[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
PREMATURITY AND INFANT MORTALITY: WHAT HAPPENS WHEN BABIES ARE BORN TOO 
                                 EARLY?

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 12, 2010

                               __________

                           Serial No. 111-121


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov


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                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
JANE HARMAN, California              TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     2
Hon. Lois Capps, a Representative in Congress from the State of 
  California, opening statement..................................     3
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     4
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     5
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     6
Hon. Janice D. Schakowsky, a Representative in Congress from the 
  State of Illinois, opening statement...........................    12
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    13
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................    14
Hon. Christopher S. Murphy, a Representative in Congress from the 
  State of Connecticut, opening statement........................    15
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, prepared statement.........................    16
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................    16
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, opening statement.....................................    18
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, prepared statement..............................   113
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, prepared statement..............................   117
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................   118

                               Witnesses

William Callaghan, MD, MPH, Senior Scientist, Maternal and Infant 
  Health Branch, Division of Reproductive Health, National Center 
  for Chronic Disease Prevention and Health Promotion, Centers 
  for Disease Control and Prevention.............................    19
    Prepared statement...........................................    21
    Answers to submitted questions...............................   155
Catherine Spong, MD, Branch Chief, National Institute of Child 
  Health and Human Development, National Institutes of Health....    32
    Prepared statement...........................................    35
    Answers to submitted questions...............................   155
Alan R. Fleischman, MD, Senior Vice President and Medical 
  Director, March of Dimes Foundation............................    61
    Prepared statement...........................................    64
    Answers to submitted questions...............................   157
Charles S. Mahan, MD, FACOG, Dean and Professor Emeritus, USF 
  College of Public Health, Lawton and Rhea Chiles Center for 
  Healthy Mothers and Babies.....................................    74
    Prepared statement...........................................    77
Hal Lawrence, MD, Vice President, Practice Activities, American 
  College of Obstetricians and Gynecologists.....................    81
    Prepared statement...........................................    83

                           Submitted Material

Statement of Craig Rubens of Seattle Children's Hospital, 
  submitted by Ms. Schakowsky....................................     8
Letter of May 10, 2010, from Health and Human Services to the 
  House and Senate, submitted by Ms. Capps.......................   123
Articles by the American Association of Prolife Obstetricians and 
  Gynecologists..................................................   127
Testimony of Dr. Paula Braveman..................................   143
Prepared material of Dr. Nicholas Eberstadt......................   147


PREMATURITY AND INFANT MORTALITY: WHAT HAPPENS WHEN BABIES ARE BORN TOO 
                                 EARLY?

                              ----------                              


                        WEDNESDAY, MAY 12, 2010

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 3:05 p.m., in 
Room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. [Chairman of the Subcommittee] presiding.
    Members present: Representatives Pallone, Green, Capps, 
Schakowsky, Barrow, Christensen, Castor, Murphy of Connecticut, 
Braley, Shimkus, Whitfield, Pitts, Murphy of Pennsylvania, 
Burgess, Blackburn and Gingrey.
    Staff present: Ruth Katz, Chief Public Health Counsel; 
Sarah Despres, Counsel; Jack Ebeler, Senior Advisor on Health 
Policy; Robert Clark, Policy Advisor; Stephen Cha, Professional 
Staff Member; Alvin Banks, Special Assistant; Allison Corr, 
Special Assistant; Camille Sealy, Fellow; Ryan Long, Minority 
Chief Counsel, Health; and Aarti Shah, Minority Counsel, 
Health.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. The meeting of the Health Subcommittee is 
called to order, and today we are having a hearing on 
``Prematurity and Infant Mortality: What Happens When Babies 
Are Born Too Early.'' I will recognize myself for an opening 
statement initially.
    The consequences of premature births and infant mortality, 
both the causes and consequences, need to be examined because 
this is an important but complicated public health issue for 
which much is still unknown. According to the Centers for 
Disease Control and Prevention, each year more than a half-
million babies in the United States, or one in every eight, are 
born prematurely. This statistic is up 20 percent from 1990 and 
we are just starting to see a decline. Despite the recent 
decrease, preterm birth remains a pressing health issue which 
deserves ample attention as it is the greatest risk factor for 
infant mortality and contributes to a host of acute and chronic 
conditions.
    While much advanced research has been conducted and 
continues today, researchers are still trying to understand why 
preterm labor occurs. However, we do know that there is a set 
of factors that put women at higher risk of having a premature 
baby. Some known factors include carrying more than one baby, 
having a previous preterm birth, high blood pressure and 
diabetes. In addition, we know that there are also external 
factors that occur either alone or in combination with other 
individual characteristics, and these include age, race, 
poverty, marital status, stress, environmental chemicals and 
many others. I am interested to hear from our witnesses today 
how these factors intertwine and what we can do moving forward 
to limit their effects.
    While not directly linked to prematurity, I am particularly 
interested to hear today about the prevalence of stillbirths 
and sudden unexpected infant death, or SUID, within the infant 
mortality rate in the United States. Like preterm birth, 
stillbirth, there are some risk factors and causes such as 
maternal medical conditions, fetal factors, umbilical cord 
problems and placental abnormalities. However, despite these 
known risk factors, there is no known cause for as many as half 
of all stillbirths, leaving many parents without answers to the 
reasons for these deaths. No parent should have to endure the 
pain of losing a child, especially without knowing why that 
child was taken from them so soon.
    And I have introduced a bill called the Stillbirth and SUID 
Prevention Education Awareness Act, which would improve data 
collection and education so we can better understand the cause 
of these deaths and help parents get the information and 
answers they want to prevent. The bill would also fund 
investigations to finally provide some answers by creating a 
national registry to help researchers understand the scope and 
impact of these tragedies. By understanding the causes of 
death, we can prevent these tragedies in the future, and we 
want every child to have the chance to grow up healthy.
    In my opinion, infant mortality is a public health problem 
that needs the attention of the subcommittee, so I would like 
to thank all of our witnesses for being here today. I know 
other members have raised this. This is not a legislative 
hearing on my bill but an oversight hearing essentially to find 
more about these issues and to determine whether or not we 
should move forward with some legislation.
    At this time I guess we will go to Mr. Whitfield. The 
gentleman from Kentucky is recognized.

  OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Whitfield. Well, Mr. Chairman, thank you very much, and 
I certainly want to thank the panel of witnesses for being here 
today on this very important subject.
    As the chairman said, half a million babies are born 
preterm in the United States each year, and the Centers for 
Disease Controls states that preterm births are the greatest 
risk factor for infant mortality with over one-third of all 
infant deaths being attributed to preterm births, and according 
to the Institute of Medicine, there is no one cause of preterm 
birth, rather, there are socioeconomic, biological and 
environmental factors that all can lead to prematurity.
    One area that I am particularly interested in and I think 
it is very important that we explore is the reporting methods 
used by different countries. I think it is important that we 
all have the same reporting standards so that we can really 
determine what the health statistics are as they relate to 
infant mortality. According to the CDC, in 2005, the latest 
year that the international ranking is available, the United 
States ranked 30th in the world in infant mortality behind most 
European countries, but there is not one consistent reporting 
standard for many of these countries and I do feel it is 
important that we establish a uniform standard.
    I look forward to our witnesses today and the information 
that they will provide us, and I yield back the balance of my 
time.
    Mr. Pallone. Thank you, Mr. Whitfield.
    Next is our vice chair, Ms. Capps, the gentlewoman from 
California.

   OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mrs. Capps. Thank you, Chairman Pallone, for holding this 
extremely important hearing, to our witnesses for being here 
today, and to the fact that we have this bill being discussed. 
We have quite a few health professionals in the audience and we 
have a group on the Hill visiting of CARE, an international 
organization with very strong ties to this legislation as well.
    Many people would just assume that the United States being 
as advanced as it is doesn't have significant infant mortality 
rates or that everyone has access to high-quality prenatal 
care, it is kind of a given, and that prevention of prematurity 
or other complications is not a serious situation. But the 
truth is, and that is why I am so thankful that we are having 
this hearing today, the United States lags far behind other 
industrialized nations in infant mortality rates, and I might 
add, maternal mortality rates as well.
    So why is this happening in our country? First and 
foremost, we have a problem of access. Fortunately, we have now 
new health reform law which puts into place several measures 
that will improve the health of our mothers and of our infants. 
This will happen through eventually universal coverage, 
training of more health care providers, greater emphasis on 
prevention and wellness through grants and other incentives but 
there is always more than we can and should be doing to ensure 
safe pregnancies and safe babies.
    For example, I was proud to join in the recent Capitol Hill 
launch of a new service called Text for Baby, and this is done 
with the Congressional Caucus for Women's Issues, and Text for 
Baby is a new, free mobile health information service designed 
to promote maternal and child health among underserved 
populations through simple text messaging, and I plan in my 
Congressional district to find a way to allow some of my 
constituents to see this program demonstrated, and I hope that 
we will see more programs like this to get funded through the 
new mandatory spending which are put in place for prevention 
and wellness.
    The other important need is to better gather data and 
conduct further research so that we can develop a more 
coordinated and comprehensive strategy. I am proud to cosponsor 
two important pieces of legislation that do address infant 
health research and education. One is the Birth Defects 
Prevention, Risk Reduction and Awareness Act, and this is 
sponsored by Rosa DeLauro, and then there is also your own 
bill, Mr. Chairman, SID prevention, Stillbirth and SUID 
Prevention Education and Awareness Act, sponsored by Chairman 
Frank Pallone. Having a healthy pregnancy and a healthy baby 
shouldn't be determined by the color of your skin, where you 
live or how much money you earn.
    I am eager to hear from our witnesses today to see what 
steps we can take to reduce infant mortality and morbidity for 
all families in the United States. I pledge my continued 
support to make pregnancy and childbirth safe and healthy for 
all moms and their newborns, and I yield back.
    Mr. Pallone. I thank the gentlewoman.
    The gentleman from Pennsylvania, Mr. Pitts.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Pitts. Thank you, Mr. Chairman.
    As we will hear, prematurity is the number one risk factor 
in infant mortality, and preterm birth rate in the United 
States has been on the rise for the past few decades. Not only 
is the potential for mortality a risk for preterm infant but 
these babies could also face a wide range of health problems, 
some lifelong, such as breathing and respiratory problems, 
vision problems, increased susceptibility to infection and 
intellectual disabilities, to name a few.
    While we do not know precisely why more babies are being 
born preterm, one thing we do know is that we need medical 
professionals to care for women and their babies throughout 
pregnancy, and this brings us to the issue of medical 
liability. One of our witnesses on the second panel, Dr. Hal 
Lawrence, is here representing the American College of 
Obstetricians and Gynecologists, or ACOG. ACOG's 2009 survey on 
professional liability sought to determine how medical 
liability legislation and medical liability insurance issues 
affect the practices of its members. Some of the survey's 
statistics and conclusions are astounding. This comes from the 
survey's executive summary: ``Of the survey respondents who 
reported making changes to their obstetric practice because of 
insurance portability or availability or both, 19\1/2\ percent 
reported increasing the number of Cesarean deliveries. 
Additionally, 21.4 percent decreased the number of high-risk 
obstetric patients, 10.4 percent decreased the number of total 
deliveries and 6.5 percent stopped practicing obstetrics 
altogether.'' When survey respondents were asked about making 
changes to their obstetric practice as a result of the risk or 
fear of professional liability claims or litigation, here were 
the results: 30.2 percent decreased the number of high-risk 
obstetric patients, 29.1 percent reported increasing the number 
of Cesarean deliveries, an additional 13.9 percent decreased 
the number of total deliveries and 8 percent stopped practicing 
obstetrics altogether.
    Over my years in Congress, I have heard from multiple OB/
GYNs who due to medical liability climate could no longer 
afford to practice in Pennsylvania and were either retiring 
early, no longer delivering babies or moving their practices to 
nearby Delaware. In just the city of Philadelphia and four 
surrounding counties in southeastern Pennsylvania, where I am 
from, 18 hospitals have closed their maternity wards since 
1997, and a 19th will end obstetric services next month. Since 
2001, southeastern Pennsylvania has lost 30 percent of its 
practicing obstetricians, and according to the chief of 
obstetrics at Hahnemann Hospital, Dr. Owen Montgomery, Lloyds 
of London calls southeastern Pennsylvania the worst liability 
market in the world.
    Medical liability is a serious problem with direct 
consequences for patients, particularly for mothers and their 
unborn children, and in recently passed health care law, what 
did we do to ameliorate this situation? We funded state 
demonstration projects on medical liability. We have already 
had two large and quite successful demonstration projects on 
this issue. Their names are California and Texas. We don't need 
more studies. What we need is real reform, and in this case the 
new health care reform law does not deliver.
    I yield back.
    Mr. Pallone. I thank the gentleman.
    Next is the gentleman from Texas, Mr. Green.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman, for holding the hearing 
today on infant mortality.
    According to the CDC, the United States ranks 28th among 
developed countries in infant mortality with 6.9 deaths per 
1,000 live births. Among the leading causes of infant mortality 
in the United States, birth defects, preterm birth, low birth 
weight, sudden infant death syndrome and respiratory distress 
syndrome, preterm birth and low birth weight are the only 
factors that haven't declined. According to the March of Dimes, 
who we will hear from today, insurance plans for large 
employers paid an average of $64,713 to cover the cost of 
inpatient and outpatient medical care and prescriptions for one 
preterm newborn and mother. That figure doesn't include the 
cost of potential re-hospitalization and long-term care and 
services. The Agency for Health Care and Research and Quality 
estimated in 2005 that on a national scale private insurance 
and Medicaid each paid about $7.4 billion to cover preterm 
infants' inpatient hospital charges.
    In Texas, Medicaid covers about half of all births 
annually. The Texas Health and Human Service Commission reports 
Texas Medicaid spent $408 million in 2007 on hospital costs 
associated with preterm births. Texas and our district in 
particular still leads the Nation in percentage of uninsured 
residents. Texas also has the third highest rate of births to 
teen mothers nationally at 63.1 per 1,000. From 1990 to 2006, 
CDC National Center for Health Statistics showed the rate of 
preterm birth in Texas increased 22 percent from 11.2 percent 
of live births in 1990 to 13.7 percent in 2006. The State saw a 
slight decrease from 2006, a 1 percent decrease from 2006-2007. 
In Texas, 18.7 percent of live births to African American women 
are preterm compared to 12.7 percent for Anglo women, 13.3 
percent for Hispanic women and 11.3 percent for Asian women.
    One cause that has been pointed to as a potential cause of 
preterm birth is induced or cesarean births at 34 to 36 weeks 
due to a miscalculation in the gestational age of the baby. At 
the Tex Med Conference in 2009, the Texas Medical Association 
and House of Delegates adopted a recommendation to support the 
prevention of preterm births caused by delivering a baby early 
by physicians and others who attend at the delivery of infants. 
The recommendation presented by the TMA's committee on maternal 
and prenatal health grew out of the March of Dimes' concern 
that some premature births may occur without good medical 
justification such as request or convenience of the mother or 
because of incorrect calculation of the gestational age of the 
fetus. I am hoping the witnesses today will address this topic.
    Again, I want to thank all our witnesses for being here and 
appreciate the time, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Green.
    Our ranking member, Mr. Shimkus.
    Mr. Shimkus. First of all, Mr. Chairman, thank you. I am 
going to ask unanimous consent that all opening statements are 
going to be submitted for the record. We have got competing 
hearings, and I am not sure everyone is going to be able to 
make it up.
    Mr. Pallone. Without objection, so ordered.
    Mr. Shimkus. I also want to apologize for not being here 
punctually. The Appropriations Committee is dealing with some 
testimony. Kristin Fitzgerald, who testified before our 
committee, whose husband----
    Mr. Pallone. Well, I was told you were here before me.
    Mr. Shimkus. I was, but then I left. So that is my apology.
    The last thing. I want it on the record, we asked for 
someone to testify on the second panel, a Republican witness. 
They did not get their testimony in on time. I have been very 
hard on the Administration for not getting their testimony in 
on time so I asked the chairman to disinvite the Republican 
member of the second panel, which we ended up doing, and I 
think that is appropriate and I just want to take all the 
burden----
    Mr. Pallone. It is going to make it harder for me. I am 
going to have to make sure the Administration witnesses are on 
time now.

