II 

112TH CONGRESS 

1ST SESSION S. 1440 

To reduce preterm labor and delivery and the risk of pregnancy-related 

deaths and complications due to pregnancy, and to reduce infant mortality caused by prematurity. 

IN THE SENATE OF THE UNITED STATES 

JULY 28, 2011 

Mr. ALEXANDER (for himself and Mr. BENNET) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To reduce preterm labor and delivery and the risk of pregnancy-related deaths and complications due to pregnancy, 

and to reduce infant mortality caused by prematurity. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prematurity Research 

5 Expansion and Education for Mothers who deliver Infants 

6 Early Reauthorization Act’’ or the ‘‘PREEMIE Reauthor7 ization Act’’. 

8 SEC. 2. PURPOSES. 

9 It is the purpose of this Act to— 


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1 (1) help reduce preterm birth, associated dis2 abilities of preterm birth, and deaths of babies born 

3 preterm; 

4 (2) expand research into the causes of preterm 

5 birth; and 

6 (3) promote the development, availability, and 

7 use of evidence-based practices of care for pregnant 

8 women at risk of preterm labor or other serious 

9 pregnancy-related complications and for infants born 

10 preterm. 

11 SEC. 3. RESEARCH AND ACTIVITIES AT THE NATIONAL IN12 STITUTES OF HEALTH. 

13 Part B of title IV of the Public Health Service Act 

14 (42 U.S.C. 284 et seq.) is amended by adding at the end 

15 the following: 

16 ‘‘SEC. 409K. EXPANSION AND COORDINATION OF RESEARCH 

17 RELATING TO PRETERM LABOR AND DELIV18 ERY AND INFANT MORTALITY. 

19 ‘‘(a) IN GENERAL.—The Secretary, acting through 

20 the Director of NIH, shall, subject to the availability of 

21 appropriations, expand, intensify, and coordinate the ac22 tivities of the National Institutes of Health with respect 

23 to research on the causes of preterm labor and delivery, 

24 tools to detect, prevent, or reduce prevalence of preterm 


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1 labor and delivery, and the care and treatment of preterm 

2 infants. 

3 ‘‘(b) AUTHORIZATION OF CLINICAL RESEARCH NET4 WORKS.—There shall be established within the National 

5 Institutes of Health a multi-center clinical program (that 

6 shall be initially established utilizing existing networks) 

7 designed to— 

8 ‘‘(1) investigate problems in clinical obstetrics, 

9 particularly those related to prevention of low birth 

10 weight, prematurity, and medical problems of preg11 nancy; 

12 ‘‘(2) improve the care and outcomes of neo13 nates, especially very-low-birth weight infants; and 

14 ‘‘(3) enhance the understanding of DNA and 

15 proteins as they relate to the underlying processes 

16 that lead to preterm birth to aid in formulating 

17 more effective interventions to prevent preterm 

18 birth. 

19 ‘‘(c) TRANS-DISCIPLINARY CENTERS FOR PRETERM

20 BIRTH RESEARCH.— 

21 ‘‘(1) IN GENERAL.—The Director of NIH shall, 

22 subject to appropriations made available to carry out 

23 this subsection, award grants and contracts to public 

24 and nonprofit private entities to pay all or part of 

25 the cost of planning, establishing, improving, and 


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1 providing basic operating support for trans-discipli2 nary research centers for prematurity. Research sup3 ported under this subsection shall integrate clinical, 

4 public health, basic, and behavioral and social 

5 science disciplines together with bioinformatics, engi6 neering, mathematical, and computer sciences to ad7 dress the causes of preterm labor and delivery col8 laboratively. 

9 ‘‘(2) ELIGIBILITY.—To be eligible to receive a 

10 grant or contract under paragraph (1), an entity 

11 shall submit to the Director an application at such 

12 time, in such manner, and containing such informa13 tion as the Director may require, including, if appro14 priate, an assurance that the entity will coordinate 

15 with clinical research networks authorized in sub16 section (b). 

17 ‘‘(3) REPORT.—The Director of NIH shall in18 clude in the report under section 402A(c) informa19 tion on the activities of the trans-disciplinary re20 search centers for prematurity under this subsection. 

