[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]


. 
               EXAMINING PUBLIC HEALTH LEGISLATION: H.R. 
                  2820, H.R. 1344, AND H.R. 1462

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

                                 HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 25, 2015

                               __________

                           Serial No. 114-61


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Chairman Emeritus                    Ranking Member
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania        ELIOT L. ENGEL, New York
GREG WALDEN, Oregon                  GENE GREEN, Texas
TIM MURPHY, Pennsylvania             DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas            LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee          MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   KATHY CASTOR, Florida
GREGG HARPER, Mississippi            JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky              PETER WELCH, Vermont
PETE OLSON, Texas                    BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia     PAUL TONKO, New York
MIKE POMPEO, Kansas                  JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois             YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia         DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILL JOHNSON, Ohio                   JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                 Massachusetts
RENEE L. ELLMERS, North Carolina     TONY CARDENAS, California7
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota

                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            KURT SCHRADER, Oregon
BILLY LONG, Missouri                 JOSEPH P. KENNEDY, III, 
RENEE L. ELLMERS, North Carolina         Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

                                  (ii)
                            
                            C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     2
    Prepared statement...........................................     2
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, prepared statement......................................     3
Hon. Brett Guthrie, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     4
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     5
    Prepared statement...........................................     5

                               Witnesses

Jeffrey W. Chell, M.D., Chief Executive Officer, National Marrow 
  Donor Program..................................................     7
    Prepared statement...........................................     9
    Answers to submitted questions...............................   134
Joanne Kurtzberg, M.D., President, Cord Blood Association........    24
    Prepared statement...........................................    26
    Answers to submitted questions...............................   139
Patti Freemyer Martin, Ph.D., Director, Audiology/Speech-Language 
  Pathology Department, Arkansas Children's Hospital.............    33
    Prepared statement...........................................    35
Stephen W. Patrick, M.D., Assistant Professor of Pediatrics and 
  Health Policy, Division of Neonatology, Vanderbilt University 
  School of Medicine.............................................    41
    Prepared statement...........................................    43
Mishka Terplan, M.D., Medical Director, Behavior Health System 
  Baltimore......................................................    69
    Prepared statement...........................................    71

                           Submitted Material

Discussion draft of H.R. 2820, the Stem Cell Therapeutic and 
  Research Reauthorization Act of 2015, submitted by Mr. Pitts...   103
H.R. 1344, the Early Hearing Detection and Intervention Act of 
  2015, submitted by Mr. Pitts...................................   105
H.R. 1462, the Protecting Our Infants Act of 2015, submitted by 
  Mr. Pitts......................................................   119
Statement of Hon. David W. Jolly, a Representative in Congress 
  from the State of Florida, submitted by Mr. Pitts and Ms. 
  Matsui.........................................................   128
Letter of June 25, 2015, from the American Academy of Pediatrics, 
  et al., to Mr. Pitts and Mr. Green, submitted by Mr. Pitts.....   131
Letter of March 26, 2015, from Sandra G. Hassink, President, 
  American Academy of Pediatrics, to Mr. Guthrie and Mrs. Capps, 
  submitted by Mrs. Capps........................................   133

 
  EXAMINING PUBLIC HEALTH LEGISLATION: H.R. 2820, H.R. 1344, AND H.R. 
                                  1462

                              ----------                              


                        THURSDAY, JUNE 25, 2015

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:13 a.m., in 
room 2322 of the Rayburn House Office Building, Hon. Joseph R. 
Pitts (chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Guthrie, Barton, 
Murphy, Lance, Griffith, Bilirakis, Ellmers, Bucshon, Brooks, 
Collins, Green, Capps, Butterfield, Castor, Matsui, Schrader, 
Kennedy, and Pallone (ex officio).
    Staff present: Clay Alspach, Chief Counsel, Health; Noelle 
Clemente, Press Secretary; Katie Novaria, Professional Staff 
Member, Health; Graham Pittman, Legislative Clerk; Chris 
Santini, Policy Coordinator, Oversight and Investigations; 
Adrianna Simonelli, Legislative Associate, Health; Heidi 
Stirrup, Policy Coordinator, Health; Traci Vitek, Detailee, 
Health; Gregory Watson, Staff Assistant; Christine Brennan, 
Democratic Press Secretary; Jeff Carroll, Democratic Staff 
Director; Waverly Gordon, Democratic Professional Staff Member; 
Tiffany Guarascio, Democratic Deputy Staff Director and Chief 
Health Advisor; Meredith Jones, Democratic Director of 
Communications, Member Services, and Outreach; Una Lee, 
Democratic Chief Oversight Counsel; and Samantha Satchell, 
Democratic Policy Analyst.
    Mr. Pitts. Our guests can take their seats. We are voting 
on the floor right now, so we are going to try to expedite this 
a little bit, get through our opening statements on the panel. 
I would ask the Members to abbreviate their opening statements 
so that we can go to the floor and came back after the votes to 
hear the testimony and do the Q&A.
    I have a UC request. I would like to submit the following 
documents for the record: a statement from Representative David 
Jolly, Florida 13; a letter of support from American Academy of 
Pediatrics, American Congress of Obstetricians and 
Gynecologists, March of Dimes, and Society of Maternal-Fetal 
Medicine. Without objection, those will be entered into the 
record.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. The chairman will now call the subcommittee to 
order and recognize himself for an opening statement.

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

    Today's hearing will examine three bipartisan public health 
bills to improve health care for newborns, infants and 
children. As many of you know, one of this subcommittee's top 
priorities has been helping and protecting children and 
families. These bipartisan bills that are the subject of 
today's hearing represent our ongoing effort to work together 
to strengthen public health and solve problems in our Nation's 
health care system.
    H.R. 2820, the Stem Cell Therapeutic and Research 
Reauthorization Act, introduced by Representative Chris Smith 
of New Jersey and Doris Matsui of California, reauthorizes the 
Stem Cell Therapeutic and Research Act of 2005, which provides 
Federal support for cord blood donation and research essential 
to increasing patient access to transplant.
    H.R. 1462, the Protecting Our Infants Act of 2015, authored 
by Representatives Katherine Clark of Massachusetts and Steve 
Stivers of Ohio, will combat the rise of prenatal opioid abuse 
and neonatal abstinence syndrome. The bill will address the 
growing problem of overdose deaths involving heroin and help 
protect newborns and infants. Additionally, this bill has a 
Senate companion bill, S. 799, sponsored by the Senate Majority 
Leader, Mitch McConnell.
    Finally, H.R. 1344, the Early Hearing Detection and 
Intervention Act of 2015, authored by Health Subcommittee Vice 
Chairman Brett Guthrie and Representative Lois Capps, amends 
the Public Health Service Act to reauthorize a program for 
early detection, diagnosis, and treatment regarding deaf and 
hard-of-hearing newborns, infants, and young children.
    I would like to welcome all of our witnesses here today. We 
look forward to your testimony.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    Today's hearing will examine three bipartisan public health 
bills to improve health care for newborns, infants and 
children. As many of you know, one of this subcommittee's top 
priorities has been helping and protecting children and 
families. These bipartisan bills that are the subject of 
today's hearing, represent our ongoing effort to work together 
to strengthen public health and solve problems in our Nation's 
health care system.
    H.R. 2820, the Stem Cell Therapeutic and Research 
Reauthorization Act, introduced by Reps. Chris Smith (NJ) and 
Doris Matsui (CA), reauthorizes the Stem Cell Therapeutic and 
Research Act of 2005, which provides Federal support for cord 
blood donation and research essential to increasing patient 
access to transplant.
    The purpose of the National Marrow Donor Program is to help 
save lives of patients with blood cancers, like leukemia, 
lymphoma, and other life-threatening diseases through adult 
stem cell transplants. Every 4 minutes, someone is diagnosed 
with blood cancer. In most cases, a bone marrow, cord blood, 
and peripheral blood stem cell transplant is the only option 
for a cure. 70 percent of patients do not have a donor in their 
family and rely upon the national registry to find a match.
    The National Marrow Donor Program in my home State of 
Pennsylvania has already conducted 2,159 transplants as of 
2014. The Transplant Centers in PA include:
     Thomas Jefferson University Hospital in 
Philadelphia
     Hahnemann University Hospital in Philadelphia
     University of Pennsylvania Medical Center in 
Philadelphia
     Temple University Hospital in Philadelphia
     Western Pennsylvania Cancer Institute in Homeacre
     UPMC Hillman Cancer Center in Pittsburgh
     Penn State Hershey Medical Center in Hershey
     Children's Hospital of Philadelphia
     And Children's Hospital of Pittsburgh
    There are 930 donors in PA. Since 1987, more than 61,000 
transplants nationwide have occurred through this program.
    H.R. 1462, the Protecting Our Infants Act of 2015, authored 
by Reps. Katherine Clark (MA) and Steve Stivers (OH), will 
combat the rise of prenatal opioid abuse and neonatal 
abstinence syndrome. In recent years, sadly, there has been a 
steady rise in the number of overdose deaths involving heroin. 
According to the Centers for Disease Control and Prevention, 
the death rate for heroin overdose doubled from 2010 to 2012. 
The bill will address the growing problem and help protect 
newborns and infants. Additionally, this bill has a Senate 
companion bill, S. 79 sponsored by the Senate Majority Leader 
Mitch McConnell (KY).
    Finally, H.R. 1344, the Early Hearing Detection and 
Intervention Act of 2015, authored by Health Subcommittee Vice 
Chairman Brett Guthrie (KY) and Rep. Lois Capps (CA), amends 
the Public Health Service Act to reauthorize a program for 
early detection, diagnosis and treatment regarding deaf and 
hard-of-hearing newborns, infants, and young children.
    I would like to welcome all of our witnesses for being here 
today. I look forward to your testimony.

    Mr. Pitts. I now recognize the ranking member, Mr. Green, 
for his opening statement.
    Mr. Green. Thank you, Mr. Chairman. I have a statement I 
would like to put in the record.
    I want to welcome our panels.
    These bills are all very bipartisan, and I appreciate the 
Chair and the majority setting them for today, but I would like 
to ask unanimous consent to place my statement into the record 
and yield----
    Mr. Pitts. Without objection, so ordered.
    Mr. Green [continuing]. My time to my colleague from 
California.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Good morning and thank you all for being here today.
    This hearing was called to examine three bills that will 
strengthen public health, each of which is the product of 
bipartisan effort.
    H.R. 2820, the Stem Cell Therapeutic and Research 
Reauthorization Act, is led by Representatives Doris Matsui and 
Chris Smith. According to the Health Resources and Service 
Administration, nearly 20,000 patients in the United States 
need a bone marrow, peripheral, or cord blood transplant each 
year.
    H.R. 2820 will reauthorize Federal programs that support 
cord blood donation, a national bone marrow registry, and 
related research, all of which expand access to transplants for 
patients in need.
    H.R. 1344, the Early Hearing Detection and Intervention 
Act, is championed by Representatives Lois Capps and Brett 
Guthrie. Beginning in 2000, Congress took steps to facilitate 
the development of newborn and infant screening, and 
intervention programs.
    H.R. 1344 reauthorizes and makes further improvements to 
the Early Hearing Detection and Intervention program. Early 
identification of a child's hearing loss increases the 
likelihood that intervention and treatment services can 
successfully prevent or limit development delays.
    Finally, we are considering H.R. 1462, the Protecting Our 
Infants Act. The CDC has found drug overdose to be the leading 
cause of injury death in the U.S., and according to a recent 
study in the New England Journal of Medicine, the incidence 
rate of neonatal abstinence syndrome (N.A.S.) quadrupled 
between 2004 and 2013.
    H.R. 1462, led by Representatives Katherine Clarke and 
Steve Stivers, is an important step to combat the rise of 
N.A.S. and prenatal opioid abuse. It will require the Agency 
for Healthcare Research and Quality to develop recommendations 
for preventing and treating prenatal opioid abuse and N.A.S., 
provide for better coordination of Federal efforts, and improve 
data collection.
    I thank all of my colleagues from both sides of the aisle 
for putting forward these thoughtful and worthy proposals, and 
for their commitment to improving access to and delivery of 
health care. I look forward to continuing to work in a 
bipartisan manner on the many issues before our subcommittee.
    I yield the balance of my time to my colleague from 
California.

    Mrs. Capps. Thank you, Mr. Chairman, and thank you, Mr. 
Green for yielding time, and I appreciate the hearing on these 
important bills.
    I am particularly pleased that H.R. 1344, the Early Hearing 
Detection and Intervention Act, will be discussed here today. 
As a co-author of that bill along with my colleague, 
Representative Guthrie, I thank you for including this 
reauthorization in today's hearing.
    Since the program received its authorization in 2000, we 
have seen how vital it is for babies and their families. As a 
school nurse, this hits home for me too. Back in 2000, only 44 
percent of newborns were being screened for hearing loss. Now 
we are screening newborns at a rate of over 98 percent before 
they leave the hospital and linking them to follow-up care, 
which is the critical piece, and we know that early 
intervention is key in helping children with hearing loss 
achieve academically and developing in line with their peers.
    Our work isn't done. As a school nurse, I had a lot of 
interaction with students who were already behind lagging from 
their classmates due to undiagnosed and/or untreated hearing 
loss. We can prevent more children from suffering in the 
classroom through better investment in follow-up and 
intervention as part of a successful hearing screening program 
for newborns and infants. We need to ensure that every newborn 
is screened, every family has access to follow-up care. Early 
identification and intervention are key to a child's well-
being, and that is what this bill would support.
    I am hopeful we continue to work in a bipartisan way to 
move this and other bills that we are examining today and bring 
them all to the floor this year.
    So thank you, witnesses, for being here, and I yield back.
    Mr. Pitts. The Chair thanks the gentlelady.
    Chairman Upton has asked to yield his time to 
Representative Guthrie, so the Chair recognizes Representative 
Guthrie at this time.

 OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Guthrie. Thank you very much. In the interests of time, 
Congresswoman Capps had a lot of statements that I was going to 
make, so I am pleased to be here to support 1344 that I am 
pleased to have co-authored with Congresswoman Capps. And I 
have been interested in this issue, early detection and 
screening, since I was in the State legislature. I did research 
when a bill was going through the legislature and learned if a 
newborn--at the early stages if you have hearing loss and you 
don't have the opportunity to hear correctly, you can never 
gain that back, even if you learn it as a young adult or a 
teenager or whatever. You can never gain it back. So it's 
important to do it early, through early detection.
    The current law is set to expire September of 2015, a mere 
3 months from now, and these services will go away and we will 
lose the opportunity to catch these early screenings. So I am 
pleased that Chairman Pitts has put this on the agenda for 
today. This bill appears to be moving forward, and I appreciate 
working with Congresswoman Capps, and I appreciate your time, 
Mr. Chairman, and I yield back.
    Mr. Pitts. The Chair thanks the gentleman. I thank him for 
expediting as well.
    The Chair now recognizes the ranking member of the full 
committee, Mr. Pallone, for his opening statement.
    Mr. Pallone. Thank you, Mr. Chairman.
    Did you have a statement on the other side?
    Mr. Pitts. Yes, we did.
    Mr. Pallone. OK. I know you are trying to get it done fast 
here.

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

    Let me thank Chairman Pitts and Ranking Member Green for 
holding this hearing on important pieces of legislation that 
will surely improve the health of our Nation. I am pleased that 
all three bills have robust bipartisan support and continue 
this committee's tradition of a thoughtful, collaborative 
approach to public health legislation.
    I am not going to read all the bills. I mean, obviously 
H.R. 2820, the Stem Cell Therapeutic and Research 
Reauthorization Act, it continues the highly successful Be The 
Match Registry for bone marrow, and this bill ensures that this 
critically important program continues to operate.
    As far as H.R. 1344, the Early Hearing Detection and 
Intervention Act of 2015 introduced by Representatives Capps 
and Guthrie, obviously this is important for newborns who now 
are regularly screened for hearing loss, and so this is 
something that we support.
    And finally, H.R. 1462, the Protecting Our Infants Act of 
2015, is a greatly needed piece of legislation to address a sad 
reality of our country's opioid epidemic. This bill rightly 
recognizes the immediate need for a comprehensive national 
strategy to address prenatal opioid abuse. So I also thank 
Representative Clark. She has talked to me about this in the 
past. I look forward to working with you and our colleagues on 
these important public health bills.
    I yield the remainder of my time to Representative Capps--
she already spoke.
    I yield back. Thank you.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you Chairman Pitts and Ranking Member Green for 
holding this hearing on important pieces of legislation that 
will surely improve the health of our Nation. I am pleased that 
all three bills have robust bipartisan support and continue 
this committee's tradition of a thoughtful, collaborative 
approach to public health legislation.
    H.R. 2820, the Stem Cell Therapeutic and Research 
Reauthorization Act, continues our highly successful Be the 
Match Registry for bone marrow and umbilical cord blood 
transplantation. I'd especially like to thank Representative 
Matsui for her continued leadership on this issue. For nearly 
20,000 patients each year, such transplants are lifesaving. Of 
those patients, 70 percent will not find a match within their 
family member and will require a non-relative donor. That is 
why the Be the Match Registry and its nearly 12.5 million 
registered bone marrow donors and the collection of more than 
209,000 cord blood units is so important. This bill ensures 
that this critically important program continues to operate.
    We will also hear about H.R. 1344, the Early Hearing 
Detection and Intervention Act of 2015 which was introduced by 
Representatives Capps and Guthrie. Prior to the authorization 
of the Early Hearing Detection and Intervention Program, less 
than half of all newborns were regularly screened for hearing 
loss. We're proud to say that now approximately 97 percent of 
newborns receive hearing screening. This gives hearing impaired 
children early access to the interventions and treatments they 
desperately need. The evidence tells us that these early 
treatments are critical in minimizing a hearing-impaired 
child's risk of developmental delays, especially communication, 
social skills and cognition. This bill would ensure that we 
continue to support a public health program that has a proven 
track record of success as well as continue our obligation to 
protect the health of our children.
    Finally, H.R. 1462, the Protecting Our Infants Act of 
2015is a greatly needed piece of legislation to address a sad 
reality of our country's opioid epidemic: prenatal opioid abuse 
and the steep increase in the incidence of neonatal abstinence 
syndrome or NAS. According to a recent study the incidence of 
NAS quadrupled between 2004 and 2013. NAS occurs in newborns 
who were exposed to opiates while in their mother's womb and is 
associated with negative health outcomes including preterm 
births, low birthweight, and complications such as respiratory 
distress.
    This bill rightly recognizes our imminent need for a 
comprehensive national strategy to address prenatal opioid 
abuse and NAS. H.R. 1462 would require HHS to develop 
recommendations for the treatment and prevention of prenatal 
opiate abuse and neonatal abstinence syndrome, it would require 
the CDC to assist States in collecting data to monitor the 
problem and would direct HHS to develop a coordinated research 
and programming strategy to address the public health challenge 
of NAS. I want to also thank Rep. Katherine Clark for her 
leadership on this critical and timely issue.
    Mr. Chairman, I look forward to working with you and our 
colleagues on these important public health bills.

    Mr. Pitts. The Chair thanks the gentleman, and the Chair 
recognizes Mr. Green for a UC request.
    Mr. Green. Mr. Chairman, I ask unanimous consent to place 
into the record a statement by our colleague Doris Matsui in 
support of the bills.
    Mr. Pitts. Without objection, so ordered.
    I have someone monitoring the floor with the number of 
minutes and Members not voting, so I will keep you updated on 
that.
    At this time I will introduce our panel. We have one panel 
today, and thank you all for coming. I will introduce you in 
the order of your presentations and ask if you can abbreviate 
them somewhat. At some point if we don't get through them, we 
will have to go to the floor and return to hear the rest.
    But first Dr. Jeff Chell, Chief Executive Officer, National 
Marrow Donor Program; Dr. Joanne Kurtzberg, President of the 
Cord Blood Association; Dr. Patti Freemyer Martin, Ph.D., 
Director of Audiology and Speech and Language Pathology, 
Arkansas Children's Hospital; Dr. Stephen Patrick, Assistant 
Professor of Pediatrics and Health Policy, Department of 
Pediatrics, Vanderbilt University School of Medicine; and 
finally, Dr. Mishka Terplan, Medical Director of Behavior 
Health Systems of Baltimore.
    Thank you for coming today. Your written opening statements 
will be made a part of the record as will all Members' written 
opening statements as usual. You will be given 5 minutes to 
make your summary. If you can abbreviate that, we would 
appreciate it.
    So at this point, the Chair recognizes Dr. Chell for 5 
minutes.

STATEMENTS OF JEFFREY W. CHELL, M.D., CHIEF EXECUTIVE OFFICER. 
    NATIONAL MARROW DONOR PROGRAM; JOANNE KURTZBERG, M.D., 
   PRESIDENT, CORD BLOOD ASSOCIATION; PATTI FREEMYER MARTIN, 
     PH.D., DIRECTOR, AUDIOLOGY/SPEECH-LANGUAGE PATHOLOGY 
 DEPARTMENT, ARKANSAS CHILDREN'S HOSPITAL; STEPHEN W. PATRICK, 
  M.D., ASSISTANT PROFESSOR OF PEDIATRICS AND HEALTH POLICY, 
   DIVISION OF NEONATOLOGY, VANDERBILT UNIVERSITY SCHOOL OF 
MEDICINE; AND MISHKA TERPLAN, M.D., MEDICAL DIRECTOR, BEHAVIOR 
                    HEALTH SYSTEM BALTIMORE

                 STATEMENT OF JEFFREY W. CHELL

    Dr. Chell. Good morning, Mr. Chairman and other 
distinguished members of the committee. Thank you so much for 
inviting us today.
    As you have heard, I serve as the CEO of the National 
Marrow Donor Program and Be The Match. We have operated the 
C.W. Bill Young Cell Transplantation Program since its 
inception, and that includes a single point of access, the 
Office of Patient Advocacy, the Bone Marrow Coordinating 
Center, as well as the Cord Blood Coordinating Center, and with 
the Medical College of Wisconsin, we hold a contract for the 
Stem Cell Therapeutics Outcome Database through our research 
entity, the CIBMTR. I serve as Executive Director of that 
entity.
    I would like to thank you all and members of the 
subcommittee for inviting us to speak on behalf of our 565 
network partners all over the world, and at the NMDP, we deeply 
appreciate your support of helping us fight blood cancers 
through transplantation, often, the only potential cure for 
these deadly diseases. I would also like to thank 
Representatives Chris Smith, Doris Matsui, David Jolly, and 
Chaka Fattah for their leadership in introducing H.R. 2820.
    As I testify before you today, I am reminded of a hearing 
in 1987. On that day, the late Congressman Bill Young called on 
Congress to establish the national registry where children and 
adults with leukemia and other fatal blood disorders could find 
a donor. Congress heard that call at that point and established 
the national registry.
    Congressman Young's vision was inspired by a child, 11-
year-old Brandy Bly, who was fighting leukemia. No one in her 
family was a suitable match, and without access to a 
transplant, she would not survive. At that time there was no 
registry available, and it was the simple statement from her 
physician that really stimulated Congressman Young to take 
action, and he said, ``Wouldn't it be great if there was a 
registry of donors that we could tap in to help save a life 
like this this?'' And that really became the basis of our 
national registry.
    Since that hearing in 1987, we have made great progress. 
The NMDP is now the global leader in providing cellular 
therapy, which is often the only treatment available that can 
cure some of these life-threatening blood disorders and other 
significant diseases like sickle cell disease. We also educate 
healthcare professionals, conduct research, and offer support 
and education in multiple languages to help patients lead 
healthy lives after transplant. Today, children like Brandy 
have a much better chance for a lifesaving transplant.
    We have been honored to serve as the steward of this 
critical resource for the last 28 years. During that time, the 
growth of transplant has increased significantly, and even 
since 2005, transplants overall have grown 200 percent, and for 
minorities it has grown 250 percent. We now have over 12 
million donors in our registry and over 200,000 cord blood 
units, but we partnered with 66 registries all over the world 
to provide a total of 25 million donors and over 600,000 units 
of cord blood, and it is as easy to find a donor and make that 
transplant happen if that donor was halfway across the world or 
across the street.
    Outcomes for transplant for have also improved as well as 
the number of transplants, so your survival has gone from 40 
percent to over 70 percent in the last 10 years. But we are 
especially proud--if we could show the first slide--of our work 
fighting diseases afflicting children.
    [Slide.]
    In 2014, we facilitated 1,200 unrelated transplants for 
patients 18 years and older, and the first slide shows how 
important the source, not only bone marrow but also umbilical 
cord blood, is in fighting transplants. Dr. Kurtzberg and other 
pioneers in this field introduced cord blood in the late 1990s, 
and those truly are helping patients that we would have 
otherwise not been able to help.
    But your ongoing commitment has made these advances 
possible and turned the tragic loss of Brandy into hopes for 
tens of thousands of Americans. One of those is Hadley Mercer. 
She was just 6 months old when she was diagnosed with acute 
myeloid leukemia. After two rounds of chemotherapy, her parents 
and physicians agreed that a bone marrow transplant was likely 
her only chance as well as her best chance of survival. We 
found a perfect match for her, a young man in his 20s. Now 
almost 2 years old, she is going to have a normal and healthy 
life because of her donor angel. She is also alive because of 
your continued support for the C.W. Bill Young Cell 
Transplantation Program.
    The NMDP has never forgotten the importance of that 
physician's simple statement that inspired Congressman Young, 
and every day we are inspired by people who we meet, young and 
old, who are seeking to find that match. If we could show the 
next slide?
    [Slide.]
    It shows us that, even though we have made tremendous 
progress, we are meeting less than half the need of the 
pediatric population, and in this slide you can see the 
lighter-colored areas are areas where we are only meeting 25 
percent or more of the total need, and as we get darker colors, 
you can see that there is more and more. So there are many, 
many more children we can help. So thank you very much for your 
time and attention.
    [The prepared statement of Dr. Chell follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Pitts. The Chair thanks the gentleman, and we are out 
of time on votes for the floor. At this point the Chair 
recognizes Dr. Kurtzberg.