  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Mr. Shimkus. You have to lead by example. That is the key, 
Mr. Chairman.
    Thank you, Mr. Chairman. Any time a child a born is 
special. Although preemie births make it challenging, I have 
been able, just like many members, to go through hospitals and 
see great facilities that are doing all they can to save the 
lives of premature babies. We have passed the PREEMIE Act a 
couple years ago, and so hence the analysis of data and the 
follow-up that is occurring here.
    We do have issues with making sure--no one is going to 
dispute that we are not as good as we could be in this country. 
We want to make sure we are comparing apples to apples versus 
apples to oranges, and I do this in other committees. In 
Telecom, I hate it when we are compared to Liechtenstein on 
broadband access. So we just make sure that when we want to 
compare apples to apples, we are doing--other countries may not 
consider a live birth what we consider a live birth, and so let 
us throw that out there and just get clear data so if we are 
going to do some comparisons, we are going to do some 
comparisons.
    As always, I also want to make sure that as ranking member 
I continue to stay on record calling for additional hearings on 
the health care law. We just had a CBO report out this week. It 
says oh, we made a mistake, there is $110 billion in additional 
costs. That is all part of that calculation that we were told 
that this was going to save money. So we know that those stats 
were not correct. We think it is time to start talking about 
this and we think it is time, especially on this issue, the 
Medicaid issue for the poor, as we add 18 million more people 
to the Medicaid rolls without funding, who gets left out? And I 
think the very people we are talking about today, the poor 
mothers with no care. Because what docs will do, in Illinois we 
are $12.5 billion in debt. Medicaid is paying 30 cents on the 
dollar 280 days late. Thirty cents on the dollar, 280 days 
late. And the doctors who are servicing Medicaid patients, some 
are just writing it off and some are going to start limiting 
that access to care, and this is the issue that has also been 
raised by the Administration and Secretary Sebelius when she 
said we need more docs, we need more primary care physicians, 
and guess what? This health care law does nothing to address 
more providers. So we will continue the clarion call to say let 
us have some hearings on the law.
    I am going to end with this. An individual who recently 
served in my staff left and went to Colorado and now has been 
working in the private sector. She sent me an e-mail, and as a 
direct result of the passage of this health care law, her 
insurance company folded. Her child, who had a preexisting 
condition, now has no coverage. As a direct result of this law, 
she cannot purchase insurance for her family because of a child 
with a preexisting condition. Now, folks, that is something we 
can fix. We can have a hearing today. We can draft legislative 
language tomorrow and we can move it to the floor next week. 
Why do we accept a gap in this period of time when we are 
allowing folks to not have coverage based on preexisting 
conditions when we were promised that that would not be the 
case?
    So Mr. Chairman, hopefully you will raise this issue to the 
full committee chairman. I know he is busy down in the 
Oversight and Investigation hearing. But we will continue to 
say I think it is time to start talking about the effects of 
this health care law, and I yield back my time.
    Mr. Pallone. Thank you.
    The gentlewoman from Illinois, Ms. Schakowsky.
    Ms. Schakowsky. Thank you.
    First, at the request of our Energy and Commerce Committee 
colleague, Jay Inslee, I ask unanimous consent to enter into 
the record a statement from Seattle Children's Hospital.
    [The information follows:]

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    Mr. Pallone. Without objection, so ordered.

       OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 
     REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS

    Ms. Schakowsky. Thank you.
    The creation of the--oh, first let me say that fortunately 
the health care bill that we passed does allow for children 
with preexisting conditions requires that they be eligible for 
health care and not be excluded.
    The creation of the Millennium Development Goals has placed 
significant attention on maternal and infant mortality rates 
within the international community. The aim is to drastically 
reduce these rates by 2015, and we have made visible, albeit 
slow, progress toward these goals, but as we work with our 
international partners to reduce infant and maternal deaths in 
some of the most challenging places in the world, I am 
constantly reminded that we face a health disparities crisis 
right here at home. In fact, one out of eight U.S. babies is 
born prematurely.
    Gwen Moore, our colleague and vice chair of the 
Congressional Caucus for Women's Issues, represents Milwaukee, 
Wisconsin, and she often talks about the absolutely abhorrent 
health disparities that are so evident in the infant and 
maternal mortality rates in her district. Thirty-three out of 
every 100,000 African American women died from pregnancy-
related complications in 2006 compared to fewer than 10 among 
white women during that same period. There are studies showing 
that even when researchers control for socioeconomic factors, 
health risks like smoking or chronic disease and geographic 
locations, a poor white woman is more likely to have a healthy 
childbirth than a wealthy African American woman.
    So most of our witnesses today have referenced this 
disparity and have pointed to reasons why these statistics 
might bear out the way that they do but what I am left with 
when looking at the collective testimony is that it doesn't 
seem that we really know why there is such a discrepancy in the 
rates of premature births, birth defects and infant mortality 
and maternal mortality across different populations. Is it an 
access to health care issue? Is it culture? Is it socioeconomic 
status or location or the number of children born to one 
mother? Why is it that African American women are 1-1/2 times 
more likely to deliver a preterm infant compared to a white 
woman? I hope we will get some of those answers today.
    While I am concerned about the plateau that we seem to have 
hit in reducing infant mortality in this country in the 21st 
century, I do know that there is a lot of interest and a lot of 
collaboration aimed at bringing healthy pregnancies to healthy 
term. Congresswoman Capps mentioned a very interesting and 
innovative program, Text for Baby, which is a collaborative 
effort among the Department of Health and Human Services, White 
House Office on Science and Technology and seven major 
corporations, a public-private partnership to work with at-risk 
expecting moms. So you go to text baby, b-a-b-y or b-e-b-e, at 
511411, and at-risk young women can receive text messages 
reminding them to schedule a prenatal visit or get a flu shot 
or avoid drugs and alcohol, et cetera. One small step.
    I look forward to hearing the testimony today and I yield 
back, and thank you, Mr. Chairman.
    Mr. Pallone. I thank the gentlewoman.
    The gentleman from Pennsylvania, Mr. Murphy.

   OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman.
    Years ago, before I ran for the State Senate, I practiced 
as a psychologist at Magee Women's Hospital in Pittsburgh and 
followed up infants in the newborn intensive care unit. There 
was a moment when I was seeing one of the babies there, very 
premature, very small, transparent skin, hooked up to all sorts 
of equipment, probably not much bigger than my hand, and 
another baby born addicted to crack cocaine, and I remember 
saying to the nurse, I have had enough of this, I can't put up 
with this anymore. She said well, are you going to run for 
office and change the system, and I said sure. So here I am. 
The system still has problems, and I want to point out how I 
hope the scope of this hearing actually expands so we can deal 
with these problems.
    Some years ago when we looked at murder rates in this 
country as declining, people looked upon that as a reason 
either to give their community a pat on the back or a kick in 
the rear because their murder rates were either going up or 
down. One factor that was not computed into that was the access 
to paramedics and a critical-care hospital, which was making a 
difference in life and death and of course reducing rates of 
murder because some people didn't die. It is important that 
Congress at that time and this time does not misread statistics 
and we get accurate information on a number of things and that 
I suggest is not just mortality but long-term developmental 
outcome. It is extremely important. I hope this is something 
the witnesses can provide today with this.
    We will take about a number of epidemiological issues and I 
hope we don't just caught up in which nation wins the contest 
of the lowest mortality rate because for me, that is not valid 
information at all. We need accurate information of what 
exactly happens. We need to know maternal factors, external 
factors. Is it income, education, family issues? Is it other 
factors such as maternal smoking, weight gain or loss, 
nutrition, drug use, age, trauma, complications during 
pregnancy, race? Are there medical issues we need to know 
about? Is it infection rates, prenatal care, access to level 3 
nurseries, access to developmental intervention, levels of 
training of neonatologists, pediatricians, family physicians, 
schools, other educational institutions and statistical 
analysis to making sure that the definition of each one of 
these is the same between communities and between nations.
    I might add this, that over the years of the children that 
I have seen born premature or very premature, it is interesting 
to me now as I go through in going back to visit communities 
and inevitably some parent will come up to me and introduce 
their child to me who I took care of and who is--when they were 
very, very young. In many cases the child is successful, 
working, they introduce me to their own children. In addition 
to not making me feel so young when I see that happening, it 
also makes me very proud that when you surround people with 
good quality medical care and tertiary care, good NSU care, 
that is a very important factor.
    I know the research I did on persistent pulmonary 
intervention in newborns, of all the factors we looked at, what 
was one of the most significant factors relating also to 
seizure disorders and infarcts and developmental outcome, had 
to do with where the child was cared for, how close they were 
to a level 3 nursery and not just the other medical care 
around. This is so extremely important. I want to make sure 
that any funding that Congress looks at or any change of policy 
directly addresses these issues. Rather than just saying let us 
throw money at this issue and make sure we have some there, let 
us make sure we are doing a critically good job, and I hope 
that the witnesses will provide this Congress with this 
information. We want to do it right but it is a matter of just 
doing more than comparing us to other nations.
    With that, I yield back, Mr. Chairman.
    Mr. Pallone. Thank you.
    The gentleman from Georgia, Mr. Barrow.
    Mr. Barrow. I thank the Chair, but in the interest of the 
witnesses' time, I will waive an opening.
    Mr. Pallone. Thank you. The gentleman reserves.
    The gentleman from Georgia, Mr. Gingrey.

  OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Gingrey. Mr. Chairman, thank you, and thank you for 
calling this hearing. Obviously as a physician member of the 
House, I am extremely interested in the subject, having 
practiced and delivered babies for 31 years.
    You know, what concerns me most when I hear that CDC report 
going back to 2005 that ranks the United States 30th in the 
world in regard to infant mortality, which as we all know is 
the death of a child within the first year of life, and you 
start scratching your head and say well, how could that be when 
we spend two and a half times as much per capita on health care 
in this country, and clearly with all corrections that need to 
be done in making those comparisons, our prematurity rate and 
our infant mortality rate is too high and we should make every 
effort to do something about that, and I really look forward to 
both panels of witnesses today to help us understand how we can 
do that.
    But when you compare our country to countries that count a 
death in the first 24 hours of life as a miscarriage 
essentially, that is not a fair comparison. Forty percent of 
premature infants in our country, many of them immature, born 
before 32 weeks, not just before 37 weeks, many of them are 
going to die in the first 24 hours of life, in fact 40 percent. 
So when some countries don't even count those as live births 
and others say well, you know--I think France does this--any 
child that is less than 500 grams is not considered a live 
birth or other countries that say any child that is less than 
30 centimeters in length is not considered a live birth. We 
have got to as other colleagues have mentioned compare apples 
to apples to get a true meaning and understanding, and I am not 
going to say these statistics were necessarily used to make a 
point that we need to have a universal health care system or 
single-payer system or pass the Senate bill 3590 that we did 
here just a month ago but let us use the right statistics. It 
is very important that we do that.
    As we look at matters related to obstetric and pediatric 
care, I think we should not overlook the need to enact 
meaningful tort reform to help address a shortage of OB/GYN 
providers in markets all across the country. I believe that 
Republicans and Democrats together can work on this issue, one 
that I think most Americans support.
    And Mr. Chairman, I want to make one last point. I realize 
my time is up. But I want to welcome Dr. Lawrence from the 
American College of OB/GYN, who is going to be on the second 
panel. Dr. Lawrence as a practicing OB/GYN for more than 30 
years, I am interested in hearing more about your MOMS 
Initiative. It is my hope that efforts like yours might improve 
both maternal and infant health in our country, and I would 
like to find out ways that we can work together in this area.
    Thank you, Mr. Chairman, and with that I will yield back.
    Mr. Pallone. Thank you, Mr. Gingrey.
    Next is the gentleman from Connecticut, Mr. Murphy.

      OPENING STATEMENT OF HON. CHRISTOPHER S. MURPHY, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF CONNECTICUT

    Mr. Murphy of Connecticut. Thank you, Mr. Chairman, for 
calling this hearing today.
    I recently met with a constituent of mine, Arnold Goodman 
of Avon, Connecticut, whose wife died during childbirth, and he 
explained to me the causes of maternal mortality such as 
multiple Cesarean sections, increased age and obesity that are 
also risk factors for premature birth. He told me that the gaps 
in the research and the lack of uniform reporting that 
perpetuate both maternal mortality and premature birth and 
infant mortality still persist, so I am interested here today 
in learning more about the fact that maternal mortality and 
prematurity rates are on the rise, the connections between the 
two and what we can do on both of those issues, and just as Mr. 
Shimkus is, I am also interested in the issue of access to 
maternal and pediatric care for expectant mothers. I have no 
doubt that the health care reform bill that extends coverage to 
millions of women across this country is going to be able to 
link them up with the care that they have not had previous to 
today, but I also share Representative Shimkus's concern about 
the rates that are paid under the Medicaid program and would 
just remind this committee that at one time this Congress had 
in place a system by which the federal government oversaw both 
the rates for OB care and for pediatric care called the Born 
amendment. That amendment was stripped out of the law in 1997, 
and in the House version of the bill, we put back in that 
federal oversight over obstetric rates and pediatric rates, and 
I would be happy to work on a bipartisan basis to try to put 
back into place some of the lost oversight that the federal 
government has had to make sure that States do the right thing 
when it comes to obstetric and pediatric rates. That issue of 
access to care is made much, much better by the health care 
bill but can be made even stronger with strong federal 
oversight over Medicaid rates.
    I am thrilled that the panel is here. I am very eager to 
hear your testimony and again thankful for the opportunity to 
listen.
    Mr. Pallone. Thank you.
    The gentlewoman from Tennessee, Mrs. Blackburn.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF TENNESSEE

    Mrs. Blackburn. Thank you, Mr. Chairman, and welcome to our 
witnesses. I want to thank you for the hearing.
    In my district, Memphis, Tennessee, has one of the highest 
prematurity and infant mortality rates in the entire Nation, 
and it is a stat that impacts our neighborhoods, our State, and 
we know the impact it has here in our country. Too many mothers 
around the country just do not have, those young mothers don't 
have the information that they need and the educational 
resources that they need to keep their babies healthy. And DHS 
has stated that children of mothers who receive no prenatal 
care are three times more likely to be born at a low birth 
weight and five times more likely to die than those who are 
born to moms that get that necessary prenatal care.
    And earlier this year, the Commercial Appeal, which is the 
Memphis newspaper, reported that premature birth and low birth 
weight are the biggest causes of those infant deaths in 
Memphis, Tennessee. So we are watching those numbers very 
closely. And since my days in the State Senate, this is an area 
where we have watched this very closely. Indeed, Congressman 
Cohen and I had legislation last year, had a resolution focused 
on our concern with this infant mortality rate. We have some 
great work that is being done in our State to address this. The 
Porterly Children's Hospital, the March of Dimes, University of 
Memphis and Memphis city schools all have programs, so we have 
got a partnership that we are doing in the public not-for-
profit sector to help improve this rate. We have also got the 
UT Health Sciences Center that has a grant, a $1.7 million 
grant that they are working to expand the Blues Project, hoping 
to reduce those rates, and we are focusing that on our TennCare 
eligible moms.
    So welcome. We are pleased to have you with us today. We 
look forward to your testimony, and I look forward to working 
with you on this issue and I yield back, Mr. Chairman.
    Mr. Pallone. Thank you.
    Next is the gentlewoman from Florida, Ms. Castor. I should 
mention that Ms. Castor has done quite a bit of work on this 
prematurity and infant mortality bill and also asked that we 
have a hearing on this subject.

  OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF FLORIDA

    Ms. Castor. Well, thank you, Chairman Pallone, very much 
for today's hearing so we can address infant prematurity and 
mortality and some of my specific concerns about the rising 
rates of elective preterm Cesarean deliveries in the United 
States, and thank you for inviting Dr. Charles Mahan from the 
University of South Florida, the founder of the Lawton and Rhea 
Chiles Center for Healthy Mothers and Babies. I am honored that 
he is here today. I would also like to extend a special welcome 
to Dr. Fleischman, everyone at the March of Dimes and from the 
American College of Obstetricians and Gynecologists.
    The overriding message for pregnant mothers and families 
and health providers in the United States has got to be taking 
babies fully to term, to that 39 weeks, 40 weeks unless there 
is an intervening medical reason. Researchers at the National 
Center for Health Statistics just reported this week that the 
high rate of premature births is the primary reason that the 
United States has a higher infant mortality rate than other 
industrialized nations. Preterm births are linked to 
neurodevelopmental disorders and developmental delays. Let us 
face it, brain development is the key to success for babies, 
when they are young and even into their adult years.
    Many premature babies grow up healthy but sadly many do 
not. Some need lifelong constant care and have health problems 
throughout their lives. Although the National Center reported 
this week that preterm births have slightly declined in the 
United States, the rates are still way too high and the rates 
of preterm and low birth weight babies in my home State of 
Florida are much higher and of great concern. Even with all the 
great advances in science, technology, medicine, too many 
babies are born prematurely and there are disturbing racial 
disparities we must address. Nationally, the preterm birth rate 
is 12.3 percent. In my home State of Florida, it is nearly 14 
percent. The March of Dimes gave Florida an F grade on its 2009 
premature birth report card, so I am committed to working with 
you to bring that grade up.
    And the Cesarean rate has risen across the country to 32 
percent of all births as of 2008, and one factor in preterm 
births may be this rising rate of elective C-sections. In 
Florida, the C-section rate is even higher, accounting for 
roughly 38 percent of all childbirths, and they think that in 
Dade County, Miami, we are approaching 50 percent now where the 
World Health Organization said it really should be half of 
that. Elective C-sections prior to 39 weeks really put babies 
at risk, so we need to understand these troubling numbers. The 
data displaying the rise in C-sections is clear and speculation 
about the potential overuse of these surgeries is strong. The 
New York Times has featured several articles over the past 6 to 
7 months reporting that late preterm births are the fasting 
growing subgroup of premature births. Cesareans have become the 
most common surgery in American hospitals, and ACOG has 
recognized that the surgery is overused, and the March of Dimes 
reports that C-sections accounted for 92 percent of all preterm 
births in the United States from 1996 to 2004.
    So I would really like to hear from our witnesses about 
this. I think we need more data and research, so I am looking 
forward to your testimony and the input of my colleagues moving 
forward. Thank you.
    Mr. Pallone. Thank you.
    The gentlewoman from the Virgin Islands, Ms. Christensen.
    Mrs. Christensen. Thank you, Mr. Chair. In the interest of 
time, I am going to submit my statement for the record.
    [The information was unavailable at the time of printing.]
    Mr. Pallone. And Mr. Braley, the gentleman from Iowa.

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF IOWA

    Mr. Braley. Thank you, Mr. Chairman, for holding this 
hearing on premature and infant mortality. It is important that 
we examine the many risk factors and variables that relate to 
these tragedies.
    In Iowa, five mothers who each lost a daughter to 
stillbirth or infant death got together in 2003 and founded 
Healthy Birthday, a nonprofit organization dedicated to 
preventing stillbirths and infant deaths through education, 
advocacy and parent support. This group of friends including 
State Representative Janet Peterson launched the Count the 
Kicks campaign in June of 2009, which is a public health and 
awareness effort to improve pregnancy outcomes. This campaign 
is supported by the March of Dimes Iowa chapter and seeks to 
reduce the number of preventable stillbirths by teaching 
expectant parents how to self-monitor their babies' movements 
and about the importance of tracking daily movements during the 
third trimester of pregnancy. Less than a year after the 
campaign's launch, 55 percent of OB/GYN clinics in Iowa and 56 
percent of the birthing hospitals had begun using the program. 
Research has shown that this type of education and awareness is 
very effective.
    A 2009 study conducted in Norway reported an overall 
decrease in stillbirth rate by one-third when patients were 
educated on monitoring fetal movements. If the United States 
achieved the same level of success, we could save more than 
8,000 babies every year. With one out of every 150 pregnancies 
ending in stillbirth in the United States, it is hard to 
understand why this issue hasn't gotten more attention, but I 
believe that expanded awareness and education should be an 
integral part of efforts to reduce stillbirths.
    I commend Chairman Pallone for introducing the Stillbirth 
and SUID Prevention, Education and Awareness Act. This bill 
will improve the health of children, enhance public health 
activities related to stillbirth and reduce the occurrence of 
infant death. I am proud to be a cosponsor of this bill and I 
encourage other members of the committee to support the bill, 
and I yield back the balance of my time.
    Mr. Pallone. Thank you, and I think that concludes our 
opening statements by the members of the subcommittee, so we 
will turn to our witnesses. I want to welcome you. Let me 
introduce our first panel. On my left is Dr. William Callaghan, 
who is the senior scientist for Maternal and Infant Health 
Branch, Division of Reproductive Health, the National Centers 
for Chronic Disease Prevention and Health Promotion of the 
Centers for Disease Control and Prevention. And then we have 
Dr. Catherine Spong, who is the branch chief for the National 
Institute of Child Health and Human Development of the National 
Institutes of Health. The drill is 5-minute opening statements, 
and they become part of the record and then we may--well, you 
actually on your own discretion if you like can submit 
additional statements in writing afterwards, but if you would 
start, Dr. Callaghan. We appreciate your being here.

  STATEMENTS OF WILLIAM CALLAGHAN, MD, MPH, SENIOR SCIENTIST, 
  MATERNAL AND INFANT HEALTH BRANCH, DIVISION OF REPRODUCTIVE 
  HEALTH, NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND 
 HEALTH PROMOTION, CENTERS FOR DISEASE CONTROL AND PREVENTION; 
 AND CATHERINE SPONG, MD, BRANCH CHIEF, NATIONAL INSTITUTE OF 
  CHILD HEALTH AND HUMAN DEVELOPMENT, NATIONAL INSTITUTES OF 
                             HEALTH

                 STATEMENT OF WILLIAM CALLAGHAN

    Dr. Callaghan. Mr. Chairman, Mr. Shimkus and distinguished 
members of the subcommittee, thank you for the opportunity to 
participate in this hearing on preterm birth and infant 
mortality. I am Dr. William Callaghan, acting chief, Maternal 
and Infant Health Branch in the Division of Reproductive 
Health, the Centers for Disease Control and Prevention. I am 
also board certified in obstetrics and gynecology. Prior to 
making the transition to public health in 2001, I spent 14 
years in private practice caring for thousands of women during 
their pregnancies. Today I will briefly outline the burden of 
disease in the United States due to preterm birth and summarize 
our current and continuing surveillance and research 
activities.
    Preterm birth is defined as being born at less than 37 
weeks, that is, at least 3 weeks before the predicted due date 
for the pregnancy. Today, more than half a million babies are 
born preterm each year in the United States. Although a CDC 
report released yesterday shows a very welcome and small 
decline in the preterm birth rate for 2007 and 2008 down to 
12.3 percent, levels still remain higher than at any point in 
the 1980s and 1990s. Most of the increase prior to this recent 
decline was among late preterm births, and those are births 
from 34 to 36 weeks of gestation.
    Preterm birth is an important risk for infant mortality. 
More than one-third of infant deaths can be directly attributed 
to preterm birth. Preterm birth and infant mortality are 
particularly critical issues in the African American community. 
African American women are one and a half times more likely to 
deliver a preterm infant compared to white women, and the 
infant mortality rate for black infants is more than twice that 
of white infants. We also need to think beyond infant mortality 
when we discuss prematurity. Preterm birth is the leading cause 
of disability in children. Moreover, in 2005 it was estimated 
the costs associated with preterm birth were $26.2 billion.
    At CDC, our work addresses preterm delivery through three 
basic mechanisms: surveillance, research and building public 
health capacity. Surveillance is the core of CDC's work. We 
monitor how many infants are born prematurely, analyze trends 
and define risk factors. There are several important 
surveillance systems that we use. The first is through 
collection of birth certificates and death certificates by the 
National Center for Health Statistics. The national statistics 
for prematurity rates are compiled from information on birth 
certificates. When birth certificate information is linked to 
information on death certificates, we are able to look at the 
causes of death for those babies who died during their first 
year of life.
    CDC's second largest surveillance system on maternal and 
infant health is called PRAMS, the pregnancy risk assessment 
monitoring system. PRAMS is an ongoing state-specific 
surveillance system designed to identify and monitor maternal 
behaviors and experiences before, during and after pregnancy 
among women who had live births. PRAMS has served to expand the 
information capacity of 37 States and New York City and this 
unique surveillance system is now representative of 
approximately 75 percent of all births in the United States. 
CDC also provides resources to assist States in conducting 
surveillance of major birth defects, which are important causes 
of infant mortality.
    In terms of research, we are working with partners to try 
to understand some of the biology among women who delivered 
preterm. These studies focus on the interactions among genes, 
other biologic markers, race and ethnicity, and social and 
economic exposures for women. We really don't know a lot about 
why late preterm births increased and drove the overall preterm 
birth rate during the last several decades. We are currently 
involved in a study to review hospital medical records in order 
to discover why and how late preterm births occur. In the area 
of capacity building, CDC has 23 federal staff assigned to 
State health departments providing technical support for 
epidemiological research, public health surveillance and State-
based programs.
    As we move forward, we will be investigating how the 
quality of surveillance information can be improved and how we 
can use it to inform programs and public health practice. A 
society measures what it values, and we will strive to improve 
the core public health function of surveillance. As new ideas 
emerge about the reasons for and predictors of preterm birth 
and about possible prevention interventions, we will continue 
to synthesize evidence and attempt to fill in knowledge gaps 
through research. We will continue to press forward with our 
work in the area of understanding late preterm birth as this 
group continues to comprise the largest proportion of preterm 
births. As we learn more about causes and prevention, we 
anticipate the result will be more healthy babies and healthy 
families.
    Thank you for the opportunity to speak today, and I would 
be happy to answer questions.
    [The prepared statement of Dr. Callaghan follows:]

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    Mr. Pallone. Thank you, Dr. Callaghan.
    Dr. Spong.

                  STATEMENT OF CATHERINE SPONG

    Dr. Spong. On behalf of the Eunice Kennedy Shriver National 
Institute of Child Health and Human Development at the National 
Institutes of Health, I appreciate the opportunity to provide 
the committee with information about our research programs on 
preterm birth and infant mortality.
    I am Dr. Catherine Spong, chief of the Pregnancy and 
Perinatology Branch at the NICHD. The NICHD mission is to 
ensure that every person is born healthy and wanted, that women 
suffer no adverse harmful effects from reproductive processes 
and that all children have the chance to achieve their full 
potential for healthy and productive lives free from disease or 
disability. As such, research on prematurity and its health 
outcomes falls squarely within the Institute's mission.
    As we have heard from your opening statements and as Dr. 
Callaghan eloquently stated, preterm birth is a major public 
health problem. In 2001, preterm birth became the leading cause 
of death among newborns, and those who survive preterm birth 
account for one in five children with mental retardation, one 
of three children with vision impairment and almost half of all 
children with cerebral palsy. Late preterm infants appear to be 
at higher risk for sudden infant death syndrome and have higher 
rates of neurological and developmental morbidities during 
childhood. In adulthood, children born at low birth weight have 
an increased risk for cardiovascular disease such as heart 
attacks, strokes and hypertension and an increased risk for 
diabetes.
    The NIH is committed to understanding the causes and to 
reducing the incidence of preterm birth, low birth weight and 
infant mortality and their consequences. The NICHD was the lead 
federal agency in planning and coordinating the surgeon 
general's conference on prematurity prevention held in June of 
2008. As I will describe, NICHD preterm research efforts 
address these recommendations and range from basic work on the 
mechanisms of labor, genetics and proteomics to research 
regarding specific questions encountered in clinical practice 
and the long-term implications on the infant, mother and 
family.
    While the NICHD supports the bulk of NIH research in this 
area, other institutes and centers also contribute to the 
overall NIH funding for infant mortality, low birth weight and 
prematurity research projects. This totaled $278 million in 
fiscal year 2009 including ARRA funds, the last year for which 
we have complete data.
    One of the most successful approaches for research related 
to prematurity are the NICHE research networks, which allow 
physicians and scientists across the country to coordinate 
their work and share data. The Maternal Fetal Medicine Units 
Network, composed of 14 sites across the country, conducts 
clinical studies to improve maternal, fetal and neonatal 
health. This network has a remarkable track record of 
conducting high-priority clinical trials with its findings 
incorporated into practice. The Neonatal Research Network 
focuses on babies in neonatal intensive care units to improve 
their health and outcome.
    The NICHD recently has funded a study on women in their 
first pregnancy, the Nulliparous Pregnancy Outcome Study. The 
best predictor of preterm birth, pregnancy outcome, is not 
available for these women yet they account for 40 percent of 
all deliveries each year. The aim of this large multicenter 
study is to identify markers early in pregnancy that will 
identify women at the highest risk for preterm birth, 
preeclampsia and stillbirth with the goal to ultimately develop 
interventions and therapies.
    To understand the biologic mechanisms underlying 
spontaneous preterm births, the NICHD is supporting a wide 
range of research including intrauterine infection, bleeding 
and psychosocial stress. Another major emphasis is on 
preeclampsia as it is the primary reason for medically 
indicated preterm births. Research supported by NICHD has shown 
that this disease is associated with an abnormal development of 
the placenta. NICHD-supported research identified and 
highlighted the significant complications associated with late 
preterm births, those babies born between 34 and 37 weeks, that 
account for 70 percent of all preterm births, these supported 
practice guidelines affect changes in practice.
    One aspect of research is to identify markers or predictors 
of preterm birth. A short cervical length is a predictive 
marker and was identified through NICHD research. In a blinded, 
multicenter observational study of women with a prior preterm 
birth, shortened cervical length in mid-pregnancy can predict 
early spontaneous preterm birth. This has led to screening for 
cervical length in women who are at risk for preterm delivery.
    Ideally, the best outcome would be to prevent preterm birth 
in the first place. A major advance in prevention was made by 
the NICHD's Maternal Fetal Medicine Network studying women who 
have had a previous preterm delivery and therefore were at risk 
for a recurrent preterm birth. This trial compared progesterone 
to placebo, and progesterone treatment lowered the risk of 
preterm birth by one-third, the first successful preventative 
therapy to reduce the risk of recurrent preterm birth and 
improve neonatal outcomes. The impact of this treatment was 
evaluated in a 2005 study, which estimated that 10,000 preterm 
births could be prevented annually if all eligible pregnant 
women received progesterone. The American College of 
Obstetricians and Gynecologists has recommended the use of 
progesterone to prevent preterm birth for women with a prior 
spontaneous preterm birth.
    In addition to studying preventative therapies, the MFMU 
Network studies interventions during pregnancy to prevent 
complications in preterm infants. Recently, the network 
identified a therapy, magnesium sulfate, or Epsom salts, which 
when administered to women who are at risk of delivering 
preterm, reduces the risk of cerebral palsy in surviving 
preterm infants by 45 percent.
    The NICHD also supports research on how to manage and care 
for preterm infants. One example is nitric oxide, a compound 
that is used to treat infants with severe breathing problems, 
but the safety and efficacy for premature infants has had mixed 
results. To better understand the potential risks and benefits 
of inhaled nitric oxide therapy, the NIH will convene a 
consensus development conference in October of this year to 
assess the available scientific evidence and form conclusions 
about its clinical use in preterm infants.
    Both preterm infants and infant mortality have dramatic 
health disparities with higher overall rates in African 
American women. NICHD-supported researchers are attempting to 
identify the factors to explain these disparities, and in 
August of this year the NICHD will hold a scientific workshop 
focused on disparities in infant mortality, stillbirth and 
preterm birth.
    Given the implications of preterm birth on long-term health 
and disease of the child and family and affecting over half a 
million pregnancies each year, preterm birth truly is a public 
health priority. Were we able to prevent preterm births, not 
only would infant mortality improve, we would actually improve 
the health of the Nation with less heart disease and diabetes 
in the children and healthier mothers and families. This is our 
goal.
    Again, thanks to the committee for your time and interest, 
and I am pleased to answer any questions that you may have.
    [The prepared statement of Dr. Spong follows:]

