U.S. GOVERNMENT PUBLISHING OFFICE

32–978 PDF WASHINGTON : 2018

FEDERAL EFFORTS TO COMBAT THE OPIOID CRISIS: A STATUS UPDATE ON CARA AND OTHER 

INITIATIVES 

HEARING 

BEFORE THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

OCTOBER 25, 2017 

Serial No. 115–68 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

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 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

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 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

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 

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 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

(III) 

C O N T E N T S 

Page 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 2 

Prepared statement .......................................................................................... 3 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 4 

Prepared statement .......................................................................................... 6 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, prepared statement .................................................................................. 120 

Hon. Steve Scalise, a Representative in Congress from the State of Louisiana, 

prepared statement .............................................................................................. 120 

WITNESSES

Scott Gottlieb, M.D., Commissioner, Food and Drug Administration, Department of Health and Human Services ................................................................. 8 

Answers to submitted questions ...................................................................... 172 

Elinore McCance-Katz, M.D., Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration, 

Department of Health and Human Services ...................................................... 10 

Answers to submitted questions ...................................................................... 191 

Anne Schuchat, M.D., Principal Deputy Director, Centers for Disease Control 

and Prevention, Department of Health and Human Services .......................... 12 

Answers to submitted questions ...................................................................... 228 

Nora Volkow, M.D., Director, National Institute on Drug Abuse, National 

Institutes of Health, Department of Health and Human Services .................. 14 

Prepared joint statement 1 ............................................................................... 16 

Answers to submitted questions ...................................................................... 256 

Neil D. Doherty, Deputy Assistant Administrator, Office of Diversion Control 

Operations, Diversion Control Division, Drug Enforcement Administration, 

Department of Justice ......................................................................................... 31 

Prepared statement .......................................................................................... 33 

Answers to submitted questions ...................................................................... 272 

SUBMITTED MATERIAL

Statement of the American Physical Therapy Association, October 25, 2017, 

submitted by Mr. Shimkus .................................................................................. 122 

Letter of October 24, 2017, from Mrs. Blackburn to Eric Hargan, Acting 

Secretary, Department of Health and Human Services, and Robert Patterson, Acting Administrator, Drug Enforcement Administration, submitted 

by Mrs. Blackburn ................................................................................................ 126 

Statement of the American Hospital Association, October 25, 2017, submitted 

by Mr. Tonko ........................................................................................................ 127 

Statement of the Protecting Access to Pain Relief Coalition, October 25, 

2017, submitted by Mr. Tonko ............................................................................ 131 

Letter of October 25, 2017, from Kelly Clark, President, American Society 

of Addiction Medicine, to Mr. Walden and Mr. Pallone, submitted by Mr. 

Tonko ..................................................................................................................... 135 

Statement of Ronald M. Hendrickson, Executive Director, International 

Chiropractors Association, October 25, 2017, submitted by Mr. Carter .......... 138 

Statement of Mike Durant, President, Peace Officers Research Association 

of California, submitted by Mrs. Walters ........................................................... 142 

1Dr. Gottlieb, Dr. McCance-Katz, Dr. Schuchat, and Dr. Volkow submitted a joint written 

statement. 

Page

IV 

Statement of the American Medical Association, October 25, 2017, submitted 

by Mr. Burgess ..................................................................................................... 148 

Letter of October 18, 2017, from Robert Twillman, Executive Director, Academy of Integrative Pain Management, to Hon. Orrin G. Hatch, a United 

States Senator from Utah, submitted by Mr. Burgess ..................................... 153 

Statement of the American Dental Association, October 25, 2017, submitted 

by Mr. Burgess ..................................................................................................... 155 

Statement of the American Pharmacists Association, et al., October 25, 2017, 

submitted by Mr. Burgess ................................................................................... 159 

Statement of J. Paul Molloy, Chief Executive Officer, Oxford House, Inc., 

October 25, 2017, submitted by Mr. Burgess ..................................................... 161 

Statement of America’s Health Insurance Plans, October 25, 2017, submitted 

by Mr. Burgess ..................................................................................................... 164 

(1) 

FEDERAL EFFORTS TO COMBAT THE OPIOID 

CRISIS: A STATUS UPDATE ON CARA AND 

OTHER INITIATIVES 

WEDNESDAY, OCTOBER 25, 2017 

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The committee met, pursuant to call, at 10:00 a.m., in Room 

2123, Rayburn House Office Building, Hon. Greg Walden (chairman of the committee) presiding. 

Members present: Representatives Walden, Barton, Upton, Shimkus, Burgess, Blackburn, Latta, McMorris Rodgers, Harper, Lance, 

Guthrie, Olson, McKinley, Kinzinger, Griffith, Bilirakis, Johnson, 

Bucshon, Flores, Brooks, Mullin, Hudson, Collins, Cramer, 

Walberg, Walters, Costello, Carter, Duncan, Pallone, Eshoo, Engel, 

Green, DeGette, Doyle, Schakowsky, Butterfield, Matsui, Castor, 

Sarbanes, McNerney, Welch, Luja ́n, Tonko, Loebsack, Schrader, 

Kennedy, Ca ́ rdenas, Ruiz, Peters, and Dingell. 

Staff present: Jennifer Barblan, Chief Counsel, Oversight and Investigations; Ray Baum, Staff Director; Mike Bloomquist, Deputy 

Staff Director; Adam Buckalew, Professional Staff Member, Health; 

Karen Christian, General Counsel; Kelly Collins, Staff Assistant; 

Zack Dareshori, Staff Assistant; Jordan Davis, Director of Policy 

and External Affairs; Paul Edattel, Chief Counsel, Health; Adam 

Fromm, Director of Outreach and Coalitions; Caleb Graff, Professional Staff Member, Health; Jay Gulshen, Legislative Clerk, 

Health; Brittany Havens, Professional Staff Member, Oversight 

and Investigations; Zach Hunter, Communications Director; Peter 

Kielty, Deputy General Counsel; Alex Miller, Video Production 

Aide and Press Assistant; Christopher Santini, Counsel, Oversight 

and Investigations; Kristen Shatynski, Professional Staff Member, 

Health; Jennifer Sherman, Press Secretary; Alan Slobodin, Chief 

Investigative Counsel, Oversight and Investigations; Danielle 

Steele, Counsel; Christina Calce, Minority Counsel; Jeff Carroll, 

Minority Staff Director; Waverly Gordon, Minority Counsel, Health; 

Tiffany Guarascio, Minority Deputy Staff Director and Chief 

Health Advisor; Chris Knauer, Minority Oversight Staff Director; 

Jourdan Lewis, Minority Staff Assistant; Miles Lichtman, Minority 

Policy Analyst; Jessica Martinez, Minority Outreach and Member 

Services Coordinator; Kevin McAloon, Minority Professional Staff 

Member; Tim Robinson, Minority Chief Counsel; Samantha 

Satchell, Minority Policy Analyst; Andrew Souvall, Minority DirecVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
2 

tor of Communications, Member Services, and Outreach; and 

Kimberlee Trzeciak, Minority Senior Health Policy Advisor. 

Mr. WALDEN. If our members and guests would take their seats, 

it is 10 o’clock. We want to get started on time. I want to thank 

our witnesses for being here. Before I start, I especially want to 

thank the head of the FDA, Dr. Gottlieb. I think we are going to 

have to give you an office, you have been here so much this week, 

the third or fourth time, and we really appreciate your cooperation 

with our committee and your assistance in this and many other 

matters. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

OK, I will call to order the Energy and Commerce Committee. 

This is, I think, our first full committee on a matter and I think 

it points to the concerns we have about this issue as a committee 

and as a country. 

Each day, more than a thousand people are treated in emergency 

rooms for misusing prescription opioids. Each day, 91 Americans 

die from an opioid overdose. In last year alone, opioid overdoses 

have claimed the lives of more Americans than the entire Vietnam 

War. In my home State of Oregon, more people died last year from 

drug overdoses than from car accidents. 

We hear these statistics over and over again at roundtables 

throughout my district, most recently in Grants Pass in Southern 

Oregon and Bend in Central Oregon. I have heard the stories of 

Oregonians, put names and faces to these data points. Addiction 

and overdoses are happening at alarming rates in every community 

in our Nation. Just scan the headlines on any given day and you 

will hear about a life destroyed by addiction or about a raid that 

seized obscene quantities of prescription painkillers or illicit drugs. 

The United States is in the midst of a crisis that has become a 

national emergency. The number of individuals dying from opioid 

overdoses has reached epidemic proportions and even more individuals with substance use disorders have become estranged from 

their families, they are unable to work, or living as shells of their 

former selves because of their addiction. It is truly heartbreaking. 

To respond to this growing epidemic, the Energy and Commerce 

Committee has held countless conversations and numerous hearings with experts and stakeholders, law enforcement, individuals in 

recovery, and family members of opioid abuse victims in order to 

improve the prevention and treatment of this terrible addiction. 

From the earliest hearings before our Oversight and Investigation Subcommittee to legislative solutions tested in our Health 

Subcommittee, our multiyear, multi-Congress findings have led to 

bills that are now law, namely the Comprehensive Addiction and 

Recovery Act known as CARA, and the 21st Century Cures Act. 

This year, this committee has initiated multiple bipartisan investigations into allegations of pill dumping in West Virginia and patient brokering schemes elsewhere in the country. We have held 

hearings on the growing threat of fentanyl, innovative ideas in the 

States, we have heard directly from more than 50 members of Congress both on and off this committee just 2 weeks ago, but more 

3 

work needs to be done and we must redouble our efforts to combat 

the growing crisis. 

The primary purpose of this hearing is to hear from the Federal 

agencies charged with implementing the provisions of CARA and 

the 21st Century Cures Act and we appreciate you all being here, 

but it also allows this committee to have an important conversation 

with the DEA, first, to discuss recent news reports that suggested 

a bipartisan bill that passed through this committee and signed 

into law by President Obama has negatively impacted the DEA’s 

ability to combat the opioid crisis. Second, we are looking for some 

long overdue answers to basic questions and requests for data that 

this committee has made to the DEA related to our ongoing investigation into alleged pill dumping in the State of West Virginia. 

I am going to be very blunt. My patience is wearing thin. Our 

requests for data from DEA are met with delay, excuses and, 

frankly, inadequate response. People are dying, lives and families 

are ruined. It is time for DEA to get to this committee the information we need and to do it quickly. No more dodges, no more delays. 

We look forward to finally hearing directly from DEA on these matters. In addition to the DEA, we will be hearing testimony from officials at the Food and Drug Administration, the Substance Abuse 

and Mental Health Services Administration, the Centers for Disease Control and Prevention, and the National Institute on Drug 

Abuse at the National Institutes of Health. 

It is our hope that today’s testimony will allow us all to learn 

more about the Government’s shared efforts to address this crisis, 

allowing us the opportunity to drill deeper to learn about what is 

working and what is not working. It is our job to always do that 

oversight and fix problems. We will also have an opportunity to discuss how we can better prevent lawful prescription use from spiraling into abuse and, more importantly, we will discuss what more 

we can do to reduce overdoses and save lives. 

To the witnesses before us today, consider this another call to action. We need your help as we pursue both our investigative and 

our legislative work. It is imperative we confront this problem from 

every side and it is crucial that everyone remembers we are on the 

same team. This crisis requires an all-hands-on-deck response. 

We all want to end this scourge but we must be willing to work 

together. From the most basic requests for data to crafting and implementing laws, the lines of communication must be open. If there 

are changes we need to make in the law, please tell us. We have 

a duty to our constituents and the American people to combat the 

epidemic from all angles. Everyone has a stake in this fight. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Each day, more than 1,000 people are treated in emergency departments for misusing prescription opioids. 

Each day, 91 Americans die from an opioid overdose. 

In last year alone, opioid overdoses have claimed the lives of more Americans 

than the entire Vietnam War. 

In my home State of Oregon, more people died last year from drug overdoses than 

from car accidents. We hear these statistics over and over again. At roundtables 

throughout my district—most recently in Grants Pass, in southern Oregon, and 

4 

Bend, in central Oregon—I’ve heard the stories of Oregonians who put names and 

faces to these data points. 

Addiction and overdoses are happening at alarming rates in every single community. Scan the headlines on any given day and you’ll hear about a life destroyed by 

addiction or about a raid that seized obscene quantities of prescription painkillers 

or illicit drugs. 

The United States is in the midst of a crisis that has become a national emergency. The number of individuals dying from opioid overdoses has reached epidemic 

proportions. And even more individuals with substance use disorders have become 

estranged from their families, unable to work, or living as shells of their former 

selves because of their addiction. It’s heartbreaking. 

To respond to this growing epidemic, the Energy and Commerce Committee has 

held countless conversations and numerous hearings with experts, stakeholders, law 

enforcement, individuals in recovery, and family members of opioid abuse victims 

in order to improve the prevention and treatment of addiction. 

From the earliest hearings before our Oversight and Investigations Subcommittee 

to legislative solutions tested in our Health Subcommittee, our multiyear, multiCongress findings have led to bills that are now law—namely the Comprehensive 

Addiction and Recovery Act (CARA) and the 21st Century Cures Act. 

This year, this committee has initiated multiple, bipartisan investigations into allegations of pill dumping in West Virginia and patient brokering schemes. We have 

held hearings on the growing threat of fentanyl, innovative ideas in the States, and 

heard directly from more than 50 members—both on and off this committee—just 

two weeks ago. But more work needs to be done and we must redouble our efforts 

to combat the growing crisis. 

The primary purpose of this hearing is to hear from the Federal agencies charged 

with implementing the provisions of CARA and the 21st Century Cures Act. 

But it also allows this committee to have an important conversation with the 

DEA. 

First, to discuss recent news reports that suggested a bipartisan bill passed 

through this committee and signed into law by President Obama has negatively impacted DEA’s ability to combat the opioid crisis. 

Second, we are also looking for some long overdue answers to basic questions and 

requests for data that this committee has made to the DEA related to our ongoing 

investigation into alleged pill dumping in the State of West Virginia. 

I’m going to be very blunt: My patience is wearing thin. Our requests for data 

from the DEA are met with delay, excuses and, frankly, inadequate response. People 

are dying. Lives and families are ruined. 

It is time for DEA to get this committee the information we need, and to do it 

quickly. No more dodges. No more delays. We look forward to finally hearing directly from DEA on these matters. 

In addition to the DEA, we will be hearing testimony from officials at the Food 

and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Centers for Disease Control and Prevention, and the National Institute on Drug Abuse at the National Institutes of Health. 

It is our hope that today’s testimony will allow us all to learn more about the Federal Government’s shared efforts to address this crisis, allowing us the opportunity 

to drill deeper to learn about what’s working and what’s not working. We’ll also 

have an opportunity to discuss how we can better prevent lawful prescription use 

from spiraling into abuse; and most importantly, we will discuss what more we can 

do to reduce overdoses and save lives. 

To the witnesses before us today—consider this another call to action. We need 

your help as we pursue both our investigative work and our legislative work. It is 

imperative we confront this problem from every side. And it is crucial that everyone 

remembers we are on the same team. 

This crisis requires an ‘‘all hands on deck’’ effort. 

We all want to end this scourge. But we must be willing to work together. From 

the most basic requests for data to crafting and implementing laws, the lines of 

communication need to be open. If there are changes we need to make in the law, 

tell us. We have a duty to our constituents and the American people to combat the 

epidemic from all angles—everyone has a stake in this fight. 

Mr. WALDEN. And with that, I yield back the balance of my time 

and I recognize my friend from New Jersey, the ranking member 

of the committee, Mr. Pallone, for an opening statement. 

5 

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

Mr. PALLONE. Thank you, Mr. Chairman, for calling today’s hearing. It provides the opportunity to hear from several agencies within the Department of Health and Human Services as well as the 

Drug Enforcement Administration about the opioid abuse epidemic 

and the status of Federal efforts to combat the crisis, including the 

implementation of CARA and 21st Century Cures. 

While I am pleased to hear from the witnesses before us today, 

I am disappointed that you did not invite the Centers for Medicare 

and Medicaid Services or CMS. Most people access substance abuse 

treatment through their health insurance coverage and it is a fundamental link and one without the other leaves the millions of people of all ages that struggle with this addiction out in the cold. 

Between Medicare, Medicaid, CHIP, and the ACA marketplace, 

it is well over a third of the population receives health insurance 

through the programs that CMS oversees. Medicaid alone is the 

single largest payor for behavioral health services in the U.S. Put 

simply, a full and appropriate review of this issue requires the 

presence of CMS. 

Unfortunately, we all are too familiar with the tragic consequences of the opioid crisis. Ninety one Americans lose their lives 

to opioid overdose every day and millions more are battling this 

chronic and potentially deadly health condition. No community is 

immune. I know that like me each member here today has heard 

far too many tragic stories about lives cut short, families torn 

apart, and people left with few places to turn as they struggle to 

find treatment. 

In New Jersey, more than 1,900 people died from opioids last 

year. The crisis has taken such a toll in my community that we are 

hearing cries for help from some unlikely places. Earlier this year, 

Peter Kulbacki, the owner of the Brunswick Memorial Funeral 

Home in East Brunswick, New Jersey, published a blog on the funeral home’s Web site expressing his frustration with the monthly 

calls he receives telling him that someone has passed away from 

an opioid overdose. 

I would like to share a brief excerpt from his blog because I think 

it helps capture the true toll of this epidemic on families, and I 

quote, I am witness to the parents left with inexplicable grief. I am 

witness to the spouses left to carry the emotional and economic 

burden of raising a family alone. I am witness to the children who 

are left wondering why, and experiences like this reinforce the 

need for Federal action to address this crisis. 

I am happy that last year we were able to work together on a 

bipartisan basis to pass CARA and 21st Century Cures. These laws 

are expanding access to treatment and recovery support services as 

well as advancing efforts to prevent the misuse and abuse of 

opioids. For example, New Jersey is using the $13 million it received as part of the larger CURES law to expand treatment and 

support services, invest in primary and secondary prevention and 

training. Through CARA we also took steps to reduce the amount 

of opioids in circulation by permitting for the partial fill of conVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
6 

trolled substance subscriptions and supporting the expansion of 

drug disposal sites for unwanted prescriptions. 

These were positive steps in the right direction, but committee 

Democrats have repeatedly stated that they were never enough 

and, sadly, the growing epidemic proves that today. These laws 

were a down payment on the types of efforts and increased funding 

that Congress must support to respond and eventually end this epidemic. 

In addition to supporting positive bipartisan laws and increase 

funding for substance abuse initiatives, Republicans must end their 

pursuit of taking away health coverage for millions of Americans. 

This is the very thing that ensures people can actually access treatment. Republicans have spent all year sabotaging the Affordable 

Care Act and attempting to gut the Medicaid program by more 

than $800 billion. 

This week, House Republicans including most on this committee 

will support a budget that includes these cuts and more. If successful, these actions by Republicans would have an immediate and 

harsh impact on those struggling with addictions and I will continue to fight these efforts. 

Advancing efforts to respond to this crisis also means Congress 

has a responsibility to figure out what went wrong, how it went 

wrong, and how to make sure something like this never happens 

again. That is why this committee is conducting a bipartisan investigation into the role drug distributors may have played in the ongoing opioid crisis and what systems failed to protect communities. 

The committee has sent a number of letters to several distributors and DEA requesting information about drug distribution practices including the amount of opioids shipped into certain communities. Unfortunately, however, up to this point we have had difficulty getting answers from DEA. In fact, I asked a number of follow-up questions to DEA following a committee hearing in March 

about opioid distribution in rural West Virginia. 

After 6 months, DEA just last night sent us the responses to 

these questions. Of course there are also still many questions in 

our letters to DEA that remain unanswered and DEA has pledged 

its cooperation to work with the committee. So I hope, moving forward, they can help us determine what systems failed in West Virginia and what needs to be done to make sure other communities 

are protected from such abusive practices. 

So it is clear, Mr. Chairman, the Nation is in crisis and Congress 

must do more to address the opioid epidemic. And I thank you and 

yield back. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Thank you, Mr. Chairman, for calling today’s hearing. It provides the opportunity 

to hear from several agencies within the Department of Health and Human Services 

as well as the Drug Enforcement Administration about the opioid abuse epidemic 

and the status of Federal efforts to combat the crisis, including the implementation 

of CARA and 21st Century Cures. 

While I am pleased to hear from the witnesses before us today, I am disappointed 

that you did not invite the Centers for Medicare and Medicaid Services—CMS. Most 

people access substance abuse treatment through their health insurance coverageit’s a fundamental link and one without the other leaves the millions of people of 

7 

all ages that struggle with this addiction out in the cold. Between Medicare, Medicaid, CHIP and the ACA Marketplaces, well over a third of the population receives 

health insurance through the programs that CMS oversees. Medicaid alone is the 

single largest payer for behavioral health services in the United States. Put simply, 

a full and appropriate review of this issue requires the presence of CMS. 

Unfortunately we all are too familiar with the tragic consequences of the opioid 

crisis. 91 Americans lose their lives to opioid overdose each day and millions more 

are battling this chronic and potentially deadly health condition. No community is 

immune. I know that like me, each Member here today has heard far too many tragic stories about lives cut short, families torn apart, and people left with few places 

to turn as they struggle to find treatment. 

In New Jersey, more than 1,900 people died from opioids last year. The crisis has 

taken such a toll in my community that we are hearing cries for help from some 

unlikely places. Earlier this year, Peter Kulbacki, the owner of Brunswick Memorial 

Funeral Home in East Brunswick, New Jersey, published a blog on the funeral 

home’s Web site expressing his frustration with the monthly calls he receives telling 

him that someone has passed away from an opioid overdose. I would like to share 

a brief excerpt from his blog because I think it helps capture the true toll of this 

epidemic on families: ‘‘I am witness to the parents left with inexplicable grief. I am 

witness to the spouses left to carry the emotional and economic burden of raising 

a family alone. I am witness to the children who are left wondering, ’why?’’’ 

Experiences like this reinforce the need for Federal action to address this crisis. 

I am happy that last year we were able to work together on a bipartisan basis to 

pass CARA and 21st Century Cures. These laws are expanding access to treatment 

and recovery support services, as well as advancing efforts to prevent the misuse 

and abuse of opioids. For example, New Jersey is using the $13 million it received 

as part of the larger Cures law to expand treatment and support services, invest 

in primary and secondary prevention and training. Through CARA, we also took 

steps to reduce the amount of opioids in circulation by permitting for the partial 

fill of controlled substance prescriptions and supporting the expansion of drug disposal sites for unwanted prescriptions. 

These were positive steps in the right direction, but committee Democrats have 

repeatedly stated that they were never enough. And sadly, the growing epidemic 

proves that today. These laws were a down payment on the type of efforts and increased funding that Congress must support to respond, and eventually end, this 

epidemic. 

In addition to supporting positive bipartisan laws and increased funding for substance abuse initiatives, Republicans must end their pursuit of taking away health 

coverage from millions of Americans. This is the very thing that ensures people can 

actually access treatment. Republicans have spent all year sabotaging the Affordable Care Act and attempting to gut the Medicaid program by more than $800 billion. This week, House Republicans, including most on this committee, will support 

a budget that includes these cuts and more. If successful, these actions by Republicans would have an immediate and harsh impact on those struggling with addiction. I will continue to fight these efforts. 

Advancing efforts to respond to this crisis also means Congress has a responsibility to figure out what went wrong, how it went wrong, and how to make sure 

something like this never happens again. That is why this committee is conducting 

a bipartisan investigation into the role drug distributors may have played in the ongoing opioid crisis, and what systems failed to protect communities. 

The committee has sent a number of letters to several distributors and DEA requesting information about drug distribution practices, including the amount of 

opioids shipped into certain communities. Unfortunately, however, up to this point, 

we have had difficulty getting answers from DEA. 

In fact, I asked a number of follow up questions to DEA following a committee 

hearing in March about opioid distribution in rural West Virginia. After six months, 

DEA just last night sent us their responses to these questions. Of course there are 

also still many questions in our letters to DEA that remain unanswered. DEA has 

pledged its cooperation to work with the committee, so I hope moving forward they 

can help us determine what systems failed in West Virginia, and what needs to be 

done to make sure other communities are protected from such abusive practices. 

It is clear, the Nation is in crisis and Congress must do more to address the opioid 

epidemic. Thank you, I yield back. 

Mr. WALDEN. The gentleman yields back. We now go to our witnesses. Full committee hearing, only the chairman and the ranking 

member give opening statements, just for our committee’s benefit. 

8 

So now we go to our witnesses. We want to thank you all for being 

here today and taking time to testify before the committee. Each 

witness will have the opportunity to give an opening statement followed by a round of questions from members. 

So today we will hear from Dr. Elinore McCance-Katz, Assistant 

Secretary for Mental Health and Substance Abuse, Substance 

Abuse and Mental Health Services Administration, easily known as 

SAMHSA; Dr. Anne Schuchat, Principal Deputy Director, Centers 

for Disease Control and Prevention at CDC; Dr. Nora Volkow, who 

is the Director of National Institute on Drug Abuse, NIDA, at National Institutes of Health, NIH; and Dr. Scott Gottlieb, Commissioner of Food and Drug Administration, FDA; and Mr. Neil 

Doherty, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 

We appreciate you being here today and we look forward to your 

testimony. We will start at this end of the table with the gentleman who has been here at least one other time this week, and 

maybe more. 

Dr. Gottlieb, thank you for your work with our committee. We 

greatly value your work there and at FDA, and we look forward to 

hearing your testimony this morning on this matter, sir. 

STATEMENTS OF SCOTT GOTTLIEB, M.D., COMMISSIONER, 

FOOD AND DRUG ADMINISTRATION; ELINORE MCCANCE– 

KATZ, M.D., ASSISTANT SECRETARY FOR MENTAL HEALTH 

AND SUBSTANCE USE, SUBSTANCE ABUSE AND MENTAL 

HEALTH SERVICES ADMINISTRATION; ANNE SCHUCHAT, 

M.D., PRINCIPAL DEPUTY DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION; NORA VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL 

INSTITUTES OF HEALTH; AND NEIL D. DOHERTY, DEPUTY 

ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION CONTROL OPERATIONS, DIVERSION CONTROL DIVISION, DRUG 

ENFORCEMENT ADMINISTRATION 

STATEMENT OF SCOTT GOTTLIEB 

Dr. GOTTLIEB. Thank you, Chairman Walden, Ranking Member 

Pallone. Thank you for the opportunity to testify today before the 

committee. The epidemic of opioid addiction that is devastating our 

Nation is the biggest crisis facing public health officials, FDA included. As this crisis grew, many of us didn’t recognize the consequence of this threat. In the past we missed opportunities to 

stem its spread, so we find ourselves at a tragic crossroad. 

We have a crisis of such massive proportion that the actions we 

need to take are going to be hard. We will need to touch clinical 

practice in ways that may make certain parties uncomfortable. 

This may include steps such as restrictions on prescribing or mandatory education on providers. Long ago we ran out of straightforward options. 

At FDA we are working across the full scope of our regulatory 

obligations to impact this crisis. That means updating and extending the risk management plans and educational requirements that 

we impose on sponsors as a condition of a product’s approval. It 

means doubling our efforts to promote the development of new, less 

9 

addictive pain remedies as well as opioids that are harder to manipulate and abuse. It means updating our risk benefit framework 

to take measure of the risks associated with misuse and abuse of 

opioids and using this information to inform our decisions, including recommending that products be withdrawn from the market. 

These steps and others are needed to prevent new addiction, but 

given the scale of this epidemic with millions of Americans already 

affected, prevention is not enough. We must also help those who 

are suffering from addiction by expanding access to lifesaving 

treatment. I would like to announce three new steps today towards 

this goal. 

First, FDA will issue guidance for product developers as a way 

to promote the development of new addiction treatments. As part 

of this guidance we will clearly lay out our interest in the development and use of novel, nonabstinence-based endpoints as part of 

product development. We also want to make it easier to develop 

new products that address the full range of symptoms of addiction 

such as craving. 

Second, FDA will take steps to promote more widespread use of 

existing, safe and effective, FDA-approved therapies to help combat 

addiction. There are several FDA-approved treatments. All of these 

treatments work in combination with counseling and psychological 

support. Everyone who seeks treatment deserves the opportunity to 

be offered all three options as a way to allow patients and providers to select the treatment best suited to the needs of each individual patient. 

Unfortunately, far too few people who are addicted to opioids are 

offered an adequate chance for treatment that uses medications. In 

part, this is because insurance coverage for treatment with medications is often inadequate. To tackle the treatment gap, FDA plans 

to convene experts to discuss the evidence of treatment benefits at 

the population level such as studies that show communitywide reductions in overdose following expansion of access to therapy. 

There is a wealth of information supporting the use of these 

medications. We are focusing on the data and the drug labeling 

that can help drive broader appropriate prescribing, so one concept 

that FDA is actively pursuing is the research necessary to support 

a label indication for medication-assisted treatment for everyone 

who presents with an overdose based on data showing a reduction 

in death at a broader population level. Such an effort would be a 

first for FDA. We believe that granting such an indication can help 

promote more widespread use of and coverage for these treatments. 

A common question that arises with treatment is the proper duration of medical therapy. Clinical evidence shows that people may 

need treatment with medications for long periods of time to achieve 

a sustained recovery. Some may even need a lifetime of treatment. 

Recognizing this, FDA is revising the labels of these medical products to reflect this fact. 

Now I know all this may make some people uncomfortable. That 

is why the third step I am announcing today is that FDA will join 

efforts to break the stigma associated with medications used for addiction treatment. This means taking a more active role in speaking about the proper use of these drugs. It is part of our existing 

public health mandate to promote the appropriate use of medicine. 

10 

Misunderstanding around the profile of these products enables 

stigma to attach to their use. This stigma serves to keep many 

Americans who are seeking a life of sobriety from reaching their 

goal. In this case, in the setting of a public health crisis, we need 

to take a more active role in challenging these conventions around 

medical therapy. This stigma reflects a view some have that a patient is still suffering from addiction even when they are in full recovery just because they require medication to treat their illness. 

This attitude reveals a flawed interpretation of science. It stems 

from a key misunderstanding that many of us have about the difference between a physical dependence and an addiction. Because 

of the biology of the human body, everyone who uses opioids for 

any length of time develops a physical dependence, meaning there 

are withdrawal symptoms after the use stops. Even a cancer patient requiring long-term treatment for the adequate treatment of 

metastatic pain develops a physical dependence to the opioid medication. That is very different than being addicted. 

Addiction requires the continued use of opioid despite the harmful consequences. Addiction involves a psychological craving above 

and beyond a physical dependence. Someone who neglects his family, has trouble holding a job, or commits crimes to obtain the 

opioids has an addiction. But someone who is physically dependent 

on opioid as a result of the treatment of pain but is not craving 

more or harming themselves or others is not addicted. 

The same principle applies to medications used to treat opioid 

addiction. Someone who requires long-term treatment for opioid addiction with medication including those that cause a physical dependence is not addicted to those medications. Here is the bottom 

line. We should not consider people who hold jobs, re-engage with 

their families, and regain control over their lives through treatment that uses medications to be addicted. 

Committee members, we need to embrace long-term treatment 

with proven therapies to address this crisis. At FDA we will step 

up our efforts to do our part to promote these goals. I look forward 

to discussing these issues with the committee and appreciate the 

opportunity to be hear today. 

Mr. WALDEN. Dr. Gottlieb, thank you for your testimony and 

your good work at FDA. 

We will now go to Dr. Elinore McCance-Katz, assistant secretary 

for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration, SAMHSA. 

Dr. McCance-Katz, thank you for being here today, please go 

ahead with your opening statement. 

STATEMENT OF ELINORE MCCANCE–KATZ 

Dr. MCCANCE-KATZ. Thank you. Chairman Walden, Ranking 

Member Pallone, and members of the House Energy and Commerce 

Committee, thank you for inviting me to testify at this important 

hearing. I am honored to testify today along with my colleagues 

from the Department of Health and Human Services and the Drug 

Enforcement Administration on Federal efforts to combat the 

opioid crisis, a status update on CARA, and other initiatives. 

Over the past 15 years, communities across our Nation have 

been devastated by increasing prescription and illicit opioid abuse, 

11 

addiction, and overdose. In 2016, over 11 million Americans misused prescription opioids, nearly one million used heroin, and 2.1 

million had an opioid use disorder due to prescription opioids or 

heroin. Most alarming are the continued increases in overdose 

deaths, especially the rapid increase in deaths involving illicitly 

made fentanyl and other highly potent synthetic opioids since 2013. 

The Trump administration is committed to bringing everything 

the Federal Government has to bear on this health crisis. HHS is 

implementing five specific strategies that are guiding our response. 

The comprehensive, evidence-based strategy aims to improve access to treatment and recovery services to prevent the health, social, and economic consequences associated with opioid addiction 

and to enable individuals to achieve long-term recovery; to target 

the availability and distribution of these drugs and ensure the 

broad provision of overdose-reversing drugs to save lives; to 

strengthen public health data reporting and collection to improve 

the timeliness and specificity of data and to inform a real-time public health response as the epidemic evolves; to support cutting edge 

research that advances our understanding of pain and addiction 

and leads to the development of new treatments and identifies effective public health interventions to reduce opioid related health 

harms; and to advance the practice of pain management to enable 

access to high quality, evidence-based pain care that reduces the 

burden of pain for individuals, families, and society while also reducing the inappropriate use of opioids and opioid-related harms. 

HHS appreciates Congress’ dedication to this issue as evidenced 

by passage of the 21st Century Cures Act and the Comprehensive 

Addiction and Recovery Act. In my role as Assistant Secretary for 

Mental Health and Substance Use at HHS, I lead the Substance 

Abuse and Mental Health Services Administration. I appreciate the 

opportunity to share with you a portion of SAMHSA’s portfolio of 

activities in alignment with HHS’s five strategies and how 

SAMHSA is implementing CARA and the 21st Century Cures Act. 

SAMHSA is administering the Opioid State Targeted Response 

grants program created by the 21st Century Cures Act. By providing $485 million to States in fiscal year 2017, this program is 

increasing access to treatment, reducing unmet treatment need, 

and reducing opioid overdose-related deaths through the provision 

of prevention, treatment, and recovery services. HHS is working to 

ensure the future funding allocations and policies are as clinically 

sound and evidence-based, effective, and efficient as they can be. 

SAMHSA has several initiatives aimed at advancing the utilization of medication-assisted treatment for opioid use disorder. For 

example, in the past 4 years, more than 62,000 medical professionals have participated in online or in-person SAMHSA-funded 

trainings on medication-assisted treatment for opioid use disorders. 

SAMHSA regulates opioid treatment programs and provides waivers to providers that prescribe buprenorphine. Last year, SAMHSA 

published a final rule allowing qualified physicians to obtain a 

waiver to treat up to 275 patients. SAMHSA has also implemented 

the CARA provision that allows nurse practitioners and physician 

assistants to prescribe buprenorphine. 

SAMHSA has been actively implementing new initiatives to address the opioid crisis made possible by CARA. In September, 

12 

SAMHSA awarded $4.6 million over 3 years in the Building Communities of Recovery grant program created by CARA. Last month, 

SAMHSA also awarded $9.8 million over 3 years for new State 

Pilot Pregnant and Postpartum Women grants authorized by the 

CARA act and $49 million over 5 years in new service grants to 

help pregnant and postpartum women and their children. 

SAMHSA has been a leader in efforts to reduce overdose deaths 

by increasing the availability and use of naloxone to reverse overdose. SAMHSA is currently providing grants to prevent opioid overdose related deaths which are being used to train first responders 

as well as to purchase and distribute naloxone. In September, 

SAMHSA awarded additional grants authorized by CARA including 

almost $46 million over 5 years to grantees in 22 States to provide 

naloxone and related resources to first responders and treatment 

providers. SAMHSA’s National Survey on Drug Use and Health 

provides key national and State-level data and is a vital part of the 

surveillance effort related to opioids. 

Thank you again for the opportunity to share with you our work 

to combat the opioid epidemic and I look forward to answering any 

questions you may have. 

Mr. WALDEN. Thank you very much. We appreciate your testimony. We are going to stay on the healthcare side of this and go 

to Dr. Anne Schuchat now, the principal deputy director, Centers 

for Disease Control and Prevention, CDC. 

Dr. Schuchat, thank you very much for being here and the good 

work you do. Please go ahead with your statement. You might pull 

the microphones a little closer. Thank you. 

STATEMENT OF ANNE SCHUCHAT 

Dr. SCHUCHAT. Good morning, Chairman Walden, Ranking Member Pallone, and members of the committee. CDC has vast experience in defending Americans against epidemics and I appreciate 

the opportunity to be here today to speak about the issues surrounding the opioid crisis facing our Nation. 

CDC’s expertise as the Nation’s public health and prevention 

agency is essential in reversing the opioid overdose epidemic. CDC 

is focused on preventing people from becoming addicted in the first 

place. CDC has the unique role of leading prevention by addressing 

opioid prescribing, tracking trends, and driving community-based 

prevention activities. 

America’s opioid overdose epidemic affects people from every 

community, and it is one of the few public health problems that is 

getting worse instead of better. Drug overdoses have dramatically 

increased, nearly tripling over the last two decades. The opioid 

overdose crisis has led to a number of other problems, including increases in babies born withdrawing from narcotics and a drop in 

life expectancy for the first time since the AIDS epidemic in 1993. 

But today’s overdose fatalities are just the tip of the iceberg. 

For every one person who dies of an opioid overdose, over 60 

more are already addicted to prescription opioids. Almost 400 misuse them, and nearly 3,000 have taken one. Using a comprehensive 

approach as outlined in the HHS priorities, we will work together 

to stop this epidemic. 

13 

CDC has been on the front lines since the beginning. Over a decade ago, after hearing alarming news from medical examiners 

about increases in overdose deaths and after an outbreak investigation in North Carolina, CDC scientists made the connection to prescription opioids. Today, we are working closely with State health 

departments and providing guidance on best practices so States can 

rapidly adapt as we learn what works best in this evolving epidemic. 

CDC now funds 45 States and Washington, DC, to advance prevention in key areas at the community level including improving 

prescription drug monitoring programs, improving prescribing practices, and evaluating policies. In Kentucky, prompts were added to 

the prescription drug monitoring program to alert to high doses, 

which resulted in a 25 percent reduction in opioid prescribing to 

youth. Illinois has expanded efforts to integrate patient health information into their prescription drug monitoring programs improving the completeness of data available to prescribers and leading 

to much greater PDMP use. 

These are just a few examples of the great work being done. 

These are the kind of improvements that can literally save lives. 

CDC is also leading improvements to the public health data we 

rely on to understand the crisis. We are now releasing preliminary 

overdose death data and have improved reporting significantly 

from a lag of 2 years down to a lag of 7 months. 

As part of our funding to States, we are ramping up efforts to 

get more reliable and timely data from emergency rooms, medical 

examiners, and coroners through our enhanced surveillance program. For the first time, we are tracking non-fatal opioid overdoses 

so that we have a better understanding of the changing epidemic 

so that States can respond accordingly. 

This is the value of nimble public health. States call on CDC to 

provide on-the-ground assistance when they experience an opioidrelated crisis. We helped Massachusetts identify that a surge in 

opioid deaths was caused by fentanyl and we assisted Indiana to 

identify and contain an HIV and hepatitis C outbreak related to injections of prescription opioids. 

We truly appreciate the support we received from this committee 

for our guideline for prescribing opioids for chronic pain which we 

released last March 2016. Now we are focused on making the 

guideline easy for clinicians to implement through interactive 

trainings, mobile apps, and other ways. We are also focusing on patients and their families. Just last month, CDC released Rx Awareness, a communication campaign aimed to raise awareness about 

the risk of prescription opioids. The campaign features real-life stories like the one you described, accounts of individuals living in recovery, and those who have lost someone to an overdose. 

CDC’s unique approach to surveillance and prevention will be 

key in reducing the opioid epidemic. We continue to be committed 

to the comprehensive priorities outlined in the HHS strategy and 

to saving the lives of those touched by this epidemic. Thank you. 

Mr. WALDEN. Thank you, Doctor. We appreciate your testimony. 

Now we go to Dr. Nora Volkow, director, National Institutes on 

Drug Abuse in the National Institutes of Health. 

14 

Doctor, thank you for being with us as well, please go ahead with 

your opening statement. 

STATEMENT OF NORA VOLKOW 

Dr. VOLKOW. So good morning, everybody. Chairman Walden, 

Ranking Member Pallone, and distinguished members of the committee, I am extremely grateful for your support and commitment 

to addressing the opioid crisis and for having me here along with 

my colleagues to actually try to integrate our efforts. You have already heard about the devastating scope of the opioid epidemic. 

Today, I would like to discuss how science is helping us address 

this crisis. 

The story of a patient named Jeff illustrates the impact research 

can make in the lives of those suffering from addiction. Jeff developed a heroin use disorder after returning from serving in the war 

in Afghanistan. He ended up homeless in the streets of Seattle and 

eventually sought treatment. NIDA-funded researchers at the VA 

in Seattle enrolled him a pilot buprenorphine treatment program. 

Unlike traditional treatment programs with long waiting lists, Jeff 

was started right away on oral buprenorphine which immediately 

helped him stop using heroin. The treatment helped Jeff recover. 

He has not used heroin since for several months, he is no longer 

homeless, and now has a regular job. 

Unfortunately, Jeff’s story is not typical. Most people who suffer 

from an opioid addiction do not receive treatment and when they 

do it is frequently not evidence-based. Jeff’s story illustrates how 

implementing research findings can significantly improve treatment outcomes. 

Addiction is a brain disease that is associated with disruption of 

brain sequence that make it progressively more difficult to stop 

using drugs even at the risk of losing one’s own life. When people 

suffering from addictions seek help, we owe it to them and their 

families to provide the treatments that research has proven most 

effective. 

Thanks in part to NIDA support there are now three FDA-approved medications for opioid use disorders: buprenorphine, methadone, naltrexone. While significantly improving outcomes, these 

medications are vastly underutilized and relapse rates are still too 

high. Thus, more research is needed to develop new treatments so 

we can reduce relapse rates in all patients. 

NIDA has a successful record of partnering with industry to develop new treatments. For example, NIDA and the FDA partner 

with Lightlake and other pharma to develop a user-friendly 

naloxone. Anyone can use this and it will deliver very rapidly, very 

high concentrations of naloxone into the bloodstream which is what 

you need in order to reverse an overdose. This product which was 

done in partnership with pharmaceutical, as I mentioned, was 

taken from concept into a product in basically 3 years. So we can 

do it. 

In the face of this opioid crisis, NIH wants to expand on these 

alliances and is working on establishing a public-private partnership in collaboration with the FDA, academic research centers, and 

the pharmaceutical industry that will focus on two major goals: 

Goal number one, to develop effective non-addictive pain medicaVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
15 

tions to prevent Americans from developing opioid use disorders 

while providing them relief from the pain condition that they suffer. 

The second goal is to expand medication options to treat opioid 

addictions and to prevent and reverse overdoses. A short-term 

focus will be the development of new formulations of existing medications to facilitate compliance and the treatment of hard-to-reach 

populations. Weekly and monthly depot formulations of 

buprenorphine have already been submitted to FDA approval. It 

would be a real gamechanger especially for people who live in rural 

communities and face significant logistical challenges accessing 

treatment. Other research is building on our growing understanding of the neurobiology of addiction to identify potential targets for treating it. This includes not only medications, but also 

known pharmacological therapies including vaccines. 

In parallel and in collaboration with SAMHSA, we are expanding 

services and implementation research to develop new strategies for 

delivery of addiction treatment across healthcare and criminal justice settings. An example is a story that recently showed that initiating buprenorphine in the emergency room to help ensure people 

will prevent them from overdoses and effectively engage them in 

ongoing treatment. 

We have an urgent crisis and as stated by the chairman, an allhands-on-deck approach is needed to solve it. NIH and NIDA are 

fully committed to integrate our efforts with those from other Federal agencies, industry, community organizations, patients and 

their families, and Congress to solve it. Thanks very much. 

[The joint prepared statement of Dr. Gottlieb, Dr. McCance-Katz, 

Dr. Schuchat, and Dr. Volkow follows:] 

16 


32978.001

House Committee on Energy and Commerce 

Hearing titled, "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA 

and Other Initiatives" 

October 25,2017 

Written testimony on behalf of the following witnesses from the 

Department of Health and Human Services (HHS): 

Elinore McCance-Katz, M.D., Ph.D .. Assistant Secretary for Mental Health and 

Substance Use, Substance Abuse and Mental Health Services Administration, HHS 

Anne Schuehat, M.D., Rear Admiral, U.S. Public Health Service; Principal Deputy 

Director. Centers for Disease Control and Prevention, HHS 

Nora Volkow, M.D., Director, National institutes on Drug Abuse, National Institutes of 

Health, !-!liS 

Scott Gottlieb, M.D., Commissioner, Food and Drug Administration, HHS 
17 


32978.002

Good morning Chairman Walden, Ranking Member Pallone, and Members of the Committee. 

Thank you for the opportunity to discuss the opioid crisis in the United States and the Federal 

response. From the start of his Administration, President Trump has made addressing the opioid 

epidemic a top priority, and at the Department of Health and Human Services (HHS) we share 

the President's commitment to bringing an end to this crisis, which is exacting a toll on 

individuals, families, and communities across the country. The Department has made the crisis a 

top clinical priority and is committed to using our full expertise and resources to combat the 

epidemic. 

Over the past 15 years, communities across our Nation have been devastated by increasing 

prescription and illicit opioid abuse, addiction, and overdose. According the Substance Abuse 

and Mental Health Services Administration (SAMHSA)'s National Survey on Drug Use and 

Health (NSDUH), in 2016, over 11 million Americans misused prescription opioids, nearly l 

million used heroin, and 2.1 million had an opioid use disorder due to prescription opioids or 

heroin. Over the past decade, the U.S. has experienced significant increases in rates of neonatal 

abstinence syndrome (NAS), hepatitis C infections, and opioid-related emergency department 

visits and hospitalizations. Most alarming are the continued increases in overdose deaths, 

especially the rapid increase since 2013 in deaths involving illicitly made fentanyl and other 

highly potent synthetic opioids. Since 2000, more than 300,000 Americans have died of an 

opioid overdose. Preliminary data for 2016 indicate at least 64,000 drug overdose deaths, the 

highest number ever recorded in the U.S. Too many of our citizens are being robbed of their 

God-given potential in the prime of their life. 

The opioid epidemic in the U.S. is fundamentally tied to two primary issues. The first issue was 

the significant rise in opioid analgesic prescriptions that began in the mid-to-late 1990s. Not only 

did the volume of opioids prescribed increase, but well-intentioned healthcarc providers began to 

prescribe opioids to treat pain in ways that we now know are high-risk and have been associated 

with opioid abuse, addiction, and overdose, such as prescribing at high doses and for longer 

durations. The second issue is a lack of health system and healthcare provider capacity to 

identify and engage individuals, and provide them with high-quality, evidence-based opioid 

addiction treatment, in particular the full spectrum of medication-assisted treatment (MAT). It is 

well-documented that the majority of people with opioid addiction in the U.S. do not receive 

treatment, and even among those who do, many do not receive evidence-based care. Accounting 

for these factors is paramount to the development of a successful strategy to combat the opioid 

crisis. Further, there is a need for more rigorous research to better understand how existing 

programs or policies might be contributing to or mitigating the opioid epidemic. 

In April 2017, HHS outlined its five-point Opioid Strategy, which provides the overarching 

framework to leverage the expertise and resources of HHS agencies in a strategic and 

coordinated manner. The comprehensive, evidence-based Opioid Strategy aims to: 

• Improve access to prevention, treatment, and recovery support services to prevent the 

health, social, and economic consequences associated with opioid addiction and to enable 

individuals to achieve long-term recovery; 

2 
18 


32978.003

• Target the availability and distribution of overdose-reversing drugs to ensure the broad 

provision of these drugs to people likely to experience or respond to an overdose, with a 

particular focus on targeting high-risk populations; 

• Strengthen public health data reporting and collection to improve the timeliness and 

specificity of data and to inform a real-time public health response as the epidemic 

evolves; 

• Support cutting-edge research that advances our understanding of pain and addiction, 

leads to the development of new treatments, and identifies effective public health 

interventions to reduce opioid-related health harms; and 

• Advance the practice of pain management to enable access to high-quality, evidencebased pain care that reduces the burden of pain for individuals, families, and society 

while also reducing the inappropriate use of opioids and opioid-related harms. 

To date, the Department has taken significant steps to advance the goals of our Opioid Strategy. 

While this statement docs not represent an exhaustive list of HHS activities underway, 

SAMHSA, CDC, NIH, and FDA bring unique expertise and capabilities that enable HHS to take 

a comprehensive, complementary, and f1exible approach to the opioid crisis. 

Substance Abuse and Mental Health Services Administration (SAMHSA) 

As HHS's lead agency for behavioral health, SAMHSA's core mission is to reduce the impact of 

substance abuse and mental illness on America's communities. SAMHSA supports a portfolio of 

activities that address all five prongs of HHS's Opioid Strategy. 

Improving Access to Prevention, Treatment, ami Recovery Support Services 

SAMl-lSA administers the Opioid State Targeted Response (STR) grants, a two-year 

program authorized by the 21st Century Cures Act (P.L 114-255). By providing $485 

million to states and U.S. territories in fiscal year (FY) 2017, this program allows states 

to focus on areas of greatest need, including increasing access to treatment, reducing 

unmet treatment need, and reducing opioid overdose related deaths through the provision 

of the full range of prevention, treatment and recovery services for opioid usc disorder. 

The President's Budget requests $500 million for this program in FY 2018, the full level 

authorized by Congress. 

The Substance Abuse Prevention and Treatment Block Grant (SABG), first authorized in 

1992, is a vital source of funding for states that accounts for approximately 32 percent of 

total state substance abuse agency tl.mding. For many people seeking to recover from 

opioid addiction, this public funding represents the only support for treatment In 

addition, the block grant's flexible structure enables states to use the funds to address 

pressing challenges within their communities, such as the opioid crisis. 

SAMHSA also has several initiatives aimed specii1cally at advancing the utilization of 

MAT for opioid use disorder, which is proven effective but is highly underuti!ized. 

SAMHSA's Medication Assisted Treatment for Prescription Drug and Opioid Addiction 

(MAT-PDOA) program expands MAT access by providing grants to states with the 

highest rates of treatment admissions for opioid addiction. Tvvcnty-two states arc 

currently funded by MAT-PDOA, and in September 2017, SAMHSA awarded $35 

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32978.004

million dollars over three years in additional MAT-PDOA grants to six states. 

SAMHSA also provides critical funding for MAT for specific high-risk and vulnerable 

populations, such as those involved with the criminal justice system and pregnant and 

postpartum women. SAMHSA's criminal justice grantees can usc up to 20 percent of 

their grant awards for the purchase of FDA-approved medications for treatment of opioid 

and alcohol addiction. Since 2013, SAMHSA has seen a steady increase in the number of 

drug courts integrating MAT into their programs with 57 percent of active programs 

currently integrating MAT. 

Under SAMHSA's Pregnant and Postpartum Women's (PPW) program, which serves 

women with opioid or other substance use disorders who are pregnant and/or newly 

parenting, grantees are encouraged to ensure access to MAT for opioid addiction, which 

has been shown to improve birth outcomes. Last month SAMHSA awarded $9.8 million 

over three years for new State Pilot PPW grants authorized by the Comprehensive 

Addiction and Recovery Act (CARA, P.L. 114-198) and $49 million over five years in 

new PPW service grants to support the recovery of pregnant and postpartum women 

struggling with substance abuse, including opioid addiction. 

A well-documented challenge to improving access to opioid usc disorder treatment is a 

lack of providers who can provide MAT. SAMHSA supports a number of training 

initiatives to increase the number of qualified healthcare providers who can provide 

treatment for opioid addiction. In the last four years, more than 62,000 medical 

professionals have participated in online or in-person trainings on MAT for opioid 

addiction through SAMHSA 's Provider's Clinical Support System (PCSS)-MAT. This 

program is a national training and clinical mentoring project that provides mentoring of 

newly trained physicians by experienced specialists, maintains a library of evidencebased practice materials, and offers at no cost to the trainee the required DATA 2000 

waiver training to enable providers to prescribe buprenorphine for opioid addiction 

treatment. 

SAMHSA regulates opioid treatment programs (OTPs), which dispense methadone and 

may also dispense and prescribe buprenorphine and administer extended-release 

naltrexone. In coordination with the Drug Enforcement Administration (DEA) and 

states, territories, and the District of Columbia, SAMHSA reviews new and renewal 

applications for OTPs through an accreditation process that ensures programs have sound 

risk management practices in place and are using evidence-based treatments. SAMHSA 

also oversees physicians, nurse practitioners (NPs), and physician assistants' (PAs) 

ability to prescribe buprenorphine in office-based outpatient treatment settings. Last 

year, SAMHSA published a final rule which allows certain qualified physicians who 

have obtained a waiver to prescribe buprenorphinc for up to 100 patients for at least a 

year, to now acquire a waiver to treat up to 275 patients. The regulation provides that 

these licensed physicians can become eligible for the patient limit of275 either by being 

board certified in Addiction Medicine or Addiction Psychiatry or by practicing in a 

qualified practice setting. 

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32978.005

These physicians are required to complete a SAMHSA reporting form each year to 

ensure that physicians prescribing at the new, higher level are in compliance with safe 

and appropriate prescribing practices. As of September 19th, 3,573 physicians have 

obtained a waiver to treat up to 275 patients. Most recently, SAMHSA began processing 

waivers to allow NPs and PAs to prescribe buprenorphine in accordance with the 

requirements ofCARA. As of September 19th, 2,756 NPs and 773 PAs have received a 

waiver. 

SAMHSA also promotes recovery through targeted grants. such as last month's award of 

$4.6 million over three years in Building Communities of Recovery program grants, 

created by CARA. The purpose of this program is to mobilize resources within and 

outside of the recovery community to increase the availability and quality of long-term 

recovery supports for individuals in or seeking recovery from addiction. These grants are 

intended to support the development, enhancement, expansion, and delivery of recovery 

support services as well as promotion of and education about recovery. Programs will be 

principally governed by people in recovery from substance abuse and addiction who 

reflect the community served. 

Targeting Overdose-Reversing Drugs 

SAMHSA has been a leader in efforts to reduce overdose deaths by increasing, through 

funding and technical assistance, the availability and use of naloxone to reverse overdose. 

SAMHSA's "Opioid Overdose Prevention Toolkit," first released in 20\3, is one of 

SAMHSA's most downloaded resources. The Toolkit provides information on risks for 

opioid overdose, recognition of overdose, and how to provide emergency care in an 

overdose situation. 'fhe Toolkit is intended for community members, first responders, 

prescribers, people who have recovered from an opioid overdose and family members, as 

well as communities and local governments. 

SAMHSA provides a number of funding streams that can be used to expand access to 

naloxone. States are able to usc Opioid STR funds to purchase and distribute naloxone, 

and some states are also using a portion of their SABG funds for opioid overdose 

prevention activities. 

SAMHSA is currently providing $11 million per year in Grants to Prevent Prescription 

Drug/Opioid Overdose Related Deaths to 12 states. These grants arc also being used to 

train first responders on emergency medical care to be rendered in an overdose situation 

and how to administer naloxone as well as how to purchase and distribute naloxone. 

In September 2017, SAMHSA awarded funding for grants authorized by CARA, 

including almost $46 million over five years to grantees in 22 states to provide resources 

to first responders and treatment providers who work directly with the populations at 

highest risk for opioid overdose. 

Strengthening Public Health Data and Reporting 

SAMHSA's National Survey on Drug Usc and Health (NSDUH) provides key national 

and state level data on a variety of substance usc and mental health topics, including 

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opioid misuse. NSDUH is a vital part of the surveillance effort related to opioids, and the 

data from NSDUH has been used to track historical and emerging trends in opioid 

misuse, including geographic and demographic variability. 

SAMHSA also works collaboratively with other agencies to better understand the 

epidemic through sharing of data and assessing the implications of that data and develops 

publications based on NSDUH and other national surveys and data. Examples of recent 

SAMHSA publications include: Trends in the Use of Methadone, Buprenorphine, and 

Extended-release Naltrexone at Substance Abuse Treatment Facilities; Trends in Average 

Days' Supply of Opioid Medications in Medicaid and Commercial Insurance; and Opioid 

Prescribing Trends fix Adolescents and Young Adults with Commercial Insurance and 

Medicaid. 

Supporting Cutting-Edge Research 

SAMHSA is building on existing partnerships with the NIH to improve the research to 

practice pipeline and is committed to promoting evidence-based practices and service 

delivery models. The newly formed Office of the Chief Medical Oftlcer and the National 

Mentalllealth and Substance Use Policy Laboratory, which were authorized through the 

21st Century Cures Act to promote evidence-based practices and service delivery models, 

will be pivotal to these efforts. Additionally, the National Mental Health and Substance 

Use Policy Laboratory will assist in addressing the opioid crisis through its evaluation of 

models that would benefit from further development and through expanding, replicating, 

or scaling evidence-based practices across wider areas as we seek to increase access to 

and delivery of the best treatment services for opioid use disorders across America. 

Centers for Disease Control and Prevention (CDC) 

As the Nation's public health and prevention agency, CDC's expertise and leadership is essential 

in reversing the opioid epidemic. It was CDC that first identified the increase in opioid overdose 

deaths in 2004, and since then the agency has applied its scientific expertise to track the 

epidemic and develop evidence-based prevention strategies. Through various programs and 

initiatives, CDC supports all five parts of the Secretary's Opioid Strategy: 

Strengthening Publie Health Data and Reporting 

Timely, high-quality data help both public health officials and law enforcement 

understand the extent of the problem and how it is evolving, develop interventions, focus 

resources where they are needed most, and evaluate the success of prevention and 

response efforts. Understanding that data is crucial, CDC is helping states build capacity 

to monitor the scope of the epidemic and better focus their prevention activities through 

several programs and activities. 

CDC's Overdose Prevention in States (OPIS) provides resources and scientifk support to 

45 states and Washington, D.C. through three programs. The first two programs, 

Prescription Drug Overdose: Prevention for States (PfS) and Data-Driven Prevention 

Initiative (DDPI), provide states with the resources, tools and technical expertise to 

execute and evaluate prevention strategies to improve saJe prescribing practices and 

prevent prescription drug misuse, abuse, and overdose. States use their funding to 

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advance prevention in four key areas: 1) Enhancing Prescription Drug Monitoring 

Programs (POMP) and leveraging them as public health tools; 2) Improving health 

system and insurer practices for safer opioid prescribing; 3) Evaluating policies that may 

have an impact on the opioid epidemic (e.g .. naloxone distribution and Good Samaritan 

laws); and 4) Quickly responding to emerging and critical needs. 

CDC's Enhanced State Opioid Overdose Surveillance (ESOOS) program, the third 

program under OPIS, funds 32 states and Washington, D.C. Started in 2016, ESOOS 

strives to improve the timeliness of reporting both fatal and non-fatal opioid overdoses 

and associated risk factors in order to inform public health responses within and across 

states. What is particularly unique and innovative about this program is the use of 

emergency department and emergency medical services (EMS) data to track and analyze 

morbidity data. ESOOS uses this data to establish an early warning system to detect 

sharp increases (e.g. potential outbreaks) or decreases (e.g. successful intervention 

efforts) in non-fatal overdoses. 

CDC has made progress in improving the timeliness of data reporting and is now 

releasing quarterly and, as of August 2017, monthly provisional counts of overall drug 

and opioid overdose deaths in the Vital Statistics Rapid Release (VSRR) series. CDC also 

relies on its existing infrastructure to monitor rates of new eases of H!V and viral 

hepatitis in many states. CDC is working with Coroners and Medical examiners to 

improve both comprehensive toxicology efforts that help with the detection of fentanyl 

analogs and the capacity for mortality surveillance by identifying ways to help strengthen 

case management systems to report data more easily and quickly. While CDC has made 

progress, improvements are needed to build infrastructure (medical examiners, coroners, 

toxicological testing, additional electronic reporting, etc.). A stronger disease detection 

system will identify potential problems sooner. 

CDC is also tracking opioid usc among pregnant and reproductive-aged women and its 

impact on the mother and newborn as a part of the Treating for Two: Safer Medication 

Use in Pregnancy initiative. Pilot programs are underway to obtain state-level estimates 

ofNAS to better understand hospital readmissions and long-term adverse outcomes 

among infants identified with NAS. 

In addition to providing funding and technical assistance, CDC conducts epidemiological 

investigations (Epi-Aids) in states, providing on the ground assistance during a public 

health crisis. Between 2012 and 2015, Massachusetts experienced a surge of opioidrelated deaths, from 698 to l ,747, with over 74 percent of these deaths involving 

fentanyl. The Massachusetts Department of Public Health (MDPH) called on CDC to 

help investigate the extent to which illicitly-manufactured fentanyl (IMF) contributed to 

the surge in opioid-related overdose deaths. CDC worked closely with the MDPH, 

SAMHSA, and DEA to determine whether lMF mixed with or sold as heroin was the 

primary cause of the surge of deaths and found that 82 percent of fentanyl-related 

overdose deaths were suspected to have involved IMF. 

To stop the surge, CDC recommended that the MDPH train physicians, treatment 

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providers, and law enforcement on overdose prevention, screen at-risk people for heroin 

or fentanyl usc, and expand access to naloxone. CDC also recommended outreach to 

those who experienced an opioid overdose, had a history of substance abuse, or were 

accessing health programs for active users to link them to treatment and educate them on 

the dangers of fentanyl. 

Often, CDC's work in states leads to further, national initiatives. The 2015 response to an 

1-l!V and Hepatitis C (HCV) outbreak in Scott County, Indiana, led to a CDC analysis 

which identified over 220 U.S. communities that could be especially vulnerable to HIV 

and HCV outbreaks among persons who inject opioid drugs. One of those states, 

Tennessee, used CDC's assessment to do further analysis of the state's vulnerabilities. As 

a result, Tennessee is working to direct its I !IV and viral hepatitis resources where they 

are most needed. 

In addition to working with states, a partnership across sectors is necessary. CDC has 

been working on initiatives with law enforcement agencies, like the DEA, to strengthen 

public health and law enforcement collaboration on the federal level. 

In addition, the Heroin Response Strategy (HRS), funded by the Office of National Drug 

Control Policy (ONDCP) and deployed in eight High Intensity Drug Trafficking Areas 

(HJDTAs), covering 20 states, links public health and public safety at the state level. 

CDC works with the HIDTA directors to sharpen strategic directions, ensure proper 

coordination and training, support the 20 public health analysts embedded in the program, 

and improve performance measurement. There is currently a shortage of evidence to 

guide public health-law enforcement integrated community response, thus as part of the 

HRS, CDC is launching eight pilot projects across the 20-state initiative to build 

scientitie evidence about what works. 

Advancing the Practice of Pain Management 

Another of CDC's key focus areas is supplying health care providers with the tools and 

resources necessary to advance the practice of pain management. ln March 2016, CDC 

released the Guideline for Prescribing Opioids for Chronic Pain, which was developed to 

help primary care doctors provide safer, more effective care for patients with chronic pain 

outside of active cancer, palliative, and end-of-life care. The Guideline provides 12 

voluntary recommendations for prescribing opioids for patients 18 and older, in primary 

care settings, based on the most current scientific evidence. This helps patients and 

physicians better understand and assess risks and benefits of opioid therapy and 

determine the optimal method for each patient to manage their pain. 

CDC has created a number of resources for health care providers to make the Guideline 

easy to understand and access. Earlier this year, CDC launched the first in a series of 

interactive, online trainings which provide sample scenarios, feedback, and resources for 

each recommendation. CDC is also capitalizing on technology to help disseminate the 

Guideline through the development of an Opioid Guideline Application (mobile app) 

which contains all of the Guideline recommendations, a morphine milligram equivalent 

(MME) calculator, and an interactive interviewing feature to help providers prescribe 

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with confidence. Other materials developed for providers, pharmacists, and patients 

include graphics, fact sheets, posters, and podcasts, all available on CDC's website. 

CDC is also committed to educating consumers about the risks of opioids and the 

importance of discussing safer, more effective pain management options with their 

healtheare providers. In September 2017, CDC released the Rx Awareness 

communications campaign to increase awareness about the risks of prescription opioids 

and deter inappropriate use. The campaign features real-life accounts of individuals 

living in recovery, and those who have lost someone to an overdose. CDC is running 

digital, radio, and out-of-home campaign ads for 14 weeks in select states (KY, MA, NM, 

and OH) with broader release anticipated in 22 additional OPIS funded states. 

Improving Access to Prevention, Treatment, and Recovery Support Services 

CDC brings scientific expertise and leverages existing relationships with health systems 

to link patients who need MAT to the appropriate care. As part of the OPIS effort, several 

states funded under the PfS program are supporting health system approaches to link 

patients to treatment and recovery services. For example, states are building systems that 

facilitate better linkages to treatment, emergency room peer patient navigators, and data 

dashboards to identify hot spots for treatment needs. 

Additionally, CDC is conducting an epidemiologic study to assess what type of MAT 

(methadone maintenance; buprenorphine; naltrexone) or counseling and other nonmedication interventions is most effective, and which contextual, provider, and individual 

factors influence implementation, prevent relapse, and improve patient wellbeing over a 

two-year period. This study can help identify who may benetit from which type of 

treatment to ensure individuals receive the treatment best suited to their needs. 

Targeting Overdose-Reversing Drugs 

CDC is currently working with SAMHSA to evaluate its Grants to Prevent Prescription 

Drug/Opioid Overdose-Related Deaths program with the goals of describing and 

understanding the scope and impact of naloxone education and distribution efforts in 

high-need communities and to identify barriers and potential solutions to increase 

program effectiveness. Additionally, states funded under OPJS are evaluating practices to 

improve the distribution and use of overdose reversing drugs and Good Samaritan laws 

(policies that protect the victim and the bystander from drug possession charges). States 

utilize CDC data to identify communities experiencing a significant increase in opioid 

overdose deaths, which helps to inform both the targeted distribution of naloxone and the 

training of community members, EMS, and law enforcement on naloxone administration. 

Supporting Cutting-Edge Research 

To better understand the epidemic, identify risk and protective factors, and determine 

effective interventions, CDC also funds innovative research to prevent misuse and abuse. 

