[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.
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