1.This Act may be cited as
the Improving Access to Clinical
Trials Act of 2009
.
2.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.
3.Exclusion for
compensation for participation in clinical trials for rare diseases or
conditions
(a)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)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)
(1)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 conditionThe 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)Section 1902(a)(17) of such Act (42 U.S.C.
1396a(a)(17)) is amended by inserting (e)(14),
before
(l)(3)
.
(d)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)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.
4.
(a)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)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.