H.R. 1281 — what changed

Section 1109 of the Public Health Service Act (42 U.S.C. 300b–8) is amended—

added “(2) to assist in providing health care professionals and newborn screening laboratory personnel with education in newborn screening, counseling, and training in—

added “(A) relevant and new technologies in newborn screening and congenital, genetic, and metabolic disorders;

added “(B) the importance of the timeliness of collection, delivery, receipt, and screening of specimens; and

added “(C) sharing of medical and diagnostic information with providers and families;”

added “(5) to improve the timeliness of—

added “(A) the collection, delivery, receipt, and screening of specimens; and

added “(B) the diagnosis of heritable disorders in newborns.”

removed “(5) a health professional organization;

removed “(6) an early childhood health system; or”

Section 1110 of the Public Health Service Act (42 U.S.C. 300b–9) is amended—

changed “(4) methods that may be identified to improve quality in the availability diagnosis, treatment, and effectiveness disease management of treatment and followup care for newborns and their families after screening and diagnosis.”heritable disorders based on gaps in services or care; or

added “(5) methods or best practices by which the eligible entities described in section 1109 can achieve in a timely manner—

added “(A) collection, delivery, receipt, and screening of newborn screening specimens; and

added “(B) diagnosis of heritable disorders in newborns.”

Section 1111 of the Public Health Service Act (42 U.S.C. 300b–10) is amended—

added “(4) provide technical assistance, as appropriate, to individuals and organizations regarding the submission of nominations to the uniform screening panel, including prior to the submission of such nominations;

added “(5) take appropriate steps, at its discretion, to prepare for the review of nominations prior to their submission, including for conditions for which a screening method has been validated but other nomination criteria are not yet met, in order to facilitate timely action by the Advisory Committee once such submission has been received by the Committee;”

added “(L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and followup.”

added “(3) Deadline for review—For each condition nominated to be added to the recommended uniform screening panel in accordance with the requirements of this section, the Advisory Committee shall review and vote on the nominated condition within 9 months of the date on which the Advisory Committee referred the nominated condition to the condition review workgroup.”

added “(f) Meetings—The Advisory Committee shall meet at least 4 times each calendar year, or at the discretion of the Designated Federal Officer in consultation with the Chair.”

removed “(f) Meetings—The Advisory Committee shall meet in person at least twice each year.”

“(g) Continuation of operation of committee

added “(1) In general—Notwithstanding section 14 of the Federal Advisory Committee Act, the Advisory Committee shall continue to operate through the end of fiscal year 2019.

added “(2) Continuation if not reauthorized—If at the end of fiscal year 2019 the duration of the Advisory Committee has not been extended by statute, the Advisory Committee may be deemed, for purposes of the Federal Advisory Committee Act, an advisory committee established by the President or an officer of the Federal Government under section 9(a) of such Act.”

removed “(1) In general—Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue to operate for the period beginning on the date of enactment of the Newborn Screening Saves Lives Reauthorization Act of 2013 and concluding at the end of the fifth fiscal year which begins after such date.

removed “(2) Continuation if not reauthorized—If at the end of the fifth fiscal year described in paragraph (1) the duration of the Advisory Committee has not been extended by statute—

removed “(A) the Advisory Committee may be considered, for the purposes of the Federal Advisory Committee Act, to be an advisory committee established by the President or an officer of the Federal Government under section 9(a) of such Act; and

removed “(B) the Secretary may renew the Advisory Committee under section 14(a)(1)(A) of such Act.”

Section 1112 of the Public Health Service Act (42 U.S.C. 300b–11) is amended—

changed “(4) maintain current data information on the number of conditions for which screening is conducted in each State; and

changed “(5) establish or disseminate available evidence-based guidelines for services and personnel necessary for followup, related to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening.”

Section 1113 of the Public Health Service Act (42 U.S.C. 300b–12) is amended—

added “(b) Surveillance activities—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111, may provide, as appropriate, for the coordination of surveillance activities, including—

added “(1) through standardized data collection and reporting, as well as the use of electronic health records; and

added “(2) by promoting data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs.”