                 STATEMENT OF JOANNE KURTZBERG

    Dr. Kurtzberg. Mr. Chairman, Ranking Member Green, and 
members of the subcommittee, thank you for inviting me to 
discuss H.R. 2820, the Stem Cell Therapeutics and Research 
Reauthorization Act of 2015. My name is Joanne Kurtzberg, and I 
am the President of the Cord Blood Association of Pediatric 
Transplant and I am the founder and Director of the Carolinas 
Cord Blood Bank, which is a public cord blood bank at Duke.
    I want to thank both Congressman Chris Smith and 
Congresswoman Doris Matsui for their leadership and the 
introduction of this legislation. I also want to acknowledge 
the subcommittee's bipartisan commitment to the creation and 
support of the NCBI, or National Cord Blood Inventory, a public 
cord blood banking network which began when this bill was 
introduced in 2005.
    I am talking about a network of banks that save cord blood, 
which is the baby's blood remaining in the placenta, or 
afterbirth, after the baby is born. In the past, this cord 
blood was discarded as medical waste, so it has never been a 
controversial source of stem cells. Cord blood contains stem 
and progenitor cells of the blood and other tissues, and it can 
be collected without harming the mother or the baby and banked 
for future use, and I put a picture up there of what the bag 
looks like that we save cord blood in.
    [Slide.]
    We save it in less than an ounce of fluid in two 
compartments with little pigtails so we can test it later and 
make sure it is appropriate for a patient for transplant.
    If I could have the next slide, it shows you a picture of 
the very first recipient of cord blood transplant in the world, 
who is a little boy from North Carolina with a fatal disease 
called Fanconi anemia.
    [Slide.]
    His sister was a match and not affected, and when he was 5 
years old he went to France for this transplant, and you can 
see him 27 years later doing well, a happy, healthy, working, 
married adult with me. He reached the benchmark of being taller 
than me, which is what many of my patients like to do post-
transplant. But most importantly, he is fully engrafted with 
his baby sister's cells, and that proved that cord blood 
contains stem cells of the blood.
    Next slide.
    [Slide.]
    Briefly, after that transplant, unrelated donor cord blood 
banks were established, first at the New York Blood Center, 
later through support from Congress to establish at NHLBI the 
COBLT program at Duke and two other sites, and as you know, the 
first legislation was passed in 2005 establishing the National 
Cord Blood Inventory as part of the C.W. Bill Young Cell 
Transplantation program. This stem cell source is unique 
because FDA has issued guidance to license cord blood, and 
there are now five licensed cord blood banks in the United 
States. In 2014, we also created the Cord Blood Association to 
represent both public and private cord blood banks and the cord 
blood community.
    Next slide, you can see just the milestones in cord blood 
transplantation.
    [Slide.]
    It has been pioneered in children with inherited metabolic 
diseases. It has been used with two cord blood or double cord 
blood transplantation at the University of Minnesota, and there 
have been over 35,000 cord blood transplants performed 
worldwide and 160 banks established worldwide since it started.
    [Slide.]
    This just shows you--next slide--some of the research that 
is going on, so we now have ways to expand cord blood in the 
red line, so that the patient is in graft in 6 to 10 days 
instead of 20 to 30 days, and if you would go to the next 
slide, you will see some just facts about the NCBI.
    [Slide.]
    There are 13 members, 5 licensed banks, and not all the 
money appropriated has actually been--authorized has been 
appropriated over the past 10 years, but with the funding we 
have had, 90,000 high-quality, diverse cord blood units have 
been stored.
    The next slide shows you a kit that we can send out to moms 
who want to donate anywhere in the country so the cord blood 
can be stored in the national inventory.
    [Slide.]
    The next slide shows you just an example of a little boy 
with Hurler syndrome.
    [Slide.]
    This is a fatal disease where children die by age 5. With a 
cord blood transplant, you can see on the right, this child is 
a healthy adolescent with normal intelligence, and many 
children with these kind of diseases have been helped.
    The next slide lists some of the exciting regenerative 
medicine trials that are emerging for uses of cord blood beyond 
treating patients with leukemia and other diseases, and that 
includes autism, hearing loss, stroke, and cerebral palsy.
    [Slide.]
    The next slide shows you some data showing that babies with 
birth asphyxia have had their outcomes improved when they 
receive a cord blood infusion in the first 2 days of life.
    [Slide.]
    The next slide shows you our data from Duke showing that a 
cord blood infusion can actually help children with cerebral 
palsy regain function and regain normal performance.
    [Slide.]
    And the next slide shows you just how the brain can, in the 
lower left, actually re-form connections after a cord blood 
infusion.
    [Slide.]
    So I thank you for your attention and for your support, and 
we will be able to entertain questions later.
    [The prepared statement of Dr. Kurtzberg follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    
    Mr. Pitts. The Chair thanks the gentlelady, and I apologize 
for the interruption here but we must now go to the floor to 
vote. We are going to vote for three bills and then we will 
recess for that and come back immediately for the rest of the 
hearing.
    So without objection, the subcommittee stands in recess.
    [Recess.]
    Mr. Pitts. The time for our recess having expired, we will 
reconvene the subcommittee, and we are now ready for Dr. 
Martin. You are recognized for 5 minutes for your opening 
statement.

               STATEMENT OF PATTI FREEMYER MARTIN

    Dr. Martin. Good morning, Mr. Chairman and members of the 
committee. I want to express ACH's and my appreciation to 
Congressman Guthrie and Congresswoman Capps for their 
leadership in introducing H.R. 1344, the Reauthorization of the 
Early Hearing and Detection Intervention Act for Children.
    This important bill provides assistance to States in 
identifying hearing loss in infants and young children and 
places an emphasis on ensuring that those identified with 
hearing loss receive appropriate intervention.
    Hearing loss is the most commonly occurring condition that 
newborns are screened for. Three babies per thousand are born 
with hearing loss, and this number almost triples by the time 
children enter kindergarten.
    When hearing loss is detected early, children can learn 
sign language, be fit with hearing aids for cochlear implants 
and/or receive early intervention services that enable them to 
achieve on par with their hearing peers. If it is not detected 
early, it can be devastating to children's academic and 
psychosexual development. There is now abundant scientific 
evidence that the brain develops in response to early visual 
and/or auditory stimulation, which is critical for children 
with hearing loss. Almost 30 years ago, a report commissioned 
by Congress showed that the average deaf child at that time had 
a 4th-grade reading level when they were old enough to graduate 
from high school, in large part due to the fact that these 
children were not identified until they were 2 \1/2\ years to 3 
years old. Since newborn hearing screening has been 
implemented, we have seen the average age of identification 
drop to 2 to 3 months. More importantly, deaf children who are 
diagnosed early and receive appropriate early intervention 
often achieve on the same level with their hearing peers by the 
time they reach 1st grade.
    H.R. 1344 is the reauthorization of a very successful 
program, which has been in place for 15 years. Because of this 
initiative called EHDI, 98 percent of babies are now screened 
for hearing loss before they are discharged from the hospital. 
Most of these babies go home to families where it never even 
occurred to their parents to wonder if they could hear them 
sing or whisper or cool mommy loves you or daddy's big boy. 
Early screening allows those infants who do not need assistance 
to be connected with services--who need assistance to be 
connected with services, to learn to communicate with their 
families using sign language and/or hearing technology and 
start on the path to prepare them for school readiness. Of 
babies who need follow-up, we know that 95 percent of those are 
born to hearing parents, often with little or no exposure to 
individuals who are deaf or hard of hearing. They find 
themselves in a situation that was unanticipated and for which 
their roadmap on parenting and all their how-to guides may not 
really apply. A great resource for many of these parents is 
having access to adults who are deaf or hard of hearing or 
other forms of parent-to-parent support and family-to-family 
support as stipulated in this bill.
    There is much to be proud about this previous legislation 
that has captured in the reauthorization. The EHDI program has 
enabled unprecedented collaboration between public and private 
agencies and across all levels of Government. The EHDI program 
is often cited as a model of how Government at different levels 
and private and public entities should and can work together. 
The reauthorization continues to emphasize the partnerships 
among HRSA, CDC and the NIH, and includes language for those 
agencies for further collaboration.
    I want to call your attention to a couple of sections in 
the bill. First, it focuses on continuing to provide limited 
Federal support to programs already in place for infants. In 
the previous version of the bill, the focus was exclusively on 
babies. This bill reauthorizes services for babies and extends 
it to young children. This is critical because now we know that 
by the time children are 5 years of age, we will almost triple 
the number of children who have hearing loss, and we need to 
intervene with this group early so that they are ready to learn 
when they hit school age.
    Another important aspect is the focus on families being 
involved and empowered in the process for their children in a 
timely way. So engaging and enabling these families is not just 
desirable but critical. Family involvement is described as the 
tipping point for children having full access to language, 
whether it is visual, spoken or a combination of both, and 
involvement with families is described as family-to-family 
support and from a variety of professionals including deaf and 
hard-of-hearing consumers in this bill.
    It is about more than just screening for hearing loss. We 
do screening really well but there is work to be done on 
getting appropriate services for many infants and young 
children. We have the basis in place but systems to ensure that 
infants with hearing loss receive the appropriate follow-up for 
diagnosis, for medical care, and early intervention services 
from providers that have the knowledge and skills to help them 
communicate with their families needs to be refined and 
improved.
    Because of previous funding for the EHDI programs, loss to 
follow-up has been reduced by half over the last 10 years, but 
there is much more work to be done.
    Thank you.
    [The prepared statement of Dr. Martin follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
       
    Mr. Pitts. The Chair thanks the gentlelady and now 
recognizes Dr. Patrick, 5 minutes for your opening statement.

                STATEMENT OF STEPHEN W. PATRICK

    Dr. Patrick. Chairman Pitts, Ranking Member Green, and 
honorable members of the committee, my name is Stephen Patrick. 
I am a Neonatologist and Researcher at Vanderbilt University 
School of Medicine.
    It is a privilege to speak with you today about the rising 
number of infants being born diagnosed with drug withdrawal in 
the United States. The bill before you, H.R. 1462, the 
Protecting Our Infants Act of 2015, makes positive steps to 
improve the health of women and infants impacted by opioid use 
and misuse.
    A few months ago, I was caring for a 2-day-old baby in the 
neonatal intensive care unit at Vanderbilt Children's Hospital. 
At just 48 hours of life, the infant became fussy and jittery. 
Over the next 24 hours, the infant continued to worsen with 
diarrhea, sneezing and increased fussiness. Each of these signs 
are classic for drug withdrawal. However, as mother denied use 
of any drugs that may cause withdrawal, until the baby's drug 
screen came back positive for prescription opioids. Once I 
informed the mother of the baby's drug screen, she reluctantly 
admitted that she had been using pain pills without a 
prescription. The baby remained in the hospital for a bit 
undergoing treatment.
    And as I reflected on this case, I began to wonder, what if 
the infant had been discharged to home at the typical 24 hours 
of life only to have drug withdrawal at home. Would he have 
been brought back to the hospital critically ill, and with 
systems may help his mother be more knowledgeable and 
forthcoming about her drug use, and how do we connect her with 
drug treatment, particularly during pregnancy. This situation 
unfortunately is increasingly common.
    Neonatal abstinence syndrome is a drug withdrawal syndrome 
that infants exposed to opioids experience shortly after birth. 
Opioids pass from the mother through the placenta to the fetus. 
At the time of birth when the supply is stopped, the infant is 
at risk of developing drug withdrawal within the first few days 
of life. Infants with neonatal abstinence syndrome have 
difficulty feeding and are more likely to have breathing 
problems, tremors, increased muscle tone, fever, difficulty 
sleeping, and inconsolability. Severe neonatal abstinence 
syndrome requires treatment with an opioid like morphine or 
methadone and an average hospital stay of about 3 weeks. 
Watching an infant have drug withdrawal is distressing for 
doctors, nurses, and for parents.
    According to the Centers for Disease Control and 
Prevention, the number of prescription opioids used in the 
United States quadrupled over the last decade, and by 2012, 
there were 259 million prescriptions written for an opioid, 
more than one for every American adult. This rapid increase in 
opioid use and misuse impacted nearly every population in the 
United States including women of childbearing age and pregnant 
women, and a study our group published in May using data from 
the Tennessee Medicaid program, we found that of 110,000 
pregnancies in a 3-year period, nearly 30 percent filled a 
prescription for an opioid pain reliever during pregnancy.
    Throughout the country, as prescription opioid use grew, so 
did the incidence of neonatal abstinence syndrome. Using 
billing data from the Nation's hospitals, our research team 
conducted a series of studies to determine national rates of 
neonatal abstinence syndrome. From 2000 to 2012, the number of 
infants diagnosed with the syndrome grew nearly fivefold. By 
2012, one infant was born every 25 minutes on average in the 
United States with neonatal abstinence syndrome, accounting for 
an estimated $1.5 billion in healthcare expenditures, 80 
percent of which are paid for by Medicaid.
    The scope of the problem is staggering in some communities. 
For example, some areas of my home State, Tennessee, reported 
one in 20 infants born in their community have neonatal 
abstinence syndrome, and in some NICUs, nearly 50 percent of 
their total annual hospital days are dedicated to treating this 
one condition. This rapid increase has largely caught 
communities and providers off guard. Today there are no well-
researched standard treatment protocols for infants with NAS, 
and as a result, treatment and clinical outcomes vary widely 
throughout hospitals in the United States.
    Addressing the complexity of perinatal opioid use and 
neonatal abstinence syndrome requires a thoughtful public 
health approach. Our goal should be to promote healthy mothers 
and infants by supporting prevention and recovery, and this 
must begin with primary prevention--engaging public health 
measures to prevent opioid misuse even before pregnancy 
including bolstering prescription drugs monitoring programs, 
improving access to contraception, ensuring opioid prescribing 
is necessary and appropriate, especially among pregnant women; 
and secondary prevention--improving screening for drug use in 
pregnancy and ensuring that drug treatment is available when it 
is needed and that it includes medication-assisted treatment 
when appropriate; treatment should be comprehensive, gender-
specific, and inclusive of obstetric care; and tertiary 
prevention--improving identification and treatment of infants 
suffering with neonatal abstinence syndrome and working to 
improve post-discharge outcomes.
    Mothers and infants impacted by the prescription of opioid 
and heroin epidemics are in desperate need of a public health 
approach to address this problem. We cannot wait any longer to 
respond, and the status quo is simply unacceptable.
    The Protecting Our Infants Act takes the necessary and 
important steps forward to improving research and service care 
delivery. For the patient I described in my introduction and 
for the thousands like him, we need the tools to learn how to 
treat him better, and perhaps even more importantly to prevent 
him from being there in the first place.
    As a neonatologist and researcher, I applaud the bill's 
authors and the committee's interest in this critical public 
health problem and this issue that affects so many vulnerable 
mothers and infants in the United States today.
    Mr. Chairman, I thank you for the opportunity to speak 
today and I look forward to your questions.
    [The prepared statement of Dr. Patrick follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
        
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Dr. Terplan for 5 minutes for an opening statement.

