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97–714 PDF 2015

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 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

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 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California7 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

DORIS O. MATSUI, California 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

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 

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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. 

2 

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 

3 

• 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 

4 

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 coauthor 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 

5 

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. 

6 

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 openVerDate Mar 15 2010 11:00 Dec 08, 2015 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\114X61PUBLICHEALTHLEGPENDING WAYNE
7 

ing 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 

8 

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:] 

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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 AssoVerDate Mar 15 2010 11:00 Dec 08, 2015 Jkt 037690 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\114X61PUBLICHEALTHLEGPENDING WAYNE
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ciation 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:] 

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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 individVerDate Mar 15 2010 11:00 Dec 08, 2015 Jkt 037690 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\114X61PUBLICHEALTHLEGPENDING WAYNE
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uals 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:] 

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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 

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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:] 

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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. 

70 

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 Statespecific 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 longterm 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:] 

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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 

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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. 

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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 medicationassisted therapy for pregnant women. 

Dr. Terplan, is medication-assisted treatment the standard of 

care for pregnant women with opioid use disorders? 

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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 deVerDate Mar 15 2010 11:00 Dec 08, 2015 Jkt 037690 PO 00000 Frm 00087 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\114X61PUBLICHEALTHLEGPENDING WAYNE
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veloping, 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 

85 

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 danVerDate Mar 15 2010 11:00 Dec 08, 2015 Jkt 037690 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 C:\USERS\WLAUFERT\DESKTOP\114X61PUBLICHEALTHLEGPENDING WAYNE
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gerous 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? 

87 

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. 

88 

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 

89 

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. 

90 

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 

91 

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 

92 

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. 

93 

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. 

94 

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. 

95 

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 

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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 

97 

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, 

98 

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 

99 

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 

100 

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 longterm 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. 

101 

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. 

102 

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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