One CDC funded project at the Carolinas Medical Center in Charlotte, North Carolina, is 

working to assess and compare changes in prescribing behaviors when providers are 

presented with electronic alerts on potential misuse or abuse of opioids. This research 

will inform efforts to improve clinical decision-making. In addition, CDC funds 

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academic research centers to conduct translational research in order to better understand 

how to get information into the hands of practitioners. For example, the Johns Hopkins 

Injury Control Research Center (lCRC) is working to reduce injured patients' risk for 

opioid misuse through mobile health technology while the West Virginia University 

(WYU) JCRC was instrumental in the development and implementation of a pilot takehome program for naloxone in rural communities. There were at least 25 overdose 

reversals in the first nine months of the program in 16 counties. As part of a rapid 

response project using CDC funds, the WVU ICRC distributed 8,250 naloxone kits to 

first response agencies and take-home naloxone programs throughout the state in the first 

halfof2017. 

National Institutes of Health (NIH) 

Nil! is the lead HHS agency providing support for cutting-edge research on pain and opioid 

misuse, addiction, and overdose. Drug addiction is a complex neurological condition, driven by 

many biological, environmental, social, and developmental factors. Continued research will be 

key to understanding the crisis and informing future efforts. Pain is an equally complex 

condition. To this end, NIH supports a range of activities to advance research on pain and 

addiction. 

Supporting Cutting-Edge Research 

Because the most effective way to end opioid misuse and addiction is to prevent it from 

beginning, NIH is supporting innovative research to better understand what makes an 

individual vulnerable to opioid misuse. For example, the Adolescent Brain Cognitive 

Development (ABCD) study, the largest long-term study of brain development and child 

health in the U.S., will help build an evidence base to draw on for a future of precision 

medicine approaches to prevent opioid addiction. 

With the goal of bringing scientific solutions to the opioid crisis, NIH is exploring ways 

to promote I) new, innovative medications and technologies to treat opioid addiction and 

improve overdose prevention and reversal interventions, and 2) safe, effective, nonaddictive strategies to manage pain. In April 2017, NIH Director Francis S. Collins, 

M.D., Ph.D .. met with research and development leaders from the world's leading 

biopharmaceutical companies to discuss new ways for government and industry to work 

together to address the opioid crisis. NIH continued meetings throughout the summer. As 

part of these ongoing discussions, NIH participated in a recent meeting with 

Pharmaceutical CEOs convened by Governor Christie, co-chair of the President's 

Commission on Combating Drug Addiction and the Opioid Crisis, in Trenton, New 

Jersey, on September 18th. Some advances NIH is working to promote may occur 

rapidly, such as improved formulations of existing medications, longer-acting overdosereversal drugs, and repurposing of treatments approved for other conditions. Others may 

take longer, such as novel overdose-reversal medications and identifying biomarkers to 

measure pain in patients. Our goal for these activities is to cut in half the time needed to 

develop new safe and effective therapeutics to help end the opioid crisis. 

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NIH will continue to build upon breakthroughs in the treatment of opioid addiction and 

the reversal of opioid overdose and find ways to advance the development of new 

products. For example, buprenorphine, one of the three FDA-approved options for MAT 

treatment, was developed through a partnership between NIH and industry. The 

intramural program of the National Institute on Drug Abuse (NIDA) conducted the early 

clinical studies on buprenorphine and then later partnered with industry to develop userfriendly and abuse deterrent formulations. In addition, a NIH public-private partnership 

helped to develop the only FDA-approved intranasal naloxone product to reverse opioid 

overdose, an invaluable tool to those on the front lines combating the opioid crisis. In 

2013, NIDA funded a biopharmaceutical company for clinical studies to evaluate the 

pharmacokinetic properties- how much and how rapidly the naloxone is absorbed- of 

an intranasal formulation. In 2015, the intranasal naloxone was approved by the FDA. 

With knowledge gained from neuroscience advances, NIH researchers now seek ways to 

turn the tide in the opioid crisis through a wider range of formulations of existing and 

new medications, as well as innovative strategies to treat opioid use disorder and prevent 

and reverse overdose. 

NIH is also working toward preventing the most serious health consequences for infants 

born with NAS. Currently, NIH research aims to determine more precise dosing of 

buprenorphine in pregnant women, and to reduce the time to develop new treatments. 

NIH is also launching a new effort on opioid use in pregnancy, to study the effects of 

medically supervised opioid withdrawal on mother and newborn, and better understand 

the genetic or epigenetic factors associated with opioid usc on neonatal outcomes. NIH 

will also develop and pilot a common study protocol to generate evidence for best 

practices in treating newborns with NAS, through a partnership between the NIH 

Neonatal Research Network and the new IDeA States Pediatric Clinical Trials Network. 

NIH researchers are also working to build an understanding of how to effectively 

integrate prevention and treatment services within healtheare and community systems. 

For example, NIH is studying strategies to improve the implementation of MAT for 

people with opioid use disorder in the criminal justice system. This research aims to 

optimize implementation of evidence-based screening, assessment, and treatment services 

by juvenile justice agencies and improve coordination with community healthcare 

providers in a way that promotes long-term recovery from opioid addiction in real-world 

settings. 

Advance the Practice of Pain Management 

Our mission to end the opioid crisis will not be successful until we can provide patients 

with better options for the treatment of pain, which touches 25 million Americans every 

day. NIH funds a broad range of research on pain. from basic research into the 

molecular, genetic, and bio-bchavioral basis of chronic pain to large-scale clinical studies 

of potential treatments. NIH funded basic research has identified a myriad of potential 

targets for future non-addictive therapies. Pathological pain and addiction are classic 

disorders of brain circuits and the neurotechnologics emanating from the US BRAIN 

Initiative enable scientists to explore these circuits to advance both diagnostics and 

therapeutics. Research efTorts to understand and alleviate pain depend on better objective 

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measures of the pain experience for patients. To address this. NIH also supports 

development of resources to advance the research agenda. One example is the PatientReported Outcomes Measurement Information System (PROM IS). PROMIS provides a 

rigorously tested patient-reported outcome measurement tool to measure pain, fatigue, 

physical functioning, and emotional well-being. 

NIH works with Federal paiiners across government to carry out cutting-edge research on 

pain. Through the Interagency Pain Research Coordinating Committee, NIH developed 

the Federal Pain Research Strategy, a long-term strategic plan to coordinate and advance 

the federal research agenda on pain. The Strategy's research priorities include prevention 

of acute and chronic pain, management of acute pain, transition from acute to chronic 

pain, and understanding the disparities that influence pain and pain management. 

Ongoing projects that already arc advancing the goals laid out in the Strategy include the 

NIH-DoD-VA Pain Management Col laboratory program, which recently announced $81 

million in research funding to implement cost-effective large-scale clinical research in 

military and veteran healthcare delivery organizations, focusing on non-pharmacologic 

approaches to pain management and other comorbid conditions. 

Beyond research activities, NIH is engaged in efforts to advance the HHS Opioid 

Strategy pillar of advancing the practice of pain management. NIH worked with HHS and 

agencies across government to develop the National Pain Strategy, the government's first 

broad-ranging effort to improve how pain is perceived, assessed, and treated, which 

highlights the need for evidence based treatments. NIH is actively working with other 

Departments and Agencies and external stakeholders to implement the Strategy. In 

addition, NIH is supporting Centers of Excellence for Pain Education that act as hubs for 

the development, evaluation, and distribution of pain management curriculum resources 

for medical, dental, nursing, pharmacy and other schools to enhance education about pain 

and pain care. 

Food and Drug Administration (FDA) 

FDA, the Agency responsible for protecting the public health by ensuring the safety, efficacy, 

and security of human and veterinary drugs, biological products, and medical devices, is 

focusing on three broad areas to help address the opioid crisis: lowering overall exposure to 

opioid drugs and, in turn, reducing the number of new cases of addiction; enabling more 

oppOiiunities for those currently addicted to opioid drugs to seek MAT that can help them 

recover; and helping expedite the development of progressively more-effective abuse deterrent 

formulations of opioid drugs, and better still, non-opioid alternatives for the treatment of pain. 

To advance these goals, FDA, earlier this year, established an Opioid Policy Steering Committee 

that brings together the Agency's most senior career leaders to explore and develop additional 

tools and strategies to confront the opioid crisis. 

Support Cutting-Edge Research 

Abuse Deterrent Formulations (ADF): FDA's emphasis on assessing the full public 

health effects of opioids is reflected in the Agency's ongoing work to suppOit the 

development of forms of prescription opioids that deter abuse. The Agency strongly 

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supports a transition from the current market dominated by conventional opioids to one in 

which the majority of opioids have meaningful abuse-deterrent properties. In support of 

this transition and potential future actions against products without these properties, FDA 

is focusing its efforts on determining how effective the current abuse deterrent products 

are in the real world. To assist this effoti, the Agency recently gathered independent 

experts for a scientific workshop to discuss both the existing science and what else is 

needed to properly assess the impact of opioid formulations with abuse-deterrent 

properties on misuse, abuse, addiction, overdose, and death. Separately, FDA is working 

to support generic forms of abuse deterrent opioids by issuing final guidance on their 

development, in recognition of the important role generic drugs play in the United States. 

Alternatives to Opioids for Pain: FDA strongly suppotis the development of new 

treatment options for patients in pain, especially treatments that do not have the same 

addictive features of traditional opioids. To advance both non-addictive and nonpharmacologic treatments for pain, FDA commits to using all of the Agency's authorities. 

This includes programs such as the Fast Track and Breakthrough Therapy Designations 

that are intended to facilitate development and to expedite review of products that, for 

example, are intended to treat a serious condition for which there is an unmet medical 

need. As a part of these efforts, FDA is meeting with innovators who are pursuing nonopioid alternatives for the treatment of pain to provide guidance on their individual 

products. Agency steps also include a more careful consideration of non-drug alternatives 

for pain, such as medical devices that can deliver more localized analgesia. FDA is 

considering how to more closely fit medical device alternatives into a comprehensive 

approach to the development of treatments for pain. 

We know that developing non-opioid and non-addictive pain medicines is challenging for 

many reasons; therefore, FDA is interested in progressing the entire field of pain drug 

development. To address the issues related to the trials needed for approval, FDA has 

participated in a public-private-partnership (PPP) under the Critical Path initiative, the 

Analgesic Clinical Trial Translation, Innovations, Opportunities, and Networks 

(ACTTION). The ACTT!ON PPP is a collaboration among a broad spectrum of national 

and international groups aimed at advancing the science in this area, including academia, 

FDA and other government agencies, pharmaceutical and device companies, professional 

organizations, and patient advocacy groups. 

At the same time as we are prioritizing work on non-opioid and non-abusable pain 

medicines, FDA is also taking new steps to help facilitate the development of 

medications that can help patients with addiction recover as well as overdose reversal 

drugs, such as naloxone. FDA is laying the groundwork for naloxone to be available 

more broadly and is supporting research aimed at encouraging the potential development 

of over the counter naloxone products. 

Advance the Practice of Pain Management 

Changes in Prescribing: To reduce the rate of new opioid addiction, we need to 

decrease overall exposure to opioids. For many people, that first prescription will be for 

an immediate release (IR) formulation of the drug. Some people will go on to become 

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addicted and abuse longer-acting formulations that can deliver higher doses, especially 

when manipulated. Some of these people will eventually move onto street drugs, such as 

heroin, which are increasingly the low-cost alternative. We know that this route of 

addiction cotTelates with exposure. A certain percentage of patients exposed to opioids 

will go on to develop an addiction to the drugs. One approach to reducing the rate of new 

addiction, then, is to reduce exposure to prescription npioid drugs. To accomplish this, 

we need to explore ways to use our regulatory authorities to influence how opioids are 

prescribed to make sure that only appropriately indicated patients are prescribed opioids, 

and that the prescriptions are written for durations and doses that properly match the 

clinical reason for which the drug is being prescribed in the first place. We are exploring 

whether FDA should take additional steps to make sure that general prescribing and the 

number of opioid doses that an individual patient can be dispensed, is more closely 

tailored to the medical indication. Among other steps, FDA is soliciting public input on 

these questions in the form of a public docket that was established the week of September 

25. 

Expanded Education through Modification of Opioid REMS, and Changes to the 

Education Blueprint: Since 2012, FDA has required manufacturers of extended-release 

long-acting opioids to make available educational materials through a Risk Evaluation 

and Mitigation Strategy (REMS). We know that most of the exposure to opioids is not 

from extended-release or long-acting formulations, but ti·om !R formulations like 

hydrocodone and acetaminophen or oxycodone and acetaminophen combinations. In 

fact, about 90 percent of all opioid prescriptions in the United States are written for IR 

formulations of these drugs. IR opioid products serve as the gateway for patients and 

non-patients who may continue to use or misuse these products, which could lead to new 

addiction. Given this fact, we need to advance policies that rationalize the prescribing 

and dispensing of IR opioid drugs. 

As one step, FDA has determined that a REMS to support education is also necessary for 

the prescribing of !R opioid products. This regulatory tool is needed to ensure that the 

benefits of these drugs continue to outweigh the risks of adverse outcomes (addiction, 

overdose, and death) resulting from inappropriate prescribing, abuse, and misuse, and 

that providers are properly informed about suitable prescribing and the risks and benefits 

associated with opioid drugs. FDA has announced its intention to update the existing 

REMS on extended-release/long-acting opioid analgesics, and for the first time, extend 

these same regulatory requirements (including prescriber training) to the manufacturers 

of IR opioid analgesic products. FDA is currently implementing that plan. We have also 

announced plans to revise the Blueprint used to create education materials to include 

broader information on pain management, including the principles of acute and chronic 

pain management; non-pharmacologic treatments for pain; and pharmacologic treatments 

for pain (both non-opioid analgesic and opioid analgesic). To start this process, the 

relevant letters, detailing the new requirements, were recently sent to sponsors that 

manufacture the IR drugs. 

In addition to the efforts described above, HHS continues to engage with a broad range of 

stakeholders state and local governments, addiction specialists, medical, nursing, dental, and 

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pharmacy providers, community and faith-based organizations, private-sector partners, 

community organizations, and law enforcement partners to share best practices, build 

collaborations, and identify barriers that could prevent success. We are committed to this fight 

and will continue to advance a multi-pronged strategy, never forgetting that behind all the 

statistics are individuals, families, and communities who are being torn apart each day. Our 

guiding vision must be to improve the lives of all Americans who have been touched by this 

crisis. That will be the true measure of our success. 

Lastly, HHS, through the President's FY 2018 budget, has requested more than $800 million to 

continue to support the Department's critical opioid investments. We look forward to continuing 

to work with Congress to identify solutions and to secure the funding needed to turn the tide 

against the opioid crisis. 

Thank you again for inviting SAMHSA, CDC, NIH, and FDA to testify today. We look forward 

to answering your questions. 

15 
31 

Mr. WALDEN. Thank you, Doctor. 

And now our final witness, Mr. Neil Doherty, deputy assistant 

administrator, Office of Diversion Control, Drug Enforcement Administration. We appreciate your being here as well. 

Mr. Doherty, please go ahead with your opening statement. 

STATEMENT OF NEIL D. DOHERTY 

Mr. DOHERTY. Chairman Walden, Ranking Member Pallone, and 

distinguished members of the committee, thank you for holding 

this hearing today to discuss the opioid epidemic and DEA’s response to this ongoing threat. For DEA, the opioid is the top drug 

threat facing our Nation. This unprecedented epidemic includes not 

only prescription opioids otherwise known as controlled prescription drugs, or CPDs, but also the proliferation of heroin and 

fentanyl trafficking, ultimately leading to record levels of overdose 

deaths. 

I believe that all of us at this table are collectively making 

progress on CPDs, but I fear we are witnessing a fundamental shift 

towards cheaper, easier to obtain heroin and fentanyl. With illicitly 

produced fentanyl you have substances up to 50 times more potent 

than heroin, sold as heroin, mixed with heroin, and increasingly 

and often with a fatal result, pressed into pill form by criminal networks as counterfeit prescription painkillers. Of the estimated 

64,000 Americans who overdosed in 2016, 54 percent died of an 

opioid overdose. That is one life taken every 15 minutes. 

Mexican cartels are continuing to exploit the opioid use epidemic 

and are continuing to produce and transport heroin across the 

Southwest border. These cartels are aggressively purchasing illicitly produced fentanyl from China, shipping it into Mexico, mixing 

it with heroin and other substances, pressing it into pill form, and 

shipping it into the U.S. through established distribution networks. 

What is the motivation behind the often deadly tactics employed 

by the cartels regarding fentanyl? In a word, profit. Fentanyl and 

associated analogues provide criminal organizations with highly 

elevated margins for illicit revenue. For example, one kilogram of 

fentanyl in China costs between 3 and $5,000, yet yields approximately 1.5 million on the streets of the United States. 

DEA stands with our interagency partners including those represented here today to combat this epidemic across all fronts. For 

DEA and our Federal, State, and local partners to be successful in 

dealing with this threat we need a balanced, whole-of-Government 

approach, one that attacks supply and also works to reduce demand. We need to continue to lean forward and use all available 

tools to identify, infiltrate, indict, capture, and convict all members 

of these organizations, foreign and domestic. With 221 domestic offices, 21 field divisions, and 92 foreign offices in 70 countries, DEA 

is well positioned to engage in this fight. 

Foreign-based fentanyl manufacturers and domestic distributors 

often operate with impunity as they exploit loopholes in the analogue provisions of the Controlled Substance Act and capitalize on 

the lengthy, resource-intensive process to temporarily or permanently control these dangerous substances. Every day, criminal 

chemists in foreign countries are altering the molecular structure 

of different fentanyl analogues keeping the same dangerous pharVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00035 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
32 

macological properties as the substances that are already controlled. 

Despite these challenges there is good news. Our partnership 

with our counterparts in China has resulted in the scheduling of 

128 new pyschoactive substances since October 2015 including numerous fentanyl and fentanyl analogues. In addition, you probably 

heard last week that two Chinese nationals were indicted as part 

of an investigation conducted by DEA and other agencies and these 

individuals were designated as CPOTs, Consolidated Priority Organization Targets, the designation reserved for the most prolific 

drug traffickers in the world. 

Our investigators remain relentless in their pursuit to dismantle 

these organizations and bring those responsible to justice. DEA 

along with our global network of enforcement partners will go after 

these types of criminals wherever they operate. The DEA will continue to address these threats by investigating and bringing to justice not those suffering from opioid use disorders, but those who 

are exploiting human frailty for profit. 

DEA will use all criminal and regulatory tools available to identify, target, disrupt, and dismantle organizations and individuals 

responsible for the diversion and illicit distribution of pharmaceutical controlled substances in violation of the CSA. We will also 

work to reduce demand with our community outreach and prevention efforts throughout the country. 

One example of such efforts is the DEA 360 Strategy which 

brings together three distinct pillars of law enforcement aimed at 

addressing the opioid, heroin, and violent crime crisis: traditional 

enforcement, diversion control, and community outreach. Now in 

its second year, this strategy has been deployed to some of the 

hardest hit communities in the Nation. 

The brave men and women of the DEA remain committed to 

doing everything they can to address this threat. One pill is 

enough; one life is worth it. Every pill that we stop from hitting 

the street through diversion or counterfeiting potentially stops it 

from getting into the hands of a young American and saves them 

from opioid dependency, heroin use, and possibly a fatal overdose. 

Thank you for the opportunity to appear before you today and I 

look forward to answering any questions you may have. 

[The prepared statement of Mr. Doherty follows:] 

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ileparlment of Justice 

STATEMENT OF 

NEIL D. DOHERTY 

DEPUTY ASSISTANT ADMINISTRATOR 

OFFICE OF DIVERSION CONTROL OPERA TJONS 

DIVERSION CONTROL DlVISION 

DRUG ENFORCEMENT ADMINISTRATION 

BEFORE THE 

HOUSE ENERGY AND COMMERCE COMMITTEE 

UNITED STATES HOUSE OF REPRESENTATIVES 

FOR A HEARING ENTITLED 

"FEDERAL EFFORTS TO COMBAT THE OPIOID CRISIS: A STATUS 

UPDATE ON CARA AND OTHER INITIATIVES" 

PRESENTED 

OCTOBER 25,2017 
34 


32978.017

Statement of 

Neill). Boherty 

Deputy Assistant Administrator 

Office of Diversion Control Operations 

l)iversion Control Division 

Drug Enforcement Administration 

Before the 

Energy and Commerce Committee 

U.S. House of Representatives 

For a Hearing Entitled 

"Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other 

Initiatives" 

October 25, 2017 

Chairman Walden, Ranking Member Pallone, and Members of the Committee: on behalf 

of the approximately 9,000 employees of the Drug Enforcement Administration (DEA), thank 

you for the opportunity to discuss the threat posed by the opioid epidemic. The abuse of 

controlled prescription drugs (CPDs) is inextricably linked with the threat the United States faces 

from the trafficking of heroin, fentanyl and fentanyl analogues. 

Drug overdoses, suffered by family, friends, neighbors and colleagues, are now the 

leading cause of injury-related death in the United States, eclipsing deaths from motor vehicle 

crashes or firearms. 1 According to initial estimates provided by the Centers for Disease Control 

and Prevention (CDC), there were more than 64,000 overdose deaths in 2016, or approximately 

175 per day. Over 34,500 (54 percent) of these deaths were caused by opioids. The sharpest 

increase in drug overdose deaths from 2015 to 2016 was fueled by a surge in fentanyl and 

fentanyl analogue (synthetic opioids) ovcrdoses 2 

The misuse of CPDs and the growing use of heroin, tentanyl, and fentanyl analogues are 

being reported in the United States in unprecedented numbers. According to the Substance 

Abuse and Mental Health Services Administration (SAMHSA) 2016 National Survey on Drug 

Use and Health (NSDUH), 6.2 million people over the age of 12 misused psychotherapeutic 

drugs (e.g., pain relievers, tranquilizers, stimulants, and sedatives) during the past month3 This 

represents 22 percent of the 28.6 million current illicit drug users and is second only to marijuana 

1 Rose !\. Rudd. Noah Aleslmc, Jon 

Morbidity and [Vlortality Weekly 

WONDlR data, rctnevcd from the 

Results from the 2016 National ~urvev on 

Center for Behav10ra! ! !ca!th . 

https://'I.VW\V samhsa gov/data/ 

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(24 million users) in terms ofusage. 4 There are more current misusers of psychotherapeutic 

drugs than current users of cocaine, heroin, and hallucinogens combined 5 

The increase in the number of people using heroin in recent years- from 373,000 past 

year users in 2007 to 948,000 in 2016- is troubling.6 More alarming is the proliferation of 

illicit fentanyl and its analogues. DEA investigations reveal that fentanyl and its analogues arc 

being added to heroin and other illicit substances and in many instances pressed into counterfeit 

tablets resembling CPDs. Because of its high potency, the more fentanyl is introduced to the 

11 .5 million people that misused a pain reliever in the previous year, there is a likelihood that 

drug overdoses will continue to climb7 Since fentanyl and its analogues can be harmful to 

public safety personnel who encounter these substances during the course of their daily 

operations, it is critical they know how to protect themselves. DEA is part of an interagency 

working group to develop a set of scientific, evidence-based recommendations that first 

responders can take to protect themselves. 

CONTROLLED PRESCRIPTION DRUGS (CPDs) 

In 2016, almost 3.4 million Americans age 12 or older reported misusing prescription 

pain relievers within the past month. 8 This makes prescription opioid misuse more common than 

usc of any category of illicit drug in the United States except for marijuana. Whereas the vast 

majority of individuals misusing opioid CPDs do not go on to use heroin, this information 

provides valuable insight into the role that CPDs play in the opioid epidemic and underscores the 

need for a robust regulatory program that seeks to stop diversion of CPDs. 

Black-market sales for opioid CPDs are typically five to ten times their retail value. DEA 

intelligence reveals the "street" cost of prescription opioids steadily increases with the relative 

strength of the drug. f-or example, generally, hydrocodone combination products (a Schedule Il 

prescription drug and also the most prescribed CPD in the country)9 can be purchased for $5 to 

$7 per tablet on the street. Slightly stronger drugs like oxycodone combined with acetaminophen 

(e.g., Pcrcocet) can be purchased for $7 to $! 0 per tablet on the street. Even stronger 

prescription drugs are sold for as much as $1 per milligram (mg). For example, 30 mg 

20 !6 National Survey on Drug Usc and Health: Detailed Tables. Substance Abuse 

2016 National Survey on Drug Use and Health· Dcta!led Tables Substance Abuse 

and Mental Health Scrv!ces Admie,i,tcetioe 

t Substanr.:c Abuse aml Menta! I lea!th Scrvtccs AdmmlstratJOn 

Results from the 2016 Nalwnal Survey on 

Center for Behav10rul Health Statlstics and 

pubhshed a final rule m the 

Schedule ll! to Schedule II, as recommended by the Assistant Secretary for Health 

Services 

-2-

from 

and lluman 
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32978.019

oxycodone (immediate release) and 30 mg oxymorphone (extended release) cost $30 to $40 per 

tablet on the street. The costs that ensue with greater tolerance make it difficult to purchase these 

drugs in order to support a developing substance use disorder, particularly when many first 

obtain these drugs for free from the family medicine cabinet or from friends. 

HEROIN 

Heroin is transported to the United States predominantly across the Southwest Border 

(SWB) and is produced with greater sophistication ti·om powerful tmnsnational criminal 

organizations (TCOs) like the Sinaloa Cartel and New Generation Jalisco Cartel or CJNG. 

These Mexico-based TCOs are extremely dangerous, violent and continue to be the principal 

suppliers of heroin to the United States. 

Not surprisingly, a small number of people who misuse prescription opioids turn to 

heroin. Heroin traffickers produce high purity white powder heroin that costs approximately $10 

per bag, and usually contains approximately 0.30 grams per bag. This makes heroin significantly 

less expensive than CPDs. Heroin produces a "high" similar to CPDs and can keep some 

individuals who are dependent on opioids from experiencing painful withdrawal symptoms. 

This cycle has been repeatedly observed by law enforcement agencies. For some time now, law 

enforcement agencies across the country have been specifically reporting an increase in heroin 

use by those who began misusing prescription opioids. 10 

According to reporting by treatment providers, many individuals with serious opioid usc 

disorders will use whichever drug is cheaper and/or available to them at the time. 11 Heroin 

purity and dosage amounts vary, and heroin is often cut with other substances (e.g., fentanyl and 

fentanyl analogues). This means that heroin users arc at higher risk of unintentional overdose 

because they cannot predict the dosage of opioid in the product they purchase on the street as 

heroin. 12 Additionally, varying potencies found in diverted or counterfeit prescription opioids 

purchased on the street have led to increased unintentional drug overdoses. 

A report published by SAMHSA found that four out of five recent new heroin users had 

previously misused prescription pain rclieversn The reasons an individual may shift from one 

opiate to another vary, but today's heroin is high in purity, less expensive and often easier to 

obtain than illegal CPDs. High-purity heroin can be smoked or snorted, thereby circumventing a 

''US. Department of Justice, Drug EntOrccment i\dmin1s.tration, 2016 National Heroin Threat Assessment Summary, DFA 

Report. 

awulable at 

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barrier to entry (i.e .. needle use) and avoiding the stigma associated with injection. However, 

many who smoke or snort are vulnerable to eventually injecting heroin. Heroin users today tend 

to be younger and more ethnically and geographically diverse than ever before. 14 

Overdose deaths involving heroin are increasing at an alarming rate, having almost 

increased more than five-fold since 201 0_~ 5 Today's heroin at the retail level costs less and is 

more potent than the heroin that DEA encountered two decades ago. It is also not uncommon for 

heroin users to seek out heroin that dealers claim is "hot," meaning that it is likely cut with 

fentanyl or its analogues. Users seeking "hot" heroin is an indicator that as higher opioid 

tolerance levels develop among users, they will continue to seek out more potent forms of 

opioids. 

FENTANYL AND FENTANYL ANALOGUES (SYNTHETIC OPIOIDS) 

Fentanyl is a Schedule II controlled substance produced in the United States and used 

widely in medicine. It is an extremely potent analgesic widely used for anesthesia and also pain 

control in people with serious pain problems and, in such cases, it is indicated only for use in 

people who have high opioid tolerance. 

Illicit fentanyl, fentanyl analogues, and their immediate precursors are often produced in 

China. From China, these substances are shipped primarily through mail carriers directly to the 

United States or alternatively shipped directly to transnational criminal organizations ("TCOs") 

in Mexico, Canada, and the Caribbean. Once in the Western Hemisphere, fentanyl or its 

analogues are prepared to be mixed into the U.S. heroin supply domestically, or pressed into a 

pill form, and then moved to the illicit U.S. market where demand for prescription opioids and 

heroin remain at epidemic proportions. In some cases, traffickers have industrial pill presses 

shipped into the United States directly from China and operate fentanyl pill press mills 

domestically. Mexican TCOs have seized upon this business opportunity because of the profit 

potential of synthetic opioids, and have invested in growing their share of this market. Because 

of its low dosage range and potency, one kilogram of fentanyl purchased in China for $3,000-

$5,000 can generate upwards of S 1.5 million in revenue on the illicit market. 

According to the DEA National Forensic Laboratory Information System ("NFL!S"), 

from January 2013 through December 2016, over 58,000 fentanyl reports were identified by 

federal, state and local forensic laboratories. 16 During 2016, there were 36,061 fentanyl reports 

compared to 1,042 reports in 2013, 17 an exponential increase over the past four years. The 

consequences of fentanyl misuse are often fatal and occur amongst a diverse user base. 

According to a December 2016 Centers for Disease Control Morbidity and Mortality Weekly 

, Surratt, H, Kurv .. S. The Changmg Face ofHcrom Use in the United States· A Retrospective Analysis of 

Laboratory Jnforma1mn System. acnwl data queried on 

Drug: EnfOn.:cmcnt Admimstrut10n, Nutional Forensic Laboratory lnfonnation System, actual data queried on 
38 


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Report, from 2014 to 2015, the death rate from synthetic opioids other than methadone, which 

include fentanyl, increased 72.2%, from 5,544 (age adjusted rate 1.8) to 9,581 (3.1)18 Over a 

two-week period in late March and early April 2016, DEA issued a public safety alert for the 

Sacramento, California region following an outbreak of overdoses related to counterfeit 

hydrocodone which had been laced with fentanyl. In all, there were 52 individuals who 

overdosed, 14 of whom ultimately lost their lives. Additionally, between January and March 

2016, nine people died in Pinellas County, Florida from counterfeit Xanax® pills that contained 

fentanyl. The number of overdose fatalities resulting from fentanyl and fentanyl analogues is 

under-reported and will increase as postmortem drug testing expands. 

DEA RESPONSE TO THE OPIOID EPIDEMIC, HEROIN EPIDEMIC, AND THE 

THREAT OF FENTANYL AND OTHER SYNTHETIC DRUGS 

E{fi;ctive Outreach 

Due to the complexity of DEA's regulatory program, the Diversion Control Division has 

worked aggressively to improve its communication and cooperation with its more than 1.7 

million registrants, who represent medical professionals, pharmaceutical drug manufacturers, and 

those in the drug supply chain. DEA works with its registrant population by (1) hosting 

Pharmacy Diversion Awareness Conferences ("PDACs") throughout the country; (2) 

administering the Distributor Initiative Program with a goal of educating distributors on how to 

detect and guard against diversion activities; and (3) maintaining an open dialogue with various 

national associations such as the National Association of Boards of Pharmacy ("NABP"), 

American Medical Association ("AMA"), and other groups to address diversion problems and 

educate the medical community on improving prescribing practices 19 By the end of October, 

2017, DEA will have hosted 97 PDACs in 48 states (including the District of Colombia and 

Puerto Rico) and will have trained in excess of 13,100 pharmacists, pharmacy technicians, and 

others on the important role they play in ensuring that valid prescriptions for controlled 

substances are filled. ln2018, DEA will initiate a nationwide program to offer similar training to 

individual practitioners. 

Prescription Drug Afonitoring Programs 

Prescription drug monitoring programs (PDMPs) are state-run electronic database 

systems used by practitioners, pharmacists, medical and pharmacy boards, and law enforcement 

but access varies according to state law. These programs are estahlished through state legislation 

and are tailored to the specific needs of each state. DEA strongly supports robust PDMPs and 

encourages medical professionals to use this important tool to detect and prevent doctor 

shopping and other forms of diversion. Currently, 49 states have an operational PDMP. 

Missouri will become the 501

11, pursuant to the Governor's Executive Order in July 2017. As of 

August 2017,24 of these 49 states with operational PDMPs require controlled substance 

Increases in Drug and Opi01d Overdose Deaths- United States, 2000-

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32978.022

prescribers to use the state's POMP prior to prescribing a controlled substance in certain 

circumstances as mandated by each state's legislation 20 The DEA encourages all practitioners 

and pharmacists to use their state PDMPs. 

While PDMPs are valuable tools for prescribers, pharmacists, and law enforcement 

agencies to identify, detect, and prevent nonmedical prescription drug use and diversion, PDMPs 

do have some limits in their use for detecting diversion at the retail level. For example, drug 

traffickers and drug seekers willingly travel hundreds of miles to gain easy access to pain clinics 

and physicians that are operating unscrupulously and outside of the law, making 

interconnectivity between PDMPs vital. Federal partners are working to address the 

interoperability problems. The Office of National Drug Control Policy (ONDCP) and the 

Bureau of Justice Assistance (B.! A) also offer assistance for interstate and state-tribal PDMP 

linkages. CDC supports 29 states to advance interventions for preventing prescription drug 

overdoses, through its Prevention for States program, which could include activities focused on 

improving interoperability between PDMPs and Electronic Health Record (EHR) technology and 

provide real-time provider access. The Indian Health Service (1!-IS) developed a policy that 

requires fedcrallHS facilities to report all controlled substance prescriptions to their respective 

State PDMPs and requires federal prescribers to check State PDMPs prior to prescribing opioids. 

Finally, the National Association of Boards of Pharmacy (NABP) hosts NABP Prescription 

Monitoring Program (PMP) InterConnect, which facilitates the transfer of PDMP data across 

state lines to authorized users. The program allows users of participating PDMPs to securely 

exchange prescription data between cetiain states. Currently, PDMPs in over 41 states are 

participating in the program. 

Law enforcement access to request, view, and utilize POMP data in support of ongoing 

investigations in a manner that protects personally identifiable information (I'll) is vital. 

Unfortunately, access to information in support of active state and federal investigations varies 

widely from state to state, with some states requiring a court order in order for law enforcement 

to obtain data. 

Medication Disposal 

On September 9, 2014. DEA issued a final rule, titled "Disposal of Controlled 

Substances." These regulations implement the Secure and Responsible Drug Disposal Act of 

2010 and expand upon the previous methods of disposal by including disposal at drop-boxes in 

pharmacies and law enforcement agencies, mail back programs and drug deactivation systems if 

they render the product irretrievable. Through these regulations, DEA continues to focus its 

national attention on the issue of the misuse use of prescription drugs and related substance use 

disorders (SUDs), and promotes awareness that one source of these drugs is often the home 

medicine cabinet. as 53% of persons aged 12 or older who misused pain relievers in the past year 

bought or took the pain relievers from a fi·iend or relative, or that friend or relative gave it to the 

-'·" PDMP Center ()fExcellcn-:e, Brandeis University http·//www p~Wmg/pdf!Mand.ill.~..Qnditions 20170824.pdf 

retneved Ot:tobcr !9, 20!7 

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user for free 21 • These regulations provide a safe and legal method for the public to dispose of 

unused or expired CPDs. As of October 17, 2017, 2.829 DEA registrants have become 

·'authorized collecwrs." 

Since 2010, DEA has held its National Drug ''Take Back" Initiative (NTBl) to provide a 

convenient and safe option to dispose of unused, expired and/or unwanted prescription drugs. 

DEA's most recent NTBI was held on April 29, 2017. As a result of all thirteen National Take 

Back Days, DEA, in conjunction with its state, local, and tribal law enforcement partners, has 

removed a total of 8.1 million pounds ( 4,052 tons) of medications from circulation. The DEA is 

conducting a Federal Take-Back Day today, October 25, and the fourteenth National Drug Take 

Back Day is scheduled for October 28,2017. 

DEA 'S 360 Strategv 

To counter the opioid crisis, DEA initiated and continues to expand upon its 360 

Strategy. The strategy leverages existing Federal, State, local, and tribal partnerships to address 

the problem on three different fronts: law enforcement, diversion control, and demand reduction. 

Our enfixcement activities are directed at the violent cartels and drug trafficking gangs 

responsible for feeding the heroin and prescription drug epidemic in our communities. We arc 

also enhancing our diversion control efforts and working with community partners for them to 

implement evidence-based programs and efforts designed to reduce demand and to prevent the 

same problems from resurfacing. 

As part of the 360 Strategy, DEA recently partnered with Discovery Education, a division 

of Discovery Communications, to develop and distribute a prescription opioid and heroin 

education curriculum to middle and high school students, their teachers, and parents. We are 

calling it Operation Prevention and have started nationwide development of this program. Our 

goal is to educate children about the science of addiction and the true danger of prescription 

opioids and heroin, and to "kick start" life-saving conversations in the home and classroom. 

This award-winning program is available at no cost to schools nationwide and includes resources 

such as standards-aligned lesson plans, interactive student activities, parent resources and more 

all available through an online portal. Operation Prevention launched in October 2016 with a 

virtual field trip, viewed live by more than 200,000 students, in all 50 States and in seven foreign 

countries. The program has reached more than 1.1 million students to date and will run for at 

least three consecutive school years (through spring 20 19) and will be free for all law 

enforcement, prevention, treatment, and community groups to use and distribute. 

Since its implementation in 2016, the 360 Strategy has been implemented in eight citiesLouisville, Kentucky; St. Louis, Missouri; Pittsburgh, Pennsylvania; Milwaukee, Wisconsin; 

: 1 Substance Abuse and Menta! ! fca!th Services Admimstration. (20 17) Key substance usc and mental health mdicators in the United States 

Re~ults from the 2016 Nat1onal Survey on Drug Use and Health (HHS Publicat1on No SMA !7~5044, NSDUH Series H~52). Rockville, MD 

Center for Bchav!oralllealth StatJSUcs and Quality, Substance Abuse and tvlcntal ! !ealth ScrvJCes 1\dmumtrauon. Rctm'ved from 

https //www.samhs:::1 govid<lli./L 

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Dayton, Ohio; Albuquerque, New Mexico; Charleston, West Virginia; and Manchester, New 

Hampshire. DEA is expanding this program to additional locations including the announcement 

of Salt Lake City. Utah in September 2017. Our enforcement efforts will continue across the 

United States with our law enforcement and community partners. 

Tactical Diversion Squads 

DEA Tactical Diversion Squads (TDSs) investigate suspected violations of the Controlled 

Substances Act (CSA) and other federal and state statutes pertaining to the diversion of controlled 

substance pham1aceuticals and listed chemicals. These unique groups combine the skill sets of 

Special Agents, Diversion Investigators, and a variety of state and local law enforcement agencies. 

They arc dedicated solely towards investigating, disrupting, and dismantling those individuals or 

organizations involved in diversion schemes (e.g., ''doctor shoppers," prescription forgery rings, and 

DEA registrants who knowingly divert controlled substance phmmaceuticals). Between March 2011 

and present, DEA increased the number of operational TDSs from 37 to 77. In addition, we 

established two mobile TDS that can deploy quickly to "hot spots" in fmthcrance of the Diversion 

Control Division's mission. One mobile TDS was recently deployed to West Virginia and is 

supporting DEA's offices in Charleston and Clarksburg. 

Temporary Scheduling o(Svnthetic Opioids and New Psychoactive Substances (,VPS) 

Even though many fentanyl and NPS compounds have been controlled in Schedule lor 

Schedule II of the CSA, drug traffickers produce and procure new synthetic compounds with 

relative ease. Over the past several years, DEA has identified hundreds of designer drugs from at 

least eight different drug classes, including synthetic opioids, the vast majority of which are 

manufactured in China. DEA continues to utilize its regulatory authority to place many synthetic 

substances into the CSA pursuant to the aforementioned temporary scheduling authority. Once a 

substance is temporarily placed in Schedule I, DEA moves towards permanent control by 

requesting a scientific and medical evaluation and scheduling recommendation from HHS and 

gathering and analyzing additional scientific data and other information collected from all 

sources, including poison control centers, hospitals, medical examiners, treatment professionals, 

and law enforcement agencies, in order to consider the additional factors warranting its 

permanent control. Since January 2011, DEA has utilized this authority on fifteen occasions to 

place 45 synthetic designer drugs temporarily (emergency control) into Schedule I. This 

includes the following fentanyl analogues: acetyl fentanyl, butyryl fentanyl, betahydroxythiofentanyl, furanyl fentanyl, 4-fluoroisobutyryl fentanyl, and aery! fentanyl. !n 

addition, DEA has published a notice of intent to temporarily control the following three 

additional fentanyl analogues: methoxyacetyl fentanyl, tetrahydrofuranyl fentanyl, and orthofluorofentanyl. In comparison. over the first 25 years (1985-20 1 0) after Congress created this 

authority, DEA utilized it a total of 13 times to control 25 substances. 

However, clandestine chemists continue to develop and synthesize new synthetic drugs. 

They do this hoping that the new drugs are not covered by any schedule of controlled substances. 

In fact, when DEA takes an action to temporarily schedule a substance, retailers and traftlckers 

begin selling new versions of their products, which contain new, and they hope unregulated, 

compounds. In addition, many of these retailers are provided with spurious chemical analyses 

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that purport to document that the new product line did not contain any controlled substance. 

Manufacturers and distributors will continue to stay one step ahead of any state or federal drugspecific banning or control action by introducing new synthetic analogue products that arc not 

listed as such in any of the controlled substance schedules. 

Significant En(brcement Effbrls 

The DEA Special Operations Division ("SOD'') Heroin/Fentanyl Task Force ("HFTF") 

Working Group consists of several agencies using a joint ·'whole of government" approach to 

counter the fentanyl/opioid epidemic in the United States. The HFTF consists of personnel from 

DEA, U.S. Immigration and Custom Enforcement Homeland Security Investigations ("HSI") 

and Customs and Border Protection ("CBP"); supplemented by the Federal Bureau of 

Investigation ("FBI") and the U.S. Postal Inspection Service. HFTF utilizes every resource 

available, including support from the Department of Justice's Organized Crime Drug 

Enforcement Task Forces ("OCDETF") Fusion Center (''Ot'C") and Criminal Division, the 

Department of Defense ("DOD"). Intelligence Community ("lC") and other government entities. 

and provides field offices (all agencies) with valuable support in their respective investigations. 

The 1-!FTF mission aims to: 

ldentify, target, and dismantle command and control networks of national and 

international fentanyl and NPS trafficking organizations. 

Provide case coordination and de-confliction on all domestic and foreign investigations to 

ensure that multi-jurisdictional, multi-national, and multi-agency investigations and 

prosecutions have the greatest impact on targeted organizations. 

Provide direct and dynamic operational and investigative support for domestic and foreign 

field offices for all agencies. 

Identify new foreign and domestic trafficking, manufacturing, importation, production and 

financial trends utilized by criminal enterprises. 

Analyze raw intelligence and documented evidence from multiple resources to develop 

actionable leads on viable target(s) involved in possible illicit pill production and/or 

distribution networks. 

Educate overall awareness, hand I ing, trafficking trends, investigative techniques and 

safety to domestic and foreign field offices for all law enforcement. DOD, IC and 

governmental agencies. 

Facilitate, coordinate and educate judicial districts during prosecutions of fentanyl and 

other NPS related cases. 

AlphaBav "Dark Afarkel" Shutdown 

In July 2017, the Justice Department announced the seizure of the largest criminal 

marketplace on the Internet, AlphaBay, which operated for over two years on the dark web and 

was used to sell deadly illegal drugs, stolen and fraudulent identification documents and access 

devices, counterfeit goods, mal ware and other computer hacking tools, firearms, and toxic 

chemicals throughout the world. The international operation to seize AlphaBay's infi·astructure 

was led by the United States and involved cooperation and efforts by law enforcement authorities 

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in Thailand, the Netherlands, Lithuania, Canada. the United Kingdom, and France, as well as the 

European law enforcement agency EuropoL The interagency investigation into AlphaBay 

revealed that numerous vendors sold fentanyl and heroin, and there have been multiple overdose 

deaths across the country attributed to purchases on the site. 

Mexico: Partnership to Reduce Supplv o(lllicii-Narcolics 

DEA, through its partnership with the U.S. Department of State, helps Mexican 

government officials to improve capacity to interdict and seize illicit-narcotics. DEA routinely 

engages with Mexico through the bilateral drug policy working group with the Office of the 

Attorney General (PGR) in Mexico City. These efforts were instrumental in constructive policy 

changes such as Mexico's decision to schedule the two primary fentanyl precursors, ANPP and 

NPP in mid-20 17. 

China: Government Action and Cooperation 

DEA, through its leadership here in the United States and its country office in Beijing, 

has maintained an ongoing relationship with government officials of the People's Republic of 

China for years, and has been able to leverage this relationship to combat the rising threat from 

NPS and their precursors. Engagement has been occurring at the leadership level through 

interagency working groups that operate under the U.S.-China Joint Liaison Group (JLG) 

framework co-chaired by the Department of State's Bureau of International Narcotics and Law 

Enforcement Affairs, DEA, and DHS, including the Counternarcotics Working Group led by the 

Department of Justice, and the Bilateral Drug Intelligence Working Group led by DEA. 

On March 1, 2017, China's National Narcotics Control Commission announced 

scheduling controls against four fentanyl-class substances: carfentanil; furanyl fentanyl; valery! 

fentanyl; and, aery! fentanyl. This announcement was the culmination of ongoing collaboration 

between DEA and the Government of China, and reaffirms an expanding collaborative 

commitment to countering illicit fentanyl. 

Over the past year, DEA and Chinese officials have met regularly to discuss mutual 

interests and shared responsibilities in countering the threat from fentanyl class substances. 

Representatives from the China National Narcotics Laboratory, the Narcotics Control Bureau, 

and the Ministry of Public Security met with DEA (along with Department of Justice and 

Department of Homeland Security) officials to exchange information on emerging substances' 

scientific data, trafficking trends, and sample exchanges. This continued dialogue is anticipated 

to foster a bilateral information exchange related, but not limited to, the identification of new 

substances of abuse that may then be considered for national control. The meeting also deepened 

professional contacts between relevant technical and legal experts. 

A key moment in enhanced cooperation on synthetic drugs came in October of2015, 

when, following similar discussions, China decided to implement domestic controls on 116 NPS, 

which included a number of fentanyl analogues, and streamlined its procedures to control 

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additional substances with no known medicinal use. In total, China has scheduled 138 different 

NPS, including !28 since October 20 !5. 

Finally, as this threat has increased, law enforcement cooperation at the street level has 

been very productive, particularly on fentanyl cases. DEA will continue to collaborate with the 

Government of the People's Republic of China as the threat from fentanyl continues to evolve. 

CONCLUSION 

The United States continues to be affected by a national opioid epidemic, which has been 

spurred, in part, by the rise of abuse of prescription opioids. DEA 's Diversion Control Division 

will continue to use all criminal and regulatory tools possible to identify, target, disrupt, and 

dismantle individuals and organizations responsible for the illicit distribution of pharmaceutical 

controlled substances in violation of the CSA. Additionally, DEA expects that demand for 

opioids will continue to be met in part by Mexican-based TCOs who produce high purity heroin, 

which is being laced with fentanyl, fentanyl analogues, and other synthetic opioids, and then 

pressed into counterfeit pills. DEA will continue to address this threat by pursuing the Mexicanbased TCOs, which have brought tremendous harm to our communities. Working with DOJ and 

our interagency partners, DEA will continue to engage our international counterparts, especially 

China, both multilaterally and bilaterally. We look forward to continuing to work with Congress 

to find solutions necessary to address the threats posed by controlled prescription drugs, heroin, 

and fentanyl. 

-11-
45 

Mr. WALDEN. Mr. Doherty, thank you. We certainly appreciate 

the work that your agents and you all do in this cause and they 

have dangerous work and it is important work and we do appreciate what they do. 

I do want to start with you, however, with a simple question that 

this committee has been asking the DEA for months. Which companies supplied the pharmacy in Kermit, West Virginia that received 

nine million opioid pills in 2 years, and the pharmacy in Oceana, 

West Virginia that received 600 times as many oxycodone pills as 

another pharmacy just eight blocks away between 2005 and 2016? 

Can you give us the names of those companies? 

Mr. DOHERTY. Thank you for that question, Chairman. Currently, we are reviewing the request from the committee and I do 

not have that data with me today. I apologize. 

Mr. WALDEN. So we have asked for this information in a meeting. We have asked for this information in an email. We have 

asked this information in a letter and we have asked this information now in a hearing. If you needed to get this information for enforcement action, I suspect and hope you would get it very quickly, 

right, within hours or days? 

The bipartisan letter this committee sent to your agency earlier 

this month asked the DEA to produce data and documents answering this question and others that we asked by this Friday. Is the 

DEA going to give us this information and documents that we have 

requested by Friday? 

Mr. DOHERTY. Sir, thank you for the follow-up. To your point, sir, 

the DEA, we realize the importance of all the requests from the 

committee and we treat them as such in light of the opioid epidemic. With respect to the questions, for the record, we did turn 

those over last night, sir. 

Mr. WALDEN. Questions from April, I think, right? 

Mr. DOHERTY. Yes, sir. And in terms of a May 8th letter, we have 

been providing the answers on a rolling basis as to not delay an 

overall lengthy response. Those have been provided to the committee on a rolling basis and we continue to work on the few outstanding questions. And to your point, sir, the most recent letter, 

we are in receipt of that and we are preparing a response. 

Mr. WALDEN. So I hope you can appreciate our frustration on 

this side. We have been trying to get to the bottom of this pill 

dumping issue. 

Can we please silence our phones? 

We have been trying to get to the pill dumping issue in West Virginia for a very long time. To me, this is a pretty basic question, 

who are the suppliers? Just yesterday, we finally received answers 

to the questions as you mentioned that we asked for back in April. 

We still don’t have all the answers to the bipartisan letter we sent 

in May. 

Some of the responses the DEA provided, frankly, are not adequate. For example, in the May letter we asked the DEA to 

produce documents about delayed or blocked enforcement actions. 

Do you know how many documents your agency has produced? The 

answer is zero. The agency responded and this is a direct quote, 

DEA is unaware of documents related to the delayed or blocked enforcement actions and suspension orders, close quote. 

46 

We obtained from another source a whole bunch of documents 

that look pretty responsive to our request, and yet from the agency 

we are told you are unaware of documents related to delayed or 

blocked enforcement actions and suspension orders. This is a problem. Enough is enough. Will you on behalf of the DEA commit 

today to producing the documents and information we have requested and soon, or do I simply need to issue a subpoena because 

we are done waiting? 

Mr. DOHERTY. Sir, we appreciate your concern and absolutely we 

are treating it with the utmost importance as it should be treated. 

There is no reason for the extended delay of the questions for the 

record which is now in the possession of the committee. We will 

make every effort to expedite every request that is outstanding to 

the committee. 

Mr. WALDEN. I mean just for members’ awareness on both sides 

of the aisle, the committee received yesterday a set of documents 

from an anonymous source. Bipartisan committee staff are now reviewing these documents. 

Mr. Doherty, I have one more question before I move on. Have 

you or anyone at the DEA that you are aware of received any instructions or directives to erase emails or otherwise destroy documents on this matter or any others? 

Mr. DOHERTY. No, sir. I am not aware of that nor have I been 

involved in any conversation relative to that matter. 

Mr. WALDEN. Dr. McCance-Katz, let me move to you. Given 

SAMHSA’s central role in much of the Federal Government’s efforts to combat the opioid epidemic, it is imperative that you and 

your staff have all of the tools necessary to perform these duties. 

Are there currently any obstacles or barriers hindering you and 

your staff’s ability to respond effectively to this crisis and, if so, 

what can Congress do to help? 

Dr. MCCANCE-KATZ. Thank you, Chairman Walden. We have— 

we are very grateful, actually, for the legislation that has recently 

been passed by Congress in the 21st Century Cures Act and in 

CARA that adds to the armamentarium that SAMHSA had available to it to work with States and communities on issues related 

to mental disorders and substance use disorders, and so at this 

point we are in the process of implementing the laws and are looking to have feedback to then determine whether we need more than 

what we have. 

We have, as you know, through the Cures Act made $500 million, 

each of 2 years, available to the States. We are working with the 

States to develop their plans for evidence-based interventions and 

treatments in their communities and we are following up with 

them to determine outcomes. We collect data as required by law 

and as we get that data we will be looking at it to determine if 

more is needed. 

Mr. WALDEN. Thank you very much. 

Ms. DEGETTE. Mr. Chairman? 

Mr. WALDEN. For what purpose does the gentlelady from Colorado—— 

Ms. DEGETTE. I have a unanimous consent request. 

Mr. WALDEN [continuing]. Seek recognition? Proceed with your 

request. 

47 

Ms. DEGETTE. Mr. Chairman, I would ask unanimous consent to 

place two letters into the record. One is the May 8th, 2017, letter 

that you referred to, which the DEA gave incomplete responses in 

particular documents to that was signed by you, Mr. Pallone, Mr. 

Murphy, me, and Mr. McKinley. And then I would also ask unanimous consent to put the October 13, 2017, letter in the record. That 

is the one that was signed by you and Mr. Pallone and Mr. McKinley and me, which you referred to, under which we have received 

none of the documents that are referenced in that letter. 

And I just think it would be really useful to this hearing if the 

witnesses and the public would know that we have been trying to 

get these documents out of the DEA for quite some number of 

months now. 

Mr. WALDEN. Without objection, those letters will be entered into 

the record. 

And I would encourage our colleagues and others to avail themselves of those letters. I think they ask pretty specific questions 

that shouldn’t be this difficult to get answers to. 

Now I would turn to Mr. Pallone from New Jersey for 5 minutes 

for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. And let me just reiterate again representing the Democrats in support of what Chairman Walden has been saying that we have sent these bipartisan 

letters to DEA requesting specific information, but we have had a 

very difficult problem in getting any answers. So I guess I just 

wanted to start out, Mr. Doherty, by getting a commitment that 

you will provide the committee with timely information and answers to our questions as we move forward because I totally agree 

with everything that the chairman has said. I just—yes or no, 

please. 

Mr. DOHERTY. Ranking Member Pallone, you have our commitment that we will take every request from this committee seriously. We will review it carefully and we will try to make every effort whatsoever to respond in a timely, timely fashion. Yes, sir. 

Mr. PALLONE. Thank you. Now I wanted to move to another issue 

here. Coverage of the response to the epidemic often focuses on expanding access to treatment and increasing the availability of 

naloxone and, however, there are two elements that must fit into 

a larger more comprehensive response. 

Let me go to Dr. McCance-Katz. Could you briefly discuss the importance of deploying a comprehensive response to this epidemic 

spanning the entire spectrum from prevention to recovery? 

Dr. MCCANCE-KATZ. Yes, Ranking Member Pallone. What I can 

say is that there are issues that we need to address in terms of 

prevention, prevention in terms of working with children and families around education, prevention that is targeted to individuals at 

risk for opioid overdose that includes making available the antidote 

naloxone widely available. It also includes providing training to 

first responders and to family members and to getting to physicians and other prescribers to help them understand who is at risk 

given medications they may be receiving in the course of treatment, 

and co-prescribing naloxone when needed. 

In addition, when people develop opioid use disorders they also 

may be at high risk for overdose. They are at risk for overdose 

48 

death and they also need access to the naloxone antidote. We address this in a number of ways. We do that through our treatment 

programs that provide medication-assisted treatment for opioid use 

disorder. And by the way that is a great way for demand reduction. 

We need to increase access to treatment so that people have less 

demand for illicit opioid use. 

Mr. PALLONE. Let me just—I am just running out of time. 

Dr. MCCANCE-KATZ. Oh, sorry. 

Mr. PALLONE. Look, let me just say this. I know you mentioned 

CARA, you mentioned the grants that had been available with the 

21st Century Cures bill, and obviously as I have said, you know, 

I consider these down payments. I still think we need a lot more 

funding for some of these things that you are mentioning and that 

you know, we shouldn’t just see those as down payments. 

I know, tomorrow, the President is having an event at the White 

House and he is going to talk about establishing a national emergency, but I really think that we have to talk about more funding 

for some of these things. Not just the grants that are already out 

there, which are great, don’t get me wrong, but there just needs to 

be a lot more. 

Let me just get to the second question, and this is my only other 

question but I will ask it to you as well as to Dr. Volkow. As previously mentioned, treatment must be part of our comprehensive 

respond efforts. Could you discuss how limiting access or creating 

barriers to treatment could hinder our ability to respond to the crisis? I will ask you and then I will ask Dr. Volkow the same question. 

Dr. MCCANCE-KATZ. Individuals who have opiate addiction, 

which means they are physically dependent on opioid as well as 

have the behavioral dysfunction associated with addiction, are at 

risk for overdose and death and cannot live productive lives. If they 

cannot get access to evidence-based treatment, which includes 

medication-assisted treatment and psychosocial interventions, then 

that places them at greater risk and it is, I will just say it is very 

near impossible to recover without getting assistance in the form 

of these evidence-based interventions. 

And by evidence-based interventions I do mean medication and 

psychosocial services and one of the problems that we see is that 

too often people do not get all of the components of treatment that 

they need to recover. 

Mr. PALLONE. Dr. Volkow, did you want to add to that? 

Dr. VOLKOW. Yes. No, I agree with Dr. McCance. And there are 

three, I would add three things. One of them has to do with the 

notion of how do you get access to medication-assisted treatment? 

One of them is stigma, the other one is lack of sufficient treatment 

programs to be able to deliver it, and the third one is actually the 

lack of reimbursement for these treatments. 

And I think that there are unique opportunities to change these 

and in particular, for example, one of the aspects that we are very 

much invested in partnership with SAMHSA is engaging the 

healthcare system in the expansion of the treatment of individuals 

with substance use disorders. And also I think an opportunity is 

to actually create policy to ensure that individuals are offered, as 

was mentioned earlier by Dr. Gottlieb, the opportunity of having 

49 

access of to any one of the three medications and that they will be 

reimbursed for them and there will be no place of limitations on 

that time that these medications are actually prescribed. 

Mr. PALLONE. I thank you. 

And Mr. Chairman, just let me say again that my concern continues to be that if the effort continues on the Republican side to 

repeal or sabotage the ACA or cut back on Medicaid, that this type 

of treatment will be even more difficult for people to access. But 

thank you, Mr. Chairman. 

Mr. WALDEN. The Chair now recognizes the vice chair of the full 

committee, Mr. Barton, for 5 minutes. 

Mr. BARTON. Thank you, Mr. Chairman. 

I wasn’t aware until I listened to your questions the difficulty the 

committee has had in receiving answers to questions on a bipartisan basis, so I am going to direct what would normally be my 

question period and opening statement to Mr. Doherty. 

We represent the people of the United States. When you get a 

letter or your agency gets a letter from this committee that is 

signed by the chairman and the ranking member and maybe the 

subcommittee chairman, you are supposed to answer it. You are 

not supposed to dodge it. Now, I am a former subcommittee chairman of this committee and I am a former full committee chairman 

of this committee. I have issued subpoenas with the support of the 

minority to members of an administration of my own political 

party. I have had confrontations with cabinet secretaries, with directors of agencies that were appointed by Presidents of my own 

political party. 

It is absolutely unacceptable to listen with a straight face to your 

answers to our chairman. Now if I were you I would go back, get 

the answers in plain English as quickly as possible. If you don’t— 

and I know you are just the spear carrier, you are not the decision 

maker; it is your agency—I am going to recommend to the chairman that we bring the wrath of this committee down on DEA. It 

is inexcusable when people are dying every day from opioid 

overdoses that we have got apparently a 3-month, 4-month running 

dodge from the Trump administration. 

Now our chairman is much more polite than I am, you know, but 

you look up the definition of subpoena, the Constitution of the 

United States and the American people, and get the answers. Can 

you say yes sir to that? I don’t want a dodge answer, I want a yes 

or no answer. Are you going to go back and tell whoever is running 

the show to get the answers our committee chairman on a bipartisan basis wants, yes or no? 

Mr. DOHERTY. Yes, sir. 

Mr. BARTON. Thank you. We will follow up on that. 

Now I want to go to Dr. Gottlieb. What percentage of the opioid 

crisis is prescription drugs versus illegal drugs? Which—— 

Dr. GOTTLIEB. I will defer to my colleague from SAMHSA for the 

current data. It has shifted a lot. 

Dr. MCCANCE-KATZ. So if we look at the most recent NSDUH 

data from 2016 there are about 11.5 million opioid misusers in the 

country, about 948,000 are heroin users. So that—— 

Mr. BARTON. So it is kind of 10 to 1? 

Dr. MCCANCE-KATZ. Yes, sir. 

50 

Mr. BARTON. OK. On the legal prescriptions should we on this 

committee consider criminalizing the prescription, the prescribing 

of legal opioid prescriptions if it is considered excessive? Should 

that become a Federal criminal act? 

Dr. GOTTLIEB. I don’t know who the question is directed, I mean 

that would fall within the context of the Controlled Substances Act. 

We don’t have jurisdiction over the criminalization of prescribing in 

that context. 

Mr. BARTON. Well, we know we have a problem on the illegal 

side and we have been dealing or not dealing with it successfully 

for a number of years. But this excessive use of legal prescription 

drugs, at some point in time the finger points to the doctor that 

is prescribing the drug and that is currently not an illegal act. 

Should we make that an illegal act? When Chairman Walden says 

some pharmacy in West Virginia gets 11 million pills or 9 million 

pills, somebody is prescribing those excessively. Should that be a 

criminal act, Federal criminal act? 

Dr. MCCANCE-KATZ. So if I could, if there is excessive prescribing 

and there is harm to a patient or death of a patient that does become a criminal act. If it is found to be excessive and negligent it 

can be charged as a criminal act. There have been many prescribers who have been prosecuted under current law. The difficulty becomes people who are not dying or having those kinds of 

adverse events that really get to public attention and so that excessive prescribing that puts you at risk for addiction. 

Mr. BARTON. My time is expired. I know on an individual basis 

it is difficult to determine what is excessive prescription—— 

Dr. MCCANCE-KATZ. Yes. 

Mr. BARTON [continuing]. You know, in terms of the patient. But 

the prescriber, if you have a prescriber who is routinely prescribing 

a hundred times opioid prescriptions to the average doctor in the 

area that is somebody I believe we ought to look at. With that, Mr. 

Chairman, I yield back. 

Mr. WALDEN. I think Dr. Schuchat wanted to—— 

Dr. SCHUCHAT. I just wanted to say that quite a lot of the overprescribing is not at that very extreme level, but we are really just 

at the beginning of getting clinicians to do better prescribing. It is 

only a year and a half since the CDC guidelines on prescribing for 

chronic pain and in places that are implementing them we are seeing pretty rapid changes in prescribing. So I think we need to do 

a lot with prescribing that was sort of within the range of practice. 

Mr. WALDEN. All right, thank you. We will now go to my friend 

from California, the gentlelady Ms. Eshoo, for 5 minutes for questions. 

Ms. ESHOO. Thank you, Mr. Chairman. Thank you to all of the 

witnesses. I read your testimony very carefully last night and I am 

left with the following observations. We have passed laws to address the opioid crisis in our country and those two laws have been 

mentioned. We have all of the respective agencies before us working on it. We have a raft of statistics that are the horrible of 

horribles in terms of what this is doing to the country, how many 

people are addicted, how it is ravaging families, communities, et 

cetera, et cetera. 

51 

How much of the crisis is due to opioids being prescribed legally? 

I know that CDC handed this out and I think it tells part of the 

story. For every one prescription or illicit opioid overdose death in 

2015, there were—and then it goes through all of these numbers. 

But what I am trying to figure out is, are we a nation that is just 

almost hopelessly addicted to heroin—and just say that out loud. 

How much is due what is legally prescribed for pain management, 

whatever, and versus how much is due to illegal use? 

And I ask that question because I think we need to direct what 

we are doing. If we are going to put in place new laws or see how 

the laws are already working we need to know this. So who can 

answer that question just very briefly? 

Dr. SCHUCHAT. Yes. This is not an either/or situation. 

Ms. ESHOO. I am not presenting it that way. 

Dr. SCHUCHAT. But to say that—— 

Ms. ESHOO. But I want to understand it better. 

Dr. SCHUCHAT. Sure. 

Ms. ESHOO. I mean is it tilted towards just prescriptions that are 

written? 

Dr. SCHUCHAT. We got into this issue with the prescribing. 

Ms. ESHOO. Pardon me? 

Dr. SCHUCHAT. We got into this issue with prescribing of opiates. 

We prescribe three times higher levels. 

Ms. ESHOO. No, I understand that. I want to know what the—— 

Dr. SCHUCHAT. And most people—— 

Ms. ESHOO [continuing]. Where the dividing line is. Is it 10 percent prescription drugs and 90 percent people that love heroin? 

Dr. SCHUCHAT. Over the last 2 years we had a spike in illicit 

drug-related overdose deaths. 

Ms. ESHOO. But can you tell me what the numbers are? 

Dr. SCHUCHAT. And that was—— 

Ms. ESHOO. Does anyone know? 

Dr. SCHUCHAT. Yes. Well, we had 65,000 deaths in 2016. 

Ms. ESHOO. I know about the deaths. 

Dr. SCHUCHAT. About 49,000 of them were—— 

Ms. ESHOO. I want to know what is bringing it about, though—— 

Dr. SCHUCHAT [continuing]. Related to—— 

Ms. ESHOO [continuing]. In terms of usage. 

Dr. SCHUCHAT. Yes. The increase in 2016 was fentanyl illicit 

laced with heroin. So the increase is the illicit drugs, but most of 

the people who are using illicit drugs became addicted through prescribing, through prescription opioids. That was their initial addictive product. 

Ms. ESHOO. Have the agencies come together to examine, set 

down the, you know, CARA and the 21st Century Act and what 

was contained in them kind of as an overlay on this whole issue 

on opioids and made any kind of determination as to the early effectiveness of these laws; do we know? We don’t know. 

Dr. VOLKOW. No. We don’t know, but we know that—— 

Ms. ESHOO. We don’t know because it is too early? 

Dr. VOLKOW. It is too early. 

Ms. ESHOO. It is too early to know. In the area of treatment how 

much in terms of Federal health insurance programs contain the 

money for this for treatment overall, does anyone know? Well, 

52 

maybe someone can respond later in writing. It would be good to 

know, because if we are busy cutting and undermining that then 

it upends the underlying purpose of this hearing. I mean we can 

talk and talk and talk. We know we have a tremendous problem. 

People are dying daily. But if we are undermining the treatment 

at the same time, I think we need to have that documented. 

Mr. Doherty, how many—you testified that your agency is doing 

everything you can possibly do, overwhelming commitment, et 

cetera, et cetera. I believe you or I would like to believe you. How 

many opioid-related cases have actually been successfully adjudicated and how many open, active cases are there coming out of 

your agency and its work doubling down on the opioid crisis in our 

country? 

