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.

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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

Summary: Improving Access to Clinical Trials Act of 2009 - Amends title XVI (SSI) of the Social Security Act (SSA) to exclude from income for SSI eligibility purposes any compensation in the amount of the first $2,000 per year received by an individual for participation in clinical trials involving research and testing of treatments for rare diseases or conditions. Amends SSA title XIX (Medicaid) to make a similar exclusion from income of such compensation for the purposes of eligibility under the Medicaid program. Directs the Comptroller General to study and report to Congress on the impact of this Act on enrollment of individuals who receive SSI benefits in clinical trials for rare diseases or conditions.