[111th Congress Public Law 255]
[From the U.S. Government Printing Office]



[[Page 2639]]

             IMPROVING ACCESS TO CLINICAL TRIALS ACT OF 2009

[[Page 124 STAT. 2640]]

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. <<NOTE: Oct. 5, 2010 -  [S. 1674]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Improving Access 
to Clinical Trials Act of 2009.>> 
SECTION 1. <<NOTE: 42 USC 1305 note.>> SHORT TITLE.

    This Act may be cited as the ``Improving Access to Clinical Trials 
Act of 2009''.
SEC. 2. <<NOTE: 42 USC 1382a note.>> 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 124 STAT. 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 <<NOTE: 42 USC 1382a note.>> Date.--The amendments 
made by this section shall take effect on the date that is the earlier 
of--
            (1) <<NOTE: Regulations.>> 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 <<NOTE: 42 USC 1382a note, 1305 note, 1382a, 1382b, 
1396a.>> 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 124 STAT. 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.

                                  <all>