Mr. DOHERTY. Ma’am, historically, in the—— 

Ms. ESHOO. No, I don’t want to know historically. I want to know 

up to date. 

Mr. DOHERTY. Well, ma’am, during the last year there have been 

approximately 2,000 arrests made with respect to diversion control 

cases and that would represent approximately 1,600 cases that 

were initiated. Those represent sweeping enforcement actions such 

as a weeklong action that took place this past July in partnerships 

with HHS and the FBI, the National Health Care Fraud Takedown 

initiative. 

This was the first year the DEA was a full partner, 120 of the 

412—— 

Ms. ESHOO. Does it include the companies that you haven’t identified yet? 

Mr. DOHERTY. I am sorry, ma’am? 

Ms. ESHOO. Does it include the companies that you have not 

identified yet? 

Mr. DOHERTY. That did not include companies. These were 120 

individuals prescribing opioids of which 115 of the 412 were medical professionals. 

Ms. ESHOO. I am way over my time. Thank you, Mr. Chairman. 

Mr. WALDEN. Thank you. We now go to the gentleman from Illinois, Mr. Shimkus, for 5 minutes on questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. Thanks for the hearing. Thank you all for being here. 

I am going to shift some of the tone. Just a couple days ago I 

tweaked my back. I was in pain. When we went through this process last Congress, I was visited by a lot of patient groups who were 

just concerned that the pendulum would shift. And we use the term 

‘‘chronic pain,’’ you know, people who have it forever, and I want 

to make sure that we don’t lose them in this debate, people who 

wouldn’t be able to get out of bed without some assistance. 

So I do have a statement for the record, Mr. Chairman, I would 

ask unanimous consent, from the American Physical Therapy Association addressing this. 

Mr. WALDEN. Without objection. 

[The information appears at the conclusion of the hearing.] 

Mr. SHIMKUS. Because then it goes into my first question for Dr. 

McCance-Katz. In your question-and-answer and some of your comments, you talked about all of the components of treatment, which 

as I am getting more educated in this process it seems to me that 

53 

we are not always considering all of the components, or maybe physicians, they may get stovepiped into one delivery system. And 

every patient is different, every pain issue, and that is kind of 

where the physical therapists are saying, hey, this should be part 

of some treatment. 

So can you for the sake of all of us kind of talk about the difference between naltrexone, Suboxone, and methadone, just briefly? 

Dr. MCCANCE-KATZ. I will try. Yes, so naltrexone is an opioid antagonist. What that means is that it will block the effects of an opiate. So if somebody is opiate-addicted and they are withdrawn from 

those opioids and then started on naltrexone and then they use an 

opioid again they will not get the effect that they were expecting, 

so it will block them from getting high. So that is the value of 

naltrexone. 

It is often seen as a medication that gives a person a chance to 

get back to counseling because they may relapse while they are in 

their regular using environments—— 

Mr. SHIMKUS. OK, just pushing you—Suboxone. 

Dr. MCCANCE-KATZ. I am sorry? Oh, you want me to go on. 

Mr. SHIMKUS. Just pushing you. 

Dr. MCCANCE-KATZ. OK, here you go. Suboxone is what we call 

an opioid partial agonist, and what that means is that it has lower 

abuse liability and has less potency in terms of euphoric effects—— 

Mr. SHIMKUS. OK, methadone. 

Dr. MCCANCE-KATZ [continuing]. Than does methadone which is 

what we call a full agonist and it is a medication that is only available for the treatment of opioid use disorder through federally regulated opioid treatment programs which my agency regulates. 

Mr. SHIMKUS. OK, let me go to Dr. Schuchat. How does CDC inform evidence-based best practices? So if you are using these three 

different things how do you collect that data? 

Dr. SCHUCHAT. CDC is working to evaluate the medication-assisted treatment and counseling efforts that SAMHSA has right 

now, so we actually have a study in the field with these different 

modalities, look at outcomes—— 

Mr. SHIMKUS. So then the information can get out and people—— 

Dr. SCHUCHAT. Right, so that we can share—— 

Mr. SHIMKUS [continuing]. Can make better determinations. 

OK, let me go to Mr. Doherty. This will be a friendly question. 

Category II or III what is the difference? 

Mr. DOHERTY. Schedule? 

Mr. SHIMKUS. Schedule, yes, Schedule II or III on the drug listing. 

Mr. DOHERTY. Yes, sir. So with respect to Schedule II, for instance, those are controlled prescription pain medications in the 

oxycodone, hydrocodone family and we certainly, they go in a range 

from III, IV, and so on. 

Mr. SHIMKUS. So what is the difference between a II and a III? 

Mr. DOHERTY. The difference is, sir, is that it is more strictly 

controlled within DEA on the schedule. 

Mr. SHIMKUS. Why? 

Mr. DOHERTY. Based on the scientific dependency of it too. 

Mr. SHIMKUS. OK, dependency, what else? 

54 

Mr. DOHERTY. Danger for abuse. 

Mr. SHIMKUS. Danger for abuse. 

OK, let me go to Dr. Gottlieb, FDA black box labeling. It is my 

understanding there is no communication based upon Schedule and 

what might be labeled. Now you see where my whole thrust of 

these questions is more information, more different practices, and 

then that would also go to labeling. If DEA says Schedule III is less 

addictive, shouldn’t that maybe be listed on the label? 

Dr. GOTTLIEB. I could certainly take it back to the agency. There 

is labeling language that reflects some of the qualities of the drugs 

that relate to their abuse potential currently. 

Mr. SHIMKUS. Do you agree that there may or, I mean I would 

hope that we would talk together and that our agencies would communicate that. That might give the practitioners a little more information. 

Mr. Chairman, my time is expired. I yield back. 

Mr. WALDEN. I thank the gentleman’s comments. It is interesting 

in Oregon, I think through the Oregon Health Plan, they actually 

often give the antidote naloxone with the prescription for opioids, 

which the people in the roundtables I have been in sends a real signal of seriousness about what people are being given to take, the 

opiates, because here is the antidote because it may kill you. And 

they tell me that gets the attention of those receiving the prescription. 

With that we will turn to the gentleman from New York, Mr. 

Engel, for 5 minutes for questions. 

Mr. ENGEL. Thank you, Mr. Chairman and Mr. Pallone, for convening today’s hearing. 

This epidemic has touched so many people in each of our districts 

in so many ways, so I would like to talk about the specific challenges in my district facing Westchester County in New York and 

the Bronx in New York City. I represent a large portion of Westchester where opioid-related deaths shot up more than 200 percent 

between 2010 and 2015, but that changed in 2016 when the rate 

of opioid-related deaths in Westchester fell nearly 30 percent and 

evidence suggests this was thanks to the overdose reversal drug 

naloxone. Naloxone. That is why I didn’t go to medical school, law 

school was easier. 

Between 2015 and 2016, Westchester EMS workers and law enforcement began using this medication much more frequently following State and local efforts to make it more accessible and ensure first responders know how to use it, so I believe this shows 

what is possible when we afford communities the resources they 

need. So Congress must continue to invest the necessary funds to 

respond to the opioid epidemic and support proven public health 

approaches spanning the entire spectrum from prevention all the 

way to recovery. 

I am so encouraged to see a devastating trend reversed in Westchester, but this battle obviously is far from over. Naloxone is certainly a lifesaver but it could also be a gamechanger, and if we can 

connect people with treatment after they have overdosed we might 

even save more lives. 

55 

So Dr. McCance-Katz, how are we doing as a country with respect to connecting Americans with treatment after they have 

overdosed and how can Congress help us do even better? 

Dr. MCCANCE-KATZ. Yes. Thank you for that question. 

And so we have, SAMHSA has a number of programs that are 

demonstration programs across the country that address issues 

around the need for naloxone as an antidote. Treatment in EDs 

and what we are doing in the models that we are working with include bringing peers, people with lived experience of opiate addiction into the emergency departments so that they can talk with 

people who have experienced an overdose and provide them some 

guidance and help and support to get them to treatment. And we 

are in the process of having these programs under—they are ongoing right now and we will be evaluating those programs. 

I will tell you though I am from Rhode Island. I come to Federal 

service having been a practicing physician, a psychiatrist in Rhode 

Island, and was involved with the opioid epidemic in Rhode Island. 

And one of the things that we observed in Rhode Island was that 

a lot of times when people are reversed they are not comfortable, 

that sometimes they will experience opiate withdrawal when they 

are given naloxone and they are not ready. They are not ready to 

commit to treatment at that time. 

And so what we started doing was getting consent from people 

so that our peers could follow up with them in communities. And 

we think this is going to be a key piece of connecting people to 

treatment and we will be expanding those kinds of models at 

SAMHSA. 

Mr. ENGEL. Well, thank you. And let me say the other part of 

my district is the Bronx. We are not seeing, unfortunately, the 

same signs of hope there. More New Yorkers die of overdoses in the 

Bronx than in any other city borough last year. Eighty-five percent 

of those deaths involved opioids. 

And despite the proximity and attached to each other, Westchester and the Bronx have many differences. On average, communities in the Bronx have fewer resources, the uninsured rate is 

higher, and communities are more diverse. So the disparity that we 

are seeing and the trajectory of these counties’ opioid epidemics is 

also an economic disparity and a racial disparity. So the consequences of this disparity are really heartbreaking. Your ZIP Code 

should not determine your health or what you get to make you better. We need to do better. 

So on the basis of that statement, let me ask Dr. Schuchat and 

Dr. McCance-Katz again, how can Congress address these disparities and ensure that every person regardless of sex, race, location, 

or income has the same ability to get treatment? 

Dr. MCCANCE-KATZ. I will just say SAMHSA has an Office for 

Behavioral Health Equity. We are very involved in monitoring 

those kinds of issues and we work very hard to provide guidance 

to States and communities on culturally appropriate, culturally 

sensitive interventions, and we will be continuing that work. 

Mr. ENGEL. Dr. Schuchat? 

Dr. SCHUCHAT. Yes. And one of the things CDC was able to do 

with the increased funding this past year was strengthen the 

syndromic surveillance goal from 12 States to 32. And what that 

56 

has allowed is better data on where the problems are, hotspots or 

inequities can be followed up and so you can get more resources. 

Even the naloxone distribution can be targeted to where the 

overdoses are highest and expanding services into those areas. 

I know in the New York area, in New York City area that has 

been done, trying to figure out where the need is and get the clinical services closer to those hotspots. 

Mr. ENGEL. Thank you both. Thank you, Mr. Chairman. 

Mr. WALDEN. Thank you, Mr. Engel. We will now go to the chairman of the Subcommittee on Health, the doctor from Texas, Dr. 

Burgess. 

Mr. BURGESS. Thank you, Mr. Chairman, and thanks for holding 

this hearing. First off, I am going to ask unanimous consent to my 

opening statement being made part of the record. 

Mr. WALDEN. Without objection. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. And I will point out that your attention to this 

issue has been important. At the subcommittee level as you know 

we heard from over 50 members, not just from on the committee 

but throughout the Congress, 50 members. We held a Members’ 

Day on problems that people were having with opiate abuse back 

in their districts and we did hear that it literally touches every 

part of the country. 

I am going to ask questions of the doctors on the panel. I have 

been on this committee long enough to remember when we had a 

hearing on the underprescribing of pain medicine in 2005, so just 

for those of you who are still in practice, what is a doctor to do? 

You have a patient that has a condition that is painful and you 

want to alleviate that suffering. How do you now approach that? 

Are you not going to use an opiate where you might have otherwise 

thought it was appropriate? 

Dr. Gottlieb, you referenced that it is going to cause us to think 

in some uncomfortable ways because we have run out of reasonable 

options. So starting with you I would just like to go down the panel 

and hear from you. 

Dr. GOTTLIEB. Thank you for the question, Congressman. There 

is a role for these medications in medical practice and there is patients who have acute pain conditions where these medications can 

be effective. There are some patients with chronic conditions like 

metastatic cancer pain that are going to require long-term treatment with opioids. But I do think that there was a generation of 

physicians trained, and I think it was my generation of physicians 

trained, to make more indiscriminate use of these drugs than we 

should have. 

I remember when I was practicing in the hospital as a resident, 

and that is not too long ago, every patient had a standing order for 

Percocet. Every 6 hours a patient had a standing order for two tabs 

of Percocet that could be prescribed at the nurse’s discretion, almost every patient. That wasn’t good medical practice we now 

know. That sensitized a lot of patients who were hospitalized for 

5 or 6 days to round-the-clock, immediate-release formulations of 

opioids, and some of those patients left the hospital addicted. 

So I think we need to rethink how we use these drugs and I 

think we are in the process of doing that. But that is going to also 

57 

require to reeducate a generation of physicians and that is what we 

are doing. 

Mr. BURGESS. Since you brought up your residency I will bring 

up mine. My generation of doctors was able to put a refill on a prescription that we sent home with the patient and somewhere along 

the line that ended. Now I realize those are State laws, but the inability to refill a prescription, and really this is for any of you, the 

inability to refill a prescription without going back and seeing the 

doctor and having that face-to-face encounter, I mean it seems to 

me that human behavior might dictate that a doctor would—I don’t 

want to get calls for a refill on a pain medicine so I will write it 

for twice the amount that I used to write it for. Does that happen? 

Dr. GOTTLIEB. Look, I will defer to my colleagues who have more 

substantive data on these issues. But when we look at the epidemiology we see too many 30-day prescriptions being written for indications for which, you know, the proper course would be a 4- or 5- 

day prescription. You have dental procedures, minor surgical procedures, so we do see that happening. 

And to the extent that we believe that addiction correlates with 

exposure, and one of the keys to solving the new addiction crisis 

is to reduce overall exposure to opioid drugs, you would want to encourage approaches that make it easier if not try to create more direct incentives to prescribe shorter duration uses. That includes 

packaging. It includes proper education. These are things we are 

looking at doing. 

Mr. BURGESS. Sure. I am going to have to jump ahead so I am 

going to ask all of you to respond to that question in writing to me 

if you would, because I do need to ask Mr. Doherty a question on— 

you used a term that I was not familiar with, the CPOT; is that 

right? 

Mr. DOHERTY. That is correct, sir. 

Mr. BURGESS. And that stood for? 

Mr. DOHERTY. CPOT stands for Consolidated Priority Organization Target, and it is a Department of Justice term designated for 

our most prolific trafficking organizations in the world. 

Mr. BURGESS. And what legal tools do you have? When you arrest a CPOT and bring a successful prosecution what are you 

charging them with, just the drug laws or are you able to charge 

them with injury to a person or murder? 

Mr. DOHERTY. Well, with respect to your question, sir, and thank 

you, the CPOT designation is typically affiliated with organizations, mainly international organizations, our large target list in 

China, our target list in Mexico. So to point out the press release 

last week of the two Chinese nationals that I mentioned in my 

opening statement—— 

Mr. BURGESS. Right. 

Mr. DOHERTY [continuing]. These individuals are prolific in nature shipping massive amounts of fentanyl to our country. 

Mr. BURGESS. So if you are successful in prosecuting them, what 

statute are they prosecuted under? 

Mr. DOHERTY. Sir, they would be prosecuted under a variety of 

violations, importation. 

Mr. BURGESS. So how long do they go away for? 

Mr. DOHERTY. Sir, I can’t comment on that particular case. 

58 

Mr. BURGESS. But in general what would the sentencing guidelines be? 

Mr. DOHERTY. Generally speaking, if we were to go after a CPOT 

and either arrest him in the United States or have him extradited, 

potentially, hypothetically he could stand RICO charges. He could 

stand murder charges. He could stand money laundering charges. 

He could stand wire fraud charges. So really—— 

Mr. BURGESS. Is it theoretically possible to bring murder charges 

against someone in that situation? 

Mr. DOHERTY. If we can definitely prove, and again I realize this 

is a hypothetical situation. 

Mr. BURGESS. Sure. 

Mr. DOHERTY. If we can definitively prove that either he was directly involved, he or she was directly involved in murder or supplied fentanyl to individuals in this country that overdosed and 

died, we would definitely, unequivocally, bring murder charges, 

death resulting charges on these individuals. 

Mr. BURGESS. And I would make that widely known and dispersed. Thank you, Mr. Chairman. Thank you, sir. 

Mr. WALDEN. Thank you, Mr. Chairman. And one of those folks, 

an Oregonian overdosed related to that case where the indictments 

came down, so it is personal to our State. We will go now to the 

gentleman from Texas, Mr. Green, for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman and our ranking member, 

for this really important hearing today. The 21st Century Cures 

Act contained a billion dollars to fight the opioid epidemic. This is 

substantial but certainly not enough to win the fight. 

Dr. Schuchat, can you talk about how this funding is being used 

on the ground? 

Dr. SCHUCHAT. Well, the 21st Century Cures Act didn’t actually 

provide funding to the CDC, so I probably want to let my colleagues talk about that. The committee in last year’s 2017 appropriation did give, separately give CDC a $50 million increase which 

has been incredibly helpful in our reaching out to more States to 

speed up the timing of the quality data that helps them know what 

they are doing and to increase the consumer awareness with the 

communication effort. 

But I should probably let my colleagues talk about the funding. 

Mr. GREEN. Whichever has the information, I was wondering 

what the outreach was. You know, it is relatively soon for even 

though the bill was passed, but what are we seeing changed now 

because of that? 

Dr. MCCANCE-KATZ. Yes. So SAMHSA is responsible for the 

State Targeted Response. This is the 500 million a year for each 

of 2 years. The first year was allocated to the States. We have been 

working with the States on developing their plans based on their 

assessments of their communities and their needs related to prevention, treatment, and recovery services. 

We review those. We make sure that evidence-based practices 

are being used and then the States will procure the services that 

they need to implement those plans and we are at that point right 

now, sir. 

59 

Mr. GREEN. OK. I would hope you would continue because, you 

know, we want to see where this—and you are learning I guess 

from different States on what works and what doesn’t. 

Dr. MCCANCE-KATZ. Yes. And we would be happy to provide additional information as time goes on to this committee. 

Mr. GREEN. OK, thank you. 

Dr. Volkow, I understand that NIH is partnering public and private stakeholders to accelerate the research in the non-opioid, nonaddictive therapies. I also understand that Dr. Gottlieb has taken 

proactive steps to provide information and to reshape the provider 

behaviors as it relates to prescribing practices for opioid. 

This panel would be the experts who are actively engaged in 

fighting the public health battle, so I want to ask you what I believe is a key question on the strategy going forward. How do we 

elevate the value and utilization of alternatives of the opioids 

across the healthcare system? Some alternatives do exist today and 

are we hearing more are in the development? 

But given the rampant rate of prescribing and use of opioids how 

do we change that part of the problem? And that was any—— 

Dr. VOLKOW. Yes. No, and I think that the point has to do with 

how do you change the practice of clinicians that have been overrelying on the utilization of opiate medications for a variety of reasons to treat severe pain and become actually to treat not so severe 

pain. 

So one of the big challenges is how do you implement the CDC 

guidelines, number one. And number two, among one of the challenges is to ensure that physicians will be reimbursed for actually 

following the guidelines. Because what they recommend is a multipronged approach for the management of pain, integrated response 

that is much more expensive than what it would cost to give you 

an opioid prescription. 

So as we are discussing the notion of changing and educating 

and training physicians on the use of prescription opioids and management of pain, we need to change the structure of reimbursement 

so that the doctors can do the right thing for their patients and get 

reimbursed for it. 

Dr. GOTTLIEB. I will just, I can pick up just to add that we do 

see innovations in the pipeline that could provide alternatives to 

opioids and provide opioids that are harder to manipulate in ways 

that could help defeat abuse. We see technologies that where the 

opioid-like drugs but are biased at the mu-opioid receptor in ways 

that might not have the same addictive potential. We see second 

and third generation abuse deterrent formulations that are potentially much harder to abuse, things like prodrugs in development. 

So there are very interesting, very promising technologies available 

that could potentially treat chronic and acute pain in ways that 

don’t lead to the same addiction. 

And I would also offer that there is a lot of medical device alternatives. We have approved about 200 different medical devices that 

have components that treat pain, about ten of those are very novel 

devices. And so we see a lot of opportunity looking across the continuum of medical devices as well to help address painful syndromes locally rather than systemically. 

60 

So there is a lot of opportunity and we have fast tracked some 

of these products. These products would be also eligible for the 

breakthrough therapy designation that this committee made available to the agency. 

Mr. GREEN. Thank you, Mr. Chairman. 

Mr. BURGESS [presiding]. The gentleman’s time has expired. The 

gentleman yields back. The Chair recognizes the gentlelady from 

Tennessee, 5 minutes for questions, please. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. We appreciate that 

all of you are here. As you have heard from everybody, this is work 

we have been working on for years and trying to figure out how 

to best get a handle on this issue and end this epidemic and it is 

so important that we hear from you. 

What I want to start with, and this is to each of you on this 

panel, are there any existing statutes that prevent your agency, 

your respective agencies, from effectively responding to the opioid 

crisis? 

Dr. GOTTLIEB. Well, Congresswoman, we would be delighted to 

work with the committee to look across the range of our different 

authorities and what more we can be doing. The one that I would 

just point out in response to your question is where we are trying 

to take some new steps to think about how we step up our oversight in the international mail facilities to target synthetic drugs 

coming in through the mail. And in this regard we have worked 

very closely with Customs and Border Patrol, the commissioner 

there has been a very good colleague to FDA. 

But there is the potential that we might want to take a look at 

some point at some of the seizure authority we have—— 

Mrs. BLACKBURN. OK. 

Dr. GOTTLIEB [continuing]. To perhaps make it more efficient to 

operate inside those IMFs. 

Mrs. BLACKBURN. OK, anyone else have any existing statute that 

is an impediment? 

Mr. DOHERTY. Ma’am, from DEA’s standpoint, and I will address 

what was recently reported in the media, one of our administrative 

tools, an immediate suspension order recently came under report in 

the media. 

We would be happy to work with Congress and we look forward 

to working with Congress with Department of Justice oversight to 

ensure that from an enforcement, criminal enforcement perspective, a civil sanction perspective, and an administrative perspective, which are all tools that we use to prevent the diversion of illicit pharmaceuticals, we would be more than happy to work, as I 

said, with Congress with Department of Justice oversight to ensure 

that we have the most updated and applicable tools moving forward to attack the opioid crisis. 

Mrs. BLACKBURN. OK, anyone else? 

Dr. VOLKOW. Well, I think that on following my DEA colleague, 

I think one of the issues that becomes very important on the aspect 

of research is our ability to work with substances that are being 

abused, illicit substances that are very, very dangerous. And that 

is important because if we don’t understand it from microbiological 

properties we cannot actually develop treatments. And one of the 

61 

aspects on it is that because they are Schedule I substances then 

it can become very, very difficult to actually do research on them. 

So being able to generate the category that allows us to protect 

the public from these substances what allows us to do that research would facilitate our ability to respond to this. 

Mrs. BLACKBURN. OK. That is great. And if any of you would like 

to submit something to us in writing that would be helpful. 

And Dr. McCance-Katz, you mentioned and I will just ask you 

to submit this in writing, you talked about implementation of 21st 

Century Cures. If you will give us your timeline for where you are 

on that because, and you can just give it to us in writing. 

Dr. MCCANCE-KATZ. I will. 

Mrs. BLACKBURN. We are all interested in that because that is 

getting the money out to our States and that is an imperative for 

us. 

Mr. Doherty, I am coming back to you on the Ensuring Patient 

Access and Effective Drug Enforcement Act. It required, it required 

the DEA and HHS to submit a report to Congress identifying current issues with diversion efforts including information on whether 

coordination between the industry and law enforcement has helped. 

And that report was due to us in April, so it is now 6 months late. 

I sent a letter over this week asking about this report, so why 

don’t you—and Mr. Chairman, I would like to submit for the record 

the letter that was sent over requesting the delayed report. 

Mr. BURGESS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mrs. BLACKBURN. And what I would like to hear from you is, 

what is the status of that report? You have heard the frustration 

with this panel for not getting information we need from the DEA, 

so we are adding this to the list. Where is the report? What is the 

status of it, when should we receive it? 

Mr. DOHERTY. Congresswoman, thank you for that question. And 

with respect to the report that you mentioned, DEA has engaged 

with Health and Human Services on that report and it is my—— 

Mrs. BLACKBURN. Engaging isn’t getting a report to us that is 

now 6 months late. So when do we get the report? 

Mr. DOHERTY. It is my understanding, ma’am, that HHS has the 

lead on this report that you reference. 

Mrs. BLACKBURN. Have you all submitted your needed information to HHS to write this report? 

Mr. DOHERTY. I believe we have and we have been actively working on our part of the report with them. 

Mrs. BLACKBURN. OK, thank you, yield back. 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. The Chair recognizes the gentlelady from Colorado, 

Ms. DeGette, for 5 minutes for questions, please. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Mr. Chairman, we have been talking today about 21st Century 

Cures and the billion dollars that Fred Upton and I were pleased 

to put into that bill for State funding to develop opioid prevention 

programs. Just for the record, in Colorado we have a program 

called the Consortium for Prescription Drug Abuse Prevention. 

They are already taking this money from Cures and they are already doing work to reduce overdose deaths. It is really important 

62 

that we do this on a State-by-State level because the States have 

different needs, and I would hope that we would work as a committee to extend that funding out past 2018 because it expires in 

2018. 

Mr. Doherty, I just want to follow up—I am over here. I want 

to follow up on a couple of the chairman’s questions and others. We 

have been talking to you about that May and that October letter 

that we sent to the DEA asking for responses and documents. Were 

you aware that the chairman and several other members also met 

with the Acting Director of the DEA in July, on July 28th of this 

year? Were you aware of that meeting? 

Mr. DOHERTY. Yes, ma’am. 

Ms. DEGETTE. And were you aware that at that meeting we also 

asked him to provide that documentation and those answers, and 

he said he would? 

Mr. DOHERTY. Ma’am, I am generally aware of the meeting. I am 

not sure what was discussed at the meeting. 

Ms. DEGETTE. OK. Well, I will tell you that is what happened. 

Now I also want to ask you, as the chairman said, we have been 

investigating reports of shipments of large amounts of opioids to 

Kermit, West Virginia. Can you tell us today which distributor, or 

distributors, supplies those large amounts of opioids to the pharmacies in Kermit, West Virginia? 

Mr. DOHERTY. Ma’am, as I said before, I don’t have that information with me. 

Ms. DEGETTE. When can we expect to get that information from 

you? 

Mr. DOHERTY. And we will expedite that information and after 

the hearing. 

Ms. DEGETTE. One week, one month, one year—when can we expect to get it? 

Mr. DOHERTY. Ma’am, I would not be able to put a timetable on 

that. 

Ms. DEGETTE. You are not going to tell me. 

Mr. DOHERTY. I will—— 

Ms. DEGETTE. Chairman, I think that subpoenas may be really 

considered in this point. 

Let me ask you another question. On the October 13th letter 

which I put into the record a little while ago, the committee using 

DEA’s collected ARCOS data looked at the amount of hydrocodone 

and oxycodone that went into the various regions of West Virginia 

and they show that from 2000 to 2010 there were dramatic increases in the distribution of opioids to the regions examined by 

the committee. Would you agree that some of these trends are troubling? 

Mr. DOHERTY. Yes, ma’am. I would. 

Ms. DEGETTE. OK. And has the DEA conducted its on analysis 

of its ARCOS data regarding the trends in West Virginia and does 

the DEA know which distributors were responsible for this? 

Mr. DOHERTY. Ma’am, the DEA has upgraded our office—— 

Ms. DEGETTE. I think yes or no will work. Do you know who did 

this? 

63 

Mr. DOHERTY. Ma’am, with respect to the shipments, the ARCOS 

data provides information and we are currently unable to determine definitively—— 

Ms. DEGETTE. So you don’t know. 

Mr. DOHERTY. It is my understanding currently that we have information relative to companies involved and we are reviewing that 

data to determine what we can legally—— 

Ms. DEGETTE. And I assume we will get that answer too, correct? 

Mr. DOHERTY. Yes, ma’am. 

Ms. DEGETTE. OK. 

Dr. Volkow, I wanted to ask you a question about the naloxone. 

You had a really snappy spray of the naloxone that you used, but 

I think you can probably tell us that most of the people who are 

distributing naloxone cannot afford that; isn’t that accurate? 

Dr. VOLKOW. Thanks for the question because I think it is very 

important. 

Ms. DEGETTE. OK. 

Dr. VOLKOW. We can have very fancy scientific tools that are so 

expensive that nobody can afford it. 

Ms. DEGETTE. Right. 

Dr. VOLKOW. This thing costs $37.50. 

Ms. DEGETTE. Well, unfortunately, I—what is the manufacturer 

of that? 

Dr. VOLKOW. This is Opiant, and it is in partnership with the 

Adapt Pharma. 

Ms. DEGETTE. OK. So the Adapt price in 2016 according to the 

New England Journal of Medicine was $150. And in fact, in the 

August recess this year, I went over to the Harm Reduction Center 

in Denver. I actually got trained how to use naloxone, and they 

gave me some naloxone that they give out to people. They told me 

they can’t afford to use that. And what they gave me was this little 

vial of chemicals and they gave me a syringe and another little 

vial—which I actually learned how to inject somebody—and the 

reason they use that is because that one costs only $39.50. 

And so my point to you and the point I want to make to the 

chairman: We are going to have to do some more investigation in 

this committee. This is where it intersects with the increase in prescription drug prices. Because the auto injector was $690 and now 

it is $4,500, the one that you have got there it is $150. Even the 

one I have here, between I think 2014 and 2016 has gone up to 

39.60. 

So it is great to have naloxone for people, but if you don’t have 

something that is easy to administer because the prices are just 

going up, then it is not going to be usable. 

Dr. VOLKOW. And I completely resonate with you we want to do 

things that are affordable. But I want to comment on the notion 

that this implementing the syringe does not deliver naloxone at 

sufficiently high concentrations because it is very diluted. So we 

not only have to give something that is affordable, but we need to 

give something that is effective. 

Ms. DEGETTE. You are totally right. I agree, thank you. Thanks, 

Mr. Chairman. 

64 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. The Chair recognizes the gentleman from Ohio, Mr. 

Latta, 5 minutes for questions, please. 

Mr. LATTA. Well, thank you very much, Mr. Chairman. And 

thank you very much to our panel today. We really appreciate you 

being here and this is a very, very important hearing that we are 

having today. Ohio, in 2015, we lost 3,050 people because of opioid 

overdoses and last year that total went up to 4,050. And our county 

coroners are now predicting that unfortunately we are on a pace 

to exceed the 2016 numbers. 

And I have my second opioid forum and that was held last week 

and, you know, when you are talking about these statistics of 3,050 

or 4,050 people losing their lives, you know, those are the statistics 

but you put a face with them. And I talked with a parent who had 

lost a child because of opioid overdose and it is, you know, it is 

heartbreaking. And so I am very happy that you are here today because this is a very important subject and we are in an epidemic 

across this country. 

And Dr. McCance-Katz, if I can start with you, CARA provided 

significant funding for States to expand substance use disorder 

treatment through grants administered by SAMHSA. In addition, 

CARA required that grantees submit data that will be posted online and easily searchable. Can you provide us with a status update 

of those requirements? 

Dr. MCCANCE-KATZ. Yes. So SAMHSA has awarded grants under 

the CARA initiative, the legislative requirements. Some of those we 

call this our MAT–PDOA program which is focused on medicationassisted treatment specifically for prescription opioids and heroin 

users. And so we are collecting data and that data will be available 

at the end of the program and it will be available to individuals 

to easily analyze, yes. 

Mr. LATTA. Let me follow up too. And what accountability measures is SAMHSA requiring to make sure of States to make sure 

that that grant money is being wisely spent out there? 

Dr. MCCANCE-KATZ. Yes. Thank you for that question. What is 

required is that they submit to SAMHSA their plans for their 

States and what practices they intend to use. We review those. We 

provide guidance to them. And in the terms and conditions of grant 

award they are required to use evidence-based practices going forward and so we will be working very closely with them. 

Now that requires that we provide them technical assistance and 

so that they can make determinations of what evidence-based practices are best for their communities, every State being different of 

course. And we are developing a new program of enhanced technical assistance where we will help States to get experts from the 

various fields that provide care in substance use disorder treatment—psychiatrists, addiction medicine specialists, advanced practice nurse practitioners, physician assistants, social workers, 

peers—that will be available to States to help them as they think 

through their needs and put evidence-based practices in place. 

Mr. LATTA. Well, thank you. And when we had the forum last 

week in my district one of the things that came up, and this will 

pretty much be a yes or no answer for all of the panel that is here 

today, part of the issue is for a lot of the folks out there is a lack 

65 

of reliable information and data that is available out there and it 

is difficult for many of especially smaller communities to find funding streams and access information on how effective Government 

programs have been to combat opiate abuse. I am working on a bill 

right now that would create a publicly accessible electronic database to help mitigate these problems. 

And I would just like to ask each of you real quickly if yes or 

no would you all be, as we are working on this legislation to collaborate with me to make sure we can get this information out 

there to the public, because again it is a very, very difficult thing 

for the smaller communities, smaller agencies to do. So if I could 

just go right down the line, if I could ask for your cooperation on 

that. 

Dr. GOTTLIEB. Yes, sir, Congressman. 

Dr. MCCANCE-KATZ. Yes, happy to do that. 

Mr. DOHERTY. Yes, sir. We would be happy to work on that. 

Dr. SCHUCHAT. Absolutely. 

Dr. VOLKOW. We would be delighted. 

Mr. LATTA. Well, thank you very much. And maybe if I can just 

follow up with the remaining time that I have with FDA. You 

know, when we were talking and you mentioning, Doctor, about 

that you know what we have with the epidemic we have in the 

United States, but looking around the world, do other countries 

have the same situation that we have with this opioid epidemic? 

Dr. GOTTLIEB. I would defer to my colleague from SAMHSA, but 

my experience with the data is no, Congressman, and prescribing 

in other countries isn’t as rampant as it is here in the United 

States. 

Mr. LATTA. So you are saying it is on the prescribing side because of where we have gone. 

Maybe I could, Mr. Chairman, I am a little bit over my time 

but—— 

Dr. GOTTLIEB. Certainly that started on the prescribing side. We 

still have, I think it is a fair assessment we still have too many 

prescriptions being written particularly for the IR formulations of 

these drugs, 190 million prescriptions a year represents 90 percent 

of all the prescriptions that are written for opioids. But increasingly, it is shifting to a problem of illicit drugs and low-cost alternatives which are the heroins and the synthetic fentanyls. 

Mr. LATTA. Well, thank you very much, Mr. Chairman. My time 

is expired. 

Mr. BURGESS. The gentleman is correct, his time has expired. 

The Chair recognizes the gentleman from Pennsylvania, Mr. Doyle, 

5 minutes for questions, please. 

Mr. DOYLE. Thank you, Mr. Chairman. 

Based on CDC data in 2015, over 4,200 individuals age 15 to 24 

died of drug-related overdose deaths. This is an increase of almost 

200 percent since 2000 when the number was less than 1,500. So 

we know that children, adolescents, and young adults are part of 

this epidemic. Not just because they are losing parents and being 

sent to foster care, but because they are using drugs, getting addicted, and dying. The Children’s Hospital of Pittsburgh has 

screened more than 31,000 children in the first 3 months of their 

66 

new program rollout and has already found 60 children to be at 

high risk for or at levels of substance abuse. 

So my question for the panelists, and I would start with Dr. 

McCance-Katz, what resources are being directed across the agency 

to the prevention and treatment of substance use disorder in children and adolescents? 

Dr. MCCANCE-KATZ. We have a number of initiatives that address substance abuse and substance abuse prevention in children 

and adolescence and I will just start with pregnant women who are 

opioid-dependent and we have programs to assist them with treatment. We also make technical assistance available to providers so 

that they can provide the best care to women and their infants who 

may be born physically dependent on opioids and need treatment. 

We also have a program that has just recently started that will address issues and what we call transitional age youth. 

And so the age group that you are speaking of and this would 

be 18-to-25-year-olds is a difficult group to treat. Traditionally, 

they are more difficult to engage in treatment. We don’t have a lot 

of information as we do in older, in adults as to what works best 

for them. And so we are bringing experts into SAMHSA to give us 

information about how to work best with this age group and to provide that guidance then to States and communities. 

In addition, we are also putting together a workgroup that will 

look at the effects of opioids on the developing fetus, and so what 

kinds of issues could be expected in terms of development of children who have been opioid-exposed in utero. That is an ongoing 

project. 

I might though ask my colleague Dr. Volkow to mention some of 

the initiatives and research they are doing, some excellent research 

at NIH on these issues as well. 

Dr. VOLKOW. I want to highlight only one because I think that 

the issue of preventing the drug use among teenagers and young 

individuals is one of the most impactful things that we can do. So 

one of our main initiatives in partnership with other institutes is 

that a story that will be prospectively following 10,000 children as 

they transition into adulthood and periodically assessing them for 

their brain development in order to understand how exposure to 

drugs actually influences the development and architecture of the 

brain. 

And that is very important, because if we understand it then 

that we can tailor intervention to try to reverse them, to reverse 

them and provide resilience for those that may have 

vulnerabilities. So this is one of our top priorities, to actually protect that adolescent from getting exposed to drug and if they get 

exposed how do we actually restructure it into one intervention 

that will provide them with resilience. 

Mr. DOYLE. Yes. 

Dr. SCHUCHAT. Maybe I could just say some of the CDC initiatives really do target that age group. In terms of improved prescribing, we know that a lot of people who become addicted’s first 

prescriptions were for, you know, youth sports-related problems for 

instance. Our consumer-facing communication campaign really targets the families of survivors, the parents who have lost a child. 

67 

And then the last thing I would mention is a technical package 

that CDC released about efforts that can intervene against the 

problem of youth suicide which has an overlap with the opioid 

issue. 

Mr. DOYLE. Thank you. I would just like to, you know, I appreciate all these answers, but I would just like to add that it seems 

a lot of what is being discussed also needs to be tied into children 

having health insurance and access to care. 

And in my State in Pennsylvania, over 1.2 million kids rely on 

Medicaid and CHIP for their health care and as we all know, we 

have spent a lot of time this year talking about huge cuts to Medicaid and this body, unfortunately, has yet to come to an agreement 

on how to fund CHIP. So I guess it really begs the question how 

much do all of these programs matter if children don’t have basic 

health insurance. 

Mr. Chairman, with that I see my time is expired, and I will 

yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. The Chair recognizes the gentleman from Kentucky, 

the vice chairman of the Health Subcommittee, 5 minutes for questions. 

Mr. GUTHRIE. Thank you, Mr. Chairman. Thank you for yielding. 

I appreciate everybody being here, this is important. 

Kentucky, like a lot of States, has had its share of tragedies 

through the heroin and opioid overdoses. Our State legislators, our 

Governor, and everybody is working very hard, our physicians, trying to move forward, and our Drug Task Force folks, I mean it is 

all-out effort and it is still a very, very serious problem as that is 

why we are here today. 

Dr. McCance-Katz, I wanted to ask you a question. A behavioral 

health provider in my district reported that it is not uncommon— 

not uncommon, I guess that means it is a little less than common, 

but not uncommon—for some of the managed care organizations to 

request up to 70 pages of authorizing paperwork from their boardcertified addiction specialists to treat one patient with medicationassisted treatment. This provider stated that it can require 2 to 3 

hours of staff time to submit the requested paperwork to treat one 

patient. 

In your testimony you mentioned the Medication Assisted Treatment for Prescription Drug and Opioid Addiction grants within 

SAMHSA. Would you please elaborate on this program and inform 

me of what SAMHSA is currently doing to evaluate and ensure patients receive timely treatment and quality providers are able to 

deliver care to their patients? 

Dr. MCCANCE-KATZ. So SAMHSA has a number of initiatives to 

bring people to medical attention early on. We have a program that 

has been in place for a number of years. Not the program that you 

are speaking of, but it is called our SBIRT program which is 

Screening, Brief Intervention, and Referral to Treatment. This is a 

paradigm that involves training primary care providers on how to 

screen for hazardous substance use or use that has evolved into a 

use disorder and get people to appropriate treatment. So we do a 

lot of work in that area. 

68 

In addition, we have our what I said was our MAT–PDOA, Medication Assisted Treatment program that is funded through the 

CARA act and this is a program that allows States to develop programs that focus on medication-assisted treatment to getting that 

to their community. States can do this in any number of ways. 

In fact, before I had this position I had one of those MAT–PDOA 

grants in Rhode Island and what we did was we put together what 

we called a center of excellence for the treatment of opioid use disorder to stabilize people coming into treatment for serious opioid 

addiction and then to transfer them to community providers who 

were willing to take on this care. They previously were not willing 

to do that because, because they were concerned that they didn’t 

have the skill set needed to deal with all of the aspects that addiction brings to care. 

And so every State will do this differently, but those are the 

types of programs and there are different iterations. We call them 

sort of hub and spoke models where you have—well, I will stop 

there. 

Mr. GUTHRIE. OK, thanks. Well, I think we agree that patients 

have to receive timely treatment. 

Dr. MCCANCE-KATZ. Yes. 

Mr. GUTHRIE. And at the facility in my district they found that 

in 1-year follow up the majority of patients on medication-assisted 

treatment are still actively involved in the treatment, and these individuals are less likely to be incarcerated and to relapse, and to 

be employed. So, you know, it is important. 

One more question for you then. One of the recommendations of 

the interim report of the President’s opioid commission was to repeal the prohibition of Medicaid paying for services for some patients in an institution for mental diseases or IMD exclusion as we 

all refer to it here. I have heard from many that we should dial 

back this limitation in certain instances, if not entirely, particularly in the midst of a national opioid epidemic where only a small 

percentage of individuals who need treatment are getting it. 

Do you support some kind of repeal of the IMD exclusion and if 

so what should it look like? 

Dr. MCCANCE-KATZ. What I would say is that this is an issue for 

the President and Congress to deal with, and at HHS we would be 

happy to implement whatever you decide on in that area. 

Mr. GUTHRIE. OK. One of the issues that when we deal with this 

repeal of the IMD exclusion has been the subject of a lot of debate 

for a couple years, and the greatest barrier that is preventing is 

the cost to the Federal Government. In 2016, CBO estimated a 40- 

to-60-billion-a-year cost over 10 years. What do you think Congress 

and CMS and SAMHSA or the States could do to try to counter 

this major cost increase? 

Dr. MCCANCE-KATZ. Again, this is not an area that the administration has a position on that I can provide to you today, but certainly we would be happy to work with you on those kinds of 

issues. But I will say one thing. Not everything with addiction 

needs to be in an inpatient setting and in fact most people can be 

treated very effectively on an outpatient basis with medication-assisted treatment, psychosocial supports, and community supports. 

69 

Mr. GUTHRIE. OK, thank you very much. I appreciate those answers and I appreciate your position. And my time is expired and 

I yield back. Thanks. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair recognizes the gentlelady from California, Ms. Matsui, 

5 minutes for questions, please. 

Ms. MATSUI. Thank you, Mr. Chairman, and I want to thank the 

witnesses for being here today. 

We all know the opioid epidemic affects us all and certainly no 

community is immune to this disorder. This committee has done 

important work to begin addressing the epidemic but I must reiterate the point that we can’t talk about this crisis without acknowledging the importance of protecting Medicaid. Addiction is a medical condition and requires treatment. And for many, that treatment is made available through the Medicaid program, which the 

ACA expanded to millions more adults in need. Taking away those 

critical services will certainly take us backwards. 

The Prevention and Public Health Fund created by the ACA to 

make targeted investments in prevention programs in our Nation’s 

public health infrastructure now funds 12 percent of CDC’s annual 

budget. If the Prevention Fund were to be repealed, States would 

lose billions of dollars to spend on programs in communities, including programs to address the opioid crisis. 

Dr. Schuchat, can you discuss the work that CDC has done on 

public health research and infrastructure relating to the opioid epidemic? 

Dr. SCHUCHAT. CDC is really focused on strengthening prevention by improving prescribing implementation of our treatment 

guidelines for chronic pain, the use of opioids and chronic pain with 

efforts to find out how can we best implement them, making it easy 

for clinicians, doctors, pharmacists, nurse practitioners to prescribe 

carefully. 

We are also focused on evaluating the medication-assisted treatment that we hear about to understand what works best for different circumstances and evaluating the naloxone distribution program that SAMHSA has as well. 

Lastly, we are focused on this consumer-facing campaign, evaluating its impact as we try to scale it up. Right now, we have been 

able to fund four States to launch the campaign and 22 of the 

States that receive funding from CDC will be using their funds to 

mount it but we really hope that that will be able to go nationwide 

and reach the public. 

Ms. MATSUI. Well would that be affected if CDC funding were cut 

by 12 percent across the board? 

Dr. SCHUCHAT. No. Every dollar that goes for prevention is lifesaving and cost-saving. And so we will work with Congress with 

the resources that we get to do the most good. 

Ms. MATSUI. OK, in order to truly address the opioid crisis, we 

will need to build up our behavioral health system so that everyone 

has access to prevention and treatment in their communities. That 

is the goal of the Excellence in Mental Health Demonstration 

Project that my colleague, Representative Lance and I worked to 

70 

create and that is now being administered by SAMHSA in eight 

States. 

Dr. McCance-Katz, can you give us an update on the implementation of Certified Community Behavior Health Clinics? 

Dr. MCCANCE-KATZ. Yes, I can. So those funds have been released to the eight States, as you mentioned, that were selected. 

These States are putting together what we call Certified Community Behavioral Health Centers, which bring together the elements 

of treatment, evidence-based treatment for serious mental illness 

and for substance use disorders so that an individual can get all 

of the care they need because we know that co-occurring disorders 

are quite common in one place. 

We think the model is quite nice. It is a model that is not a 

standard fee for service model but it is a bundle payment similar 

to what goes on in community health centers. We are very hopeful 

that that is going to be a model that will yield positive results and 

we hope can be sustained. 

Ms. MATSUI. Well, we hope so, too, absolutely. 

Now, in addition to the short-term funding we provided in 21st 

Century Cures, we authorized additional funding for a variety of 

programs intended to address the mental health and substance use 

treatment system in a more long-term manner. For example, we 

authorized additional funding for treatment and recovery for homeless individuals, behavioral health integration and community 

health centers, mental health awareness training, and more. 

Dr. McCance-Katz, can you provide an update on some of these 

programs authorized or reauthorized in 21st Century Cures? 

Dr. MCCANCE-KATZ. So we are working with Federal partners to 

address issues of behavioral health and primary care. We have a 

strong alliance with HRSA. And as you know, HRSA just released 

$200 million in new grant funding to integrate substance abuse 

treatment into community health centers. SAMHSA works with 

them on technical assistance to assure that evidence-based practices are being used. 

We also continue our homeless grant initiatives at SAMHSA and 

we could get you the data if you would like to have it but—— 

Ms. MATSUI. That would be lovely. 

Dr. MCCANCE-KATZ [continuing]. We see very positive results in 

getting people stably housed. 

Ms. MATSUI. OK, thank you very much and I see my time has 

expired. Thank you. 

Mr. WALDEN. The Chair now recognizes the gentleman from New 

Jersey, Mr. Lance, for 5 minutes. 

Mr. LANCE. Thank you, Mr. Chairman, and good afternoon to the 

panel. 

Congresswoman Matsui and I are a tag team on the demonstration projects in the eight States and I am sure you are shocked to 

learn that New Jersey and California are two of the eight States. 

Now I am increasingly of the view that fee for services is outdated and outmoded. To Dr. McCance-Katz, do we have analysis 

yet on the bundled payment system for the eight States? 

Dr. MCCANCE-KATZ. No, sir, we don’t. We don’t but we will be 

following that very closely and happy to share when we get it. 

71 

Mr. LANCE. Do you have any indication when that might be within the next year or —— 

Dr. MCCANCE-KATZ. I think within a year, but this has—really 

it has just started. And so I would say in a year, yes. 

Mr. LANCE. Thank you. And the Congresswoman and I are working on expanding that program. I think we are both of the belief 

that this is the wave of the future and, certainly, I will continue 

to work with my colleagues in that area. 

According to CMS, the Medicare population has among the highest and fastest growing rates of diagnosed opiate use disorder; if 

I understand it, currently six of every one thousand beneficiaries. 

But CMS policy appears to be blocking access for our Nation’s senior citizens to receive treatment for their substance use disorder 

with two primary treatment modalities, buprenorphine and methadone. 

I know this is not your agency, Dr. McCance-Katz, but in what 

ways, in your judgment, could CMS work with SAMHSA and other 

Federal partners to ensure that senior citizens utilizing Medicare 

who need treatment can get the help they need? 

Dr. MCCANCE-KATZ. Yes, so we do work collaboratively with all 

of our sister agencies within HHS, CMS being one of them. And 

SAMHSA has the ability to provide CMS any information on the 

effectiveness of these treatments in all age groups and we would 

advocate for that. 

Mr. LANCE. Thank you very much. 

Mr. Doherty, my understanding is, as the legal prescription drug 

supply is constrained the use of street heroin increases. I suppose 

this is logical because addicts seek to get the drugs, they, unfortunately, are addicted, and regardless of the source or the medium. 

Is there a direct statistical correlation between the availability of 

prescription opioids and increased usage rates of illegal heroin? 

Mr. DOHERTY. Yes, sir. As you correctly point out and we appreciate your question, the statistics show that 80 percent of first initiate heroin users, so 80 percent of first-time heroin users are now 

getting to that dark place through the use of prescription opioid 

pain killers. 

Mr. LANCE. Eighty percent? 

Mr. DOHERTY. Eighty percent of first-time heroin users. Four out 

of five first-time heroin users are now using heroin and turning to 

cheaper heroin. And with the advent of fentanyl coming into our 

country in pill form, many times these individuals are playing Russian roulette. They truly do not know what they are getting and 

they truly are taking their own lives in their hands. And DEA is 

committed to not only stopping counterfeit prescription pill manufacturing but also elicit importation of fentanyl, as I mentioned in 

my opening statement. 

Mr. LANCE. Is there a way that we can use advanced data 

metrics to predict where users will seek illegal heroin so that we 

can direct interdiction resources to those places? 

Mr. DOHERTY. Sir, we have many programs currently initiated 

that normally use data analytics but also use investigative resources across the spectrum to show where places will eventually 

have heroin imported to. 

72 

So in other words, our DEA 360 Strategy has hit some of the 

hardest communities in the country that have been plagued by this 

disease and this opioid scourge. 

Mr. LANCE. Where would some of those places be in the country, 

the hardest hit places? 

Mr. DOHERTY. Dayton, Ohio; Albuquerque, New Mexico; Manchester, New Hampshire. These are places that our DEA 360 Strategy has been deployed to. It is a three-prong strategy. We use traditional enforcement, data analytics, diversion control, and community outreach in bringing the communities back. 

Mr. LANCE. So you mentioned Dayton, for example. So these are 

just average American cities with the same challenges that the rest 

of the country has. 

Mr. DOHERTY. Well, yes, sir. And certainly the opioid epidemic is 

exasperated by the controlled prescription drugs now getting people 

to the point where they have an opioid disorder, switching to 

cheaper heroin and now really playing, as I said Russian roulette 

with respect to content. 

Mr. LANCE. And my time has expired. I yield back. 

Thank you, Mr. Chairman. 

Mr. WALDEN. The Chair thanks the gentleman. The Chair recognizes the gentleman from California, Mr. McNerney, for 5 minutes. 

Mr. MCNERNEY. Well, I thank the Chair and I thank the witnesses. 

Ms. McCance-Katz, how would limiting access to treatment impact the opioid epidemic? So how is that going to affect it, limiting 

treatment? 

Dr. MCCANCE-KATZ. Well, if treatment were limited, people 

would have more serious adverse events, deaths, inability to function in society, all of the fallout of opioid addiction. 

Mr. MCNERNEY. What about limiting early intervention care? 

Dr. MCCANCE-KATZ. I am sorry? 

Mr. MCNERNEY. Early intervention. 

Dr. MCCANCE-KATZ. Early intervention. 

Mr. MCNERNEY. Same story, right? 

Dr. MCCANCE-KATZ. Yes, sir. 

Mr. MCNERNEY. Well the Affordable Care Act and Medicaid expansion have been crucial for treatment for those with opioid use 

disorders and also for providing early intervention care. I know this 

has been the case in my district, which includes Stockton, California, a city where opioid overdoses up to six times higher than 

the State average. 

So I am very disappointed that instead of focusing on finding solutions to address the opioid epidemic, Republicans have been engaged in an nonstop effort to repeal Affordable Care Act, which 

would have a devastating impact on people struggling with opioid 

use disorders and would be catastrophic for combating the opioid 

epidemic. 

So, Ms. Volkow, your written testimony mentions the HHS 5– 

Point Opioid Strategy. The fourth pillar of the strategy is to support cutting-edge research that advances our understanding of pain 

and addiction. What are some examples of recent developments in 

this area of nonaddictive pain management that resulted from your 

research? 

73 

Dr. VOLKOW. This is quite extensive. And as Dr. Gottlieb was 

mentioning, in the area of pain, for example, one of our partnerships has been to develop abuse deterrent formulations of opioid 

medication so that the person cannot divert them and abuse them 

and there are several drugs already approved by the FDA. 

We are also working with pharmaceuticals to develop non-opioid 

based medications that are going to be effective in addressing pain. 

And in the field of opioid use disorder, for example, we have 

partnered with pharmaceuticals to develop extended release formulation such that the patient does not need to go to the clinic on a 

daily basis to get their medication but can go every week, every 

month, every 6 months and that improves compliance. And as a result of compliance, they are also protecting them from actually 

overdosing. 

So these are some of the examples in terms of successful partnerships that are developing treatments for those that need them. 

Mr. MCNERNEY. So what are the ultimate goals of this partnership, then? 

Dr. VOLKOW. To accelerate and incentivize pharmaceutical industry to get into these spaces. Pharmaceutical industry has not been 

traditionally engaged in developing medications for addictions. Addictions are too stigmatized. It was felt that they wouldn’t recover 

their investment. So we have to reach them, by being a Federal 

agency to reach those products and then present it to pharmaceuticals so that they can bring them to the market. 

In the pain space, also, there is a need of energizing pharmaceuticals because they have been decreasing their investment on 

medications for brain-related diseases, including pain. So how do 

we create a partnership engaging also FDA to ensure that they see 

an incentive to move forward and develop pain treatments? Because right now, of course, they are making already a lot of money 

from selling opioid medications. So it is a little bit they are in competition with themselves. So how do you incentivize them to go beyond that? 

Mr. MCNERNEY. So it sounds like we would have—Congress 

would have a role in—— 

Dr. VOLKOW. Yes. 

Mr. MCNERNEY [continuing]. Developing those practices. 

Dr. VOLKOW. And, indeed, there are ways in which Congress can 

help develop, facilitate. I mean for example, in terms of how do you 

make an incentive for a pharmaceutical to go into the development 

of medications for addiction, could you not treat them like you treat 

for example developmental vaccines? So can you get them expansion of their paths? Can you give them priority evaluation? 

So the Institute of Medicine did an analysis on how actually 

changes in policy could lead to incentivizing pharmaceuticals to 

help us develop better treatments for opioid addiction. 

Mr. MCNERNEY. Thank you. 

Ms. Schuchat, do you think that high school sports are a significant role in opioid addiction? 

Dr. SCHUCHAT. What I would say is I don’t know. I think that 

the principle issue is to change the culture in the doctor’s office or 

the nurse practitioner’s office to help people follow our recommendations about chronic pain. We say think twice before startVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00077 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
74 

ing an opioid. Start low. Go slow, if you are increasing it. And follow-up regularly about whether the goals of treatment are being 

met. 

A lot of our history as docs over the past 15 years or so has been 

to begin with opioids, where we really don’t think that is a good 

idea. 

Mr. MCNERNEY. Thank you. 

Mr. Chairman, I yield back. 

Mr. WALDEN. I thank the gentleman. 

I now recognize the gentleman from Mississippi, Mr. Harper, for 

5 minutes. 

Mr. HARPER. Thank you, Mr. Chairman, and thanks to each of 

you for being here on this very critical subject. 

I mean the opioid epidemic is certainly destroying our country 

and we see this every single day and how it is impacting lives and 

families. You know you have seen families that have been lost and 

destroyed because we haven’t been able to provide perhaps the resources, perhaps the right action to take. And I know we have 

made great resources in making—great strides in making those resources available. But one of the biggest concerns that I have—and 

I will say this. I think this may be some of the most important 

work that our committee is going to do this year is to try to assist 

and provide some guidance and those resources here. 

But one of the biggest problems that we see on the ground is how 

do you get those resources that we put out to the local level, particularly predominantly this country is still rural in most of our geography. So how do you get that to rural America? How do we do 

that? 

Because you know when you have, perhaps, a county with some 

small cities or municipalities, law enforcement is stretched so thin 

that these groups can operate with impunity on selling and destroying those lives. 

So that would be my question is, How do we get this down to 

rural America? And I would like each of you to give me your quick 

thoughts on that. 

Dr. GOTTLIEB. I would defer to my colleague from SAMHSA on 

that, Congressman, but I would echo the need to get the treatments into those settings. 

Dr. MCCANCE-KATZ. Yes, and so we have to use technologies to 

reach rural communities and we have a couple of programs at 

SAMHSA that address rural health directly. One of those is telehealth. That is an evolving way of providing care so that you can 

really extend the reach of a single practitioner who may be a distance away from where they are providing care but that is a model 

that we are very much working on at SAMHSA with partners in 

various States and we are supporting efforts in developing those 

models. 

And the other way that we do this is through some of our training programs. We have a lot of very effective training programs 

that SAMHSA sponsors and one of them is something called 

Project ECHO. What that is is a program where at a site you will 

have experts that get together and will be able to do conferencing, 

conference calls, video conferencing, and be able to talk with cliniVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00078 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
75 

cians in distant areas about problems that they are having and 

how to provide care to patients. 

Mr. HARPER. You mentioned telehealth, which obviously is an 

amazing item and certainly very important in my home State of 

Mississippi because University of Mississippi Medical Center has 

been one of leading proponents of that for almost 15 years that 

have developed that in a great way. 

But then we are talking about rural America. So yes, we have 

telehealth but then we also have problems with broadband access 

in those same rural areas that are stretched for resources. So we 

have got to come up with a plan here that actually will help not 

only in law enforcement and prosecution. And while these things 

are here, usually you see these people after they have entered into 

a problem and are looking for treatment and help. 

We want to stop this before it can happen and so that is why I 

think we are in a great need there. 

We are very limited on time. Dr. Schuchat, why don’t you give 

me your response? 

Dr. SCHUCHAT. Yes, just to say that CDC is funding 45 States 

and DC right now. And in many of those States, it is the rural populations that are being harder hit with the opioid epidemic. We just 

did a report on that in our Morbidity and Mortality Weekly Report. 

But we have injury control research centers, for instance in West 

Virginia, that have been doing rural pilots of distribution of 

naloxone, the Kentucky coalitions that are really looking at what 

works in those rural communities that have been hardest hit. I 

think we heard it before that every State is different and there are 

different solutions but we have really been trying to get resources 

out there to the front line so that the solutions will make sense for 

the communities. 

Mr. HARPER. And you have had a rollout of communications program, obviously, that I know you have discussed. Is that having the 

right impact? Is that going to be something that will help on that 

preventive end? 

Dr. SCHUCHAT. It is just beginning and the four States that we 

have just launched it in were hard-hit States, including Kentucky, 

New Mexico, Ohio, and Massachusetts. Those are areas that high 

burden. We are hoping, though, that it will get rolled out much 

more widely. 

Mr. HARPER. And we look forward to seeing the impact of that. 

With that, I yield back. 

Mr. WALDEN. I thank the gentleman. 

I now turn to the gentleman from Vermont, Mr. Welch, for 5 

minutes. 

Mr. WELCH. Thank you very much. I am delighted to have you 

here and I want to talk to Mr. Doherty from the DEA. 

All of us on this panel were involved in hearings on the Ensuring 

Patient Access and Effective Drug Enforcement Act and it passed 

out of this committee unanimously. I was one of the co-sponsors, 

along with Mrs. Blackburn and Mr. Costello. And that was the subject of a commentary or a report by 60 Minutes and the Washington Post, both respected journalistic organizations. 

And those of us who supported the bill, and that is all of us here, 

were very concerned and we want to get to the bottom of it. In fact, 

76 

I have sent a letter to Mr. Walden, the chairman, asking for a full 

investigation allowing the whistle blower to come in, allowing the 

DEA to get in because bottom line, we are on the same page. We 

want to do everything we can to stem the tide of illegal opioids and 

we want to pass legislation that by no means handcuffs the ability 

of your organization to do its job. 

But I have got a chart here because I want to ask a couple of 

questions. The focus of that report had to do with the falloff in the 

use of immediate suspension orders. And as I understand it, that 

order was one where pretty much on any suspicion that the DEA 

had, they could close down a distributor. But if you look at the 

chart, the reduction went from 65 immediate suspension orders in 

2011 down to five. That was a low point and that was in 2015, correct? 

Mr. DOHERTY. Yes, sir. 

Mr. WELCH. And it went up to nine in 2016. So the law that we 

supported was signed into law in 2016. So here is my question. Unless the effect of the law occurred before the passage of the law, 

the law that we passed was after there had been already a decline 

in the use of that tool, one of many tools by the DEA. Is that correct? 

Mr. DOHERTY. That is absolutely correct, sir. 

Mr. WELCH. So is it fair to say, because I think that we need 

some reassurance on this, that the law we passed, whatever its 

issues and I want to get to those, was not responsible for the preexisting decline in the use of that tool, the immediate suspension 

order. 

Mr. DOHERTY. Sir, to answer your question, the law that was 

passed in April of last year, it is too early to tell what the demonstrative impact of the—— 

Mr. WELCH. No, wait. I am asking something else because I want 

to get to that. 

Mr. DOHERTY. Yes, sir. 

Mr. WELCH. But isn’t it irrefutable that the demonstrable impact 

on immediate suspension orders, that those started declining before 

the law was in effect in 2016? You went from 65 to 5 before the 

law had passed. 

Mr. DOHERTY. That is correct. 

Mr. WELCH. So the law, obviously, was not what caused the decline in the use of that tool. You had many other tools and were 

using them vigorously. Thank you. Correct? 

Mr. DOHERTY. We have many tools. You are correct, sir, yes, we 

are using—— 

Mr. WELCH. Right but the immediate suspension—because this 

is the heart of the question and we really have to know. We have 

to know. All of us have to know. That law that we passed occurred 

after immediate suspension orders had already declined from 65 

down to 5, right? 

Mr. DOHERTY. That is correct. 

Mr. WELCH. And then after the law was passed, it went up to 

nine. 

Mr. DOHERTY. That is correct. 

Mr. WELCH. OK. So we all want to help. And do you have some 

specific legislative recommendations for our committee that we 

77 

could take that would give additional authority within the Constitution to assist you in getting your job done? 

Mr. DOHERTY. Sir, thank you for that follow-up. And let me say 

from the diversion control perspective, we use a variety of tools. 

The tool you mentioned is an administrative action and we certainly look forward to working with Congress with Department of 

Justice oversight to ensure we have the most up-to-date tools. 

Mr. WELCH. Look, you have got a very important job. We support 

it. Do you have recommendations, including any specific things you 

suggest we should do to amend the law we passed or even repeal 

the law we passed? 

Mr. Chairman, I bet I speak for every single member of this committee. We want to know that information because we would take 

that up immediately. 

Mr. DOHERTY. Yes, sir, and DEA shares your concern. And that 

matter is under coordination with the Department of Justice as we 

speak. 

Mr. WELCH. All right. We need a date certain. I mean time is 

marching on. This story shocked folks and rightly so because everybody in America is just devastated by what is happening to friends, 

to family, to loved ones. OK? So, we are ready to go. 

And Mr. Chairman, I will leave it up to you but we are having 

a hard time, at times, getting the responses back. And now that 

this question is out there about a law where the suggestion is we 

did harm, not good, I think all of us want to correct that. 

Mr. WALDEN. Correct. 

Mr. WELCH. I will leave it to you. 

Mr. WALDEN. Yes, Mr. Welch. And on behalf of the committee, 

my view has always been, when we pass a bill that is just the 

starting place. By the way, that is why we are having the hearing 

today is to look at is CARA working. Is 21st Century Cures Working? You need to go back and do the oversight and see what is 

working. And if something is not working, we need to know so that 

we can fix it. 

My question is, What led to the decline in use of what you 

showed there on the graph? Was there an internal decision that led 

to that? Are there people that are upset about it? I mean because 

that clearly all happened, as you point out, the law ever was 

passed, unanimously, by the way, House, Senate, President Obama 

signed it. 

So the question is, Why did the agencies stop using that tool or 

dramatically reduce use of that tool? That is the heart of the matter here. Who made those decisions? But when we can’t even get 

basic information about who is supplying a pharmacy or two in 

West Virginia nine million pills in 2 years, it leads me to believe 

we have much bigger issues at stake here we also have to deal 

with. 

So we look forward to working in partnership with you on this, 

Mr. Welch. 

I will now go to the gentleman from Texas, Mr. Olson for 5 minutes. 

Mr. OLSON. I thank the Chair and welcome to our witnesses. 

Mr. Chairman, this may be the most important hearing this committee has in the 115th Congress because we are dealing with life 

78 

and death. Life and death. I will bet someone in this room knows 

someone who has been addicted to prescription opiates. Some in 

this room may know someone who has died from the addiction. 

Some in this room may know someone who is addicted to illicit opiates. I guarantee you the people watching on C–SPAN know these 

people and they are hurting. 

My first question is for you, Mr. Doherty. You mentioned that 

the opioid prescription crisis is now expanding to other illicit drugs, 

mostly heroin. It is roaring back with a vengeance with a new synthetic sidekick cousin, fentanyl. I have been told a piece of fentanyl 

the size of a grain of salt can be lethal to a human being. It is that 

dangerous. 

The cartels, as you mentioned, are mixing up down there with 

heroin with stuff coming from China. There is no quality assurance. It is the cartels. That poison is coming to America. And that 

means it is coming across the southern border, my own State of 

Texas. 

I talked to our Border Patrol yesterday about their enforcement 

actions. They say right now they capture about 50 percent of the 

traffic coming across our border. They can do better. They will do 

better with more resources and support from Congress. 

But the cartels, they are good at adapting. When I was in the 

Navy, we were trying to get them down in Panama. And I would 

see submarines. They would come up here, go across, come up 

Northern Mexico, go across by San Diego, pop up at night. You 

can’t see them. They dig tunnels. They can get over. 