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    Mr. Pallone. Thank you, Dr. Spong.
    What we do now is, we have questions from the members for 5 
minutes or sometimes 8 if they didn't do an opening, and I am 
going to begin with myself.
    I will ask initially Dr. Callaghan, in your testimony you 
discussed CDC's role in surveillance in terms of monitoring 
infants born prematurely, analyzing trends, defining risk 
factors and targeting prevention programs. I mentioned that I 
sponsored H.R. 3212, the Stillbirth and SUID Prevention, 
Education and Awareness Act, and I am particularly interested 
in the collection of critical data to determine the causes of 
stillbirth and sudden unexpected infant death. Can you tell me 
what the CDC is doing to understand the causes and risk factors 
associated with stillbirths, sudden unexpected infant death and 
sudden unexplained death in childhood, and are there ways to 
reduce those risks? And then secondly, how would better data 
collection help reduce and prevent these deaths in the future, 
if you could?
    Dr. Callaghan. The National Center for Health Statistics 
collects information on fetal deaths from fetal death 
certificates. Fetal death certificates are not birth 
certificates. A fetal death report is what it is called. So 
they are able to--those are collected by States, sent to NHS 
and NHS compiles those for the Nation. The quality of 
information on fetal death certificates is not always what we 
would hope it would be. These are filled out essentially in 
real time at the bedside in the hospital and sent in, and there 
is a fair amount of variability in how stringently people fill 
those out. There is also a fair amount of variability on how 
much each fetal death is investigated at the individual level. 
To do this correctly, there needs to be fetal autopsy, there 
needs to be fetal genetic studies. These aren't always done 
consistently and so the amount of information that is 
ultimately reported as to the cause of death can be variable, 
which leads us to your statement that in many cases we are left 
without a real good reason about why that happened. So efforts 
to improve the quality of fetal death reporting at each 
individual level at the time of each individual fetal death 
would be important in terms of improving our information.
    There is also some pilot work that is being done at CDC at 
Atlanta in the National Center for Birth Defects and 
Developmental Disabilities. There is Atlanta Metropolitan Birth 
Defects Surveillance System and there is some pilot work being 
tagged onto that to try to see if fetal death registration can 
also be used with that same infrastructure. If that was 
successful, that could be expanded to other birth defect 
surveillance systems. Birth defect surveillance systems collect 
much more nuanced information, almost through survey.
    Lastly, about sudden unexplained infant death, we have done 
a lot of work in this area, and we have learned that there is a 
difference between the sudden unexplained infant death and 
sudden infant death syndrome. Sudden infant death syndrome 
means there is no plausible explanation for the cause of death. 
It is truly unexplained. The more and more that people do death 
scene investigations on the ground, again, in and around the 
time of the infant death, the more and more people are finding 
that there actually may be explanations. The good thing about 
having an explanation, it doesn't bring a lot of relief to the 
grief of parents, but if you have an explanation, now we have a 
chance of prevention. So we are in the process of establishing 
pilot registries for that.
    Mr. Pallone. Thank you.
    I am going to try to summarize this next one for Dr. Spong. 
I think it is critically important that we do everything we can 
to ensure that we have the right research infrastructure and so 
I wanted to ask you three questions about the research network. 
First, how many women are usually in the clinical trials 
conducted by the network? I guess we are talking about the 
Maternal Fetal Medicine Unit Network. And is there a diverse 
population of women represented in the trials? Can you 
elaborate on use of 17P to prevent prematurity and would you 
discuss other interventions that have impacted patient care to 
date?
    Dr. Spong. Thank you, Mr. Chairman. The first question was 
the number of patients enrolled in clinical trials?
    Mr. Pallone. How many women are usually in them, yes, and 
is there a diverse population of women?
    Dr. Spong. So the number of patients enrolled in a given 
trial depends on what the trial is looking at and what the 
question is to be addressed, how big the effect needs to be, 
how rare the outcome is. We have had trials that have included 
few number of patients, for example, 200, 300, and we have 
recently completed a trial that included over 10,000 women. In 
addition, some of the observational studies have included, you 
know, many, many more women than that. The diversity of the 
population is assured when the network is openly and actively 
recompeted every 5 years. As part of that recompetition, as 
part of looking at who should be part of the network includes 
geographic diversity and diversity in the patient population.
    Your question about 17 alpha hydroxyprogesterone caproate 
or progesterone for the use to prevent preterm birth, this was 
a landmark study as the first preventative therapy identified 
for women who had a prior preterm birth. As a clinician, I knew 
that one of the very common things that you would see with a 
patient who had come in for prenatal care who had had a prior 
preterm birth, we would say that you are at very high risk for 
another preterm birth but we had nothing to offer her. Now with 
the use of 17 alpha hydroxyprogesterone caproate, we have 
something that we can offer her that can reduce her risk of 
another preterm birth by about one-third. That progesterone is 
now being studied in other high-risk populations so women who 
have had a prior preterm birth or are at high risk, women who 
have multiple gestations are at high risk, and they have been 
studied, both women with twins and triplets, and it was found 
that progesterone did not reduce the rates of preterm birth in 
that population, and I think that is very important to know, 
that it is not a cure-all for all prematurity, it is for 
specific conditions and it is currently being evaluated in the 
setting of a shortened cervix in an asymptomatic woman.
    There are a number of other studies that the network has 
undertaken that have impacted practice. One example is the use 
of antenatal corticosteroids which are given to women who are 
risk of delivering preterm with the understanding that it will 
improve outcome for the babies. It decreases their 
complications such as breathing complications and bleeding 
complications. The network undertook a study looking at 
repeated doses of those steroids and found that in fact that 
was not beneficial, so it was a change in practice from 
repeating multiple doses of steroids.
    Another example is one of magnesium sulfate being 
administered to women who are at risk for preterm birth where 
it significantly reduced the risk of cerebral palsy by about 45 
percent. One of the unique factors from this network is that 
when these trials are published, their findings are then often 
incorporated into professional guidelines such as those by the 
American College of Obstetricians and Gynecologists making 
recommendations for how that should change and how that should 
be implemented into practice. I can give a number of other 
examples as well.
    Mr. Pallone. No, I think we better stop there because I 
made you go over. It is not your fault.
    Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman.
    I want to throw this out there. In the health care law, 
either I am right that my constituent is denied the ability to 
purchase insurance on the sole reason of a preexisting 
condition of their child, or I am wrong, and I would ask 
someone on the majority side to help me have a hearing on this 
issue to see who is right. It is not a question. I am asking 
for a hearing. I have a case of a former staffer who cannot get 
insurance because of a preexisting condition of their child. My 
colleague from Illinois said that is not true, and I think this 
would be a good hearing to have on this issue of whether people 
right now under this health care law are being denied access 
because of preexisting condition. So I want to put that on the 
record. My colleague is not here from Illinois, who rejected my 
claim, but I throw that out as an issue.
    I appreciate your testimony, and you say words I can't even 
pronounce, but I do have a question, Dr. Spong. The mission of 
the NICHD is to ensure that every person is born healthy and 
wanted, and I am curious of why you have the word ``wanted'' 
there. What does that mean and what does that mean for what you 
do? It is a curious word. Can you explain that?
    Dr. Spong. Thank you for your question. The question is why 
the NICHD mission includes the word ``wanted,'' and I will be 
the first to admit that the mission was created before I 
started working at the National Institute of Child Health and 
Human Development so I do not have that information for you at 
this time, but I would be happy to get back to you in written 
testimony.
    Mr. Shimkus. Yes, it is an interesting word. I mean, I 
don't know what it means. So if you could get back to me. 
Before we make conjectures and think things, I will just wait 
for a response because I just don't know what that means.
    Let me follow up with this question. If individuals change 
their lifestyle, stop smoking and manage their weight, would 
that reduce the risk of prematurity, Dr. Spong?
    Dr. Spong. The risk factors that you stated were if they 
lost weight and if they stopped smoking, would that reduce 
preterm birth. Obesity itself--healthy lifestyles are good for 
pregnancy. Obesity itself has a mixed message on whether or not 
it actually causes preterm birth. There are studies that would 
suggest that obesity is not in fact associated with preterm 
birth. That said, starting out with a healthy weight is optimal 
for pregnancy for a number of reasons regardless of preterm 
birth, so we would certainly encourage all women to start 
pregnancy at a healthy weight. Smoking itself is associated 
with low birth weight or smaller babies, and clearly is one 
major lifestyle change that people can make that can improve 
the health of their children and remove the risk of low birth 
weight.
    Mr. Shimkus. Let me follow up, because Dr. Callaghan 
mentioned that infection itself may not be the cause of 
prematurity but rather the inflammation associated with the 
infection. Do you agree with that?
    Dr. Spong. The question regards to the role of infection 
versus inflammation on preterm birth, and preterm birth is a 
very complex condition, and I believe there are multiple 
pathways that can lead to a preterm birth. One is going to be 
an infectious pathway. Clearly, that can cause preterm birth 
but the inflammation itself in the absence of infection can 
also cause preterm birth.
    Mr. Shimkus. And then are there contributing factors to 
increased inflammation that could be avoided through a change 
in lifestyle?
    Dr. Spong. That is an excellent condition. Those are areas 
that are currently getting teased out. It is likely that it is 
not a single factor that causes much of preterm birth but a 
constellation of events, so whether you have certain 
environmental factors, certain genetics, certain inflammatory 
markers and then certain lifestyle events that can ultimately 
result in a preterm birth.
    Mr. Shimkus. And I want to thank you. I am going to end. Of 
course, on our side we have Dr. Gingrey and Dr. Burgess, who 
are both obstetricians, and I am waiting for their follow-up 
questioning as they are experts in the field, and I yield back 
my time. Thank you, Mr. Chairman.
    Mr. Pallone. Ms. Capps asked that we enter into the record 
this letter from Secretary of Health and Human Services to the 
Speaker and I guess to the Republican leadership, and it 
basically goes into the different provisions in the health care 
reform on adult and child coverage, preexisting conditions, 
early retirement, reinsurance, rescissions, Medicare Part B 
with a timeline.
    Mr. Shimkus. That is correct. The point that Secretary 
Sebelius has said please, insurance companies continue to cover 
people, kids with preexisting conditions. The issue is they are 
not, and so I would suggest that we have a hearing on this, 
and----
    Mr. Pallone. I am not just reading it.
    Mr. Shimkus. I am just----
    Mr. Pallone. You know what it is.
    Mr. Shimkus. I am just----
    Mr. Pallone. Effective beginning----
    Mrs. Capps. The date September 23rd is there.
    Mr. Pallone. And on March----
    Mr. Shimkus. So right now people if they have no insurance, 
they cannot get coverage with preexisting conditions. That is 
the law.
    Mrs. Capps. Because some insurance companies are operating 
to do it----
    Mr. Shimkus. So you are not disputing the fact that my 
former staffer, this family cannot get health insurance right 
now?
    Mrs. Capps. It isn't required yet.
    Mr. Shimkus. It is not required. Thank you for----
    Mrs. Capps. But it will be very soon.
    Mr. Pallone. But on March 29th it is required for children.
    Mr. Shimkus. But it is now right now.
    Mrs. Capps. September 23rd.
    Mr. Shimkus. But it is not right now.
    Mr. Pallone. It says on March 29th----
    Mr. Shimkus. So my point is, we could pass a law tomorrow 
to do this.
    Mr. Pallone. Well, Mr. Shimkus, first of all, does anybody 
have an objection to entering this into the record? I mean, the 
only thing it says on preexisting conditions, it says, 
``Effective for policies or plan year beginning on or after 
September 23rd be prohibited from excluding coverage of 
children.''
    Mr. Shimkus. If the chairman would yield, my point is, I am 
going to continue to raise issues that we ought to have 
hearings on this law, and this is just another example of 
people not having access to health insurance because of 
preexisting conditions, and this is something we can fix.
    Mr. Pallone. I don't think there is any question that the 
law is the September date, but you can look at it.
    Mr. Shimkus. And we could bring a bill to the floor 
tomorrow and fix this. That is my point.
    Mr. Burgess. Mr. Chairman, if I could just stand in 
agreement with my colleague from Illinois. We handed an 
enormous task to the Department of Health and Human Services to 
create something out of whole cloth in this law that we passed 
hurriedly a couple months ago and really it is incumbent upon 
this committee to maintain the vigilance and oversight over HHS 
and CMS as they come up with these rules and regulations that 
are literally going to affect every American, not between today 
and Election Day but for the next three generations. So I hope 
you will consider Mr. Shimkus's request to hold the appropriate 
hearings at this level.
    Mr. Pallone. Let me just have that back.
    Without objection, it is entered into the record.
    The gentlewoman from California has the time.
    [The information appears at the conclusion of the hearing.]
    Mrs. Capps. Mr. Chairman, you may not wish to call on me 
after all of that, but thank you. This has been a good 
discussion. Back to the topic, but before I ask my question for 
Dr. Callaghan, I want to just acknowledge that there are many 
members of a non-governmental organization called CARE on 
Capitol Hill today because they are very interested not only in 
this hearing but in other topics having to do with preterm 
delivery and birth, and one of them is a constituent of mine so 
I want to welcome a particular group that was here. We had 
nurses earlier as well. And I appreciate the testimony that 
both of you have given us.
    Dr. Callaghan, in your testimony you included some of the 
surveillance mechanisms that the CDC uses to monitor the 
pregnancy outcome and also infant health. Especially with 
issues such as the ones we are discussing today, I believe it 
is critical to have really accurate and robust surveillance and 
data collection strategies. Now, you mentioned that only 37 
States and New York City participate in what is called the 
PRAMS program and that the survey is representative is 75 
percent of all births. It is too bad we can't have closer to 
100 percent. What are some of the barriers to implementation of 
this participation in all States and for full representation so 
that we really have a much more robust data collection?
    Dr. Callaghan. The one thing I will say, and this is very 
pertinent to your state, is California has a very complementary 
system that does not participate in PRAMS. I could get the 
precise name of it. I think it is called MEWA.
    Mrs. Capps. So we do something different but you can't use 
it in the national data collection?
    Dr. Callaghan. No, we cannot use that in the national data 
collection. That is parochial to California. It is a very good 
system.
    Mrs. Capps. The California system is good but it doesn't 
help nationally?
    Dr. Callaghan. It doesn't help nationally.
    Mrs. Capps. I see. So that in of the barriers then?
    Dr. Callaghan. It is a barrier because----
    Mrs. Capps. And so maybe some kind of smart scientist can 
figure--a number cruncher can figure out how to coordinate it 
so it will be useful to California but also to the United 
States.
    Dr. Callaghan. Because then one of the other problems that 
is left with some of the other smaller States is the births are 
so small, and this is based on not a sampling of total births 
but on a sample of births and so some very small States, it 
becomes very difficult to get a sample that is representative.
    Mrs. Capps. And you really want to have a large State like 
California and all of New York, not just New York City 
involved?
    Dr. Callaghan. Right.
    Mrs. Capps. That is useful. Thank you very much. It gives 
me something to think about with my own State.
    Here is another question. I am very excited to hear of the 
move to modernize vital records systems. Maybe this is one 
arena where we need to do this. But there seems to be more room 
for data collection. Can you tell us more about what is 
currently being collected on electronic records in light of the 
many factors? Maybe we are not even asking enough questions 
when we do data collection. In light of the many factors 
associate with premature birth and infant mortality and 
morbidity, what other data would be helpful to collect? 
Especially with the kind of technology we have to collect and 
sort data.
    Dr. Callaghan. You are asking what other information could 
we collect on birth certificates?
    Mrs. Capps. Are we lacking----
    Dr. Callaghan. We collect a lot of information on birth 
certificates. We collect a lot of information about maternal 
conditions during pregnancy. We collect information about 
problems that occurred during labor and delivery. But one of 
the things that we have seen over and over again when we go 
back and do validation of that information is that it doesn't 
do very well most of the time.
    Mrs. Capps. So there is room for improvement?
    Dr. Callaghan. There is room for improvement at the level 
of data collection, and data collection occurs individually at 
individual hospital level.
    Mrs. Capps. So there might be some legislation that would 
be useful to you to help with the CDC to do a better--to be 
more equipped to do a better data collection?
    Dr. Callaghan. I have always said that if there is anything 
that I could do in career in public health is to improve vital 
statistics because we have an infrastructure in place.
    Mrs. Capps. Mr. Chairman, I am going to suggest, or just 
suggest it to my fellow committee members that this is an area 
that would seem to be the low-hanging fruit, if you will, for 
some of the challenges that we face in this area, that if we 
can put some bright heads together to figure out a better way 
to collect data and use it in a proper way, that would be very 
useful.
    I am going to try one more question because I have 17 
seconds. Dr. Spong, I appreciated your testimony as well. You 
know, there are so many factors associated with preterm birth, 
the health status of the mother, you know, issues like 
diabetes, obesity, deficiencies of certain nutrients and so 
forth, high blood pressure. Can you just say in a couple of 
seconds more about the importance of preconception health? This 
is such a huge issue that starts really prebirth with the one-
day mother, doesn't it?
    Dr. Spong. Yes, preconception care is clearly important. 
Women who start pregnancy healthy tend to have healthier 
pregnancies. That said, I cannot point to research or data as 
to what exactly needs to go into that preconception care that 
will actually ultimately result in improved outcomes. But we do 
know that women who have a healthy lifestyle, who are an 
appropriate weight, who don't have habits such as smoking or 
alcohol exposure tend to have healthier pregnancies.
    Mr. Pallone. Thank you.
    The gentleman from Pennsylvania, Mr. Pitts.
    Mr. Pitts. Thank you, Mr. Chairman. First, I would like to 
ask unanimous consent to enter into the record a couple of 
