H.R. 2507 — what changed
Newborn Screening Saves Lives Reauthorization Act of 2019
From Introduced in House to Reported in House. 3 sections amended between Introduced in House and Reported in House.
Sec. 2 Improved newborn and child screening and follow-up for heritable disorders
added
Purposes— Section 1109(a) of the Public Health Service Act (42 U.S.C. 300b–8(a)) is amended—
added
in paragraph (1), by striking “enhance, improve or” and inserting “facilitate, enhance, improve, or”;
added
by amending paragraph (3) to read as follows:
added “(3) to develop, and deliver to parents, families, and patient advocacy and support groups, educational programs that—
added “(A) address newborn screening counseling, testing (including newborn screening pilot studies), follow-up, treatment, specialty services, and long-term care;
added “(B) assess the target audience’s current knowledge, incorporate health communications strategies, and measure impact; and
added “(C) are at appropriate literacy levels;”
added
in paragraph (4)—
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by striking “followup” and inserting “follow-up”; and
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by inserting before the semicolon at the end the following: “, including re-engaging patients who have not received recommended follow-up services and supports”.
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Approval factors— Section 1109(c) of the Public Health Service Act (42 U.S.C. 300b–8(c)) is amended—
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by striking “or will use” and inserting “will use”; and
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by inserting “, or will use amounts received under such grant to enhance capacity and infrastructure to facilitate the adoption of,” before “the guidelines and recommendations”.
removed
Section 1109(a)(3) of the Public Health Service Act (42 U.S.C. 300b–8(a)(3)) is amended to read as follows:
removed
“(3) to develop and deliver educational programs (at appropriate literacy levels) about newborn screening counseling, testing, follow-up, treatment, specialty services, and long-term care to parents, families, and patient advocacy and support groups that assess the target audience’s current knowledge, incorporate health communications strategies, and measure impact;”
Sec. 3 Advisory committee on heritable disorders in newborns and children
Section 1111 of the Public Health Service Act (42 U.S.C. 300b–10) is amended—
in subsection (b)—
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in paragraph (5), by inserting “and adopt process improvements” after “take appropriate steps”;
renumbered
was (3)(2)
in paragraph (7) by striking “and” at the end;
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by redesignating paragraph (8) as paragraph (9);
removed
by redesignating paragraph (8) as paragraph (9); and
renumbered
was (3)(4)
by inserting after paragraph (7) the following:
“(8) develop, maintain, and publish on a publicly accessible website consumer-friendly materials detailing—
“(A) the uniform screening panel nomination process, including data requirements, standards, and the use of international data in nomination submissions; and
“(B) the process for obtaining technical assistance for submitting nominations to the uniform screening panel and detailing the instances in which the provision of technical assistance would introduce a conflict of interest for members of the Advisory Committee; and”
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in paragraph (9), as redesignated—
added
by redesignating subparagraphs (K) and (L) as subparagraphs (L) and (M), respectively; and
added
by inserting after subparagraph (J) the following:
added “(K) the appropriate and recommended use of safe and effective genetic testing by health care professionals in newborns and children with an initial diagnosis of a disease or condition characterized by a variety of genetic causes and manifestations;”
in subsection (g)—
in paragraph (1) by striking “2019” and inserting “2024”; and
in paragraph (2) by striking “2019” and inserting “2024”.
Sec. 9 NAM report on the modernization of newborn screening
Study— Not later than 60 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall seek to enter into an agreement with the National Academy of Medicine (in this section referred to as “NAM”) (or if NAM declines to enter into such an agreement, another appropriate entity) under which NAM, or such other appropriate entity, agrees to conduct a study on the following:
The uniform screening panel review and recommendation processes to identify factors that impact decisions to add new conditions to the uniform screening panel, to describe challenges posed by newly nominated conditions, including low-incidence diseases, late onset variants, and new treatments without long-term efficacy data.
The barriers that preclude States from adding new uniform screening panel conditions to their State screening panels with recommendations on resources needed to help States implement uniform screening panel recommendations.
The current state of federally and privately funded newborn screening research with recommendations for optimizing the capacity of this research, including piloting multiple prospective conditions at once and addressing rare disease questions.
New and emerging technologies that would permit screening for new categories of disorders, or would make current screening more effective, more efficient, or less expensive.
Technological and other infrastructure needs to improve timeliness of diagnosis and short- and long-term follow-up for infants identified through newborn screening and improve public health surveillance.
Current and future communication and educational needs for priority stakeholders and the public to promote understanding and knowledge of a modernized newborn screening system with an emphasis on evolving communication channels and messaging.
The extent to which newborn screening yields better data on the disease prevalence for screened conditions and improves long-term outcomes for those identified through newborn screening, including existing systems supporting such data collection and recommendations for systems that would allow for improved data collection.
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The impact on newborn morbidity and mortality in States that adopt newborn screening tests included on the uniform panel.
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Public stakeholder meeting— In the course of completing the study described in subsection (a), NAM or such other appropriate entity shall hold not less than one public meeting to obtain stakeholder input on the topics of such study.
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was (3)
Report— Not later than 18 months after the effective date of the agreement under subsection (a), such agreement shall require NAM, or such other appropriate entity, to submit to the Secretary of Health and Human Services and the appropriate committees of jurisdiction of Congress a report containing—
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was (3)(3)
the results of the study conducted under subsection (a);
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was (3)(4)
recommendations to modernize the processes described in subsection (a)(1); and
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was (3)(5)
recommendations for such legislative and administrative action as NAM, or such other appropriate entity, determines appropriate.
renumbered
was (4)
Authorization of appropriations— There is authorized to be appropriated $2,000,000 for the period of fiscal years 2020 and 2021 to carry out this section.