So my question is, What is DEA doing to combat the opioid crisis 

coming across the border working with CBP, probably some of the 

Drug Task Forces, and also local authorities? What are you doing 

right now to stop drugs from coming across, the fentanyl mixed 

with illicit opiates? 

Mr. DOHERTY. Congressman, thank you for that question. I 

would point directly to our Special Operations Division, our 

Fentanyl Heroin Task Force. It is a multi-agency task force that 

collates, coordinates, and deconflicts information across all of the 

United States and all over the world, quite frankly. And we work 

closely with CBP and all of our Federal, State, and local partners. 

However, as a command and control targeting center, our SOD, 

Special Operations Division, is specifically designed to look at cartel activity, and to target them at the appropriate level, and then, 

obviously, bring those seizures to bear, and follow up on leads within the domestic United States. We stand with all of our Federal 

partners in combatting this and share information on a routine 

basis. 

I truly believe it is a whole of Government approach in that DEA 

partnered with Federal, State, and local agencies. We need to redouble all of our efforts. We can do better and we should do better. 

Mr. OLSON. Another question. What is DEA doing to combat online sales of fentanyl and new psychoactive substances via the dark 

web, online sales, getting around the border? 

Mr. DOHERTY. Thank you for the follow-up, Congressman. With 

respect to online pharmaceutical sales, fentanyl sales, NPS, new 

psychoactive substances, DEA has been very aggressive in this 

area. 

79 

Just last month, there was a joint takedown of AlphaBay, the 

world’s largest dark net network for criminal activity, however, 

selling fentanyl and other dangerous drugs. It was estimated that 

this network earned approximately $1 billion annually. It was a 

sweeping investigation with DEA, and the FBI, and others. And we 

think that DEA, in partnership with other Federal agencies, in concert with our State and local agencies can make a difference with 

respect to dark net trafficking and internet trafficking. And we will 

stand with all of our partners in doing so. 

Mr. OLSON. Thank you. I am out of time. I want to conclude by 

saying the fact that thousands of Americans have died with these 

prescription drugs, illicit drugs is a collective failure of American 

society. And Americans know that failure is not an option. It never 

has been. It never will be. Let’s get this fixed ASAP. 

I yield back. 

Mr. WALDEN. The gentleman yields back. The Chair recognizes 

Mr. Tonko for 5 minutes. 

Mr. TONKO. Thank you, Mr. Chair. Thank you to our witnesses 

for your work on this critical issue. 

Something that keeps me up at night when thinking about this 

epidemic is the so-called treatment gap, the idea that when someone is struggling with the disease of addiction has that moment of 

clarity and attempts to get help, that they will be met with a closed 

door and a waiting list. 

This idea is not simply theoretical. Last year I toured an addiction clinic in my district, where I spoke to a person who had waited 

over a year to get off of the waiting list to access treatment. Nationwide, we know that only 20 percent of those with opioid use 

disorder are engaged in any form of treatment. These delays are 

deadly. Our Nation wouldn’t tolerate a diabetic having to wait one 

year to get insulin and we can’t tolerate this delay. 

Now, this committee took some good first steps to address this 

issue last Congress by passing legislation offered by Dr. Bucshon 

and myself to expand buprenorphine prescribing privileges to nurse 

practitioners and physician assistants, an option that almost 4,000 

NPs and PAs have utilized to date, however, I believe we need to 

do more. 

So Dr. McCance-Katz, would you agree that we currently lack 

the treatment capacity that we need as a nation to take care of everyone who is seeking help from this deadly disease without delay? 

Dr. MCCANCE-KATZ. I would agree with that. 

Mr. TONKO. Thank you. And with the passage of CARA and the 

new DATA 2000 regulations promulgated by SAMHSA IN 2016, 

NPs and PAs are now able to treat patients with buprenorphine 

and certain doctors are able to treat up to 275 patients at a time. 

How has the healthcare work force responded to these new authorities? And has SAMHSA heard any feedback from the provider 

community about barriers that still exist which are preventing additional providers from seeking a DATA 2000 waiver? 

Dr. MCCANCE-KATZ. So we do have some data. What I can tell 

you is we checked. As of yesterday, we have 3,656 physicians who 

have asked for a waiver to prescribe to up to 275 patients. We have 

had over 3,000 nurse practitioners get the DATA waiver. And a little over 800 physician assistants get the waiver. 

80 

There are multiple reasons that people in the healthcare professions don’t get the waiver. There is still a lot of stigma attached 

to the treatment. We don’t do a lot of training in medical and pregraduate programs for advance practice clinicians in the area of addiction medicine and so we need to increase our workforce. 

Mr. TONKO. I thank you for that. 

I have heard from other advanced nursing professions, such as 

certified nurse-midwives who are willing and able to provide additional medication-assisted treatment capacity but are prevented 

from doing so under current law. An expansion of DATA 2000 

privileges to these professionals would, in particular, help vulnerable populations like pregnant and postpartum women. While this 

change would ultimately require new legislation to implement, 

would you commit to working with Congress in helping to examine 

the feasibility of including additional highly trained medical professionals in the DATA 2000 waiver program? 

Dr. MCCANCE-KATZ. Oh, yes, indeed. 

Mr. TONKO. Thank you. 

And shifting gears, quickly, I wanted to talk about another population that is particularly vulnerable to opioid overdose and that is 

individual reentering society after a stay in jail or prison. I have 

read research that indicates that these individuals are up to eight 

times more likely to die of an overdose during their first 2 weeks 

post-release than at other times. 

Can anyone on the panel validate that number and provide some 

context on why these individuals are at such high risk? 

Dr. VOLKOW. This is correct. And one of the reasons why they are 

at greater risk is once you actually have been away from taking 

opioids, you lose your tolerance but the addiction still persists unless you have actually attempted to treat it. 

So if you don’t treat it, the prisoner leaves jail or prison and then 

they immediately relapse without the tolerance. And that is why 

the risk of overdose is much higher. And that is why we are proposing research that actually implementing the medication-assisted 

treatment at the time of release from jail or prison to protect them 

from overdosing. 

Mr. TONKO. Thank you. Anyone else? 

Dr. MCCANCE-KATZ. I would just add that SAMHSA has an offender reentry program. That is one of the focuses of that program. 

We are also working with the Bureau of Prisons on identification 

of inmates with opioid use disorder and how to address when they 

are about to leave. 

Mr. TONKO. OK, might I just add — I thank you for that. I just 

want to add that I believe that Medicaid could play a key role in 

improving outcomes during reentry and I hope to work with our 

witnesses and my colleagues on this committee on legislation I 

have introduced to explore this concept further. In other words, 

providing Medicaid coverage 30 days before release so that we can 

get these individuals under some sort of structured program before 

they are released and at such high risk of overdose. 

With that, I yield back. 

Mr. WALDEN. I thank the gentleman. 

I will now turn to the gentleman from West Virginia, Mr. McKinley, for 5 minutes for questions. 

81 

Mr. MCKINLEY. Thank you, Mr. Chairman. 

I tried to come up with questions that haven’t been raised so far 

with it and my first question primarily would be just how much 

Federal resources are truly being allocated to this issue. Do any of 

you have a grasp of how much money? I am talking from NIH, 

CDC, DOJ, DEA. How much money are we putting into this program nationally? 

Dr. VOLKOW. Well, I can speak for NIH because it is actually the 

agency that I am representing. And from the perspective, for example, there are two components to it, one of them addressing—— 

Mr. MCKINLEY. Can you just give me an amount, an approximate 

amount? 

Dr. VOLKOW. For paying, we are putting $500 million on opioid 

use disorders. 

Mr. MCKINLEY. Collectively. Collectively. We have a short time. 

So collectively, are we talking $2 billion, $5 billion? 

Dr. MCCANCE-KATZ. We have a little over $2 billion in our block 

grants for substance abuse, prevention and treatment, plus discretionary. 

Mr. MCKINLEY. But is there some way that one of you or however can collectively come up with how much money is the Federal 

allocating? Because Mr. Pallone suggested in his testimony—in his 

comments we need to put more money into it. I don’t know how 

much money we are currently putting into it. 

If I could move on to the second—so if someone could get back 

to me, maybe from CDC. 

Dr. SCHUCHAT. We just have $125 million at CDC. 

Mr. MCKINLEY. Yes, OK, but collectively. Everybody, what priority are we really setting on this issue? 

Secondly, I would like to know how much money is coming to 

West Virginia. We have been asking for over a year. We can’t get 

answers from any of you. 

So here is a chart that shows it. We have opioid-related deaths. 

We are the highest in the Nation at 41 per 100,000. That is 20 percent higher than the number-two state and almost 40 percent higher than the number-three state. It is nearly 21⁄2 times the national 

average. I don’t understand why more resources aren’t flowing to 

help out a rural State like West Virginia. 

Let me give you an example, though, on the neonatal births with 

opioid dependency. The national average is six per thousand but in 

West Virginia it is 140, nearly 25 times worse than the national 

average. 

So when West Virginia applied for a grant from you all, 

SAMHSA, they were denied. I would sure like to know why because you all stood up, sat there and talked about how you are 

dedicated to this issue and here we are with a desperate situation, 

we are under water, and we put in a grant and we are turned 

down. 

We also were excluded under their first round of the CARA, $180 

million were supposed to be assured; $144 million was distributed. 

West Virginia got zero in that first round. 

This has got to stop, this idea coming from the Beltway, you all 

sitting back here. We are on the front lines. And I want to build 

back on what Harper was talking about in rural America. 

82 

I just came from a county, Taylor County, 27,000 people, 125 arrests already this year. They have no resources from the Federal 

Government for help on this. They have, for 5 years, gotten not one 

dime to help out on the opioid problem they are having in Taylor 

County with 27,000 people. 

And then I went to another county, Preston County. Three little 

towns, all collectively, between the three of them have less than a 

thousand people. They don’t have the resources to have a teleconference. They don’t have the resources to apply for a grant, to 

seek money. They are getting zero. No money is going to that rural 

county because they can’t apply for it. 

I would like to hear how we do this for rural America. Are we 

telling them you have got to file for an application? We did and we 

were denied by your group. What is the other group? Are we telling 

this little counties or towns that have 200 or 300 people you have 

to get a grant writer to submit something for you? They can’t afford 

it. They don’t know how to do it. 

What is your suggestion? And get out of the Beltway and come 

with me back into rural America to find out how this physically 

works in a town of 200 people with an 84-year-old mayor. How are 

they supposed to address it when they know—the mayors talk— 

they know they are selling drugs in the Post Office parking lot and 

they don’t have a police officer in that community to make an arrest? They physically see it every day, drugs being sold there. How 

do we stop it? 

I am sorry, did I miss something? 

Dr. SCHUCHAT. I can just say that CDC’s funding the State of 

West Virginia to work with all the counties. I am so sorry that the 

people in the towns you have been reaching haven’t been getting 

support. 

Mr. MCKINLEY. Zero. 

Dr. SCHUCHAT. We need to do better. We are getting $2.6 million 

to the State of West Virginia to work statewide for—— 

Mr. MCKINLEY. We have got the worst situation in the country 

and we are saying file applications. Make an application. They 

don’t know how to make an application. They don’t have the resources to do it. There is no grant writer. And then when we did, 

we were denied. Twenty-five times worse than the national average, and we were denied on neonatal. Someone has got to tell me 

what we did wrong or why we don’t deserve to have more treatment. 

Dr. VOLKOW. And you deserve and I have actually gone to the 

communities in West Virginia and Kentucky. I am going to Ohio. 

I think that what we are trying to understand is the infrastructure 

and create partnerships. 

And also, interestingly, West Virginia learned from what the 

communities have developed that actually have been effective to 

help other communities with similar problems. 

But you are absolutely right, the needs of rural America are 

some that require special attention. 

Mr. MCKINLEY. Thank you. I yield back. 

Mr. WALDEN. The gentleman’s time has expired. 

The Chair recognizes the gentlelady from Michigan, Mrs. Dingle 

for 5 minutes. 

83 

Mrs. DINGELL. Thank you, Mr. Chairman. I want to thank all— 

I have no voice. I have no voice because I did 10 town halls in the 

last district work period on opioid drug addiction. And I thank all 

of you for your service. 

It is a really complicated issue, which we can tell by all the questions. And I put a human face on it. My father was a drug addict 

from prescription drugs before anybody ever talked about it or 

knew what it was. And my sister started young and there is nothing that I didn’t do. I know what it was like to go look on the 

streets to see people selling the drugs, to have her in and out of 

drug treatment centers, and ultimately she lost the battle and died 

of a drug overdose. 

I am married to a man, who is not going to be happy I am saying 

this publicly, who this room is named after, who has a legitimate 

pain need. And I have learned more about pain drugs than I ever 

wanted to do and it is becoming an even more serious problem with 

people with chronic disease. 

And at these town hall meetings because I have said this is a 

complicated issue and we have to make sure that the pendulum 

doesn’t go too far the other way, how do we make sure those who 

need pain pills and the oncologists are coming out—I did a town 

hall with Joe Kennedy last week and I have been hearing at every 

town hall—and we have started community coalitions, and we have 

got the law enforcement, and the police, and the hospitals, and 

school teachers, and the kids all part of it. And we have all got to 

be part of it. 

But it is complicated and we all need to understand it is complicated. But how do we work together to start to address it? 

So my first question, Dr. Gottlieb, I am going to address it to you 

because you talked about it a little earlier. In order to mitigate the 

opioid crisis, we have got to change the paradigm. 

The other point I will make before asking this question, because 

there has been very little discussion about mental illness today, 

and the fact of the matter is too many people are self-medicating 

for anxiety and depression. And I will bet that half the constituents 

in West Virginia don’t have jobs. They are turning to that for solace and now they can’t get a job. People don’t understand that most 

of the jobs in this country that are open are going unfilled because 

people are failing those urine tests. We need to start to do some 

reality but I want to make sure that people who have legitimate 

pain needs are getting treated, too. 

So what are we doing to change the paradigm for treating pain 

and addiction in America? One way to do this is to advance the understanding of the biology of pain and addiction in order to enable 

the development of innovative treatments. 

Dr. Gottlieb, how are you partnering with industry in order to 

ensure that novel and safer treatments for pain and addiction are 

being developed? 

Dr. GOTTLIEB. Thank you, Congresswoman. I will just echo your 

comments. 

In economically and socially challenged environments where the 

drugs are abundant and treatment is scarce, I think widespread 

addiction only seems inevitable. 

84 

We announced a series of steps today that we are going to take. 

Principle among them is trying to look at how we advance the 

guidelines that we have in place to help innovators and drug developers develop novel treatments for the treatment of addiction. We 

want to advance the endpoints that we use in those clinical trials 

to perhaps open up a full range of potential treatments that can 

address aspects of addiction like craving, and look at novel 

endpoints like perhaps reduction in overdoses, or hospitalization. 

But I will just close by saying that we also know that the medical treatments, while highly effective, need to be delivered in the 

context of psychosocial interventions and services that help them 

be most effective. The evidence shows us that these treatments are 

most effective when they are delivered in the context of services 

and also deliver other forms of treatment that address some of the 

psychosocial aspects of addiction. 

And I would just point to my colleague from SAMHSA, who was 

a pioneer in developing these kinds of programs in Rhode Island 

and really developed a model for how this can be done successfully 

nationwide. 

Mrs. DINGELL. I would come back at though and we are talking 

about the addiction that has happened. We need to be developing 

new ways to treat pain and come up with alternatives so we are 

using non-addictive pain medicine. 

Dr. GOTTLIEB. So I appreciate the question. I might have misunderstood it, Congresswoman. 

Mrs. DINGELL. Well, it is both but we need to be talking about 

that. 

Dr. GOTTLIEB. I fully agree with you and you know there are 

products in development right now and products in the pipeline 

that address aspects of pain through pathways that we think might 

not have the same addictive potential as opioids. That, obviously, 

needs to be demonstrated scientifically. We are looking at abusedeterrent formulations. 

I would also just point out to the committee that if you look at 

the clinical data on NSAID use in arthritic patients, it went down 

sharply after we imposed some additional warnings related to 

NSAID use. And I think we have to look at that in the context of 

the current crisis because it seems intuitive that some of those patients who might have been prescribed NSAIDs now were prescribed immediate release formulations of opioids instead. 

And so I think we need to look at the risk benefit of all these 

drugs in concert. We sought to do that with the blueprint we advanced with respect to new educational requirements for physicians 

for the first time asking physicians to be educated not just on proper prescribing of opioids but proper prescribing of opioids in the 

context of all of the available therapy for treating pain. 

Mrs. DINGELL. Thank you. 

Mr. WALDEN. I thank the gentlelady. 

I will now go to the gentleman from Illinois, Mr. Kinzinger, for 

5 minutes. 

Mr. KINZINGER. Thank you, Mr. Chairman. Again, all of you, 

thank you for being here. 

And I want to make it clear you know this is a tough hearing 

I think but we know that you guys all want to solve this problem. 

85 

And you are working hard to do it whether it is whatever agency. 

This is something that we wish would go away but there is some 

difficulty in what we are dealing with. 

You know one of the conundrums we have is the idea that people, as was mentioned, have a legitimate need for pain medicine. 

Some people find themselves addicted with that. Some people don’t. 

And then we very strictly regulate how that pain medicine is put 

out. And in many cases they just transition to heroin, then, because they can’t get access to the drugs that hooked them. 

In fact in my district, law enforcement agencies say that heroin 

is cheaper on the street than marijuana right now, which is incredible. And that is why you see a lot of what you do. 

I was just, about 3 or 4 weeks ago, I was leaving church going 

to the gym. And I pulled into the parking lot and there was a 

wrecked vehicle in the gym parking lot and somebody I knew was 

standing outside of it. So I went over and there was a guy, probably my age, slumped over in the car in an apparent heroin overdose. So EMS came over, we called 911, and they administered 

Narcan. And he came back and then proceeded to not talk about 

what happened at all. 

So I, in fact, as I think we all did, a lot of us did, in the last 

district work period, we had these opioid roundtables to hear from 

people what is going on. And I remember a funeral director in LaSalle County saying that he buried his own son to a heroin overdose and that it used to be 20 years ago they would have one death 

a year related to ODing, and now it is one a month. And he says 

every time he has to deal with a family with something like this, 

it like reopens all his old wounds. 

And so I hear all these stories. You know but I am hopeful. 

There are groups like The Perfectly Flawed Foundation in LaSalle, 

which is a recovery addict that started this to help folks, or Safe 

Passage, which is a program in Dixon, Illinois run by the police. 

So I know the communities are rising to the challenge. 

One of the concerns we have, though, is in rural areas like my 

district, the access to treatment facilities. You know usually if 

somebody wakes up from an overdose, or is pulled out, or whatever, 

they have about maybe 30 minutes to an hour where they want to 

recover. But then once that hour is up, the addiction takes back 

over. And so when you have a massive delay in being able to get 

people treatment, obviously in many cases they choose, at the time 

they can finally get in they have either gone back to drugs or the 

addiction has just taken back over. 

So I just want to kind of open it to the floor and just say you 

know what are your agencies doing to kind of address the unique 

challenges that are specific to rural communities. And I know this 

question may have been asked already but if you guys just want 

to take that over, we will start here. 

Dr. VOLKOW. Yes, from the perspective of research, we are actually funding researchers to develop new models of care that actually can address the unique needs of rural communities. And one 

of them is the spokes and hub, for example, where you can have 

one physician with expertise actually linked with nurse practitioners that deliver the care. The telehealth is another approach 

that is actually quite widely utilized. 

86 

We are also evaluating models that will expand our ability to 

provide with medication-assisted therapy, for example. In Rhode Island, we are funding a project where the pharmacists are actually 

not only dispensing the buprenorphine but actually following it up. 

And that gives the visibility of touching a much greater number of 

individuals. We are—— 

Mr. KINZINGER. Could you keep it brief because I want to make 

sure everybody gets a chance here? 

Dr. VOLKOW. So we are taking these, providing these evidencebased treatments in communities and then we try to transfer them, 

or translate them, into other communities. So we are funding research on those in that model. 

Mr. KINZINGER. OK, next? 

Dr. SCHUCHAT. Yes, I would just say that the State funding that 

we give has a requirement that public health and public safety 

work closely together. And what that really means is at that local 

or town level you have the right people coming together, like in 

that parking lot that you were talking about. 

Mr. KINZINGER. Yes, sir? 

Mr. DOHERTY. Sir, from a law enforcement perspective, DEA, I 

would also say a 360 Strategy is effective in the rural areas. We 

are leveraging our State, local, and district partnerships with police 

departments. We have become adept, more adept, in my opinion, 

at data analytics. We are putting out threat assessments to all 21 

of our field divisions to look at every area of potential diversion of 

pharmaceutical controlled substances. 

DEA, along with HHS, and FBI is part of the Attorney General 

Opioid Fraud and Detection Unit that is in 12 select districts, Federal districts in this country. So we are getting better at intelligence, sharing intelligence, providing additional resources. 

Mr. McKinley is no longer with us in the room, but I wanted to 

address his concerns about West Virginia. We have devoted tremendous resources to West Virginia in the last 2 years, namely, an 

upgrade in the office in terms of leadership, tactical diversion 

teams, mobile tactical diversion teams, and data analytics. So we 

are very concerned, as the committee is, with respect to rural areas 

and we are doing all we can. Thank you. 

Mr. KINZINGER. Thank you. And let me just conclude by saying 

I am still a pilot in the Air Guard and we do a lot of border stuff. 

And the amount of drugs coming over the border is just absolutely 

mind-blowing. 

With that, I will yield back. 

Mr. WALDEN. I thank the gentleman. 

I will now turn to the gentleman from New Mexico, Mr. Luja ́n, 

for 5 minutes. Mr. Luja ́n? 

Mr. LUJA ́ N. Mr. Chairman, thank you very much. I really appreciate you calling this important hearing, Mr. Chairman, and I 

think I will begin where Mr. McKinley left off. 

I also represent a rural district, 47,000 square miles across the 

entire Colorado border, Arizona to New Mexico. I have heard at 

least two of the witnesses today talk about resources that they are 

taking to the State. We have a problem. And people at home don’t 

feel like they are getting help. There is a big concern. 

87 

I would highlight the handout that the CDC gave us today, 

which those red dots that follow that top brown dot show that 

there is 18 for every one; 18 heroin users for every one that we are 

also seeing with prescription or illicit opioid deaths in 2015 alone. 

Even as we take a step back, Mr. Chairman, I think that you 

know sometimes we need a history lesson, understanding that we 

tried to curb opium use and addiction in the 1800s. There was a 

response by a drug manufacturer in Germany to come up with morphine. And then in response to the morphine epidemic that we saw 

across America, a drug manufacturer said well, in 1874, we have 

another answer and it is called heroin. We will manufacture that 

and we will ship it to the United States. 

Then in 1937, another manufacturer said well, we can come up 

with methadone. And that hit the streets and hit the communities. 

This isn’t a new problem. And I just hope that we are asking are 

we doing something different. 

I appreciate the testimony associated with looking at non-addictive pain treatment. There is a letter, Dr. Gottlieb, that I sent to 

you. I appreciate your testimony today, the work that you are 

doing. I just put that on your radar so that way we can work with 

your team to get a response. And it is in the area of non-opioid 

drug products. 

We need to have something game-changing with all that we are 

doing in this space. We can’t repeat what was done in 1800, and 

1847 to 1850, to 1874, to 1927, and then 1947, and we wonder why 

people are dying in our communities. They are getting the same 

stuff. 

But that heroin that is coming in, we know that 90 percent of 

those poppies are grown in Afghanistan. We know that less than 

four percent of that is making its way to the United States. We 

know that Southeast Asia heroin is coming into the United States 

as well. We also know about the heroin from Mexico and from 

South America. 

We also know that it is coming in through Canada. It is not just 

the southern border. It is the norther border and it is the ports. 

We have a huge problem. And I hope that when we talk about 

the expansiveness of what we are dealing with that we look at it 

through that lens. 

And I just, in the limited time that I have, one question that I 

wanted to bring to your attention is, like many of our colleagues, 

I went to visit a few facilities this last week. One is in Espanola, 

New Mexico in Rio Arriba County. It is called Hoy Recovery. Some 

incredible leaders committed to our community but, Mr. Chairman, 

this is going to impact all of us in rural communities. 

They told me about a few of these grants that they were going 

after, one in particular, by the way, that was trying to get someone 

to help them go after additional grants for capacity building but 

they were told that because they didn’t have the person to write 

the grant that they were trying to get to expand capacity, that they 

didn’t qualify. 

Another one that said that unless they were serving a community of 100,000 people, that they wouldn’t qualify. These are small 

rural towns. 

88 

We have got a problem and I am hoping that we can get a commitment to work with you, Dr. McCance-Katz, to work with you on 

this issue. 

And then the last question I would ask is the budget that you 

all submitted to us on behalf of the administration, are you getting 

what you need to do what we are talking about today? Yes, no? 

Mr. DOHERTY. Sir, from a DEA perspective, we fully support the 

Department of Justice budget that we are a part of. Some of our 

major initiatives with respect to cartel infrastructure investigation, 

intelligence initiatives, and the—— 

Mr. LUJA ́ N. Let me just interrupt, Mr. Doherty. It is not necessarily towards you, sir. This is towards the others around the 

table. 

The Trump administration budget cuts HHS by 60 percent. The 

CDC gets cut by 17 percent. The National Institutes of Health gets 

cut by 19 percent. The funding for addiction research treatment 

and prevention, even the White House Office on National Drug 

Control Policy takes a hit. 

So we are talking about not enough out of here. And I know we 

need to be smart. These are tough times. I get that. But as we dig 

in here and, Mr. Chairman, the impacts to these rural communities 

and what we can be doing across the country, this hearing and 

pulling everyone in here is critically important. 

And I just thank the chairman. I will submit my full statement 

and all my questions into the record, Mr. Chairman. 

Mr. WALDEN. Without objection. 

Mr. LUJA ́ N. But please, we need your help in a profound way. 

Mr. WALDEN. The gentleman’s time has expired. I thank the gentleman. 

We will now go to the gentleman from Virginia, Mr. Griffith for 

5 minutes. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. 

Mr. Doherty, isn’t it true an immediate suspension order is a law 

enforcement tool that can empower the DEA to freeze suspicious 

narcotics shipments from companies? Yes or no, please. 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. Thank you. And isn’t it also true that a similar enforcement measure would be a show cause order? 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. Thank you. And all these questions are going to 

be yes or no. Thank you. 

The DEA told this committee, in response to an Oversight request dated May 8, 2017, that the ‘‘DEA is unaware of documents 

related to delayed or blocked enforcement actions and suspension 

orders.’’ 

Over the last 6 years, have there been enforcement actions proposed by DEA personnel that were not approved by DEA; yes or 

no? 

Mr. DOHERTY. Yes. 

Mr. GRIFFITH. And if you could detail those for me at a later 

time, I will follow up with that after the hearing. 

Over the last 6 years, to the best of your knowledge, was there 

any communication within the DEA about suspension orders; yes 

or no? 

89 

Mr. DOHERTY. Yes. 

Mr. GRIFFITH. Likewise, we will want to get copies of those. 

Thank you. 

Over the last 6 years, to the best of your knowledge, were there 

any communications at DEA related to additional evidence needed 

to support a proposed suspension order that resulted in delays; yes 

or no? 

Mr. DOHERTY. I am not sure of that, sir. I would have to check. 

Mr. GRIFFITH. I would appreciate that. 

Over the last 6 years, to the best of your knowledge, as a DEA 

enforcement official, when a DEA enforcement action is approved 

or not approved, was such a decision ever communicated writing; 

yes or no? 

Mr. DOHERTY. I would have to check on that as well, sir. 

Mr. GRIFFITH. All right. 

Over the last 6 years, to the best of your knowledge, has a DEA 

enforcement official, when there were discussions by DEA enforcement officials with DEA attorneys about the need for additional 

evidence in an enforcement action, would such concerns only be 

conveyed verbally and never in writing; yes or no? Were these communications oral only? 

Mr. DOHERTY. No. 

Mr. GRIFFITH. No. So there are some written documents is what 

you are telling me; yes or no? 

Mr. DOHERTY. So are you referring to documents that would request additional evidence, sir? 

Mr. GRIFFITH. Yes, sir. 

Mr. DOHERTY. Yes. 

Mr. GRIFFITH. They were all oral or there are writings? 

Mr. DOHERTY. There would be documents—— 

Mr. GRIFFITH. Thank you. 

Mr. DOHERTY [continuing]. That would have requested case-related evidence. 

Mr. GRIFFITH. Thank you. 

Do you an attorney in the DEA by the name of Clifford Reeves; 

yes or no? 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. And did you ever have any communications with 

Mr. Reeves about cases brought by the DEA’s Diversion Control Office; yes or no? 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. And were any of these communications with Mr. 

Reeves in writing; yes or no? 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. Is it your experience with DEA lawyers that they 

never communicate in writing? 

Mr. DOHERTY. No, sir. 

Mr. GRIFFITH. Thank you. 

Both 60 Minutes TV program and the Washington Post, in their 

reporting, featured former DEA law enforcement officials such as 

Mr. Jim Geldhof, who detailed their concerns about the handling 

of enforcement cases at the DEA. 

90 

Because of your denial of documents to this committee, should 

we assume that these officials never put anything in writing about 

their concerns while they were at the DEA; yes or no? 

Mr. DOHERTY. Sir, having not been assigned to the Diversion 

Control Division at that time, I don’t know what the correspondence would have been. I don’t have the background to answer that 

question. 

Mr. GRIFFITH. You don’t have the correspondence, don’t have the 

background, but it would be—OK, never mind. 

Are you familiar with DEA’s Chief Administrative Law Judge 

John Mulrooney; yes or no? 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. And were you aware that the Washington Post reported that Chief DEA Judge Mulrooney wrote in a 2014 quarterly 

report that there was a decline in the number of orders to show 

cause or enforcement actions by the DEA? 

Mr. DOHERTY. And what was the date of that, sir? 

Mr. GRIFFITH. June 2014. 

Mr. DOHERTY. I am unaware of that, sir. 

Mr. GRIFFITH. You are not aware of that. 

Would such a quarterly report be in the form of a written document; yes or no? 

Mr. DOHERTY. Yes, sir. 

Mr. GRIFFITH. Mr. Doherty, did you play any role in the development or clearance of the answer to the committee that ‘‘DEA is unaware of documents related to delayed or blocked enforcement actions and suspension orders?’’ Yes or no? 

Mr. DOHERTY. No, sir, that was provided by my staff, by the Diversion Staff. 

Mr. GRIFFITH. By the Diversion—somebody that works under 

your division? 

Mr. DOHERTY. Someone that works in the Diversion Staff, yes, 

sir. 

Mr. GRIFFITH. All right. Mr. Doherty, were you asked to search 

your documents in your possession to respond to the committee’s 

request; yes or no? 

Mr. DOHERTY. I don’t believe I was asked directly, sir. 

Mr. GRIFFITH. And do you personally have emails or document 

going back to 2011; yes or no? 

Mr. DOHERTY. Yes, sir, but not on this subject. So I have documents from my employment prior to my assignment to the Diversion Control Division, yes, sir. 

Mr. GRIFFITH. All right, thank you. 

And do you know if there was—because former Agent Jim 

Geldhof told the Washington Post that before Reeves’ arrival in the 

DEA Diversion Control Office in December of 2012, DEA investigators had to demonstrate that they had amassed a preponderance of 

evidence before moving forward with criminal enforcement cases 

which are administrative not criminal? And prior to December 

2012, was there a preponderance of evidence standard for enforcement cases on opioid distribution; yes or no? 

Mr. DOHERTY. Yes. 

Mr. GRIFFITH. Was that standard later changed to a beyond a 

reasonable doubt standard; yes or no? 

91 

Mr. DOHERTY. I am not aware of that change, sir, no. 

Mr. GRIFFITH. All right, I appreciate you answering the question. 

I see that my time has expired and I yield back. 

Mr. WALDEN. I thank the gentleman. 

All right, so we go to Mr. Ca ́ rdenas next, is what I am instructed. 

So the gentleman from California. I will let you two fight it out, 

but—— 

Mr. CA ́ RDENAS. We are both from California. 

Mr. WALDEN. Yes, there you go. 

Mr. CA ́ RDENAS. Well, thank you, Mr. Chairman. I appreciate this 

opportunity for us to bring this important issue before the public 

with so many of our dedicated Federal individuals in various departments who are somehow involved in making sure that we get 

in front or on top of this epidemic. 

My first question is, Is there anybody on the panel that would 

like to defend whether or not we, in the United States of America, 

were in front of this issue and on top of this issue and it is already 

getting under control? 

[No response.] 

Mr. CA ́ RDENAS. So the answer is no. OK. So we have much work 

to do, correct? 

Is part of the effort of making sure that we go from crisis—I 

would like to describe it as a crisis. I don’t know if anybody on the 

panel is saying that it is not a crisis. 

Does anybody on the panel want to defend that it is not a crisis 

in the United States at the moment, this opioid epidemic? 

[No response.] 

Mr. CA ́ RDENAS. OK. So that being the case, if we, Congress, were 

to reduce the access, or in some way by policy, or allowing the providers of health care out there in the United States to reduce the 

current level of care, such as mental health and/or substance abuse 

care that is now afforded individuals since the ACA has now become law, if we were to reduce that, would that make the situation 

better or worse in the United States for individuals and families 

who are faced with this crisis? 

Would anybody like to say whether it would be better or worse 

if we were to roll back the current status within the ACA law that 

many insurers today are now providing more substance abuse and 

mental health services today that they were not providing before 

the ACA? 

[No response.] 

Mr. CA ́ RDENAS. Anybody that would like to say or give me an example of whether or not you believe it would be better to reduce 

those benefits to millions of Americans or worse? 

Please. 

Dr. VOLKOW. Well I think that evidently we need to address the 

treatment needs of those that are suffering from an opioid use disorder if we are going to solve the problem and we need to prevent 

the overdoses. But we also need to look at the structure and understand how changes that we are making ultimately are having an 

impact and that is where the data is still lacking. 

And I was expecting that there would be a significant increase 

in number of individuals given access to opioid use disorder with 

the expansion of the insurance to these individuals. And what is 

92 

surprising is because many of these treatment programs don’t have 

the knowledge of how to get reimbursement, something as simple 

as that, they are not taking advantage of it. 

So my perspective in all of this is that we need to create a structure that will increase the likelihood of people that are suffering 

from the disease to get treatment. That is what we need to achieve. 

Mr. CA ́ RDENAS. OK. So if we were to reduce the access, that 

would not help, correct? 

Dr. VOLKOW. Anything that decreases access that does not provide an alternative—that does not provide an alternative—— 

Mr. CA ́ RDENAS. Would it make the situation worse? 

Dr. VOLKOW. If it does not provide an alternative. And all evidence, good quality care, if you don’t provide that, anything that 

doesn’t provide that will not help us address the crisis. 

Mr. CA ́ RDENAS. Will it make it worse; yes or no? 

Dr. VOLKOW. Without, it is—— 

Mr. CA ́ RDENAS. OK, I am sorry. I only have 1 minute left. 

I contend that it would make it worse. I contend that it would 

make it worse. I understand that you went into a bit of a—tried 

to go into detail in a limited amount of time as to the some of the 

issues that we still have yet to tackle. But I truly do believe that, 

for example, by repealing mental and substance—access to substance abuse disorder coverage, provisions that are currently in the 

ACA, this would impact working families across America. 

And one last question that I would like to ask in the limited 

time. Please point out to me what community in the United States 

of America is immune to this crisis. Has this affected every strata 

of the United States’ individuals? Are rich people immune? Are 

poor people immune? Are people who work for a living immune? 

Are people who work on Wall Street immune? 

My point is this, ladies and gentlemen: This is something that 

is affecting every part of America, and it is, in fact, a crisis. And 

I would venture to say that this was a crisis in what we believed— 

and we were wrong—we believed that this was a crisis of poor communities. And this has always been an American crisis, and it is 

about damn time that we are actually facing this. But Congress 

has a lot of work to do, and with it comes the resources necessary 

to combat this crisis. 

I yield back. 

Mr. WALDEN. The gentleman yields back. 

The Chair recognizes the gentleman from Florida, Mr. Bilirakis, 

for 5 minutes. 

Mr. BILIRAKIS. Thank you, Mr. Chairman; I appreciate it. And I 

really appreciate you holding this hearing. You know, I am glad for 

the most part it is a bipartisan hearing and this is a major issue. 

I can’t think of a more important issue to tackle. 

So but I want to start with Mr. Doherty, if that is OK. The law 

has been written again about the Ensuring Patient Access and Effective Drug Enforcement Act. I want to take the opportunity to 

ask you a couple of questions. Yes or no, please, because of time. 

Was DEA part of the negotiation for the final language of this 

particular bill? 

Mr. DOHERTY. Yes, sir. 

93 

Mr. BILIRAKIS. OK. Did DEA recommend that President Obama 

veto the bill? 

Mr. DOHERTY. No, sir. 

Mr. BILIRAKIS. OK. Has DEA made any communication to this 

committee, this particular committee, Energy and Commerce Committee, about the need to change statute? 

Mr. DOHERTY. Not to my knowledge, sir, no. 

Mr. BILIRAKIS. Did DEA include any requests for statutory 

changes in their budget submission this year, dealing with this 

particular law? 

Mr. DOHERTY. Not to my knowledge, sir. 

Mr. BILIRAKIS. OK. Has DEA’s ability to enforce our Nation’s 

drug laws been compromised because of the passage of this particular bill? 

Mr. DOHERTY. This changes the way we look at the ISO, sir, but 

we use an array of other tools. 

Mr. BILIRAKIS. All right. Let me ask you this briefly because I 

have other questions. 

Give us suggestions. Talk to us. We want to do the right thing. 

We all, everyone on this panel, wants to do the right thing and 

solve this public health crisis. I commend the President for addressing it tomorrow, as well. 

So, please, give us suggestions. We need to know the tools that 

you need to handle this. We are on the same team with regard to 

this. So please, I want you to respond to me, personally, but I am 

sure every member of the committee, particularly the chairman, 

would like a response as well. 

OK, Dr. McCance-Katz, currently there isn’t a clear standard for 

medication-assisted treatment, MAT, prescribing. And we have 

heard reports of an increasing number of rogue actors offering 

MAT. In many cases, these popup clinics actively recruit vulnerable 

client populations to provide substandard service with minimal 

oversight. 

While we support consumer choice and market competition, we 

also want to balance this with the consumer safeguards to ensure 

that this problem improves and not worsens—so we need to solve 

this—and that bad actors are not rewarded via Federal dollars. 

Additionally, questions have been raised as to whether States are 

requiring evidence-based practices to be used in the STR Grant 

Program. 

The question is, What is SAMHSA doing to ensure rogue actors 

are not the recipient of Federal dollars and evidence-based practices are being used so that the funds expended go to providing the 

best possible treatment and recovery services? 

Dr. MCCANCE-KATZ. So, as I mentioned earlier, we have a program in place to review the State plans. The States make the decisions about what providers in their States they wish to fund with 

dollars that SAMHSA has oversight for. And we assist them with 

determining and making sure that evidence-based practices are 

being used. 

In terms of the kinds of rogue providers that you mentioned, 

SAMHSA has purview over a couple of things. One, we regulate 

opioid treatment programs and, two, we also certify physicians and 

other practitioners named in law that can provide office-based 

94 

treatment of opioid use disorder, nurse practitioners, physicians’ 

assistants. So we regulate and manage that. 

However, we don’t have, we do not have any jurisdiction over 

these other types of providers within States. What we do is we try 

to inform States about what constitutes best practices so that they 

can decide how they want to regulate within their boundaries. 

Mr. BILIRAKIS. Thank you. 

A question for Commissioner Gottlieb. Last August, FDA authorized a blog post titled FDA Supports Greater Access to Naloxone 

to Help Reduce Opioid Overdose Deaths. I know you are familiar 

with that. 

Can you provide this committee with an update on the development of any over-the-counter version of naloxone? 

Dr. GOTTLIEB. We have had conversations with a number of 

sponsors about naloxone over the counter. And as you know, we are 

working on an actual use study, where we would, I think for the 

first time, actually publish in the Federal Register the specifications, the scientific specifications on how a sponsor could demonstrate that a product can be properly labeled for the purposes of 

bring it over the counter. 

So rather than putting the obligation on the sponsors to go out 

and do that study, we would proactively, effectively publish the 

specification that they can follow to help facilitate a more rapid 

entry of an OTC alternative into the marketplace. And we are fully 

committed to that and working pretty actively on it. 

Mr. BILIRAKIS. I appreciate it. Please, we need to work together 

and solve this problem. It is a real crisis in this country. 

Thank you very much and I yield back. 

Mr. WALDEN. The gentleman’s time has expired. 

The Chair recognizes the gentleman from Iowa, Mr. Loebsack, for 

5 minutes. 

Mr. LOEBSACK. Thank you, Mr. Chair. This is one of those rare 

opportunities that we can take here in Congress, where we all have 

the same concerns, I think. And we may differ about how to resolve 

the problems but we share the very same concerns about this crisis. 

You know this epidemic is more than tragic, I think, and it has 

hit every corner of America, rural, urban, suburban areas alike. I 

am in a rural area. I have got 24 counties in my district. The Chair 

likes to remind me that his district is bigger than the whole State 

of Iowa but, nonetheless, I have got a lot of rural areas. 

And I get around. This weekend, I am going to go with the police 

chief or one of his deputies, a small town in Iowa, in Pella, Iowa. 

And I hear these stories all the time more and more. I have been 

in—this is my 11th year now and we really didn’t think too much 

about opioids at that time but, clearly, we do now. 

Just some quick numbers, according to the University of Iowa. In 

the past 15 years, heroin deaths have increased nine-fold in the 

State of Iowa and prescription opioid overdose deaths in Iowa have 

quadrupled since 1999. 

Clearly, we have got to do more about this. And maybe some 

folks—I have to go sort in it now, maybe some folks have covered 

kind of the rural aspect of this but given that I represent so much 

rural area and I do hear of the same concerns in rural America as 

95 

I do in some of my bigger towns and probably the bigger cities in 

the country. 

What are the differences, if there any, and I will open this up 

to the whole panel, that you are seeing in the rural opioid crisis 

compared to urban counterparts? And given the differences, if there 

are any, how do your agencies—how do you strategize, if you will, 

for rural communities? How do your rural community strategies 

differ from our urban areas? 

I am going to open that up to whoever wants to answer that 

question. 

Dr. MCCANCE-KATZ. So we know that we have difficulty with getting providers to rural areas. 

Mr. LOEBSACK. Definitely. 

Dr. MCCANCE-KATZ. And so we, as I mentioned earlier, we try to 

use innovative ways of reaching individuals by extending the ability of a practitioner, say in an urban area, to reach out to rural 

areas and provide care. 

We also try, as best we can, to leverage primary care. We do a 

lot more work now with integration of behavioral health care into 

primary care settings, which rural areas still don’t have as much 

as they need but are much more likely to have primary care services often than they would behavioral health services. 

Mr. LOEBSACK. And I have a bill that attempts to address that 

by providing more behavioral health training for those primary 

care folks as well. 

Dr. MCCANCE-KATZ. And so that is where I was just going to go 

with that and talk about that we do have programs. We do work 

very hard to expand those programs as best that we can and we 

agree that that is one of the keys to providing care to those communities. 

Mr. LOEBSACK. Thank you. And we did have, unfortunately, have 

something happen a few years back. Our Governor did close down 

a couple of mental health institutes and one of them also dealt 

with substance abuse. And so that dual purpose is really, really 

critical, clearly there. 

Yes, anyone else? Yes. 

Dr. SCHUCHAT. Just to say CDC has been doing a series of tracking the health issues in rural America and there are a number of 

disparities. The opioid overdose problem has now started to be 

worse in rural areas than urban or metropolitan areas and there 

are a number of other chronic conditions that are worse off. The 

solutions are probably going to be different. And one of the things 

that we do is support States to get better data that is locally 

granular and to track interventions into the hot spots, if they are 

rural, or urban, or suburban. 

Mr. LOEBSACK. So that is great. We have got to have good data. 

There is no question about it. 

Yes, anyone else? 

Dr. VOLKOW. So and we are planning also pilot trials to actually 

address the unique needs of the rural communities in places that 

have been hard hit by the epidemic to try to understand why the 

interventions are the most effective. 

Mr. LOEBSACK. Right. And when meth was—and meth is still a 

problem but when that was a real problem, even greater than it 

96 

is now, it hit rural areas big time. There was a lot of cooking of 

meth that was going on at that time, too. We cracked down on 

some of that through some State laws but you know, again, we 

can’t leave out the rural areas. I think that is the important thing 

to keep in mind. We don’t hear much about them but it is important for someone like me to continue to voice those concerns. 

So thanks to the panel. Thank you, Mr. Chair, I really appreciate 

it. Thanks, everyone. 

Mr. WALDEN. Thank you, Mr. Loebsack, I appreciate it. 

The Chair now recognizes the gentleman from Ohio, Mr. Johnson, for 5 minutes. 

Mr. JOHNSON. Thank you, Mr. Chairman, and I thank the panelists for being here today. This is a critical, critical issue that we 

are talking about. 

In my district, as in so many communities around the country, 

the opioid and drug abuse epidemic is a blight that is infecting and 

engulfing entire communities. 

We here on the Energy and Commerce Committee did some important work when we passed the 21st Century Cures Act and 

CARA on a bipartisan basis last year, but we can’t rest on our laurels. There is a lot more work to do. We must ensure that our efforts empower communities, healthcare providers, patients, and 

families to fight back against this vicious cycle of substance abuse. 

I recently visited an organization called Field of Hope. It is a facility, a faith-based, nonprofit treatment facility in my district. It 

is founded by a father whose daughter struggled with and eventually overcame addiction herself and now she works in the facility 

there. 

And in hearing the stories of the dozens of men, women, and 

children impacted by the work done by organizations like the Field 

of Hope, it becomes glaringly apparent that we are in danger of losing an entire generation. I mean hundreds of Americans are dying 

every day as a result of this epidemic and many of those people are 

in some of the most impoverished, low-income, high unemployment 

places around our country. 

Too many people began their slide into addiction as young people, as young as 12 years old, through prescription drugs for a 

sports injury, or getting in with the wrong crowd, or even taking 

what parents think are safe medications over the counter for common cough and cold. We see that happening, too. 

So many of the testimonies document years of unrealized potential, frayed or destroyed relationships, and physical, emotional, and 

spiritual suffering but the testimonies also speak to the hope and 

the joy of recovery, if only people have access to the resources and 

the support that they need. 

And I am proud of the work that we have done on this committee 

and I am grateful, Mr. Chairman, for the continued focus that our 

committee is putting on it. 

So Dr. Gottlieb and Dr. Volkow, innovative non-opioid treatments 

for pain are being developed that can prevent addiction before it 

starts. How can we better align the approval process with Federal 

reimbursement policies for approved medications and devices so 

that, once new treatments are approved, patients are not barred 

97 

from accessing them because they are not covered by Medicare, for 

example? 

Dr. GOTTLIEB. I can start, Congressman. I echo your sentiment. 

I think the Nation has weathered epidemics before but the current 

affliction is very different and very pervasive. 

We don’t speak specifically to issues of reimbursement but it is 

the case that a lot of the drugs that are most commonly used are 

now generic drugs and they are very inexpensive. So you do see 

preferential treatments on formularies for some of the drugs that 

are more addictive, or lack the abuse-deterrent formulations. 

We have taken steps recently, we will be issuing a final guidance 

document to delineate a more efficient pathway to bring generic 

versions of abuse-deterrent formulations to the market. And we 

have also taken steps to try to facilitate non-addictive forms of pain 

relievers. But it will be the case that some of those newer drugs 

will be more expensive than the older formulations and I think we 

need to think about how we provide incentives for those to be used, 

perhaps preferentially, if we think the public health outcome is 

going to be better. 

Mr. JOHNSON. OK, my time has actually expired but can Dr. 

Volkow respond as well? 

Mr. WALDEN. Yes. 

Dr. VOLKOW. Yes, and I will just echo what Dr. Gottlieb said. 

And that is why in this public-private partnership not only are we 

working very closely with the FDA but it is important that we 

work with CMS. Because it is not just in terms of the patients 

being prescribed but in order to incentivize pharmaceuticals to develop products to invest, they need to have assurance that there 

will be a mechanism by which they are going to be able to recover 

their investments. 

Because if we are going to develop an opioid that has much less 

vulnerability for abuse, diversion, and addiction, this is going to be 

more expensive but no one is going to cover for it, then they don’t 

even start there. So it is also at the essence of being successful in 

getting them engaged in development of other medications. 

Mr. WALDEN. The gentleman’s time has expired. 

Mr. JOHNSON. Thank you, Mr. Chairman. 

Mr. WALDEN. I recognize the gentleman from Maryland, Mr. Sarbanes, for 5 minutes. 

Mr. SARBANES. Thank you, Mr. Chairman. I want to thank the 

panel. 

Dr. Volkow, I want to thank you for your terrific work. I had the 

opportunity, as you know, to come out to Bayview and see some of 

the research that is being done there, particularly with respect to 

kind of the brain response to these various medications and opioids 

and so forth and how we can use that research to develop effective 

responses to it. 

I also want to thank you, Ms. McCance-Katz in terms of your describing the importance of making naloxone available. I was proud 

that we were able to have included in one of the bills that we 

passed here on the Hill, a demonstration program to look at the coprescribing of naloxone. And that is an important best practice, I 

think, for physicians to take up. And as more physicians are examVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00101 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
98 

ining their practices, we can, hopefully, make some progress in addressing this crisis. 

So thank you for referring to that. And that was a very bipartisan approach I wanted to add. 

I wanted to focus a little bit on the issue of workforce because 

I have been very focused for many years now on the kind of workforce side of our healthcare system and whether we have adequate 

people to provide whatever the particular care needs are but in this 

context, it is around the issue of treatment. And certainly we heard 

from Commissioner Gottlieb about some of the important medication responses that can be undertaken in response to this crisis and 

that is a critical component of it. But I am interested in hearing 

from you about what we need to do with some of these other treatment elements. 

I mean who are the kinds of professionals that need to be deployed as part of robust, meaningful treatment programs that can 

make a difference? I think, Dr. Volkow, you talked about key elements, being addressing the stigma, the lack of treatment slots in 

a lot of these programs, the lack of reimbursement for certain 

kinds of things. 

So let me ask—why don’t I start here? And then any others who 

want to come, I invite your perspective on the workforce side of 

this. Are there gaps? Are there shortages? Which of the kinds of 

professionals along the care continuum that we need to respond to 

this crisis where we have got put more resources, recruit people 

into this? 

Dr. MCCANCE-KATZ. Well there definitely are gaps. We have, I 

don’t have the exact number but I will guess around 10,000 physicians who are addiction specialists in this country. We graduate 

only 1200 psychiatric residents a year to go into psychiatry, a very 

high-need area, where a lot of addiction work is done. We don’t 

have enough advance practice clinicians. 

But what we need to do, one of the ways we can address this, 

is to integrate better addiction curriculum into the pre-graduate 

training. I actually wrote about a model that my colleagues and I 

at Brown University developed for our medical school, where every 

medical student will graduate qualified for a DATA waiver. And we 

do that through the addiction curriculum that we have put into our 

medical school. This not only makes people eligible to practice, once 

they become residents that are fully licensed with the DEA registration, but it also legitimizes addiction treatment. It makes addiction treatment a regular part of medical care, regardless of specialty. We need to do that in all medical schools, in all advance 

practice clinician programs, and we also need more psychologists, 

more counselors, more peer professionals. We lack all of these and 

it is one of the reasonsMr. SARBANES. I would love to get more information from you on 

that initiative. 

Dr. Volkow, I am going to run out of time so maybe I will just 

come to you. You talked about sort of the psycho-social services 

component of the treatment response. 

Can you speak to the needs we have there in terms of the workforce? 

99 

Dr. VOLKOW. One of the issues that has been brought up in the 

opioid crisis is yes, we over-prescribe opioids in our country. But 

the question is, What allowed it to disseminate so rapidly? And 

there is this concept of addiction being a disease of distress, and 

the fact that we have addiction is very, very frequently comorbid 

with mental illnesses, and there is some diseases that relate to adverse conditions that make you vulnerable. 

So as we are discussing the opioid crisis, we need to be mindful 

that we are going to need to have interventions that address those 

behavioral needs and psychological and psychiatric needs that 

many of these patients have. 

Mr. SARBANES. Thank you. I yield back. 

Mr. WALDEN. The gentleman yields back. 

Just for the committee and for our witnesses, who I am sure 

would appreciate a break here at some point, we are going to go 

to Mr. Bucshon for 5 minutes. 

We have votes on the House floor that have been scheduled. So 

we will take a break. I think we have got three or four votes; probably half an hour, 45 minutes before we would reconvene. Dr. Burgess will take over as subcommittee chair and run the remainder 

of the hearing. 

So there are Members I know who want to ask some additional 

questions. So, Mr. Bucshon, we will go with you, then we will recess, then we will return after the votes. 

Mr. BUCSHON. Thank you, Chairman. 

The question is for Dr. McCance-Katz. Section 303 of the CARA 

Act, which I co-authored, requires that all office-based providers of 

addiction treatment have, and I quote, ‘‘the capacity to provide directly, by referral, or in such other manner as determined by the 

Secretary,’’ all drugs approved by the FDA for the treatment of 

opioid use disorder and appropriate counseling and appropriate ancillary services. 

What has been SAMHSA’s role in implementing this particular 

statute in CARA? 

Dr. MCCANCE-KATZ. Yes, so SAMHSA has implemented the required 24 hours of continuing education for nurse practitioners and 

physician assistants who wish to obtain a waiver for office-based 

treatment of opioid use disorder and we manage these. We keep 

the certifications. We provide that certification to the practitioners. 

And we continue to provide ongoing education through our provider 

clinical support system for medication-assisted treatment. 

Mr. BUCSHON. OK, that is not specifically what I asked but so 

what is the current status of fully implementing Section 303? 

Because you described expanding providers that are available 

but you haven’t implemented what the providers actually have to 

do. I mean because—is that true or not true? The capacity to provide direct, by referral, or such other manner determined by the 

Secretary for all treatment options. Does that make sense? 

Dr. MCCANCE-KATZ. Yes, so the education, the waiver education 

requires that all forms of approved medication-assisted treatment 

be taught. 

Mr. BUCSHON. OK because I am just being told that you haven’t 

implemented a lot of Section 303. 

Dr. MCCANCE-KATZ. We have implemented all of Section 303. 

100 

Mr. BUCSHON. OK, then I stand corrected. 

Within 18 months of enactment, HHS is required to update the 

practice guidelines for office-based treatment settings so as to conform with Section 303. What is the status of the practice guidelines? 

Dr. MCCANCE-KATZ. I got to SAMHSA 2 months ago. I will tell 

you that I have reviewed that document. That document, in my 

opinion, needs additional work but it is in the clearance process 

and we will get that done. 

Mr. BUCSHON. Very good to hear that. Thank you very much. 

Mr. Doherty, what percentage of illicit drugs that are in the 

United States come across our southern border, do you have any 

idea? 

Mr. DOHERTY. Sir, I could not give you an exact percentage but 

we determined that the Sinaloa Cartel, who currently has the control of the U.S. market share for heroin and now, alarmingly, 

fentanyl, they control a predominately large portion of the southwest border in terms of importation routes and transportation 

routes. 

Mr. BUCSHON. So at least for them, it is 100 percent? 

Mr. DOHERTY. Yes, sir. 

Mr. BUCSHON. And so do you think we are doing enough to stop 

it? 

Mr. DOHERTY. Sir—— 

Mr. BUCSHON. That is not a criticism, by the way. I mean overall, 

as a country, do you think we doing enough to stop it? 

Mr. DOHERTY. Sir, as a DEA agent for 28 years and someone 

that worked in Arizona and knows the border area, I would say 

that a comprehensive strategy, one that involves technology and 

power, boots on the ground, as well as intelligence is crucial to 

stopping the, for lack of a better term, polycriminal organizations, 

ones that traffic in drugs, humans, contraband, weapons along our 

southwest border. 

So we would stand with all of our Federal, State, and local partners in coming up with new innovative solutions; however, it has 

to be a comprehensive approach, sir. 

Mr. BUCSHON. Yes, I don’t want to cause you too much grief but 

is a physical barrier part of that? 

Mr. DOHERTY. Sir, again, it would have to be a comprehensive 

strategy and any measure that would lend itself to stop drug trafficking and other means of illegal activity from entering the United 

States, fold into an overall approach. As I said, technology, manpower, and intelligence I think would be beneficial. 

Mr. BUCSHON. Great. Thanks for that. 

So I don’t think we can overstate the importance of decreasing 

the demand for the product but also it is very important to prevent 

the supply. And I would encourage all my colleagues across Congress to work with the administration to secure the southern border using, as described, a multi-pronged approach, which may or 

may not include a physical barrier, and to quit actively preventing 

the administration from trying to secure the southern border. 

With that, Mr. Chairman, I yield back. 

Mr. WALDEN. The gentleman yields back. 

I recognize the gentleman from New York. 

101 

Mr. TONKO. Mr. Chair, I ask that three letters be included in the 

record. They include the American Hospital Association, a second 

from Protecting Access to Pain Relief Coalition, and finally, the 

American Society of Addiction Medicine. 

Mr. WALDEN. Without objection, they will be entered into the 

record. 

[The information appears at the conclusion of the hearing.] 

Mr. WALDEN. For our witnesses, we probably won’t be back for 

half an hour. So if you want to grab something to eat and whatever 

else, probably at least a half an hour before the committee starts, 

probably closer to 2:30. 

And Dr. Burgess will take over there because I know we still 

have members that want to ask questions. 

So with that, we will stand in recess. 

[Recess.] 

Mr. BURGESS [presiding]. Very well, I will ask everyone to take 

their seats, and I will call the subcommittee back to order. 

When the subcommittee adjourned for votes, pending for questions was Dr. Raul Ruiz. So we will recognize Dr. Ruiz for 5 minutes for questions, please. 

Mr. RUIZ. Thank you, Mr. Chairman. Welcome back, everybody. 

I hope you had a little nice break. I would like to thank all the witnesses for joining us. 

Many of you know I am an emergency physician. I have taken 

care hundreds of patients who have come in respiratory arrest from 

opioid overdose. I have taken care of toddlers who accidently got 

into the cabinet. I have taken care of adolescents and young adults 

who took it for the high, while they were partying. And I have 

taken care of seniors who have gotten addicted throughout the time 

because of chronic pain usage of opioids and took that extra sedative to help them sleep, you know the sleep pill, and also maybe 

a little cocktail, two cocktails at night. The next thing you know, 

they stop breathing during the night, and their spouses wake up, 

and they are blue, and they bring them into the emergency department. 

And most of the time, we are able to resuscitate and put them 

on mechanical ventilation, give them the appropriate medication 

soon enough to reverse it but sometimes, it is unfortunate, they are 

pronounced dead on the field or, after an incredible amount of resuscitation, their hearts don’t come back, and so we can’t get a 

beat, and we have to pronounce them dead. 

So this is something that I know firsthand in the community and 

in emergency departments that we are faced with. And I am extremely proud of our first responders who, in the patient’s home, 

in the streets, at the clubs, at the bars, like are the first people on 

scene and provide the first live-saving resuscitation, anywhere from 

paramedics, EMTs, the firemen and women, men and women who 

wear the badge in our law enforcement. You know they are there. 

And they oftentimes then come to us in the emergency department 

with the handoff and we take over. 

We know that last Congress and during the Obama administration, we took some steps to expand the workforce and efforts to 

ease the access due to buprenorphine so that these first responders 

and healthcare providers can provide a treatment. 

102 

I want to revisit the workforce effort because we know there is 

folks in prevention that oftentimes we don’t really think of. These 

are the high school counselors and teachers, the public health educators, the community health workers, the primary care docs, family medicine, internal medicines that can identify risks and education. Then we have the acute crisis, right, the emergency medicine, the first responders, the law enforcement, the nurses in the 

emergency departments. And then we have the detox and treatments, the addiction services for adolescents, adults, emergency 

physician nurses, psychiatrists, psychologists, mental health. And 

then we have the long-term rehabilitation services. 

So in your opinion, are we working in a coordinated mechanism 

with a strategic vision to provide enough training to all these different workforce healthcare providers with a clear set of priorities 

and understandings or is it scattered from here and there? 

I will ask Dr. Schuchat. 

Dr. SCHUCHAT. Yes, I can begin and then I think my colleagues 

will probably expand. 

Our piece is the prevention piece, prevention for prescribing, and 

then supporting State and local public health, who have a role in 

the data to speed up the information so we know where the hot 

spots are, and a role in evaluating the policies. 

Mr. RUIZ. Is it coordinated in curriculum and outreach to these 

individuals? 

Dr. SCHUCHAT. Yes, so what I can say is that the guidelines for 

treatment of chronic pain have been adopted by dozens of States 

and medical societies and are now being taken up by the medical 

schools, the pharmacy schools, and the nursing schools. 

Mr. RUIZ. So your answer is no because every different groups 

are working in silos and what we need is a coordinated response 

with leadership from the top. 

Let me ask another question. I have a minute left. 

We know what the public health motto is. We do have a plan. 

There is a framework. You are trained in it. I am trained in it. You 

know the framework to come to the answer to identify high risk, 

to institute programs catering to high risk, and then measuring the 

outcomes of those and expanding those to the population. 

So what are the highest risk individuals, and what are the programs out there where we are addressing them to prevent them 

from being evicted, and also the highest risk for relapse, and what 

are we doing for them, Dr. McCance-Katz? 

Dr. MCCANCE-KATZ. So we have training programs that one is 

our Providers’ Clinical Support System for Medication Assisted 

Treatment and that provides structured training and mentoring—— 

Mr. RUIZ. What is the population base most at risk of starting 

an addictive addiction and what are you doing to combat those in 

the public? 

Dr. MCCANCE-KATZ. So we know from a lot of research studies 

that people who are at highest risk are people who have a history 

of substance use disorder, a history of previous opiate addiction, a 

history of mental illness. We know that. And that is curriculum 

that is taught within our Providers’ Clinical Support System, which 

is a consortium of a large number of different types of professional 

103 

health organizations that do outreach to their members so that we 

can train them. 

We also have the Addiction Technology Transfer Centers that 

have the Nation divided into ten regions and we have one that also 

focuses on Native American issues. And those provide training to 

other types of practitioners, counselors, nurses, et cetera. 

Mr. RUIZ. Thank you. 

Mr. BURGESS. The gentleman’s time has expired. The gentleman 

yields back. 

The Chair recognizes the gentleman from Michigan, Mr. 

Walberg, for 5 minutes for questions please. 

Mr. WALBERG. Thank you, Chairman, for that opportunity and 

thank you for being here today. As has been noted on numerous 

occasions—I am having a hard time working with one wing here, 

Doctor, but we will get it working right—we all share the concerns 

together. It is how we meet the needs, and how we can be an assist 

to all the things that you do, and have the communications that 

make us a resource and a partner alongside. 

Dr. McCance-Katz, PDNPs normally include a patient’s history of 

prescriptions for controlled substances using data submitted by 

pharmacies and dispensing practitioners. Under Jessie’s Law, a bill 

that I have introduced with Representative Dingle, HHS would be 

required to develop best practices for including a patient’s history 

of addiction treatment with patient consent, of course, in their electronic health records. This information helps to better inform, I believe, a provider and avoids risk for relapse or dangerous side effects when a patient seeks treatment for a condition or illness separate from their addiction. And that was the genesis for this piece 

of legislation because of a very unfortunate outcome where things 

were missed. 

For similar reasons, should this same information be made available in PDNPs across the country as a way to better inform providers? 

Dr. MCCANCE-KATZ. So those kinds of questions I think are best 

left to Congress and the administration. The administration, to my 

knowledge, does not have a position on that but we would be happy 

to work with you and provide any technical assistance to move that 

forward. 

Mr. WALBERG. I appreciate that and I understand that a position 

has to be taken when the administration takes a position but this 

is something that would be of great help so that we don’t run 

amuck of a lot of things that you have to consider in the day-today practice in meeting the needs. And while we want to make 

sure those needs are met, we provide resources, we need the support. So we will take you up on that. 

Dr. MCCANCE-KATZ. Thank you. 

Mr. WALBERG. Mr. Doherty, drug diversion remains a serious 

problem and I have become aware of a particular challenge that exists in circumstances of in-home hospice care. DEA regulations 

issued in 2014 specifically forbid hospice staff from destroying leftover controlled substances, unless allowed for by State law. As a 

result, leftover pills belong to the family, which has no legal obligation to destroy them or give them up. 

104 

I believe hospice staff could play a very meaningful role in helping to prevent instances of diversion but those regulations prohibit 

hospice personnel from taking a more active role in disposing or removing medications from the home. 

And so for the first question, I would ask is your agency willing 

to work with me and this committee to help establish a uniform set 

of practices that will allow hospice professionals better to assist 

families to dispose of leftover drugs? 

Mr. DOHERTY. Congressman, thank you for that issue. And of 

course we can all look to all of our resources to do better and do 

more. We will be happy to work with Congress and the Department 

of Justice on that issue. 

Mr. WALBERG. Well along that line, in addition to prescription 

takebacks, what other opportunities exist for families in this situation to properly dispose of opioids? 

Mr. DOHERTY. Sir, DEA has been a leader in the proper disposal, 

safe and effective disposal of unwanted and unused prescription 

drugs through our Take Back Initiative. As you mentioned, sir, we 

have run that program since 2011. We have had 13 iterations of 

that program and, collectively, we have taken in 8.1 million pounds 

of unused and unwanted prescription pain medication. And we feel 

it is terribly important due to the fact that we need to keep these 

things out of the medicine cabinet. 

Another issue I would point to, sir, is under CARA we have a 

provision that we worked on in conjunction with our partners that 

allows the option to not fill a complete prescription when you are 

going to get your medication. We think that is certainly important 

for, for example, teenagers that have their wisdom teeth out and 

you have a parent caring for them. It is certainly ethical and reasonable to take only take 5 out of 30 oxycodone if you are caring 

for a teenager with that procedure. 

So we think that is another important factor. DEA has worked 

hard with HHS on that issue. Thank you for your concern, sir. 

Mr. WALBERG. We appreciate that and we will be looking forward 

to working with you. 

I yield back. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair recognizes the gentlelady from Florida, Ms. Castor, for 

5 minutes for questions, please. 

Ms. CASTOR. Thank you. I would like to focus on an issue that 

this committee has been investigating and that I raised in committee last spring after the reports in the Charleston Gazette Mail 

that drug distributors shipped 780 million hydrocodone and 

oxycodone pills to West Virginia over 6 years, which amounted to 

433 pills for every man, woman, and child in the State. And another news network further reported that one pharmacy in the 

small town of Kermit, with just 392 residents received 9 million 

hydrocodone pills in just 2 years. 