articles and a list of studies that have found that women with 
prior induced abortions are at increased risk for premature 
birth and low birth weight.
    Mr. Pallone. I am going to take a look at them but I don't 
see a problem.
    Mr. Pitts. The articles are by the American Association of 
OB/GYNs.
    Mr. Pallone. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. Thank you, Mr. Chairman.
    Dr. Callaghan, you mentioned that the CDC had worked with 
States to assist with smoking cessation programs during 
pregnancy. Have any States used their master settlement 
agreement funds to implement smoking cessation programs 
targeted at pregnant women?
    Dr. Callaghan. I really don't have the information at hand 
to answer that question. I would be happy to do that and get 
that information to you.
    Mr. Pitts. All right. You mentioned that African American 
women are more than, I think you said twice more likely than 
white women to have preterm birth, one and a half times more 
likely to have preterm birth, twice as likely to have very 
preterm infants. Why is that the case?
    Dr. Callaghan. That is one of the holy grails. 
Understanding that is probably one of the holy grails in all of 
perinatal health and perinatal medicine. These are disparities 
that we have seen over and over and over again. They are 
pernicious. When we adjust for almost anything that we can 
think of, if we adjust for socioeconomic status, we adjust for 
education levels, it doesn't go away. In fact, as was mentioned 
previously in this hearing, these gaps are even greater when we 
look at the difference between the most well-off African 
American women and the most well-off white women, the gap is 
even greater. As Dr. Spong mentioned, the paths to preterm 
birth are likely very, very complex. This has been likened to 
this other group of diseases that we call common complex 
diseases like cardiovascular disease where at the end of the 
day there is a preterm birth but there are a lot of different 
ways to get there.
    Our current kind of working hypotheses around these, that 
there are genetic factors, that are environmental exposures, 
environmental in most holistic ways such as stress, poverty, 
all of which are interacting to result in whatever happens that 
goes into spontaneous preterm birth. If we knew the answer to 
that question and if we could fix that problem, our preterm 
birth and our infant mortality rate would be dramatically 
decreased in the United States.
    Mr. Pitts. And in 2006, Congress passed the PREEMIE Act 
authored by Mr. Upton in the House, and one provision of the 
legislation called on HHS to award grants to public and private 
nonprofit entities to conduct demonstration projects for the 
purpose of improving the provision of information on 
prematurity to help professionals and the public and improving 
the treatment and outcomes for babies born preterm, and the 
grants were to support programs to test and evaluate screening 
for and treatment of infections, counseling on optimal weight 
and good nutrition, smoking cessation, education, counseling, 
stress management, appropriate prenatal care. How many grants 
have been awarded under this program and what have been the 
results of these demonstration projects so far?
    Dr. Callaghan. We began receiving appropriations for the 
PREEMIE Act in 2009, and we have continued to do work in 
preterm birth as I outlined with regard to looking at late 
preterm birth, with looking with factors associated with the 
interactions that we are looking at in California, looking at 
in Michigan, the interactions between preterm birth, race, 
genetic factors and biologic markers. There are people at CDC 
that are working in authorization and appropriations and I 
would be happy again to have them get back in touch with you, 
but as the scientific liaison for the branch that I work in, 
that is information I am just not familiar with.
    Mr. Pitts. OK.
    Dr. Spong, I don't have much time. You mentioned genomic 
research in the filed of prematurity. Can you further expand 
about what we have learned about prematurity from genomic 
perspectives?
    Dr. Spong. There have been a number of smaller studies 
looking at specific genes or specific alterations in genes to 
try to identify why one group might be at higher risk of 
delivering preterm, and they have identified certain changes in 
alleles or changes in genes. However, we realize that really 
that is not going to answer the question, looking at small 
groups of people one gene at a time or one alteration in a gene 
at a time. Because of that, the NICHD undertook launching a 
network on genomics and proteomics of preterm birth to try to 
really do a genome widescreen and really evaluate what are the 
changes in the genomics and proteomics associate with 
spontaneous preterm birth and indicated preterm birth, and that 
network is ongoing and over the next couple of years I expect 
we will have some findings from it.
    Mr. Pitts. Thank you. My time is expired.
    Mr. Pallone. Thank you, Mr. Pitts.
    I guess we are going to the gentlewoman from Florida, Ms. 
Castor.
    Ms. Castor. Thank you very much for your testimony.
    Dr. Callaghan, correct me if I am wrong, but I believe 
there is no conclusive evidence that links rising C-section 
rates to prematurity numbers or data that displays that 
increases in C-sections are the reason that prematurity rates 
went up from 1996 to 2007. However, the speculation is strong. 
The March of Dimes reported that from 1996 to 2006, C-sections 
accounted for 92 percent of all preterm births in the United 
States. Can you please discuss the type of studies that must be 
conducted to get to the bottom of this and what steps are 
currently underway?
    Dr. Callaghan. First of all, because I was a coauthor on 
that paper, it is really 92 percent of the increase in preterm 
births and not the total preterm birth rate. Still, that is a 
very compelling number. The issue about this really hinges 
around the word ``cause.'' During this time, 1996 through now 
in fact, Cesarean sections have been rising for all comers and 
pregnancy no matter what the gestational age, perhaps more 
particularly in the late preterm births but it is going up. I 
think that the issue around cause, and maybe we need to look at 
this a little bit differently, is not so much as a Cesarean 
section that is caused but might we expand that a little bit 
more to say is it intervention because there are other 
decisions that are being made around delivery. And I think that 
is what we need to get at, what kinds of decisions are being 
made. There are always two steps in this process. The first 
step on a clinical basis is the physician and the patient 
together in the best circumstances make a decision that 
delivery should occur. So that is the first thing that happens 
is should delivery occur. Next question is how delivery should 
occur. So I think that first step, should an intervention take 
place, is what we really need to get at. One of the things that 
we are doing right now is, we have a pilot study in three 
metropolitan Atlanta hospitals. We are going to identify 
through vital records a group of infants that were born between 
34 and 36 weeks, go to the medical records and see if it is 
even possible by looking through the medical records to find a 
reason why the birth occurred. We are also planning on doing 
some key informant interviews in those hospitals, physicians, 
nursing staff, et cetera, to try to get some more qualitative 
information about what might be influencing those decisions 
because I think what we really need to do is get at these 
processes, and this is hard stuff because this isn't just 
numbers, it is really getting around qualitative information 
about what process goes on when decisions are made to deliver 
prior to term and then how delivery should take place.
    Ms. Castor. You know, ACOG and the March of Dimes have 
probably the best recommendations on protocols for health 
providers. It sounds like the study in Atlanta, something along 
those lines so you support something like that on a broader 
basis as well. Yes?
    Dr. Callaghan. Yes.
    Ms. Castor. Thank you very much.
    Mr. Pallone. Thank you.
    The gentleman from Texas, Mr. Burgess.
    Mr. Burgess. Well, I am actually glad that subject Ms. 
Castor brought up, that you are having that discussion. In 2006 
when we reauthorized the National Institute of Health, there 
was report language in the bill dealing with the concept of 
doing a Cesarean suction study. Dr. Ken Leveno down at Parkland 
where I trained had been concerned that there was a movement 
toward elective Cesarean section. In my professional lifetime, 
I saw rates go from 12 percent during my residency to probably 
25 percent when I concluded active practice in 2003 and now I 
suspect they are even higher still. Dr. Leveno's concern was, 
we may reach a point where simply the indication for Cesarean 
section is patient demand, and we really ought to have the data 
before we reach that point because once we are there, it then 
becomes very hard to walk back from patient demand on something 
along those lines. So where are we with that? Are we looking 
into the concept of Cesarean section rates and elective 
Cesarean sections are the rates of late prematurity which are a 
result of some iatrogenic influences either with Cesarean 
section or planned induction of labor? Do you have data on 
those issues?
    Dr. Callaghan. Yes, that is exactly what we are trying to 
get at now with these studies. There is also another study that 
I am involved in peripherally through wearing my CDC hat in 
Florida that is trying to look at that exact issue. There are 
no national data on Cesarean section on demand.
    Mr. Burgess. Again, it was Dr. Leveno's concern that we 
ought to get that data before it becomes an established norm. I 
would never be able to go back and randomly assign people to 
groups. I mean, you know that. It becomes almost an impossible 
study to construct, so we ought to be prospective about our 
look at that.
    Dr. Callaghan. And that would probably to do that on a 
national basis to include all deliveries in the United States 
would likely demand really changing our birth reporting forms 
to have that as a check box, if you will, or questions on that 
regarding the indications for Cesarean delivery. To the degree 
that could be done, I would be in wholehearted support. I don't 
know logistically if that is going to happen very quickly.
    Mr. Burgess. Yes, it is expensive to do that type of study. 
Honestly, it may be something that we need to look at in a 
prospective fashion.
    I represent a part of north Texas, the east side of Fort 
Worth. Fort Worth is where the west begins, but I have the east 
side. That is where the east levels out. We have some infant 
mortality rates in some of my zip codes that are some of the 
highest in the country, and if you look at African American 
women and the infant mortality rates for African American 
populations in those zip codes, it is astoundingly high, and 
yet on the other side of the Trinity River in Dallas, their 
mortality rates are much more benign and you don't see the 
ratio of disparities. Both counties are large. Both have 
significant urban populations. Both have a county hospital. The 
difference between the two is the availability and the access 
to what might be referred to as a community clinic or federally 
qualified health center. And I have labored for that since 2005 
when I began representing that part of Fort Worth, to get a 
federally qualified health center there. We did not quite a 
year so, so it will be a while before we see if it makes a 
difference, but it really drove home to me that access may be a 
problem, and that is something we need to pay attention to, but 
arguably there is equal access in Dallas and Tarrant counties 
because of the availability of a county facility even for 
someone who lacks the ability to pay, and these are tax-
supported institutions. But utilization was hugely different 
between Dallas and Tarrant County, and I think I attribute part 
of that to the fact that the availability, the doctors weren't 
where the people were, and that has been one of the 
difficulties that I have sought to outcome. Do you guys have 
any experience with looking at things like that?
    Dr. Callaghan. We don't have a lot of experience with 
looking at that particular thing although I think you are 
probably referring to your home base, the Parkland experience 
and the report that they have about reducing preterm birth and 
infant mortality and it is an intriguing model where it is 
almost doing prenatal care as I read that almost as community 
outreach.
    Mr. Burgess. And interestingly, back in the 1950s, Dr. 
Prichard, looking at a map of Dallas and putting a pin in the 
map, a very low-tech activity but a pin in the map every time 
an out-of-hospital birth occurred, and that's where he set up 
the clinic after he got a cluster of pins, and we as residents 
would rotate through those clinics back in the 1970s. So they 
have a longstanding robust outpatient clinic department that is 
well accepted in the community because it has been there now 
for almost 50 years. Again, on the other side of the Trinity, 
we don't have--that is not an established part of what people 
think about. When they think of John Peter Smith, it is because 
it is the county hospital, not because there is a community 
clinic that feeds into that. I just think, you know, we talk 
about how we spend money, we have got to spend money wisely, I 
just think that is one of the areas where we perhaps missed an 
opportunity in this health care bill that we did. Well, we 
missed a lot of opportunities, but an opportunity we missed in 
this health care law was recognized in that.
    Thank you, Mr. Chairman. You have been indulgent. I will 
yield back the balance of my time.
    Mr. Pallone. Thank you.
    The gentlewoman from the Virgin Islands, Ms. Christensen.
    Mrs. Christensen. Thank you, Mr. Chairman. I would like to 
ask unanimous consent to insert into the record written 
testimony from Dr. Paula Braveman, professor of family and 
community medicine at University of California San Francisco.
    Mr. Pallone. What is it that you are giving me again?
    Mrs. Christensen. Written testimony that I would like to 
insert into the record of today's hearing.
    Mr. Pallone. Oh, OK, from----
    Mrs. Christensen. Dr. Paula Braveman.
    [The information appears at the conclusion of the hearing.]
    Mr. Pallone. Without objection, so ordered.
    Mrs. Christensen. Thank you. And just for the record, and I 
know this is not NIH but it is really CDC, but I see no reason 
why the territories' infant mortality, low birth weight and 
preterm deliveries are not reported on because we have that 
data, and I am proud to say that our infant mortality in the 
Virgin Islands last quarter was 7.56, and I can say I am proud 
because I know where we came from to get to 7.56, and that is 
in a largely African American and Puerto Rican community.
    Mr. Shimkus. Would the gentlelady yield for one second? I 
think it would be good for the Administration, because she has 
raised this a couple times that they better be prepared to 
report on the territories when they come to this committee. We 
are glad to have her on the committee.
    Mrs. Christensen. Thank you.
    Dr. Callaghan. I will be happy to take that back to 
National Center for Health Statistics.
    Mrs. Christensen. Thank you. And thank you, both of you, 
for raising the issue of the disparities in African Americans 
that I didn't have to do my opening statement.
    Dr. Callaghan, what is puzzling and has been known for a 
while is that even in African American women who are well off, 
well educated, live in supportive surroundings, there is still 
a higher low birth weight baby. They still have higher rates of 
low weight babies. Is there research being done to determine 
why this is and are you coming up with--this is sort of 
following up on the other question, but this is low birth 
weight babies, not preterm necessarily, not necessarily infant 
mortality.
    Dr. Callaghan. I came to CDC in 2001. Even prior to me 
coming there, there has been a long history of CDC bringing 
people together to look at this problem. A lot of the work in 
what is the social context of pregnancy in African American 
women and what is the context of African American women in the 
United States and looking at the long-term effects of 
institutionalized discrimination and institutionalized race and 
how does that chronic stress, which is very difficult to 
measure, there is not a blood test for it, but we know from 
some qualitative work that that stress exists and we also know 
that chronic stress plays itself out biologically. There is no 
question about it. Stress is a biologic phenomenon. There are 
pathways between what is going on in our brains and our brains 
are connected to everything, and there has been the hypothesis 
that some of these stress hormones actually regulate what has 
been euphemistically called the placental clock, and that there 
may be messages coming down that it is time to be born that are 
not in the best interest of the woman or the baby but that is 
what is going on. That being said, when we start drawing these 
pathways, there are so many lines feeding back on to one 
another that they are almost not even lines anymore, they are 
this line going up, this line going down and all of a sudden 
the line becomes a plane.
    The more important thing perhaps might be not so much the 
recognition that stress plays a part but then in the next step 
so what do we do about this, how can we ameliorate the effects 
of chronic stress, almost a bigger problem than trying to 
understand that stress affects our biology. We have done----
    Mrs. Christensen. Are you actually testing women in any way 
to see what their level of stress is? You are talking about 
people who are working in great jobs, have a decent education, 
and I mean, everybody has stress.
    Dr. Callaghan. Right, and in fact, when we look at least 
epidemiologically, we see that women who like in PRAMS, for 
example, they ask a lot of question about individual stress and 
individual stress is much worse when you sort of overlay their 
neighborhood context, for example, people who live in poor 
neighborhoods have a more profound response to stress, at least 
as it relates to preterm, than women who don't. I would like 
also Dr. Spong to weigh in because NIH is doing a lot of that 
fundamental work as well.
    Mrs. Christensen. And before you answer, though, let me 
just get my second question which is to you, Dr. Spong, and we 
are glad to hear about the August conference that you are 
having. In your answer, could you also tell me if the trials 
with magnesium sulfate, progesterone or treatment of bacterial 
vaginosis, if those trials are--the people in those trials, are 
they diverse enough to be able to tell the impact on African 
American and Latino or American Indian?
    Dr. Spong. I thank you for both of your questions. I am 
going to take the second question first. The diversity of the 
patient population in the network is required by the open 
recompetition every 5 years that the sites are geographically 
diverse and the population is geographically diverse. And I 
think one of the best examples is that progesterone was found 
to be equally beneficial in both African American women and 
non-African American women, which is so important given the 
disparities associated, so yes, we do strive for that and we 
are achieving that at least at this point.
    I would like to bring to your attention one study that the 
NICHD currently has underway called the community child health 
research network, which is focused specifically on the question 
you are asking about the African American community disparities 
in preterm birth as well as infant mortality, and the goal of 
this network is to involve the community itself along with the 
academic sites to develop the interventions to try to see if we 
can understand the disparities when measuring these markers of 
stress and to try to see if we identify potential 
interventions.
    Mrs. Christensen. Thank you. Thank for your answers, and 
Mr. Chairman, thank you. I yield back the balance of the time I 
have left.
    Mr. Pallone. I think that completes the questions for this 
panel. Thank you very much. It was helpful in terms of what we 
are trying to achieve and we appreciate it. We may send you 
additional questions from some of the members within the next 
10 days to answer in writing as well. But thanks.
    I will ask the next panel to come forward. Let me introduce 
the three of you. First on my left is Dr. Alan R. Fleischman, 
who is senior vice president and medical director of the March 
of Dimes Foundation. And next to him is Dr. Charles S. Mahan, 
who is dean and professor emeritus of the USF College of Public 
Health, the Lawton and Rhea Chiles Center for Healthy Mothers 
and Babies. Thank you for being here. And finally, Dr. Hal 
Lawrence, who is vice president for practice activities of the 
American College of Obstetricians and Gynecologists. Thank you, 
Dr. Lawrence.
    As you know, we ask you each to speak for about 5 minutes 
and then later if you want to submit additional materials in 
writing, you can.
    We will start with Dr. Fleischman.

