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.
Speaker of the House of Representatives
Vice President of the United States and President of the
Senate