CLINICAL trial to test treatment for rare disease or condition ; First $2,000 per year received by individual for participation in
Index of Sec 1909. ...CLINICAL trial ; First $2,000 per year received by individual for participation in
Index of Sec 1909. ...RARE disease or condition ; First $2,000 per year received by individual for participation in clinical trial to test treatment for
Index of Sec 1909. ...TITLE 45, Code of Federal Regulations ; Meeting standards for bodies setting forth in part 46 of
Index of Sec 1909. ...WELFARE of human subjects participating in research ; Establishing to protect rights and
Index of Sec 1909. ...1st Session |
To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes.
Mr. Dingell (for himself, Mr. Rangel, Mr. Waxman, Mr. George Miller of California, Mr. Stark, Mr. Pallone, and Mr. Andrews) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, Oversight and Government Reform, and the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
(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.