II 

111TH CONGRESS 

1ST SESSION S. 1674 

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. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 15, 2009 

Mr. WYDEN (for himself, Mr. DODD, Mr. SHELBY, and Mr. INHOFE) introduced the following bill; which was read twice and referred to the Committee on Finance 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 Clinical Trials Act of 2009’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

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1 (1) Advances in medicine depend on clinical 

2 trial research conducted at public and private re3 search institutions across the United States. 

4 (2) The challenges associated with enrolling 

5 participants in clinical research studies are especially 

6 difficult for studies that evaluate treatments for rare 

7 diseases and conditions (defined by the Orphan 

8 Drug Act as a disease or condition affecting fewer 

9 than 200,000 Americans), where the available num10 ber of willing and able research participants may be 

11 very small. 

12 (3) In accordance with ethical standards estab13 lished by the National Institutes of Health, sponsors 

14 of clinical research may provide payments to trial 

15 participants for out-of-pocket costs associated with 

16 trial enrollment and for the time and commitment 

17 demanded by those who participate in a study. When 

18 offering compensation, clinical trial sponsors are re19 quired to provide such payments to all participants. 

20 (4) The offer of payment for research participa21 tion may pose a barrier to trial enrollment when 

22 such payments threaten the eligibility of clinical trial 

23 participants for Supplemental Security Income and 

24 Medicaid benefits. 

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1 (5) With a small number of potential trial par2 ticipants and the possible loss of Supplemental Secu3 rity Income and Medicaid benefits for many who 

4 wish to participate, clinical trial research for rare 

5 diseases and conditions becomes exceptionally dif6 ficult and may hinder research on new treatments 

7 and potential cures for these rare diseases and con8 ditions. 

9 SEC. 3. EXCLUSION FOR COMPENSATION FOR PARTICIPA10 TION IN CLINICAL TRIALS FOR RARE DIS11 EASES OR CONDITIONS. 

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

13 the Social Security Act (42 U.S.C. 1382a(b)) is amend14 ed— 

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

16 (24); 

17 (2) by striking the period at the end of para18 graph (25) and inserting ‘‘; and’’; and 

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

20 ‘‘(26) the first $2,000 received during a cal21 endar year by such individual (or such spouse) as 

22 compensation for participation in a clinical trial in23 volving research and testing of treatments for a rare 

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

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

2 trial— 

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

4 an institutional review board that is estab5 lished— 

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

7 of human subjects participating in sci8 entific research; and 

9 ‘‘(ii) in accord with the requirements 

10 under part 46 of title 45, Code of Federal 

11 Regulations; and 

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

13 human subjects as provided under part 46 of 

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

15 (b) EXCLUSION FROM RESOURCES.—Section 

16 1613(a) of the Social Security Act (42 U.S.C. 1382b(a)) 

17 is amended— 

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

19 (15); 

20 (2) by striking the period at the end of para21 graph (16) and inserting ‘‘; and’’; and 

22 (3) by inserting after paragraph (16) the fol23 lowing: 

24 ‘‘(17) any amount received by such individual 

25 (or such spouse) which is excluded from income 

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

2 for participation in a clinical trial involving research 

3 and testing of treatments for a rare disease or con4 dition).’’. 

5 (c) MEDICAID EXCLUSION.— 

6 (1) IN GENERAL.—Section 1902(e) of the So7 cial Security Act (42 U.S.C. 1396a(e)), is amended 

8 by adding at the end the following: 

9 ‘‘(14) EXCLUSION OF COMPENSATION FOR PAR10 TICIPATION IN A CLINICAL TRIAL FOR TESTING OF

11 TREATMENTS FOR A RARE DISEASE OR CONDI12 TION.—The first $2,000 received by an individual 

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

14 for participation in a clinical trial meeting the re15 quirements of section 1612(b)(26) shall be dis16 regarded for purposes of determining the income eli17 gibility of such individual for medical assistance 

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

19 (2) CONFORMING AMENDMENT.—Section 

20 1902(a)(17) of such Act (42 U.S.C. 1396a(a)(17)) 

21 is amended by inserting ‘‘(e)(14),’’ before ‘‘(l)(3)’’. 

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

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

24 of— 

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1 (1) the effective date of final regulations pro2 mulgated by the Commissioner of Social Security to 

3 carry out this section and such amendments; or 

4 (2) 180 days after the date of enactment of this 

5 Act. 

6 (e) SUNSET PROVISION.—This Act and the amend7 ments made by this Act are repealed on the date that is 

8 5 years after the date of the enactment of this Act. 

9 SEC. 4. STUDY AND REPORT. 

10 (a) STUDY.—Not later than 36 months after the ef11 fective date of this Act, the Comptroller General of the 

12 United States shall conduct a study to evaluate the impact 

13 of this Act on enrollment of individuals who receive Sup14 plemental Security Income benefits under title XVI of the 

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

16 beneficiaries’’) in clinical trials for rare diseases or condi17 tions. Such study shall include an analysis of the following: 

18 (1) The percentage of enrollees in clinical trials 

19 for rare diseases or conditions who were SSI bene20 ficiaries during the 3-year period prior to the effec21 tive date of this Act as compared to such percentage 

22 during the 3-year period after the effective date of 

23 this Act. 

24 (2) The range and average amount of com25 pensation provided to SSI beneficiaries who particimstockstill on DSKH9S0YB1PROD with BILLS

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1 pated in clinical trials for rare diseases or condi2 tions. 

3 (3) The overall ability of SSI beneficiaries to 

4 participate in clinical trials. 

5 (4) Any additional related matters that the 

6 Comptroller General determines appropriate. 

7 (b) REPORT.—Not later than 12 months after com8 pletion of the study conducted under subsection (a), the 

9 Comptroller General shall submit to Congress a report 

10 containing the results of such study, together with rec11 ommendations for such legislation and administrative ac12 tion as the Comptroller General determines appropriate. 

Æ 

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