The Newborn Screening Saves Lives Reauthorization Act of 2019

II 116TH CONGRESS 1ST SESSION S. 2158 To improve certain programs of the Department of Health and Human Services with respect to heritable disorders. IN THE SENATE OF THE UNITED STATES JULY 18, 2019 Ms. HASSAN (for herself and Mr. GARDNER) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To improve certain programs of the Department of Health and Human Services with respect to heritable disorders. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘The Newborn Screen- 4 ing Saves Lives Reauthorization Act of 2019’’. 5 SEC. 2. AMENDMENTS. 6 (a) IMPROVED NEWBORN AND CHILD SCREENING 7 FOR HERITABLE DISORDERS.—Section 1109(a)(3) of the 8 Public Health Service Act (42 U.S.C. 300b–8(a)(3)) is 9 amended— 10 VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS 2 •S 2158 IS (1) by striking ‘‘develop and deliver educational 1 programs (at appropriate literacy levels)’’ and in- 2 serting ‘‘develop, deliver, and assess the impact of 3 educational programs (with varying levels of infor- 4 mation and at appropriate literacy levels)’’; and 5 (2) by striking ‘‘and specialty services’’ and in- 6 serting ‘‘specialty services, research-related pilot 7 studies, and long-term care’’. 8 (b) EXTENSION OF ADVISORY COMMITTEE ON HERI- 9 TABLE DISORDERS IN NEWBORNS AND CHILDREN.—Sec- 10 tion 1111(g) of the Public Health Service Act (42 U.S.C. 11 300b–10(g)) is amended by striking ‘‘2019’’ each place 12 it appears and inserting ‘‘2024’’. 13 (c) TECHNICAL AMENDMENTS.—Title XI of the Pub- 14 lic Health Service Act (42 U.S.C. 300b–1 et seq.) is 15 amended— 16 (1) in the section heading of section 1110, by 17 striking ‘‘FOLLOWUP’’ and inserting ‘‘FOLLOW- 18 UP’’; 19 (2) in sections 1109, 1110, and 1111, by strik- 20 ing ‘‘followup’’ each place such term appears and in- 21 serting ‘‘follow-up’’; and 22 (3) in paragraphs (1) and (2) of section 23 1110(b), by inserting ‘‘(including long-term follow- 24 up)’’ before ‘‘, or specialty’’. 25 VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS 3 •S 2158 IS (d) CLEARINGHOUSE OF NEWBORN SCREENING IN- 1 FORMATION.—Subsection (c) of section 1112 of the Public 2 Health Service Act (42 U.S.C. 300b–11) is amended to 3 read as follows: 4 ‘‘(c) NONDUPLICATION.—In carrying out activities 5 under this section, the Secretary shall ensure that such 6 activities minimize duplication and complement other ex- 7 isting Federal newborn screening-related information- 8 sharing activities.’’. 9 (e) LABORATORY QUALITY AND SURVEILLANCE.— 10 Section 1113 of the Public Health Service Act (42 U.S.C. 11 300b–12) is amended— 12 (1) in subsection (a)— 13 (A) in paragraph (1)— 14 (i) by striking ‘‘performance evalua- 15 tion services’’ and inserting ‘‘development 16 of new screening tests’’; and 17 (ii) by striking ‘‘; and’’ and inserting 18 a semicolon; 19 (B) in paragraph (2)— 20 (i) by striking ‘‘performance test ma- 21 terials’’ and inserting ‘‘test performance 22 materials’’; and 23 (ii) by striking the period and insert- 24 ing ‘‘; and’’; and 25 VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS 4 •S 2158 IS (C) by adding at the end the following: 1 ‘‘(3) performance evaluation services to enhance 2 disease detection, including the development of tools 3 and resources to improve data analysis, interpreta- 4 tion of test results, and dissemination of laboratory 5 best practices.’’; and 6 (2) in subsection (b)— 7 (A) in paragraph (1), by striking ‘‘; and’’ 8 and inserting a semicolon; 9 (B) in paragraph (2), by striking the pe- 10 riod and inserting ‘‘; and’’; and 11 (C) by adding at the end, the following: 12 ‘‘(3) by assisting States, as appropriate, in as- 13 sessing and conducting long-term follow-up and as- 14 sessing long-term outcomes.’’