S.Amdt. 3221

SA 3221. Mr. WYDEN (for himself and Mr. Durbin) submitted an
amendment intended to be proposed to amendment SA 2786 proposed by Mr.
Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr. Harkin) to the bill
H.R. 3590, to amend the Internal Revenue Code of 1986 to modify the
first-time homebuyers credit in the case of members of the Armed Forces
and certain other Federal employees, and for other purposes; which was
ordered to lie on the table; as follows:

On page 1203, between lines 16 and 17, insert the
following:

SEC. 4109. IMPROVING ACCESS TO CLINICAL TRIALS.

(a) 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.
(b) Exclusion for Compensation for Participation in
Clinical Trials for Rare Diseases or Conditions.--
(1) Exclusion from income.--Section 1612(b) of the Social
Security Act (42 U.S.C. 1382a(b)) is amended--
(A) by striking ``and'' at the end of paragraph (24);
(B) by striking the period at the end of paragraph (25) and
inserting ``; and''; and
(C) 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.''.
(2) Exclusion from resources.--Section 1613(a) of the
Social Security Act (42 U.S.C. 1382b(a)) is amended--
(A) by striking ``and'' at the end of paragraph (15);
(B) by striking the period at the end of paragraph (16) and
inserting ``; and''; and
(C) 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).''.
(3) Medicaid exclusion.--
(A) In general.--Section 1902(e) of the Social Security Act
(42 U.S.C. 1396a(e)), as amended by section 2002(a), is
amended by adding at the end the following:
``(15) 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.''.
(B) Conforming amendment.--Section 1902(a)(17) of such Act
(42 U.S.C. 1396a(a)(17)), as amended by section 2002(b), is
amended by inserting ``(e)(15),'' before ``(l)(3)''.
(4) Effective date.--The amendments made by this section
shall take effect on the date that is the earlier of--
(A) the effective date of final regulations promulgated by
the Commissioner of Social Security to carry out this section
and such amendments; or
(B) 180 days after the date of enactment of this Act.
(5) Sunset provision.--This section and the amendments made
by this section are repealed on the date that is 5 years
after the date of the enactment of this Act.
(c) Study and Report.--
(1) Study.--Not later than 36 months after the effective
date of this section, the Comptroller General of the United
States shall conduct a study to evaluate the impact of this
section 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:
(A) 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 section as
compared to such percentage during the 3-year period after
the effective date of this section.
(B) The range and average amount of compensation provided
to SSI beneficiaries who participated in clinical trials for
rare diseases or conditions.
(C) The overall ability of SSI beneficiaries to participate
in clinical trials.
(D) Any additional related matters that the Comptroller
General determines appropriate.
(2) Report.--Not later than 12 months after completion of
the study conducted under paragraph (1), 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.
______