111TH CONGRESS 

2D SESSION S. 1674 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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†S 1674 ES

1 SECTION 1. SHORT TITLE. 

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

3 Clinical Trials Act of 2009’’. 

4 SEC. 2. FINDINGS. 

5 Congress finds the following: 

6 (1) Advances in medicine depend on clinical 

7 trial research conducted at public and private re8 search institutions across the United States. 

9 (2) The challenges associated with enrolling 

10 participants in clinical research studies are especially 

11 difficult for studies that evaluate treatments for rare 

12 diseases and conditions (defined by the Orphan 

13 Drug Act as a disease or condition affecting fewer 

14 than 200,000 Americans), where the available num15 ber of willing and able research participants may be 

16 very small. 

17 (3) In accordance with ethical standards estab18 lished by the National Institutes of Health, sponsors 

19 of clinical research may provide payments to trial 

20 participants for out-of-pocket costs associated with 

21 trial enrollment and for the time and commitment 

22 demanded by those who participate in a study. When 

23 offering compensation, clinical trial sponsors are re24 quired to provide such payments to all participants. 

25 (4) The offer of payment for research participa26 tion may pose a barrier to trial enrollment when 
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1 such payments threaten the eligibility of clinical trial 

2 participants for Supplemental Security Income and 

3 Medicaid benefits. 

4 (5) With a small number of potential trial par5 ticipants and the possible loss of Supplemental Secu6 rity Income and Medicaid benefits for many who 

7 wish to participate, clinical trial research for rare 

8 diseases and conditions becomes exceptionally dif9 ficult and may hinder research on new treatments 

10 and potential cures for these rare diseases and con11 ditions. 

12 SEC. 3. EXCLUSION FOR COMPENSATION FOR PARTICIPA13 TION IN CLINICAL TRIALS FOR RARE DIS14 EASES OR CONDITIONS. 

15 (a) EXCLUSION FROM INCOME.—Section 1612(b) of 

16 the Social Security Act (42 U.S.C. 1382a(b)) is amend17 ed— 

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

19 (24); 

20 (2) by striking the period at the end of para21 graph (25) and inserting ‘‘; and’’; and 

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

23 ‘‘(26) the first $2,000 received during a cal24 endar year by such individual (or such spouse) as 

25 compensation for participation in a clinical trial in-
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1 volving research and testing of treatments for a rare 

2 disease or condition (as defined in section 5(b)(2) of 

3 the Orphan Drug Act), but only if the clinical 

4 trial— 

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

6 an institutional review board that is estab7 lished— 

8 ‘‘(i) to protect the rights and welfare 

9 of human subjects participating in sci10 entific research; and 

11 ‘‘(ii) in accord with the requirements 

12 under part 46 of title 45, Code of Federal 

13 Regulations; and 

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

15 human subjects as provided under part 46 of 

16 title 45, Code of Federal Regulations.’’. 

17 (b) EXCLUSION FROM RESOURCES.—Section 

18 1613(a) of the Social Security Act (42 U.S.C. 1382b(a)) 

19 is amended— 

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

21 (15); 

22 (2) by striking the period at the end of para23 graph (16) and inserting ‘‘; and’’; and 

24 (3) by inserting after paragraph (16) the fol25 lowing: 
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1 ‘‘(17) any amount received by such individual 

2 (or such spouse) which is excluded from income 

3 under section 1612(b)(26) (relating to compensation 

4 for participation in a clinical trial involving research 

5 and testing of treatments for a rare disease or con6 dition).’’. 

7 (c) MEDICAID EXCLUSION.— 

8 (1) IN GENERAL.—Section 1902(e) of the So9 cial Security Act (42 U.S.C. 1396a(e)), is amended 

10 by adding at the end the following: 

11 ‘‘(14) EXCLUSION OF COMPENSATION FOR PAR12 TICIPATION IN A CLINICAL TRIAL FOR TESTING OF

13 TREATMENTS FOR A RARE DISEASE OR CONDI14 TION.—The first $2,000 received by an individual 

15 (who has attained 19 years of age) as compensation 

16 for participation in a clinical trial meeting the re17 quirements of section 1612(b)(26) shall be dis18 regarded for purposes of determining the income eli19 gibility of such individual for medical assistance 

20 under the State plan or any waiver of such plan.’’. 

21 (2) CONFORMING AMENDMENT.—Section 

22 1902(a)(17) of such Act (42 U.S.C. 1396a(a)(17)) 

23 is amended by inserting ‘‘(e)(14),’’ before ‘‘(l)(3)’’. 
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†S 1674 ES

1 (d) EFFECTIVE DATE.—The amendments made by 

2 this section shall take effect on the date that is the earlier 

3 of— 

4 (1) the effective date of final regulations pro5 mulgated by the Commissioner of Social Security to 

6 carry out this section and such amendments; or 

7 (2) 180 days after the date of enactment of this 

8 Act. 

9 (e) SUNSET PROVISION.—This Act and the amend10 ments made by this Act are repealed on the date that is 

11 5 years after the date of the enactment of this Act. 

12 SEC. 4. STUDY AND REPORT. 

13 (a) STUDY.—Not later than 36 months after the ef14 fective date of this Act, the Comptroller General of the 

15 United States shall conduct a study to evaluate the impact 

16 of this Act on enrollment of individuals who receive Sup17 plemental Security Income benefits under title XVI of the 

18 Social Security Act (referred to in this section as ‘‘SSI 

19 beneficiaries’’) in clinical trials for rare diseases or condi20 tions. Such study shall include an analysis of the following: 

21 (1) The percentage of enrollees in clinical trials 

22 for rare diseases or conditions who were SSI bene23 ficiaries during the 3-year period prior to the effec24 tive date of this Act as compared to such percentage 
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1 during the 3-year period after the effective date of 

2 this Act. 

3 (2) The range and average amount of com4 pensation provided to SSI beneficiaries who partici5 pated in clinical trials for rare diseases or condi6 tions. 

7 (3) The overall ability of SSI beneficiaries to 

8 participate in clinical trials. 

9 (4) Any additional related matters that the 

10 Comptroller General determines appropriate. 

11 (b) REPORT.—Not later than 12 months after com12 pletion of the study conducted under subsection (a), the 

13 Comptroller General shall submit to Congress a report 

14 containing the results of such study, together with rec15 ommendations for such legislation and administrative ac16 tion as the Comptroller General determines appropriate. 

Passed the Senate August 5, 2010. 

Attest: 

Secretary. 
111TH CONGRESS 

2D SESSION S. 1674 

AN ACT 

To provide for an exclusion under the Supplemental 

or conditions. who participate in clinical trials for rare diseases gram for compensation provided to individuals Security Income program and the Medicaid pro-