    [United States Statutes at Large, Volume 124, 111th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 111-255
    111th Congress

    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.

    [[Page 2641]]

    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.

    [[Page 2642]]

    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.

    Approved October 5, 2010.

    LEGISLATIVE HISTORY--S. 1674:
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    CONGRESSIONAL RECORD, Vol. 156 (2010):
    Aug. 5, considered and passed Senate.
    Sept. 23, considered and passed House.