                  STATEMENT OF MISHKA TERPLAN

    Dr. Terplan. Good morning, Chairman Pitts, Ranking Member 
Green, and distinguished members of the subcommittee, and thank 
you for having me here today.
    My name is Mishka Terplan, and I am an OB/GYN and Addiction 
Medicine Specialist and the Medical Director of Behavioral 
Health System Baltimore. I am pleased to testify on behalf of 
the American Congress of Obstetricians and Gynecologists in 
support of H.R. 1462, the Protecting Our Infants Act. I would 
like to thank Representatives Katherine Clark and Steve Stivers 
for their leadership in introducing this legislation and the 
eight cosponsors on the Health Subcommittee, and I urge the 
committee to act swiftly in reporting out this bill.
    H.R. 1462 represents a bipartisan, bicameral effort to 
address the critical problem of opioid addiction and neonatal 
abstinence syndrome facing pregnant women from all 
socioeconomic backgrounds. NAS refers to medical issues 
associated with drug withdrawal in newborns following prenatal 
opioid exposure and is expected and treatable with no long-term 
negative outcomes documented in the literature.
    While I want to stress the importance of the mother-infant 
dyad, my testimony will focus primarily on the woman and how 
passage and implementation of this bill would improve access to 
quality treatment and care for this population.
    Specifically, the bill would commence three important 
initiatives that address the following: One, prevention and 
treatment of prenatal opioid use disorders. Preventing 
inappropriate opioid use among pregnant women and women of 
childbearing age is crucial. Quality preconception care and 
family planning optimize a woman's health and knowledge before 
conceiving a pregnancy, improving the likelihood of having a 
healthy pregnancy and a healthy baby. Among women with opioid 
addiction, almost 90 percent of their pregnancies are 
unplanned. All pregnant women are concerned for the health of 
their baby-to-be and are motivated to change unhealthy 
behaviors. Most pregnant women who use substances including 
opioids quit or cut back. Those who cannot stop using by 
definition meet criteria for having a substance use disorder. 
In other words, continued use in pregnancy is pathognomonic for 
addiction, which is a chronic relapsing brain disease.
    When treating pregnant women with opioid addiction, 
withdrawal or detoxification are rarely clinically appropriate. 
Detox results in relapse, and any abrupt discontinuation of 
opioids can result in preterm labor, fetal distress, or fetal 
demise. Safe prescribing during pregnancy includes opioid-based 
medications such as methadone or buprenorphine, which are 
standard of care for pregnant women with opioid addiction. 
However, pregnant women continue to face access issues and most 
do not receive opioid agonist therapy. Denying pregnant women 
evidence-based treatment in order to prevent NAS is 
discriminatory.
    Additionally, opioid medication should be accurately 
labeled to ensure appropriate access to medication for women 
who are addicted and for whom the alternatives such as heroin 
or withdrawal during pregnancy are much more dangerous. 
Specifically, the FDA boxed warning related to pregnancy should 
be removed or updated to remove the inaccurate information 
linking opioid use during pregnancy with ``life-threatening 
neonatal opioid withdrawal syndrome,'' a claim with no 
scientific evidence.
    Number two: Gaps in research and programming. Additional 
research is needed on effective and non-addictive pain 
treatment, and any such research should include women of 
childbearing age and pregnant women. However, it is important 
to note that medically appropriate opioid use in pregnancy is 
not uncommon, and opioids are often the safest and most 
appropriate treatment for a variety of medical conditions and 
severe pain during pregnancy. Pregnant women with substance use 
disorders need access to comprehensive services including 
prenatal care, drug treatment, and social support. Punishing 
pregnant women with substance use disorders by targeting them 
for criminal prosecution or forced treatment is inappropriate 
and will drive women away from care. Innovative treatment 
models are needed and should be tailored to pregnant or 
parenting women and should provide priority access.
    Number three: Improved data collection and surveillance. 
Opioid addiction has become more widespread geographically and 
demographically. In communities with high opioid prescription 
and addiction rates, there will be higher rates of pregnant 
women with opioid addiction and subsequent NAS. Access to 
national and State-specific NAS data would enable trend 
analysis and foster greater sharing of best practices and 
treatment strategies. Improved data collection would also help 
us better track and understand the long-term outcomes of 
infants with NAS. For those purposes, data endpoints need to be 
of both clinical and sociological significance.
    Thank you for the opportunity to testify at today's 
hearing. The committee's attention to and interest in reducing 
maternal opioid addiction and NAS are crucial, and the 
Protecting Our Infants Act represents a positive step forward 
in addressing this growing issue I welcome your questions. 
Thank you.
    [The prepared statement of Dr. Terplan follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    
    Mr. Pitts. The Chair thanks the gentleman. That concludes 
the opening statements of our panel. We will now begin 
questioning. I will recognize myself for 5 minutes for that 
purpose.
    Dr. Chell, we will start with you. In what patient 
population do you see the number of transplants rising the 
fastest, if you can give us sort of a----
    Dr. Chell. Yes. The group that is rising the most quickly 
is the elderly population, the senior population, and that is 
growing by double digits every year, and the reason for that 
is, the medical conditions for which transplant is often the 
only cure tend to occur in older populations, diseases like 
acute myeloid leukemia, myelodysplastic syndrome, 
myelofibrosis, and others.
    Mr. Pitts. Dr. Kurtzberg, while the cord blood and the bone 
marrow donor programs have enjoyed great success over the past 
10 years, what, if any, are the barriers you face to realizing 
the full potential of these programs?
    Dr. Kurtzberg. There are two major barriers I would cite. 
The first is that cord blood grows slower than bone marrow when 
you first give it for a transplant, and so there is a big need 
for more research to develop ways to expand cord blood in the 
laboratory before it is infused, and I showed one slide showing 
that there is promising work being done in that area.
    The second is that the cost of a cord blood transplant, and 
that is for procuring the donor and also taking care of the 
patient, is higher than some other types of transplantation, 
and part of that is due to the fact that with licensure of cord 
blood, the costs of manufacturing have gone up while the 
market-bearing price for reimbursement cannot change because 
really, it is already too expensive to have a transplant. So we 
are really struggling for cord blood to be able to be 
subsidized through programs like this so that the patient can 
afford to use the donor.
    Mr. Pitts. Thank you.
    Dr. Martin, can you elaborate on the importance of medical 
intervention for and follow-up with medical services for deaf 
individuals? Why is a public health-based approach important at 
this time?
    Dr. Martin. Children with hearing loss need follow-up for 
medical intervention because sometimes hearing loss will be 
coexisting with other conditions. We want these children to be 
evaluated for what other coexisting morbidities might occur 
with hearing loss. What we do know is about a third of children 
with hearing loss also have another disability as well, and so 
that medical pace is really critical for them. It makes it a 
very important public health program. The American Speech and 
Hearing Association, the National Center for Hearing Assessment 
and Management, the American Academy of Pediatrics, and 
American Academy of Otolaryngology have all worked really well 
on this to ensure that these children get the type of medical 
care that they need to assist them in having improved outcomes.
    Mr. Pitts. Thank you.
    Dr. Patrick, you have performed extensive research on 
neonatal abstinence syndrome. In your written testimony, you 
state that Medicaid spent $1.2 billion for NAS hospitalizations 
in 2012. In February of 2015, the GAO released a report that 
showed gaps in research funded by the Federal Government in 
this area. Where should future research focus to close those 
gaps?
    Dr. Patrick. Well, we have research gaps throughout the 
continuum of neonatal abstinence syndrome. We need better 
measures to identify patients at risk of drug withdrawal. We 
need better systems to diagnose drug withdrawal. The current 
way we diagnose drug withdrawal is if we have an infant that we 
know has been exposed to an opioid, so we have to know that 
first, and then we score them on a system that can be pretty 
subjective. Basically it's an observation of the infant, and we 
go through a checklist of what they look like. That was 
developed decades ago. We need better systems that are more 
objective and perhaps use technology to aid in that, and we 
also don't have great mechanisms to understand what is the most 
effective way to treat these infants, how can we be most 
efficient, how can we ensure that we can keep mom and baby 
together when we can. There is a lot that we have to learn, and 
I think there are gaps throughout the continuum of our 
treatment of infants.
    Mr. Pitts. Thank you.
    Dr. Terplan, can you provide more background on the 
statement in your testimony that the FDA boxed warning related 
to pregnancy is incorrect and is not validated with scientific 
evidence? What problems has this caused? To your knowledge, is 
the FDA in the process of addressing this?
    Dr. Terplan. So the statement on the box is that use of 
methadone can cause life-threatening neonatal opioid withdrawal 
syndrome. The likelihood of death from NAS is no different from 
the likelihood of death for other infants born at matched 
gestational age. So it does not contribute in excess mortality 
risk to newborns, neonatal abstinence syndrome. So that is 
scientifically inaccurate.
    The FDA has convened a panel to discuss the labeling of 
this medication that both ACOG and the American Society of 
Addiction Medication testified at a couple weeks ago, so they 
are working towards that.
    Mr. Pitts. All right. Thank you. My time is expired.
    The Chair recognizes the ranking member, Mr. Green, 5 
minutes for his questions.
    Mr. Green. Thank you, Mr. Chairman. Again, I would like to 
thank our witnesses for being here today and also for your 
understanding of our unusual schedules to run and vote on the 
floor.
    I would like to ask about the treatment that is available 
to women with opioid use disorders during pregnancy. The GAO 
report released earlier this year cited numerous gaps in the 
treatment of NAS as well as into the treatment of women with 
opioid use disorders. One of the major barriers the GAO 
identified was the stigma and criminalization of pregnant women 
who struggle with substance use during pregnancy. For instance, 
some State laws require healthcare providers to report 
substance use during pregnancy to State or local law 
enforcement officials. One State, Tennessee, defines drug use 
during pregnancy as criminal assault. According to Guttmacher 
Institute, 18 other States treat substance abuse during 
pregnancy as child abuse under civil child welfare statutes.
    Dr. Terplan, what is the impact of such laws on the 
incentive for pregnant women to seek treatment for addiction as 
well as prenatal care?
    Dr. Terplan. Thank you very much for asking that question. 
Criminalizing or punishing pregnant women for substance use 
during pregnancy is a disincentive for them to seek prenatal 
care or seek substance treatment services or to continue with 
them. I know anecdotally from colleagues of mine who practice 
in Tennessee, which is the only State that has explicitly 
criminalized substance use during pregnancy that they are 
seeing women who are entering prenatal care late, going across 
State lines to deliver, delivering at home. One colleague of 
mine had a patient who delivered at home out of concern for 
being reported. She started bleeding, and the infant had 
something going on. They went to the emergency room, and that 
point in time she was arrested, so her concern, her actual 
concern with avoiding healthcare because of a fear of being 
caught up in the criminal system was realized.
    Mr. Green. How do these--Dr. Patrick, how do these laws 
impact the diagnosis of treatment of NAS?
    Dr. Patrick. Well, I think in part, beginning with women 
avoid care, they are more likely to not seek care in a 
hospital, and that alone is a disincentive. It creates a 
barrier to improving infant outcomes. The other piece is that 
we have to know about the exposure. If there aren't systems 
that allow women to be forthcoming about their drug use and 
seek treatment, then we don't know about the exposure. So the 
infant that I described in my introduction, if we didn't know 
about it and that infant didn't have a rapid weight loss within 
the first 2 days of life, that infant would have been 
discharged home because we wouldn't have known about it, having 
to withdraw at home and potentially having complications at 
home including severe dehydration.
    So I think that is why these systems, public health systems 
and public health approach, is much preferred to a criminal 
justice approach.
    Mr. Green. Well, and I understand the legislature and 
people are being shocked by a mother having a child that is a 
user. What would you recommend as effective alternatives to 
address the issue of the prenatal drug use and improve health 
outcomes for both the mother and the child?
    Dr. Patrick. Well, I think it begins with a lot of what the 
bill is doing, to begin to get people at the table, to 
understand what are the knowledge gaps, how do we coordinate 
things better. It begins with a public health approach to 
improving access to treatments and to understanding how we curb 
opioid use and misuse overall, even before pregnancy. I think 
the easiest way to prevent an infant having drug withdrawal in 
my unit is to prevent opioid misuse even before pregnancy. So I 
think those public health measures are critical.
    Mr. Green. Dr. Terplan, you had identified a number of 
additional treatment gaps for pregnant women with substance use 
disorders. You mentioned, for instance, a lack of access to 
medication-assisted therapy for pregnant women.
    Dr. Terplan, is medication-assisted treatment the standard 
of care for pregnant women with opioid use disorders?
    Dr. Terplan. Yes, and not just for pregnant women. It would 
be for men and non-pregnant women. Medication-assisted 
treatment would be the standard of care for opioid use 
disorders.
    Mr. Green. What are the barriers to women accessing 
medication-assisted therapy and what can the Federal Government 
do to address these barriers?
    Dr. Terplan. There seems to be--we did some research on 
this. Only 40 percent of pregnant women who are admitted into 
drug treatment for an opioid use disorder receive medication-