Section 1114 of the Public Health Service Act (42 U.S.C. 300b–13) is amended—

removed “(e) Report to congress

removed “(1) In general—The Secretary shall—

removed “(A) not later than 1 year after the date of enactment of the Newborn Screening Saves Lives Reauthorization Act of 2013, submit to the Health, Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce Committee of the House of Representatives a report on activities related to—

removed “(i) newborn screening; and

removed “(ii) screening children who have or are at risk for heritable disorders; and

removed “(B) not less than every 2 years, shall submit to such committees an updated version of such report.

removed “(2) Contents—The report submitted under subsection (a) shall contain a description of—

removed “(A) the implementation of sections 1111 through 1116B, including this section; and

removed “(B) the amounts expended on such implementation.”

changed Section 1115(a) of the Public Health Service Act (42 U.S.C. 300b–14(a)) is amended by adding at the end the following: “The plan shall be updated as needed and at least every five years.”.amended—

changed Section 1116(a)(1) 1116 of the Public Health Service Act (42 U.S.C. 300b–15(a)(1)) 300b–15) is amended—

added “(C) providing research findings and data for newborn conditions under review by the Advisory Committee on Heritable Disorders in Newborns and Children to be added to the recommended uniform screening panel;

removed “(C) providing research and data for newborn conditions under review by the Advisory Committee on Heritable Disorders in Newborns and Children to be added to the Recommended Uniform Screening Panel;

“(D) conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation; and”

changed The Part A of title XI of the Public Health Service Act (42 U.S.C. 300b–1 et seq.) is amended by inserting after section 1116 of such Act (42 U.S.C. 300b–15) adding at the end, the following:

changed “1116A. Newborn “1117. Authorization of appropriations for newborn screening surveillance, followup, programs and applied researchactivities

changed “(a) In general—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to, or enter into cooperative agreements with, eligible entities “There are authorized to develop longitudinal followup and tracking programs for newborn screening.be appropriated—

changed “(b) Program—Longitudinal followup “(1) to carry out sections 1109, 1110, 1111, and tracking programs developed through a grant under subsection (a) shall incorporate standardized procedures 1112, $11,900,000 for data management and program effectiveness and costs, such as—each of fiscal years 2015 through 2019; and

changed “(1) studying the costs and effectiveness of newborn screening, evaluation and intervention programs, and surveillance systems conducted by State-based programs in order “(2) to answer issues carry out section 1113, $8,000,000 for each of importance to State and national policymakers;fiscal years 2015 through 2019.”

removed “(2) studying the effectiveness of newborn screening followup and intervention programs by assessing the health and development of children at school age and as young adults;

removed “(3) promoting the sharing of data regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs;

removed “(4) ensuring coordination of surveillance activities, including—

removed “(A) standardized data collection and reporting; and

removed “(B) use of electronic health records;

removed “(5) facilitating quality improvement in treatment and disease management based on gaps in services or care identified by longitudinal tracking systems; and

removed “(6) utilizing data from longitudinal tracking systems to support the development and evaluation of evidence-based guidelines for diagnosis, treatment, and disease management.

removed “(c) Eligible entity—In this section, the term eligible entity means—

removed “(1) a State or a political subdivision of a State;

removed “(2) a consortium of 2 or more States or subdivisions described in paragraph (1);

removed “(3) a health facility or program operated by or pursuant to a contract with, or a grant from, the Indian Health Service; or

removed “(4) any other entity with appropriate expertise in newborn screening, as determined by the Secretary.”

removed The Public Health Service Act is amended by inserting after section 1116A of such Act, as added by section 10 of this Act, the following:

removed “1116B. Authorization of appropriations for newborn screening programs and activities

removed “There are authorized to be appropriated—

removed “(1) to carry out sections 1109, 1110, 1111, and 1112, $13,334,000 for each of fiscal years 2014 through 2018;

removed “(2) to carry out section 1113, $7,500,000 for each of fiscal years 2014 through 2018; and

removed “(3) to carry out section 1116A, $5,000,000 for each of fiscal years 2014 through 2018.”