So after our previous hearing in March, the committee asked the 

DEA what actions it took in response to the reported oversupply 

of opioids in West Virginia over the course of the 6 years. In DEA’s 

response that we just received last night, DEA noted that it established a tactical diversion squad in Clarksburg, West Virginia in 

105 

December 2016. But DEA’s own data would suggest that the distributors began sending large shipments of opioids to West Virginia 

well before that date. 

Mr. Doherty, please refer to the committee’s October 13th letter 

to DEA. The charts in this letter, which utilized DEA’s ARCOS 

data, showed that these massive shipments began taking place as 

early as 2007 and 2008. 

I am glad that DEA has now established a greater presence in 

West Virginia but, in hindsight, should DEA have spotted these 

trends earlier? 

Mr. DOHERTY. Ma’am, thank you for that question. And DEA 

agrees the amount of pills going into that area was excessive in 

looking back. At the time that you referenced, ma’am, and to your 

point, we had another phenomenon going on in this country. It was 

the proliferation of rogue pain clinics and pill mills in Florida. Florida was the epicenter of the beginning, in some ways, of the opioid 

crisis that we face today. 

DEA devoted a tremendous amount of resources and then we 

shifted our resources. We shifted our resources to areas like West 

Virginia when we realized this problem. 

Ms. CASTOR. So that tells me, though, that maybe DEA did not 

have the information on the flood of opioids going into West Virginia because certainly if you knew 780 million hydrocodone/ 

oxycodone pills—I mean that is your own, the data of the pills 

flooding in there. 

How were you monitoring the flood of opioids into a particular 

community at that time? 

Mr. DOHERTY. Ma’am, I was not assigned to the Diversion Control Division at that time. I could tell you—— 

Ms. CASTOR. How as the agency? 

Mr. DOHERTY. I could not speak to that, ma’am. 

Ms. CASTOR. Don’t they have the tools to monitor shipments, a 

flood of opioids into a particular community? Weren’t you able to 

monitor that? 

Mr. DOHERTY. Ma’am, the way these are monitored in conjunction with distributors, they are monitored through the submission 

of suspicious orders. And the distributors have an obligation to report that to DEA and that was a flaw and that is why—— 

Ms. CASTOR. Are you saying they did not report it and DEA had 

to rely on news reports? That can’t be the case. 

Mr. DOHERTY. No, ma’am, that is not what I am saying. What 

I am saying is in combined with the suspicious orders that are reported in oversight of our regulatory registrant community, specifically the distributors, as you mentioned, we realized that some 

were not reporting as required. And then we shifted resources to 

those areas and we became more stringent with our distributors by 

initiating a—— 

Ms. CASTOR. So besides some suspicious, besides the distributors 

reporting and some suspicious filing, DEA didn’t have any other 

tools at its disposal to understand the flood of opioids into a community? 

Mr. DOHERTY. Ma’am, we do have, as you mentioned, in these 

charts, ARCOS data, which is not real-time data. And we use data 

106 

analytics and we are getting better at data analytics to prevent 

this from happening again. 

Ms. CASTOR. What is the lag time in the ARCOS data? 

Mr. DOHERTY. I do not have that information, ma’am. 

Ms. CASTOR. So clearly, there is a breakdown here. 

What can you say to other communities across the country that 

maybe experiencing something similar right now, a flood of opioids, 

some new epidemic, some hot spot? What is DEA able to do to monitor that situation so it is not too late? 

Mr. DOHERTY. Ma’am, as I mentioned earlier, we are providing 

threat assessments to our 21 Domestic Field Divisions, with respect 

to ARCOS data specifically, and we are conducting a long-term 

overhaul of our SORS system, Suspicious Order Report System, to 

keep distributors in line and to prevent this from ever happening 

again. 

Ms. CASTOR. And then what other tools do you need from the 

Congress? 

Mr. DOHERTY. Ma’am, we would be happy to work with Members 

of Congress through the Department of Justice and we would also 

advocate for full support of the President’s budget. 

Ms. CASTOR. Well, we need to get to the bottom of this to protect 

communities that have been damaged by opioids and to ensure that 

other communities do not suffer the same fate. 

And people are relying on DEA to be the safeguard. And I hope 

the agency can be more proactive and use all the data at its disposal. 

Thank you very much. 

Mr. BURGESS. The gentlelady yields back. The Chair thanks the 

gentlelady. 

The Chair recognizes the gentleman from Pennsylvania, Mr. Costello, for 5 minutes, please. 

Mr. COSTELLO. Thank you. 

Mr. Doherty, what is your title with DEA? 

Mr. DOHERTY. Deputy Assistant Administrator Office of Diversion Control Operations. 

Mr. COSTELLO. Amongst your duties is to stem the flow or ensure 

that the excessive illegal distribution of opiates around this country 

does not occur. Is that correct? 

Mr. DOHERTY. Yes, sir. 

Mr. COSTELLO. If we could refer to the chart, if you could put 

that chart up, I am going to reference the bill that passed last year 

that is the subject of some journalistic inspection right now. 

Clearly, between 2011 and 2016, prior to this bill being passed, 

the number of immediate suspension orders has reduced substantially, correct? 

Mr. DOHERTY. Yes. 

Mr. COSTELLO. And an immediate suspension order is an order 

that, without prior notice, terminates a distributor’s ability to distribute controlled substances. It is an extraordinary measure intended to supplement standard agency procedures in cases of imminent danger. Is that correct? 

Mr. DOHERTY. Yes, sir. 

Mr. COSTELLO. And the legislation sought to define the term imminent danger because there was litigation and concern raised by 

107 

many patient advocate groups, local pharmacies, et cetera, that 

that standard was unclear. Is that correct? 

Mr. DOHERTY. That is my understanding, sir. 

Mr. COSTELLO. Is it true that since passage of the bill the number of ISOs has actually increased? 

Mr. DOHERTY. That is not true, sir. 

Mr. COSTELLO. I believe that eight orders have been issued subsequent to the passage of the bill. Isn’t that correct? 

Mr. DOHERTY. I stand corrected, sir. Since the passage of the bill, 

yes, sir. 

Mr. COSTELLO. It has increased. Has the amount of opiates distributed decreased since passage of the bill? 

Mr. DOHERTY. I would have to confer with my diversion staff and 

get back to you on that. 

Mr. COSTELLO. If I read data points that indicated that amount 

of opiates manufactured and distributed in 2017 is less than 2016, 

would that be accurate? 

Mr. DOHERTY. That would be accurate, sir. 

Mr. COSTELLO. So is it fair to say that since passage of the bill, 

the number of opiates manufactured and distributed has been less 

than before it was passed? 

Mr. DOHERTY. Yes, sir, and that would be directly in line with 

the reduction in the APQ, the aggregate production quota—— 

Mr. COSTELLO. Yes. 

Mr. DOHERTY [continuing]. That DEA oversees. 

Mr. COSTELLO. So if someone says the law has helped fuel the 

opiate epidemic, would that have any basis in fact, given the fact 

that the number of ISOs has increased since passage of the bill and 

then the number of opiates manufactured and distributed has decreased since the passage of the bill? 

Mr. DOHERTY. No, sir, I don’t believe the data shows that. 

Mr. COSTELLO. OK, thank you. 

DEA and DOJ contributed significantly to the language of the 

bill that was passed. This has been generally represented by Senator Hatch and Senator Whitehouse, a Republican and a Democrat, 

in the Senate. Do you agree that the DEA and the Department of 

Justice provided technical assistance to the bill that was ultimately 

passed and signed into law? 

Mr. DOHERTY. Yes, sir, that is my understanding. 

Mr. COSTELLO. And if DEA had opposed the bill, they would have 

provided testimony, or correspondence, or done some level of advocacy with Members of Congress. Is that correct? 

Mr. DOHERTY. Yes, sir, I believe there was a technical advisement period and then, ultimately, the bill moved forward and was 

signed into law last April. 

Mr. COSTELLO. And it is fair to say that there were previous 

iterations of the bill that the DEA took issue with and they did object to it. Is that correct? 

Mr. DOHERTY. That is my understanding, yes, sir. 

Mr. COSTELLO. Is it further true, based upon reports that the 

Obama administration actually requested of the DEA whether or 

not they recommend that the President sign it and the DEA must 

have said, in some form or fashion, yes, this bill is appropriate to 

sign. Is that correct? 

108 

Mr. DOHERTY. That is correct, sir. 

Mr. COSTELLO. Let’s talk about this. Do you think that the law 

should be repealed? 

Mr. DOHERTY. Sir, in terms of the bill that affects, as you say, 

the ISOs that we use in our administrative toolbox, we also use 

criminal tools. 

Mr. COSTELLO. Absolutely. 

Mr. DOHERTY. We also use investigative tools. 

Mr. COSTELLO. There is a lot of other things you do. 

Mr. DOHERTY. Right. 

Mr. COSTELLO. And you do it effectively in very many measures. 

But on this specific bill, which deals with ISOs, do you think it 

should be repealed or do you think that it is doing what it what 

it was intended to do, which was provide clarity so that you can 

actually go out and issue ISOs without having to deal with litigation that might actually call into question your enforcement powers 

in the first instance? 

Mr. DOHERTY. Sir, let me say that the bill—the law changed the 

way that we looked at ISOs. It did not stop DEA from doing its job 

in the diversion space and we would be happy to work with Congress and DOJ, who is looking at this issue, as I said earlier, currently, to make sure that DEA has all the appropriate and updated 

tools. 

Mr. COSTELLO. Do you agree that if we did repeal this law, and 

didn’t supplement it with something else, then the same vagueness 

that caused litigation to occur, that raised concerns from a whole 

host of constituencies would come to bear once again? 

Mr. DOHERTY. Yes, sir, I believe we do need a mechanism at that 

level with respect to that tool. 

Mr. COSTELLO. One final question I am going to try and sneak 

in. 

Was there an internal policy change why the DEA so dramatically reduced ISOs between 2011 and 2016? 

Mr. DOHERTY. Not to my knowledge, sir. 

Mr. COSTELLO. Thank you. I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

The Chair recognizes the gentleman from Georgia, Mr. Carter, 5 

minutes for questions, please. 

Mr. CARTER. Thank you, Mr. Chairman, and thank you for this 

most important hearing. 

Mr. Chairman, I would ask unanimous consent to add into the 

record the written testimony from the International Chiropractors 

Association about nonpharmacological treatment of pain. Mr. 

Chairman? 

Mr. Chairman—— 

Mr. BURGESS. Is that your unanimous consent request? 

Mr. CARTER. Yes. 

Mr. BURGESS. Would you restate it, please? 

Mr. CARTER. Yes, sir. Mr. Chairman, I would ask unanimous consent to add into the record the written testimony by the International Chiropractors Association on nonpharmaceutical treatment of pain. 

Mr. BURGESS. Without objection, so ordered. 

109 

[The information appears at the conclusion of the hearing.] 

Mr. CARTER. Thank you. 

Dr. Schuchat, last year there was a study done that I believe was 

done in collaboration with the CDC and John Hopkins, and HHS, 

and NIH, and CMS that was called examining insurance coverage 

for acute and chronic back pain treatment pilots. Now are you familiar with this, dealing with insurance companies and how they 

can actually not approve non-pharmaceutical treatments and actually push more opioid use by what they cover and what they don’t 

cover? 

Dr. SCHUCHAT. I am not familiar with the specific study but I am 

familiar with that issue of what is reimbursed and what isn’t and 

that there has been a problem with opioids being easily reimbursed 

and the alternative approaches were recommended not to be paid. 

Mr. CARTER. OK, well this is the study that I am speaking of. 

Because I want to make sure because CMS has actually cited this 

as being a problem. 

Also, in the New York Times, there was an article last week that 

addressed this well that I want to bring to your attention. And essentially what it says, it gave very many examples about how pharmacy benefit managers, PBMs, if you will, and insurance companies are actually pushing more opioid use by the fact that they are 

not approving the use of non-pharmaceutical or non-opioids. 

Whereas, I agree with Dr. Gottlieb that there is a gap there between ibuprofen and the NSAIDs and then we go to opioids and we 

need to fill in that gap but there are some things can be used. You 

can use gabapentin. You can use Neurontin, Lyrica, those type of 

things but, in many cases, the insurance companies don’t cover 

them. The PBMs don’t cover them. The copay is higher, or you 

have to get a prior approval, or it is another tier, a higher tier so 

that you have to go through more hoops in order to get it approved 

which, of course, is leaning to more opioid use. 

Do you care to comment on that? Is that something you see? 

Dr. SCHUCHAT. Yes, our incentives have been going the wrong 

way to get better practice, better paying management, and avoiding 

the harms of opioids. 

Mr. CARTER. What can you do? What can CDC do? I mean is 

there anything you can do to encourage—I have not had any success in dealing with the PBMs, I can tell you that, but perhaps you 

will. 

Dr. SCHUCHAT. You know CDC’s guidelines for the treatment of 

chronic pain are now being taken up by a number of health plans, 

insurers, medical societies and the defaults in the electronic medical records—— 

Mr. CARTER. OK. 

Dr. SCHUCHAT [continuing]. And the ordering are better in many 

places. 

But I wanted to say something about the pharmacy benefit managers and the—— 

Mr. CARTER. Please hurry. 

Dr. SCHUCHAT. Sorry. Just that they have actually been helpful 

in spotting the problematic providers. 

Mr. CARTER. They have been helpful to a certain extent but also 

they have been part of the problem because they have been not apVerDate Mar 15 2010 10:47 Dec 18, 2018 Jkt 037690 PO 00000 Frm 00113 Fmt 6633 Sfmt 6633 I:\HIF FILES\WS_FTP\32978.TXT WAYNE
110 

proving some of the drugs that could have been used and, instead, 

have been approving the cheaper opioids; therefore, increasing the 

amount of opioid use. So that is the point that I am trying to make 

here. 

Dr. SCHUCHAT. Yes, absolutely. 

Mr. CARTER. OK. 

Dr. SCHUCHAT. We need better prescribing. 

Mr. CARTER. OK, Dr. Gottlieb, I want to first of all applaud you. 

In July you made an announcement that you were expanding, that 

FDA was expanding prescriber educational opportunities for instant release opioids. And this is a step in the right direction. 

There is no question about that. As a practicing pharmacists for 

many years, I can tell you we need more physician education. 

And you also said at that time that you were exploring making 

prescription training mandatory. Has FDA addressed that in any 

way at all? 

Dr. GOTTLIEB. We also expanded that education for pharmacists 

as well, Congressman Carter. 

Mr. CARTER. And thank you for doing that. That needs to be 

done. 

Dr. GOTTLIEB. Right. We are still working—we have a task force, 

a working group that is looking at different ways that we would 

operationalize a potential mandatory requirement for education, 

some of which could be contemplated by working in close concert, 

which we have been doing, with our partners at DEA. But we are 

looking at alternatives for how we could make education mandatory. 

Mr. CARTER. One other thing I want to get in before my time is 

up and that is this. Dr. Gottlieb, I thought you made a great point 

in your opening statement when you made the point that there 

really are two problems we are facing here. 

First of all, we are facing the prevention of this happening and 

trying to prevent people from being addicted. But another problem 

that we have is that we have got over 11 million people that are 

addicted now. We have got to deal with that and that is a big, big 

problem. 

My question is—you know last week I was in the treatment centers—what will work? It is going to take more than just throwing 

money at it. This is not a situation where we can say ‘‘OK, we have 

hit $50 billion, therefore we have done our job.’’ That is not what 

I am looking for at all. I am looking for effective treatments that 

are going to work. 

And I can tell you from personal experience I have seen opioid 

abuse firsthand. I have seen it ruin lives. I have seen it ruin families and careers. It is tough. 

What do you know, Dr. Volkow—I have served on many panels 

with you and you do a great job. What works? What works in the 

way of rehabilitation? 

Dr. VOLKOW. First of all, I want to thank you for bringing up the 

issue that it is not just throwing money at something. You have to 

actually throw money at a solution that is going to be effective. 

And I think that what we are demanding. That is why one of the 

things that we are demanding is that the treatment that is provided for individuals with opioid use disorder with quality care 

111 

treatment for which there is evidence of benefit and that we need 

to actually change the way that we provide that treatment so that 

we have a means to monitor the outcomes of the patients such that 

we can learn from what leads to a good response in a given patient 

and what in another one. 

We know, in general, that medication-assisted treatment significantly improved the outcomes and it prevents overdoses but we 

also know that not every patient responds and there is still significant relapse. 

Mr. CARTER. And thank you for that. 

And I am way over my time but one thing I want to warn all 

of us is that let’s don’t become too dependent on naloxone because 

it becomes a crutch and that is just not good. 

We have had problems already in Jacksonville, Florida, south of 

my district, where they can’t even carry it on the ambulances anymore because of the high cost and people getting it three or four 

times a week. It does not need to become a crutch for these people 

as well, although I understand fully the value of it. 

Thank you, Mr. Chairman. 

Mr. BURGESS. The gentleman’s time has expired. 

The Chair recognizes the gentleman from South Carolina, Mr. 

Duncan, the newest member of the committee, 5 minutes for questions, please. 

Mr. DUNCAN. Thank you, Mr. Chairman. And I have waited a 

long time to be on this committee. It is an honor to be part of Energy and Commerce. 

I would be remiss if I didn’t mention the work of a good friend 

of mine, State Representative Eric Bedingfield in South Carolina, 

who lost his son a year ago after a decade-long battle with opioids. 

And Eric and his family are very much in my thoughts as we have 

this hearing today. So I want to honor his continuing work and the 

State legislature on this issue. 

As we have seen today, this is an issue that transcends partisanship. It affects Americans in all 50 States. The opioid epidemic is 

real. 

Mr. Doherty, you mentioned tools that you had in your tool box 

for combatting the opioid epidemic. Could you tell me what some 

of those tools are, if not all of them? And then what would you say 

is the most valuable tools you have in this fight? 

Mr. DOHERTY. Congressman, thank you for that question. And I 

would say that from a law enforcement perspective and a DEA perspective, first of all, the scope of the problem is enormous and we 

need, literally, all hands on deck across the Federal, State, and 

local level, the medical community, the scientific community, and 

the law enforcement community. 

In terms of addressing the problem, we need to attack supply 

with the overseas suppliers with respect to heroin and fentanyl. We 

need to work to take the gang element out. 

Mr. DUNCAN. How do you do that without cooperation of the foreign Governments? Are they cooperating, I guess is what I am asking? 

Mr. DOHERTY. Yes, sir, we have had great cooperation at the 

international level, the bilateral level, and the multilateral level. 

Yes, sir. 

112 

Additionally, I would add that domestically we are initiating additional 360 Program cities for fiscal year 2018 and the 360 Program has been a crucial part of having, as I said, three distinct pillars of law enforcement attack this problem. 

We are also very much into the prevention space with the 360 

Prevention and also with Operation Prevention, which is a webbased curriculum that is cutting edge and designed to teach young 

adults the dangers of opioid use. And it is free. It is distributed to 

educators throughout the country and it has been viewed by hundreds of thousands of individuals so far. 

And we feel that partnership across Government is key to establishing a dialogue, number one, about new and innovative ways to 

attack the opioid crisis. And I think that no idea facing all of us 

is off the table with respect to this problem. 

Mr. DUNCAN. All right. It is an immense challenge. 

I came to this committee from Homeland Security Committee 

and also the Foreign Affairs Committee, where I chaired the Western Hemisphere Subcommittee. Opioids is the focus of this today 

but let me just let the committee know that due to circumstances 

in Colombia and Peru, the cocoa production has been up over the 

last year, 18 months. Coca production has been up. As a result, 

there is a lot of cocaine out there ready to come north. They are 

not flooding the market with it. That is going to be our next issue 

to deal with with regard to drugs. 

I appreciate the work you guys do, your men and women around 

the globe. And I have dealt with them in South America, so I know 

the challenges they face. 

Mr. Chairman, thank you so much, and I yield back. 

Mr. BURGESS. The Chair thanks the gentleman. 

The Chair recognizes the gentlelady from Indiana, Mrs. Brooks, 

5 minutes for questions. 

Mrs. BROOKS. Thank you, Mr. Chairman, and I appreciate the 

fact that you all got a break. I want to thank you all so very much 

for your work because each of your agencies is so critically important. 

And I want to start out because in the CARA effort the first section of that bill was a section that my colleague from Massachusetts, Representative Kennedy and I worked on, and it was to establish an interagency and medical professional task force to review and, when necessary, update and modify the CDC best practices guidelines for pain management. 

And so, Dr. Schuchat, can you tell me did you know about this 

formation and that it needs to be formed by the end of December 

of 2018 and report? And you are looking at Dr. McCance-Katz. So 

I am curious. I just want to know. Is it happening? Is it in formation and will we get a report without great detail? I just want to 

know. You know we have had a change in administration. So I 

want to know that it is on people’s radars. 

Dr. MCCANCE-KATZ. Yes, it is. And so we have members of the 

public that the application process closed. They are in the process 

of being selected now. And that committee is definitely going to be 

in place and you will get the report. 

Mrs. BROOKS. OK, outstanding. Thank you. 

113 

Dr. Gottlieb, building on what Representative Carter talked 

about with respect to prescriber education, you talked about we are 

at a point, in your opening remarks you said, where we might be 

doing some hard things, things we are not really comfortable with. 

And you talked about prescriber education and that we have a generation of prescribers that need more education. 

Can you—and I am interested in the entire panel’s very quick 

answer because I have like so many things I would like to ask all 

of you. Do you believe that mandatory prescriber education for either renewal, or for the first DEA licensure of someone who gets 

a DEA license or for renewal, that should come up with some mandatory prescriber education? 

Dr. GOTTLIEB. I would certainly support that goal and I have 

said as much. 

One caveat I would add is I don’t think it needs to be a 3-day 

course. I think it is more efficient if it a short course and we hit 

doctors with some key principles. I think there is ways to do that. 

Mrs. BROOKS. OK, where does a 3-day course come in? 

Dr. GOTTLIEB. I just threw it out there because there some States 

that have these long courses. 

Mrs. BROOKS. OK. 

Dr. GOTTLIEB. But I think something short, and targeted, and focused would be the most effective way to try to operationalize this. 

Mrs. BROOKS. Do you agree with that, Dr. McCance-Katz? 

Dr. MCCANCE-KATZ. I agree with it in general. I think that any 

prescriber who wants to prescribe controlled substances needs to 

have that education. 

Mrs. BROOKS. Needs to have that education. 

Dr. MCCANCE-KATZ. Absolutely. 

Mrs. BROOKS. Does anyone disagree with that? 

[No response.] 

Mrs. BROOKS. OK, thank you. 

Mr. Doherty, you may not know but I am a former U.S. Attorney 

and I did an OxyContin case against a physician that distributed 

to a community in southern Indiana and where people died, an 

OxyContin mill that was happening. 

So this type of challenge has been with us for a long time but 

when I met with IMPD last week, our Indianapolis Metropolitan 

Police Department, they said they took off a 55-gallon drum of pills 

in our community, full of pills laced with fentanyl. And can you tell 

me do you need any additional authorities that would help DEA 

improve its enforcement actions that have to do with pill presses? 

Mr. DOHERTY. Ma’am, DEA has been very active in leaning forward on issues with respect to pill presses. We have formalized a 

rule that requires the import/export of pill presses to be electronically sent to DEA. We work very closely with CBP. 

That said, we would certainly welcome a dialogue with Congress 

and with the Department of Justice to look at—— 

Mrs. BROOKS. Do you need more teeth? Do you need anything? 

And if you would please give some thought to that, whether or not 

legislation needs to happen. Because as I understand, some of 

these pills that are coming in our police department believes that 

the traffickers don’t even know what is in them. They don’t even 

know that they are dealing fentanyl, necessarily. 

114 

Is that something that you have seen? 

Mr. DOHERTY. Yes, ma’am, we have seen the fact that certainly 

the end user doesn’t know what they are getting and some individuals in the supply chain are also unwitting, to a certain extent in 

terms of what they are trafficking. 

So I would be happy to take that back, ma’am, and have a dialogue on that and reengage with Congress and the Department. 

Mrs. BROOKS. And then finally, Dr. McCance-Katz, in the context 

of the opioid crisis, do you believe it is important that a patient’s 

provider, their primary care or their main doctor, has access to his 

or her substance use disorder records? Because I understand there 

is not a connection between the behavioral specialists—and I am 

seeing nodding here from Dr. Volkow and Dr. Schuchat. 

And so why is that a problem and how do we fix that, that a primary care provider or another physician cannot have access to the 

mental health provider record? 

Dr. MCCANCE-KATZ. So there are several laws in place that prevent certain types of communications and the 42 CFR prevents organizations or treatment providers, if you will, that hold themselves out as substance abuse treatment providers from sharing 

records without specific permission from the patient. 

I will tell you that this is something that the Trump administration has been looking at since before I got here. We will be coming 

out in a couple of months with some revisions to communication 

that could be allowed under 42 CFR to better serve communication 

with physicians who are not substance abuse treatment providers 

but may be treating a patient with a substance use disorder. 

Why is this important? Because very often, somebody has got a 

co-occurring illness which will require them to be on a medication 

and could have a significant drug-drug interaction that could place 

a person’s life at risk, even on standard doses of medication. So it 

becomes a very important issue clinically. 

Mrs. BROOKS. Thank you. 

And if I could just close with, and I know I am over time, but 

I think what hopefully you have seen is that if there is legislation 

that anyone on either side of the aisle of this hearing we want to 

either resolve issues that occur either in statute or in regulation 

and please make sure we know what those are. 

Thank you. I yield back. 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. 

I recognize the gentlelady from California, Mrs. Walters, 5 minutes for questions. 

Mrs. WALTERS. Thank you, Mr. Chairman. And I have a letter 

from the Peace Officers Research Association of California that I 

would like to submit for the record. 

Mr. BURGESS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mrs. WALTERS. Thank you, Mr. Chairman. 

An increasing number of reports have revealed problems resulting from the dramatic surge of addiction facilities in sober homes. 

My home of Orange County, California has a significant number of 

these facilities. 

115 

These reports detail how individuals, as patient brokers, are recruiting patients and, in many cases, are flying them to a treatment facility across State lines, California being a very common 

destination. These patient brokers receive a generous financial 

kickback, amounts reportedly ranging from $500 to $5,000 for each 

patient who has successfully entered into a treatment facility or 

sober home. 

It is appalling that there are individuals treating those fighting 

addiction as a commodity and prioritizing profit over the well-being 

and sobriety of these vulnerable individuals. 

In light of these disturbing reports, the committee has sent HHS 

a letter on this very issue on July 13th. HHS provided a response 

last month and I have some questions for Dr. McCance-Katz following up on that response. 

Dr. McCance-Katz, in response, HHS noted that 80 percent of 

treatment facilities are licensed or certified by State bodies. First 

question: Who licenses and certifies these facilities? 

Dr. MCCANCE-KATZ. The States do, and some of these facilities 

are not licensed or regulated within States. 

So the Federal Government—SAMHSA regulates opioid treatment programs and certain types of credentialing of providers but 

we do not have purview over what goes on in the States regarding 

other types of substance abuse treatment programs or recovery 

housing. 

Mrs. WALTERS. OK so if you flip that 80 percent figure, that 

means that 20 percent of the facilities are not licensed or certified. 

OK, so why aren’t all facilities licensed or certified? 

Dr. MCCANCE-KATZ. Different States take different approaches to 

this. I would recommend that one of the things that States consider 

is requiring that these types of facilities get credentialed. There are 

national accreditation bodies that could do this. States would need 

to require it, and then States would charge a licensing fee. 

The other thing that happens at these facilities is that they often 

use practitioners, or what they call practitioners, who have no certification or qualifications in the field. That can also be addressed 

by State regulatory bodies. 

Mrs. WALTERS. So do you know which States do require certifications and licenses and which don’t? 

Dr. MCCANCE-KATZ. I don’t have that information at my fingertips. 

Mrs. WALTERS. OK. HHS also noted in its response that 

SAMHSA is working with States to share best practices on how to 

address patient brokering with provider associations. And what are 

those best practices and who developed them? 

Dr. MCCANCE-KATZ. So SAMHSA does have a work group on this 

and that work group met over the summer. There is a report that 

is being put together right now. 

But I can tell you that some of the best practices that will come 

out will be, as I mentioned, requiring the licensure of practitioners 

in these programs, requiring accreditation of the programs themselves. 

We are going to make a bigger effort than we already do to put 

families in touch with our treatment locator system. We actually 

have a treatment locator system on our SAMHSA Web site that is 

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linked to by other HHS agencies as well that has investigation that 

goes on. All of the programs on our system are approved by the 

SSAs in the different States. So they have a certain quality indicator if they are on that treatment locator. 

We also think it is important for families to be able to ask specific questions. So if I am a family member looking for a provider, 

I need to ask, What are your credentials? Are you accredited by a 

national organization? Have you been inspected? And if you have 

been inspected, were there any citations of your facility and what 

did you do about them? Those questions right there can tell families whether that is a facility that they would want their loved one 

at. 

Mrs. WALTERS. OK, just shifting gears a bit to focus on sober 

homes, which, based on the aforementioned reports, are equal offenders in the patient broker scheme. 

It is the committee’s understanding that sober homes are regulated much differently than treatment facilities. Is that correct? 

Dr. MCCANCE-KATZ. That is my understanding. 

Mrs. WALTERS. OK and what is SAMHSA’s role in overseeing or 

regulating sober homes? 

Dr. MCCANCE-KATZ. We have no authority over sober homes. 

Mrs. WALTERS. OK. Well, I will yield the balance of my time. 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. 

And I believe that concludes members’ questions. I was going to 

yield 5 minutes for questions to Mr. Green because he has been sitting her so patiently, if you have a follow-up or redirect. 

Mr. GREEN. Thank you, Mr. Chairman. 

Mr. Doherty, among the things the Controlled Substances Act establishes is a quota system that controls the qualities of basic ingredients needed to manufacture controlled substances. These 

quotas serve to try and reduce diversion, while also providing the 

adequate supply of controlled substance for legitimate medical 

need. 

DEA sets these quotas using data regarding manufacturing history, forecasts, prescriptions dispensed, past quota histories, and 

internal DEA data on controlled substance transactions. 

Deputy Assistant Administrative Doherty, I would like to ask 

about DEA’s process on establishing these quotas. In reviewing the 

aggregate production quota history of oxycodone, hydrocodone, and 

morphine, and fentanyl, the quotas from 2007 to 2015 show dramatic increase. 

For example, the quota for oxycodone doubled from 70,000 kilograms in 2007 to 149,000 in 2014. This is true for hydrocodone, 

which increased from 46,000 kilograms in 2007 to 99,000 kilograms 

in 2014. 

Can you explain to the committee the process DEA undertakes 

in setting these quotas? 

Mr. DOHERTY. Sir, thank you for that question. Sir, my oversight 

responsibilities with respect to the Diversion Control Division are 

over the criminal investigative side of the house, the law enforcement side of the house. 

Last year, the DEA Diversion Control Division was reorganized 

in such that we are now a complete division. We were formally an 

117 

office, an Office of Diversion Control under the Operations Division 

of DEA. We are now a standalone division and we have two offices, 

the Office of Diversion Control Operations, which I oversee, as the 

law enforcement arm, running the criminal investigations and 

technology aspect. And then we have a regulatory compliance oversight arm, which is the Office of Diversion Control Regulatory. 

So, sir, I am generally aware of the quota system, in terms of the 

points you mentioned. And I can state that last year the APQ, the 

aggregate production quota, was reduced 25 percent across the 

board and additional reductions are proposed for, as you mentioned, certain drugs, hydrocodone, oxycodone, and fentanyl for an 

additional 20 percent. 

I would be happy to take that back and get you a complete answer, sir. 

Mr. GREEN. Yes, if you could, just to share with the committee, 

to the Chair, of how that decision is made. Because again, from 

2007 to 2015, the quotas were double and I wanted to see why 

DEA decided to do that, if they felt like that was needed. 

According to DEA’s history, quota history, it is not until 2016 

and 2017 that DEA announced that the quotas for oxycodone, 

hydrocodone, and morphine, and fentanyl would be reduced. And if 

you don’t know that question, if you could get it back to us why 

all of a sudden they waited until 2016 and 2017 to do that. 

And I understand the DEA has the authority to revise their 

quota at any during the year in response to change in sales, new 

manufacturers entering the market, new product development, or 

product recalls. 

Does DEA have the authority to revise the quota of controlled 

substance in response to patterns of abuse, or misuse, or increase 

diversion? 

Mr. DOHERTY. Again, sir, not under my direct purview but I do 

know, generally speaking, that that authority does rest with DEA, 

as well as decreasing quota when requested by a registrant. 

Mr. GREEN. OK. Well, Mr. Chairman, I would hope we could 

get—if you could have somebody who has that information to get 

to the committee. And if we have to send a letter, hopefully the 

committee would send that. 

Mr. Chairman, before I yield back, when we did the Affordable 

Care Act, it is crucial to address the opioid crisis. And what we did 

with the Affordable Care Act, prior to the ACA there was 34 percent of individual market policies did not cover substance use treatment. Now all health care policies that are sold in marketplaces 

must include these services for substance use disorders. And repealing the mental health and substance use disorder coverage provisions of the ACA will remove at least $5.5 billion annually from 

the treatment of low-income people with mental and substance use 

disorders. 

In my early days as a probate lawyer, I also did mental health. 

And so often, back in the 1980s and even the 1990s, we did not 

have a place where people would go. And most insurance policies 

in Texas, in their State, did not cover mental health, unless you 

were very wealthy. 

And so that is why the ACA was changed, to do that. And as I 

recall, for mental health and substance abuse, Medicaid is probably 

118 

still the biggest provider in the country. And so by cutting Medicaid, it is making it even more of a problem. 

And I know I am running 17 seconds over my time, but I run 

through the 3 minutes. So, I yield back. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

is correct to observe the Chair has been very indulgent with letting 

people go over because this is an important topic. 

And I am also going to yield myself a time for redirect. I want 

to ask a couple of additional questions on the PDMD programs. 

This committee authorized NASPER, probably in 2005. It has 

been funded. In this year’s Labor/HHS appropriations bill as 

passed by the house in September, there was an amendment offered and accepted by your chairman that funded, for the first 

time, the NASPER program, which I think is terribly important. 

In my home community, an obituary in the paper the other day 

of a young man in the mid-20s was the child of a woman who was 

my daughter’s best friend—my sister’s best friend in high school. 

And it was quite a shock to the community. And you ask questions 

and it comes out that it probably was opiate-related and probably 

was a rather substantial number of pills that this young man was 

given his last physician visit. 

So it bothers me that we have the data and Mr. Doherty, this 

probably for you. I realize it is not law enforcement data but I will 

even broaden it for anyone. The information is now there. It is 

being collected in a prescription drug monitoring program. There 

has to be some sort of algorithm and a red flag go up, even de-identified patient data, to help identify a hot spot, either a pharmacy— 

so much of the PDMP program is provider-directed but it seems 

like it could also be pharmacy-directed as well. 

You identify a hot spot. Here is one prescriber where more pills 

are going out the door than any other prescriber in town or here 

is a pharmacy where more are filled. Is there any way to create 

that nexus so that at least there is the reason to do a little bit 

more investigation? 

De-identify the patient data. I am not trying to out the patient 

who has a problem but where are these facilities where the difficulty is occurring? 

Mr. DOHERTY. Sir, thank you for that question. And in terms of 

data analytics, such as a PDMP, DEA supports them and DEA supports law enforcement access to them. 

Unfortunately, sir, the 49 States that currently have PDMPs 

have a varying degree of access. Some require a court order. DEA 

advocates for law enforcement access, obviously with the PII, personal identification information, in mind and we feel it is a vital 

tool for law enforcement to do as you said, sir, to identify hot spots 

and to further our criminal investigations and take action against 

registrants operating outside the law. 

As I said, 49 States have them; 41, to my knowledge, reconnected 

through a program called InterConnect. We think that is a positive 

step as well. However, as I stated before, the degree of access varies. It varies quite a bit, sir. 

Mr. BURGESS. I think going forward that is something that we 

do have to keep in mind. There has to be a way to identify these 

119 

places where problems are occurring and at least have a chance for 

intervention. 

Dr. McCance-Katz, you and I talked briefly before the hearing 

started. You know I am not a fan of needle exchange programs but 

let me just ask you this. 

There is technology where a syringe and needle can only be used 

one time. Retractable Technologies, in my district, has developed 

such a syringe. You push the plunger all the way in and the needle 

retracts up into the barrel and you cannot retrieve the needle without destroying the device. 

I don’t know whether that is something that SAMHSA has 

looked at but in the needle exchange programs, as they exist, I 

would at least like the assurance that it is a true single-use device 

that is being dispensed in a needle exchange program. 

Dr. MCCANCE-KATZ. Well, what I believe to be the case, sir, is 

that the Federal Government, our funds do not go to purchase syringe equipment of any kind. What funds can be used for are 

things like support staff within a program that does syringe exchange, mainly to help people get to treatment. 

So we do not have any authority over that and are not involved 

in that. 

Mr. BURGESS. To get the continuing medical education I required 

for my license this year, I took your online SAMHSA-sponsored 

opioid abuse. I took two of the three modules. And thank you for 

having it online. Thank you for having it at a price I could afford. 

But one of the harm-reduction strategies that they talk about in 

this SAMHSA-authorized product out of Harvard Medical School is 

our needle exchange programs. And again, I am not a fan of that. 

But if we are involved in that, I really think the effort should be 

that they be a single-use device and this retractable technology is 

FDA approved. It has been around for a while. It has never been 

widely used because they are a little bit more expensive. But if we 

are going to the trouble to do harm reduction, I think that is a type 

of harm reduction I would like to see. 

Dr. MCCANCE-KATZ. I think that is a very good suggestion. And 

I actually, since you bring that up, I will take it back to our staff 

at SAMHSA and we will look at that course you are talking about. 

Mr. BURGESS. Thank you. I am not trying to be the Chamber of 

Commerce guy for Retractable Technologies, but they do have a 

good product. 

I want to thank all of you. This has been a lengthy but I think 

important and informative hearing. I know I have gotten a lot of 

information. This coupled with the 50 members that we heard from 

2 weeks’ ago with the individual opiate problems they have in their 

district, I hope will form the nidus of the ability to come together 

on some things. We obviously have a problem that needs to be 

fixed. We have heard it expressed passionately several times today. 

Dr. Gottlieb, I do have one question for the record that I am 

going to submit to you in writing because it was so technically complicated, I didn’t think I could do it justice by reading it to you. But 

it is an important question, and it deals with distribution of counterfeit products. And again, I will submit that in writing because 

we have gone significantly overtime. 

120 

Seeing that there are no further members wishing to ask questions, I do want to thank all of our witnesses for being here today. 

We have received outside feedback from a number of organizations and I would like to submit statements from the following for 

the record: The American Medical Association, the Academy of Integrated Pain Management, the American Dental Association, the 

American Society of Addiction Medicine, Medication Assisted Treatment Coalition, International Chiropractors Association, Oxford 

Housing Incorporated, American Association of Nurse Anesthetists, 

Protecting Access to Pain Relief, and America’s Health Insurance 

Plans. 

Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. BURGESS. Pursuant to committee rules, I remind members 

they have 10 business days to submit additional questions for the 

record and I ask the witnesses to submit their response within 10 

business days upon receipt of the questions. 

Without objection, the committee is adjourned. 

[Whereupon, at 3:26 p.m., the committee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

Thank you, Mr. Chairman, for holding this important hearing today. 

I also appreciate all of the witnesses here for coming before our committee and 

sharing their agency’s efforts to fight the opioid crisis at the Federal level. 

The Health Subcommittee recently heard from more than 50 members on how the 

opioid epidemic is affecting their communities. The opioid crisis has touched every 

corner of American society—no one is immune from this heartbreaking problem. 

Just this month, our North Texas community lost a young man in his mid-20s from 

a suspected overdose. This young man, who was the son of one of my daughter’s 

closest friends, had his whole life ahead of him. Too many American families have 

been devastated by this epidemic. The statistics on this issue are shocking, particularly as we consider that 91 Americans die every day from an opioid overdose, and 

in 2016 alone, drug overdoses claimed more American lives than the entire Vietnam 

War. 

The debate around pain medication is not a new issue for our committee. In fact, 

one of the first Energy and Commerce Committee hearings I participated in more 

than a decade ago focused on physicians’ treatment of pain. However, at the time, 

we were concerned that physicians were not treating pain adequately. Today, we are 

hearing about a much different situation. 

As we consider solutions critical to stemming the opioid crisis, we must strike a 

careful balance before casting blame. It bothers me when I hear doctors placed at 

fault for this epidemic. Physicians are our allies, not our adversaries, in this battle 

against the opioid epidemic. In fact, a caring doctor on the front line can do more 

to stem this problem than any Federal Government action. 

PREPARED STATEMENT OF HON. STEVE SCALISE

Opioid abuse is a major crisis in this country. We’ve all heard stories from families back home in our districts as this horrible epidemic has swept through communities across America. 

Despite everyone’s best efforts, the troubling statistics continue to rise. Louisiana 

was one of many States that experienced double-digit increases in the percentage 

of opioid related deaths in recent years. Last year there were more opioid related 

deaths in southeast Louisiana than car crash fatalities. 

There is no silver bullet to this problem which is what makes the committee’s 

work so important. Today’s hearing will allow us to measure how well recent reforms passed in Congress are being implemented, and tell us what more we can be 

doing in our fight against opioid abuse. 

121 

I want to thank Chairman Walden for allowing the full committee a chance to 

be a part of today’s hearing, and I look forward to working with all of my colleagues 

to address our country’s opioid crisis. 

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32978.028

AnH•rican Physical Therapy Assoda.tion,. 

ENT 

Statement for the Record 

American Physical Therapy Association 

House Energy & Commerce Committee 

"Federal Efforts to Combat the Opioid Crisis: 

A Status Update on CARA and Other Initiatives" 

October 25, 2017 

On behalf of our more than 1 OOJlOO member physical therapists, physical therapist 

assistants, and students of physical therapy, the American Physical Therapy Association 

(APTA) appreciates the opportunity to submit comments to the House Energy and 

Commen:e Committee as it strives to address the concerns relating to pharmacological 

pain management. 

Physical therapists play an important role in managing acute and chronic pain by 

administering treatments thal include strengthening and flexibility exercises, manual 

therapy, posture awareness. and body mechanics instruction. Nonphannacological 

therapies, such as physical therapy, offer an alternative to opioids and other 

pharmacologies for pain by helping patients improve their function and range of motion, 

and understand the underlying causes of their pain. 

APTA seeks to light the opioid epidemic and positively influence public health and wellbeing by enhancing prescriber, patient, and policymaker understanding of safe and 

ciTectivc pain management through interdisciplinary care that improves movement and 

function. We actiYely work to enhance awareness of and access to pain management 

options that best suit patients' needs, goals, and desires, \vhich can ultimately play a 

major role in turning around our nation's opioid epidemic. APTA has taken an active role 

in combating opioid addiction by promoting physical therapy as a viable alternative to 

opioids to manage acute and chronic pain. As part of this effort, last year APTA launched 

the #ChooscPT campaign to educate consumers on the unique role physical therapy plays 

in the treatment of pain. For more information about the campaign. please sec: 

http://\\ww.moveforwardpt.com/Dclaplt,~'i· 

As Congress continues to explore ways to address the crisis, APTA is pleased to make 

the following recommendations: 
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Recognition and Promotion ofiolfective Nonpharmacological Pain Management 

Treatments 

In 2016, the Centers for Disease Control and Prevention (CDC) released guidelines for 

prescribing opioids for chronic pain. The CDC made clear within its guidelines that there 

are better, safer ways to treat chronic pain than the use of opioids, specifically stating that 

many nonpharmacological therapies, including physical therapy, can ameliorate chronic 

pain. It is important for stakeholders to be able to recognize physical therapy as a 

nonphannacological option that is considered a safe and effective treatment for pain. 

Accordingly, as Congress develops policies and practices for combating drug addiction, 

with a particular focus on the opioid epidemic, APTA recommends that Congress more 

effectively promote the different types of nonplwrmacologica/ treatments that are 

effective for tlte treatment of pain and put forth recommendations related to such. 

Advancement of Safe and Effective Interdisciplinary, Nonpharmacological Pain 

lvfanagement Care lviodels 

Pain management often needs a comprehensive, integrative approach that focuses on 

nonpharmacological, interdisciplinary interventions. Successful interdisciplinary pain 

management models encompass multiple disciplines-including physical therapy, 

nursing, pharmacy, primary care, and behavioral health~-that encourage providers to 

work as a unified team in the delivery of care. Better supporting the development of and 

access to interdisciplinary, comprehensive pain management models that evaluate and 

treat the different factors influencing the presence of pain will only serve to enhance the 

ef1'ectiveness, efficiency, and safety of care delivered to patients with pain. 

Accordingly, as Congress develops policies and practices for addressing the opioid 

epidemic, APTA recommends that Congress prioritize the evaluation, development, and 

improvement of interdisciplinary pain management models that are safe and effective 

for the treatment of chronic pain. 

Clinician and Patient Education 

APTA strongly believes that dissemination of information and education about valuable 

alternatives to opioids for the treatment of pain, such as physical therapy, will help to 

move this nation forward in its efTorts to improve pain management and promote safe 

opioid prescribing. Clinicians must be equipped with the knowledge and resources 

necessary to be able to evaluate treatment options for a patient's pain, both 

pharmacological and nonpharmacological, and provide a well-informed recommendation 

on the best treatment for pain management, specific to the needs of the patient. 

Patients often do not have the knowledge or opportunity to engage in informed, shared 

decision-making about the ditTerent treatment possibilities for their acute or chronic pain. 

They desire results and rely on the wisdom of their health care providers to otTer them the 

best treatment option. If clinicians have not been educated on pain management solutions 

other than over-the-counter or prescription medications, and how such options may suit 

patients' needs, then alternative treatments such as physical therapy will neither be 

discussed nor offered to patients. This not only places patients at a significant 
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disadvantage during the course of treatment but, at the same time, encourages overuse of 

opioids to treat pain. 

The message that successful pain management requires the use of nonpharmacologieal 

therapies must be conveyed and reinforced to clinicians, as well as to patients, payers, 

and the general public. As discussions evolve related to what federal et1orts should be 

undertaken to address the opioid epidemic, APT A recommends that Congress provide 

resources to support training and education to prescribers and others who are directly 

involved in the management or support of patients with pain, on the value of 

nonpltarmacological treatments and !tow to recognize wit en such therapy options are 

the safer, more effective option for tlte patient's condition. 

Additionally, educating patients on how to manage their pain is a key component to 

e1Tectively reducing pain intensity and interference. As patients acquire information 

related to the management of their condition, their sense of empowerment grows. Being 

empowered by their health care providers can help patients actively manage their pain, 

resulting in improved outcomes and reduced costs of care. To support the promotion of 

patient empowerment and self-reliance, however, clinicians must be educated on the 

methods by which they can empower their patients. APT A urges Congress to recognize 

the benefits of patient empowerment as it relates to pain management, and the methods 

and materials most e.ffective in educating clinicians on patient empowerment. 

Eliminating Barriers to Nonpharmacological Pain A1anagement Treatments 

As the health care industry moves forward, it is imperative that patients have direct 

access to nonpharmacologieal pain management treatments, including physical therapy, 

as well as interdisciplinary pain management models. Given that the CDC has concluded 

there is insufficient evidence that opioid use alone improves functional outcomes tor 

those in pain, we recommend that if a clinician prescribes an opioid for pain, then the 

clinician also refer a patient to physical therapy. Research has demonstrated that when a 

patient in pain receives early access to a physical therapist, the patient experiences 

improved functional outcomes, and there is a significant reduction in overall costs. 

Unfortunately, barriers to nonpharmacological pain management treatments continue to 

persist. For example, many insurers continue to promote the use of medications while 

restricting access to safer, more cost-etiective nonpharmaeological therapies. Other 

barriers include patient attitudes toward pharmacological and nonpharmaeological 

therapies, gaps in clinician knowledge, high copayments, and time and visit limits. Until 

such barriers are addressed, access to nonpharmacological therapies will continue to 

remain limited, and opioids will remain a go-to quick fix for pain despite their dangerous 

side effects and, in some instances, long-term ineffectiveness. Moreover, reducing the 

number of barriers to nonpharmacologieal treatments will help to inform the design of 

effective strategies for increasing use of these treatments. There must be a commitment to 

ensuring that patients have access to the appropriate therapy for pain management and 

treatment. APTA strongly encourages Congress to examine and resolve the existing 

barriers to nonpltarmacological treatments, including interdisciplinary pain 

management models of care. 
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32978.031

We appreciate the opportunity to provide comments and look forward to partnering with 

Congress, as well as with the greater community, in a joint effort to improve the safety 

and quality of care for patients. Should you have any questions regarding our comments, 

please contact Kara Gainer, director of regulatory affairs, at karagainer@apta.org or 

703/706-8547. Thank you for your consideration. 
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32978.032

MARSHA BLACKBURN 

7Th01STfllCl, TENN£SSEL 

COMMITIEEON 

ENERGY AND COMMERCE 

<!Congress of tbe Wniteb $tates ~ou!lc of l\cpresentatibes 

~asbington, ill!lt 20515-4207 

October 24, 2017 

Acting Secretary Eric Hargan 

United States Department of Health and Human Services 

200 Independence Ave, SW 

Washington, DC 20201 

Acting Administrator Robert Patterson 

United States Drug Enforcement Administration 

8701 Morrissette Dr. 

Springfield, VA 22152 

Dear Acting Secretary Hargan and Acting Administrator Patterson: 

Recent press reports related to the opioid epidemic have raised questions regarding the effects of the 

Ensuring Patient Access and Effective Drug Enforcement Act IP.L. 114-145), signed into law in April2016. 

As a Member of Congress whose district and state has been heavily impacted by the opioid epidemic, I 

am deeply concerned about the issues raised in these reports and write to request information from· 

your agencies detailing the impact of the law. 

The House Energy and Commerce Committee, on which I serve, has continued its work to address this 

crisis. It is critical that we have a full accounting of the effects of laws passed in recent years in order to 

inform our decision making going forward. 

As you are aware, P .L 114~145 requires the HHS Secretary to coordinate with the DEA Administrator 

and other officials from related departments and agencies to submit a report to Congress that: details 

the effects of the law; notes significant barriers to improved enforcement and appropriate and safe 

clinical care of patients; and identifies ways to improve both Congress' access to information gleaned 

from data on opioid prescription and distribution and states' prescription drug monitoring programs 

that collect this data. 

The law states that the report is due one year following enactment, which occurred on April19, 2016. 

At this time, six months after the deadline established in the law, no such report has been submitted to 

Congress. This missed deadline is unacceptable. 

HHS and DEA must act swiftly to submit this report to the appropriate committees in the House of 

Representatives and Senate and should include information about the law's impact on agencies' efforts 

to prevent diversion and stop the flow of prescription opioids into our communities. 

Member of Congress 
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32978.033

American 

~ Hospital 

Association. 

Statement 

of the 

American Hospital Association 

for the 

Committee on Energy and Commerce 

of the 

United States House of Representatives 

"Federal Efforts to Combat the Opioid Crisis: 

A Status Update on CARA and Other Initiatives" 

October 25, 2017 

800 10th Stree( NW 

Two CityCenter,Surre41l0 

Washington, DC ZOOJJ-4951' 1102)638-1100 Phone 

vvvvvv.aha.org 

On behalf of our nearly 5,000 member hospitals, health systems and other health care 

organizations, our clinician partners- including more than 270,000 affiliated physicians, 2 

million nurses and other caregivers and the 43,000 health care leaders who belong to our 

professional membership groups, the American Hospital Association (AHA) appreciates the 

opportunity to submit testimony on solutions to address the opioid crisis. We thank you for 

convening the leadership of key agencies of the Department of Health and Human Services to 

examine the opioid crisis and the role of federal agencies in responding. 

Every day, hospitals witness the devastating effects of the opioid epidemic on the patients and 

communities we serve. While prescription opioids can be a safe and necessary clement of pain 

management, they also carry serious risks of harm because of the potential for misuse. addiction, 

overdose and death. The Centers for Disease Control and Prevention (CDC) reported that more 

than 14,000 people died from overdoses involving prescription opioids in 2014. In 2015, mental 

health and substance use disorders together were the leading cause of disease burden in the 

United States, surpassing cancer and cardiovascular disease, according to an infographic 
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published in the Journal of the American Medical Association. A June 2017 report from the 

Agency for Health Care Research and Quality found that opioid-relatcd hospital stays increased 

by 75 percent for women and 55 percent for men between 2005 and 2014, while opioid-related 

emergency department visits doubled for both men and women. 

America's hospitals and health systems play a distinct role in helping to address the opioid 

epidemic. Our members arc working to end this epidemic, employing a multitude of strategies to 

fight this serious public health problem. They are implementing standard protocols for 

prescribing opioids, educating clinicians, promoting the usc of state prescription drug monitoring 

programs, offering treatment and referrals to patients. implementing alternative ways to address 

pain management, and safeguarding prescription medicines from diversion. 

At the same time, hospitals recognize that the medical community cannot end the opioid 

epidemic alone. Success will require sustained collaboration between private and public entities. 

As one example of such collaboration. last year, the AHA and CDC created a patient education 

resource on prescription opioids. Developed with input from CDC subject matter experts and 

hospital clinical and behavioral health leaders, the document provides evidence-based 

information about the risks and side effects of opioids. Our resource, distributed to all member 

hospitals and health systems and available through the AHA's website, is designed to facilitate 

discussions between health care providers and patients about the risks ot; and alternatives to, 

opioids. In addition, the resource includes recommendations on the proper storage of opioids and 

disposal of unused opioids. 

Hospitals and health systems recognize the essential role of federal resources in this effort. The 

AHA applauds the leadership of the members of the Committee in enacting the Comprehensive 

Addiction and Recovery Act and the 21st Century Cures Act, and we continue to support full 

funding and implementation of these laws. We urge you to assess the progress made to date in 

implementing their provisions, especially those related to expanding treatment, promoting 

education and training, reducing stigma and enforcing parity. The AHA further urges the 

Committee to support additional federal initiatives that promote access to comprehensive 

treatment for opioid-dependent patients and the allocation of adequate resources for such 

treatment, appropriate data sharing, prescriber education and parity enforcement. 

RECOMMENDA TIOl"iS 

We would like to offer the following actions the government could take to help stem the tide of 

the opioid epidemic. 

First, the AHA continues to urge Congress to eliminate barriers to treatment created by the 

Medicaid Institutions for Mental Disease (!MD) exclusion, which prohibits federal financial 

participation for inpatient care tor individuals age 21-64 provided in an !MD with more than 16 

beds. If the exclusion were eliminated, lMDs could expand access to services for patients with 

substance use disorders. This would be particularly helpful in improving access to treatment for 

those with severe or more complex suhstancc use disorders (SUDs), reducing wait times tor 

treatment, and possibly reducing boarding of patients with substance use and mental health 

disorders who would benefit from inpatient treatment. 
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32978.035

Second, we urge the Committee to support amending 42 CFR Part 2, which governs the 

confidentiality of SUD patient records and impedes the sharing of patient information necessary 

for delivering the most efficient and effective care. The AHA supports legislation to fully align 

the Part 2 regulation with the Health Insurance Portability and Accountability Act (HIPAA) 

regulation as the best way to eliminate these barriers. Recent revisions made by the Substance 

Abuse and Mental Health Services Administration (SAMHSA) to the Part 2 regulations do little 

to eliminate existing barriers. In fact, complete alignment of Patt 2 and HIPAA will require 

statutory changes, and we urge the Committee to support legislation necessary to achieve this 

outcome. Applying the same requirements to all patient information- whether behavioral or 

medical would support the appropriate information sharing essential for clinical care 

coordination and population health improvement, while safeguarding patient information from 

unwarranted disclosure. 

Third, the AHA encourages the Committee to enhance access to Medication Assisted Treatment 

(MAT). A recent report from the National Academics of Sciences, Engineering and Medicine 

underscores the gaps in the availability of MAT. The AHA has supported efforts to increase 

patient limits for buprenorphine prescribing. We agree that the federal government should 

continue to incentivize adequate access to MAT, and we urge the Committee to identify ways to 

increase the number of providers with specialty training as well. Among the key challenges for 

hospitals and health systems is finding physicians and psychiatrists with certifications in 

addiction medicine who can help oversee MAT services, directing evidenced-based medicine and 

serving as a resource for other clinicians, psychiatrists and staff. 

Fourth, the AHA believes that fully employing and connecting prescription drug monitoring 

programs (PDMPs)- statewide electronic databases that collect designated data on substances 

dispensed in the state- will bolster federal efforts to combat the opioid epidemic. The AHA 

supports strengthening PDMPs and ensuring that POMP information is shared across state lines. 

The federal government should seek ways to maximize their capacity to help clinicians avoid 

unnecessary or potentially harmful opioid prescriptions. We understand that most PDMPs 

already engage in some level of information sharing, especially with their neighboring states. In 

addition to enhancing these efforts, the potential exists to use certified electronic health records 

(EHRs) to improve knowledge about a patient's active and prior medications. We urge the 

Committee to find ways to suppmt the inclusion of POMP information in the certified EHR in a 

timely and efficient manner that is easy for clinicians to use in the course of their clinical 

workflow. 

Fifth, the AHA strongly supports prescriber education through medical and dental school 

training, as well as continuing medical education, and has worked to disseminate information to 

hospitals on opioid prescribing guidelines, such as the CDC guidelines for chronic pain. We also 

have committed to continue sharing successful hospital practices related to education, prescriber 

monitoring and alternatives to pain management. We plan to release a toolkit later this fall with 

additional information and resources for hospitals. While the AHA supports increased prescriber 

education initiatives, we caution that mandatory requirements can have unintended 

consequences. 
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32978.036

Finally, the AHA applauds the Committee's record of commitment to improving enforcement of 

the Mental Health Parity and Addiction Equity Act (MHPAEA). Our members and the patients 

they serve continue to face obstacles in securing coverage and payment as intended by federal 

mental health and substance use disorder parity laws. We agree that more must be done to 

enhance parity compliance, including ensuring that parity provisions in the 21st Century Cures 

Act are fully implemented. New guidance for health plans, improved transparency of benefit 

information, and additional parity compliance analysis tools can all support better adherence to 

MHPAEA provisions. All federal agencies, and especially the Department of Labor, must make 

parity enforcement a priority. 

CONCLUSION 

The AHA thanks you again for your ongoing efforts to address the opioid crisis. Our member 

hospitals and health systems stand ready to work with you to improve the health of all our 

communities. 

4 
131 


32978.037

Testimony 

From The 

Protecting Access to Pain Relief (PAPR) Coalition 

House Committee on Energy and Commerce 

October 25, 2017 

The Protecting Access to Pain Relief (PAPR) Coalition is pleased to submit this testimony in 

response to the House Energy and Commerce Subcommittee on Health's hearing entitled 

"Federal Efforts to Combat the Opioid Crisis: A Status Updated on CARA and Other 

Initiatives." 

The PAPR Coalition is a multi-stakeholder group of 16 public health organizations able to 

collectively reach out to millions of medical professionals, people living with pain, patients 

managing chronic disease, and concerned citizens whose mission is to advocate for public policy 

that supports continued access to and choice of appropriate over-the-counter (OTC) pain relief. 

Our list of members and other information can be found at our website www.paprcoalition.com. 

The PAPR Coalition remains dedicated to ensuring patients' access to the OTC pain relief they 

need as a part of their care regimen while continuing its efforts to educate the public about the 

appropriate use of acetaminophen and ensure patient safety by promoting the use of non-opioid 

pain relief options. 

Currently, over I 00 million Americans suffer from chronic pain; that is more than the number of 

patients suffering from diabetes, stroke, coronary artery disease and cancer combined. 1 Because 

of its near ubiquity nationwide, pain presents a significant public health problem in the U.S. An 

Institute of Medicine report found that pain costs our society at least $560-$635 billion annually 

(equal to about $2,000 per person) in lost wages and compensation for disability days. In 

addition, the costs of care associated with chronic pain, which include diagnostic tests, physical 

1 AAPM Facts and Figures on Pain. lhe American Academy of Pain Afedicine. 

http://www .painmed.org/patientccntcr/facts on pain.aspx#refer. 

' Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving 

Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies 

Press, 2011. 
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32978.038

therapy, medications, and medication management, can be extremely burdensome on both 

patients and the healthcare system as a whole. A 2015 study of a large U.S. health integrated 

delivery system found that treating chronic pain costs approximately $32,000 per patient per 

year, with an annual average of nearly 19 outpatient visits and five imaging tests per patient3 

Within these overall expenditures, the total cost of medication prescribed for pain is enormous, 

with one study indicating $17.8 billion in total annual spending on prescription medication for 

pain that includes analgesics, nonsteroidal inflammatory drugs (NSA!Ds), opioids, muscle 

relaxants, and topical products 4 Further, over a seven-year period the number of outpatient visits 

made for chronic pain increased by three percentage points, indicating that diagnoses of chronic 

pain requiring some form of medication-based treatment will likely continue to increase over 

time 5 

OTC pain medication, specifically acetaminophen, is often a medically necessary and cost 

effective way for patients to manage pain. There arc approximately 120 million adults in the U.S. 

have a health condition for which NSA!Ds and certain other pain medications are 

contraindicated. These patients rely on acetaminophen for pain relief. 

Therefore, in addition to lower costs, for many patients, OTC pain relief, and specifically 

acetaminophen, represents the safest medically recommended means of alleviating pain caused 

by illnesses and co-morbidities ranging from osteoporosis to end-stage renal disease. 

Moreover, access to non-opioid therapies for pain are more important than ever. The opioid 

epidemic is still tlourishing nationwide. Opioid overdose alone led to the death of more than 

500,000 people in the U.S. from 2000 through 2015, and in 2014 alone almost 2 million 

Americans abused or were dependent on opioids for pain relief. 6 Increased availability of these 

potentially harmful medications has fueled this epidemic. Nearly 250 million prescriptions for 

3 Park PW et al. Cost burden of chronic pain patients in a large integrated delivery system in the United States. Pain 

Practice. November 2016. 16(8): I 001-10 II. 

'Rasu RS et al. Cost of pain medication to treat adult patients with nonmalignant chronic pain in the United States. 

Journal of Managed Care & Specialty Pharmacy. September 2014. 20(9):921-928. 

'Ibid. 

30 Aug. 

2 #53878850_v! 
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opioid medication were written in 2014 alone, with significant differences in the numbers of 

prescriptions written across geographic areas and states that make public health responses to 

these issues difficult.7 Thus, in the U.S., addictive opioid medications have become the de facto 

first-line treatment for chronic pain rather than a possible secondary option carefully considered 

by a patient and his or her healthcare team. 

The opioid crisis provides another reason for policy makers to ensure that patients have full 

access to all appropriate doses ofOTC acetaminophen. While any medication is only a part of 

the total balanced approach to pain management, the Coalition believes that any attempt to 

curtail access to these safe and effective pain relief options would be a detriment to the vast 

number of patients whose chronic pain may be effectively managed through OTC and other nonopioid medications. In addition. the Coalition believes policy makers should take additional steps 

to educate prescribers, other health providers, and professionals and patients about the value of 

OTC pain medication while ensuring these products are used safely. 

The PAPR Coalition strongly supports efforts by Congress to empower federal agencies, such as 

the FDA, the NIH, the CDC, and the Office of National Drug Control Policy (ONDCP), to 

responsibly and constructively address not only access to important OTC pain relief therapies but 

also promote provider and patient education to ensure that patients are using safe and effective 

pain relief while avoiding the strong potential for misuse and abuse associated with opioids. 

More specifically, the PAPR Coalition looks forward to working with policy makers and external 

stakeholders to pursue specific policy objectives including: 

• Improving public health by ensuring patients have full access to OTC pain relief 

therapies, including maximum strength acetaminophen; 

Partnering with external stakeholders, including the FDA and Nil I, to ensure the safe usc 

of pain medications, including OTC pain medications, through patient and provider 

education and other informational activities; 

1 "Opioid Overdose: Prescription Opioids." Centers for Disease Control and Prevention (CDC). 30 Aug. 2017. 

https:l/www.cdc.gov/drugoverdosciopioids/prcscribed.html. 

3 #53878850 __ v1 
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• Promoting the use of non-pharmacologic and non-addictive pharmacologic pain relief 

options, including OTC pain relief, to ensure patients are not harmed through dependency 

on opioid and other potentially addictive pain relief options; 

• Incorporating the patient experience and patient preference information into the FDA's 

decision-making regarding policies related to current and future OTC pain relief 

therapies. 

As new efforts are being developed to combat the opioid crisis while increasing patient health 

and quality of life, the PAPR Coalition is dedicated to working with other interested stakeholders 

and Congress to help educate patients and their physicians about the need for access to safe and 

dependable treatment options for the millions of Americans who suffer from chronic pain. 

If you have any further questions about the Coalition, please email Michael Werner 

(michael.werner(a)hklaw.com) or Joel Roberson (joel.roberson@hklaw.com). 

4 #53878850- v 1 
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32978.041

OFFICERS 

BOARD OF DIRECTORS 

Directors-at-Large 

Regional Directors 

FOUNDING PRESIDENT 

October 25, 2017 

The Honorable Greg Walden 

U.S. House of Representatives 

2185 Rayburn HOB 

Washington, D.C. 20515 

American Society of 

Addiction Medicine 

The Honorable Frank Pallone 

U.S. House of Representatives 

237 Cannon HOB 

Washington D.C. 20515 

Dear Chairman Walden and Ranking Member Pallone, 

On behalf of the American Society of Addiction Medicine (ASAM), a 

national medical specialty society representing more than 5,100 physicians 

and aligned health professionals who specialize in the treatment and 

prevention of addiction, thank you for the opportunity to provide 

comments and recommendations as the House Energy and Commerce 

Committee considers next steps in combatting the opioid epidemic. 

ASAM agrees that our nation is in a crisis. Opioid overdoses and deaths 

continue to devastate families and communities across the country, and it 

is imperative that Congress take action to increase access to evidencebased addiction treatment and recovery support services, as well as take 

steps to enhance prevention and early intervention efforts. 

ASAM appreciates the work the Committee has done to combat the opioid 

epidemic. The Comprehensive Addiction and Recovery Act (CARA) and the 

21'' Century Cures Act have made a valuable impact in increasing access 

to addiction treatment and recovery services and growing the treatment 

workforce. However, there is much more work to be done. The Centers 

for Disease Control and Prevention's (CDC) provisional count of drug 

overdose deaths reports a 21% increase in drug overdose deaths between 

2016 and 2017, largely due to the increase prevalence of potent synthetic 

opioids such as fentanyl. 

