[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1674 Enrolled Bill (ENR)]
S.1674
One Hundred Eleventh Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the fifth day of January, two thousand and ten
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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.