assisted treatment in the United States. Some of that has to do 
with context of treatment. There are many abstinence-only 
treatment modalities and treatment programs so they are not 
getting access to it in the treatment context. I know in my 
State of Maryland, I hear a lot of questions from providers 
throughout the State. There are large counties in Maryland 
where there is not a single buprenorphine provider who will 
take pregnant women. So I am in the process of going around the 
State and educating the substance treatment providers on how to 
care for the pregnant women, and one of the concerns that 
people have is that misperception and perhaps a medical legal 
liability, lack of knowledge in how to care for the pregnant 
woman, and oftentimes a lack of good, integrated care between 
the prenatal care providers and the addiction treatment 
providers.
    Mr. Green. OK. Thank you, Mr. Chairman. I know I am out of 
time.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the vice chairman of the subcommittee, Mr. Guthrie, 
5 minutes for questions.
    Mr. Guthrie. Thank you very much
    Before I get to my questions, Dr. Patrick, I am from 
Bowling Green, Kentucky, so a lot of people have been to the 
NICU at Vanderbilt, and it has been a blessing to have such a 
world-class facility that close. We do have a NICU in our area, 
and my cousin, Scott Guthrie--I am not sure if you have ever 
practiced with him--he is from Jackson, Tennessee, but does 
cover the NICU in Bowling Green.
    Dr. Patrick. Yes.
    Mr. Guthrie. So thanks for what you do.
    So I want to talk to Dr. Martin. I am the sponsor of the 
early detection hearing bill, so I want to focus on that. 
Universal newborn screenings work very well, the newborn side. 
Could you help the committee understand why it is important to 
expand to early childhood screening? You know, I can see where 
a parent would not understand if their newborn wasn't 
listening, particularly if it is your first one and you are not 
sure exactly what they are supposed to communicate, but 
wouldn't a parent know if a child was 3 or 4 and they couldn't 
hear?
    Dr. Martin. Well, one of the things that we see is that 
children who have what is called light-onset hearing loss like 
that that were born with normal hearing and acquired hearing 
loss in the first 3 to 5 years of life, that really they are 
pretty good at hiding out from their parents. So they read lots 
of visual cues that go on in their environment. There is lots 
of redundancy in how we tell kids to do things at that age, and 
parents want their kids to be typically developing, so it 
really flies under the radar a lot with that age child. We know 
from the statistics that we will almost triple the number of 
kids who are identified. So if it is three per thousand at 
birth, we are going to have two to three times that number of 
kids who enter kindergarten, and even a mild, moderate to 
severe hearing loss in a child can be missed until they enter 
school age, and we want to intervene with them early. We have 
got great programs in place that can help them be ready to 
learn when they enter school. So it is important to expand it.
    Mr. Guthrie. OK. Thank you. Also, there seems to be a sense 
of urgency about deciding how to communicate with your child 
once they are diagnosed with a hearing issue and some strong 
opinions about whether families should use American Sign 
Language or spoken language. How does the early detection bill 
address this issue?
    Dr. Martin. One of the important decisions that families 
have to make when their child is diagnosed with hearing loss is 
how they want to communicate with them, so they are making 
decisions about technology use, they are making decisions about 
the best way to communicate with their child or not. One of the 
stipulations in this bill is that families be given all the 
information about all the options that are available to them. 
So we want for families is for them to have the opportunity of 
informed choice, so we want to give them the information and 
help them weigh that in their family situation with their 
family dynamics, what their desired outcomes long term are for 
their child, with their culture and traditions and beliefs and 
their family and make a decision about what sort of 
communication mode they choose. So it might be ASL, American 
Sign Language. It might be listening and spoken language. It 
might be some combination of both.
    The good news is that there is not a right choice. The 
right choice is the choice that a family makes for their child, 
and we know that the EHDI bill has provisions in it that help 
us engage and equip families to make those decisions and to 
follow through with whatever decision that the make.
    Mr. Guthrie. Well, thanks, and I was involved in creating 
and expanding the Governor's initiative, involved in getting it 
passed when I was in the State legislature, and so a lot of 
States are doing this. What is important for Federal funding? 
What is the role of the Federal Government in this?
    Dr. Martin. Well, the Federal funding really primes the 
pump for this. It is a great example of the Federal Government 
seeing something that could take place and really be beneficial 
to families and to children, and stepping in and setting that 
program up, and so basically it is money that primes the pump 
for States to do what needs to be done to identify these 
children and get them enrolled in services and helps them 
continue that process. So the States are all implementing it in 
different ways, in lots of different successful ways. The 
Federal money helps us be able to share information back and 
forth and to be able to move towards best practice and 
evidence-based practice as we move forward in helping these 
kids attain their full potential.
    Mr. Guthrie. Well, thank you very much. When I was 
involved, I did research on the bill, and I remember talking to 
a researcher at Vanderbilt--that is where I went down to really 
understand what was moving forward and whether to move forward 
or not, how much Government do you get involved in--and they 
told me that if a newborn child, even if it is healthy, put 
them in a room where they couldn't hear, by the time they were 
3, they would never be able to develop the proper speech 
patterns. So what if a child could be corrected or get on the 
right path in the earliest stages?
    The other thing they did was eye screening, and the only 
reason I bring that up, because this is a hearing, is they said 
the normal pediatric screening would catch you going into 
kindergarten almost all the time except for about 1 or 2 
percent, and so do you increase this program for 1 or 2 
percent? Well, if you are one of those parents, you do, and it 
turned out when we passed the bill, my child had to go to an 
optometrist before kindergarten at 5, and he was one of the 1 
or 2 percent. So these are important programs, and I am pleased 
to be involved and pleased to work with Congresswoman Capps on 
this, and thank you for coming from Arkansas.
    Dr. Martin. Thank you very much.
    Mr. Guthrie. I yield back.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentlemen from Oregon, Mr. Schrader, 5 minutes 
for questions.
    Mr. Schrader. No questions, Mr. Chairman.
    Mr. Pitts. All right. We will go to Mr. Kennedy.
    Mr. Kennedy. Thank you, Mr. Chairman. I want to thank the 
witnesses for attending today and your testimony, and I really 
want to recognize the chairman for calling a very important 
hearing.
    I am going to focus my comments a bit on the opioid 
epidemic, which has been devastating for parts of Massachusetts 
and for expanding communities across our country. One thing 
that I know the entire group can agree on is with regards to 
the opioid crisis that is devastating in its reach, as we have 
heard from your testimony so far this morning. It does not 
discriminate, not by race, gender, age, demographics, income, 
or any other metric. The breadth and depth of this epidemic is 
particularly painful when it comes to its youngest victims--
newborns--and the rise of neonatal abstinence syndrome, NAS.
    In the United States, the rate of opiate-dependent births 
has nearly tripled since 2009. In my home State of 
Massachusetts, the Department of Children and Families received 
2,376 reports of substance use-exposed newborns between March 
of 2014 and March of 2015. In Tennessee, a recent study of the 
State's Medicaid program found that over a quarter of all women 
in the program were prescribed opioid pain relievers during 
pregnancy. Of the infants born there with NAS, 65 percent were 
born to mothers who were legally prescribed opioids. These 
statistics make it clear: We are falling far short in our 
efforts to protect the youngest among us from an epidemic and 
we are failing to provide reliable, appropriate care to 
pregnant women. We need to start researching today to protect 
our children tomorrow.
    I want to recognize and congratulate and celebrate the 
efforts of Congresswoman Katherine Clark from Massachusetts and 
Congressman Steve Stivers, whose efforts will help address this 
dangerous failure to grasp the reach of NAS, and I thank them 
both for their leadership on this critical issue.
    With that said, I wanted to focus my first question to both 
Dr. Patrick and Dr. Terplan. Can you expand on the gaps in 
research in NAS, particularly around prevention and treatment, 
and what evidence-based medical guidance is currently available 
to doctors and nurses who treat mothers and newborns? I know 
you both touched on it a little bit in some of the questions 
but I would like to flesh it out a little bit more.
    Dr. Patrick. Well, I think the gaps--we talked a little bit 
about some of the issues with diagnosis. We can go on 
throughout the spectrum in understanding how we send these kids 
home safely. We have--infants with neonatal abstinence syndrome 
are about two and a half times as likely to be readmitted to 
the hospital within 30 days after discharge. We really need 
systems, both service care delivery as well as research into 
the best mechanisms to ease that transition home. It is a 
complicated time for families, and you can think about an 
infant who is already a bit more fussy than usual and how this 
can be a challenging time for families. And so part of it is 
supporting families in that transition, perhaps using things 
that we know work well with the evidence that exists for 
childhood like home visitation programs. There really needs to 
be more targeted evidence towards this population and perhaps 
using evidence that we have garnered from other places.
    And as far as prevention, I think the committee's work that 
the committee has been working on more broadly on the heroin 
and prescription drugs epidemics, I think bolstering programs 
like prescription drugs monitoring programs and targeting 
special populations is really important, and ensuring that they 
are well funded at the State level and perhaps even targeted 
towards special populations such as women of childbearing age.
    Mr. Kennedy. Thank you.
    Doctor?
    Dr. Terplan. So I am going to focus my comments more on 
women. Identifying women with substance use disorders at the 
time of labor and delivery is 9 months too late. So we need to 
be doing universal screening for substance use during prenatal 
care, and that should be done not just with toxicology testing, 
which is the most common way we test for things with a urine 
test, which is not a test for a behavioral disorder that 
addiction is but with an instrument, a validated instrument, 
and we actually need to have more good comparison between what 
is the right set of questions to ask. There is a CDC-funded 
study that just--I don't know if it started yet but it just got 
approved--to compare different screening instruments during 
pregnancy. So we will have better data for that in the future.
    Really, for me, the research question is one about 
implementation. We know what treatment modalities work. The 
issue is that women aren't getting access to them, and so it 
becomes not a hypothesis question of what is, you know, best 
practice per se but how to deliver what we know to a 
population.
    Mr. Kennedy. I have got 25 seconds, Doctor. I want to push 
a little bit. What are the barriers to access? What can we do 
to alleviate those?
    Dr. Terplan. I think there is a knowledge deficit. I think 
that also criminalizing of pregnant women for substance use 
disorders discourages adherence with treatment or access and 
care, and so they are showing up on labor and delivery rather 
than during treatment or during pregnancy, and I think there is 
also some Federal barriers in terms of dissemination of 
methadone and also we don't have enough prescribers for 
buprenorphine in the United States.
    Mr. Kennedy. Thank you both. I yield back. I thank the 
chairman.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from Pennsylvania, Dr. Murphy, 5 
minutes for questions.
    Mr. Murphy. Thank you. I will try and rush through these.
    First, Dr. Kurtzberg, as an experienced cord blood banker 
and cord blood transplanter, what is your definition of a high-
quality cord blood unit?
    Dr. Kurtzberg. That is a great question. So a high-quality 
cord blood unit needs to be sterile. It needs to be checked 
incapable of transmitting genetic or infectious diseases, and 
most importantly, it needs to be potent, and potency can be 
measured by the number of cells that are in the unit, and we 
know now that we need a certain dose of cells to transplant 
individual patients and that many of the units that are 
collected are too small and don't contain that number of cells.
    Mr. Murphy. So do you think the current HRSA contracting 
policies optimize the collection of high-quality cord blood 
units?
    Dr. Kurtzberg. No, I think HRSA needs to help the banks to 
be incentivized to collect bigger units with more cells, and 
right now their policy does not do that.
    Mr. Murphy. And you mentioned that among the potential uses 
for cord blood are in regenerative medicine. You have initiated 
trials using cord blood to treat brain disorders including 
autism. Could you please explain for the committee the current 
status of that project and insight you have about the future of 
that research?
    Dr. Kurtzberg. Sure. So we think this research has enormous 
potential in autism, cerebral palsy and other brain disorders 
in children that are probably acquired and not genetic, and in 
these cases, we have initiated studies predominantly funded 
through the Marcus Foundation or the Robertson Foundation where 
we are looking at the role of cord blood infusions in those 
children.
    In autism, we have completed a 25-patient study for 
children ages 2 to 6 where we are looking at endpoints at 6 
months and changes in symptoms of ASD, and we have shown that 
children who get a higher dose of cord blood cells similar to 
the dose we would give a patient with leukemia or another 
malignant diagnosis benefit and have improvement in the 
symptoms with decrease in autistic symptoms. We think and we 
have evidence on MRI that this is due to a normalization of the 
connectivity in the brain that is coming from signaling of the 
cord blood cells to cells in the child's brain, which helps 
repair these conduction pathways.
    Mr. Murphy. That is fascinating. I want to follow up with 
you in the future.
    But let me ask Dr. Terplan and Dr. Patrick, I used to work 
in an NICU as a psychologist and would follow up children with 