Respectfully, ASAM offers the following recommendations for the 

Committee's consideration as it works to develop strategies and craft 

legislation to combat the opioid epidemic. 

Growing the Treatment Workforce 

The current addiction treatment gap will never be closed with the current 

addiction treatment workforce. There are simply too few physicians and 

11400 Rockville Pike Suite 200 

Phone: 301·656·3920 Fax· :lU'1.656.3K15 
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American Society of 

Addiction Medicine 

other clinicians with the requisite training to meet the treatment needs of the estimated 19.4 

million Americans suffering from untreated substance use disorders. To make a meaningful and 

sustainable impact on the current opioid overdose epidemic, and to stave off future epidemics 

related to other addictive substances such as cocaine, benzodiazepines or methamphetamine, it is 

imperative that our nation invest in training opportunities for clinicians seeking to specialize in 

addiction treatment. 

ASAM urges the Committee· to take up H.R. 3692, the Addiction Treatment Access 

Improvement Act, introduced by Rep. Paul Tonka (NY-20) and Rep. Ben Ray Lujan (NM03). This legislation would codify the 275-patient limit for addiction specialist physicians 

who treat patients in the office setting with FDA-approved Schedule 111-V narcotic 

medications, eliminate the sunset date for nurse practitioners' and physician assistants' 

prescribing authority, and expand the definition of 'qualifying practitioner' to include nurse 

anesthetists, clinical nurse specialists, and nurse midwives. 

Congress should fully appropriate $10 million in funding for Section 9022 of the 21st 

Century Cures Act, which authorizes the Secretary to establish a training demonstration 

program within the Health Resources and Services Administration (HRSA} to award grants 

for medical residents and fellows to practice psychiatry and addiction medicine in 

underserved, community-based settings. 

ASAM supports the proposal currently being finalized by Rep. Hal Rogers (KY -05) and Rep. 

Katherine Clark (MA-05} to authorize loan repayment for health professionals who 

specialize in addiction treatment and recommends the Committee take it up as soon as 

possible. 

Opioid Prescriber Education 

ASAM supports mandatory prescriber education on safe prescribing practices and the recognition 

and treatment of addiction for all health professionals registered with the Drug Enforcement 

Administration (DEA) to prescribe controlled substances. Thus, ASAM urges the Committee take 

up H.R. 4075, the Improved Addiction Education Act, introduced by Rep. Brian Fitzpatrick (PA08), Rep. Thomas MacArthur (NJ-03), Rep. Donald Norcross (NJ-01), and Rep. Ann Kuster (NH02). This legislation would establish guidelines for the content and certification of courses on safe 

prescribing and identifying patients with addiction and require that clinicians who prescribe 

Schedule II or Ill drugs demonstrate they have completed a certified course on the issue. This 

mandated education on safe prescribing and addiction is critical, and ASAM stands ready to 

support the Committee in this effort. 

CARA Implementation 

1. The Pain Management Best Practices Inter-Agency Task Force 
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American Society of 

Addiction Medicine 

ASAM commends the Department of Health and Human Services (HHS) for accepting 

nominations for the Task Force on Pain Management. The Task Force was authorized in Section 

101 of CARA to review research and best practices and recommend strategies to combat the 

opioid epidemic. ASAM urges HHS to swiftly convene the Task Force and include an addiction 

specialist as a member of the Task Force. ASAM submitted a letter of support for the nomination 

of addiction specialist Dr. James Murphy and believes his work on the front lines of the opioid 

addiction epidemic will serve as an invaluable asset to the Task Force. 

2. Improving Access to Overdose Treatment 

Section 107 of CARA authorizes HHS to award grants to addiction treatment programs to expand 

access to drugs or devices for opioid overdose reversal. ASAM commends the Substance Abuse 

and Mental Health Services Administration (SAMHSA) for expeditiously awarding these grants 

and is looking forward to seeing grantees develop protocols to connect patients who have 

experienced a drug overdose with appropriate treatment. ASAM urges Congress to inquire about 

the results of these grant programs upon their completion. so that lessons learned about effective 

ways to connect patients who have experienced an overdose to treatment can be shared. 

3. Improving Treatment for Pregnant and Postpartum Women 

ASAM commends SAMHSA and the Center for Substance Abuse Treatment (CSAT) for issuing 

grants under Section 501 of CARA to improve addiction treatment for pregnant and postpartum 

women. Pregnant and postpartum women face numerous additional barriers that inhibit their 

ability to access the addiction treatment they need. Thus, these grants have a particularly valuable 

impact in ensuring that pregnant and postpartum women have access to the appropriate levels of 

care. 

Patient Brokering 

ASAM shares the Committee's concerns about predatory marketing campaigns that advertise nonmedical, non-evidence-based addiction treatment. These campaigns take advantage of patients 

who are often desperate to find treatment for their addiction and are not aware of what is or is 

not evidence-based addiction treatment. ASAM stands ready to work with the Committee to 

develop strategies to ensure that patients can access high quality, evidence-based care. 

Thank you again for your continued attention to this pressing public health crisis. ASAM looks 

forward to continuing to work with the Committee to expand access to high-quality addiction 

treatment and expand evidence-based prevention practices. 

Sincerely, 

Kelly Clark, MD, MBA, DFASAM 

President, American Society of Addiction Medicine 
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October 25, 2017 

Written Testimony to the Record 

Hearing: Federal Efforts to Combat the Opioid Epidemic: 

A Status Update on CARA and Other Initiatives 

Energy and Commerce Committee 

U.S. House of Representatives 

4.WOA.IIington&tvd. 

Svlhl &00 

folb Church.. VA. 22042 

{703)528·$000 

(703)528·5023fAX 

www.eklfoproelic.OrQ 

Chairman Walden, Ranking Member Pallone, and Members of the Committee, as the Executive 

Director of the Intcmational Chiropractic Association, I am providing information to the Committee 

that I believe will be hclpltll as you address the curreut state of the opioid epidemic, pain management, 

and addiction recovery in our nation. l ask that this information be included in the hearing record and 

shared with all Committee members. 

Chiropractic is a non-invasive, druglcss form ofhcallh care that seeks to maximize the body's capacity 

to heal itsclfby restoring the structural balance and integrity of the human spine and remove any 

interference to the vitally important nerves it houses. It is estimated that over one million chiropractic 

adjustments are provided every day around the world. There is a significant body of peer-reviewed 

scientific evidence that supports the benefits of chiropractic care, particularly for management of 

conditions that present the symptom of pain. The evidence is clear, chiropractic care is safe, effective, 

and otlcn offers significant cost-savings opportunities. 

The International Chiropractors Association (lCA) is the world's oldest, continually operating 

international chiropractic professional organization representing practitioners, students, chiropractic 

assistants, educators, and lay persons world-wide. The ICA was founded in 1926 in Davenport, Iowa 

by Dr. B. J. Palmer. We arc dedicated to the growth and development of the chiropractic profession 

based on Dr. Palmer's commitment to professional and clinical excellence and, the fundamental 

principle of chiropractic as a unique, separate, distinct, and druglcss health care profession. 

To receive the doctor of chiropractic (DC) degree, candidates must complete extensive undergraduate 

prerequisites and several years of graduate-level instruction and internship at an accredited 

chiropractic institution. Comprehensive knowledge of all systems of the body and diagnostic 

procedures enable the DC to thoroughly evaluate a patient, address disorders relating to the spine and 

determine the need for referral to another health care provider. The practice of chiropractic is 

recognized and regulated in over 52 countries; and doctors of chiropractic arc licensed in all 50 states, 

the District of Columbia. Puerto Rico, and the Virgin Islands. There are more than 75,000 doctors of 

chiropractic in active practice and more than 10,000 students currently enrolled in chiropractic 

education in the United States. 

The anatomical focus of the DC on the human spine has created the perception of the DC as just a 

back doctor. Although this perception is not entirely incotTcct, it is very much incomplete. Doctors of 

chiropractic arc a highly appropriate resource in matters of work-place safety, stress management, fall 

risk assessment and injury prevention, postural correction, and lifestyle and wcllncss counseling. 

Chiropractic care is a tremendous tool for opioid avoidance which continues to be under-utilized in the 

federal response to the opioid epidemic. If we as a nation are to accurately address the quandary we 
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find onrsclves in, it is important to address the root cause of the problem, the over reliance of 

prescription drugs for the management of pain and the resulting addiction crisis. There arc a host of 

non-dmg options to treat pain including chiropractic. It is also important to recognize that the solution 

to dmg addiction is not shifting patients from addiction to opioids legal (such as oxycodone) or illegal 

(such as heroin) to another medication (such as methadone); but to move towards recovery from 

addiction. Swapping one drug for another does not eliminate the risk of preventable deaths from 

accidental overdose or adverse reaciion to drugs or drug interactions. 

For decades the !CA and members of the complcmcnhrry and integrative health community have 

worked across the levels of government to improve the health care system, and the quality of health 

care by being included in federal programs, advisory bodies, and to have greater research resources. 

There are a host of surveys that underscore that chiropractic and other complementary approaches are 

what Americans desire to utilize. 

Numerous task forces, practice guidelines from professional organizations and govemmcntal agencies, 

the Joint Commission and the former Surgeon General's Turn the Tide Campaign recommend nonphannacological approaches to pain. 

Moving Beyond Medications is a new campaign that International Chiropractors Association as a 

member of the Integrative Health Policy Consortium (IHPC), and the Academic Consortium for 

Integrative Medicine and Health, and others recommend to promote non-pharmacological approaches 

as first line pain treatment, with opioids considered only if these and non-opioid treatments are 

ineffective. 

The Pocket Guide is attached to this testimony expands on these recommendations to help primary 

care clinicians and their patients with this approach. Further information about the evidence-base for 

non-phannacological approaches is available at the Academic Consortium's websitehttps:l/www. imconsortium. orgl 

ICA's Vice President, Dr. Stephen Welsh observed, "To solve the opioid epidemic, public policy 

makers and the entire medical system need to rethink the inclusion of and access to chiropractic, not as 

an afterthought, but as a first line referral. Congress and both state and federal policy makers need to 

embrace the true value that chiropractic and other complementary and integrative approaches provide 

and to enable open access to those services, before a prescription for an opioid is written. All citizens, 

especially veterans, active duty military members and their families, should be able to seek 

chiropractic care without a physician referral, as a first line of care." 

Cost Savings: An NIH-funded study published in 2016 reports back pain is the most common Social 

Security Disability Insurance (SSDI) program qualifying diagnoses and accounts for 30.5% of 

program participants and 40% of the growth in the SSDI enrollment since 1996. Researchers reviewed 

Medicare data found that the per-capita supply of doctors of chiropractic and spending on chiropractic 

adjustive care were strongly inversely correlated with the percentage ofyoungcr Medicare 

beneficiaries obtaining an opioid prescription. 

There are multiple evaluations pointing to both the significant benefit and the cost savings of 

chiropractic care, They inclnde: 
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The doctor of chiropractic as the primary care provider resulted in a 52 percent reduction in 

pharmaceutical costs, 43 percent decrease in hospital admissions, and 43 percent fewer outpatient 

surgeries and procedures. This was the finding in a four-year study begun in 1999 ofDCs in a primary 

care role in a large Chicago HMO, 

Twenty-five percent reduction in backpain related costs associated when chiropractic was utilized as 

well as lower overall total annual health care costs. These were the findings in a 4-year retrospective 

review of claims from I. 7 million health plan members in an HMO insurance plan. 

A 200 I analysis of chiropractic utilization cost savings in Medicare found a lower overall payment for 

Medicare Services -$4.426 versus $8103. 

A study in the Ontario health System (Canada) indicated that greater chiropractic coverage would 

result in increased visits, but also net savings in both direct and indirect costs for Ontario's health 

system between $380 and 770 million. 

A 1997 review of health insurance payments and patient utilization episodes for common lumbar and 

low back conditions in over 6, I 00 patients who first visited doctors of chiropractic or medical doctors. 

Chiropractic care was more satisfying and 50 percent lower costs ($518 versus $1 020). 

A 2011 comparison of provider types and management costs for complicated and uncomplicated low 

back pain for North Carolina teacher and state employees found that while there were more provider 

claims for doctors of chiropractic that the cost was 30 to 50 'Yo less than either physical therapist or 

medical doctors. 

Further analysis in Workman's Compensation data include: 

In a 2003 Texas analysis: The lower back injury claims cost average is $15,884. The claim costs 

average decreases to $12,202 when the worker receives at least 75% of their care from a doctor of 

chiropractic. When 90% of the care is provided by a chiropractor, the average cost declines to $7,632. 

A 2002 Florida analysis of workers' compensation claims fi·om 1994-1999 found that the average total 

cost for low-back cases treated medically was $16,998 while chiropractic care was only $7,309. 

Patients treated primarily by chiropractors were found to reach maximum improvement almost 28 days 

sooner that if treated by a medical doctor. 

The ICA appreciates this opportunity to share this infom1ation and perspective. We stand ready to answer 

any questions or provide additional information the Committee or staff may find helpfuL 

Ronald M. Hendrickson 

Executive Director 

cc: Members, House Energy and Commerce Committee 
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-

~ 

NGBEYONDMEDICATIONS 

Non-Pharmacological Approaches to Pain Management and Well-Being 

In response to the current public health crisis of opioid abuse, overdose, and death, many organizations have issued guidelines and 

recommendations for treating pain, including the former Surgeon General's "Turn the Tide~ campaign. Similar to other guidelines, 

this campaign recommends non~ pharmacological approaches as first line pain treatment, with opioids to be considered only if these 

and non~opioid pharmacological treatments are ineffective. This document expands upon those recommendations to help primary 

care clinicians and their patients with this approach. 

1 

2 

3 about 

4 Develop a Treatment ), 

Plan with the Patient; , <)';~~ 

Assess Potential ChaHenges · ,. 

5 FollowUp1 Troubleshoot and 

Treatment Plan as 

Resources for Information on Nonpharmacologlcal Approaches to Pain Management and Wellbeing 

ACADEMIC 

COLLABORATIVE 

FOR INTE:GRA TIVE 

wwwintegrativehealth_org 

www.imconsortium.org 

@AIHM www.lhpc.org 
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House Energy & Commerce Committee 

Hearing on: 

"Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other 

Initiatives" 

On behalf of the Peace Officers Research Association of California ("PORAC"), I 

appreciate this opportunity to provide the Committee with testimony on the toll the opioid abuse 

epidemic is taking on our local communities and the dangers that law enforcement agencies face 

in our fight against this deadly scourge. 

We commend Congress for taking action to address this multifaceted problem with the 

passage of the Comprehensive Addiction and Recovery Act (CARA) last year. CARA supports 

education, prevention, treatment, and recovery effotts to address the epidemic and aims to help 

those addicted to opioids get and stay well. And while this legislation is an important step in the 

fight against opioid abuse, its impact may not be fully realized for some time and we must not 

grow complacent after its passage. Rather, based on what PORAC members are experiencing in 

the communities they serve, we encourage Congress to double-down on its efforts to eradicate 

this deadly epidemic. 

PORAC is our nation's largest statewide association representing public safety personnel. 

As the organization's president, it is my distinct privilege to represent over 70,000 members of 

the public safety community. Our members serve in California and include active, retired, and 

reserve municipal police officers and sheriffs deputies as well as correctional and probation 

officers, airport police, and officers in other statewide groups. PORAC is dedicated to 

empowering and representing the interests of rank-and-file peace officers and to protecting the 

rights of the men and women who on a daily basis keep our nation's communities safe. 

Police and public safety personnel do much more than safeguard our communities from 

crime. As funding and programming for community health initiatives continue to decline, law 

enforcement has stepped up to fill the void. In many instances, local police are the first to 

respond to crisis calls relating to drug use, mental illness, and other health matters. 1 

Good policing, therefore, has expanded beyond securing just the physical safety and wellbeing of our communities. Law enforcement is on the front lines combatting the opioid abuse 

epidemic, and it is my hope this Committee takes note of this new role being taken on by peace 

officers across the country . 

1 It is not uncommon for law enforcement to be called to a scene of a drug overdose and have to administer overdose 

reversal drugs. See general(v, http:listopovcrdose.orgi. 

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I. The Economics and Origins of Heroin and Opioid Abnsc 

Heroin and opioids have historically been available to American cttlzens and Jaw 

enforcement has consistently worked to combat the abuse and illegal trafficking of those 

substances. Over the past several years, opioid abuse has increased dramatically throughout the 

nation. According to data from the Center for Disease Control and Prevention ("CDC"), for 

example, drug overdose deaths in 2016 most likely exceeded 64,000, an increase of22% percent 

from the previous year-the largest annual increase ever recorded. 2 These figures are deeply 

troubling and should inspire lawmakers and law enforcement to reinforce their collaborative 

efforts. 

There are multiple factors at play in this trend. But chief among them is the price 

competitiveness of heroin and other opioids vis-a-vis other illegal substances, including cocaine 

and methamphetamines. This is unsurprising. The ebbs and flows of specific illegal drugs arc 

often linked to cyclical patterns based on supply and price competitiveness. 

There is an interesting additional factor at play in the case of opioids: legality. Since 

legitimate medical treatment can often involve opioids without running afoul of the law, opioid 

addiction and abuse - in contrast to the use of other drugs - can be the result of a legitimate 

medical use. Our local law enforcement has noticed that pharmaceutical opioids, including drugs 

such as Vicodin or Percocet, are often a source of experimentation for young people. In many 

instances, youth experiment at parties with an opioid stolen from a family member's prescription 

and once hooked, eventually shift to cheaper tar heroin sold on the streets. 

Street heroin is commonly laced with fentanyl, a highly addictive and dangerous 

synthetic opiate that many have attributed to the increase in overdoses and heroin deaths. drug 

overdoses involving fentanyl have increased by 540% in the past three years, rising from 3,000 

to 20,000 deaths from 2013 to 2016. 3 The increase in incidence of fentanyl use has presented 

new, potentially lethal challenges for police and public safety personnel -- which I discuss in 

greater detail below. 

California law enforcement has seen a rise in the trafficking of street heroin by Mexican 

drug cartels. California's Central Valley, for example, is a primary destination and distribution 

point for heroin once it crosses the border from Mexico. From the Central Valley, the drug is 

moved north and east: to northern California and to other states. Local law enforcement is 

collaborating with federal authorities to halt the ever-increasing flow of heroin into our country. 

2 Katz. Josh. "Fentanyl Overtakes Heroin as Leading Cause ofU.S. Drug Deaths." The New York Times, 2 Sept. 

2017, www.nytimes.com/interactive/20 17 /09102/upshot/fentanyl-drug-overdosc-dcaths.html. 

'!d. 

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However, it is not an easy task a task made more difficult by the cuts to both local and federal 

law enforcement budgets that limit the ability of law enforcement to engage in effective 

community policing. 

II. The Growing Health Risks Facing Law Enforcement 

As noted above. law enforcement has been encountering more and more drugs that 

contain fentanyl, which can be more than 50 times as potent as heroin. Because of fentanyl's 

potency-and because law enforcement must respond to drug overdoses with increasing 

regularity-it represents an unusual health hazard for police and public safety personnel.4 

The Drug Enforcement Agency (DEA) this past summer issued an urgent warning to law 

enforcement and first responders that contained the following cautionary language: "Since 

fentanyl can be ingested orally, inhaled through the nose or mouth, or absorbed through the skin 

or eyes, any substance suspected to contain fentanyl should be treated with extreme caution as 

exposure to a small amount can lead to significant health-related complications, respiratory 

depression, or death."5 

The DEA's alert came after multiple incidents of officers unknowingly came into contact 

with the drug and suffered serious reactions. In May of this year, for example, a police officer in 

Ohio wiped a trace of white powder off of his shirt after searching a car containing drugs. The 

white powder turned out to be fentanyl, and an hour later he lost consciousness only to be saved 

by four doses of naloxone 6 It should be noted that our canine partners arc also at risk of 

ingesting, inhaling, or absorbing (through their paws) the drug and obviously have a much lower 

tolerance than humans. 

PORAC is encouraged by the DEA's focus on educating law enforcement and the public 

about the lethality of fentanyl and, in turn, the dangers it poses to police and public safety 

personnel who while carrying out their duties come into contact with the drug. 

4 Sarah Zhang, Fentanyl is So Deadline That It's Changing How First Responders Do Their Jobs, The Atlantic (May 

15, 20 17), hups://www.theatlantic.com/health/archive/20 17/05/fentanyl-first-responders/526389/. 

5 For Fentanyl: A briefing Guide for First Responders, see 

https :I /www.dea.gov /drugin fo/F entany I_ B riefingGuideforF i rstResponders _ June20 17 .pdf 

6 Megan Cerullo, Ohio police officer accidental~v overdoses on fentanyl by brushing it off shirt after drug bust, New 

York Daily News. (May 16, 2017). http://www.nydailynews.com/news/crime/ohio-po1ice-officer-accidentallyoverdoses-fentanyl-article-1.317082l. 

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III. Opioid Abuse and Criminal Justice 

In California and across the nation, there has been a big push to enact sentencing reform 

in light of rising prison costs and over-crowding. For drug crimes in particular, the sentencing 

reform movement has tended to discourage incarceration and instead focus on the benefits of 

rehabilitation and treatment. 

PORAC recognizes that our state and federal jails and prisons are seriously overcrowded 

and believes it is imperative that we fix this problem. To be efTective, sentencing reform must 

adjust sentencing practices in a meaningful way that keeps our communities safe. With regard to 

opioid abuse, this means that sentencing reforms must be paired with well-supported and 

effective social services. 

California's experience has been instructive in this regard7 Of particular relevance is the 

state's most recent sentencing reform initiative, Proposition 47, which California voters 

approved on November 4. 2014. 

Historically, when an individual was arrested in California for possession of narcotics 

such as cocaine, heroin, or methamphetamine he or she was charged with a felony (and the 

charge could not be reduced to a misdemeanor). Proposition 47 reclassified many "non-serious" 

and "non-violent" propertv and drug felonies, including possession of heroin for personal use, as 

misdemeanors.x · 

Problematically, Proposition 47 took prison "off the table" for those charged with drug 

possession, but failed to fill that void with sufficient social services. So, while the number of 

individuals that are being charged with misdemeanor possession of heroin and other illegal drugs 

continues to increase, there is no place to send these people for treatment for drug addiction. 

There are not enough beds in rehabilitation facilities or enough providers of social 

services in the state of California to support addicts. Furthermore, given the toothless nature of 

our state's criminal laws since passage of Proposition 47, it is also difficult to ensure an 

7 California has had a circuitous path to sentencing reform and many of those efforts have been blamed for present 

day overcrowding. This has included the 1993 "Three Strikes" sentencing law, when California went "tough on 

crime." Similarly, California law enforcement has been on the front lines in dealing with the fallout since 2011 from 

AB I 09 "prison realignment," which diverted low-level offenders from state prisons to local county jails, and placed 

an enormous financial and administrative burden on local law enforcement. Specifically, AB 109 prison realignment 

"altered both sentencing and post~prison supervision for the newly statutorily classified ''non·serlous, non-violent, 

non-sex" offenders." See general~v California's ''Three Strikes" Sentencing Law, 

http://www.courts.ca.gov/20142.htm; Stanford Law School, California Realignment, available at 

http://www.law.stanford.edu/organizations/programs-and~centers/stanford-criminal-justice-centercjc/californiarealignment. 

8 For the text of Proposition 47. see http://vig.cdn.sos.ca.gov/20 !4/gencral/pdf/tcxt-of-proposed-lawsl.pdf#prop47; 

see also Attorney General of California, Official Title and Summary of Proposition 47, available at 

http ://vig.cdn.sos.ca.gov/20 14/ generallpdf/proposition-4 7 -title-summary-analysis. pdf. 

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individual provided a spot in a rehabilitation facility actually receives treatment. This is very 

problematic given how hard it is to break any drug addiction, and opioid addiction in particular. 

Unfortunately, without treatment, many addicts are turning to crime to fund their drug habits. In 

fact, California law enforcement has already begun noting an uptick in the number of property 

crimes since passage of Proposition 479 

III. Policy Solutions 

The escalation of opioid abuse is very real. Tackling the opioid epidemic will be 

difficult. PORAC supports rational and meaningful policy reforms that consider the views of all 

stakeholders and encourages lawmakers to consider the following policy solutions. 

First, PORAC urges Congress to work to seal our borders to prevent the entry of illegal 

drugs from abroad. People choose heroin because it is plentiful and cheap. Smart security and 

customs policy can change this reality, and when it does, it is very likely that heroin's street 

popularity will decline-helping to reduce the supply and to mitigate the trend of opioid addicts 

transitioning to heroin. 

Second, PORAC believes it is imperative lawmakers enact laws to ensure that opioid 

pharmaceuticals are being prescribed in a safe manner. Irresponsible prescribing practices are 

exacerbating this epidemic. Every day, our rank-and-file officers are trying to work with and 

help people whose addictions to heroin began with access to legally prescribed opiates. It is time 

for policymakers to cut this "access point" by meaningfully regulating medical prescribing 

practices and pain clinics while also promoting systems to monitor prescription use and identify 

fraudulent prescriptions. 

Third, PORAC exhorts lawmakers to fully fund community policing efforts and social 

services programs. Without sufficient funding, local police cannot protect citizens and social 

service providers cannot help address addiction and other health concerns that are often closely 

connected with criminal justice. 

Fourth, PORAC encourages policymakcrs in Congress and at the federal agencies to 

recognize the health risks posed to law enforcement by fentanyl and provide appropriate 

resources and materials to mitigate these risks. For instance, PORAC urges the Food and Drug 

Administration to consider developing guidance similar to what the DEA has produced in order 

to educate first responders about the dangers of fentanyl. 

9 For example, according to the most recent crime statistics provided by the City of Sacramento Police Department 

to the FBI for inclusion in their federally mandated Uniform Crime Rep01t, between January-October 2015, in 

Sacramento the number of burglaries increased by !6.16%, larceny by 2.56%, and motor vehicle theft by 27.39% as 

compared to the data from January-October 2014. See also City of Sacramento, Sacramento Year-to-Date Crime 

Statistics, available at http://data.cityofsacramento.org/datastrcams/92971/sacramento-year-to-date-crime-statistics/. 

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Fifth, PORAC urges Congress to carefully review and consider the forthcoming 

recommendations of the newly-formed President's Commission on Combatting Drug Addiction 

and the Opioid Crisis. PORAC looks forward to the Commission's report and believes it can help 

to guide the development of public policy. 

IV. Conclusion 

On behalf of PORAC, I thank the members of this Committee for again providing us the 

opportunity to share our views. Members may note I provided similar testimony to this 

Committee when it examined the opioid crisis nearly two years ago. Unfortunately, since that 

time, the problem has only worsened in many areas of the country. 

PORAC asks federal lawmakers to learn from California and to continue to discuss the 

various proposals relating to the heroin epidemic with law enforcement- with the women and 

men who keep our communities safe from crime every day and who are often front line providers 

of health services. We stand ready and willing to work with members of the Committee, and with 

Congress to ensure that federal policy relating to opioid abuse is effective. 

Mike Durant 

President, Peace Officers Research Association of California 

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STATEMENT 

of the 

American Medical Association 

for the Record 

House Committee on Energy and Commerce 

RE: Federal Efforts to Combat the Opioid Crisis: A Status 

Update on CARA and Other Initiatives 

October 25,2017 

Division of Legislative Counsel 

(202) 789-7426 
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2 

Statement 

For the Record 

of the 

American Medical Association 

to the 

House Committee on Energy and Commerce 

RE: Federal Efforts to Combat the Opioid Crisis: A Status Update on 

CARA and Other Initiatives 

October 25,2017 

The American Medical Association (AMA) recognizes the need for continued and increased physician 

leadership, a greater emphasis on overdose prevention and treatment, and the need to coordinate and 

amplify the efforts and best practices already occurring across the country. Much more work remains to 

reverse the nation's opioid epidemic and the AMA, our partners on the AMA Opioid Task Force, and 

physicians across the country are committed to doing what is necessary to end the epidemic. It is clear, 

however, that the nation's opioid-related overdose and death epidemic will not end until there is a 

national commitment to ensure that patients receive comprehensive, multi modal pain care and access to 

treatment for substance use disorders and that the necessary resources are available to meet those goals. 

The AMA continues efforts to urge physicians to use prescription drug monitoring programs (PDMPs), 

make judicious prescribing decisions, enhance their education, and co-prescribe naloxone, and the 

statistics show that some positive changes are occurring: 

Between 2012 and 2016 the number ofopioid prescriptions decreased every year by a total of 

more than 43 million-a 16.9 percent decrease. Every state saw a decrease. 

From 2014-2016, the number ofhea1th care professionals registered with their state's POMP 

increased 180 percent to more than 1.3 million. 

In 2016, physicians and other health care professionals used PDMPs 136.1 million times, at 121 

percent increase since 2014. 

In 2015 and 2016, 118,550 physicians completed courses on opioid prescribing. pain 

management, addiction and related areas. 

In the first two months of20 17, 32,659 naloxone prescriptions were dispensed, an increase of340 

percent from the 2016. 

On each of these measures, there has been progress. Yet these efforts are not enough. The number of 

overdose deaths continues to rise. 

The two most important metrics that must drive public policy remain improved patient outcomes and 

reduced opioid-related overdose and death. Central to improving outcomes on these measures is access to 

and support for treatment for both non-opioid pain care and comprehensive treatment for substance use 

disorders. 
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We applaud the committee's hard work on the Comprehensive Addiction and Recovery Act (CARA) and 

appreciate that Congress provided funding for grants to states for opioid treatment and other programs as 

part of the 21" Century Cures Act. However. more resources are needed, especially for treatment 

programs. Right now, only a small percentage of individuals who need substance use disorder treatment 

programs have access to them. We urge Congress to fully fund CARA and make additional investments 

to increase desperately needed treatment capacity. 

We arc confident that progress in areas such as PDMP use, education, and naloxone access will continue. 

More than 10,000 physicians became certified to treat patients with buprenorphine in the last year alone. 

These steps will help but. alone. they will not be enough. Further action is needed by Congress and the 

Administration to turn the tide on this epidemic. The President's Commission on Combating Drug 

Addiction and the Opioid Crisis has already identitled several critical actions that must be taken. 

First, waive Medicaid's 16-bed federal limit to treat patients with a substance use disorder. The 

AMA strongly supports the Commission's recommendation to "rapidly increase treatment capacity" and 

to '·grant waiver approvals for all 50 states to quickly eliminate barriers to treatment resulting from the 

federal Institutes for Mental Diseases (!MD) exclusion within the Medicaid program." Given that only 

about 10 percent of the nearly two million patients with a substance use disorder can access treatment, it 

is essential that treatment capacity be increased as expeditiously as possible. Removing the 16-bed !MD 

exclusion is an important first step to increasing physicians' ability to care for patients with an opioid usc 

disorder. 

Second, suspend federal regulatory and other barriers to providing buprenorphine. The AMA 

supports eliminating the requirement for obtaining a special federal waiver to prescribe buprenorphine for 

the treatment of opioid use disorder. Even though the regulatory approach has eased somewhat over the 

past year, there still arc considerable barriers in place. Removing the federal waiver requirement will give 

many more patients new access to treatment from physicians and other qualified health care professionals. 

The safety and effectiveness of medication assisted treatment (MAT) is well-established, and we need to 

do all we can to encourage more qualilied clinicians to care for patients with an opioid use disorder. 

Third, direct the Attorney General to enforce existing substance use disorder parity laws. We 

strongly agree with the recommendation to "enforce the Mental Health Parity and Addiction Equity Act." 

This can be done at both the state and federal levels, but America's patients also need your leadership to 

encourage health insurance companies and pharmacy benefit managers to end the type of prior 

authorization, step therapy, and fail first protocols that only serve as barriers to MAT and multi modal pain 

care. Some payers already have taken positive steps to remove some barriers, but this epidemic requires 

all payers to work with us to ensure access to care. 

There are additional steps that we believe should also be taken to further efforts to address the current 

crisis: 

Support implementation of the National Pain Strategy (NPS). The NPS was published in 2016 but 

little progress has been made on implementing its core elements to improve the state of pain care in the 

nation. The AMA believes that-along with comprehensive treatment of opioid use disorder-the 

capability to deliver multidisciplinary treatment of pain is also necessary to reverse the nation's opioid 

overdose and death epidemic. The NPS calls for developing a system of patient-centered integrated pain 

management practices based on a biopsychosocial model of care that enables health professionals and 

patients to access the full spectrum of pain treatment options, and it also calls for taking steps to reduce 

barriers to and improve the quality of pain care for vulnerable, stigmatized and underserved populations. 

NPS implementation will change the paradigm for treating pain and ensure that physicians can 

recommend all pain management modalities to patients and know that insurance plans will cover those 
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4 

treatments. When payers usc high deductibles, yearly limits on treatments such as physical therapy, and 

prior authorization to delay or deny care, patients often are leil with few non-opioid pain treatments. In 

addition, employers need to recognize that patients may require time away from work to participate in 

therapeutic modalities so that opioid analgesics are not the only affordable option. 

Encourage electronic prescribing of controlled substances (EPCS). Drug Enforcement 

Administration requirements for biometric devices limit user-friendly consumer electronics already found 

in physicians' offices, such as fingerprint readers on laptop computers and mobile phones, from being 

utilized for two-factor authentication in EPCS. This and other rules contribute to cumbersome workflows 

and applications which are an impediment to physician EPCS uptake. Encouraging EPCS uptake and 

interoperability of PDMP databases and electronic health records would improve the integration of 

controlled substance use data into practice workflows and clinical decision-making. 

Improve access to Naloxone. !fit were not for expanded use of naloxone, there would likely be tens of 

thousands more deaths from opioid-related overdoses. State policies have helped spur widespread access, 

but the AMA remains concerned that some patients may not be able to access this life-saving opioid 

antidote medication due to its high cost. The AMA urges manufacturers and health insurers to help 

ensure that first responders, community-based organizations, family members and patients can readily 

access and administer naloxone. 

Strengthen state-based PDMPs. Physicians' consultation of these databases has increased from 61 

million queries in 2014 to more than 136 million in 2016. PDMPs are now functional in almost every 

state, and most state PDMPs can share data. To expand the use of these clinical support tools, the AMA 

urges increased research and funding to help integrate PDMPs into electronic health records and 

physician workflow in a meaningful, user-friendly manner. In addition, the AMA supports effotis to 

identify best practices in POMP use and implementation for others to learn from and potentially emulate. 

Integrate opioid epidemic solutions into federal payment programs. Federal payment and delivery 

system reforms provide opportunities to better support and incentivize clinicians who enhance their 

education on pain management and safe prescribing, become certified to prescribe buprenorphine, coprescribe naloxone, utilize POMP data in clinical practice, and coordinate treatment and support services 

for patients experiencing pain and/or addiction. The AMA recommends that, as they design new payment 

models, health programs such as Medicare and Medicaid prioritize innovative approaches to preventing 

and treating pain and addiction. 

Support state-based innovations. In the past 2-3 years, several hundred new policies have been enacted 

at the state and local levels to address the opioid epidemic. The AMA strongly urges that efforts be 

undertaken to fully eva! uate how these new laws and policies affect access to treatment for opioid use 

disorder, impact pain care, or might be associated with unintended consequences. As the nation's opioid 

epidemic is increasingly fueled by heroin and fentanyl and other illicit, synthetic derivatives, the AMA 

urges the Commission to take a hard look at how public policies focusing on opioid supply need to be 

balanced by policies that offer a measure of hope to those individuals and tlunilies already affected by this 

epidemic. 

Support continued Medicaid coverage for treatment of opioid use disorders and pain management. 

The Medicaid expansion under the Affordable Care Act has been a path to treatment for hundreds of 

thousands of individuals with opioid use disorders. Such treatment must be sustained in any future health 

system reform legislation or regulation. In addition, Medicaid also provides insurance coverage that is 

critical to treatment of acute pain so that it does not become chronic pain, as well as treatment of mental 

health issues that people with opioid use disorders often have. 
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5 

Thank you for the opportunity to present these views. The AMA looks forward to working with the 

Committee, Congress as a whole, and the Administration to turn the tide of this epidemic. 
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October 18, 2017 

The Honorable Orrin Hatch 

United States Senate 

Washington, DC 

Dear Senator Hatch: 

Leaders in Multidisciplinary Care Since 1988 

I am writing on behalf of the Academy of Integrative Pain Management (AI PM; formerly the American 

Academy of Pain Management) to thank you for your remarks on the Senate floor, in the wake of the 

recent reporting from 60 Minutes and The Washington Post, regarding the Ensuring Patient Access and 

Effective Drug Enforcement Act. As you know, the American Academy of Pain Management signed on 

to a letter supporting passage of this legislation in 2015. We remain in support of the provisions of this 

legislation. 

Our concern in 2015 was that the US Drug Enforcement Administration (DEA) was making use of its 

power to impose immediate suspension orders on drug distributors in such a way that access to 

necessary medications was threatened for many people with legitimate prescriptions for documented 

chronic pain. In attempt to stem the flow of opioid medications that were being misused and abused 

primarily by people who did not have a legitimate medical need for them, DEA chose to adopt the most 

adversarial position possible, issuing immediate suspension orders that summarily closed medication 

distribution warehouses. While this action might have cut off access for people who abused the 

medications, unfortunately, it also cut off access for people using the medications appropriately in 

ways that improved their quality of life. In short, DEA's actions could have affected a person with Stage 

IV cancer to the same extent as they could have affected someone intent on crushing and injecting 

medications with the intent of "getting high". We felt that some balance in enforcement actions 

needed to be struck, and that the Ensuring Patient Access and Effective Drug Enforcement Act did just 

that. 

Since the passage of this act, we have been heartened by the increased level of cooperation between 

DEA and the companies it regulates. Working together with manufacturers and distributors in a less 

adversarial manner, DEA has played a role in eliminating the vast majority of "pill mill" activity 

supported by distribution of suspicious opioid orders. This also has resulted in ensuring access to vital 

medications for those people with pain who need them. This improved balance in enforcement activity 

is, we believe, appropriate and necessary. 

We oppose efforts to repeal the provisions of this act in response to news reports that rely largely on 

the opinions of disaffected former DEA staff, without attempting to present the views of other former 

8700 Monrovia St., Suite 310. Lenexa, KS 66215 

T: 209-533-9744 F: 209-533-9750 E: aapm@aapainmanage.org W: www.aapainmanage.org 
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DEA staff who wrote the very language at question in this legislation. Achieving balance should be the 

goal in many aspects of our nation's current opioid overdose epidemic: balance in the ways we treat 

pain so as to reduce unnecessary opioid exposures, balance in efforts to address both the supply of 

abused drugs and the demand for them, and balance in law enforcement efforts so that the needs of 

people with pain are protected while access is denied for those without a legitimate medical need. The 

Ensuring Patient Access and Effective Drug Enforcement Act provides this last type of balance, and it 

should not be repealed. 

We encourage Congress to take a more reasonable, measured, and balanced approach to the issue of 

this act's impact on the ability of DEA to effectively enforce the Controlled Substances Act. We 

encourage· the relevant committees of jurisdiction in the House and the Senate to hold hearings at 

which current DEA staff are asked about the extent to which this law hampers their ability to act in 

cases of extreme and imminent danger to American citizens. We hope that these hearings would also 

enable the committees to hear from drug manufacturers, distributors, prescribers, dispensers, and 

patients, all of whom can explain the impact of DEA practices before and after passage of this act. If 

these hearings reveal a real pattern of ineffective enforcement due to the provisions of this law, then 

the committees can act in a measured and balanced manner to remedy the problems without 

completely invalidating the law. 

Again, thank you for standing up for the needs of people with pain and the clinicians who care for 

them. We stand ready to help in not only this regard, but also with opportunities to improve the care 

of people with pain by expanding access to non-pharmacological treatments for pain, including 

integrative and complementary medicine treatments. 

Sincerely yours, 

Robert Twillman, Ph.D., FAPM 

Executive Director 
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American Dental Association® 

STATEMENT OF THE 

AMERICAN DENTAL ASSOCIATION 

TO THE 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

ON 

FEDERAL EFFORTS TO COMBAT THE OPIOID CRISIS 

SUBMITTED BY 

THE AMERICAN DENTAL ASSOCIATION 

October 25, 2017 

Washington Office: 1111 14th Street NW Washington DC 20005 (202) 898-2400 
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The American Dental Association is pleased to submit this statement for the record for 

the House Committee on Energy and Commerce's hearing on "Federal Efforts to 

Combat the Opioid Crisis," held October 25,2017. 

The American Dental Association recommends that the federal response to the opioid 

crisis begin to address the nuances of managing acute pain following one-time surgical 

procedures, such as a wisdom tooth extraction. We also recommend that any prescriber 

education opportunities be coordinated with professional societies and administered by 

an accredited continuing education provider-and that the coursework be dually 

recognized for state licensure purposes. 

The misuse and abuse of opioid pain relievers-such as Vicodin® and Percocet®-has 

reached epidemic proportions. As the sixth most frequent prescribers of these 

potentially addictive pain medications, dentists are well positioned to help keep them 

from becoming a source of harm. 

The federal government has invested considerable time and resources to raise 

professional awareness about the opioid epidemic and encourage more judicious 

prescribing of opioid pain medications. Our main criticism is that the federal response 

has not sufficiently distinguished pain management in dentistry from pain management 

in medicine, specifically when it comes to managing acute pain versus chronic pain. For 

that reason, it has not been particularly useful for dentists. 

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For example, the highly touted Centers for Disease Control and Prevention Guideline 

for Prescribing Opioids for Chronic Pain does not address the particulars of managing 

acute pain following a one-time surgery. In fact, the document expressly states, "Some 

of the recommendations might be relevant for acute care settings or other specialists, 

such as emergency physicians or dentists, but use in these settings or by other 

specialists is not the focus of this guideline." 

Another example is the Food and Drug Administration's Risk Evaluation and Mitigation 

Strategy for Extended Release and long Acting Opioid Analgesics. The goal of the 

REMS has been to reduce inappropriate prescribing, misuse, and abuse of long acting 

opioids. While long acting opioids can be useful in managing chronic pain, there is 

rarely, if ever, a need to manage chronic pain following a one-time dental surgery (e.g., 

wisdom tooth extraction, etc.), much less to prescribe a long acting opioid. 

We would like to iterate that dentists have benefited from some federal activities, such 

as the Substance Abuse and Mental Health Services Administration's Providers' Clinical 

Support System for Opioid Therapies. 

Thanks, in part, to a grant from SAMHSA and the American Academy of Addiction 

Psychiatry, the ADA has been able to offer free continuing education webinars covering 

the latest pain management techniques to help prevent opioid abuse. The webinars are 

tailored to illustrate the way acute dental pain can be managed safely using IR/SA 

opioids. Plus, the ADA Continuing Education Recognition Program credential provides a 

sound basis for state regulatory agencies to accept the CE credit for licensure. 

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Also, the National Institute of Dental and Craniofacial Research is currently investigating 

the biological triggers of dental pain and novel ways to alleviate it using non-narcotic 

therapies. NIDCR is also studying dentists' knowledge of opioid abuse and what leads 

them to prescribe opioids in the first place. Together, the findings will enable us to target 

our education and outreach messages to dentists and, ideally, lead them to use nonnarcotic pain relievers as the first-line therapy for acute pain management. 

We were pleased by a recent statement from FDA Commissioner Scott Gottlieb 

suggesting that the agency will be revisiting its risk management program to ensure 

opioid prescribing is better tailored to the medical indication. We hope this is an 

indication that federal agencies are beginning to appreciate that acute pain is managed 

differently from chronic pain. 

Again, the American Dental Association recommends that the federal government's 

opioid prescriber education and outreach efforts begin addressing the nuances of 

managing acute pain following one-time surgical procedures, such as a wisdom tooth 

extraction. We also recommend that any prescriber education opportunities be 

coordinated with professional societies and administered by an accredited continuing 

education provider-and that the coursework be dually recognized for state licensure 

purposes. 

We would like to thank the committee for this opportunity to submit this statement for 

the record. We share your commitment to ending this tragic and entirely preventable 

public health crisis, and we are committed to working with you to do just that. 

-3 
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32978.065

~· ~P~C~S~ ~p Academy of 

Managed Care 

Pharmacy• lmprovon.g m"di~lltion us.,. Advnncl!!\1 P"U"nl <:Me. 

October 25,2017 

American Pharmacists Association (APhA), Academy of Managed Care Pharmacy 

(AMCP), American Society of Consultant Pharmacists (ASCP), American Society of 

Health-System Pharmacists (ASH!'), College of Psychiatric and Neurologic Pharmacists 

(CPNP), National Association of State Pharmacy Associations (NASI' A) and National 

Community Pharmacists Association (NCPA) 

STATEMENT FOR THE RECORD 

TO THE HOUSE ENERGY & COMMERCE COMMITTEE HEARING: "FEDERAL 

EFFORTS TO COI\c1BAT THE OPIOID CRISIS: A STATUS UPDATE ON CARA AND 

OTHER INITIATIVES" 

On behalf of the American Pharmacists Association ("APhA')), Academy of Managed 

Care Pharmacy (''AMCP"), American Society of Consultant Pharmacists ("ASCP"), American 

Society of Health-System Pharmacists ("ASIJP"), College of Psychiatric and Neurologic 

Pharmacists ("CPNP''), National Alliance of State Pharmacy Associations ("NASPA") and 

National Community Pharmacists Association ("NCPA")) we appreciate the opportunity to 

provide our perspective regarding federal efforts to combat the opioid crisis. 

Our organizations view medication-assisted treatment (MAT) as an important component 

of a multi pronged approach to addressing opioid abuse and improving treatment. We applaud 

efforts to expand access to MAT, such as increasing Drug Addiction Treatment Act (DATA)-

waivercd physician's prescribing caps and allowing nurse practitioners (NPs) and physician 

assistants (PAs) to obtain a DATA waiver. To further expand access to MAT, we urge the 

Committee to pass legislation that allows pharmacists to obtain a DATA waiver. H.R. 3991, the 
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Expanded Access to Opioid Abuse Treatment Act of201 7, a recently introduced bill, enables 

pharmacists to obtain a DATA waiver in the same manner as PAs and NPs. 

Pharmacist involvement in MAT for opioid usc disorders helps improve access and 

outcomes, while reducing the risk ofrclapse. 1

.2 Currently, 48 states and the District of Columbia 

allow pharmacists to enter into collaborative practice agreements with physicians and other 

prescribers to provide advanced care to patients, which may include components of MAT. In 

addition. pharmacists arc mid-level practitioners like PAs and NPs, and six states allow 

pharmacists to prescribe Schedule ll-V controlled substances under a collaborative practice 

agreement.3,4 Consequently, under certain states' scope of practice laws, pharmacists arc eligible 

to prescribe Schedule Ill controlled substances but are unable to meaningfully expand access to 

MAT because they are not eligible for aDA TA waiver. 

When pharmacists partner with physicians and other health care professionals to provide 

MAT, they can streamline care and improve outcomes. Pharmacists' responsibilities may include 

treatment plan development, dispensing, patient communication. care coordination, and 

adherence monitoring and improvement activities, among others. Allowing pharmacists to obtain 

a DATA-waiver will increase patients' access to MAT and address treatment gaps. 

Pharmacists are often an underutilizcd health care resource despite their medication 

expertise and accessibility. Pharmacists today graduate with a Doctorate of Pharmacy degree, 

which requires six to eight years of higher education to complete, and have more medicationrelated training than any other health care professional. We thank you for the opportunity to 

provide our recommendation regarding an important opportunity to increase patients' access to 

substance use treatment programs by utilizing pharmacists. 

: DiPuu!a, B.A. & Mcnachcry, E. (Mar/Apr 2015). Physician~pharmncist collaborative care model for buprenorphinc~nwintaincd 

opioid~dcpendent patients, Journal of the American Pharmacists Association, 55(2), 187-192" available at: 

http://w\\ w.iapha.org/atiic!e/S 15·14-3191( 15)300.:1 l-:i/q_bstract 2 Raisch, W. {2002). Opioid Dependence Treatment. Including Buprcnorphine/Naloxonc, Pharmacology & Pharmacy, 36(2). 

312-32 L available at: https:f/wwwnc!2j.1~JJI1!lil1gm !pubn1QQ{jj_~.:t.?tt5J 3 See Drug Enforcement Agency, Mid-Level Practitioners Authorization by State. available at: 

htlps:/i~\ \V\v.deadivt:rsion.usdoi.go'~>/dru!lregiprnctioJlCrs/mlp bv shttc.pdC last accessed: October 18, 2017. 4 See Centers for Disease Control and Prevention (20 17), Advancing Team-Based Care Through Collaborative Practice 

.-lgreements, availabte at: https://v .. ·ww.cdc.E!ovrdbdspipubs/docs/CPA-Temn-Rascd-Care.pdf(last accessed: August 14, 2017). 

2 
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32978.067

Statement of J. Paul Molloy, CEO 

Oxford House, Inc. the umbrella nonprofit for the 

National Network of2,259 Oxford Houses 

House Energy and Commerce Committee 

Health Subcommittee 

October 25, 2017 

Mr. Chairman, I am pleased to re-connect with this Committee to bring you up-todate about the progress Oxford HouseTM has made following enactment of §2036 

ofPL l 00-690 the 1988 Anti-Drug Abuse Act [42 USC 300x-25]. I appeared as a 

witness before this Committee in August 1988 along with three residents of local 

cluster of 13 Oxford Houses. Following that testimony, the Congress added 

§2936 to the Anti-Drug Abuse Act and that provision served as a catalyst for 

expanding the local network of 13 Oxford I-Iouscs into the national network of 

more than 2,250 Oxford Houses spread throughout the country. Together, these 

Oxf(n·d Houses have 17,890 recovery beds but many more Oxford Houses arc 

needed. I would also note that Oxford House is the only recovery program listed 

on the federal government's National Registry of Evidence-based Programs and 

Practices (NREPP). 

I would like to briefly discuss the Oxford House program and its emphasis on 

long-term recovery without relapse. Recovery requires more than short-tem1 

treatment and/or medication; while these may both be necessary, long-term 

sustained recovery requires behavior change and that takes time. I urge this 

Committee to address this part of the recovery process along with the critical early 

stages of recovery. Supporting long-term recovery options like the Oxford House 

program cost little but minimal support can save lives and reduce the much higher 

costs of repeated treatment episodes. 

The Treatment Episode Data Set [TEDS] maintained by the federal government 

shows that 15% of those in treatment have had five previous treatment episodes. 

The average number of times through treatment is more than three. The idea that 

"relapse is part of the disease" has become a slogan or mantra for the treatment 

industry_ Oxford House shows that recovery without relapse can be the norm 

rather than the exception. 

Each Oxford House is a rented ordinary single-family home that is self-run and 

self-supported by the House residents. Oxford House, Inc. [OHIJ is the nonprofit, 

502(c](3] umbrella organization that provides groups of six or more recovering 

individuals a charter that permits each group to operate using the organization's 

time-test system of operation. There is no charge for the charter but the group 

must agree to abide by the tem1s of the charter to remain an Oxford House. The 

chartet· requires that the residents run the House democratically, each pay an equal 
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share of rent and household expenses and immediately expel any resident who 

relapses. 

Oxford Houses permit recovering individuals to live together as long as they want 

in order to maintain long-term recovery. The self-run, self-supported aspect of the 

program permits Oxford Houses to expand to meet the need. OIII owns no 

property; the grants it receives supports providing technical assistance to help start 

new Oxford Houses and teach residents the system of operation. OHI also 

sponsors an annual convention. The 2017 convention, held in Washington, DC, 

over Labor Day weekend, attracted over 1 ,200 Oxford House residents and alumni. 

Portions of the program were broadcast on C-Span2 and are available on that site. 

The 1988 Anti-Drug Abuse Act served as a catalyst for national expansion of 

Oxford Houses by providing the means for recovering individuals to organize and 

help themselves to transition from active addiction to comfortable sobriety. The 

underlying question is whether it can be expanded enough to significantly mitigate 

the current opioid epidemic and its terrible cost. Like every other proposal Oxford 

House is not a magic bullet. The decline in alcoholism and drug addiction can 

occur with a cultural shift Jrom promotion of instant gratification to one that 

focuses on personal and civic responsibility. However, greatly expanding the 

number of Oxford Houses can significantly help change our current culture by 

providing both symbolic and real opportunity tor addicts to develop long-term 

recovery. Without massive expansion of Oxford Houses, long-term recovery 

without relapse will be thwarted. 

Public money and more teachers of the Oxford House system of operation can 

once again serve as a catalyst for squarely addressing the most efrective way to 

make recovery without relapse the norm rather than the exception. Smal! start-up 

loans and training residents of new Oxford Houses has proven to be eilective in 

creating the existing national network of2,256 Oxford Houses. Both can be 

expanded at low cost but such expansion should utilize the existing alcoholism and 

dmg addiction infrastructure. State incentive payments can achieve that outcome. 

When the 1988 Act became law, many t<~lt that the revolving loan provision would 

be a total failure. IIow could anyone expect newly recovering alcoholics and drug 

addicts to repay a start-up loan of$4,000? Experience has shown those fears were 

unfbunded. In state after state, newly recovering alcoholics and drug addicts have 

in fact repaid start-up loans so other houses could be stmied. For example, in 

Oregon the 180 Oxford Houses have bon-owed $720,000 from the revolving loan 

fund. Repayment has been on schedule with each house repaying $170 for 23 

month and a final repayment of $90 in month 24. In other words, the original 

$100,000 revolving loan fund has been turned over more than 7 times. In North 

Carolina the 244 Oxford Houses have honowed $976,000 turning over the original 

$100,000 almost ten times. 
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The $4,000 loan amount is set as a cap in the 1988 law and if inflation [CPIJ were 

applied it would now be $8,345. The proposed amendment suggests changing the 

cap to $6,000, which does not fully account for inflation but OHI experience has 

shown it would work well for starting a new Oxford House. The amendment also 

readjusts the repayment time fi·om 24 months to 36 months to enable house to 

repay on the existing $170 a month repayment schedule. The importance that the 

start-up fund is a revolving loan fund cannot be overstated. The revolving nature 

of the fund inspires houses to repay so that other recovering alcoholics and drug 

addicts can enjoy what they have - a functional Oxford House. 

I have attached a draft ofthe proposed changes in PL 100-690 the 1988 AntiDrug Abuse Act. I hope this committee will include those changes as part of any 

legislative effort to mitigate the cutrent opioid epidemic. l have also attached a 

brief summary entitled "Saving Money-Saving Lives" showing where Oxford 

Houses are already established and helping individuals achieve long-term recovery 

without relapse year after year. 
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___A,r 

AHIP 

STATEMENT !<'OR THE RECORD 

Submitted to the 

House Energy and Commerce Committee 

Federal Efforts to Combat the Opioid Crisis 

October 25, 2017 

America's Health Insurance Plans 

601 Pennsylvania Avenue, NW 

Suite 500, South Building 

Washington, D.C. 20004 

1 
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32978.071

America's Health Insurance Plans (AHIP) is the national association whose members provide 

coverage for health care and related services to millions of Americans every day. Through these 

offerings, we improve and protect the health and financial security of consumers, families, 

businesses, communities and the nation. We are committed to market-based solutions and publicprivate partnerships that improve affordability, value, access and well-being for consumers. 

W c appreciate this opportunity to comment on issues surrounding the pervasive opioid crisis. 

Opioid misuse and addiction is an urgent public health crisis in America, now the number one 

cause of death for those under 50 years old. The consequences are profound, impacting 

individuals and families no matter where they live, how much they earn, or how young or old they 

arc. The impact is broad, affecting social services, the health care system, communities, and the 

economy. 

As leaders of America's health insurance providers, we have seen the tragic consequences of the 

opioid crisis. It has harmed our members and their families, and it has weakened our communities. 

We share the committee's commitment to reducing the number of addictive substances in 

American communities, and to dramatically reducing the chronic condition of addiction. 

On October 20, AHIP and a panel of health plan leaders including chief executive officers, chief 

medical officers, and physician executives from AHIP member companies- participated in a 

public meeting held by the President's Commission on Combating Drug Addiction and the Opioid 

Crisis. Our industry delivered a clear message: the health plan community is committed and taking 

concrete steps to stem the opioid crisis and effectively treat drug addiction. 

While testifying before the President's Commission, our members highlighted important examples 

of a comprehensive, integrated approach to reduce the use of opioids and cover and provide 

treatments and services that include both physical and behavioral health. They presented strategies 

such as non-opioid pain alternatives, medical management techniques, and provider training that 

they arc using on the front lines to combat the opioid crisis. They also described cutting edge data 

analytic tools that are being used to identify at-risk individuals and inform future treatment efforts. 

Additionally, plans highlighted areas of potential improvement including privacy reform (42 CFR 

Part 2) to improve appropriate access to patient information regarding opioid use and the shortage 

of providers who are trained to provide medication-assisted treatment (MAT). 

Our members' leadership in addressing the opioid crisis is further demonstrated by a new effort we 

announced last week the Safe, Transparent Opioid Prescribing (STOP) Initiative- to support the 

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widespread adoption of clinical guidelines for pain care and opioid prescribing. The STOP 

Initiative begins with a robust, evidence-based methodology that health plans can use to measure 

how care provider practices compare to the Centers for Disease Control and Prevention's (CDC) 

Guidelines for Prescribing Opioids for Chronic Pain. This measurement will help health plans and 

care providers collaborate to improve adherence with the CDC guidelines, significantly improving 

patient safety and reducing the risk of opioid misuse. The STOP Initiative establishes an industrywide approach to measuring performance against the CDC guidelines, tracking and reducing the 

number of opioid prescriptions. 

Our members recognize that collaboration among all stakeholders is essential to achieving progress 

in the opioid crisis. Accordingly, health plans are actively engaged with social services agencies, 

state Medicaid programs, health care providers, pharmacists, and pharmaceutical companies to 

advance solutions. Health plans have been working closely with federal, state, and health care 

leaders to find other safer, more effective ways to treat chronic pain; understand the crisis and 

develop strategies to address it; understand prescribing patterns and how they may affect 

dependence and addiction; and ensure patients struggling with addiction get the treatment and 

support needed for recovery. 

Our statement focuses on: (I) effective strategies that health plans are developing and deploying to 

combat the opioid epidemic; (2) our members' commitment to mental health parity and substance 

use treatment; and (3) our recommendations for improving federal and state efforts to address the 

opioid crisis. 

Health Plans are Combating the Opioid Epidemic 

This is a crisis we need to solve, and health plans arc working hard to be part of the solution. 

Health plans are embracing a comprehensive approach to tackling opioid misuse and addiction, 

while ensuring access to effective treatment for patients. Health plans cover multi-faceted, 

effective approaches to pain management that include evidence-based treatments, more cautious 

opioid prescribing, and careful patient monitoring. By combining education, prevention, 

behavioral health care, and evidence-based treatment, health plans arc making real progress in 

addressing addiction and improving the health and well-being of families and communities. 

Health plans have robust checks and balances in place to ensure that patients get the right 

medication in the right dosages for their conditions. These checks and balances include: 

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Building high quality networks with quality doctors, pharmacies and facilities; 

• Utilizing a sequenced approach, which guides patients through evidence-based pain 

management before prescribing an opioid; 

• Requiring prior authorization for opioids, so health plans' clinical experts can work with 

doctors to ensure adherence to evidence and offer the most effective treatments; and 

When an opioid is prescribed, using the lowest dosage and shortest duration to effectively 

treat the individual's pain. 

Health plans also analyze their data to identify potentially ham1ful prescribing patterns that 

trigger fiJrther review. When signs of fraud or abuse are detected, health plans investigate and 

work with law enforcement to stop it. 

Health plans have a unique view of how health care works, and how patients experience 

coverage and care. With that unique insight, they continue to expand and refine a 

comprehensive, multi-faceted approach to preventing and managing opioid misuse and related 

conditions, including: 

• Education: Developing community-wide consumer education campaigns to increase 

awareness of opioid abuse and misuse, consisting of marketing outreach, dedicated websites, 

school curriculum and related documentaries. 

Partnering with Providers: Working closely with and often directly employing 

physicians, nurses, and pain management experts to ensure their members receive the safest, 

most proven, and most effective approaches to pain care. Their case management programs 

provide ongoing services, support, and education to prevent and treat people with, or at risk 

of developing, opioid and other substance usc disorders, as well as their caregivers and 

families. Health plans also develop an appropriate network of facilities and providers, 

identify centers of excellence, and collaborate with providers and emergency departments to 

facilitate appropriate triage and care coordination. 

• CDC Guidelines: Utilizing and promoting the CDC's guidelines for prescribing opioids for 

chronic pain to encourage non-opioid pain care, cautious prescribing of opioids, and 

4 
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improved outcomes. 1 The CDC recommendations include prescribing the lowest possible 

dose and shortest duration effective for each patient, and close patient monitoring. 

• M~sii((~J.M;;11agement: Pursuing effective provider incentive structures to protect patient 

safety and affordability. These structures include medical management techniques, such as 

step therapy, prior authorization, and quantity limits consistent with best practices. Medical 

management is particularly beneficial when there is wide variation in practice and the 

potential for overuse or misuse of services. 

• Physician-Pharmacist Coordinatio!]: Facilitating coordination between physicians and 

pharmacies for patients who receive prescriptions from multiple providers and who may also 

be prescribed medications that have dangerous reactions with narcotic medications snch as 

muscle relaxants or benzodiazcpines. 

• Data Analytics: Leveraging data analytics to monitor pharmacy claims for prescription 

patterns that indicate someone at high risk of potential overuse or misuse. This includes 

information sharing among Medicare Part D plans when beneficiaries who have been 

identified as potential over-users of opioids move from one Part D plan to another. 

Support Programs: Engaging patients and providing them with support programs, such as 

substance usc disorder coaching, Pharmacy Home programs to coordinate care and 

medication access, outreach to prescribers, and alerts to pharmacies. 

• Medication-Assisted Treatment: Improving access to evidence-based medication assisted 

treatment (MAT) to help a person overcome their substance use disorder, along with 

treatment services such as counseling, peer support services, and community-based support 

groups. AHIP and our members support the Substance Abuse and Mental Health Services 

Administration's (SAMHSA) goal ofincrcasing patient access to qualified practitioners 

waivered to prescribe Food and Dmg Administration (FDA) approved controlled substances 

for usc in maintenance and withdrawal MAT. 

• Services for High-Risk Patients: Working with state and federal partners to promote rapid 

and effective access to evidence-based treatment for populations at increased risk of overdose 

and death, such as individuals re-entering the community aller serving prison time. Efforts 

1 https://www.cdc.gov/drugoverdose/prescribingiguidelinc 

5 
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may include pre-release of Medicaid enrollment, enhanced care coordination efforts to ensure 

linkage to community-treatment providers, and recovery services to support stability during 

the transition home. 

Health Plans are Committed to Mental Health Parity and Substance Abuse Treatment 

We fully agree that those who arc struggling with an opioid use disorder need to have timely 

access to support for recovery and treatment. Health insurance providers ot1er services to 

members that include in addition to MAT, as we discussed above- cognitive behavioral health 

counseling and recovery support. Because individuals struggling with addiction often have other 

chronic medical and behavioral health conditions, we strongly believe that these services must be 

customized and coordinated to ensure the best possible opportunity for recovery. 

We support the protections established by the federal Mental Health Parity and Addiction Equity 

Act (MHP AEA), and health insurance providers have been working diligently to implement 

them. However, mental health parity still faces many issues. For example, the mechanisms to 

measure quality in mental health arc much less developed than those that exist for medical or 

surgical care. There are no validated standards, certifications or accreditations for behavioral 

health facilities. Federal rules limit providers' ability to share substance use information, 

hindering efforts to support an individual through recovery. Laws and regulations that apply to 

mental health and substance nsc disorder treatment arc subject to multiple jurisdictions and 

interpretations, making it difficult to comply with federal and state requirements. 

To help improve mental health parity and treatment for those with a substance use disorder, we 

recommend two actions to modernize federal laws and guidelines: (1) modernizing existing 

regulations (42 C.F.R. Part 2) to allow providers to confidentially share information about a 

patient's substance usc disorder diagnosis and treatment, for the purpose of improving access to 

treatment, enhancing treatment quality, and strengthening care coordination; and (2) encouraging 

the Department of Labor and the Department of Health and Human Services to provide guidance 

to states regarding mental health benefits and parity and to expand awareness regarding federal 

jurisdiction and state roles. This will help ensure clarity on which rules and guidelines govern, 

and also assure that federal and state guidelines do not conflict regarding mental health parity. 

6 
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Recommendations to Improve Federal and State Efforts to Address the Opioid Crisis 

To continue to address this issue, and to create an open dialogue with our members on effective 

solutions, AHIP has sponsored an opioid working group, which meets regularly. This group 

represents plans across the country that serve millions of consumers in every insurance market, 

from large national providers to small, Medicaid-only plans. It is led by health plan physicians, 

pharmacists, and policy cxpmis who share their expertise on the most effective strategies to 

address this public health crisis. 

While health plans are working collaboratively across their communities to make real, 

measurable progress in addressing opioid misuse and addiction, there is no question that more 

must be done. To effectively solve the crisis, all stakeholders must do their part. Federal and 

State policymakcrs can be important conduits to drive collaboration between public and private 

stakeholders, and prioritize and promote best practice policy solutions. Based on feedback from 

Al-IIP's opioid working group, we recommend federal and state policymakers focus on the 

following: 

• Expanding access to evidence-based MAT and recovery services, including related efforts to 

expand and strengthen the workforce and infrastructure. Unfortunately, the demand for these 

treatment services currently exceeds the supply, in part due to the process for providers to be 

certified to prescribe MAT and a shortage of behavioral health professionals generally. This 

also includes allowing for access to MAT in correctional facilities and upon reentry into 

society. 

• Prioritizing research on pain and substance use disorder treatment to better evaluate 

effectiveness and impact on outcomes. This includes developing best practices and 

validated, evidence-based criteria for establishing "centers of excellence" in pain 

management and substance usc disorder treatment. 

• Improving the completeness, workflow integration, and interoperability of state prescription 

drug monitoring programs (PDMPs), and ensuring plan access. 

• Adopting a comprehensive opioid management program in Medicaid and other state-run 

health programs, and allowing for greater flexibility in opioid management program 

approaches in these programs. 

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Encouraging integration of primary and behavioral health care, including modernizing 42 

C.F.R. Part 2 regulations as we recommend above to allow for the confidential sharing of 

information on substance usc diagnoses to improve access, quality, and care coordination. 

