[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2866 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 2866

   To provide for a disregard under the Supplemental Security Income 
 program of compensation for participation in clinical trials for rare 
                        diseases or conditions.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 15, 2009

 Mr. Markey of Massachusetts (for himself, Mr. Stearns, Mr. Berry, Mr. 
Boustany, Ms. Ginny Brown-Waite of Florida, Mr. Cohen, Mr. Conaway, Ms. 
 DeGette, Ms. DeLauro, Mr. Dicks, Mr. Doyle, Mr. Gordon of Tennessee, 
 Mr. Gene Green of Texas, Ms. Jenkins, Mr. King of New York, Mr. Lewis 
 of Georgia, Mr. McGovern, Mr. Meek of Florida, Mr. Moran of Virginia, 
Mr. Murphy of Connecticut, Mr. Olver, Mr. Paul, Mr. Rogers of Alabama, 
  Mr. Ross, Ms. Schakowsky, Ms. Schwartz, Mr. Stark, Mr. Waxman, Mr. 
  Wexler, and Mr. Whitfield) introduced the following bill; which was 
              referred to the Committee on Ways and Means

_______________________________________________________________________

                                 A BILL


 
   To provide for a disregard under the Supplemental Security Income 
 program of compensation for participation 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.

    The Congress finds as follows:
            (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 severe for studies 
        evaluating treatments for rare diseases and conditions--those 
        diseases and conditions defined by the Orphan Drug Act of 1983 
        as 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 of the National 
        Institutes of Health, sponsors of clinical trial research may 
        provide payments to trial participants for the out-of-pocket 
        costs associated with trial enrollment and for the time and 
        commitment demanded by enrolling in a study. Such financial 
        incentives aid the recruitment of trial participants.
            (4) The offer of payment for trial participation may also 
        pose a barrier to trial enrollment since such payments threaten 
        the eligibility of clinical trial participants for Supplemental 
        Security Income and Medicaid benefits.
            (5) The small numbers of potential trial participants and 
        the possible loss of Supplemental Security Income and Medicaid 
        benefits make clinical trial research for rare diseases and 
        conditions exceptionally difficult and may hinder research on 
        new treatments and potential cures for these rare diseases and 
        conditions.
            (6) Individuals with rare diseases and conditions may 
        suffer a severe negative effect if trials on new therapies are 
        delayed or abandoned because of the inability to enroll 
        sufficient numbers of trial participants.
            (7) A change in the Supplemental Security Income program 
        rules affecting payments for trial participation would help 
        ensure that clinical studies on rare diseases and conditions 
        proceed without delay.

SEC. 3. DISREGARD UNDER THE SUPPLEMENTAL SECURITY INCOME PROGRAM OF 
              COMPENSATION FOR PARTICIPATION IN CLINICAL TRIALS FOR 
              RARE DISEASES OR CONDITIONS.

    (a) Income Disregard.--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 per year received by such 
        individual (or such spouse) for participation in a clinical 
        trial to test a treatment for a rare disease or condition 
        (within the meaning of section 5(b)(2) of the Orphan Drug Act 
        (Public Law 97-414)), that--
                    ``(A) has been reviewed and approved by an 
                institutional review board that--
                            ``(i) is established to protect the rights 
                        and welfare of human subjects participating in 
                        research; and
                            ``(ii) meet the standards for such bodies 
                        set forth in part 46 of title 45, Code of 
                        Federal Regulations; and
                    ``(B) meets the standards for protection of human 
                subjects for clinical research (as set forth in such 
                part).''.
    (b) Resource Disregard.--Section 1613(a) of such 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) the first $2,000 per year received by such 
        individual (or such spouse) for participation in a clinical 
        trial, as described in section 1612(b)(26).''.
    (c) Effective Date.--The amendments made by this section shall 
apply to benefits payable for calendar months beginning after the 
earlier of--
            (1) the date the Commissioner of Social Security 
        promulgates regulations to carry out the amendments; or
            (2) the 180-day period that begins with the date of the 
        enactment of this Act.
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