21 ‘‘(d) NATIONAL EDUCATIONAL CAMPAIGN.— 

22 ‘‘(1) ESTABLISHMENT.—The Secretary, acting 

23 through the Surgeon General of the Public Health 

24 Service and in consultation with the Director of the 

25 Eunice Kennedy Shriver National Institute on Child 


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1 Health and Human Development, shall establish and 

2 implement a national science-based provider and 

3 consumer education campaign on promoting healthy 

4 pregnancies and preventing preterm birth. 

5 ‘‘(2) TARGETING.—The campaign established 

6 under paragraph (1) shall target women of child7 bearing age, high risk populations, ethnic and mi8 nority groups, individuals with a low socioeconomic 

9 status, obstetricians and gynecologists, nurse practi10 tioners, certified nurse-midwives, certified midwives, 

11 and other health care providers.’’. 

12 SEC. 4. RESEARCH AND ACTIVITIES AT THE CENTERS FOR 

13 DISEASE CONTROL AND PREVENTION. 

14 (a) EPIDEMIOLOGICAL STUDIES.—Section 3 of the 

15 Prematurity Research Expansion and Education for 

16 Mothers who deliver Infants Early Act (42 U.S.C. 247b– 

17 4f) is amended by striking subsection (b) and inserting 

18 the following: 

19 ‘‘(b) STUDIES AND ACTIVITIES ON PRETERM

20 BIRTH.— 

21 ‘‘(1) IN GENERAL.—The Secretary of Health 

22 and Human Services, acting through the Director of 

23 the Centers for Disease Control and Prevention, 

24 shall, subject to the availability of appropriations— 


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1 ‘‘(A) conduct ongoing epidemiological stud2 ies on the clinical, biological, social, environ3 mental, genetic, and behavioral factors relating 

4 to prematurity; 

5 ‘‘(B) conduct activities to improve national 

6 data to facilitate tracking the burden of 

7 preterm birth; 

8 ‘‘(C) develop, implement, and evaluate 

9 novel methods for prevention to better under10 stand the growing problem of late preterm 

11 birth; 

12 ‘‘(D) conduct etiologic and epidemiologic 

13 studies of preterm birth; 

14 ‘‘(E) expand research on racial and ethnic 

15 disparities as they relate to preterm birth; and 

16 ‘‘(F) conduct ongoing epidemiological stud17 ies on the effectiveness of community based 

18 interventions. 

19 ‘‘(2) REPORT.—Not later than 2 years after the 

20 date of enactment of the PREEMIE Reauthoriza21 tion Act, and every 2 years thereafter, the Secretary 

22 of Health and Human Services, acting through the 

23 Director of the Centers for Disease Control and Pre24 vention, shall submit to the appropriate committees 


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1 of Congress reports concerning the progress and any 

2 results of studies conducted under paragraph (1).’’. 

3 (b) REAUTHORIZATION.—Section 3(e) of the Pre4 maturity Research Expansion and Education for Mothers 

5 who deliver Infants Early Act (42 U.S.C. 247b–4f(e)) is 

6 amended by striking ‘‘2011’’ and inserting ‘‘2016’’. 

7 SEC. 5. RESEARCH AND ACTIVITIES AT THE HEALTH RE8 SOURCES AND SERVICES ADMINISTRATION. 

9 (a) TELEMEDICINE DEMONSTRATION PROJECT ON

10 HIGH RISK PREGNANCIES.—Section 330I of the Public 

11 Health Service Act (42 U.S.C. 254c–14) is amended— 

12 (1) by redesignating subsections (q) through (s) 

13 as subsections (r) through (t), respectively; 

14 (2) by inserting after subsection (p), the fol15 lowing: 

16 ‘‘(q) TELEMEDICINE DEMONSTRATION PROJECT ON

17 HIGH RISK PREGNANCIES.— 

18 ‘‘(1) IN GENERAL.—The Director shall award 

19 grants under this section to eligible entities to estab20 lish demonstration projects for— 

21 ‘‘(A) the provision of preconception, 

22 antepartum, intrapartum, and obstetric services 

23 to high risk women of child bearing age re24 motely by obstetricians and gynecologists, nurse 

25 practitioners, certified nurse-midwives, certified 


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1 midwives, or other health care providers using 

2 telehealth; and 

3 ‘‘(B) for the conduct of educational activi4 ties regarding risk factors for preterm birth. 

