Newborn Screening Saves Lives Reauthorization Act of 2013

Summary: (This measure has not been amended since it was reported to the Senate on December 19, 2013.  Newborn Screening Saves Lives Reauthorization Act of 2013 - (Sec. 2) Amends the Public Health Service Act to extend through FY2018 a grant program for newborn and child screening programs for heritable disorders. Includes the improvement of the timely collection, delivery, and receipts, and screening of specimens, and the timely diagnosis of heritable disorders in newborns as a permissible use of grant funds. (Sec. 3) Extends through FY2018 a demonstration program to evaluate the effectiveness of screening, follow-up, counseling or health care services in reducing the morbidity and mortality caused by heritable disorders in newborn and children. Permits the program to also evaluate and assess: (1) methods to improve quality in the diagnosis, treatment, and disease management of heritable disorders based on gaps in services or care; and (2) methods or best practices by which states or political subdivisions of a state, territories, Indian health care facilities or programs, or any entity with appropriate expertise in newborn screening can achieve the timely collection, delivery, receipt, and screening of newborn screening specimens, and the timely diagnosis of heritable disorders in newborns. (Sec. 4) Reauthorizes through FY2018 and extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Expands the duties of the Advisory Committee to include providing technical assistance to individuals and organizations regarding the submission of nominations to the uniform screening panel. Requires the Advisory Committee to give recommendations, advice, or information to the Secretary of Health and Human Services (HHS) on the timely collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns.  Revises the process for the Secretary to consider the Advisory Committee's recommendations. Requires the Advisory Committee to meet at least four times per year. (Sec. 5) Extends through FY2018 the Newborn Screening Clearinghouse of current education and family support and services information, materials, resources, research, and data on newborn screening. (Sec. 6) Extends through FY2018 a quality assurance program requiring the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to provide for quality assurance of laboratories involved in screening for heritable disorders. Authorizes the Secretary, acting through the Director, to also provide for the coordination of surveillance activities. (Sec. 7) Makes the Interagency Coordinating Committee on Newborn and Child Screening permanent. Includes the Commissioner of Food and Drugs (FDA) as a member of the Interagency Committee. (Sec. 8) Requires the national contingency plan for newborn screening to be updated at least every five years. (Sec. 9) Allows the expansion of the Hunter Kelly Newborn Screening Research Program to include: (1) providing research findings and data for newborn conditions under review by the Advisory Committee to be added to the recommended uniform screening panel, and (2) conducting pilot studies on conditions recommended by the Advisory Committee to ensure that the screenings are ready for nationwide implementation. (Sec. 11) Requires the Comptroller General to report to the relevant congressional committees on the timeliness of screening for heritable disorders in newborns. Requires the Secretary to report to the relevant congressional committees biennially on activities related to newborn screening and screening children who have or are at risk for heritable disorders.

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Newborn Screening 
Saves Lives Reauthorization Act of 2013''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Improved newborn and child screening and follow-up for 
                            heritable disorders.
Sec. 3. Evaluating the effectiveness of newborn and child screening and 
                            follow-up programs.
Sec. 4. Advisory Committee on Heritable Disorders in Newborns and 
                            Children.
Sec. 5. Clearinghouse of Newborn Screening Information.
Sec. 6. Laboratory quality and surveillance.
Sec. 7. Interagency Coordinating Committee on Newborn and Child 
                            Screening.
Sec. 8. National contingency plan for newborn screening.
Sec. 9. Hunter Kelly Research Program.
Sec. 10. Authorization of appropriations.
Sec. 11. Reports to Congress

SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOW-UP FOR 
              HERITABLE DISORDERS.

    Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is 
amended--
            (1) in subsection (a)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by striking ``subsection (j)'' and 
                        inserting ``section 1117''; and
                            (ii) by striking ``and in consultation with 
                        the Advisory Committee'' and inserting ``and 
                        taking into consideration the expertise of the 
                        Advisory Committee'';
                    (B) in paragraph (2), by striking ``screening and 
                training'' and inserting ``screening, counseling, and 
                training'';
                    (C) in paragraph (3), by striking ``and'' at the 
                end;
                    (D) in paragraph (4)--
                            (i) by striking ``treatment'' and inserting 
                        ``follow-up and treatment''; and
                            (ii) by striking the period and inserting 
                        ``; and''; and
                    (E) by adding at the end the following:
            ``(5) to improve the timely collection, delivery, receipt, 
        and screening of specimens, and the timely diagnosis of 
        heritable disorders in newborns.'';
            (2) in subsection (h), by striking ``subsection (c)(2)'' 
        each place that such appears and inserting ``subsection (c)''; 
        and
            (3) by striking subsection (j) (relating to authorization 
        of appropriations).

SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING AND 
              FOLLOW-UP PROGRAMS.