developmental disorders, and I would be correct in saying that 
maternal opiate use has increased risk for developmental 
problems in a child either directly or also related to such 
things as low birthweight, prematurity, decreased head 
circumference? Am I correct in that continuing to be a concern?
    Dr. Patrick. I am happy to address that. I think the 
literature is difficult. There have been several studies 
demonstrating some issues with behavior, particularly some 
other issues, lazy eye, strabismus has also been described. But 
one of the things that we need is more research to follow these 
infants long term.
    Mr. Murphy. Well, let me ask this too, and also concern for 
increased risk for mortality if a physician is not aware of 
some of these problems during pregnancy and increased risk for 
fetal demise. Am I correct with those?
    I am going to ask this question. I believe, Dr. Terplan, 
you mentioned one of the issues is information. I also chair 
the Oversight and Investigations Subcommittee here, and many of 
my colleagues have been part of that. We have looked at the 
issue of the concern for if someone is in treatment, those 
medical records are not there, so you can't find out, an OB/GYN 
cannot find out because it is not in the record, and we have 
tried to address it, should it be wholly within the record, 
should it be under the patient's approval. This was based on 
1970s law and regulations. Should the patient say, well, put a 
1-year waiver in to allow that information in there? We had 
testimony just a week ago where one of our former colleagues 
had said, you know, it is in the chart if he has an allergy to 
penicillin, why can't it be in the chart that he has a reaction 
to opiates, please don't prescribe it, or if I am on there, to 
know those things. I wonder if you can comment on this 42 
C.F.R. part 2, the thing that we tried to deal with. Do you 
want access to those records?
    Dr. Terplan. So the reason for that legislation was just 
because individuals with substance use disorders are prejudiced 
against in our society and to protect them----
    Mr. Murphy. But I understand, but we have already 
established it is the neonates that suffer.
    Mr. Terplan. Yes, and so I think that the law which had a 
reason in the past actually does serve as a barrier to 
effective communication between parties. What I stressed when I 
talk about this is that there needs to be close collaboration 
between prenatal care providers and drug treatment providers 
and that consent forms need to be signed to get around that so 
that information can be easily shared.
    Mr. Murphy. I just want to make sure we are not making 
behavioral medicine and physical medicine separate but equal.
    Dr. Terplan. Correct.
    Mr. Murphy. And if these are--you can have toxic and higher 
mortality rates. We know the mortality rate has skyrocketed to 
42,000 deaths from drug overdose last year. We know there is a 
huge problem with neonatal abstinence syndrome. I hope you will 
respond more to this committee with your insights. I am 
fascinated by them and I want to hear more, because we want to 
make sure that you as providers have the information you need 
to know when you are dealing with a baby so you can deal with 
it effectively.
    I thank you very much. I yield back.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the Ranking Member of the full committee, Mr. 
Pallone, 5 minutes for questions.
    Mr. Pallone. Thank you, Mr. Chairman.
    I think it is important to understand neonatal abstinence 
syndrome, or NAS, in the context of the public health challenge 
of the overprescribing of opioid painkillers in the United 
States. Between 2000 and 2010, there was a fourfold increase in 
the use of prescribed opioids for the treatment of pain. In 
2012, healthcare providers wrote 259 million prescriptions for 
opioid painkillers, enough for every adult American to have a 
bottle of pills.
    So my questions. Dr. Patrick, first, can you describe what 
has happened with the incidence of NAS in the past decade? In 
your opinion, is this phenomenon tied to the issue of the 
overprescribing of opioid painkillers for pain?
    Dr. Patrick. Well, over the last decade, we know that 
neonatal abstinence syndrome has grown fivefold, and by 2012, 
one infant was born every 25 minutes on average with the 
syndrome. When we look at specific studies, there have been 
several studies looking at what is happening in generally 
prescribing, as you described, it has increased, but it has 
also increased among women of childbearing age as well as 
pregnant women over time. In a recent study we conducted in 
Tennessee, we looked specifically at opioid prescribing in 
pregnancy, and we found that nearly a third of pregnant woman 
had an opioid pain reliever prescribed in pregnancy, and most 
of those, 96 percent, were short-acting opioids. So yes, I 
think there is compelling evidence that what we have seen in 
our neonatal intensive care units and in labor and delivery is 
a result of the broader prescription opioid epidemic and it is 
the downstream effect that we are seeing negatively impact both 
women and infants.
    Mr. Pallone. I think I was going to ask some questions 
about the Tennessee Medicaid program but I think you just 
answered them, so let me move on.
    I was surprised by the prevalence of opioid prescribing in 
pregnant woman. It is eye-opening, to say the least, and I 
think most of us associate NAS with illicit opioid use 
including heroin. While it is certainly important to ensure 
that pregnant women have access to treatment for pain, it is 
also important for patients and providers to understand that 
medical use of opioids during pregnancy presents a risk of NAS.
    So do you think there needs to be more research conducted 
to inform us on when it is indicated to prescribe opioid 
painkillers during pregnancy?
    Dr. Patrick. So from my perspective as a neonatologist, 
yes, I think guidelines would be helpful. I think the nuance 
here is that we have in one population perhaps overprescribing 
but we also have difficulty accessing medication-assisted 
treatment. So one thing that is important to know is that 
neonatal abstinence syndrome is not the worst complication of 
pregnancy; preterm birth is. And in some women with substance 
use disorder, accessing medication-assisted treatment is vital.
    So we have this group of patients who have difficulty 
accessing medication-assisted treatment and we have another 
group of patients who are likely being overprescribed opioid 
pain relievers and another group of patients who are now using 
heroin, and so we need more research to understand this diverse 
population and how we improve outcomes based upon all of them, 
and I think that is why the goal needs to be overall to improve 
health for moms and babies because they are tied so closely 
together.
    Mr. Pallone. Thanks. In your paper, you conclude, and I 
quote, ``Prescription opioid use in pregnancy is common and 
strongly associated with neonatal complications.'' Could you 
just elaborate on that statement? In other words, what are the 
neonatal complications associate with NAS and how are they 
linked to prescription opioid use during pregnancy?
    Dr. Patrick. Well, in that study, we looked at two 
different groups of people. We looked at--or three, actually--
where there were no opioids prescribed, where there were 
opioids prescribed but neonatal abstinence syndrome did not 
occur, and when neonatal abstinence syndrome occurred. For 
infants that were exposed to opioids and for infants with 
neonatal abstinence syndrome, they are more likely to be born 
preterm and low birthweight, more likely to have respiratory 
complications, have things like jaundice and feeding 
difficulty. That was much more common among those infants, and 
I think, again, that is why primary prevention aimed at both 
moms and babies is really where we should target.
    Mr. Pallone. All right. I want to thank you for your good 
work on this issue and for bringing much-needed public 
attention to the issue of NAS. I also want to thank 
Representatives Clark and Stivers for their work on Protecting 
Our Infants Act of 2015, which will hopefully focus our efforts 
to address NAS at the Federal level.
    You were pretty fast in answering those questions so we can 
get it within our 5 minutes. Thanks again.
    Dr. Patrick. I am a fast talker. Thank you.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from New Jersey, Mr. Lance, 5 minutes 
for questions.
    Mr. Lance. Thank you very much, Mr. Chairman, and good 
morning to the distinguished panel.
    To Dr. Patrick, opiate abuse is a growing problem across 
the country obviously including in New Jersey. As a result, 
about 5 years ago, the Children's Specialized Hospital in New 
Jersey developed a neonatal withdrawal and rehabilitation 
program. When a baby is admitted, the hospital evaluates the 
child's symptoms using a 21-point checklist to determine how 
much medicine needs to be administered as the baby is weaned 
from its opiate, and a course of therapies designed to address 
many of the symptoms associated with neonatal abstinence 
syndrome, NAS, which has been discussed here this morning.
    For example, the hospital uses a special stimulation device 
on the baby's throat to teach the infant how to swallow, and 
the hospital also teaches the mother massage and calming 
techniques. Can you discuss the role that these types of 
rehabilitative therapies play in a child's recovery and how 
will H.R. 1462 help to ensure that more children receive the 
comprehensive care that they receive at a wonderful hospital in 
New Jersey, the Children's Specialized Hospital?
    Dr. Patrick. Well, one of the things that we need to learn 
are more innovation such as the things that you have described 
where the literature may not be as robust, and so I think that 
is one thing that this bill provides. It outlines potential 
gaps. You know, I think that is one of the targets and one of 
the potential ways that this bill helps. What was the second 
part of your question?
    Mr. Lance. I think you have answered it. We want to make 
sure that the bill is effective in developing techniques that 
will save the child's life.
    Are there similar programs--I am sure that our program in 
New Jersey is not the only program that is trying to develop 
techniques in this area. Are there other programs across the 
Nation, and what are some of the methods used in other 
programs?
    Dr. Patrick. Well, one of the most important things that we 
have seen grown up over the last several years are States 
building perinatal collaboratives focused on improving care to 
moms and babies, and nationally, a group called the Vermont 
Oxford Network that we have been involved in that----
    Mr. Lance. The Vermont Oxford----
    Dr. Patrick. Network, yes, sir.
    Mr. Lance. That is Oxford in England or----
    Dr. Patrick. It initially started that way. But this 
program involves at the start 200 NICUs, mostly in the United 
States but in a couple other countries, focused on improving 
the care to infants with neonatal abstinence syndrome. One of 
the first things that we needed to do was just standardize the 
care that occurred because there's great variability from place 
to place, and hospitals like the hospital that you described 
where they have a standard approach, were focused on this one 
population and we know that we treat this population the same 
way every time, that alone is associated with improved 
outcomes. And so that is part of where we have been working 
over the last several years. There are a few hospitals that 
have popped up specifically focused--West Virginia is one 
specifically called Lily's Place just to treat infants with 
neonatal abstinence syndrome, and those innovations, to be able 
to allow rooming in where moms and babies stay together--
because the NICU environment can be a chaotic environment where 
we have ventilators and all kinds of machinery--places where 
there can be a dark, quiet environment where healing can occur 
as you have described.
    Mr. Lance. Thank you. Is there anyone else on the panel who 
would like to comment?
    Very good. Mr. Chairman, I yield back 1 \1/2\ minutes.
    Mr. Pitts. Excellent. Thank you, Mr. Lance.
    The Chair now recognizes Mr. Butterfield, 5 minutes for 
questions.
    Mr. Butterfield. Thank you very much, Mr. Chairman, and I 
thank all of the panelists for their willingness to testify 
today.
    I will start off by apologizing for being late for the 
hearing. I have been trying to watch some of it on television 
while I have been trying to read the Supreme Court decision in 
the Burwell case a few moments ago, the 6-3 decision that for 
the second time affirms the Affordable Care Act, which was the 
historic law that we debated in this committee some years ago, 
and I was part of that debate, and our committee passed it, it 
passed the Congress, and now it is the law of the land and it 
is working, and I just wanted to make that statement for the 
record. I realize that is not the subject of today's hearing 
but I could not go back to my office without saying it. I am 
not gloating, Mr. Chairman. I am not gloating. I am not. I am 
not. I am not gloating. I just wanted to reach across the aisle 
and say to my colleagues that the law is working and let us 
make it work and let us get healthcare to all Americans because 
they deserve it.
    I welcome the witnesses and I am happy to recognize Dr. 
Joanne Kurtzberg, who is testifying today in her capacity as 
President of the Cord Blood Association. She is a Professor of 
Pediatrics and Pathology at Duke University School of Medicine. 
Duke is one of the world's premier healthcare providers. That 
is undisputed. It educates and employs the world's top doctors 
and nurses and researchers, and I am proud to represent Duke 
Med here in the Congress.
    Mr. Chairman, I support these three bills that we are 
discussing today. I encourage their expeditious consideration. 
As chairman of the Congressional Black Caucus, I know that many 
of the conditions which can be treated using cells from cord 
blood like sickle cell anemia disproportionately impact African 
Americans, and also as a member of Gallaudet University Board 
of Trustees, I care deeply about preventing hearing loss and 
supporting the deaf and hard-of-hearing community.
    Equally concerning is the marked increase in prescription 
opiate abuse among pregnant women and its impact on infants.
    Mr. Chairman, H.R. 1462 addresses this important issue and 
will identify ways to reduce neonatal abstinence syndrome, and 
so I appreciate the opportunity to discuss these very important 
topics.
    Now, Dr. Kurtzberg, it is no surprise that I am going to go 
to you first with the time that I have. What are some of the 
diseases which impact African Americans disproportionately and 
are treatable by using cells from cord blood?
    Dr. Kurtzberg. So the first disease we all think of is 
sickle cell anemia, which can be cured with hematopoietic stem 
cell transplant, and children and adults with sickle cell often 
have a hard time finding a match donor in their family or in 
the registry. Cord blood has the advantage of not having to be 
completely matched and therefore it has become one of the 
optimal donor sources for patients with sickle cell disease.
    Mr. Butterfield. Can you elaborate on the need for racially 
diverse units in the NCBI?
    Dr. Kurtzberg. Yes. So, you know, it is kind of a debate 