STATEMENTS OF ALAN R. FLEISCHMAN, MD, SENIOR VICE PRESIDENT AND 
MEDICAL DIRECTOR, MARCH OF DIMES FOUNDATION; CHARLES S. MAHAN, 
 MD, FACOG, DEAN AND PROFESSOR EMERITUS, USF COLLEGE OF PUBLIC 
 HEALTH, LAWTON AND RHEA CHILES CENTER FOR HEALTHY MOTHERS AND 
    BABIES; AND HAL LAWRENCE, MD, VICE PRESIDENT, PRACTICE 
ACTIVITIES, AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS

                  STATEMENT OF ALAN FLEISCHMAN

    Dr. Fleischman. Thank you, Chairman Pallone, Ranking 
Shimkus and members of the subcommittee. On behalf of the 3 
million volunteers and 1,400 staff members of the March of 
Dimes, I want to thank the committee for your interest in the 
public health crisis of premature birth.
    As you know, the March of Dimes is a national voluntary 
health organization founded in 1938 by President Franklin 
Delano Roosevelt to prevent polio. Today, the foundation works 
to improve the health of mothers, infants and children by 
preventing birth defects, premature birth and infant mortality 
through research, community services, education and advocacy.
    After 3 decades of continual increases in the rate of 
prematurity, the March of Dimes is heartened by the news that 
the rate of preterm birth has finally leveled off and has begun 
to decline. But now is not the time to rest on our laurels. The 
life-threatening and lifelong consequences of prematurity as 
well as its extraordinary costs in dollars can still be felt by 
more than half a million babies and their families and each 
year in the United States some 28,000 babies die before the 
first year of life due to preterm birth. Prematurity is also 
the number one cause of neonatal death and is the major 
contributor to infant mortality. It is responsible for lifelong 
disabilities.
    We have also learned that the complications of being born 
late preterm, just four to six weeks premature at 34 to 36 
weeks' gestation are also significant since one-third of brain 
growth and development occurs in the last 5 weeks of pregnancy. 
Infants born just 4 to 6 weeks early are more likely than term 
infants to have significant long-term deficits such as school 
learning problems, disabilities and lower rate of college 
education and lower net incomes.
    In addition to the severe consequences, the costs of 
prematurity are immense. The Institute of Medicine estimated 
the annual societal economic costs associated with preterm 
birth are at least $26 billion a year. Approximately half, or 
48 percent, or hospital stays for preterm infants are financed 
by Medicaid. In 2007, hospital costs for these babies averaged 
$45,900 each.
    In recent years, we have seen several effective 
interventions to decrease preterm birth through comprehensive 
quality improvement strategies. The Intermountain Health System 
in Utah initiated prospective review of all elective inductions 
and C-sections and were extremely successful with dramatic 
decreases in early deliveries. Parkland Hospital in Dallas 
universal access to culturally sensitive comprehensive 
perinatal services over the past 15 to 20 years including high-
quality, evidence-based care with accountability and continuous 
quality improvement has resulted in the lowest rates of preterm 
birth among African Americans and indigent Hispanics in the 
United States.
    For the March of Dimes, the Cesarean section question is 
simple. Every baby should be delivered at the right time for 
the right reason. We applaud the guidelines and efforts of the 
American College of Obstetricians and Gynecologists. Adherence 
to their current guidelines and holding hospitals and 
clinicians accountable to these standards of care through 
quality and safety initiatives in hospitals can make a major 
difference in the rate of preterm birth and is needed in every 
hospital in the United States.
    So we are beginning to see some progress, but to sustain 
and to be truly successful in reducing the incidence of preterm 
birth and infant mortality, we require the continuing 
commitment of the federal government. That is why the March of 
Dimes is seeking reauthorization of the 2006 PREEMIE Act to 
support expanded research, education and demonstration 
projects. My written testimony provides more specific 
recommendations, but let me be clear: First, further research 
is essential into the fundamental causes of prematurity, and as 
the Institute of Medicine report and the surgeon general's 
conference recommended, transdisciplinary research centers for 
prematurity funded by the National Institutes of Health with 
new dollars allocated for these activities will integrate a 
wide range of disciplines and study this complex problem. 
Second, we need to reauthorize and expand preterm activities at 
the CDC Division of Reproductive Health to improve national 
vital statistics and increase community-based intervention 
programs, to impact on perinatal health disparities, and third, 
we need to reestablish the federal interagency coordinating 
counsel on prematurity and low birth weight to coordinate 
federal efforts and keep Congress apprised of progress on the 
issue of prematurity prevention.
    Finally, we hope that one of the outcomes of this hearing 
is that you will agree to work with us to draft and obtain 
swift enactment of legislation reauthorizing and expanding upon 
the progress made as a result of the PREEMIE Act, and I am sure 
that each of you in the room join of all at the March of Dimes 
who look forward to the day when every baby will be born 
healthy and stay healthy. Thank you very much.
    [The prepared statement of Dr. Fleischman follows:]

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    Ms. Castor. [Presiding] Thank you, Dr. Fleischman.
    Dr. Mahan.

