II 116th CONGRESS 1st Session S. 2158 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, Education, Labor, and Pensions A BILL To improve certain programs of the Department of Health and Human Services with respect to heritable disorders.

1. Short title This Act may be cited as the The Newborn Screening Saves Lives Reauthorization Act of 2019 . 2. Amendments (a) Improved newborn and child screening for heritable disorders Section 1109(a)(3) of the Public Health Service Act ( 42 U.S.C. 300b–8(a)(3) ) is amended— (1) by striking develop and deliver educational programs (at appropriate literacy levels) and inserting develop, deliver, and assess the impact of educational programs (with varying levels of information and at appropriate literacy levels) ; and (2) by striking and specialty services and inserting specialty services, research-related pilot studies, and long-term care . (b) Extension of advisory committee on heritable disorders in newborns and children Section 1111(g) of the Public Health Service Act ( 42 U.S.C. 300b–10(g) ) is amended by striking 2019 each place it appears and inserting 2024 . (c) Technical amendments Title XI of the Public Health Service Act ( 42 U.S.C. 300b–1 et seq.) is amended— (1) in the section heading of section 1110, by striking Followup and inserting Follow-Up ; (2) in sections 1109, 1110, and 1111, by striking followup each place such term appears and inserting follow-up ; and (3) in paragraphs (1) and (2) of section 1110(b), by inserting (including long-term follow-up) before , or specialty . (d) Clearinghouse of newborn screening information Subsection (c) of section 1112 of the Public Health Service Act ( 42 U.S.C. 300b–11 ) is amended to read as follows: (c) Nonduplication In carrying out activities under this section, the Secretary shall ensure that such activities minimize duplication and complement other existing Federal newborn screening-related information-sharing activities. . (e) Laboratory quality and surveillance Section 1113 of the Public Health Service Act ( 42 U.S.C. 300b–12 ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking performance evaluation services and inserting development of new screening tests ; and (ii) by striking ; and and inserting a semicolon; (B) in paragraph (2)— (i) by striking performance test materials and inserting test performance materials ; and (ii) by striking the period and inserting ; and ; and (C) by adding at the end the following: (3) performance evaluation services to enhance disease detection, including the development of tools and resources to improve data analysis, interpretation of test results, and dissemination of laboratory best practices. ; and (2) in subsection (b)— (A) in paragraph (1), by striking ; and and inserting a semicolon; (B) in paragraph (2), by striking the period and inserting ; and ; and (C) by adding at the end, the following: (3) by assisting States, as appropriate, in assessing and conducting long-term follow-up and assessing long-term outcomes. . (f) Hunter Kelly research program Section 1116(a)(1)(D) of the Public Health Service Act ( 42 U.S.C. 300b–15(a)(1)(D) ) is amended— (1) by inserting , or with a high probability of being recommend by, after recommended by ; and (2) by striking to ensure that screenings are ready for nationwide implementation and inserting , which may include those conditions that have been nominated pursuant to section 1111, to ensure that screening technologies are piloted and ready for implementation . (g) Authorization of appropriations Section 1117 of the Public Health Service Act ( 42 U.S.C. 300b–16 ) is amended— (1) in paragraph (1), by striking $11,900,000 for each of fiscal years 2015 through 2019 and inserting $16,383,000 for each of fiscal years 2020 through 2024 ; and (2) in paragraph (2), by striking $8,000,000 for each of fiscal years 2015 through 2019 and inserting $17,250,000 for each of fiscal years 2020 through 2024 . (h) Technical assistance The Secretary shall publish on the internet website of the Department of Health and Human Services, information regarding the process for obtaining technical assistance for submitting nominations to the recommended uniform screening panel. (i) Report on the modernization of newborn screening (1) In general The Secretary of Health and Human Services shall, directly or through a contract, conduct an assessment of each of the following: (A) The uniform screening panel review and recommendation processes, including an assessment of factors that impact decisions to add new conditions to the uniform screening panel and challenges associated with newly nominated conditions, including rare diseases with late onset variants. (B) Strategies to support implementation of uniform screening panel recommendations. (C) Opportunities to improve newborn screening research, such as piloting the screening of multiple conditions in a single test and optimizing the capacity for such research. (D) Technologies that would improve screening, including technologies that identify multiple, related disorders in a single test. (E) Methods to improve public health surveillance, timeliness of diagnosis, and short- and long-term follow-up for infants identified through newborn screening. (F) Strategies to improve communication with the public and stakeholders in order to promote understanding and knowledge of the newborn screening system. (G) The quality of data on disease prevalence for screened conditions. (H) The effect of newborn screening on the outcomes of those identified as newborns through such screenings. (2) Report Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report containing the results of the assessment and recommendations to improve processes described in paragraph (1).