    Section 1110 of the Public Health Service Act (42 U.S.C. 300b-9) is 
amended--
            (1) in the section heading, by inserting ``and follow-up'' 
        after ``child screening'';
            (2) in subsection (a), by striking ``of screening,'' and 
        inserting ``, including with respect to timeliness, of 
        screening, follow-up,'';
            (3) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) by striking ``counseling, testing'' and 
                        inserting ``treatment, counseling, testing, 
                        follow-up,''; and
                            (ii) by inserting before the semicolon the 
                        following: ``, including, as appropriate, 
                        through the assessment of health and 
                        development outcomes for such children through 
                        adolescence'';
                    (B) in paragraph (2)--
                            (i) by striking ``counseling, testing'' and 
                        inserting ``treatment, counseling, testing, 
                        follow-up,''; and
                            (ii) by striking ``or'' at the end;
                    (C) in paragraph (3), by striking the period at the 
                end and inserting a semicolon; and
                    (D) by adding at the end the following:
            ``(4) methods that may be identified to improve quality in 
        the diagnosis, treatment, and disease management of heritable 
        disorders based on gaps in services or care; or
            ``(5) methods or best practices by which the eligible 
        entities described in section 1109 can achieve the timely 
        collection, delivery, receipt, and screening of newborn 
        screening specimens, and the timely diagnosis of heritable 
        disorders in newborns.''; and
            (4) by striking subsection (d) (relating to authorization 
        of appropriations).

SEC. 4. 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--
            (1) in subsection (b)--
                    (A) by redesignating paragraphs (4) through (6) as 
                paragraphs (5) through (7), respectively;
                    (B) by inserting after paragraph (3), the 
                following:
            ``(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;'';
                    (C) in paragraph (5) (as so redesignated), by 
                inserting ``, including the cost'' after ``public 
                health impact''; and
                    (D) in paragraph (7) (as so redesignated)--
                            (i) in subparagraph (A), by striking 
                        ``achieve rapid diagnosis'' and inserting 
                        ``achieve best practices in rapid diagnosis and 
                        appropriate treatment'';
                            (ii) in subparagraph (D), by inserting 
                        before the semicolon ``, including information 
                        on cost and incidence'';
                            (iii) in subparagraph (J), by striking 
                        ``and'' at the end;
                            (iv) in subparagraph (K), by striking the 
                        period and inserting ``; and''; and
                            (v) by adding at the end the following:
                    ``(L) the timely collection, delivery, receipt, and 
                screening of specimens to be tested for heritable 
                disorders in newborns in order to ensure rapid 
                diagnosis and follow-up.'';
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) by striking ``180'' and inserting 
                        ``120''; and
                            (ii) by adding at the end the following: 
                        ``If the Secretary is unable to make a 
                        determination to adopt or reject such 
                        recommendation within such 120-day period, the 
                        Secretary shall notify the Advisory Committee 
                        and the appropriate committees of Congress of 
                        such determination together with an explanation 
                        for why the Secretary was unable to comply 
                        within such 120-day period, as well as a plan 
                        of action for consideration of such pending 
                        recommendations.'';
                    (B) by striking paragraph (2);
                    (C) by redesignating paragraph (3) as paragraph 
                (2); and
                    (D) by adding at the end the following:
            ``(3) Deadline for review.--For each nomination to the 
        recommended uniform screening panel, the Advisory Committee on 
        Heritable Disorders in Newborns and Children shall review and 
        vote on the nominated condition within 9 months of the date on 
        which the Advisory Committee referred the nomination to the 
        condition review workgroup.'';
            (3) by redesignating subsections (f) and (g) as subsections 
        (g) and (h), respectively;
            (4) by inserting after subsection (e) the following new 
        subsection:
    ``(f) Meetings.--The Advisory Committee shall meet at least 4 times 
each calendar year, or as subject to the discretion of the Designated 
Federal Officer in consultation with the Chair.'';
            (5) in subsection (g) (as so redesignated), by striking 
        ``Newborn Screening Saves Lives Act of 2008'' and inserting 
        ``Newborn Screening Saves Lives Reauthorization Act of 2013''; 
        and
            (6) by striking subsection (h) (relating to authorization 
        of appropriations), as redesignated by paragraph (3).

SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

    Section 1112 of the Public Health Service Act (42 U.S.C. 300b-11) 
is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in paragraph (3)--
                            (i) by striking ``data'' and inserting 
                        ``information''; and
                            (ii) by striking the period at the end and 
                        inserting a semicolon; and
                    (C) by adding at the end the following new 
                paragraphs:
            ``(4) maintain current information on the number of 
        conditions for which screening is conducted in each State; and
            ``(5) disseminate available evidence-based guidelines 
        related to diagnosis, counseling, and treatment with respect to 
        conditions detected by newborn screening.'';
            (2) in subsection (b)(4)(D), by striking ``Newborn 
        Screening Saves Lives Act of 2008'' and inserting ``Newborn 
        Screening Saves Lives Reauthorization Act of 2013'';
            (3) in subsection (c)--
                    (A) by striking ``developing the clearinghouse'' 
                and inserting ``carrying out activities''; and
                    (B) by striking ``clearinghouse minimizes'' and 
                inserting ``activities minimize''; and
            (4) by striking subsection (d) (relating to authorization 
        of appropriations).

