[Congressional Record (Bound Edition), Volume 156 (2010), Part 11]
[Senate]
[Pages 15397-15398]
[From the U.S. Government Publishing Office, www.gpo.gov]




            IMPROVING ACCESS TO CLINICAL TRIALS ACT OF 2009

  Mr. REID. Mr. President, I ask unanimous consent that the Committee 
on Finance be discharged from further consideration of S. 1674, and the 
Senate proceed to its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the bill by title.
  The assistant legislative clerk read as follows:

       A bill (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.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. REID. Mr. President, I ask unanimous consent that the bill be 
read a third time, passed, the motion to reconsider be laid upon the 
table, there be no intervening action or debate, and that any 
statements relating to the bill be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (S. 1674) was ordered to be engrossed for a third reading, 
was read the third time, and passed, as follows:

                                S. 1674

       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.

     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

[[Page 15398]]

       ``(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.

     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.

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