Assessing the available evidence and potential consequences of incentivizing abuse-deterrent 

opioid formulations, and how they may factor into prevention and treatment for patients and 

the potential to significantly increase costs without reducing the risk of abuse or addiction. 

Conclusion 

We arc committed to helping America overcome the opioid addiction epidemic. But no one 

entity can overcome this crisis alone. If we arc to succeed, we must all come togetherincluding federal and state leaders, physicians and health care systems, health insurance 

providers and community organizations, employers, and phannaceuticalmanufacturers and 

distributors. Each of us offers an important perspective into the health care system and the 

patient experience. We welcome opportunities to collaborate with other stakeholders to find 

solutions that provide patients with pathways to healing, without increasing their risk of 

addiction. 

8 
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32978.078

GRCG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

((ongrc%s of tbe 'mbtiteh $tates ;I!;Jow~e o[ l\epmitntntibell 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

The Honorable Scott Gottlieb 

Commissioner 

U.S. Food and Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Dear Dr. Gottlieb: 

(:201) ~1&·-2927 

(202i22f..-3G41 

November 17,2017 

Thank you for appearing before the Committee on Energy and Commerce on October 25, 2017, 

to testify at the hearing entitled "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA 

and Other Initiatives." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (l) the name of the 

Member whose question you arc addressing, (2) the complete text of the question you arc addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on December 5, 2017. Your responses should be mailed to Zaek 

Dareshori, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to zack.darcshori@mail.housc.gov. 

Thank you again for your time and effort preparing and delivering testimony before the Committee. 

Sincerely, 

~~ Chairman 

cc: The Honorable Frank Pallone, Jr., Ranking Member 

Attachment 
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Food and Drug Administration responses to Questions for the Record 

Committee on Energy and Commerce 

October 25, 2017 hearing entitled "l!'ederal Efforts to Combat the Opioid Crisis: A Status 

Update on CARA and Other Initiatives" 

The Honorable Michael C. Burgess 

1. As we continue to treat those addicted to opioids, we must also prevent new patients 

from abusing pain medication, which often leads to addiction. Opioids with abusedeterrent formulations (ADFs) help deter opioid misuse. Do you agree that abusedeterrent technology has a role to play in addressing the opioid crisis? 

As we continue to confront the staggering human and economic toll from opioid abuse and 

addiction, we are focused on taking actions that reduce the scope of new addiction by decreasing 

unnecessary exposure to opioids. At the same time, we also must take steps to help those with 

acute and chronic pain who need access to medicines, including opioids, get access to improved 

alternatives. Until we are able to find new non-opioid forms of pain management for those who 

need treatment for pain, it is critical that we also continue to promote the development of opioids 

that are harder to manipulate and abuse, and take steps to encourage their use over opioids that 

do not offer any form of abuse deterrence. 

2. The FDA's Opioid Action Plan calls for accelerating prescribers' uptake of opioids with 

abuse-deterrent formulations. Impediments such as prior authorization, formulary 

placement, non-medical switching and "fail first" policies can prevent patients from 

accessing abuse-deterrent formulations and are counterproductive to addressing opioid 

abuse prevention. Several states such as West Virginia, Massachusetts, Florida, 

Maryland, and Maine, have recognized the benefits of abuse-deterrent opioids and 

passed laws to remove formulary barriers to these drugs. 

a. What is the federal government doing to ensure that providers have access to 

abuse-deterrent products when appropriate? 

FDA supports the development of opioid drugs that have progressively more-effective 

abuse-deterrent formulations to reduce the opportunity for manipulation and abuse, and is 

taking a number of new steps to advance the opportunity for abuse deterrent fonnulations of 

opioid drugs to become a more viable alternative to formulations that are more prone to 

manipulation and subsequent abuse. Transitioning from the current market, dominated by 

conventional opioids, to one in which most opioids have abuse-deterrent properties, holds 

significant promise for a meaningful public health benefit. 

Recognizing the impotiance of generic drugs to ensure patient access, FDA also must lay 

out a viable path for the entry of generic versions of abuse deterrent drugs. The Agency 

recently issued a final guidance to assist industry in their development of generic versions of 
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approved ADF opioids. This guidance includes new recommendations about the type of 

studies companies should conduct to demonstrate that the generic drug is no less abusedeterrent than its brand-name counterpart. We are also taking additional steps beyond the 

new guidance to help developers of generic ADFs navigate the regulatory path to market as 

quickly as possible and make the review process more efficient and predictable. For 

example, we are developing appropriate, improved testing methodologies for evaluating 

complex features like abuse deterrence for both brand name (innovator) and generic opioid 

drug products. In addition, we are also taking a fiexible, adaptive approach to the evaluation 

and labeling of ADF opioids. 

b. Should all patients have access to abuse-deterrent technology at parity with other 

opioids? 

Although insurance companies and other payors often rely in part on FDA's approval of 

medications in making their coverage decisions, the Agency docs not have authority to 

intervene in such decisions. 

The Honorable Joe Barton 

1. The techniques for managing acute pain are different from the techniques for managing 

chronic pain. In fact, some specialties, like dentistry, rarely (if ever) have to treat 

patients for chronic pain. Even the types of opioids that would be prescribed-long 

acting versus short acting-are different. The CDC guideline and the current FDA 

REMS strategy have both focused on managing chronic pain, but what are you doing to 

help promote more judicious prescribing among those who are not in the business of 

managing chronic pain? 

To reduce the rate of new opioid addiction, we need to decrease overall exposure to opioids for 

both acute and chronic pain. This means using our regulatory authorities to address how opioids 

are prescribed. We need to make sure that only appropriately indicated patients are prescribed 

opioids, and that the prescriptions are written for durations and doses that properly match the 

clinical reason for which the drug is being prescribed in the first place. 

Given what we already know about the scope of current prescribing, and the subsequent patterns 

of abuse, it is clear that there should be fewer prescriptions being written for opioids. When 

opioids are prescribed, more of these prescriptions should be written for shorter durations of use. 

I believe there arc still too many thitiy-day prescriptions being written for conditions like dental 

procedures or minor surgery, which should require very short-term use, if they require an opioid 

prescription at all. Therefore, we are exploring whether FDA should take additional steps to 

make sure that general prescribing, and the number of opioid doses that an individual patient can 

be dispensed, is more closely tailored to the medical indication. 
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Among other steps, FDA is soliciting public input on these questions. The Agency is exploring 

whether and how it should use its authorities to better address issues related to prescribing and 

dispensing, as part of the HHS Opioid Strategy to advance the practice of pain management. 

2. What are you doing to promote the delivery of preventive services that help to control 

acute pain and stop such pain from becoming chronic? 

As part of the HHS Opioid Strategy to support cutting-edge research on pain and addiction and 

to advance the practice of pain management, FDA is committed to working with sponsors and 

with researchers who are developing non-opioid and non-addictive pain medications to bring 

these new options to patients as expeditiously as possible. FDA has a number of programs, such 

as Fast Track and Breakthrough Therapy Designation, which are intended to facilitate the 

development and review of products that, for example, are intended to treat a serious condition 

for which there is an unmet medical need. Novel non-opioid medications with the potential to 

provide effective pain relief, and that satisfy the applicable legal criteria, may be appropriate 

candidates for such programs. We have issued Fast Track Designation for more than 30 nonopioid analgesics and Breakthrough Therapy Designation for 12 non-opioid analgesics. 

The Honorable Gus Bilirakis 

1. Many patients who suffer from opioid addiction also have other co-morbidities that 

require the use of other medications and medical devices. As a result, care coordination 

can play a major role in helping stem drug abuse but also promote basic medical safety. 

a. In what ways is data currently being used to advance this end? 

FDA collects post-market safety data that can include information about other medications 

patients may be using along with the drug in question, and this infonnation may be used to 

better educate patients and providers about the benefits and risks of using a drug in 

combination with another drug. As an example of ongoing data collection, FDA has required 

post-marketing studies of the holders of new drug applications for extended-release and longacting (ER/LA) opioid analgesics. These NDA holders are currently conducting a series of 

ten observational studies and one clinical trial to provide data to better understand the risks of 

misuse, abuse, addiction, overdose, and death associated with long-term opioid analgesic use 

in patients prescribed ERJLA opioid analgesics. Risk factors for these adverse outcomes, 

which can include co-morbidities and other prescribed medications, will also be examined in 

these studies. FDA expects to have the data from these studies and trial by early or mid2020. 

b. In what role can interoperability of medical devices and the systems to which they 

report play in increasing safety and efficiency in patient care? 
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The ability of devices to communicate effectively with other devices while providing clear 

and useful information to users is a major component of device safety and efficiency of 

patient care. lnteroperability in healthcare has the potential to encourage innovation and 

facilitate new models of health care delivery by promoting the availability and sharing of 

information across systems even when products from different manufacturers are used. 

Interoperable devices can improve patient care, reduce errors and adverse events, and 

encourage innovation. FDA supports intcroperability when data can be exchanged between 

devices safely and securely. 

FDA recently issued a guidance document titled "Design Considerations and Premarket 

Submission Recommendations for Interoperable Medical Devices'' that outlines our current 

thinking on how device manufacturers should consider interoperability when designing a 

device. With respect to interoperability, we recommend device developers consider the type 

of data being exchanged, anticipated users, how to mitigate any risks identified, how best to 

label a device intended to be used in an interoperable setting, how to verify and validate data 

exchanges work correctly, how to label an interoperable device, and the use of standards. 

FDA has a robust standards program that has supported the use of standards related to 

interoperability. In 2013, we recognized an initial set of standards manufacturers could use to 

improve patient care by making sure devices work well together. We have since recognized 

additional standards related to interoperability and encourage their development and use. 

More broadly, FDA is participating in the development of the National Evaluation System 

for health Technology (abbreviated as NEST), which will link various sources of data 

collected as part of routine clinical care-including data from electronic health records, 

medical claims, and medical device registries-to improve the quantity and quality of 

information that can be used to support decision-making by a variety of medical device users 

and ev.aluators. FDA can use such information to support decisions related to marketing and 

surveillance of medical devices; insurance companies can usc such information to support 

coverage and payment decisions; hospitals can use such information to support quality 

improvement activities; and device manufacturers can use such information to support a new 

or revised indication for a new or existing product. NEST will supp01t interoperability by 

harmonizing data that are collected from devices and data about how devices arc used. 

2. Many patients who suffer from opioid addiction also have other co-morbidities that 

require the use of other medications and medical devices. As a result, care coordination 

can play a major role in helping stem drug abuse but also promote basic medical safety. 

a. In what ways is data currently being used to advance this end? 

Sec response to 1 a 

b, In what role can interoperability of medical devices and the systems to which they 

report play in increasing safety and efficiency in patient care? 
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32978.083

See response to 1 b 

3. Last August, FDA authored a blog post titled: "FDA Supports Greater Access to 

Naloxone to Help Reduce Opioid Overdose Deaths." Can you provide this Committee 

with an update on the development of an over-the-counter version of naloxone? 

Prevention and treatment of opioid overdose is an urgent public health priority, and FDA 

recognizes the need to improve access to naloxone for the emergency treatment of known or 

suspected overdoses until emergency medical help arrives. As part of the HHS Opioid 

Strategy, the Agency is focusing on: 1) expanding the utilization of naloxone; 2) accelerating 

the development and availability of new naloxone formulations and user friendly products; 

and 3) identifying and disseminating the best practice naloxone delivery models and 

strategies. FDA is reviewing options, including over-the-counter (OTC) availability, to make 

naloxone more accessible to treat opioid overdoses, building on the Agency's recent approval 

of intranasal naloxone. To lay the groundwork for naloxone to be available more broadly, 

FDA is supporting research to facilitate the development of labeling for a potential OTC 

version of naloxone aimed at encouraging manufacturers to develop OTC naloxone products. 

In addition, FDA has contacted every maker of an approved naloxone product and offered to 

meet with them to discuss the OTC process, and several have taken us up on this offer. 

The Honorable Chris Collins 

1. The opioid epidemic is a serious public health crisis, but the FDA has not prioritized 

non- opioid pain medications in the same way as antibiotics to treat drug-resistant 

bacteria. The Generating Antibiotic Incentives Now (GAIN) Act passed in 2012 to spur 

the development of new antibiotics to fight drug-resistant bacteria in hospitals and 

communities gave the FDA a path to qualify infectious disease products for Fast Track 

Designation and Priority Review. In 2013, the CDC estimated that 23,000 die each year 

due to resistant infections. In 2015, a total of33,091 persons in the United States died 

from drug overdoses involving opioids and yet similar actions have not been taken. 

a. Has the agency considered taking the same approach with the opioid epidemic? 

FDA is committed to working with sponsors and with researchers who are developing nonopioid and non-addictive pain medications to bring these new options to patients as 

expeditiously as possible. FDA has a number of programs, such as Fast Track and 

13reakthrough Therapy Designation, which are intended to facilitate the development and 

review of products that, for example, arc intended to treat a serious condition for which there 

is an unmet medical need. 1\ovel non-opioid medications with the potential to provide 

effective pain relief, and that satisfy the applicable required criteria, may be appropriate 

candidates for such programs. We have issued Fast Track Designation for more than 30 nonopioid analgesics and Breakthrough Therapy Designation for 12 non-opioid analgesics. 
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32978.084

2. The opioid epidemic is a serious public health crisis, but the J<'DA has not prioritized 

non- opioid pain medications in the same way as antibiotics to treat drug-resistant 

bacteria. The Generating Antibiotic Incentives Now (GAIN) Act passed in 2012 to spur 

the development of new antibiotics to fight drug-resistant bacteria in hospitals and 

communities gave the FDA a path to qualify infectious disease products for Fast Track 

Designation and Priority Review. In 2013, the CDC estimated that 23,000 die each year 

due to resistant infections. In 2015, a total of 33,091 persons in the United States died 

from drug overdoses involving opioids and yet similar actions have not been taken. Has 

the agency considered taking the same approach with the opioid epidemic? 

See response to l 

The Honorable Dayjd McKinley 

I. Police, fire fighters, and other emergency personnel are the first to arrive on an opioidsrelated scene. These professionals are there to protect us, but they are at risk of being 

exposed to potent opioids and their synthetic analogues, such as fentanyl and 

carfentanyL What's being done to protect these first responders, what more can be 

done, and what do you need from Congress? 

FDA recognizes the need to improve access to naloxone for the emergency treatment of known 

or suspected overdoses and accidental exposure until emergency medical help arrives. The 

Agency is focusing on: 1) expanding the utilization of naloxone; 2) accelerating the development 

and availability of new naloxone formulations and user friendly products; and 3) identifying and 

disseminating the best practice naloxone delivery models and strategies. FDA is reviewing 

options, including over-the-counter (OTC) availability, to make naloxone more accessible to 

treat opioid overdoses, building on the Agency's recent approval of intranasal naloxone. FDA is 

facilitating the development of labeling for a potential OTC version of naloxone, which is 

currently only available by prescription. 

To help facilitate the potential availability of OTC naloxone, FDA has developed a draft model 

naloxone drug facts label (DFL) and an accompanying simple pictogram that would be placed 

next to the DFL to correspond with the DFL directions, and FDA has initiated label 

comprehension testing to determine whether consumers can easily understand the information. 

This study is currently ongoing. 

In addition, HHS contributed to the development of the Fentanyl Safety Guidance for First 

Responders that was released in Fall 2017, which is available here: 

https:l/www. whitehouse.gov/siteslwhitehouse.gov!files/images!Final%20STANDARD%20size%2 

Ooj%20Fentanyl%20Sajety%20Recommendations%2Qfor%20First%20Respond. .. .pdf 
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32978.085

2. Dr. Gottlieb, your testimony describes significant efforts by the FDA to address the 

opioid crisis in the US, including encouraging use of non-addictive forms of pain 

management. Yet, the FDA announced in a press release dated January 14, 2014 that 

the agency would take regulatory action to restrict access to OTC acetaminophen to 

prevent inadvertent overdose, despite the fact that half of Americans are 

contraindicated for non- steroidal anti-inflammatory drugs (NSAIDs) and may only 

take acetaminophen. Given the need to respond to the opioid crisis with non-addictive 

treatment options for patients, does FDA still intend to take regulatory action limiting 

access to OTC acetaminophen? 

Yes, FDA remains focused on helping to ensure safe use of acetaminophen in adults and 

children. To achieve this goal, FDA is working on a proposed rule intended to reduce the 

recommended daily adult dose of acetaminophen in OTC pain relief products consistent with the 

previous action for prescription combination drug products containing acetaminophen to a dose 

that is still effective for pain relief, but will reduce the likelihood of liver damage. 

Acetaminophen is currently the most common cause of drug-induced liver injury in the US. 

FDA also is working on a proposed rule addressing acetaminophen dosing instructions in the 

labeling of OTC acetaminophen products for children that are based upon weight as well as age 

to reduce unintentional overdose. FDA has previously issued guidance recommending that the 

concentration of single-ingredient liquid acetaminophen products used in children be 

standardized to reduce dosing errors and to require warning statements on the labels of 

acetaminophen-containing prescription drugs to let consumers know that rare but serious skin 

reactions may occur with acetaminophen. In addition, manufacturers ofOTC acetaminophencontaining products have voluntarily implemented safety-related changes to their labeling. 

While working on rulemaking on these issues, FDA has provided public advisories and guidance 

to industry to make the public and drug manufacturers aware of the risks discussed above. FDA 

has also worked to educate consumers about the risks of taking multiple acetaminophencontaining products at the same time. 

3. Dr. Gottlieb, as you know, over-the-counter (OTC) pain relievers taken as directed 

provide a safe and non-addictive alternative to the usc of opioids. Advocates for patients 

that can only take acetaminophen to manage pain and for whom non-steroidal antiinflammatory drugs (NSAIDs) arc contraindicated are aware of the importance of 

balancing the need for OTC pain relief options with education on safe use of these 

medications and awareness of all pharmacologic and nonpharmacologic pain relief 

options as part of their pain management plan. What is the FDA currently doing to 

educate both providers and patients living with pain about the safe use of OTC pain 

relief options, as well as other safe and effective pain management options, and to make 

these materials easily accessible and interpretable by these populations? 
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32978.086

FDA supports expanded availability of safe nonprescription pain relievers as alternatives to 

opioids. Beginning with the labels of products that contain these pain relievers which clearly lay 

out their efficacy, FDA works both to inform the public of information on safe use of currently 

available nonprescription pain relievers, and to support industry efforts to develop new and 

improved OTC pain relievers. 

FDA continually monitors safety reports and medical literature pertaining to OTC pain 

medicines; meets frequently with sponsors of current and potential OTC pain relievers to give 

these manufacturers advice and support for development programs for new and improved OTC 

pain relievers; and routinely updates Drug Facts labeling and issues communications to providers 

and consumers on important safety topics. 

4. As you know, over-the-counter (OTC) pain relievers can serve as safe and nonaddictive alternatives to opioids. It's important that patients are aware of all options as 

part of their pain management plan. What is the FDA currently doing to educate both 

providers and patients about the safe use of OTC pain relief options, as well as other 

safe and effective pain management options, and to make these materials easily 

accessible and interpretable by these populations? 

See response to 3 

5. Your testimony describes significant efforts by the FDA to address the opioid crisis in 

the US, including encouraging use of non-addictive forms of pain management. Yet, the 

FDA announced in a press release dated January 14,2014 that the agency would take 

regulatory action to restrict access to OTC acetaminophen to prevent inadvertent 

overdose, despite the fact that half of Americans arc contraindicated for non-steroidal 

anti-inflammatory drugs (NSAIDs) and may only take acetaminophen. Given the need 

to respond to the opioid crisis with non-addictive treatment options for patients, does 

FDA still intend to take regulatory action limiting access to OTC acetaminophen? 

See response to 2 

The Honorable Buddy Carter 

On June 13th, the FDA put out a release titled "Statement from FDA Commissioner Scott 

Gottlieb, M.D.- FDA is taking new steps to help assess opioid drugs with abuse-deterrent 

properties." This is part of their commitment to take actions on opioids. 

1. The FDA released a statement in .June focusing on ways to deter opioid abuse and in 

that announcement. What are you doing to pursue those actions and combat opioid 

abuse? 
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32978.087

FDA continues to have an important role to play in addressing this crisis under the five-point 

HHS Opioid Strategy. Among other efforts, some of the steps we are initially focused on relate 

to three broad areas. First, lowering overall exposure to opioid drugs and, in turn, reducing the 

number of new cases of addiction. Second, enabling more opportunities for those currently 

addicted to opioid drugs to seek medication-assisted treatment (MAT)- the use of medication 

combined with counseling and behavioral therapies that can help them recover. And third, 

helping to expedite the development of progressively more-effective abuse deterrent 

formulations of opioid drugs, and better still, non-opioid alternatives for the treatment of pain. 

Some examples of the actions FDA is taking to address the crisis include: 

We are committed to making sure that FDA's decisions to approve new opioid drugs, as well as 

decisions related to how we evaluate the post-market safety of currently marketed medicines, are 

made within a benefit-risk framework that considers not only the outcomes of opioids when used 

as prescribed, but also the public health effects of the inappropriate use of these drugs. 

FDA supports the development of opioid drugs that have progressively more-effective abusedeterrent formulations to reduce the opportunity for manipulation and abuse, and is taking a 

number of new steps to advance the opportunity for abuse deterrent formulations of opioid drugs 

to become a more viable alternative to formulations that are more prone to manipulation and 

subsequent abuse. Transitioning from the current market, dominated by conventional opioids, to 

one in which most opioids have abuse-deterrent properties, holds significant promise for a 

meaningful public health benefit. 

FDA is committed to using all of the Agency's authorities to advance both non-addictive and 

non-pharmacologic treatments for pain,. This includes programs such as the Fast Track and 

Breakthrough Designations that are intended to facilitate development and to expedite review of 

products that, for example, are intended to treat a serious condition for which there is an unmet 

medical need. We are working to provide additional guidance to innovators who are pursuing 

non-opioid alternatives for the treatment of pain. Our steps also include a more careful 

consideration of non-drug alternatives for pain, such as medical devices that can deliver more 

localized analgesia. 

To reduce the rate of new opioid addiction, we need to decrease overall exposure to opioids. 

This means using our regulatory authorities to address how opioids are prescribed. We need to 

make sure that only appropriately indicated patients are prescribed opioids, and that the 

prescriptions are written for durations and doses that properly match the clinical reason for which 

the drug is being prescribed in the first place. We are exploring whether FDA should take 

additional steps to make sure that general prescribing, and the number of opioid doses that an 

individual patient can be dispensed, is more closely tailored to the medical indication. 

FDA is updating the existing Risk Evaluation and Mitigation Strategy (REMS) on extended 

release opioid analgesics, and for the first time, extending these same regulatory requirements 

(including prescriber training) to the manufacturers of IR opioid analgesic products. The new, 
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updated REMS will include modifications to FDA's existing Blueprint for prescriber education 

to broaden information on pain management, including the principles of acute and chronic pain 

management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain 

(both non-opioid analgesic and opioid analgesic). 

FDA's Opioid Policy Steering Committee is also considering whether there are circumstances 

when FDA should require some form of mandatory education for health care professionals, and 

how the agency would pursue such a goal, and the agency has issued a public notice to solicit 

input on a detailed series of questions related to these goals. 

2. You announced that you would be engaging with "external thought leaders." What 

were the results of that meeting? 

The public workshop held on July I 0-11, 2017, involved discussion on a central question related 

to opioid medications with abuse-deterrent properties: do we have the right information to 

determine whether these products are having their intended impact on limiting abuse and helping 

to curb the epidemic? We recognize that the science of abuse deterrence is relatively new. Both 

the formulation technologies and the analytical, clinical, and statistical methods for evaluating 

those technologies are rapidly evolving. That is why we are also focusing our efforts on 

determining how effective the current abuse-deterrent products are in the real-world setting and 

better understanding the attitudes and beliefs of health care professionals and those who are 

prescribed these products. While these innovative formulations are designed to make it harder 

for people to manipulate the opioid drug so they cannot be abused, it is important that prescribers 

and patients understand that these drugs arc not "abuse-proof," and they do not prevent 

addiction, overdose, or death. To address these issues, among other steps, we are currently 

conducting a study to evaluate whether the nomenclature we use to describe these drugs, by 

labeling them "abuse deterrent," is accurately conveying their benefits. 

The Honorable Ryan Costello 

1. What effect will increased patient access to medical technologies have on limiting longterm opioid therapies? 

Medical devices have a potential role both in pain management and in treating opioid usc 

disorders. Depending on the cause of the pain, FDA-approved or cleared devices may offer an 

alternative or adjunct to treatment with opioids or other analgesics, and FDA encourages 

physicians to consider the needs of the patient and whether an appropriate device should be used 

as part of a patient's treatment plan. 

FDA is committed to working with clinical investigators and companies to bring novel 

technologies to market for the treatment of pain as an alternative to opioids or to treat opioid use 

disorder. 
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2. What are the current policies of CMS, Tricare, and commercial insurance carriers 

when evaluating surgical procedures and medical technologies'! Is opioid use reduction 

part of that evaluation process? 

FDA defers to CMS. 

3. What statutes exist that require clarity and transparency into the levels of evidence 

required for positive payer policies for medical technologies, surgical procedures, and 

medical interventions? Can statutes be developed and implemented that would 

standardize these requirements? 

FDA defers to CMS. 

The Honorable Pete Olson 

I. Of the grant funding provided for in CARA, how much funding has been allocated to 

state prescription drug monitoring programs (PDMPs)? Do you think states need 

additional federal grant funding to improve their PDMP or to fund clinical workflow 

integrations? 

FDA defers to SAMHSA or other components of HHS. 

The Honorable Bill Johnson 

I. Innovative non-opioid treatments for pain arc being developed that can prevent 

addiction before it starts. How is the FDA working to accelerate approval of such 

treatments? How can we better align the approval process with federal reimbursement 

policies for approved innovative medications and devices, so that once new treatments 

are approved, patients are not barred from accessing them because they are not 

covered by Medicare? 

FDA is committed to working with sponsors and with researchers who are developing nonopioid and non-addictive pain medications to bring these new options to patients as expeditiously 

as possible. FDA has a number of programs, such as Fast Track and Breakthrough Therapy 

Designation, which are intended to facilitate the development and review of products that, for 

example, are intended to treat a serious condition for which there is an unmet medical need. 

Novel non-opioid medications with the potential to provide effective pain relief, and that satisfy 

the applicable legal criteria, may be appropriate candidates for such programs. We have issued 

Fast Track Designation for more than 30 non-opioid analgesics and Breakthrough Therapy 

Designation for 12 non-opioid analgesics. 
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Although insurance companies and other payors often rely in part on FDA's approval of 

medications in making their coverage decisions, the Agency docs not have authority to intervene 

in such decisions. 

2. You've been supportive of abuse-deterrent technologies as one means of deterring early 

users from progressing to more dangerous methods of consuming prescription drugs, 

and CARA encouraged FDA to enhance development and approval of abuse-deterrent 

formulations. However, even though 60% of all branded, extended-release, long-acting 

opioids have an abuse-deterrent formulation, virtually all of those prescriptions involve 

one specific opioid product- Oxycodone. When will the FDA update its existing 

Branded Guidance and publish product guidance for Generic abuse-deterrent 

formulations to incentivize additional product designs and generics, which may be as 

effective and less costly'! 

Transitioning from the current market, dominated by conventional opioids, to one in which most 

opioids have abuse-deterrent properties, holds significant promise for a mcaningf\Jl public health 

benefit. But to transition this market more quickly to the ADFs, and consider permanently 

withdrawing the older formulations that lack abuse-deterrent features in the event these products 

were judged to be less safe- there are a number of factors we must consider. One of the factors 

that the FDA would consider relates to generic access. We must have the potential to improve 

access to the newer formulations, for appropriately selected and monitored patients, through the 

introduction of generic competitors or else the market could be left without sufficient supplies to 

meet market demand. 

In order to support this transition and encourage advancements in this area, in November 2017, 

the FDA issued a final guidance to assist industry in their development of generic versions of 

approved ADF opioids. This guidance (available at 

https:/lwww.fda.gov/downloads!Drugs!GuidanceComplianceRegulatorylnformation!Guidancesl 

UClvf492172.pdj) includes new recommendations about the type of studies companies should 

conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name 

counterpart. 

The final guidance for industry entitled "Abuse-Deterrent Opioids Evaluation and Labeling" 

was issued in April2015 

(http://www.fda.gov!downloads!Drugs!GuidanceComplianceRegulatorylnformation!Guidances/ 

UCM334743.pdj). We periodically assess the need for updated or revised guidance for industry 

and may update this guidance in the future if appropriate. 

3. Dr. Gottlieb, I introduced legislation, with my colleague on this committee Doris 

Matsui, to address teen abuse ofDXM, the active ingredient in most cough medicines, 

by prohibiting sales to people under 18. Will you commit to working with us to advance 

this policy? 
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HilS will be happy to provide technical assistance on the bill if requested. 

The Honorable Richard Hudson 

t. FDA has proposed streamlining of tbe drug approval process for discovery in the area 

of Pain Management. What efficiencies could be gained by a standardized data and 

analytics platform that was the same as the submission standard? 

The availability of a standardized data and analytics platform could make analyses more 

efficient, but the review of data is not often a limiting factor in the drug approval process. Such 

standardization would improve the ability to look at data across different products to look for 

similarities and differences that may have clinical relevance. 

The Honorable Susan Brooks 

1. I have heard you say that preventing drug use before it begins is the is the most costeffective way to reduce drug use and its consequences. In your opinion, what are the 

characteristics of successful prevention intervention programs'? Besides lack of 

resources, what are the barriers to implementing intervention programs? 

FDA defers to SAMHSA or other components ofliHS. 

The Honorable Ben Ray Lujan 

Addressing the opioid epidemic is going to require a multi-faceted approach. We cannot 

cure opioid addiction through law enforcement or treatment alone. We must also work to 

address the problem at the start. This means we should also be adopting policies and 

practices to reduce the amount of opioids that are available in circulation, and educating 

health care providers on opioids, pain management, and non-opioid pain alternatives. 

Approximately 80 percent of the legal global opioid supply is consumed in the United 

States. Based on 2015 sales, the top five opioid products were made by Purdue Pharma, 

Johnson & .Johnson, Insys Therapeutics, Mylan and Depomed, according to sales. A 2016 

survey by the National Safety Council revealed that about 99 percent of physicians exceed 

the recommended three-day dosage limit, with a quarter of them writing prescriptions for 

a full month and thus overprescribing these types of medications. 

Members of this Committee have called for additional prescriber education and training to 

this effect and I want to learn more about what role FDA and DEA can play in this process. 

1. Dr. Gottlieb, you recently announced that the FDA is taking the step to require 

immediate release opioid formulations be subject to the more stringent Risk Evaluation 

and Mitigation Strategy (REMS) program that extended release and long-acting opioid 
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formulations arc subject to today. The REMS for these products requires that training 

be available to health care providers. Will yon walk us through the REMS 

requirements for these products, and specifically discuss the training that is available to 

health care practitioners under the REMS? 

Since 2012, manufacturers of extended release and long-acting (ERILA) opioid analgesics have 

been subject to a REMS, which requires, as its primary component, that training be made 

available to prescribers of those products. To meet this requirement, the sponsors of the ER/LA 

opioid analgesics have been providing unrestricted grants to accredited continuing education 

providers for the development of education courses for health care professionals based on 

content outlined by FDA, which the agency calls the "Blueprint." FDA is now extending these 

REMS requirements to the immediate release (IR) manufacturers. 

While some of the ER/LA manufacturers also make IR opioids, this action will greatly expand 

the number of products covered by the REMS. The existing REMS currently includes 64 ER/LA 

opioid analgesic products. Once the action is finalized, an additional 277 IR opioid analgesics 

will be subject to these REMS requirements. 

In addition to expanding the REMS to include lR products, FDA is modifying the content of the 

educational "Blueprint" required under the REMS. The agency is adding content on pain 

management, including non-opioid alternatives. This includes principles related to the acute and 

chronic pain management; non-pharmacologic treatments for pain; and pharmacologic 

treatments for pain (both non-opioid analgesic and opioid analgesic). The revised Blueprint will 

also cover information about the safe use of opioids, and basic information about addiction 

medicine and opioid use disorders. 

For the first time, this training will also be made available to other health care professionals who 

are involved in the management of patients with pain, including nurses and pharmacists, which is 

in addition to prescribers of opioid analgesics. FDA believes that all health care professionals 

involved in the management of patients with pain should be educated about the safe use of 

opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor 

patients receiving an opioid analgesic, they can help ensure that the product is properly indicated 

for the patient and used under appropriate clinical care. 

2. Is training under the REMS mandatory for health care practitioners today? 

Currently, this training is not mandatory for health care practitioners. 

3. Can you give us a sense of how many health care practitioners have voluntarily 

participated in the training available under the REMS? 
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As of 2/28/2017 1 there have been 430,859 health care practitioner participants in the training 

available under the ERJLA REMS. Of these participants, 208,040 completed all components of 

an educational activity and met the education provider's criteria for passing. Of the participants 

who completed all components of an education activity and met the education provider's criteria 

for passing, 88,316 were individual clinician participants who were registered with the DEA to 

prescribe schedule II and/or Ill controlled substances and who wrote at least one ERJLA opioid 

prescription in the past year. 

4. I understand that FDA is considering whether mandatory education might be 

appropriate. Dr. Gottlieb, what are your thoughts on mandatory training? Is this 

something that you would support, and if so, how would FDA operationalize such a 

requirement? 

FDA's Opioid Policy Steering Committee is considering whether there arc circumstances when 

FDA should require some form of mandatory education for health care professionals, and how 

the agency would pursue such a goal. The agency's purpose is to reduce overall exposure to 

opioids by making certain that prescribing doctors are properly informed about appropriate 

prescribing recommendations, that providers understand how to identify the risk of abuse in 

individual patients, and know how to get addicted patients into treatment. The agency has issued 

a public notice to solicit input on a detailed series of questions related to these goals. FDA has 

also been scheduling meetings with provider organizations and sponsors engaged in dispensing 

drugs- including health systems and pharmacy chains, in an effort to solicit additional input on 

new strategies. 

In 2015, 33,000 Americans died from opioids. According to the CDC, almost half of those 

deaths were from prescription opioids. The New York Times reports that in 2016, 

overdoses from all drugs was the leading cause of death of people under the age of 50. Drug 

overdoses now kill more Americans each year than at the height of the HIV epidemic and 

the worst year for auto accident deaths. The Times and drug use experts attribute the 

sharp rise in all drug overdose deaths to the rise of opioids. What we need to fight this 

epidemic is continued and reliable long- term investments in prevention, treatment, 

recovery, and monitoring. 

The President's budget proposal for fiscal year 2018, coupled with other administration 

initiatives, takes several steps back in the fight against opioid addiction, including a cut in 

funds for SAMHSA. Overall, the President's proposed budget cuts HHS by 16.2 percent, 

the CDC by 17 percent and NIH by 19 percent. It cuts funding for addiction research, 

treatment and prevention. Even the White House Office on National Drug Control Policy 

would take a 95 percent hit. 

1 Quarterly update data is unaudited and provided by CE providers directly to the REMS Program Companies (RPC). 

Collection and reporting of participants and completers is not required by the REMS Implementation Guidelines. 
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5. Commissioner Gottlieb, do you have all of the tools you need to stop the opioid 

epidemic? 

FDA intends to take whatever steps we can, under our existing legal authorities, to ensure that 

exposure to opioids is occurring under appropriate clinical circumstances, and for appropriate 

patients. 

6. Commissioner Gottlieb, given the 31 percent cuts to FDA in the President's budget 

proposal, what programs relating to the opioid epidemic will be cut? Which programs 

would have been expanded that will now not be? 

FDA is committed to addressing the opioids crisis using all available tools and strategies, and 

will continue to work with Congress to ensure we have adequate resources to carry out our 

mission. 

Opioid addiction is not a new problem. Misuse of and addiction to pharmaceuticals has 

existed for centuries, ever since morphine was heralded in the 1850s as a solution to our 

opium addiction problem- until it, in turn, morphine became a larger problem, as did 

heroin, and then methadone. Today, we understand the importance of pain relieving 

agents, but as my constituents continue to perish at alarming rates due to these drugs, we 

need to be working together to address the crisis. The public and private sectors can and 

should work together to swiftly address the opioid epidemic. The Reagan-Udall Foundation 

for the FDA is an independent 50l(c)(3) not-for-profit organization created by Congress 

for the purpose of advancing regulatory science that is necessary to helping the FDA 

accomplish its mission. The Foundation was created by Congress in the Food and Drug 

Administration Amendments Act of 2007 (FDAAA) to address regulatory science 

challenges of the 21st century. The central focus of the Foundation is to assist in the 

creation of new, applied scientific knowledge, tools, standards, and approaches the FDA 

needs to evaluate products more effectively, predictably, and efficiently, and thereby 

enhance the agency's ability to protect and promote the health of the American public. 

7. Understanding what we know now about this issue, what further information or 

support do you need from pharmaceutical manufacturers to more aggressively combat 

this crisis? 

FDA is committed to working in partnership with industry to ensure that exposure to opioids 

is occurring under only appropriate clinical circumstances, and for appropriate patients. As 

described in the response to question l, FDA has notified manufacturers of immediaterelease opioids that they will be subject to the same REMS requirements that currently apply 

to extended t·elease/long-acting opioids, including that training be made available to 

prescribers of these products. IR manufacturers will be required to inform prescribers and 

other health care providers involved in the treatment and monitoring of patients with pain 
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(e.g., pharmacists, nurses) of the existence of the REMS and the need to successfully 

complete the necessary training. 

In addition, there is a critical need to encourage the development of novel treatments for 

chronic pain, including non-opioid alternatives, as well as new and innovative treatments for 

substance use disorders in order to augment our currently limited treatments. Encouraging 

the development of these products requires both scientific and translational development. 

FDA has previously, and is currently, working in these areas, including through our 

participation in the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, 

Innovations, Opportunities, and Networks (ACTTION) public-private partnership (PPP) and 

other PPP and consortia initiatives in a wide variety of areas relevant to pain treatment, 

opioids, substance use treatment, drug safety. and accelerated drug development. 

8. How are you engaging the Reagan-Udall Foundation to develop effective, innovative 

regulatory responses to the opioid crisis? 

FDA's partnership with the Reagan-Udall Foundation for the FDA has focused on a number of 

key initiatives, including the Innovation in Medical Evidence Development and Surveillance 

(IMEDS) Program and the Expanded Access Navigator tool. We look forward to continuing this 

partnership to advance FDA's vision of collaborative innovation to address regulatory science 

challenges of the 21st century. 

There are multiple forms of opioid painkillers, including abuse-deterrent formulations 

(ADFs) and extended-release/long-acting (ERILA) formulations. Now, in addition to 

expanding the REMS to include immediate-release (IR) products, FDA is modifying the 

content of the educational "Blueprint" required under the REMS. The agency is adding 

content on pain management, including non-opioid alternatives. The content includes 

principles related to the acute and chronic pain management; non-pharmacologic 

treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and 

opioid analgesic). The revised Blueprint will also cover information about the safe use of 

opioids, and basic information about addiction medicine and opioid use disorders. 

But education alone will not be enough. Patients need to be able to access effective products 

without the risk of addiction. Non-opioid pain alternatives include biologics in the pipeline, 

such as fasinumab (an NGF antibody for osteoarthritis and chronic lower back pain, in 

Phase 3 development by Regeneron) and tanezumab (an NGF antibody for osteoarthritis 

and chronic lower back pain, in Phase 3 development by Pfizer and Eli Lilly). Tanezumab 

is the first NGF inhibitor to receive Fast Track designation from the FDA. 

9. How will you be working with the Centers for Medicare and Medicaid Services, Indian 

Health Services, and the Department of Veterans Affairs to arrange for inclusion in the 

relevant reimbursement schedules of biologics as non-opioid pain alternatives? 
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Although insurance companies and other payors often rely in part on FDA's approval of 

medications in making their coverage decisions, the Agency does not have authority to intervene 

in such decisions. We defer to CMS for further information on this topic. 
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GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

<!tongrtS'S' of tbt Wntttb $tattS' 

1!}ou11r of ii\tprei1cntatii.Je11 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYRURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 (20?12:t!,h/S:1:7 

(7.H2)225··3D41 

November 17,2017 

The Honorable Elinore McCance-Katz 

Assistant Secretary for Mental Health and Substance Use 

Substance Abuse and Mentalllcalth Services Administration 

5600 Fishers Lane 

Rockville, MD 20857 

Dear Dr. McCance-Katz: 

Thank you for appearing before the Committee on Energy and Commerce on October 25, 2017, 

to testify at the hearing entitled "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA 

and Other Initiatives." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows:(!) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To faciiitatc the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on December 5, 2017. Your responses should be mailed to Zack 

Dareshori, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mai!ed in Word format to zack.darcshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Committee, 

n~er~ly~ /Jtd.t~At 

/<[.~en Chairman 

cc: The Honorable Frank Pallone, Jr., Ranking Member 

Attachment 
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House Committee on Energy and Commerce Hearing: Federal Efforts to Combat the 

Opioid Crisis 

October 25, 2017 

Questions for the Record - SAMHSA 

The Honorable Michael C. Burgess 

1. CARA requires that resources be put in place to assist women and children affected by 

opioid addiction. What is SAMHSA doing to address opioid addiction in pregnancy and 

neonatal abstinence syndrome? 

Response: 

Congress passed the Protecting Our Infants Act of 2015, the purpose of which is to address 

opioid usc by pregnant women and resultant consequences to newborn infants. The Act tasked 

the Department of Health and Human Services to produce a three-part report to include: l) a 

review of gaps, overlap, or duplication regarding prenatal opioid use and neonatal abstinence 

syndrome (NAS); 2) state of the science and clinical practice; 3) and a strategy and set of 

recommendations. On January 17, 2017, SAMHSA provided the report to Congress. IIHS has 

convened a department-wide workgroup that is developing an implementation plan based on the 

strategy that will support decision-making by departmental leadership with regard to specific 

agency priorities. 

In addition, SAMHSA is developing Clinical Guidance for Treating Pregnant and Parenting 

Women with Opioid Use Disorder and Their Infants. This Guidance will outline the optimal 

management of pregnant and parenting women with an opioid use disorder (OUD) and their 

infants based on the recommendations of experts. This Guidance will help healthcare 

professionals determine the most clinically appropriate action for a particular circumstance, with 

the expectation that the healthcare professionals will make individualized treatment decisions. A 

cornerstone of the Guidance is that a healthy pregnancy results in a healthy infant and mother. 

In Fiscal Year 2017, SAMHSA awarded 19 new grants for residential treatment centers for 

pregnant and parenting women. There are currently a total of 29 grantees receiving a total of $16 

million. These programs provide comprehensive services to women with substance usc disorders 

and their families. Treatment is required to include access to medications for women who are 

opioid dependent. 

As a result of CARA, SAMHSA also awarded three new State Pilot Grants for Pregnant and 

Post-Partum Women (PPW). The goal of the PPW pilot is to expand outpatient services for 

pregnant and postpartum women and their families with substance use disorder, including OUD 

and/or co-occurring substance use and mental disorders at the community-level. 

SAMHSA and the Administration for Children and Families (ACF) jointly fund the National 

Center on Substance Abuse and Child Welfare (NCSACW), a national resource center providing 

1 
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information, expert consultation, training and technical assistance to child welfare, dependency 

court and substance abuse treatment professionals to improve the safety, permanency, wellbeing, 

and recovery outcomes for children, parents, and families. The NCSACW also makes available 

webinars, assessment instruments, training and program toolkits, resource lists, and other 

publications. 

With SAMHSA and ACF support during 2017, NCSACW conducted 12 presentations and 11 

web-based trainings/virtual meetings on opioids. During its September 2017 webinar, 

"Supporting Families Affected by Opioid and Other Substance Use Disorders, Child Abuse and 

Prevention Act, Plan of Safe Care," over I ,200 individuals attended. In addition, during the 

same period NCSACW received and responded to over 300 opioid-related technical assistance 

requests; produced and disseminated the Policy Academy brief, Improving Outcomes for 

Pregnant and Postpartum Women with Opioid Use Disorders and Their Infants, Families, and 

Caregivers; and developed a web-based directory of resources on best practices for the treatment 

of opioid use disorders and neonatal abstinence syndrome. 

2. Effective treatment options are key to helping solve the opioid crisis and many for-profit 

type entities have entered the treatment and recovery space. Arc we doing enough to 

ensure quality among treatment and recovery centers? What more can we do to help those 

seeking help better find and compare the quality of treatment options? 

Response: 

SAMHSA is committed to promoting effective practice across the behavioral health service 

system. Improving access to medication-assisted treatment remains a central part ofSAMHSA's 

efforts to improve practice in the treatment of opioid usc disorder. A number of SAMHSA's 

programs have this as a primary goal and a number of other related programs with a broader 

focus, such as drug courts, have also made use of medication assisted treatment a priority. 

SAMHSA requires the use of evidence-based practices (EBPs) in its grant programs, including 

the recent State Targeted Response to the Opioid Crises Grant program authorized by the 21st 

Century Cures Act. Grant project officers ensure that EBPs are used by the grantees that they 

oversee and help programs address implementation issues by linking them to training or 

technical assistance. 

To assist individuals seeking help for opioid use disorders, SAMHSA has supported a number of 

shared decision-making tools for consumers of treatment and recovery support services. Shared 

decision-making is an emerging best practice in behavioral and physical health that aims to help 

people in treatment and recovery have informed, meaningful, and collaborative discussions with 

providers about their health care services. It involves tools and resources that offer objective 

information. People in treatment and recovery can then weigh that information against their 

personal preferences and values. Shared decision-making tools empower people who are 

seeking treatment or in recovery to work together with their service providers and be active in 

their own treatment. 

2 
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In 20 I 6, SAMHSA released Decisions in Recovery: Treatment for Opioid Use Disorder, an 

innovative decision support tool for people in or seeking recovery from opioid use disorder, as 

well as for treatment providers. Consumers who use this tool learn about medication assisted 

treatment, how to be better positioned to compare treatment options and decide which is the best 

option for their recovery, and how to discuss preferences with a treatment provider. 

SAMHSA continues to explore additional opportunities to share and disseminate these tools. 

The Honorable Greg Walden 

I. The Comprehensive Addiction and Recovery Act of2016 (CARA), which was signed into 

law over a year ago, empowered the Secretary of Health and Human Services to determine 

methods by which office-based opioid addiction treatment practitioners provide all drugs 

approved by the Food and Drug Administration for the treatment of opioid use disorder. 

Similarly, CARA provides the Secretary with the authority to ensure that such 

practitioners are trained in evidence-based practices such as detoxification, relapse 

prevention and the use of all FDA-approved medications for the treatment of opioid use 

disorders. 

Please tell us what progress you have taken to implement these reforms to opioid addiction 

treatment. When do you expect SAMHSA to fulfill its requirement to ensure providers are 

educating on the full range of requirements in CARA? Finally, does SAMHSA have a 

timeline on when it will notil'y existing waivered providers ou the requirements of CARA to 

offer all FDA-approved medications to patients seeking treatment? 

Response: 

SAMHSA held a meeting for all of the eligible training providers in September 2016. At that 

meeting, the group agreed to a revised curriculum with a new set ofleaming objectives that is in 

line with section 303 ofCARA and includes information on the use of all FDA-approved 

medications. SAMHSA's training program, the Providers' Clinical Support System-Medication 

Assisted Treatment, completed its update of the online and live courses to be compliant with 

section 303 in November 2017. Now that TIP 63: Medications for Opioid Use Disorders. has 

been released, SAMHSA will ensure that currently waivered practitioners receive the TIP which 

includes information about the appropriate usc of all FDA-approved medications for the 

treatment of opioid use disorders consistent with the requirements of CARA. At the same time, 

providers that do not work in SAM l-ISA regulated Opioid Treatment Programs are still not 

permitted by law to prescribe or dispense methadone for opioid use disorder treatment under the 

Controlled Substances Act. 

2. CARA and CURES provided significant funding for states to expand substance use 

disorder treatment, through grants administered by SAMHSA. In addition, CARA 

required grantees to submit data that will be posted online and easily searchable. Can you 

provide us with a status update on those requirements? 

3 
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Response: 

All CARA program grants that were appropriated funding for Fiscal Year 2017 have been 

awarded. Funding opportunities for each of the programs required specific data elements to be 

collected. 

Grantees for the First Responders - Comprehensive Addiction and Recovery Act Cooperative 

Agreement will respond to the following measures: 

I. The number of first responders and members of other key community sectors 

equipped with a drug or device approved or cleared under the Federal Food, Drug, 

and Cosmetic Act for emergency treatment of known or suspected opioid overdose; 

2. The number of opioid and heroin overdoses reversed by first responders and members 

of other key community sectors receiving training and supplies of a drug or device 

approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency 

treatment of known or suspected opioid overdose; 

3. The number of responses to requests for services by the entity or sub-grantee, to 

opioid and heroin overdose; and 

4. The extent to which overdose victims and families receive information about 

treatment services and available data describing treatment admissions. 

The Improving Access to Overdose (OD) Treatment grantee will respond to the following 

measures. 

I. Total amount ofOD Treatment Access grant funds spent on purchase of FDAapproved overdose reversal drugs. 

2. Number of health care providers and pharmacists trained on the prescribing of drugs 

or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for 

emergency treatment of known or suspected opioid overdose. 

3. Total amount ofOD Treatment Access grant funds spent on co-payments and other 

cost sharing associated with drugs or devices approved or cleared under the Federal 

Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid 

overdose. 

4. Number of patients who have experienced a drug overdose that arc connected with 

appropriate treatment, including medication assisted treatment and appropriate 

counseling and behavioral therapies. 

a. What accountability measures is SAMHSA requiring of states to make sure that the 

grant monies are spent wisely? 

Response: 

All SAMHSA grantees are required to report data to SAMHSA on a regular basis regarding their 

program's progress. Each program is required to report both output and outcome measures 

demonstrating project progress. These measures may include, but are not limited to: 

I. Number of people served; 

2. Abstinence from substance use; 

3. Employment status; 

4. Housing status; 

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5. Criminal justice involvement; and 

6. Retention in treatment. 

b. How do we know if states are spending money on people who arc most likely to respond 

to treatment? 

Response: 

The State Targeted Response to the Opioid Crisis Grant provides states and jurisdictions with the 

flexibility to provide opioid use disorder treatment services in a variety of clinical settings. 

States were required to develop a strategic plan targeting geographic regions and populations that 

were most in need and to report the data that lead them to select those areas and populations in 

the application and in a strategic plan. The plans are monitored by grant project officers on 

regular monthly calls and by submission of progress reports by states twice per year. 

States' and jurisdictions' administrative rules require substance use disorder treatment providers 

to utilize standardized assessment instruments to determine if a person meets the criteria for an 

opioid use disorder. The states and jurisdictions and their respective sub-recipients, i.e., 

community- and faith-based organizations, arc required to implement or expand access to 

clinically appropriate evidence-based medications and services for persons with an opioid use 

disorder, including the use of FDA-approved medications designed for the treatment of an opioid 

use disorder. States and jurisdictions and their respective grant sub-recipients must also provide 

appropriate psychosocial intervention and recovery support services for persons in early 

recovery. 

c. Is there a formal risk assessment that states must usc to make sure the monies are 

targeting the people who arc most likely to benefit from such treatment programs? 

Response: 

The State Targeted Response to the Opioid Crisis Grant requires states and jurisdictions to 

develop a needs assessment using statewide epidemiologic data. The needs assessments identify: 

(1) geographic areas within a state or jurisdiction where opioid misuse and related harms are 

most prevalent; (2) the number and location of opioid use disorder treatment providers in a state 

or jurisdiction; and (3) existing activities and services and their funding sources in a state or 

jurisdiction that address opioid use prevention, treatment and recovery activities and gaps in such 

activities and services. 

Further, the State Targeted Response to the Opioid Crisis Grant requires states and jurisdictions 

to develop comprehensive strategic plans to address the gaps in prevention, treatment and 

recovery services identified in their respective needs assessments. The states and jurisdictions 

prepared and submitted their respective needs assessments on or before July 31, 2017, and their 

respective strategic plans on or before August 30,2017. 

The plans are monitored by grant project officers on regular monthly calls and by submission of 

progress reports by states twice per year. Reports on the first six month progress were due 

December 15,2017. 

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The Honorable Markwayne Mullin 

l. Preliminary estimates from the CDC show that 64,000 Americans died from opioid 

overdoses last year. Another 50,000 or 60,000 of our fellow citizens will die from medical 

conditions closely related to opioid abuse like HIV/AIDS, Hepatitis C and cirrhosis. 

Yesterday, I became the lead sponsor of Rep. Tim Murphy's bill, the Overdose Prevention 

and Patient Safety Act, which would make it easier to share addiction medical records in 

care coordination settings. Do you believe 42 CFR Part 2 is an impediment to addressing 

our nation's opioid crisis? 

Response: 

The federal regulations at 42 C.P.R. Part 2 (Part 2) allow substance usc disorder (SUD) patient 

information to be shared among providers in certain circumstances. For example, a patient can 

give written consent to authorize the sharing of his or her SUD treatment record with any treating 

provider. Also, Part 2 typically does not apply to entire hospitals, emergency rooms 

(ER)/departments, or trauma centers, which would usually be considered general medical 

facilities. Accordingly, Part 2 is not an impediment to the sharing of SUD treatment records 

among providers in these settings, where the HIPAA Privacy Rule would continue to apply. 

With regard to general medical facilities or staff within such facilities, Part 2 applies only to an 

identified unit in the facility to the extent that the unit holds itself out as providing and provides 

SUD services, or to staff within the facility whose primary function is the provision of SUD 

services and who are identified as providers of such services. When Part 2 applies, it allows 

sharing without a patient's consent in medical emergencies, such as opioid overdoses. The Part 2 

medical emergency exception allows a patient's SUD information to be shared with other 

medical personnel when there is a bona fide medical emergency in which the patient's consent 

cannot be obtained'. The determination of whether a medical emergency exists is made by the 

treating/disclosing provider. Information disclosed by a Part 2 program during a medical 

emergency can be further shared with medical providers as needed (i.e., re-disclosed) in order to 

diagnose or treat the patient during the emergency. 

At the same time, there are statutory limitations related to sharing protected SUD patient 

information absent written consent, and the exceptions to the consent requirements are limited. 

The statute has been an impediment to sharing addiction records in care coordination settings. 

Within the constraints of the statute, SAMHSA has been working diligently to issue 

clarifications and education providers about what information sharing is permissible under both 

the statute and the regulation. 

As required by the 21st Century Cures Act (section 11002), SAMHSA held a public meeting on 

January 3 L 2018, to obtain input about the impact of Part 2 on "patient care, health outcomes, 

and patient privacy." The information gathered during this Part 2 public meeting can help 

policymakers better assess what changes can and should be made under current regulations or 

whether statutory changes are required to accomplish such objectives. 

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i. If yes- Are you supportive of a legislative fix like my bill (HR 3545) that would align Part 

2 with HIP AA? 

Response: 

While the Administration has not taken a position on this bill HHS remains happy to provide 

technical assistance on any legislation if desired. SAMHSA supports further consideration of the 

benefits of aligning Part 2 with HIPAA. 

ii. If no- why do you support a separate privacy rule for patients with addictions? 

Response: 

N/A 

b. The President's Opioid Commission and the Former CDC Administrator Tom Frieden 

have highlighted a need to fix Part 2. What have your agencies heard in the numerous 

round table discussions held across the country? Can any of you address this problem 

internally? 

Response: 

SAMHSA acknowledges concerns expressed by stakeholders. SAM liSA regularly responds to 

inquiries and pmiicipates in calls with stakeholders who both generally favor and are critical of 

Part 2. While SAMHSA does not provide legal advice, the Agency strives to understand 

stakeholder concerns about Part 2 implementation and regulatory requirements. SAMHSA staff 

often discuss the rule with stakeholders and potential approaches to such issues as data sharing 

by all-payer claims databases, use of electronic health records, responding to medical 

emergencies, research and many other topics. 

In addition to such discussions with stakeholders, SAMSHA also received numerous public 

comments on Part 2 as part of the notice-and-comment rulemaking process including: 

• During a June 2014 listening session (May 12,2014, 79 FR 26929; 

h ttps ://www .samhsa. gov I about -us/who-we-are/1 aws-regu lations/pub 1 ic-comm entsconfidentiality-regulations); 

• Following publication of a notice of proposed rulemaking in February, 2016 (Feb. 9, 

20 16; 81 FR 6987); and 

• Following publication of a supplemental notice of proposed rulemaking (82 FR 5485) in 

January 2017. 

[n compliance with the 21" Century Cures Act, SAMHSA hosted a listening session on January 

31,2018. 

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c. Part 2 is cited as the reason why most states arc not sharing data or not tracking 

outcomes in regards to treatment. What guidance can be given to states to measure 

outcomes but protect patient information? 

Response: 

Part 2 does not preclude sharing of Part 2 data for purposes of research. audit, or evaluation. The 

final2017 Part 2 rule allows a Part 2 program or other lawful holder of patient identifying 

information to disclose Part 2 data to qualified personnel for purposes of conducting scientific 

research if the researcher provides documentation of meeting certain requirements for existing 

protections for human research (HIP AA and/or HHS Common Rule, 45 CFR Part 46). In the 

final rule, SAMHSA expanded pennissible data linkages to enable researchers holding Part 2 

data to link to data sets from federal and non-federal data repositories. Similarly, Part 2 permits 

a Part 2 program or other lawful holder to disclose patient identifying information to certain 

persons for audit or evaluation purposes, if certain requirements are met. Thus, states can 

measure outcomes while protecting patient information by conducting research based on client 

outcome measures as well as evaluating outcomes of patients utilizing the current Part 2 

provisions related to these areas. 

d. Does anyone have a sense of the potential savings for Medicare and Medicaid if 

we are able to amend Part 2? 

Response: 

To SAMHSA's knowledge, there is no independent, peer-reviewed research concerning the costs 

of Part 2 to Medicare and Medicaid. As noted in the final 2017 rule, SAMHSA has used HIPAA 

costs as a proxy for estimating the regulatory impact of Part 2. SAMHSA therefore cannot 

specifically quantify the estimated savings or costs to these programs, were Part 2 to be 

amended. 

e. If we are able to save money via care coordination, shouldn't we be able to adequately 

fund treatment programs back in the states? 

Response: 

Care coordination is an effective way to identify patients with high service utilization or clinical 

risks and to address these needs and risks through increased support from specialized doctors or 

a care manager/coach that collaboratively assist in the management of disease. Care 

coordination provides benefits for the individual's health status, as well as in managing 

foreseeable and expensive costs related to crisis and emergency needs, while supporting the 

individual with the provision of lower-cost alternative care. Care coordination is promising, but 

there is insufficient data to know if the savings generated would provide significant reinvestment 

opportunities. Better health at a lower cost has been a long-standing goal of health care systems. 

Coordinated care may provide some system savings that could be reintroduced into state and 

community systems to meet emerging funding needs. Currently, disclosing information related 

to treatment-related activities such as care coordination requires written consent under Part 2. 

SAMIISA supports further consideration of the benefits of aligning Part 2 with HIP AA. 

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2. According to the CDC, Native Americans have the highest rates of both opioid overdose 

deaths as well as HCV -related deaths. Does your department engage with these populations 

around risk factors associated with opioid abuse, including the spread of infectious diseases 

such as HIV and HCV? 

Response: 

SAMHSA is committed to addressing the behavioral health needs of the nation, including 

American Indians and Alaska Natives (AllAN). In response to behavioral health and related 

issues faced by Al/ANs, SAMHSA established the Office of Tribal Affairs and Policy to 

improve the Agency's response and coordination of resources for these populations. SAMHSA 

has improved access to prevention resources for Al/ANs that address behavioral health-related 

risks for tribal communities. These resources include behavioral health infonnation specifically 

for tribal communities, as well as funding opportunities that allow tribes to address targeted 

substances of abuse. 

For example, the Tribal Behavioral Health Grant program (also called TBHG or Native 

Connections) focuses on preventing and reducing suicidal behavior and substance abuse and 

promoting mental health among Native young people. Among other actions, each TBHG grantee 

assesses their substance abuse, suicide, and other mental health needs and develops a targeted 

plan for addressing them. Based on the tribal grantee's assessment, the targeted substance(s) of 

abuse may include opioids, alcohol, methamphetamines, and/or other drugs. There are similar 

opportunities to address opioids through other substance abuse prevention grants for which tribal 

entities are eligible. In addition, SAMHSA-supported resources such as the "Risk and Protective 

Factors for Substance Abuse and/or Mental Health Problems Among Alaska Native and Native 

American Populations" publication identify specific risk and protective factors based on 

published studies that assist in developing targeted tribal programming for Alaska Natives. 

Mental and substance use disorders can contribute to the risk for HIV I AIDS and viral hepatitis. 

As a result, SAMHSA supports efforts such as the HIV Capacity Building Initiative, Minority 

AIDS Initiative Continuum of Care, and Targeted Capacity Expansion-I-llY Program. Tribal 

communities have been supported through some of these efforts which allow for HIV testing 

(and pre- and post-test counseling), referrals for treatment, integration of medicalli!V/ AIDS and 

behavioral health care, and testing for other infectious diseases such as hepatitis C. SAM l-ISA 

also developed an information resource called "Hepatitis C/HIV in Native American 

Populations" and distributed it widely to elevate the awareness of tribal communities on these 

risks, actions they can take, and funds available through the agency. 

3. Do you currently have the ability to help tribal and public health systems develop 

programs to alert providers of care for opioid abuse to also test for concomitant infectious 

diseases and provide a pathway to treatment? Are you engaging in these activities 

currently, if so, can you please elaborate on these efforts and provide any findings on the 

results? 

Response: 

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Yes, SAM!-! SA has the ability to help tribal and public health systems develop programs. 

Specifically, SAMHSA addresses the risks for !-!IV/AIDS and viral hepatitis by supporting 

grants that improve coordination of mental and substance usc disorder treatment, including HlV 

testing with pre- and post-test counseling and referrals for treatment; integrated medical, 

!-!IV/AIDS, and behavioral health care; and testing for other infectious diseases. Examples of 

funded tribal projects include the following grants: 

• Native American Health Center's Ekwahness ("To Hold Tightly") 

• Salish Kootenai College Integrative Community Empowerment 

• College of the Muscogec Nation's Guarding the Future 

Currently, SAMHSA administers the "Minority AIDS Initiative Continuum of Care PilotIntegration ofHIV Prevention and Medical Care into Mental Health and Substance Abuse 

Treatment" program. This program supports projects that coordinate and integrate services 

through the co-location of behavioral health treatment and HIV medical care including American 

Indians and Alaska Natives. The focus is on substance abuse treatment programs and community 

mental health programs that can co-locate and fully integrate HIV prevention and medical care 

services within them. 

In Fiscal Year 2017, SAMHSA announced the "First Responders- Comprehensive Addiction 

and Recovery Act Cooperative Agreement" program. SAMHSA awarded over $11 million over 

four years to 21 grantees to train and provide resources for first responders and members of other 

key community sectors on carrying and administering an FDA-approved product for emergency 

treatment of known or suspected opioid overdose. States and tribal entities (American Indian 

and Alaska Native tribes, tribal organizations, and consortia of tribes or tribal organizations) 

were eligible to apply. The tribal entities receiving a grant were the Choctaw Nation of 

Oklahoma, White Earth Band of Chippewa Indians, Lac Du Flambeau Band of Lake Superior 

Chippewa Indians, and the Cherokee Nation. 

4. How could we strengthen our public health system infrastructure to better respond to 

the opioid epidemic and its long term health consequences? 

Response: 

The opioid epidemic has had a significant impact on the nation and tribal communities. 

According to SAMHSA's 2016 National Survey on Drug Use and Health report, which provides 

national and state-level data on the use of tobacco, alcohol, illicit drugs (including non-medical 

usc of prescription drugs) and mental health in the United States, 11.8 million people in the U.S. 

aged 12 or older misused opioids in the past year and 948,000 reported using heroin. Within this 

number, 63,000 American Indians and Alaska Natives aged 12 and older reported misusing 

opioids and 5,000 aged 12 and older reported using heroin. In 2015 and 2016, illicit drug use was 

higher among American Indians and Alaska Natives as compared to the total U.S. population. 

In FY 20 I 7, the Department of Health and Human Services announced that $485 million would 

be awarded to states and territories to combat opioid addiction through the State Targeted 

Response (STR) to the Opioid Crisis Grant program. The STR program is administered by 

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SAMHSA and aims to: increase access to treatment; reduce unmet treatment needs; and reduce 

opioid overdose related deaths through the provision of prevention, treatm~nt, and recovery 

activities for opioid use disorder, including prescription opioids, as well as illicit drugs such as 

heroin. By statute, tribes were not directly eligible for an STR grant, and SAMHSA can 

encourage but not compel states to include tribes in their STR plans. 

The Honorable Gus Bilirakis 

1. As more treatments for diseases transition from more expensive care settings like 

inpatient to out-patient facilities and even to the home, what is the importance of being able 

to treat addiction in a home settiug versus a traditional methadone clinic? 

Response: 

Treatment of addiction is increasingly accessible and affordable for individuals in an outpatient 

or intensive outpatient setting versus a more expensive and confining inpatient or residential 

setting. Outpatient treatment services include the availability of safe and effective medicationassisted treatment programs for patients with opioid use disorders, using methadone, 

buprenorphine, or naltrexone, in combination with evidence-based addiction counseling and 

related services and supports. For some people who are stable or for whom the risk of 

complications is low, treatment that does not require regular attendance at a facility may be the 

most appropriate because convenience of treatment often improves adherence. Having more 

options that can address the variety of patient needs improves outcomes. The Drug Addiction 

Treatment Act of2000 (DATA 2000) enabled buprenorphine to be prescribed or administered to 

a patient on an outpatient basis by a physician, nurse practitioner, or physician assistant with a 

certain type of waiver. Patients who are treated by providers with waivers are not required to 

attend a program daily, as is generally the practice when a patient begins methadone treatment in 

an Opioid Treatment Program. Another treatment option that is becoming increasingly popular 

is the usc of extended-release injectable naltrcxone, which is administered as a once a month 

injection by a physician for individuals to prevent relapse to opioid dependence, after the patient 

has completed opioid detoxification. This medication also has the advantage of not requiring 

that a patient he able to attend a daily or weekly treatment program. In addition, in May, 2016, 

the Food and Drug Administration approved the first buprenorphine implant for the maintenance 

treatment of opioid dependence. This medication is designed to provide a constant, low-level 

dose ofbuprenorphine for six months in a patient who is already stable on low-to-moderate 

doses of other forms of buprenorphine, as part of a complete treatment program. In November, 

2017 the Food and Drug Administration also approved the first once-monthly injectable 

buprenorphine product for the treatment of moderate-to-severe opioid use disorder in adult 

patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) 

buprenorphine-containing product. This product provides a new treatment option for patients in 

recovery for whom the once-monthly injection may be more appropriate than other forms of 

buprenorphine, as it may reduce the burden of taking medication daily as prescribed (medical 

adherence). 