because we need big units, and biologically, patients with 
sickle cell--I am sorry--patients who are African American have 
sticky cells and their cells stick to the walls of their blood 
vessels. So when you do a blood test or a cord blood 
collection, you actually get a fewer number of cells per volume 
of blood than you would from a Caucasian, and so it makes it 
more challenging to collect high-quality units from African 
American patients because you have to collect more to get big 
enough ones.
    Having said that, the match, which is somewhat related to 
ancestry, will be better often if a patient receives a unit 
from someone of their own race. So really, the program is 
challenged to collect probably twice as many units from African 
American patients and donors in order to have a high-quality 
inventory for those patients.
    All in all, we need more African American donations and 
collections, and they will provide better matches to African 
American patients, but they have to also be targeted to be big 
enough to serve those patients well.
    Mr. Butterfield. I am also interested in the potential for 
new applications using cord blood and some of the cutting-edge 
breakthroughs that are being made in your field. Can you 
describe how your discovery of using unrelated cord blood for 
transplant benefits patients and how it could lead to future 
breakthroughs?
    Dr. Kurtzberg. So we have specifically studied at Duke the 
use of unrelated cord blood in children with certain genetic 
diseases that affect the brain. These are leukodystrophies like 
adrenal leukodystrophy, Krabbe disease, and diseases like 
Hurler syndrome and many others, and from that work, we have 
also learned that cord blood cells go to the brain and 
facilitate repair of various abnormalities in the brain like 
demyelination or abnormal connections, and we are now using 
that observation to treat children with birth asphyxia, 
cerebral palsy, autism, and then adults with stroke, and I 
think we are just at the beginning of seeing the opportunity 
for cord blood to also treat patients with adult demyelinating 
diseases like M.S. or others.
    Mr. Butterfield. Thank you very much. I yield back.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentlelady from North Carolina, Mrs. Ellmers, 5 
minutes for questions.
    Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our 
panel for being here today discussing this very important 
issue.
    Dr. Martin, I am going to start with you. Can you talk 
about the early hearing detection and intervention program that 
has led to unprecedented collaboration between the public and 
private agencies across all levels of Government and what has 
made this model so successful?
    Dr. Martin. I think that the previous legislation--and this 
is carried on in the reauthorization--really outlines the role 
of HRSA, the role of CDC, the role of NIH, and we have just had 
great success in working together to improve outcomes for 
children. We have also partnered at the State level across 
departments of health, departments of education. We have 
accessed resources in the private sector as well, and this 
seems to be an issue that people have been able to come 
together around and really show how that has been done, so that 
has been an excellent outcome for us.
    Mrs. Ellmers. That is great. That is a great model for us 
to use into the future.
    And Dr. Terplan, I know this question was posed to Dr. 
Patrick a little earlier in the subcommittee hearing, but I 
would like to get your take on the type of innovative treatment 
models that are needed to close the gaps in research and 
programming for pregnant women who are addicted to opioids.
    Dr. Terplan. So I think we know a lot of the pieces that 
work: medication-assisted treatment for opioid-dependent women, 
which is methadone or buprenorphine. We need to think about 
there is a third medication that exists. Vivitrol is the brand 
name, and that has not really been studied in the United States 
in pregnant women, and having options is key. I think we get a 
little hung up one versus the other as if having a choice is an 
impediment rather than actually something that is great and 
liberating clinically and allows us to actually be able to 
individualize therapies.
    I think we also have to work on, it is not just the 
medication, it is also the other associated services. Pregnant 
women with substance use disorders are a unique population in 
addiction medicine and come with a whole host of needs--
psychosocial needs, transportation needs, childcare needs and 
things like that--and we have to find ways to integrate those 
into treatment and find ways to reimburse for some of those 
things, which aren't traditional medical services.
    Mrs. Ellmers. Thank you, Dr. Terplan.
    And Dr. Kurtzberg, again, thank you for being here 
representing Duke Medicine and the Core Blood Bank. Now, with 
the Cord Blood Bank at Duke and the Carolina Cord Blood Bank 
and the licensing that the FDA put forward in 2012, can you 
tell us what the impact of that licensure has made on the Cord 
Blood Bank?
    Dr. Kurtzberg. Yes. The licensure process has been 
challenging, in large part because this is the first 
hematopoietic stem cell source that has been licensed, and it 
has been a learning process on both sides of the fence. But the 
bottom line is that licensure has increased costs of running a 
bank, and because of that, banks are using more of their 
limited resources to comply with some of these regulations as 
opposed to put more cord blood units in the bank and collect 
more units from donors. So we are hoping there could be some 
conversation with the FDA to help optimize the guidelines to 
apply to cells since most of these guidelines are really 
written for drugs, and to both keep the high quality of cord 
blood units but enable more resources to go into collection and 
storage.
    Mrs. Ellmers. Again, I just truly appreciate you being here 
testifying with our subcommittee here today on H.R. 2820. Can 
you just talk a little bit about the difference between the 
cord blood stem cells and the embryonic stem cells, and what 
that means to the future of research and the role that you are 
playing?
    Dr. Kurtzberg. Well, cord blood cells are not embryonic 
cells. That is the first important thing to say. And cord blood 
cells can be collected without any risk to the mother or the 
baby, and in fact, they used to be discarded as medical waste. 
So we are literally recycling something that used to be thrown 
in the trash to save lives, so there is no real common or 
similarity between the two cells. Cord blood cells cannot give 
rise to every cell in the body. Cord blood cells are blood stem 
cells and progenitors, and they help reconstitute bone marrow 
after a transplant.
    Mrs. Ellmers. Well, thank you very much, and I yield back 
the remainder of my time.
    Mr. Pitts. The Chair thanks the gentlelady and now 
recognizes the gentlelady from California, Mrs. Capps, 5 
minutes for questions.
    Mrs. Capps. Thank you, Mr. Chairman, and thank you to each 
of our witnesses for your testimony. I appreciate this 
opportunity that we have to come together to talk about these 
important public health bills. I want to especially focus, as I 
did earlier in my remarks, on a program near and dear to my 
heart, the Early Detection Hearing and Intervention Act, to 
reauthorize this important program. It is one as a school nurse 
I have worked on for over 15 years.
    Each year, more than 12,000 infants are born with a hearing 
loss, and since the first authorization of this bill in 2000, 
we have seen a tremendous increase in the number of newborns 
who are now being screened for hearing loss. Back in 2000, only 
44 percent of newborns were being screened for hearing loss and 
now it is over 89 percent before they leave the hospital. That 
is pretty astounding.
    We have also seen an increase in the surveillance and 
tracking of hearing screens and examination. The 
reauthorization bill I have introduced with Representative 
Guthrie would not only ensure this program is there for the 
children who need it in the future but it would also strengthen 
the program based on lessons we have learned over this time.
    Once such area where reauthorization would improve the 
program is the way in which it clarifies CDC's role in 
conducting surveillance on early hearing detection and 
interventions. I want to focus three questions on our 
audiologist on the panel, Dr. Martin. You are the Audiologist 
at Arkansas Children's Hospital, and I am going to ask you 
three questions, and if you could be fairly brief so we can 
hopefully get these in.
    What is an example of the surveillance conducted by CDC in 
which we have now seen gaps in addressing hearing loss? What 
has come out that reveals areas that we need to work on?
    Dr. Martin. So one of the things that the CDC is helps us 
set benchmarks of what we want to try to track among States and 
then compare those, and so one of the most important numbers 
that we have seen come out of that work has been the loss to 
follow-up rates, and we have made really tremendous strides in 
the last few years because there has been funding available to 
help States look at loss to follow-up. We have reduced that 
number by 50 percent. There are still babies who are lost to 
follow-up and we are continuing to work on that.
    Some of those lost-to-follow-up babies are not actually 
lost to follow-up. The EHDI program coordinators know those 
babies. They know where they are and their families have opted 
not to follow up for some reason, either financial or access.
    Mrs. Capps. Let me push that a little further just to 
entice you to talk a bit more about it. While we are screening 
babies at a higher rate and we are doing better at follow-up, 
there still is a challenge, as you say, so follow-up care for 
newborns diagnosed with a hearing loss, this is such a critical 
time to get that intervention. How does this bill increase the 
likelihood that they are going to receive the appropriate 
follow-up care?
    Dr. Martin. One of the things that it does is, it expands 
the way that we can share information among States and among 
providers, and it guarantees that we--ensures that we really 
make access for families easier to find. We have had some 
programs put in place that have been collaborative between 
American Speech and Hearing Association, the American Academy 
of Pediatrics that helps primary care physicians and parents 
find audiologists so that they can get good follow-up and be 
connected to services more quickly.
    Mrs. Capps. And maybe you said this sufficiently, but if 
you could, there is a minute and a half left to elaborate on 
the importance of these programs, focusing now on the parents, 
because many of the parents are hearing parents and so this is 
all totally new territory to them.
    Dr. Martin. Absolutely brand-new territory to them. Ninety-
five percent of children who are born with hearing loss are 
born to hearing parents, and so they have really little or no 
contact prior to that time with anyone who has been deaf or 
hard of hearing, and so the great thing about the 
reauthorization is, it really recognizes the role of the 
family. So we figure that the family is the expert about their 
child. It puts the family in the driver's seat to make 
decisions. It sets up programs and systems where we provide 
information to these families so that they can make informed 
choice, and it helps engage them in the process. So it helps 
them be their child's first teacher, the expert on their child, 
and really help them partner with the different agencies in 
ensuring that their desired outcome for their child is the one 
that they get.
    Mrs. Capps. Well, if that isn't reason enough for us all to 
support this legislation and the reauthorization. I appreciate 
your answering these questions.
    I do, Mr. Chairman, wish to submit for the record a letter 
from the American Academy of Pediatrics supporting the 
reauthorization of the Early Hearing Detection and Intervention 
Act. I will submit that for the record.
    And I will yield back my time.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. The Chair now recognizes the gentlelady from 
Indiana, Mrs. Brooks, 5 minutes for questions.
    Mrs. Brooks. Thank you, Mr. Chairman, and thank you for 
calling this important hearing on public health issues.
    The Indianapolis Star--and I represent Indianapolis and to 
the north--a columnist by the name of Matt Tully has been doing 
quite a bit of series on the opioid and heroin addiction 
plaguing our country, and a recent article cited some startling 
statistics the epidemic is having on hospitals in Indiana, so I 
am very, very pleased that you are here.
    At Eskenazi Health, a hospital in downtown Indianapolis, 
officials say the hospital is on track to see a 22 percent 
increase this year in the number of newborns experiencing 
narcotic withdrawal. A doctor at St. Vincent's, a north side 
Indianapolis hospital, said between 20 and 30 percent of the 
babies admitted to the NICU suffer from drug dependency--20 to 
30 percent. And obviously, and as Matt Tully has written, wrote 
of a 5-day-old at Franciscan St. Health on the south side of 
Indianapolis--so this knows no geographic boundaries in our 
community or in our districts--who was receiving morphine 
treatments because his body was shaking so bad and he was 
wracked with diarrhea so bad that it was affecting his skin and 
it was just horrible watching the withdrawal, which actually 
this columnist was seeing, but I think what I learned today, 
Dr. Terplan, you indicated the babies can stay in the hospital 
for an average of 3 weeks when they are going through this type 
of withdrawal, and I must say that Representative Kennedy and I 
just recently introduced a companion bill to the Senate to 
Senators Donnelly and Ayotte of the Heroin and Prescription 
Opioid Abuse Prevention, Education and Enforcement Act, and it 
is a multipronged approach, and it focuses on a number of 
things including interagency task forces to try to get better 
prescribing practices specifically, focusing on prescription 
drug monitoring programs, but I have to tell you one thing. I 
am a former U.S. Attorney. I have been involved in the criminal 
justice system most of my career, and I appreciate that 
punitive approaches aren't appropriate, as you say. However, 
many of these women are in the criminal justice system or find 
themselves in the criminal justice system, and I am curious 
what you think our approaches should be with those who are in 
the criminal justice system. They are in there, in all 
likelihood, for other crimes they are committing during this 
time or maybe for being arrested for dealing or for possession, 
and so what approach do you think should work specifically for 
our children in our jails and our prisons with respect--because 
there are a lot of them, and so this is the hospitals, but I 
think if we talk to our sheriffs around the country, they are 
experiencing these issues too. What is the best approach that 
we should have for the so many pregnant women in our jails and 
prisons?
    Dr. Terplan. That is a great question, and our jails and 
prisons are the largest behavioral healthcare systems in the 
United States, unfortunately, and there are--I mean, I have 
spoken of barriers to access to medication-assisted treatment 
amongst pregnant women in general. Those barriers are far 
