for a rare disease 
or condition (within the meaning of section 5(b)(2) 
of the Orphan Drug Act (Public Law 97–414)), 
that— 
‘‘(A) has been reviewed and approved by 
an institutional review board that— 
‘‘(i) is established to protect the rights 
and welfare of human subjects partici-
pating in research; and 
‘‘(ii) meet the standards for such bod-
ies set forth in part 46 of title 45, Code of 
Federal Regulations; and 
‘‘(B) meets the standards for protection of 
human subjects for clinical research (as set 
forth in such part).’’. 
(b) RESOURCE DISREGARD.—Section 1613(a) of 
such Act (42 U.S.C. 1382b(a)) is amended— 
(1) by striking ‘‘and’’ at the end of paragraph 
(15); 
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(2) by striking the period at the end of para-
graph (16) and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (16) the fol-
lowing: 
‘‘(17) the first $2,000 per year received by such 
individual (or such spouse) for participation in a 
clinical trial, as described in section 1612(b)(26).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to benefits payable for calendar 
months beginning after the earlier of— 
(1) the date the Commissioner of Social Secu-
rity promulgates regulations to carry out the amend-
ments; or 
(2) the 180-day period that begins with the 
date of the enactment of this Act. 
Æ 
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