5 ‘‘(2) ELIGIBILITY.—To be eligible to receive a 

6 grant under paragraph (1), an entity shall submit 

7 an application to the Director at such time, in such 

8 manner, and containing such information as the Di9 rector my require.’’; and 

10 (3) in subsection (t) (as so redesignated)— 

11 (A) in paragraph (1), by striking ‘‘and’’ at 

12 the end; 

13 (B) in paragraph (2), by striking the pe14 riod and inserting ‘‘; and’’; and 

15 (C) by adding at the end the following: 

16 ‘‘(3) for grants under subsection (q), 

17 $1,000,000 for each of fiscal years 2012 through 

18 2016.’’. 

19 (b) PUBLIC AND HEALTH CARE PROVIDER EDU20 CATION.—Section 399Q of the Public Health Service Act 

21 (42 U.S.C. 280g–5) is amended— 

22 (1) in subsection (b)— 

23 (A) in paragraph (1), by striking subpara24 graphs (A) through (F) and inserting the fol25 lowing: 


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1 ‘‘(A) the core risk factors for preterm 

2 labor; 

3 ‘‘(B) medically indicated deliveries before 

4 39 weeks; 

5 ‘‘(C) outcomes for infants born before 39 

6 weeks; 

7 ‘‘(D) risk factors for preterm delivery; 

8 ‘‘(E) the importance of preconception- and 

9 prenatal care; 

10 ‘‘(F) smoking cessation, hypertension, and 

11 weight maintenance; 

12 ‘‘(G) treatments and outcomes for babies 

13 born premature; 

14 ‘‘(H) the informational needs of families 

15 during the stay of an infant in a neonatal in16 tensive care unit; 

17 ‘‘(I) preventable birth injuries if evidence18 based strategies had been utilized; 

19 ‘‘(J) depression; and 

20 ‘‘(K) the use of progesterone;’’; and 

21 (B) by striking paragraph (2) and by re22 designating paragraphs (3) and (4) as para23 graphs (2) and (3), respectively; 


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1 (2) by redesignating subsection (c) as sub2 section (d) and by inserting after subsection (b) the 

3 following new subsection: 

4 ‘‘(c) PILOT PROGRAM.— 

5 ‘‘(1) IN GENERAL.—The Secretary, acting 

6 through the Administrator of the Health Resources 

7 and Services Administration and the heads of other 

8 appropriate agencies, shall conduct (and report on) 

9 research studies and demonstration projects that 

10 test maternity care models that are designed to re11 duce the rate of preterm birth. 

12 ‘‘(2) GRANTS.—The Secretary may carry out 

13 this subsection through the awarding of grants to el14 igible entities. 

15 ‘‘(3) ELIGIBILITY.—To be eligible to receive a 

16 grant under this section an entity shall— 

17 ‘‘(A) be— 

18 ‘‘(i) a hospital or hospital systems 

19 that utilizes evidence-based best practices; 

20 or 

21 ‘‘(ii) a public or private nonprofit enti22 ty; and 

23 ‘‘(B) submit to the Secretary an applica24 tion at such time, in such manner, and conVerDate Mar 15 2010 04:20 Jul 29, 2011 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1440.IS S1440

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1 taining such information as the Secretary may 

2 require. 

3 ‘‘(4) TARGETING.—In awarding grants under 

4 this subsection, the Secretary shall give priority to 

5 projects in geographic areas with a demonstrated 

6 persistent high rate of preterm birth based on data 

7 from the National Center on Health Statistics.’’; and 

8 (3) in subsection (d), as redesignated by para9 graph (2), by striking ‘‘2011’’ and inserting ‘‘2016’’. 

10 SEC. 6. OTHER ACTIVITIES. 

11 (a) ADVISORY COMMITTEE ON INFANT MOR12 TALITY.— 

13 (1) ESTABLISHMENT.—The Secretary shall es14 tablish an advisory committee known as the ‘‘Advi15 sory Committee on Infant Mortality’’ (referred to in 

16 this section as the ‘‘Advisory Committee’’). 

