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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Improving Access to 

5 Clinical Trials Act of 2009’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) Advances in medicine depend on clinical 

4 trial research conducted at public and private re5 search institutions across the United States. 

6 (2) The challenges associated with enrolling 

7 participants in clinical research studies are especially 

8 severe for studies evaluating treatments for rare dis9 eases and conditions—those diseases and conditions 

10 defined by the Orphan Drug Act of 1983 as affect11 ing fewer than 200,000 Americans—where the avail12 able number of willing and able research partici13 pants may be very small. 

14 (3) In accordance with ethical standards of the 

15 National Institutes of Health, sponsors of clinical 

16 trial research may provide payments to trial partici17 pants for the out-of-pocket costs associated with 

18 trial enrollment and for the time and commitment 

19 demanded by enrolling in a study. Such financial in20 centives aid the recruitment of trial participants. 

21 (4) The offer of payment for trial participation 

22 may also pose a barrier to trial enrollment since 

23 such payments threaten the eligibility of clinical trial 

24 participants for Supplemental Security Income and 

25 Medicaid benefits. 


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1 (5) The small numbers of potential trial partici2 pants and the possible loss of Supplemental Security 

3 Income and Medicaid benefits make clinical trial re4 search for rare diseases and conditions exceptionally 

5 difficult and may hinder research on new treatments 

6 and potential cures for these rare diseases and con7 ditions. 

8 (6) Individuals with rare diseases and condi9 tions may suffer a severe negative effect if trials on 

10 new therapies are delayed or abandoned because of 

11 the inability to enroll sufficient numbers of trial par12 ticipants. 

13 (7) A change in the Supplemental Security In14 come program rules affecting payments for trial par15 ticipation would help ensure that clinical studies on 

16 rare diseases and conditions proceed without delay. 

17 SEC. 3. DISREGARD UNDER THE SUPPLEMENTAL SECURITY 

18 INCOME PROGRAM OF COMPENSATION FOR 

19 PARTICIPATION IN CLINICAL TRIALS FOR 

20 RARE DISEASES OR CONDITIONS. 

21 (a) INCOME DISREGARD.—Section 1612(b) of the So22 cial Security Act (42 U.S.C. 1382a(b)) is amended— 

23 (1) by striking ‘‘and’’ at the end of paragraph 

24 (24); 


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1 (2) by striking the period at the end of para2 graph (25) and inserting ‘‘; and’’; and 

3 (3) by adding at the end the following: 

4 ‘‘(26) the first $2,000 per year received by such 

5 individual (or such spouse) for participation in a 

6 clinical trial to test a treatment for a rare disease 

7 or condition (within the meaning of section 5(b)(2) 

8 of the Orphan Drug Act (Public Law 97–414)), 

9 that— 

10 ‘‘(A) has been reviewed and approved by 

11 an institutional review board that— 

12 ‘‘(i) is established to protect the rights 

13 and welfare of human subjects partici14 pating in research; and 

15 ‘‘(ii) meet the standards for such bod16 ies set forth in part 46 of title 45, Code of 

17 Federal Regulations; and 

18 ‘‘(B) meets the standards for protection of 

19 human subjects for clinical research (as set 

20 forth in such part).’’. 

21 (b) RESOURCE DISREGARD.—Section 1613(a) of 

22 such Act (42 U.S.C. 1382b(a)) is amended— 

23 (1) by striking ‘‘and’’ at the end of paragraph 

24 (15); 


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1 (2) by striking the period at the end of para2 graph (16) and inserting ‘‘; and’’; and 

3 (3) by inserting after paragraph (16) the fol4 lowing: 

5 ‘‘(17) the first $2,000 per year received by such 

6 individual (or such spouse) for participation in a 

7 clinical trial, as described in section 1612(b)(26).’’. 

8 (c) EFFECTIVE DATE.—The amendments made by 

9 this section shall apply to benefits payable for calendar 

10 months beginning after the earlier of— 

11 (1) the date the Commissioner of Social Secu12 rity promulgates regulations to carry out the amend13 ments; or 

14 (2) the 180-day period that begins with the 

15 date of the enactment of this Act. 

Æ 


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