SEC. 6. LABORATORY QUALITY AND SURVEILLANCE.

    Section 1113 of the Public Health Service Act (42 U.S.C. 300b-12) 
is amended--
            (1) in the section heading, by inserting ``and 
        surveillance'' before the period;
            (2) in subsection (a)--
                    (A) by striking the subsection enumerator and 
                heading;
                    (B) in the matter preceding paragraph (1), by 
                striking ``and in consultation with the Advisory 
                Committee'' and inserting ``and taking into 
                consideration the expertise of the Advisory 
                Committee'';
                    (C) in paragraph (1)--
                            (i) by inserting ``timeliness for 
                        processing such tests,'' after ``newborn 
                        screening tests''; and
                            (ii) by striking ``and'' at the end; and
                    (D) in paragraph (2), by striking the period and 
                inserting ``; and''; and
            (3) by striking subsection (b) (relating to authorization 
        of appropriations) and inserting the following:
    ``(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--
            ``(1) through standardized data collection and reporting, 
        as well as the use of electronic health records; and
            ``(2) by promoting data sharing regarding newborn screening 
        with State-based birth defects and developmental disabilities 
        monitoring programs.''.

SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD 
              SCREENING.

    Section 1114 of the Public Health Service Act (42 U.S.C. 300b-13) 
is amended--
            (1) in subsection (c), by striking ``the Administrator, the 
        Director of the Agency for Healthcare Research and Quality'' 
        and inserting ``the Administrator of the Health Resources and 
        Services Administration, the Director of the Agency for 
        Healthcare Research and Quality, the Commissioner of Food and 
        Drugs,''; and
            (2) by striking subsection (e) (relating to authorization 
        of appropriations).

SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.

    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.''.

SEC. 9. HUNTER KELLY RESEARCH PROGRAM.

    Section 1116(a)(1) of the Public Health Service Act (42 U.S.C. 
300b-15(a)(1)) is amended--
            (1) in subparagraph (B), by striking ``; and'' and 
        inserting a semicolon;
            (2) by redesignating subparagraph (C) as subparagraph (E); 
        and
            (3) by inserting after subparagraph (B) the following:
                    ``(C) by 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;
                    ``(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''.

SEC. 10. AUTHORIZATION OF APPROPRIATIONS.

    Part A of title XI of the Public Health Service Act is amended by 
adding at the end, the following:

``SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR NEWBORN SCREENING 
              PROGRAMS AND ACTIVITIES.

    ``There are authorized to be appropriated--
            ``(1) to carry out sections 1109, 1110, 1111, and 1112, 
        $18,334,000 for each of fiscal years 2014 through 2018; and
            ``(2) to carry out section 1113, $7,500,000 for each of 
        fiscal years 2014 through 2018.''.

SEC. 11. REPORTS TO CONGRESS.

    (a) GAO Report on Timeliness of Newborn Screening.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall submit a report to the Committee on Health, 
        Education, Labor and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives 
        concerning the timeliness of screening for heritable disorders 
        in newborns.
            (2) Contents.--The report submitted under paragraph (1) 
        shall include the following:
                    (A) An analysis of information regarding the 
                timeliness of newborn screening, which may include the 
                time elapsed from birth to specimen collection, 
                specimen collection to receipt by laboratory, specimen 
                receipt to reporting, reporting to follow-up testing, 
                and follow-up testing to confirmed diagnosis.
                    (B) A summary of any guidelines, recommendations, 
                or best practices available to States and health care 
                providers intended to support a timely newborn 
                screening system.
                    (C) An analysis of any barriers to maintaining a 
                timely newborn screening system which may exist and 
                recommendations for addressing such barriers.
    (b) Report by Secretary.--
            (1) In general.--The Secretary of Health and Human Services 
        shall--
                    (A) not later than 1 year after the date of 
                enactment of the Newborn Screening Saves Lives 
                Reauthorization Act of 2013, 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 on activities related to--
                            (i) newborn screening; and
                            (ii) screening children who have or are at 
                        risk for heritable disorders; and
                    (B) not less than every 2 years, shall submit to 
                such committees an updated version of such report.
            (2) Contents.--The report submitted under this subsection 
        shall contain a description of--
                    (A) the ongoing activities under sections 1109, 
                1110, and 1112 through 1115 of the Public Health 
                Service Act; and
                    (B) the amounts expended on such activities.

            Passed the Senate January 29, 2014.

            Attest:

                                                NANCY ERICKSON,

                                                             Secretary.