higher in prisons. So some of it has to do with how prisons are 
financed and the cost of medications, even though cheap, 
methadone across a huge population of prisoners who need it is 
a costly thing. So I think what we really need is access to 
prisoners and people in detention need access to behavioral 
healthcare in general and for opioid use disorders to 
medication-assisted treatment in particular.
    In addition, we need better linkages from release into the 
community. So right now in the State of Maryland, only 
individuals who are arrested and are on methadone receive 
methadone in the jail. People who have an opioid use disorder 
come to jail and they withdraw. We know withdrawal for pregnant 
women is dangerous to the fetus, and we need to find ways to 
provide medication and other counseling services and then 
linkage upon release into the community.
    Mrs. Brooks. Dr. Patrick, do you have any thoughts on our 
jail and prison issues with pregnant women?
    Dr. Patrick. I would just echo the access to medication-
assisted treatment when it is needed for pregnant women. It is 
really the standard of care and improves infant outcomes as 
well.
    Mrs. Brooks. Have you done any work with our drug treatment 
courts? Because a lot of times those judges who are presiding 
in the drug treatment courts see the same women. They may or 
may not be in jail or prisons, people who are in the drug 
treatment courts, and I know that we have struggled with 
learning whether or not--some believe in abstinence as the best 
method, but certainly have you done any work in following drug 
treatment courts or advising drug treatment courts?
    Dr. Terplan. A little bit in Baltimore City, and mostly 
around educating, not just the staff but especially the judges 
and also the judges who aren't drug court but might be subbing 
for somebody else around the importance of the evidence base 
for treatment for substance use disorders.
    Mrs. Brooks. Thank you. I yield back.
    Mr. Pitts. The Chair thanks the gentlelady. We are about to 
see another vote series, so we will try to move this along.
    The Chair recognizes Ms. Matsui of California, 5 minutes 
for questions.
    Ms. Matsui. Thank you, Mr. Chairman, and thank you to the 
witnesses for being here today and a special thank you to Dr. 
Chell and Dr. Kurtzberg for testifying today about the 
importance of the National Marrow Donor Program and cord blood 
banking.
    Every 4 minutes, someone is diagnosed with blood cancer or 
another blood disorder. Often, the only cure for these fatal 
diseases is a bone marrow or a cord blood transplant. Congress 
has recognized the national need for bone marrow transplant 
since 1987, and 10 years ago formally added the National Cord 
Blood Inventory to the C.W. Bill Young Cell Transplantation 
Program.
    A big part of the Stem Cell Therapeutic and Research Act is 
the national registry known as Be The Match, which matches as 
many patients as possible to bone marrow or cord blood 
donations that they need, and during the last 30 years, the 
registry has grown to include over 12 million adult volunteer 
donors and over 200,000 cord blood units donated by moms after 
the birth of their children.
    The growth of the registry over the last decade is 
promising but we know we must continue our efforts to encourage 
donors.
    Dr. Chell, as you mention in your testimony, some of the 
roles that the National Marrow Donor Program plays in addition 
to running the national registry. Can you elaborate a bit on 
all the work that Be The Match and NMDP does?
    Dr. Chell. So we are responsible for a network of centers 
all over the world that help recruit donors and recruit moms to 
donate their cord blood, to create that inventory, and yet that 
inventory, despite having 25 million donors worldwide and over 
600,000 cord blood units, is really only meeting less than half 
the need in the United States and only 5 percent of the need 
worldwide, and that is because the population of the United 
States as well as the world becomes more diverse, and so that 
diversity requires us to continue to add more donors to the 
registry.
    But we also advocate for patients from the time of 
diagnosis through survivorship through multiple languages so 
they can get the education and the information they need. 
Through the SCTOD portion of the contract, we create the 
infrastructure and the reporting mechanism so that we can 
collect data on every single transplant done in the United 
States and 60 percent of the transplants done worldwide so that 
researchers from all over the world can enter that database and 
help us define new ways of using these therapies and rapidly 
turn those discoveries into use throughout the world. We also 
work with a cord blood coordinating center to manage the 
relationships with the cord blood banks as well as multiple 
centers that recruit adult donors.
    Ms. Matsui. OK. Thank you.
    Dr. Kurtzberg, as you know, the goals in creating the NCBI 
were to create a network of high-quality, diverse cord blood 
units and to make cord blood units available for research. Can 
you elaborate on the work that you do to meet these goals?
    Dr. Kurtzberg. Sure. I have run a public cord blood bank 
named the Carolinas Cord Blood Bank at Duke and work every day 
to collect cord blood units from moms who donate their baby's 
cord blood after a healthy pregnancy and delivery. We also work 
to develop new models to increase the opportunity for cord 
blood donation from moms of minority backgrounds. We have 
opened a program recently at Grady Hospital to do that. We are 
looking at ways to decrease cost of cord blood donation and 
banking, which is always an issue in the field, and we are 
looking at ways to apply cord blood transplantation to new 
diagnoses.
    Ms. Matsui. OK. Thank you.
    Dr. Chell, you mentioned that the number of transplants for 
racial and ethnic minority patients has increased substantially 
from the year 2000 to today, and I just want to follow up on 
what my colleague, Mr. Butterfield, was talking about because 
he mentioned the African American population. I know that the 
Asian American population is feeling a great need, and you see 
the individual-type activities more forward trying to find a 
match. What efforts can Be The Match make to continue to 
increase the diversity of the registry to ensure that minority 
patients can find matches, understanding that this country 
itself is such a diverse country that we need to figure out a 
system. There is a lot going on, but what do you think you can 
do to help increase the diversity of this?
    Dr. Chell. I think it is important also to raise awareness. 
If we were to take a Caucasian patient as well as an Asian 
American patient, if they are in the right healthcare system 
and get access to a search, the likelihood to move on to 
transplant is equal. The challenge is, many Asian Americans 
don't have access to that first initial step of doing a search, 
being in a healthcare system to do that search. But with that, 
we need to across all ethnic groups significantly increase the 
diversity of the registries. For Asian Americans, we also 
benefit from having partnerships with China, Japan, Korea, Hong 
Kong, and other countries to allow us to increase the 
diversity. For African Americans, we don't have partners in 
African companies that help us with diversity.
    Ms. Matsui. Well, I know my time is up, so thank you very 
much.
    Mr. Pitts. The Chair thanks the gentlelady.
    We have less than 10 minutes left. We are going to try to 
conclude the hearing.
    The Chair recognizes Mr. Bilirakis, 5 minutes for 
questions.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate you 
very much holding this very important hearing on some really 
good bills.
    Dr. Martin, in the interests of time, I really have a lot 
of questions but we will start with the hearing loss screening. 
You stated that the number of individuals who have lacked 
follow-up care from their initial screening has been reduced by 
half over the past 10 years. H.R. 1344 states that one purpose 
for which States can use funds is to develop models that will 
ensure babies identified as needing follow-up care receive 
those services.
    My first question is, what are the challenges for a child 
who does not receive follow-up care with an early intervention 
provider and how is it harmful to the child?
    Dr. Martin. There is this critical period for children to 
acquire communication that really, birth to 3 is the most 
critical time period, and so we have seen rapid improvements in 
the outcomes for children when they enter the educational 
system and their long-term outcomes if they have been 
identified early within the first year of life as compared to 
children who are identified after that. So kids who are lost to 
follow-up fail their newborn screen and then show up at a 
pediatrician's office at 3 or 4 or fail a kindergarten 
screening, they are already significantly behind their 
typically hearing peers and are really going to have a 
difficult, if not impossible, time catching up with a language 
linguistics sort of base and from a psychosocial base as well.
    Mr. Bilirakis. Thank you.
    A question for Dr. Patrick and Dr. Terplan. Counties within 
my district were found to be suffering from some of the highest 
numbers of babies born with neonatal abstinence syndrome. What 
practices have been successful at addressing this issue in 
other regions? How would this legislation help those at-risk 
populations?
    Dr. Patrick. Well, as far as treating infants with neonatal 
abstinence syndrome, the practices that have been most 
effective have really been around standardizing care and 
working together through networks of hospitals and neonatal 
intensive care units. That has really been effective in making 
sure that we are treating these infants the same collectively. 
I mean, the bill brings together data and evidence. It also 
brings together a multidisciplinary group of people who think 
about how we attack every part of the problem including before 
pregnancy, in pregnancy and in the treatment period for the 
infant. So I think we will see a positive effect in communities 
like yours and mine as well.
    Mr. Bilirakis. Thank you, and Mr. Chairman, I will submit 
the questions for the record because I want everyone to have an 
opportunity. Thank you.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Ms. Castor, 5 minutes for questions.
    Ms. Castor. Thank you, and I thank Mr. Bilirakis as well, 
and I want to thank our witnesses for being here today to 
testify on these important public health bills. I want to thank 
Representatives Clark and Stivers for their work on H.R. 1462 
especially, Protecting Our Infants Act of 2015. I am a 
cosponsor of the bill, and I think it is clear that we need 
additional efforts and resources to address the challenges of 
neonatal abstinence syndrome, and the bill before us does that 
in many critical ways. Mr. Bilirakis and I share the counties, 
and I just want to get this on the record. In 2007, our 
counties had 67 reported cases; 2008, 108; and by just 2011, 
about 280 reported cases. So we have got to do more.
    These are the questions I would like you to answer for the 
record. According to the GAO report, there are a number of 
existing research gaps relating to best practices in the 
screening, diagnosis and treatment of NAS. You have discussed 
them, and if you would also discuss them in more detail in 
written testimony.
    Dr. Patrick, what do we know about the best practices and 
screening and diagnosis and treatment, and what are the most 
pressing research gaps? How does the Protecting Our Infants Act 
help to address the gaps? And then if you could also share in 
written response, are we underinvesting in research related to 
NAS, given the significant public health burden that it 
presents?
    Thank you all again for being here today, and I look 
forward to your written response.
    Dr. Patrick. Well, your first question was about best 
practices, and I think it begins with identifying the infants, 
so it begins with that transition from pregnancy to the infant 
being cared for. We have to know the infant has been exposed, 
and so screening, universal screening through both standardized 
verbal screenings as well as diagnostic screenings, using the 
same scoring system to identify and be consistent with that. 
Treatment--it is clear from the evidence that using an opioid 
like methadone or morphine is the most effective though we see 
some hospitals using other drugs like phenobarbital that may 
actually have some long-term harm. And----
    Ms. Castor. I am going to cut you short so Mr. Collins can 
do it, but I do want to express my gratitude to All Children's 
Hospital and St. Joseph's Children's Hospital and all of the 
medical professionals across the country who are tackling this 
issue, and I yield back the balance of my time.
    Mr. Pitts. The Chair thanks the gentlelady, and you can 
respond more fully in writing to that question. We will provide 
the questions to you in writing. Thank you.
    Dr. Patrick. Thank you.
    Mr. Pitts. Mr. Collins, you are recognized. We have 2 
minutes left on the floor.
    Mr. Collins. Well, I will be quick. Luckily they always 
hold votes over, and also if you could, I will direct this to 
Dr. Patrick perhaps answer in more detail.
    I am one of the cosponsors on H.R. 1462. Your testimony 
here has done a great job in showing the importance of 
reauthorizing these. What I would like you to perhaps respond 
in writing is, some of the differences between NAS and fetal 
alcohol syndrome. We know about those. If you could maybe 
compare and contrast what is going on in those two fields, I 
think that would be helpful to truly show the importance on the 
opioid abuse, which we have had several Oversight hearings on, 
and maybe simply--also, could you just confirm verbally now, is 
a child born with NAS impaired for life or are the treatments 
in fact moving them into what could be a normal life?
    Dr. Patrick. There is no evidence that the infants are 
impaired for life. There has been some subtle evidence of some 
behavioral issues. It is definitely an area that needs to be 
more well studied but I think it would be very unfair to say 
that the infant is affected significantly for life.
    Mr. Collins. Well, and that is what I would hope you were 
saying so the treatments in fact are life-changing, and that is 
what we are all about here.
    So Mr. Chairman, I yield back, and I guess we will go down 
and vote.
    Mr. Pitts. The Chair thanks the gentleman.
    We will provide questions in writing from those of us who 
were here and those who were in other hearings. We would ask 
that you please respond promptly.
    We thank you very much for your patience, for all the 
interruptions, really a very interesting, very important 
hearing.
    I have a unanimous consent request. I would like to submit 
for the record statements of Doris Matsui, Gene Green, and the 
American Academy of Pediatrics. Without objection, so ordered.
    Mr. Pitts. I remind Members they have 10 business days to 
submit questions for the record. I ask the witnesses to respond 
promptly. Members should submit their questions by the close of 
business Thursday, July 9th.
    Thank you very much for this very important testimony 
today. Without objection, this hearing is adjourned.
    [Whereupon, at 12:26 p.m., the subcommittee was adjourned.]
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