                 STATEMENT OF CHARLES S. MAHAN

    Dr. Mahan. Madam Chair and members of the committee, I 
finished my OB/GYN residency 45 years ago, and practiced for 
the first 20 years, and then morphed into public health and 
directed the State health department in Florida for 8 years 
before becoming dean.
    I have been asked to speak to two areas by the committee. 
One was disparities, and the other is some public health steps 
that we could take immediately and in the fairly short term to 
start turning this around. A lot of people have also spoken to 
the disparities. The biggest problems are in African Americans. 
In Florida, we have the most black births of any State in the 
union, and our black-white infant death ratio has gone from 1.9 
to 1 to 2.6 to 1, and last year we woke up our Hillsboro County 
and Tampa and found that it was four times the white rate. I 
have put some statistics there about maternal mortality again 
which black women suffer much more heavily than white women, 
and that has already been mentioned.
    As far as the causes of infant mortality, there is a chart 
on my testimony that shows sort of a flow chart that shows how 
these things develop, and as Dr. Callaghan pointed out, there 
is a very complex problem. You have root causes of which health 
and health care are only two, and stress has been mentioned, 
economics, education, family support, crime. All of these are 
things that can lead to a problematic outcome of pregnancy. And 
the two biggest factors that enter into preterm birth are 
social issues and maternal health when the mother enters 
pregnancy. By people smarter than I am, it has been predicted 
that if we corrected and every African American woman got into 
great health and great health care without addressing those 
other issues, we may be able to nibble away at 30 percent of 
this problem. But other countries that have passed us in this 
area have dealt with the education, the jobs and the other 
things that are important leading into this issue.
    Now, depending on where you live, this isn't just a problem 
in the black community. I am on the board of the Frontier 
Nursing Service in Kentucky, and in Appalachia, which is mostly 
white, we have terrible pregnancy outcomes there also. We have 
different root causes. Twenty-five percent of our patients at 
the Frontier Nursing Service are addicted to prescription 
drugs, and there is very little treatment available and many 
providers will not accept people that are addicted into their 
practice.
    The other issues that have been studied by Dr. Michael Lu 
at UCLA and Flita Mass Jackson in Atlanta Morehouse are that 
black women are victims of what is called weathering, and that 
is that if you are a black mother that has a low birth weight 
baby, your low birth weight daughter is more likely to also 
produce a low birth weight baby and then they predict it may 
take three or four generations of being upper income to 
actually shed this weathering system which they think is mostly 
due to stress. And adding to that, black women have the highest 
rates of Cesarean of any group in the country.
    Now, the second part I was asked is, what public health 
interventions could we do to reduce prematurity. Well, one 
thing you could do right now is pick up the phone, call CMS and 
tell Medicaid to stop paying for elective inductions and 
Cesareans at any stage of pregnancy, and I don't even agree 
with ACOG's recommendation of 39 weeks, and we agree that that 
may be arbitrary, but there is probably no reason a normal 
woman should ever be induced no matter where she is. The second 
thing is that in our studies in Florida, we find that women 
that are agreeing to this, and national studies show that 
generally when elective things are done, the doctor recommends 
it, the patient generally does not bring up the subject. In 
fact, national studies show that less than one-half of 1 
percent of patients do. But they are quick to go along with 
what the doctor recommends. So we have designed some informed 
consent that is true informed consent showing that elective 
procedures such as elective Cesarean are hazardous to the 
health of the mother and the baby. They are not equivalent to 
having a vaginal birth. And again, these are in low-risk women. 
And those are part of the attachments you will get. 
Unfortunately, you don't have them right now.
    Vaginal birth after Cesarean has essentially disappeared 
even though studies show that having a repeat Cesarean is 
slightly more dangerous to the mother and the baby than having 
a vaginal birth, so I would propose a new scale of payment for 
Medicaid that would be something like $2,000 for a VBAC, $1,500 
for a vaginal birth and $1,000 for a C-section, which takes 
less time and effort. Those are immediate steps that could be 
taken. In the short term, I would say in about a year, we can 
encourage the development of new pregnancy provider models. 
Most other countries have a midwife- and doula-based system for 
primary care for normal women and pregnancy. That can even be 
used for people that have high-risk problems comanaged with an 
obstetrician. Although I would recommend, and this is just 
coming from me, that we stop producing generalist OB/GYNs 
because as ACOG has pointed out, the young folks coming out 
today don't want to work on nights and weekends, and turn it 
over to midwives backed up by an increased number of maternal 
fetal medicine specialists working with groups of midwives, 
which is a model that I have worked in in Gainesville over the 
years. It is a wonderful lifestyle and way to work.
    I also put in here pay midwives the same amount as 
obstetricians get paid for taking care of normal people, but it 
was pointed out to me that that is already in the new health 
care bill, so forget that one.
    I would encourage the movement to group prenatal care that 
both ACOG and other groups have recommended instead of 
individual prenatal care, especially for low-income women, so 
that they can do some community support of each other.
    Ms. Castor. Dr. Mahan, can you bring it to a close and we 
will move on?
    Dr. Mahan. Pardon?
    Ms. Castor. Can you bring to a----
    Dr. Mahan. Yes. I think develop quality standards, provide 
preconception, interconception care, and then I have an 
extensive session on the cost savings that this could have, 
which would be to the tune of about $50 billion.
    [The prepared statement of Dr. Mahan follows:]

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    Ms. Castor. Thank you very much.
    Dr. Lawrence.

                   STATEMENT OF HAL LAWRENCE

    Dr. Lawrence. Thank you, Representative Castor and Chairman 
Pallone and the distinguished members of the subcommittee. My 
name is Dr. Hal Lawrence and I am an obstetrician/gynecologist 
and ACOG's vice president of practice activities. I am here 
today representing 53,000 physicians and partners in women's 
health care.
    Preterm birth is one of the most complicated and difficult 
issues in obstetrics. As a Nation, we still don't know very 
much about the risk factors, the causes or prevention of 
preterm labor. We do know that preterm labor is the most common 
cause of hospitalization before birth, that there is a link 
between preterm birth and infant mortality, that the rate of 
preterm births is a growing public health problem that cuts 
across social, racial, ethnic and economic groups and that our 
Nation must do better.
    ACOG firmly believes that we can make a difference and we 
are committed to leading the change and we are very clear that 
deliveries before 39 weeks' gestation should only occur when an 
accepted medical maternal or fetal indication for delivery 
exists. We have been intimately involved in a number of efforts 
over the years to improve research and practice guidelines to 
reduce the rate of premature births in America.
    ACOG is the nationally recognized source for clinical 
guidelines and medical information that help shape maternity 
care based on evidence-based peer-reviewed science and some 
expert opinion. These include practical information on late 
preterm births, management of preterm labor, assessment of risk 
factors for preterm birth, use of progesterone to reduce 
preterm birth and obesity in pregnancy. But where research has 
not been conducted, clinical guidelines have to wait. Preterm 
birth can occur in any pregnancy and our current clinical tools 
cannot determine a woman's risk except for women, as you have 
already heard, who have had previous preterm births, the only 
clear risk factor. Even so, the ability to predict whether a 
woman is at risk of preterm delivery has value only if an 
intervention is available to reduce or eliminate that risk, and 
right now we have very few effective interventions. Better 
research can be translated into more complete clinical 
guidelines and better care.
    ACOG has been intimately involved in a number of other 
efforts to advance our knowledge in this area including the 
2006 Institute of Medicine report on preterm birth, the surgeon 
general's 2008 conference on the prevention of preterm birth, 
and the 2009 Symposium on Quality Improvement to Prevent 
Prematurity that we did with the March of Dimes. These efforts 
identified gaps in clinical knowledge and research, many of 
which ACOG in our MOMS Initiative, and that stands for Making 
Obstetrics and Maternity Safer, called on Congress to support, 
and those include NIH research to reduce preterm births and the 
focus on obesity, CDC's surveillance and research to assist 
State maternity mortality reviews, modernized State birth and 
death record systems, and improve the safe motherhood program, 
the HRSA fetal and infant mortality review, which brings 
together local OB/GYNs and health departments to reduce infant 
mortality rates and improve the maternal child health block 
grant, comparative effectiveness research into preterm birth 
interventions and efficacy, disparities research, testing the 
obstetric medical home to address the unique issues of 
pregnancy and supporting quality improvement measures.
    It is also impossible not to also mention the link medical 
liability and the practice of obstetrics performing deliveries. 
In the world of childbirth, a perfect pregnancy can turn 
disastrous in a heartbeat, and through no fault or malpractice 
of the obstetrician/gynecologist. Vaginal births after Cesarean 
sections, VBACs, can seem perfectly normal until something goes 
wrong. At that moment, one and sometimes two lives can be on 
the line and seconds count. It is often in these scenarios that 
OB/GYNs get sued and result in very large awards regardless of 
the physician's care. The risk is really that great. ACOG 
recommends exploring medical liability alternatives including 
early offer programs, health care courts, alternative dispute 
resolution and birth injury compensation funds, and I would 
like to thank Representatives Pitts and Gingrey for your 
attention to this important issue in your earlier comments.
    I would also like to thank Representative Burgess, who 
plans to introduce a bipartisan piece of legislation extremely 
relevant to today's hearing. His legislation will provide for 
research on birth defects and breast feeding to help educate 
women on ways to reduce the risk to their babies and have 
healthy pregnancies. Once introduced, I urge the subcommittee 
to quickly take up this legislation.
    I would also like to thank Chairman Pallone. ACOG has been 
fortunate to be able to work with his staff and thank him for 
his focus on stillbirth and sudden infant death, and we look 
forward to offering support as that legislation goes forward.
    Again, I would like to thank you for this opportunity to 
provide this statement. A written statement of my comments has 
been supplied, and we applaud your commitment and leadership on 
this issue. We look forward to working closely with you and the 
subcommittee. Thank you.
    [The prepared statement of Dr. Lawrence follows:]