. 15 (f) HUNTER KELLY RESEARCH PROGRAM.—Section 16 1116(a)(1)(D) of the Public Health Service Act (42 17 U.S.C. 300b–15(a)(1)(D)) is amended— 18 (1) by inserting ‘‘, or with a high probability of 19 being recommend by,’’ after ‘‘recommended by’’; and 20 (2) by striking ‘‘to ensure that screenings are 21 ready for nationwide implementation’’ and inserting 22 ‘‘, which may include those conditions that have 23 been nominated pursuant to section 1111, to ensure 24 VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS 5 •S 2158 IS that screening technologies are piloted and ready for 1 implementation’’. 2 (g) AUTHORIZATION OF APPROPRIATIONS.—Section 3 1117 of the Public Health Service Act (42 U.S.C. 300b– 4 16) is amended— 5 (1) in paragraph (1), by striking ‘‘$11,900,000 6 for each of fiscal years 2015 through 2019’’ and in- 7 serting ‘‘$16,383,000 for each of fiscal years 2020 8 through 2024’’; and 9 (2) in paragraph (2), by striking ‘‘$8,000,000 10 for each of fiscal years 2015 through 2019’’ and in- 11 serting ‘‘$17,250,000 for each of fiscal years 2020 12 through 2024’’. 13 (h) TECHNICAL ASSISTANCE.—The Secretary shall 14 publish on the internet website of the Department of 15 Health and Human Services, information regarding the 16 process for obtaining technical assistance for submitting 17 nominations to the recommended uniform screening panel. 18 (i) REPORT ON THE MODERNIZATION OF NEWBORN 19 SCREENING.— 20 (1) IN GENERAL.—The Secretary of Health and 21 Human Services shall, directly or through a con- 22 tract, conduct an assessment of each of the fol- 23 lowing: 24 VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS 6 •S 2158 IS (A) The uniform screening panel review 1 and recommendation processes, including an as- 2 sessment of factors that impact decisions to add 3 new conditions to the uniform screening panel 4 and challenges associated with newly nominated 5 conditions, including rare diseases with late 6 onset variants. 7 (B) Strategies to support implementation 8 of uniform screening panel recommendations. 9 (C) Opportunities to improve newborn 10 screening research, such as piloting the screen- 11 ing of multiple conditions in a single test and 12 optimizing the capacity for such research. 13 (D) Technologies that would improve 14 screening, including technologies that identify 15 multiple, related disorders in a single test. 16 (E) Methods to improve public health sur- 17 veillance, timeliness of diagnosis, and short- and 18 long-term follow-up for infants identified 19 through newborn screening. 20 (F) Strategies to improve communication 21 with the public and stakeholders in order to 22 promote understanding and knowledge of the 23 newborn screening system. 24 VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS 7 •S 2158 IS (G) The quality of data on disease preva- 1 lence for screened conditions. 2 (H) The effect of newborn screening on the 3 outcomes of those identified as newborns 4 through such screenings. 5 (2) REPORT.—Not later than 2 years after the 6 date of enactment of this Act, the Secretary of 7 Health and Human Services shall submit, to the 8 Committee on Health, Education, Labor, and Pen- 9 sions of the Senate and the Committee on Energy 10 and Commerce of the House of Representatives, a 11 report containing the results of the assessment and 12 recommendations to improve processes described in 13 paragraph (1). 14 Æ VerDate Sep 11 2014 21:23 Jul 23, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S2158.IS S2158 kjohnson on DSK79L0C42 with BILLS