[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1674 Engrossed in Senate (ES)]

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.

    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
                    ``(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.

            Passed the Senate August 5, 2010.

            Attest:

                                                             Secretary.
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.