17 (2) DUTIES.—The Advisory Committee shall 

18 provide advice and recommendations to the Sec19 retary concerning the following activities: 

20 (A) Programs of the Department of Health 

21 and Human Services that are directed at reduc22 ing infant mortality and improving the health 

23 status of pregnant women and infants. 

24 (B) Factors affecting the continuum of 

25 care with respect to maternal and child health 


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1 care, including outcomes following childbirth 

2 and specifically preterm birth. 

3 (C) Strategies to coordinate the various 

4 Federal, State, local, and private programs and 

5 efforts that are designed to deal with the health 

6 and social problems impacting infant mortality. 

7 (D) Implementation of the Healthy Start 

8 program under section 330H of the Public 

9 Health Service Act (42 U.S.C. 254c–8) and 

10 Healthy People 2020 infant mortality objec11 tives. 

12 (E) Strategies to promote the collection of 

13 improved linked maternal and infant perinatal 

14 data. 

15 (F) Strategies to reduce preterm birth 

16 rates through research, programs, and edu17 cation. 

18 (3) PLAN FOR HHS PRETERM BIRTH ACTIVI19 TIES.—Not later than 1 year after the date of enact20 ment of this section, the Advisory Committee shall 

21 develop a plan for conducting and supporting re22 search education and programs on preterm birth 

23 through the Department of Health and Human 

24 Services and shall periodically review and revise the 

25 plan. The plan shall— 


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1 (A) provide for a broad range of research 

2 and educational activities relating to biomedical, 

3 epidemiological, psychosocial, translational, and 

4 clinical activities, including studies on racial 

5 and ethnic disparities in preterm birth rates; 

6 (B) identify priorities among the programs 

7 and activities of the Department of Health and 

8 Human Services regarding preterm birth; and 

9 (C) reflect input from a broad range of sci10 entists, patients, and advocacy groups. 

11 (4) MEMBERSHIP.—The Secretary shall ensure 

12 that the membership of the Advisory Committee in13 cludes the following: 

14 (A) Representatives provided for in the 

15 original charter of the Advisory Committee. 

16 (B) A representative of the National Cen17 ter for Health Statistics. 

18 (b) PATIENT SAFETY STUDY AND REPORT.— 

19 (1) IN GENERAL.—The Secretary shall des20 ignate an appropriate agency within the Department 

21 of Health and Human Services to conduct a study 

22 on hospital readmissions of preterm infants. Find23 ings and recommendations resulting from such study 

24 shall be based on data collected to address the fol25 lowing questions and such other related questions 


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1 which the Secretary and such designated agency 

2 deem important: 

3 (A) By State and by health care system, 

4 what is the number and rate of inpatient read5 mission for infants born preterm? 

6 (B) What are the leading diagnoses at the 

7 time of inpatient readmission for preterm in8 fants? 

9 (C) What is the average cost of treatment 

10 for preterm infant readmissions by diagnosis, 

11 by health care system, and by State? 

12 (D) What percentage of readmissions are 

13 preventable if evidence-based strategies had 

14 been utilized? 

15 (E) What percentage of treatment cost is 

16 attributable to preventable readmissions? 

17 (F) What is the source of health insurance 

18 coverage for preterm infants who are re19 admitted, such as through publicly funded pro20 grams (including the Medicaid program under 

21 title XIX of the Social Security Act and the 

22 Children’s Health Insurance Program under 

23 title XXI of such Act), private health insurance, 

24 and self payments of uninsured individuals? 


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1 (G) What evidence-based interventions are 

2 effective in preventing readmission of preterm 

3 infants, including measuring and reporting on 

4 quality of care and outcomes? 

5 (2) REPORT TO SECRETARY AND CONGRESS.— 

6 Not later than 1 year after the date of the enact7 ment of this Act, the agency designated under para8 graph (1) shall submit to the Secretary and to Con9 gress a report containing the findings and rec10 ommendations resulting from the study conducted 

11 under such subparagraph, including recommenda12 tions for hospital discharge and follow-up procedures 

13 designed to reduce rates of preventable hospital re14 admissions for preterm infants. 

15 (3) AUTHORIZATION OF APPROPRIATIONS.— 

16 There is authorized to be appropriated to carry out 

17 this subsection, $1,000,000 for fiscal year 2012. 

Æ 


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