Page:United States Statutes at Large Volume 124.djvu/2667

124 STAT. 2641 PUBLIC LAW 111–255—OCT. 5, 2010 SEC. 3. EXCLUSION FOR COMPENSATION FOR PARTICIPATION IN CLIN - ICAL TRIALS FOR RARE DISEASES OR CONDITIONS. (a) EXCLUSION FROM INCOME.—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 participa- tion in a clinical trial involving research and testing of treat- ments 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 institu- tional 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 sub- jects as provided under part 46 of title 45, Code of Federal Regulations.’’. (b) EXCLUSION FROM RESOURCES.—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) MEDICAID EXCLUSION.— (1) IN GENERAL.—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 CONDITION.—The first $2,000 received by an indi- vidual (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 deter- mining the income eligibility of such individual for medical assistance under the State plan or any waiver of such plan.’’. (2) CONFORMING AMENDMENT.—Section 1902(a)(17) of such Act (42 U.S.C. 1396a(a)(17)) is amended by inserting ‘‘(e)(14),’’ before ‘‘(l)(3)’’. (d) EFFECTIVE DATE.—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) SUNSET PROVISION.—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. 42 USC 1382a note, 1305 note, 1382a, 1382b, 1396a. Regulations. 42 USC 1382a note.