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    Ms. Castor. Thank you, gentlemen. Your testimony was 
outstanding.
    Let me start by asking about a subject that you each very 
briefly touched on, and that is the inaccurate gestational 
dating. It seems like there is a concern out there about if the 
recommendation is you go fully to term at 39, 40 weeks, how do 
you really measure, especially in certain subgroups, that you 
have an accurate due date, and then how do we--is it the same 
based on socioeconomic factors and education or is there 
something a little more concrete that we can get? I would like 
to hear from all of you on that.
    Dr. Lawrence. Thank you for that question. Obviously 
whenever you have any recommendations on timing of delivery, 
having accurate dates of that pregnancy is crucial, and we have 
published guidelines on how you determine when somebody is at 
least 39 weeks' gestation, and those guidelines clearly state 
that you have to have had an ultrasound at least in the early 
second trimester to confirm an estimated date of confinement, 
or due date, so you are sure they are 39 weeks, or you have to 
have had 36 weeks of pregnancy following a serum or urine 
pregnancy test, or you had to be able to have documented fetal 
heart tones for 30 weeks since they were first documented. All 
three of those methodologies will confirm that somebody is at 
least at 39 weeks' gestation. I know that there is discussion 
about earlier first-trimester scanning. We think that that is 
an interesting opportunity also. We have discussed this several 
times and Dr. Fleischman and I have discussed this several 
times. I know in Great Britain they do something called a 
booking scan. But when our committees look at this and 
carefully weigh the benefit and the costs of those ultrasounds 
at that 16-, 18-, 19-week gestation, not only do you get a very 
accurate gestational age calibration plus or minus seven to 
nine days, you also get a good anatomy evaluation of that 
fetus. So there is a whole lot more benefit found and so 
because of that our committees have been unable to say we 
should recommend two scans at this point in time.
    Dr. Mahan. We had talked about this before we testified, 
but the 39 weeks that ACOG recommends, I think we should look 
at that again in the college because if a woman is entirely 
normal, why should you even have the 39-week recommendation? 
You know, Mother Nature tells you when term is because labor 
starts, and the Institute for Health Care Improvement basically 
recommends that we wait for labor to begin and see how labor 
goes, again in normal people. You certainly have to count on 
all the things Dr. Lawrence said for somebody who is high risk 
if you are going to have to deliver them early.
    Dr. Fleischman. We go back to the Institute to Medicine 
report in 2006 that clearly recommended early ultrasounds in 
the first trimester as the most accurate gestational dating, 
which would, I think, give us combined with history a very 
important public health program in order to assure that the 
kinds of complex things that Dr. Lawrence is saying are the 
appropriate ways if you don't have the earliest ultrasounds. I 
think if we did that as almost every obstetrician in American 
has in their office, the ultrasound machine, at the earliest 
times to find the fetal viability as well as the fetal 
gestational age, we would be making better decisions at the end 
of pregnancy. We know time and time again from intervention 
studies that if you put off at least until 39 weeks, and I am 
not disagreeing with Dr. Mahan, but at least until 39 weeks you 
run a very low risk of prematurity, and if you don't have 
accurate gestational dating you increase the risk of premature 
birth.
    Ms. Castor. Mr. Shimkus.
    Mr. Shimkus. Thank you, Madam Chair. I concur with you. It 
is great testimony. One thing I really enjoy about this 
subcommittee on health care, it is a caring profession. I mean, 
everybody is doing it for the right reason, whether it is 
adults, and this one of course on the unborn children. So with 
all our fights and battles, it is really great to have people 
who are very concerned.
    Dr. Mahan, I really enjoyed your testimony. I have 
questions for you. I am an old Army infantry guy, and you know, 
we just keep it simple, and it seems like your testimony kind 
of keeps it simple. God has created phenomenal human beings--
not your words, mine. The body tells us when. We shouldn't be 
doing things that aren't natural unless we have to, I think if 
I could summarize. And then there is ways to incentivize that 
financially because we are a big payer. We are a third payer in 
a lot of the health care delivery system. And so why not use 
that tool? We did miss that opportunity, but then maybe there 
are other opportunities to relook at that. I really enjoyed the 
testimony.
    Dr. Fleischman, you state that there are several factors 
that have caused the increase in elective inductions, that is 
kind of leading on this debate, and Cesarean deliveries. You do 
mention in your statement about the litigious environment and 
defensive medicine. Can you talk about that? I am from 
Illinois. We have had a huge medical liability crisis. We had a 
Supreme Court campaign turn on this, and even though that was 
the primary reason because all our physicians were leaving the 
State, it wasn't enough and then we have gone back to that. So 
I know we don't like to talk about it, but it is in your 
statement. Talk about that for me, will you?
    Dr. Fleischman. Well, we are very sympathetic to the 
obstetric practitioners concerning their concerns and fears 
about the litigious environment. We believe the best way to 
prevent lawsuits is to have the highest quality care, to set 
standards, to set guidelines and to practice appropriately with 
appropriate accountability. That protects both the patient and 
the doctor, and I think we are moving in those directions. We 
have the national quality forum and the joint commission and 
others setting standards. We have CMS now to set standards 
around perinatal health and quality measures. We think that 
high-quality practice is the way for the obstetric community to 
assure that they are actually able to protect themselves and 
their patient.
    Mr. Shimkus. And I appreciate that, but how do you tie that 
in to the litigious--I get it. I mean, if we don't have 
problems, then you don't have lawsuits, but how do you tie that 
in to the courtroom drama that unfolds? Is it making sure--I 
have been through this for years now as far as the public 
policy guys, make people that say I am sorry. I mean, how do 
you tie that to the courtroom? That is the issue?
    Dr. Fleischman. Well, I think----
    Mr. Shimkus. I mean, your words. I am not putting--you 
talked about the litigious environment and defensive medicine.
    Dr. Fleischman. Well, we can stand up tall if we practice 
high-quality medicine based on ACOG guidelines and appropriate 
care, and if we do that, then even if we make our way to the 
courtroom, we can have a reasonable defense of good high-
quality practice and decrease the incentives on the part of 
those who are bringing those lawsuits----
    Mr. Shimkus. But you are not willing to talk about the 
courtroom dilemma that they still face regardless of this.
    Dr. Lawrence, do you want to weigh in on medical liability?
    Dr. Lawrence. Thank you very much. Medical liability is 
just a huge issue in our practice, and you all have heard this, 
I am sure, before, but, you know, over 90 percent of practicing 
obstetrician/gynecologists have been sued, and I would tell you 
90 percent of anybody isn't doing bad things, and I think each 
of you know that.
    Mr. Shimkus. I always usually say in any organization, you 
may have 10 percent who are bad actors. Unfortunately, we find 
that here. I found that in the military. You find that in 
schools. I would agree, 90 percent----
    Dr. Lawrence. But not 90 percent.
    Mr. Shimkus. I would have to agree, 90 percent, there is 
something else going on.
    Dr. Lawrence. And the thrust of your question, you know, 
ACOG works hard to put forth guidelines enabling medical staffs 
and local community hospitals to create practice parameters and 
protocols to help take care of these patients. The problem for 
us is that even when you do all that, even when you do it all 
right, that does not guarantee a perfect outcome. Reproduction 
has never been perfect. Sadly, reproduction will never be 
perfect. There will always be adverse events. There will always 
be situations that are not predictable. And somehow in this 
process, if the providers are doing everything right, we should 
not be held accountable for an adverse outcome that we could 
not have prevented, and that is true in the VBAC situation that 
I mentioned. It is true in many other situations in managing 
patients whether they are high-risk patients or whether they 
are deemed to be low risk and then all of a sudden there is a 
cord prolapse or all of a sudden there is an abruption or all 
of a sudden there is a vasa previa. I have been there. I have 
jumped in and done those deliveries. And fortunately, they 
usually go OK but not always, but if you do it right, somehow 
the liability system has to recognize that and deal with this 
other than within a tort arena.
    Mr. Shimkus. Madam Chair, I am not going to follow up with 
a question, but if I may just again thank you all, and I am 
going to follow up with a written question on Medicaid 
expansion and reimbursement rates and other things that I would 
like to get into but time is not going to allow me to do that.
    Ms. Castor. Thank you very much.
    Dr. Christensen.
    Mrs. Christensen. Thank you, Madam Chair.
    Dr. Mahan, true informed consent, how do you define that 
and how do you arrive at that?
    Dr. Mahan. I think it needs to be based on--and I have 
worked with the National Coalition to Improve Maternity 
Services on this for the past year, especially for informed 
consent for Cesarean, and we based all of our efforts on 
science, evidence based, but what we were finding, and this is 
among studies of upper-income people, upper middle-class 
people, was that it was really a last-minute sort of glossed-
over thing that this is all going to be OK. So in the 
attachments that you will get is a copy of the--it is called 
the risks of Cesarean section, a checklist that women should be 
given at about 32 weeks of pregnancy, not at term, so that she 
and her partner can go through it, look at the differences----
    Mrs. Christensen. Both sign?
    Dr. Mahan. Pardon?
    Mrs. Christensen. Are both supposed to sign it?
    Dr. Mahan. I believe so, yes, and so is the care provider. 
Now, this is just a suggestion. It has not been adopted except 
by this particular group. But for instance, when the mother 
looks at the section possible problems for my baby, my baby is 
more likely to have breathing difficulties--this is after 
Cesarean--it is normally best for labor to begin, so on and so 
on and so on, and my baby is more likely to die than if it was 
born vaginally, which is not a high chance but it is 
statistically more likely to do that. The mother needs to know 
that.
    Mrs. Christensen. Thank you. And your third immediate 
recommendation, I would ask you and Dr. Lawrence and perhaps 
Dr. Fleischman as well, what is the data on outcomes in vaginal 
birth after Cesarean, and does ACOG recommend that after the 
first Cesarean that women go through vaginal delivery?
    Dr. Lawrence. ACOG, in fact following the NIH consensus 
conference that we just participated in, have a new practice 
bulletin about discussing vaginal birth after Cesarean section, 
and in there we do recommend that women be offered a trial of 
labor after Cesarean section, assuming that that section was 
for a non-recurring cause, assuming that there wasn't like she 
had----
    Mrs. Christensen. If it was a breech and----
    Dr. Lawrence. Correct, like a breech, and we do recommend 
that those patients be counseled and offered that procedure. 
Institutions have to be able to provide the services to support 
that procedure, and the problem with VBAC is where the risk of 
a uterine rupture and spontaneous labor is low, it is less than 
1 percent. If, however, it occurs, the same Dr. Lu that Dr. 
Mahan used as a reference earlier has a study from Los Angeles 
County that shows you have 12 minutes to get that baby born or 
that baby will probably not survive, and if it does survive 
will be severely handicapped. So because of liability concerns, 
many institutions and many providers have said I am not willing 
to put that baby at that much risk. At that same NIH consensus 
conference on VBAC, one of the attendings from Parkland stood 
up and gave a scenario of a perfectly managed VBAC, everything 
was doing fine. In fact, this patient had delivered vaginally 
after her previous Cesarean section, which puts her in a lower 
risk. Everything was going great. The uterus ruptured, crash 
Cesarean section, baby delivered. Baby did not do well. An 
$11.5 million settlement against the institution and the 
physicians. And that group no longer does VBACs. So that is the 
scenario that vaginal birth after Cesarean section has placed 
many obstetrical providers, and that is the reason that the 
concern has been raised about that procedure.
    Dr. Mahan. And I would follow up with that, and I agree, 
and I think that was an excellent conference, but the issue 
that we have to deal with now is that, you know, I think Dr. 
Spong's studies that she has helped publish have shown that 
VBAC is slightly safer for the mother and baby other than a 
repeat Cesarean. You can lose babies and mothers with a repeat 
Cesarean. The problem that we need to deal with, and it is tied 
up with the liability issue, is that since so few hospitals are 
providing VBAC--now, USF, we do do that in our practice group. 
Women in communities that can't get it are turning to home 
birth because they can't get it anywhere else and they had such 
a bad experience with their first pregnancy that they don't 
want to go back to the hospital and we are really worried about 
that too. So it is another reason to deal with the liability 
crisis.
    Dr. Fleischman. I think the fundamental question, and I 
agree with these gentlemen, but the fundamental question is, 
how do we decrease primary Cesarean sections that are done 
unnecessarily, and we know that if we induce a woman when she's 
not ready to deliver, she is highly likely to result in a 
Cesarean section, and then we put the woman in the position of, 
you know, the question of vaginal birth after Cesarean. I think 
that is the real challenge.
    Ms. Castor. Thank you very much.
    Mr. Pitts.
    Mr. Pitts. Thank you, Madam Chairman.
    Dr. Fleischman, you mentioned Institute of Medicine. The 
Institute of Medicine recently published a 570-page resource 
book entitled ``Preterm Birth: Causes, Consequences and 
Prevention.'' On pages 517 and 518, abortion is noted as an 
``immutable'' risk factor. However, the risk factor is 
avoidable if women are given risk information prior to 
pregnancy. I would like each of you to respond to this, and I 
know of 59 studies that have found that women with prior 
induced abortions are at increased risk for premature birth and 
low birth weight. The question is two parts. Do your 
organizations acknowledge abortion as a risk factor, and is it 
included in your information searches? Are you aware of efforts 
to inform women about such a risk factor? Each of you, please. 
Dr. Fleischman?
    Dr. Fleischman. At the March of Dimes, we continually 
monitor those data that you have mentioned, and the most recent 
data from modern techniques in termination do not give 
convincing evidence of that as a significant risk factor for 
preterm birth, and we do not raise that issue within our 
materials.
    Mr. Pitts. Dr. Mahan?
    Dr. Mahan. I don't know the answer to that. I know that one 
of my--I just read the executive summary of that report. One of 
my problems with it was that it was a little behind the times 
because it really wasn't dealing with the elective induction/
Cesarean issue. But one of the things I bring out in my 
testimony that I hope you will read is that one of the key 
things to improved maternal health and infant health in the 
United States is interconception care and preconception care so 
that--especially interconception care of women who have already 
had a low-birth-weight baby. Right now essentially we just drop 
them and we wait to see when they are going to have the next 
pregnancy when we know that it would be help if we spaced their 
pregnancy for at least two years and so I think following the 
diabetic woman who just had a pregnancy, making sure she is in 
good shape, following the woman who had a low-birth-weight 
baby, trying to get her out there for 2 years before she gets 
pregnant again, if we can provide--you know, in Florida we woke 
up last year and the CDC told us that we are 51st of all the 
States plus D.C. in providing reversible contraception to 
women, and this is the 50th anniversary of the Pill. When the 
Pill came out and I was a student in Chicago, the average 
family size was six and a half, and now it is one and a half. 
If we want to reduce abortion if it does cause this problem, we 
have got to stop putting our heads in the sand about helping 
people space their pregnancies.
    Mr. Pitts. Dr. Lawrence?
    Dr. Lawrence. Well, I would like to have a couple points. 
First off, I am aware of the data. We do review that data. And 
I also agree with Dr. Fleischman that more recent studies with 
more recent technologies don't show a real correlation between 
induced pregnancy termination and premature birth. I also think 
that Dr. Mahan is right on target here, and I think one of the 
benefits of the health care reform law is that now patients are 
going to be able to have ongoing continual care, and as Dr. 
Spong said earlier, the best way to have a healthy baby is to 
have a healthy mommy and ongoing well women's health care 
rolled in with contraceptive care, rolled in with preconception 
care is a major factor in helping to reduce preterm birth and 
improve maternal and infant outcomes.
    Mr. Pitts. Thank you.
    Dr. Fleischman, I didn't quite get your response. Do you 
believe comprehensive medical malpractice reform would 
potentially help providers stop practicing defensive medicine?
    Dr. Fleischman. I guess the detail of what the 
comprehensive medical malpractice reform means----
    Mr. Pitts. Well, like they have in California or Texas.
    Dr. Fleischman. Well, we have not taken a position on that 
at the March of Dimes.
    Mr. Pitts. OK. What about you, Dr. Mahan?
    Dr. Mahan. Absolutely.
    Mr. Pitts. And Dr. Lawrence?
    Dr. Lawrence. I am in total support. If we get 
comprehensive medical liability reform, it will help not only 
OB/GYN but all areas of medicine.
    Mr. Pitts. Dr. Mahan----
    Ms. Castor. I am sorry.
    Mr. Pitts. Oh, I am out of time.
    Ms. Castor. We would like to get Dr. Burgess in before we 
adjourn.
    Mr. Pitts. Thank you. My time is up.
    Ms. Castor. Dr. Burgess.
    Mr. Burgess. We have a series of crucial votes and the 
entire Nation hangs in the balance in 15 minutes, so we will 
have to take off and do those. I appreciate you all being here 
today. I appreciate you staying with us. Listening to your 
testimony, your answers to some of the other questions is 
certainly intriguing.
    Dr. Fleischman, I am going to answer Mr. Pitts's last 
question for you. Defensive medicine is learned behavior and 
physicians are probably not likely to unlearn that behavior 
overnight. There may be--certainly it will help but when I am 
criticized by the President because we did liability reform in 
Texas, and McAllen, Texas, is still a high-cost place to get 
health care, you are not going to change it overnight even as 
good as our law has been in Texas. I don't think there is any 
question--you know, Dr. Mahan, you talk about VBACs, and I 
remember the studies that came out of Los Angeles while I was 
still in practice and I think they just absolutely threw up 
their hands and stopped offering VBACs for a while because of 
the liability issue, and certainly, Dr. Lawrence, your story of 
what the group in Dallas got into the $11 million settlement, 
if we are paying $1,000 more for a VBAC but we get hit with an 
$11 million judgment, that is 11,000 VBACs we are going to have 
to do to cover the cost of that $11 million judgment, and as 
you guys know, the numbers just don't work out.
    We do have to undertake a more sensible medical justice 
system in this country. I don't know what it is. I like early 
offer but what is happening in Texas now with a trifurcated cap 
on non-economic damages seems to be working and it seems to be 
working in a big way and not just holding down costs of 
premiums for practicing physicians but holding down costs for 
institution that self-insure for liability, allowing smaller 
not-for-profit hospitals to have more money to invest in 
capital improvements, nurses' salaries and the very things we 
want our smaller nonprofit hospitals to do in our communities. 
So I certainly stand behind what is happening in Texas. I would 
have liked to have seen us do more in the health care law that 
passed but unfortunately we didn't do it.
    Now, Dr. Mahan, your discussion on Medicaid, you said for 
Medicaid to stop paying for elective inductions and elective 
Cesarean sections in any stage of pregnancy. That may be great 
in theory but we have a problem back home where you can have a 
hard time finding a doctor who will take a patient's Medicaid 
because the reimbursement rates are so much lower than 
commercial insurance, and as a consequence are we likely to 
make it even tough for that woman to get prenatal care because 
we have now created a more hostile environment within the 
Medicaid system. The practicing physician is going to look at 
it and say well, you know, maybe I was about to get over the 
funding problem but I am darn sure not going there when they 
are telling me how to practice.
    Dr. Mahan. Well, I thought that too but we are working on 
the issue in Florida now because we did study it and find an 
association between the rising rates of Cesarean and the rising 
rates of late preterm, and that will be published pretty soon, 
and we found that our colleagues in obstetrics around the State 
and they found this already ahead of us in North Carolina and 
Ohio, that they understand that this is producing bad outcomes 
in both women and babies that otherwise would have been normal, 
but that they should not be delivered by Cesarean or induced if 
they are normal people because the outcomes are worse, and I 
think we are finding that most of the OBs as we approach them 
on this and saying we are producing a lot of bad babies because 
of this are extremely willing to listen to that and to change 
their practice. And I agree that from State to State the 
Medicaid rates are a problem but, you know, half of our births 
are Medicaid and these are doctors taking care of them and they 
seem to be willing to step in and reverse this thing.
    Mr. Burgess. Now, in the health care law that just passed, 
there was some protection for primary care that Medicaid rates 
would be 75 percent of Medicare rates, but in your State are 
OB/GYNs considered primary care?
    Dr. Mahan. I don't think so.
    Mr. Burgess. I don't think so either. And of course, in the 
law we don't know because that is all up to the Secretary of 
Health and Human Services and we are not having the types of 
hearings that would allow us to get an idea of what their 
thinking is over there so we are just all going to be surprised 
one day. But even then, if there is a funding cliff that occurs 
in 2 years' time and even if we were to get OB/GYNs designated 
as primary care so that they would get 75 percent of the 
Medicare rates, that funding cliff kicks in in 2 years' time 
and we are back to the preexisting Medicaid. So all this 
becomes terribly difficult and terribly complicated.
    I guess just one last observation. Dr. Lawrence, you 
referenced the medical home. That is what the generalist OB/
GYN, at least when I was practicing, that is what we were, and 
Dr. Mahan says we shouldn't have those anymore, the generalists 
are not helpful, let us go to midwives and perinatologists. But 
you seem to see value in the medical-home model, and I would 
just submit to you, the physicians of my generation, that is 
what we were trained to do.
    Dr. Lawrence. And I think we still train OB/GYNs to do 
that. We are the care coordinators for well women's health care 
essentially from the late teenage years up until early years to 
years after menopause, and we definitely are the care 
coordinators and providers for obstetrical patients, and we are 
the ones who are able to intervene when those acute crises 
occur.
    Ms. Castor. Thank you, Doctor, very much.
    We are going to have to bring the hearing to a close, but I 
would like to ask Dr. Fleischman to help bring us to a close 
and spend 1 minute on the implications for brain development 
because you have a terrific visual exhibit here that I am 
afraid they won't be able to see at home, but if you could 
describe the difference in brain development from 35 weeks to 
39 to 40 weeks to close us out for the hearing, I would 
appreciate it.
    Dr. Fleischman. We developed this visual for a project in 
Kentucky to help women understand that one-third of the growth 
and development of the brain occurs between 35 and 39 or 40 
weeks, that all those neurons, all those nerve cells that 
interact with each other are continually growing in those last 
5 weeks and that that growth and development is critically 
important to the fetus. It can happen outside the uterus but it 
happens better inside a uterus if the fetus is not in any 
jeopardy. And that has been very helpful both to help 
clinicians understand what they can stay to women and it helps 
women to not push hard for inappropriate early deliveries.
    Ms. Castor. Well, thank you very much. You all have been 
outstanding. All of the witnesses were just terrific today. 
That concludes all the questioning.
    In closing, I want to remind members that you may submit 
additional questions for the record to be answered by the 
relevant witnesses. The questions should be submitted to the 
committee clerk within the next 10 days. The clerk will notify 
your offices of the procedures.
    Without objection, this meeting of the Subcommittee is 
adjourned.
    [Whereupon, at 5:40 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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