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2. Currently there isn't a clear standard for medication assisted treatment (or MAT) 

prescribing, and we've heard reports of an increasing number of rogue actors offering 

MAT. In many cases these "pop up clinics" actively recruit vulnerable client populations 

and provide substandard services with minimal oversight. While we support consumer 

choice and market competition, we also want to balance this with consumer safeguards to 

ensure that this problem improves, not worsens, and that bad actors are not rewarded via 

federal dollars. Additionally, questions have been raised as to whether states arc requiring 

evidence-based practices be used in the STR grant program. What is SAMHSA doing to 

ensure rogue actors arc not the recipient of federal dollars and evidence-based practices 

are being used so that funds expended go to providing the best possible treatment and 

recovery services? 

Response: 

SAMHSA regulates Opioid Treatment Programs through an initial certification process and 

ongoing accreditation oversight. SAMHSA also manages the DATA 2000 waiver program for 

physicians, physician assistants, and nurse practitioners that provide office-based prescribing of 

certain FDA-approved medications for opioid use disorder. In addition to management and 

oversight ofSTR Grantees (as described above), SAMHSA is providing ongoing technical 

assistance (T A) to all grantees using conferences, webinars, learning collaboratives, and the $12 

million Opioid State Targeted Response T A program. Evidence-based MAT prescribing, 

supported by a variety of SAMHSA tools and resources, is an essential aspect of this T A. 

SAMHSA required states to identify the evidence-based practice that they intended to use in 

their initial application for STR funds and in their strategic plans submitted in August of2017. 

Grant project officers have monthly calls with each state to discuss progress on implementation 

of their plans and any concerns that either the state or SAMHSA has with progress. Grant project 

officers are a !so making site visits to states to meet with state staff and providers and patients to 

understand the implementation process on the ground. States are required to report twice a year 

on a set of questions including the numbers of people that received specific services. 

Additionally, the program is being evaluated by an external evaluator. The evaluation includes 

an assessment of use of evidence-based practices. 

SAMHSA also recently released a fact sheet, "Finding Quality Treatment for Substance Use 

Disorders." This fact sheet provides individuals and families with some of the right questions to 

ask when looking for quality treatment, including whether the treatment program is licensed or 

certified by the state, whether the program offers FDA approved medications, whether the 

program includes family members in the treatment process, and whether the program provides 

other supports in addition to treatment. The fact sheet is on SAMHSA's website: 

https://store.samhsa.gov/shin/content//PEP18-TREA TMENT-LOC/PEP18-TREATMENTLOC.pdf. 

The Honorable Chris Collins 

1. Despite the staggering overdose reports from my district's coroners and the CDC, 

opioids are still primarily used for the treatment of pain. It is estimated that around 250 

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million Schedule II prescriptions are filled across the country each year. However, there 

arc other effective options for pain management. For example, several academic peerreviewed journals have found that states that have legalized the use of marijuana for 

medical purposes had significantly lower state-level opioid overdose mortality rates ... and 

found that it was an effective form of pain management. Alternatively, anesthesia is utilized 

in various surgical and non-surgical procedures to improve perioperative [preoperative, 

intraoperative, and postoperatil•ej pain control while minimizing systemic opioid 

consumption. 

a. Under the Opioid State Targeted Response (STR) grants, are states using funds to 

educate physicians and providers on utilizing non-opiate treatment for pain? 

Response: 

The State Targeted Response to the Opioid Crisis Grant program provides states and 

jurisdictions with the flexibility to obligate and expend funds to train substance use and mental 

health care practitioners on topics such as best practices for prescribing opioids, pain 

management, recognizing potential cases of substance use disorder, referral of patients to 

treatment programs, and overdose prevention, including the Centers for Disease Control and 

Prevention's (CDC) Guidelines for Prescribing Opioids 

(https://www.cdc.gov/drugoverdose/prescribing/guideline.html) to train practitioners. 

The Opioid STR Mid- and End-Year Reports do not capture any information regarding the use of 

non-opioids for the treatment of chronic pain or training focused on the use ofnon-opioids for 

the treatment of pain. The states and jurisdictions also have the flexibility to train opioid use 

disorder prevention and treatment providers, such as physicians, nurses, nurse practitioners, 

physicians assistants, counselors, social workers, care coordinators, and cases managers. 

SAMHSA's Opioid Overdose Prevention Toolkit (https://store.samhsa.gov/shin/eontent/SMA 13-

4742/0verdose_Toolkit_2014_Jan.pdt) must be used when developing training to address opioid 

overdose, as well as CDC's Guidelines for Prescribing Opioids .. 

2. CARA established the Pain Management Best Practices Inter-Agency Task Force to 

provide advice and recommendations for development of best practices for pain 

management and prescribing pain medication. The Task Force is also expected to develop a 

strategy for disseminating such best practices to relevant federal agencies [the Department 

of Veterans Affairs, Department of Defense, and Department of Health and Human 

Services] and the general public. 

a. What is the current status ofthe nominations process? As this is an advisory committee, 

to what degree do you expect providers to adopt these practices? Please explain. 

Response: 

The deadline for nominations to serve on the Task Force closed on September 27, 2017; HHS is 

currently in the process of reviewing all applications, and it is anticipated that decisions will be 

made soon. Once selections have been made and agreements to serve have been secured, the 

Task Force membership roster will be announced on the HHS webpage, 

https://www.hhs.gov/ash/advisory-committees/pain/index.html. 

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The Task Force is required to propose updates to best practices and recommendations on 

addressing gaps or inconsistencies between best practices for pain management (including 

chronic and acute pain) developed or adopted by Federal agencies. The proposed updates and 

recommendations will be submitted to relevant Federal agencies and the general public to 

consider. 

3. Under CARA's Opioid State Targeted Response grants, states would distribute funds 

using a strategic planning process and upon which states were required to submit a needs 

and capacity assessment to SAMHSA. The use would go to nine allowable activities. 

Is this information and distribution of funds collected in a database? If so, can you please 

describe how you can utilize this data in further identifying gaps in prevention, treatment, 

and recovery? 

Response: 

States were required to submit both a needs assessment and strategic plan describing how needs 

would best be addressed in each state. Once the funds were released to the states, the states 

determined how to further allocate the funding. States identify who is funded in their bi-annual 

reports, and the data is compiled in SAMIISA's online block grant application system 

(WebBGAS) available for further review. 

4. Under Section 303 of the Comprehensive Addiction and Recovery Act, eligible physician 

assistants and nurse practitioners can receive a waiver to prescribe drugs for maintenance 

or detoxification treatment (i.e. buprcnorphine) for 30 or less patients that the total 

number applicable to the qualifying practitioner. The cap can be raised to 100 after the 

prescriber has been waivered for one year. As this program has gotten off the ground, we 

are starting to hear from some practitioners working in addiction clinics that may quickly 

reach the 30 patient limit, and clinics in areas that have a challenging time finding 

waivered practitioners may have to turn away patients who are seeking treatment for 

opioid addiction. 

Is raising the cap beyond Section 303 something Congress or HHS should consider raising? 

Why or why not? 

Response: 

SAMHSA began processing waiver applications for mid-level practitioners in February 20 I 7, 

and it is preparing a report, as required by CARA, that addresses, among other issues, whether 

there is a need for the Secretary to increase or decrease the number of patients a practitioner with 

a waiver may treat. That report is due in July 2019. SAM!-! SA will continue to implement the 

provisions ofCARA and looks forward to receiving input from stakeholders regarding this 

matter, which will inform the July 2019 report. 

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The Honorable Tim Walberg 

1. Section 102 ofCARA provides for a National Awareness Campaign to educate both 

parents and youth. We need to ensure that we are doing all we can to protect the next 

generation with robust prevention programming messages to serve as a counterweight to 

the proliferation of pro-drug messaging in the media today. However, the Awareness 

Campaign has yet to be funded -or even really acknowledged. An awareness campaign is 

desperately needed. 

What is the status of implementing Section 102 ofCARA? 

Response: 

The office of the Assistant Secretary of Public Affairs (ASPA) is coordinating the National 

Awareness Campaign. There are three components of this Campaign. The Campaign will help 

to educate Americans across the lifespan to: 

• Understand their roles in the opioid crisis; 

• Adopt behaviors to prevent opioid medication-sharing; and 

• Engage in safe storage and disposal practices. 

2. What is SAMBA's plan for implementing the National Awareness Campaign? 

Response: 

SAMHSA's component is still under development. 

The Honorable David McKinley 

1. Police, fire fighters, and other emergency personnel arc the first to arrive on an opioids 

related scene. These professionals are there to protect us, but they are at risk of being 

exposed to potent opioids and their synthetic analogues, such as fentanyl and carfentanyl. 

What's being done to protect these first responders, what more can be done, and what do 

you need from Congress? 

Response: 

SAMHSA acknowledges the importance of protecting our first responders who are out in the 

field saving lives, but may be at risk of exposure to opioids and/or its analogues. SAMHSA 

administers the Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths (PDO) and 
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o https://www.dea.gov/druginfo/Fentanyl BriefingGuideforFirstResponders June2 

017.pdf 

2. Fentanyl: Preventing Occupational Exposure to Emergency Responders, Protecting 

Workers at Risk (August 30, 20 17) 

o https://www.cdc.gov/niosh/topics/fentanyl/risk.html 

It is also important that all first responders have easy access to naloxone not just for preventing 

the death of the individuals they serve in the community, but for preventing the death of their 

first responder colleagues as well. This goes hand-in-hand with training of first responders on 

information such as the nature of the opioids involved, the safe handling of these drugs and how 

to protect onesclf(e.g. having access and utilizing personal protective equipment), the signs and 

symptoms of an overdose, how to administer naloxone, and the possibility of administering more 

than one or two doses. 

2. The 21st Century Cures Act passed last year provided nearly $1 billion in funding 

designated predominantly to expand treatment for opioid use disorders through the State 

Targeted Response grant program. We appreciate HHS releasing the first round of$485 

million in funding this year, but were surprised that West Virginia was not awarded 

funding in the first round of $144.1 million additional funding. Specifically, SAMHSA 

awarded $9.8 million over three years for a new State Pilot Pregnant and Postpartum 

Women's (PPW) program. We received notice from the West Virginia Department of 

Health and Human Resources (DHHR) that they applied for this funding and were denied. 

a. What determinants are taken into consideration when allocating certain dollar amounts? 

Response: 

Each grant has its own set of evaluation criteria, which are used to review applications. These 

evaluation criteria are listed in each funding opportunity announcement and includes Statement 

of Need; Proposed Approach; Staff, Management, and Relevant Experience; and Data Collection 

and Performance Measurement. The STR formula consisted of two elements: treatment gap and 

number of drug poisoning deaths. The treatment gap is weighed at 70 percent; the mortality 

figure is given at 30 percent weight. 

b. Does a state with a higher level of deaths receive more funding or preference than a 

state with a lower level of deaths? 

Response: 

Whether an applicant is successful for any of the non-formula based grants under the programs 

authorized by CARA is based on the particular need for funding as articulated in the responses 

by the applicant to the Funding Opportunity Announcement and that application then is scored 

by a peer review panel. SAMHSA provides non-formula based grants to the applicants with the 

highest scores with the funding available to SAM SA by Congress. The STR formula consisted 

of two elements: treatment gap and number of drug poisoning deaths. The treatment gap is 

weighted at 70 percent; the mortality figure is given a 30 percent weight. Each state receives a 

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proportional share of the funding based on the state's proportional share of the national numbers 

for the measures listed above. 

c. If so, then why was West Virginia's application declined? 

Response: 

Applications submitted by entities from West Virginia for additional discretionary funding did 

not score high enough in the peer review process to receive a competitive award. 

d. What can they and similar entities in their situation do in the future to strengthen their 

application? 

Summary statements will be sent to each applicant detailing the peer reviewer response to the 

application. The summary statements for each applicant will include a narrative describing the 

strengths and weaknesses for each evaluation criteria section of the application. This will help 

inform the applicant on ways to improve their submissions. The summary statements for the 

First Responders and State Pilot Grant for Treatment of Pregnant and Post-Partum Women have 

been completed and released to organizations. The summary statements for Building 

Communities of Recovery and Services Grant Program for Residential Treatment for Pregnant 

and Post-Partum Women are in the process of being written. 

3. In addition, I have heard that some states have not fully released STR funding which has 

created obstacles for rural communities to combat the opioid crisis directly. What barriers 

are preventing the use of this grant money and what is HHS doing to address these 

barriers? What can be done to expedite getting these dollars into the communities that 

need them most? 

Response: 

SAMHSA released the FY 2017 State Targeted Response (STR) to the Opioid Crisis Grant 

Notices of Award on April27, 2017, and the funds were available for distribution on May 1, 

2017. Most states' administrative rules required the Opioid STR recipients to follow their 

respective procurement rules applicable to federal funds. As a result, some states experienced 

delays in making Opioid SIR funds available to sub-recipients, i.e., community-and faith-based 

organizations approved by the states to provide opioid use disorder prevention, treatment and 

recovery services. All states have subsequently fulfilled their respective procurement processes 

and opioid funds are being made available to sub-recipients. 

4. What is being done to address difficulties that individuals have accessing treatment for 

opioid use disorder, especially in rural and underserved communities? How should we 

address the lack of treatment providers with addiction treatment skills? 

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Response: 

One way SAMHSA addresses the lack of treatment providers is by is working with the Health 

Resources and Services Administration and other operating divisions within HHS and across the 

federal government to expand access via telehealth. We are in the process of developing a use 

case that explains how telehealth can be used to provide MAT in rural areas. 

SAMHSA is also developing an Extension for Community Healthcarc Outcomes (ECHO) pilot 

to examine how additional training and mentoring impact physician practice change (e.g. treating 

more patients with opioid use disorders). Project ECHO is a model developed by the University 

of New Mexico to expand medical knowledge and get best practice care to those who need it. 

Multipoint vidcoconferencing is used to provide didactic and case-based learning to health 

professionals more effectively developing capacity to safely and effectively treat individuals 

with a substance use disorder (SUD). Many waivered providers do not prescribe because they do 

not feel competent to treat a complex condition like opioid use disorder. This method has been 

shown to help providers in rural areas provide care that is comparable to specialty care for other 

complex conditions. More than half of the slates are using their Opioid STR funding to create 

ECHO programs to support rural providers. States are also setting up hub and spoke systems 

modeled on the state of Vermont program. In this model, patients are stabilized in a specialty 

care setting (hub) and once on a stable dose of medication they are referred to a primary care 

provider (spoke) who can manage the medication. If the primary care provider has questions or 

concerns, s/he can reach out to the hub provider for guidance and support. 

In addition, SAMHSA's Addiction Technology Transfer Center (ATTC) Program develops and 

strengthens the specialized behavioral healthcare and primary hcalthcare workforce that provides 

SUD treatment and recovery support services. The ATTCs deploy a variety of methods to 

accelerate the adoption and implementation of evidence-based and promising SUD treatment and 

recovery-oriented practices and services by heightening the awareness, knowledge, and ski lis of 

the workforce addressing the needs of people with substance usc or other co-occurring health 

disorders; and fostering regional and national alliances among culturally diverse practitioners, 

researchers, policy makers, funders, and the recovery community. 

The ATTC grantees work directly with SAMHSA on activities aimed at improving the quality 

and effectiveness of treatment and recovery, and work directly with providers of clinical and 

recovery services, and others that influence the delivery of services, to improve the quality of 

workforce training and service delivery across the nation and in rural and underserved 

communities. The A TTC program supports Opioid Treatment Programs to develop their 

workforce capacity. Project ECHO (mentioned ahove) is an example of a technology that the 

ATTC's use to improve the skills of treatment providers and increase access to SUD care. 

SAMHSA supports a number of training initiatives to increase the number of qualified 

healthcare providers who can provide treatment for opioid addiction. In the last four years, more 

than 62,000 medical professionals have participated in online or in-person trainings on MAT for 

opioid addiction through SAMHSA's Providers' Clinical Support System (PCSS)-MAT. This 

program is a national training and clinical mcntoring project that provides mentoring of newly 

trained physicians by experienced specialists, maintains a library of evidence-based practice 

materials, and offers at no cost to the trainee the required DATA 2000 waiver training to enable 

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providers to prescribe buprenorphine for opioid addiction treatment. SAM l-ISA recently awarded 

a grant to provide technical assistance and training related to prevention, treatment and recovery 

from opioid use disorder to states and communities on individual needs within these jurisdictions 

as a means to better assure the use of evidence based practices and to expand the healthcare 

workforce providing treatment for opioid addiction. 

The Honorable Pete Olson 

1. Of the grant funding provided for in CARA, how much funding has been allocated to 

state prescription drug monitoring programs (PDMPs)? 

Response: 

The FY 2017 appropriations act did not provide funds to SAMI-ISA to carry out the PDMP 

provisions of CARA. 

2. Do you think states need additional federal grant funding to improve their POMP or to 

fund clinical workflow integrations? 

Response: 

States have multiple potential sources of funds to improve their PDMPs. Many specialty 

addiction care providers still do not participate in electronic data transfer as they do not have 

electronic health records. This may impact workflows and information sharing and impede the 

integration of care. 

The Honorable Bill Johnson 

I. Community-based organizations like Field of Hope arc on the front lines of the opioid 

epidemic. CARA included numerous grant programs and funding sources to address 

addiction treatment, but it does not seem to have trickled down to the front-line providers. 

What is SAMHSA doing to ensure that grant funding aimed at substance abuse benefits 

on-the- ground providers, and are there ways we could improve in that area? 

Response: 

SAM l-ISA carries out its role through a variety of mechanisms, including administering grant 

programs (e.g. drug court grants, pregnant and postpartum women treatment grants, youth and 

family treatment grants); convening policy academies and expert meetings; providing training 

and technical assistance to the field; and developing and disseminating information resources. 

SAMHSA's criminal justice programs recognized that drug court professionals needed enhanced 

awareness and skills in understanding and connecting clients with medication assisted treatment 

(MAT). SAMHSA responded by increasing the amount of grant dollars grantees can allocate 

towards MAT and provided a grantee training on how to implement MAT. As a result of these 

and other efforts, 57 percent of SAMHSA's criminal justice programs have integrated MAT into 

their programming. 

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Also, the Building Communities of Recovery grants were awarded to eight organizations in 

Fiscal Year 2017, The purpose of this new CARA-funded program is to mobilize resources 

within and outside of the recovery community to increase the prevalence and quality of longterm recovery support from substance abuse and addiction. These grants support the 

development, enhancement. expansion and delivery of recovery support services. 

Additionally, in Fiscal Year 2017, SAMHSA funded: 

Nineteen new residential treatment programs for pregnant and postpartum women and 

their families with substance use disorder (SUD) and/or co-occurring substance use and 

mental disorders at the community-level. 

Three new state programs to primarily expand outpatient services for pregnant and 

postpartum women and their families with SUD and/or co-occurring substance use and 

mental disorders at the community-level. 

Twelve new state youth treatment grants with a requirement to expand the number of 

treatment providers to serve youth with SUD and/or co-occurring substance use and 

mental disorders. 

Seventy five criminal justice grants to organizations to provide treatment to individuals 

involved in the criminal justice system. 

The Honorable Susan Brooks 

1. I have heard you say that preventing drug usc before it begins is this the most costeffective way to reduce drug use and its consequences, In your opinion, what are the 

characteristics of successful prevention intervention programs? Besides lack of resources, 

what are the barriers to implementing intervention programs? 

Response: 

Characteristics of successful prevention intervention programs are represented in the National 

Institute on Drug Abuse's Preventing Drug Use among Children and Adolescents: A ResearchBased Guide for Parents, Educators, and Community Leaders (2nd ed.). Sixteen prevention 

principles are presented to assist parents, educators, and community leaders to think about, plan 

for, and deliver research-based drug abuse prevention programs at the community level. The 

areas addressed include, but are not limited to: risk factors and protective factors, prevention 

planning, and prevention program delivery. The core elements of effective research-based 

programs include: Structure- how each program is organized and constructed; Content- how 

the information, skills, and strategies are presented; and Delivery- how the program is selected 

or adapted and implemented, as well as how it is evaluated in a specific community. When 

adapting programs to match community needs, it is important to retain these core elements to 

ensure the most effective parts of the program stay intact. SAMHSA promotes the use of its 

Strategic Prevention Framework, a planning process, as a comprehensive guide to plan, 

implement, and evaluate prevention programs. 

Successful implementation strategies take time and resources. The essential challenge is to 

ensure that the incentives, structures, and operations at the systems, organizational, and 

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practitioner level are consistent with each other and aligned in a way that supports the desired 

practitioner behavior. In "Implementation Research: A Synthesis of the Literature," researchers 

found that well planned and carefully executed implementation strategies can be used to improve 

services at the practitioner level, organizational level, and national level. In the programs that 

were examined, the core implementation components involved: careful selection; staff training, 

coaching, and performance evaluation; program evaluation and facilitative administration; and 

methods for systems interventions. 

With regard to barriers to program implementation, one of the biggest challenges to the field is 

the ability to take effective programs and replicate them with fidelity across the country. In the 

Institute of Medicine's "Strategies for Scaling Effective Family-Focused Preventive 

Interventions to Promote Children's Cognitive, Affective, and Behavioral Health (workshop 

summary),'' barriers identified to scaling up research-based programs include: lack of demand 

for the programs, insufficient organizational capacity, lack of sustainable funding, and factors 

other than evidence from research that influence decision making around whether or not to 

implement a particular program. The potential for many evidence-based interventions is not fully 

realized when interventions are not implemented with quality, or that quality is not sustained 

over time. Scaling up a program can also be hampered by an over-reliance on program 

developers who do not have the expertise or time to scale-up and disseminate their programs, and 

rigid adherence to the programs which may need to be adapted to specific populations or 

organizations. 

2. Substance use disorder confidentiality regulations limit the usc and disclosure of 

patients' addiction records from certain treatment programs. I've heard from health 

providers that separating a patient's addiction record from the rest of his or her medical 

record may hinder the delivery of receiving safe, effective, and coordinated treatment. 

a. In the context of the opioid crisis, do you believe it is important that a patient's provider 

has access to his or her substance use disorder record? 

Response: 

Yes, it is important that a patient's provider have access to the patient's substance use disorder 

treatment record as the health and safety of the patient should be the first priority of all providers. 

While SAMHSA has undertaken efforts to facilitate information exchange by revising its 

regulations related to confidentiality of substance use disorder treatment records (42 CFR Part 2), 

the current statute can be an obstacle to a providers' ability to access their patients' records and 

Part 2 is not completely aligned with HIPAA. 

b. Do you think a patient whose doctor doesu 't know that he or she is in recovery from an 

opioid addiction is getting the best evidence-based care? 

Response: 

SAMHSA believes strongly that patients who have received or are receiving treatment for a 

substance use disorder benefit from receiving integrated, coordinated care. Accordingly, 

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SAMHSA's 2017 and 2018 final Part 2 rules refiect the agency's efforts to balance the need for 

integrated care with the need to ensure patients receiving diagnosis, treatment and referral for 

treatment for substance use disorders also understand how and by whom their part 2 patient 

identifying information is used. Part 2 permits patients to consent in writing to sharing 

information with their treating providers. Indeed, the final 2017 rule makes this process easier 

than previously was the case by permitting the use of a general designation (i.e., the patient can 

choose to share their Part 2 information with "all of my current treating providers"). SAMHSA 

encourages Part 2 programs and patients to discuss the benefits patients may obtain from 

coordinated care which, in turn, is best facilitated by permitting their health care providers to 

receive part 2 information. Moreover, during a medical emergency when prior patient consent 

cannot be obtained, a Part 2 program also may disclose information needed to respond to that 

emergency (42 CFR 2.51 -Medical emergencies.) 

c. There is a lot of talk about mental health and addiction parity. Do you think it's parity 

for a substance use record to be treated differently from a mental health or HIV record? 

Can the same quality care be given when a provider does not know that their patient is 

being treated for an addiction? 

Response: 

SAMHSA supports further consideration of the benefits of aligning the statute governing Part 2 

with HIPAA to ensure parity. 

The Honorable Richard Hudson 

1. Many people coming out of the correctional system have had problems with opioids and 

represent some of those at highest risk for overdose and death. What is SAMHSA doing to 

address this? 

Response: 

SAMHSA 's role in the criminal justice system is to bring about strategic linkages between 

community-based behavioral health providers, the criminal justice system, and community 

correctional health programs; promote effective diversion and reentry programs; and foster 

policy development at the intersection of behavioral health and justice issues. Recognizing that 

individuals leaving the correctional system have a high risk for overdose and death, SAMHSA 

encourages drug coutts and offender reentry program grantees to spend up to 20 percent of their 

annual grant award to pay for Food and Drug Administration-approved medications for treatment 

or substance use disorders. 

Offender reentry program grants are also required to develop and implement an overdose 

prevention program as patt of their service delivery for soon-to-be released offenders and those 

recently released from a correctional setting. These grantees collaborate with community 

corrections programs, law enforcement, and judges on the program. The opioid overdose 

prevention programs must include an educational component, which includes SAMHSA's 

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Opioid Overdose Prevention Toolkit (https://www.samhsa.gov/capt/tools-learningresourccs/opioid-overdosc-prevention-toolkit). 

SAMHSA also provides training on how to implement opioid overdose prevention programs and 

medication assisted treatment programs for its criminal justice grants through webinars, on-site 

technical assistance, trainings, grantee meetings and conferences. 

The Honorable Ben Ray Lujan 

1. While the funding provided by the 21st Century Cures Act was extremely welcome in my 

state, we still need to do more to expand treatment capacity. For many of my constituents it 

often feels like we are trying to hold back the ocean armed with a tablespoon. Listen to a 

few lines from a letter I received just a few days ago from a distraught father in my 

district: 

"As a responsible parent, I must inform my daughter about the dangers of pills and opioids 

because, statistically speaking, she's more likely to die from an overdose than anything else. 

So bow do I begin to explain how we got here? How do I explain that Congress, the 

President, and even the DEA are ignoring the issue, and things are getting worse? This isn't 

hyperbole: overdoses are killing far more Americans than gun homicides and opioids in 

particular are killing more people than cocaine, meth, or any other illegal narcotic. And I 

am now in the impossible position of having to explain all of this to my daughter." 

So while the funding provided in Cures was a first step, we must do more. What the 

advocates and planners in our states and cities need is certainty. They can't hope to hire 

new staff or spend money on infrastructure if they don't think funding is going to last for 

more than 2 years. As a result, I've heard from my community that money has gone toward 

short-term and stopgap measures. Measures that do little to reassure parents in Santa Fe 

or in other parts of my state that Congress understands their concerns and that we are 

providing real help for a very real problem. 

We all know that short-term solutions aren't enough to seriously address this epidemic. 

We need to seriously invest time and money into combatting this crisis in our communities, 

and we need to do so in a way that builds in stability and allows our communities to do long 

term planning. 

a. Assistant Secretary McCance-Katz are you aware of which, if any, states have used the 

funding passed in 21st Century Cures to expand physical infrastructure or undertake 

strategic planning that goes beyond the 2 year funding window passed in 21st Century 

Cures? 

Response: 

The State Targeted Response to the Opioid Crisis Grant (STR) requires states to prepare and 

submit needs assessments and strategic plans. The assessments were submitted on or before July 

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31, 2017, and the strategic plans were submitted on or before August 3, 2017. States recognize 

that the 2-year funding authorized by section l 003 of the 21st Century Cures Act will assist 

states in addressing some of their emergent needs regarding prevention, treatment and recovery 

support services for persons with opioid use disorders. The STR grants allow a very small 

portion of grant funds to be used to renovate or alter existing facilities, building new facilities is 

not an allowable expense. 

2. I think we need to do more to build long-term capacity to address this epidemic. That is 

why I have introduced the Opioid and Heroin Abuse Crisis Investment Act to extend the 

21st Century Cures funding for au additional five-years- a timeframe that allows for longterm planning and more than stopgap measures. I'd welcome my colleagues support on 

this effort and hope that we can work together in a bipartisan fashion to find creative ways 

to get more support to those in need. 

The Comprehensive Addiction aud Recovery Act (CARA) made critical strides in the fight 

against the opioid epidemic. This committee worked to help expand access to vital 

addiction treatment options including medication assisted treatment (MAT). CARA 

allowed Nurse 

Practitioners (NPs) and Physician Assistants (PAs) to prescribe MAT in accordance with 

state law. I supported that effort and I think we can build on that work. 

Congressman Tonko and I recently introduced legislation to do just that. Current law 

sunsets the authority for NPs and PAs -our bill makes it permanent. The legislation also 

recognized the integral role played by Advanced Practice Registered Nurses (APRNs) in 

health care teams all across the country, but especially in rural states like New Mexico 

where thousands of families depend on APRNs for so much of their routine health care. We 

especially need to make it easier for pregnant and postpartum women struggling with 

addiction to get help. 

Allowing all APRNs, including Certified Nurse Midwives, to prescribe and refer to MAT 

will expand access for addicted New Mexicans and Americans across the country. 

a. What is SAMHSA doing to ensure medication assisted treatment is easily accessible to all 

who need the help? 

Response: 

SAMHSA develops and publishes documents to educate providers and patients regarding FDA 

approved medications for the treatment of substance use disorders. SAMHSA further provides 

education including DATA waiver training and mentoring to providers through its Providers' 

Clinical Support System on the use of medication-assisted treatment in providing care to 

populations affected by substance use disorders. SAMHSA has a treatment locator to help 

patients locate Opioid Treatment Programs and Drug Addiction Treatment Act waivered 

providers on its website. SAMHSA works in partnership with DEA and State Opioid Treatment 

Authorities to administer technical assistance to providers establishing new treatment programs. 

SAMHSA offers the State Targeted Response Grants, Medication Assisted TreatmentPrescription Drug Opioid Addiction grants, and Block grants which are all sources of funding for 

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medication assisted treatment. Finally, SAMHSA processes all applications for new providers 

regulated by the Agency as expediently as possible. 

b. How would expanding who can prescribe medication assisted treatment impact access in 

rural areas like parts of New Mexico? 

Response: 

Expanding prescribing authority to qualified providers may have a positive impact on access to 

care in all geographic settings, but could be especially helpful in rural areas that do not have as 

many physicians as NPs, PAs and other non-physician providers. 

3. Assistant Secretary McCance-Katz: We appreciate all of the work your agency has been 

doing to provide block grants to our communities back home. I recently had the 

opportunity to visit with a recovery center in Espanola, New Mexico. During this visit I was 

surprised to learn that rural treatment centers are not always considered eligible for grant 

funding because of certain grantee requirements- even as rural regions in the US are 

getting hit harder! 

I'd like to share a specific example from Hoy Recovery. Recently, a Center for Substance 

Abuse Treatment Targeted Capacity Expansion grant became available. The grant would 

have been ideal for this center except New Mexico was disqualified because the grant 

required a substantial increase in admissions to Medication Assisted Treatment. 

New Mexico was not able to demonstrate increased use MAT because we didn't have the 

workforce capacity and needed assistance to expand -the exact thing the grant would have 

provided. 

Another example: There was a recent Office of Minority Health grant that Hoy also 

applied for. However, the evaluation requirements called for a greater number of patients 

se1·ved than they, as a small, rural community, could produce. 

While I understand the importance of targeting funding to the largest number of people 

possible, many of the communities that need help the most arc much smaller than 100,000 

people. 

a. How docs SAMHSA justify requiring proof of capacity expansion for grants intended to 

help organizations expand capacity? 

Response: 

SAMHSA did not receive an application for a Targeted Capacity Expansion Medication Assisted 

Treatment Prescription Drug and Opioid Addiction grant from New Mexico. SAMHSA docs 

allow applicants for this program to spend funds on infrastructure development to begin 

developing capability not just to expand capacity. 

SAMHSA did not define eligibility for this program. Eligibility was articulated in the FY 20!7 

Omnibus, which required that eligibility for MAT-PDOA be limited to the states with the highest 

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rates of admissions, including those that had demonstrated a dramatic increase in admissions for 

the treatment of opioid use disorder. As identified by SAMHSA's Treatment Episode Data Set 

(TEDS): 2007 2014, 17 states were eligible to apply. New Mexico was not one of the 17 states 

with the highest rates of primary treatment admissions for heroin and opioids per capita, and 

therefore was not eligible to apply for a MAT-PDOA grant in FY 2017. 

b. What can we tell our constituents who live in small, rural communities that are ineligible 

for more funding simply because they are small'? 

Response 

SAMHSA does not restrict eligibility on its community-based grants based on size. All 

applications are accepted from all communities. SAMHSA has funded and continues to fund 

small, rural communities. 

c. Has SAMHSA produced any materials that explore barriers and restrictions for funding 

of rural communities? 

Response: 

While smaller, rural communities are not restricted from applying for funding opportunities, 

SAMHSA recognizes they may face challenges in developing and submitting all required 

application materials, especially the first time. For this reason, SAMHSA hosts applicant 

webinars to walk potential applicants through the entire process, including application and 

registration processes, requirements and validations, and the post-submission process. 

Recordings of the wcbinars are generally posted on the SAMHSA website as well for those 

unable to join at the scheduled times. Certain grant programs have also included program 

specific webinars and F AQs for potential applicants. As well, each funding opportunity 

announcement includes staff contacts at SAMHSA whom applicants can reach out to with 

programmatic or financial questions. 

4. In 2015, 33,000 Americans died from opioids. According to the CDC, almost half of those 

deaths were from prescription opioids. The New York Times reports that in 2016, 

overdoses from all drugs was the leading cause of death of people under the age of 50. Drug 

overdoses now kill more Americans each year than at the height of the HIV epidemic and 

the worst year for auto accident deaths. The Times and drug use experts attribute the 

sharp rise in all drug overdose deaths to the rise of opioids. What we need to fight this 

epidemic is continued and reliable long-term investments in prevention, treatment, 

recovery, and monitoring. 

The President's budget proposal for fiscal year 2018, coupled with other administration 

initiatives, takes several steps back in the fight against opioid addiction, including a cut in 

funds for SAMHSA. Overall, the President's proposed budget cuts HHS by 16.2 percent, 

the CDC by 17 percent and NIH by 19 percent. It cuts funding for addiction research, 

treatment and prevention. Even the White House Office on National Drug Control Policy 

would take a 

95 percent hit. 

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a. Assistant Secretary McCance-Katz, do you have all of the tools you need to stop the 

opioid epidemic? 

Response: 

HHS is currently reviewing the need for additional resources and authorities to address the 

opioid epidemic in order to ensure a coordinated response by the Department in partnership 

with other areas of the Federal Government. 

b. Given the 10 percent cuts to SAMHSA in the President's budget proposal, what 

programs relating to the opioid epidemic will be cut? Which programs would have been 

expanded that will now not be? 

Response: 

The Substance Abuse Treatment appropriation was preserved in its entirety. Additionally, all 

programs in the Substance Abuse Prevention appropriation specifically related to opioids were 

also preserved in their entireties in the Fiscal Y car 2018 President's Budget. 

The Honorable Paul Tonko 

1. With the passage of CARA, PAs and NPs can receive a waiver to prescribe 

buprenorphine after completing 24 hours of education. This 24 hour requirement is viewed 

by many healthcare providers as a barrier to care, given that many qualified PAs or NPs 

will have difficulty completing this requirement, and especially given the fact that 

physicians are only required to complete eight hours. Do you have any data that justifies 

the differences in requirement for this waiver, and are changes to this requirement 

something that you think the Department should consider? 

Response: 

The 24-hour training requirement is a congressional mandate under CARA. SAMHSA does not 

have any data to justify the difference in the requirement or evidence that the additional hours of 

training are a significant burden to mid-level providers. 

2. In order to receive a waiver to prescribe buprenorphine, PAs and NPs are currently 

required to have their supervising or collaborating physician be "waiver eligible." This 

requirement has the potential to restrict access to treatment for those suffering from opioid 

addiction. The Secretary HHS has the ability to allow PAs and NPs that work in 

collaboration with a physician to obtain waivers, even if that collaborating physician is not 

a waiver-qualified provider. Are changes to this requirement something that you think the 

Department should consider'? 

Response: 

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The Secretary has regulatory authority over the requirements that must be satisfied to qualify as a 

"qualifying other practitioner," and this authority includes the authority over the "collaborating 

or supervising physician requirement" under 21 USC 823(g)(2)(G)(iv )(Ill). 

In addition, some states have laws that require nurse practitioners or physician's assistants to 

prescribe medications for the treatment of opioid use disorder in collaboration with or under the 

supervision of a physician. Twenty-eight states require some degree of collaboration or 

supervision of nurse practitioners by physicians. 1 The regulations regarding what physician 

assistants (PAs) can prescribe vary by state; in 44 states and the District of Columbia PAs can 

prescribe all FDA-approved medication-assisted medications, while 5 states allow them to 

prescribe only buprenorphine and naltrexone, and Kentucky allows them to prescribe only 

naltrexone. 2 PAs generally practice under physician supervision. SAMHSA began processing 

waiver applications for mid-level practitioners in February 2017 and it is preparing a report, as 

required by CARA, informed by input from stakeholders. 

3. Can you briefly discuss your experience with expanding MAT in jails and prisons in 

Rhode Island, and how SAMHSA and this Administration could help support and expand 

these iunovative approaches'? 

Rhode Island has implemented a program in which individuals incarcerated are screened 

for opioid use disorder and evaluated to determine medical needs related to this condition. 

If a person is already receiving medication assisted treatment for an opioid use disorder, 

this is coutiuued. If a person is opioid-addieted and at risk for withdrawal they are offered 

medical treatment including initiation of medication assisted treatment (for those with 

short sentences). For those who are ncar release and have a history of opioid use disorder 

and are not on medication assisted treatment; they are offered the opportunity to begin 

treatment prior to leaving the Dept. of Corrections. All of those with opioid usc disorder 

arc connected to ongoing outpatient treatment prior to leaving and naloxone is also offered 

on release. This program has been well accepted by inmates and staff alike and Rhode 

Island is seeing success in assuring ongoing care for this population which is at high risk 

for overdose death on leaving .iail or prison without medication assisted treatment aud 

clinical follow up. 

Response: 

SAMHSA's criminal justice programs focus on developing systemic and strategic linkages 

between community-based behavioral health providers, the criminal justice system, and 

community correctional health programs to promote effective diversion and reentry programs; 

and foster policy development at the intersection of behavioral health and justice issues. 

Recognizing that individuals leaving the correctional system have a high risk for overdose and 

death, SAMHSA encourages drug courts and reentry grants to spend up to 20 percent of their 

1 https :/ /www .a an p. org/legislation-regu lati on/ state-! egislation/ state-practice-environment 

2 https:/ /www.aapa.org/wp-content/uploads/2017 /03/f-833-4-

8256527 _dk6DMjRR_Prescribing_IB_2017 _FJNAL.pdf 

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annual grant award to pay for Food and Drug Administration-approved medications for 

medication assisted treatment. Reentry grants have been required to provide a plan and 

implement an overdose prevention program as part of their service delivery for soon-to-be 

released offenders and those recently released from a correctional setting. These grantees 

collaborate with community corrections programs, law. enforcement, and judges to develop and 

implement an opioid overdose prevention program. The opioid overdose prevention programs 

must include an educational component, which includes SAMHSA's Opioid Overdose 

Prevention Toolkit (https://www.samhsa.gov/capt/tools-learning-resources/opioid-ovcrdoseprevention-toolkit). 

SAMHSA provides training on how to implement opioid overdose prevention programs and 

medication assisted treatment programs for its criminal justice grantees through webinars, on-site 

technical assistance, trainings, grantee meetings and conferences. 

SAMHSA is aware of several department of corrections programs (Rhode Island, Pennsylvania, 

Massachusetts, Kentucky) who have developed MAT programming, including all three FDA 

approved medications, with the purpose of improving outcomes and success rates after the 

individual is released to the community. SAMIISA grantees, regional administrators, and 

community partners are key links in working with the Department of Corrections to ensure there 

is a continuum of care, accountability, and support as individuals' transition from incarceration 

to the community. 

The Honorable Frank Pallone, .Jr. 

1. With 90 percent of addictions beginning in the teenage years, we know there is a critical 

need for effective drug prevention programming, especially during this current opioid 

crisis. In the past decade, our national prevention infrastructure has been decimated 

(including the elimination of funding for the National Youth Anti-Drug Media 

Campaign) and our ability to educate young people and prevent more teens from becoming 

addicted is hobbled. We need prevention messages to serve as a counterweight to the 

proliferation ofpro-drng messaging in the media today. 

In order to convey the risk of opioid and other drug abuse and reverse the stark addiction 

and overdose trends that are creating heartbreak in families across the country, investment 

in prevention messaging is crucial. Regarding Section 102 in CARA- the 

National Awareness Campaigns provision, can you please tell us what the status of 

implementation and investment is? What do the various agencies plan to do to move 

forward with this provision and how can we help? 

Response: 

The Office of the Assistant Secretary of Public Affairs (ASPA) is coordinating the National 

Awareness Campaign. There are three components of this Campaign. The Campaign will help 

to educate Americans across the lifespan to: 

• Understand their roles in the opioid crisis; 

• Adopt behaviors to prevent opioid medication-sharing; and 

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• Engage in safe storage and disposal practices. 

In addition, the Centers for Disease Control and Prevention (CDC) released the Rx Awareness 

communications campaign publicly in September. The campaign features real-life accounts of 

individuals living in recovery from opioid usc disorder, and those who have lost someone to a 

prescription drug overdose. The campaign will increase awareness and knowledge among 

Americans about the risks of prescription opioids and deter inappropriate use. 

2. Press coverage of the response to the epidemic often focuses on expanding access to 

treatment and increasing the availability of naloxone. However, those are two elements that 

must fit into a larger, more comprehensive response. 

Dr. McCance-Katz Could you briefly discuss the importance of deploying a 

comprehensive response to this epidemic spanning the entire spectrum from primary 

prevention to recovery? 

Response: 

To fully address the opioid crisis, our nation must prevent people from developing a problem by 

reducing use of opioids and stopping misuse before it develops into a disease state. If an 

individual docs develop an opioid usc disorder (OUD), service systems must make sure the 

individual has access to evidence-based treatment and recovery support services. HHS' five 

point opioid strategy is designed to cover the entire spectrum and includes: 

1) Strengthen public health data reporting and collection to improve the timeliness and 

speciJicity of data and to inform a real-time public health response; 

2) Advance the practice of pain management to enable access to high-quality, evidencebased pain care that reduces the burden of pain while also reducing inappropriate use of opioids 

and related harms; 

3) Improve access to addiction prevention, treatment, and recovery support services; 

4) Target the availability and distribution of overdose-reversing drugs to ensure broad 

availability of these medications to people likely to experience or respond to an overdose; and 

5) Support cutting-edge research to advance understanding of pain and addiction, lead to the 

development of new prevention interventions and treatments, and identify effective public health 

interventions to reduce opioid-related harms. 

3. Dr. Volkow and Dr. McCance-Katz I would like to ask you a few questions related to 

treatment approaches for opioid use disorder. I have been particularly struck by stories of 

individuals with opioid use disorder and families who have been targeted and referred to 

low quality and non-evidence-based treatment services. As I'm sure you're aware, in many 

cases, this has led to tragic consequences upon leaving such programs. 

a. Dr. Volkow and Dr. McCance-Katz- I understand that the evidence is clear that 

medication assisted treatment is the gold standard of opioid use disorder treatment. What 

are some of the barriers of widespread uptake for this treatment approach? 

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Response: 

The biggest barrier is access to providers who can prescribe or administer the medications. There 

are not enough providers who are willing and able to treat patients with opioid usc disorder. As 

of April 13, 2018, there are I ,585 Opioid Treatment Programs and over 49,000 waivered 

prescribers many of whom never prescribe MAT or do not prescribe to their patient limit3 there 

is an inadequate supply of providers who can treat individuals w·ith OUD. While any licensed 

prescriber can administer Vivitrol, the requirement to be medically withdrawn from opioids prior 

to its administration means that it can be difficult to initiate in an outpatient setting. 

The second barrier is knowledge and attitudes. Many parents of young adults report multiple 

admissions into short term residential treatment settings for their children without ever having 

been told about medication. Patients and families may not know about medication as an option 

and medication free treatment programs often do not raise it as a possibility because of 

misperceptions about utilizing medication to treat cetiain substance use disorders. 

Patients receiving MAT may face discrimination in many systems including in the work place, in 

criminal justice settings, in child protective settings and others that discourage or mandate that 

patients not take medication for their OUD. 

Finally, difficulty accessing medication by reason of insurer requirements such as prior 

authorizations and cost can be a barrier for some people. 

b. What is the difference between this and other chronic conditions as far as uptake of 

evidence-based medical care? And could you di~pel some of the stigma that exists about the 

use of medications to treat this chronic condition that docsn 't exist for the use of 

medications to treat like diabetes or heart disease? 

Response: 

Approximately 20 percent of individuals with opioid use disorder receive treatment for this 

condition. Fewer than half of private-sector treatment programs offer medications for opioid use 

disorders. Thus, uptake of treatment and evidence based care is much less than it is for other 

conditions. SAMHSA continues to work to dispel the stigma regarding use of medications to 

treat opioid use disorder, but in many communities stigma is ingrained at levels from family 

members to providers and government officials. More work needs to be done to ensure that 

patients can access evidence-based care. 

c. What are you doing to increase awareness among the general public and the medical 

community about these evidence-based approaches to opioid usc disorder? 

Response: 

SAMHSA produces a number of publications and tools, and delivers technical assistance for 

providers and laypersons to increase awareness of medication-assisted treatment (MA Tx App, 

PCSS-MA T, toolkits, continuing medical education). 

3 Drug Alcohol Depend. 2017 Dec 1;181:213-218. doi: 10.1016/j.drugalcdep.2017.10.002. Epub 2017 Oct 18. 

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As required by CARA, SAMHSA is developing a Toolkit for Improving Practice (TIP) replacing 

two TIPs on medications to treat opioid use disorder (TIP 40, "Clinical Guidelines for the Use of 

Buprenorphine in the Treatment ofOpioid Addiction"; and TIP 43, "Medication Assisted 

Treatment for Opioid Addiction in Opioid Treatment Programs") with a single TIP that covers 

all approved medications. 

SAMHSA also works with professional associations and consumer groups to inform members 

and the general public about the evidence for medication assisted treatment. 

4. According to SAMHSA's annual survey on drug use and health, in 2016, there were 

approximately 21 million Americans aged 12 years or older that need substance abuse 

treatment, however, only around 11 percent or 2.2 million of these individuals received 

treatment. 

a. What are some of the barriers that exists for individuals receiving treatment for their 

opioid use disorder? 

Response: 

There were about 2.1 million people with active opioid use disorder in 2016 and about 20 

percent of them received some type of treatment. Most people do not seek out care. For those 

that do, the primary barrier is access to care. In many locations there is no provider, or there are 

waiting lists to receive treatment. For some people, barriers are resources to pay for treatment or 

transportation to treatment programs, or other obligations like family and work that make it hard 

to find time to go through the process of becoming eligible for treatment. 

SAMHSA is encouraged by the efforts in some states to reach out to people with opioid use 

disorder in emergency departments and in community settings to try to engage them in seeking 

care. Some state programs arc guaranteeing immediate access to treatment for people with opioid 

use disorder who ask community outreach workers, first responders or others for care. 

b. I understand that approximately 96% of those who need substance abuse treatment do 

not believe they need treatment. How can we further increase the likelihood that those with 

substance abuse disorders understand the need for and their ability to acquire substance 

abuse treatment? 

Response: 

Training providers to recognize, screen for, and treat substance usc disorders, particularly in 

primary and general medical settings will assist in identifying more patients with substance use 

disorder and getting them into appropriate treatment programs. 

However, many people with substance use disorders do not access healthcare services of any 

kind. Many communities arc using people in recovery to conduct outreach and engagement 

activities to encourage more people to enter treatment. These efforts are taking place in 

emergency departments, in community settings like homeless shelters or areas where people who 

use drugs may congregate, and in other settings like fire and police stations. In addition, 

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SAMHSA's Screening, Brief Intervention, and Referral to Treatment (SBIRT) grants encourage 

the participation of Employee Assistance Programs (EAPs) to provide early identification and 

support of those with substance usc disorders. Currently, an SB!RT grantee is has a targeted 

initiative to utilize SBIRT in EAPs. 

In order to get individuals with substance use disorders to understand that they need help and that 

help is available, their perceptions about the need for and the benefit of receiving treatment must 

change. SAMI!SA works to increase availability of gender-specific and culturally-appropriate 

education, prevention, and early interventions, which includes strategies for outreach and 

engagement. SAMHSA recognizes the importance of providing outreach and other engagement 

strategies to increase participation in and access to treatment for diverse populations; thus, there 

is standard language regarding this in SAMI!SA's funding opportunity announcements. 

5. Dr. McCance-Katz, I am interested in learning more about efforts to expand the 

substance abuse treatment workforce. I am pleased that Congress and the Obama 

Administration were able to take steps to expand the workforce and efforts to expand 

access to bnprenorphine by better utilization of the existing health care workforce. 

However, we continue to hear that workforce shortages are limiting access to substance 

abuse treatment. 

a. Could you briefly describe the current supply of the substance abuse treatment 

workforce and how that matches up with the demaud for substance use disorder treatment 

services? 

Response: 

Many reports have documented the supply and distribution of professionals who oversee the care 

of persons with substance usc and mental disorders. Each report had unique methodologies and 

occupations that were included. Data exists for psychiatrists, psychologists, advance practice 

nurses, social workers, licensed professional counselors (substance use disorder and mental 

health) and other counselors, marriage and family therapists, school psychologists, and to some 

limited extent on prevention specialists, peer recovery specialists, and psychiatric aides. 

Information on Drug Addiction Treatment Act 2000 waivered prescribers is also available. 

Methodologies used to measure future demand vary, leading to mixed conclusions. However, 

most studies anticipate worker shortages. With a few exceptions, southern states and several 

mid-west states have the greatest deficits in psychologists, counselors and social workers. (2013, 

Health Resources and Services Administration "The U.S. Health Workforce Chart book. Part IV: 

Behavioral and Allied Health). 

The Rural Health Research Center Data Brief (Supply and Distribution of the Behavioral Health 

Workforce in Rural America, 2016) describes non-metropolitan counties without behavioral 

health providers, and the large percentage of counties without any of these professionals 

(psychiatrists- 65 percent; psychologists- 47 percent; psychiatric nurse practitioners- 81 

percent). 

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A report by the SAMHSA Addiction Technology Transfer Centers, "Vital Signs: Taking the 

Pulse of the Addiction Treatment Workforce, A National Report" (2012, Ryan, Murphy, Krom) 

reported that annual turnover of direct care staff newly hired in the previous 12 months was 52 

percent, and the previous 12-month turnover for all staff (new and more than 12 months) was 

18.5 percent. The report concluded that high turnover rates add to provider training and 

recruitment costs and could threaten the quality of care received by clients entering treatment. 

Retention of staff is an important consideration impacting supply and distribution of staff. 

SAMHSA and the Health Resources and Services Administration implement congressionally 

mandated programs to address workforce shortages. All of the programs aim to provide training 

fellowships/scholarships and loan repayment programs to students pursuing health professions, 

some that arc specific to behavioral health and others that are for primary health care providers 

who could provide care in an integrated health care setting. These programs are all primarily 

aimed at addressing the supply and distribution issues. The Minority Fellowship Program 

managed by SAMHSA also addresses the supply issue for Fellows working with underserved 

populations. 

As we learn to more effectively engage people in treatment and begin to better address barriers to 

care, such as stigma and misunderstanding, fragmentation of services, and insurance limitations, 

the need tor a qualified and stable workforce will grow. 

b. Could you talk about some of the barriers that prevent students and health care 

providers from pursuing careers in the treatment of substance use disorder specifically and 

behavioral health more generally? 

Response: 

There arc several barriers that, combined, make it difficult to encourage students and health care 

professionals to become behavioral health (substance usc and mental health treatment) providers. 

1. Stigma- There remains a great deal of stigma toward individuals with substance use and 

mental disorders. There is still the idea that individuals with behavioral health conditions 

can ''pull themselves up by their bootstraps'' and not a very good understanding that these 

are neurobiological disorders. 

2. As with other chronic disorders, it can be frustrating to see the struggles and not the 

success in treatment in many instances. 

3. Reimbursement- In comparison to many other fields in health care- professionals who 

treat behavioral health conditions do not make as much money as their counterparts who 

treat physical health conditions and are not reimbursed at the same rates for comparable 

work, a factor that likely drives much of the field's challenges around workforce 

turnover. 

c. What can we do to en con rage more health professional students and health care 

providers to pursue these type of careers? 

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Response: 

1. Encourage opportunities to meet with observe and interact with persons in successful 

sustained recovery. 

2. Encourage opportunities to have rotations in behavioral health treatment settings. 

3. Loan repayment programs for persons that work in behavioral health. 

4. Consider the incorporation education about treatment of behavioral health conditions in 

undergraduate and graduate medical education curriculum as well as in the curricula of 

other healthcare professions (nurses, nurse practitioners, physician assistants, 

pharmacists, psychologists, social workers, medical assistants, etc.). 

5. Encourage the modernization of behavioral health treatment facilities through 

technology, telemedicinc follow up and use of interactive applications that engage 

persons over time. 

6. Education to "normalize" these brain disorders. These are physical disorders of the brain 

not ''mental disorders." 

7. Examine issues regarding professional re-imbursement. 

8. Foster greater integration and coordination with broader health systems so that behavioral 

health generally and substance use disorder in particular, begin to be viewed as standard 

components of health care systems. 

6. Much of the discussion last year in the lead up to the passage of CARA focused on the 

overprescribing of prescription drugs. As the epidemic has continued to evolve, we 

understand that heroin and synthetic opioids like carfentinil arc playing an increasing role 

in overdose deaths across the country. I'm interested in learning more about how this 

evolution in the epidemic is changing our response. 

a. How is the increased use of heroin and increase in synthetics, such as carfentinil affecting 

our response? 

Response: 

SAMHSA is updating its publications on addressing opioid overdose awareness and response to 

ensure first responders and laypersons are aware of the nuances between traditional opioids and 

synthetics such as carfentani!. 

SAMHSA 's grantees are providing additional patient education on the potential for synthetics 

infiltrating other opioids. 

Further, treatment programs are beginning to administer greater patient education and 

dissemination of naloxone products within treatment programs. In addition, NIDA is funding 

research to address the issue that multiple doses of naloxone are sometimes needed to revive 

individuals who have taken high-potency, synthetic opioids like fentanyl and carfentanil. In the 

future, stronger formulations of naloxone would help to ensure that overdoses from powerful 

synthetic opioids can be effectively reversed when administered in time. 

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The great risks associated with fentanyl and its analogues create greater urgency to ensure people 

are able to access medication assisted treatment in a timely manner, leading to more efforts to 

engage patients in emergency departments, community settings where people use, and needle 

exchange programs. SAMHSA is working with states to ensure programs are able to triage 

patients and provide immediate access to care for people with opioid use disorder, particularly 

those that use illicit opioids. 

b. How has this change affected our response? 

Response: 

We know that many people will need multiple doses of naloxone in order to be revived, so we 

are training first responders about the changes that arc occurring. We also know that fentanyl 

analogues can and are being combined with drugs other than opioids, so we are warning first 

responders that people known to use other drugs may still have overdosed on fentanyl. This is 

important for first responders both in terms of how they approach the patient but also in terms of 

their own safety. 

Finally, because the risk of death is so high, we are working with states to increase their outreach 

and engagement activities to get active users into treatment quickly and ensure that treatment is 

available to people at high risk on demand. We are providing training and technical assistance to 

states on implementing outreach models and changing treatment practices to permit triage and 

rapid admission instead of lengthy admissions processes that create bottlenecks in access to 

care. 

c. Are there specific approaches that we should be considering to combat this change in the 

epidemic? 

Response: 

Yes, those approaches include: 

I. Ensuring adequate availability of naloxone; 

2. Beginning treatment when people are in emergency departments or other parts of a 

hospital for opioid use related causes (infections, overdose, etc.) or are otherwise 

identified as having an OUD; 

3. Access to treatment on demand through active community outreach by peer counselors 

or via drop in centers at fire (e.g., Safe Stations) and police stations (e.g. Angel 

Initiative/!' AARI); and 

4. Ensuring access to medication assisted treatment rather than relying on detoxification 

and/or residential treatment which are less effective and associated with an elevated risk 

of overdose if medication is not provided post-detoxification (extended-release naloxone 

may be used following completion of detoxification) or as part of residential treatment, 

including as part of continuing outpatient treatment: Opioid use disorder is a chronic 

disease that requires ongoing disease/recovery management and is not appropriately 

treated through short episodes of detoxification episodes or inpatient/residential 

treatment. 

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GRLG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

fRANK PALLONE, ,!R, NCW JERSEY 

RANKING MEMBEH 

C!ongre.\55 of tbe Wniteb ~tatts 

j!)ouse of l\epresentatihes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 M<liofitv l202l22b··;m:n 

Mlnon!y l202!:<:2:,<3ti41 

November 17,2017 

Dr. Anne Schuchat 

Principal Deputy Director 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329 

Dear Dr. Schuchat: 

Thank you for appearing before the Committee on Energy and Commerce on October 25, 2017, 

to testifY at the hearing entitled "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA 

and Other Initiatives.)) 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (1) tbe name oftbe 

Member whose question you are addressing, (2) the complete text oftbe question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on December 5, 2017. Your responses should be mailed to Zack 

Daresbori, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Committee. 

Sincerely, 

cc: The Honorable Frank Pallone, Jr., Ranking Member 

Attachment 
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CDCQFRs 

Energy and Commerce Committee 

Hearing 

Federal Efforts to Combat the Opioid Crisis: A Status Update 

on CARA and Other Initiatives 

October 25, 2017 

Questions for the Record 

Dr. Anne Schuchat, Principal Deputy Director, CDC 

The Honorable Michael C. Burgess 

1. The CDC has spoken about the "hidden causalities" of the opioid epidemic in regards to the 

rise of infectious diseases due to injection drug use. What further can be done to reduce the 

harms and health care costs associated with the crisis? 

Answer: 

A comprehensive, multi-sectoral approach is needed to prevent infectious diseases attributed 

to opioid use disorder which includes: 

Collaboration at the community level between public health, law enforcement, healthcare, 

education, substance use treatment providers, housing services, and faith-based 

stakeholders. 

• Coordination across multiple levels of the U.S. health care system. 

• Implementation of tailored community-based prevention services which include, but are 

not limited to, testing and treatment for infectious diseases including HIV, hepatitis B, and 

hepatitis C; provision and disposal of sterile injection equipment (where legal and 

consonant with community support); provision of naloxone and overdose prevention 

training; and provision of or referral to addiction treatment and mental health services, 

including medication-assisted treatment. 

Does the agency have appropriate authorities to respond to the rise of these infectious 

diseases? 

Answer: 

Authorities granted to CDC under the Public Health Service Act (PHSA) allow for wide-ranging 

prevention and response activities. Additionally, the Department of Health and Human Services 

is undergoing a department-wide process to identify what authorities or changes in statute 

would be helpful to combat the opioid crisis. 

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2. The Washington Post has reported on the "rampant spread of Hepatitis C" due to the opioid 

abuse epidemic. Are we doing a sufficient job identifying those with HCV or HBV and linking 

them to care? 

Answer: 

Rates of viral hepatitis have risen steadily, tripling between 2010-2015, mirroring the opioid 

crisis with young, white Americans in rural communities hit the hardest-but, few communities 

in the nation have been spared. Currently, only about half of people living with HCV and HBV 

know they are infected. Because of this and other obstacles, hundreds of thousands of 

Americans with viral hepatitis who would benefit from treatment have not yet received it. 

CDC's infectious disease programs provide an established, nationwide network asset that can 

be strengthened to prevent transmission of infectious diseases and link drug users to care. 

CDC's viral hepatitis disease monitoring activities is limited to 14 U.S. states. 

3. The CDC estimated that the total "economic burden" of opioid abuse is $78.5 billion per 

year-given the increases in Hepatitis and HIV associated with addiction does this number 

include concomitant infectious diseases of abusers and then others infected, as well as long 

term treatment? 

Answer: 

The 18-month study from which this cost estimate arose calculates overall healthcare costs for 

those with substance use disorder but does not does not fully capture the economic burden of 

infectious disease stemming from the opioid crisis. To estimate the lifetime burden from 

infectious diseases, additional analyses of healthcare costs of heroin use, HIV, and viral 

hepatitis treatment, and productivity and quality of lives lost to opioid use disorders would be 

required. 

4. We know that having a better understanding of the epidemic, including where it's hitting 

Americans the hardest, and why, is essential to building upon and improving the current 

federal government response. How can we improve the timeliness of data on opioid use and 

abuse while also maintaining quality of data? 

Answer: 

The timeliness of mortality data reporting in general has improved significantly over the past 

few years with over 50 percent of deaths now being reported to CDC within 10 days of the 

death. However, deaths involving drugs continue to be among the slowest deaths to be 

reported. A recent CDC analysis of the timeliness by cause of death showed that, on average, 
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over 80 percent of all deaths had been sent to CDC within 13 weeks (about three months) of 

the death, but less than 40 percent of drug overdose deaths had been sent. This is due largely 

to the need for toxicology testing. For drug overdose deaths, an important component of data 

quality is accurate reporting of the specific drugs involved on the death certificate and this is 

dependent on toxicology and medical examiner and coroner capacity. The single most 

important thing that could be done to improve the timeliness of data on opioid involved death 

reporting would be to improve the timeliness of conducting toxicology testing. To do this, it is 

necessary to strengthen the capacity within offices of medical examiners and coroners, and 

forensic toxicology labs. The major limiting factors in reducing the drug death data reporting lag 

are the timeliness and variability of death investigation in offices of medical examiners and 

coroners, and toxicology practices across the country. Medical examiners and corners rely on 

ancillary tests, specifically toxicology, to determine the cause of death. Many of the state labs 

that provide postmortem forensic services to the medical examiner and coroner community are 

under-resourced and have long delays. In addition, many rural counties must transport 

decedents long distances to the nearest regional site and incur additional costs for coroner and 

law enforcement personnel who attend the autopsies. Support for these labs and other 

capability enhancements could help, along with increased support for medical examiners and 

coroners to address the timeliness, quality, and reporting process for postmortem toxicology 

results. 

Greater Standardization of Procedures is also necessary. Performance of state vital records 

vary significantly across the country. It is important to establish and implement minimum 

performance standards in improving the timeliness and quality of mortality vital statistics and a 

process for ensuring that states sustain themselves at that minimum level. CDC is partnering 

with the Public Health Accreditation Board to currently beta test draft performance standards 

for improving the timeliness and quality of mortality statistics. In addition, collaboration with 

the ME/C community is needed to develop death scene investigation protocols for drug 

overdose deaths as well as standard practices for ME/C and has a real impact on their practice. 

Finally. it is important to enhance the Workforce. 

Beyond providing resources to strengthen death investigation and toxicology, Medical 

Examiners and Coroner offices need more resources, including trained personnel, especially 

trained medicolegal death investigators and forensic pathologists, to meet the increasing 

demands from the increased number of drug overdose deaths. 

To create a more comprehensive picture of opioid overdose deaths to inform prevention and 

response efforts, CDC is also working to build state capacity and to provide scientific expertise 

to assist states in improving the timeliness of data for both fatal and non-fatal overdoses 

through CDC's Enhanced State Opioid Overdose Surveillance (ESOOS) program. In its first 

programmatic year, CDC funded 12 states to: 1) Improve the timeliness of reporting of nonfatal 

opioid overdoses using Emergency Department (ED) and Emergency Medical Services (EMS) 

data; 2) Improve the timeliness of reporting of fatal opioid overdoses and associated risk 

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factors so that these data can be used to inform public health response tactics within and 

across states; and 3) Disseminate findings to stakeholders to support prevention efforts. With 

the increase in funds appropriated to CDC in Fiscal Year 2017, CDC was able to expand the 

ESOOS program to fund an additional20 states and Washington, D.C. (for a total of 32 states 

and Washington, D.C.). CDC also was able to provide supplemental funds to all ESOOS-funded 

states, with the expectation that a minimum of 60 percent of the supplemental funds were to 

go to medical examiners/coroners to primarily support comprehensive toxicology testing of 

opioid-involved deaths. One particularly novel and innovative component of this program is 

the use of emergency department (ED) and emergency medical services (EMS) data to track and 

analyze nonfatal overdose data. These data aid states in identifying "hot spots" or areas with 

emerging drug overdose clusters so prevention efforts can be targeted quickly. 

ESOOS-funded states leverage CDC's National Violent Death Reporting System (NVDRS) 

platform to collect data on all unintentional or undetermined intent opioid overdose deaths 

under a module entitled the State Unintentional Drug Overdose Reporting System (SUDORS), 

which uniquely captures detailed information on toxicology, death scene investigations, and 

other risk factors that may be associated with a fatal overdose. For instance, SUDORS data 

have identified and tracked large increases in fentanyl analog deaths driven by carfentanil 

within one state's borders. Early findings from these data, again, reinforce the need and 

urgency for more timely and comprehensive toxicology testing. 

CDC published a MMWR Early Release and a Vital Signs report in March using ESOOS data 

which will be the timeliest data CDC has published to date on drug overdoses- approximately 

within 2 months of publication. 

CDC, in partnership with March of Dimes, is working to protect mothers and babies though a 

pilot project in Illinois, New Mexico, and Vermont to explore approaches for improving the 

speed and accuracy of surveillance of Neonatal Abstinence Syndrome {NAS). Data report there 

is about one baby born every 25 minutes affected by opioid withdrawal. Surveillance of NAS is 

important to inform a public health response that can quickly identify areas of need and target 

interventions to improve outcomes for these babies by connecting mothers to services and 

care. These pilot projects are also evaluating the health services needed through their first 

birthday, which will help prepare the health system to care for these babies. 

The Honorable Joe Barton 

1. The techniques for managing acute pain are different from the techniques for managing 

chronic pain. In fact, some specialties, like dentistry, rarely (if ever) have to treat patients for 

chronic pain. Even the types of opioids that would be prescribed-long acting versus short 

acting-are different. The CDC guideline and the current FDA REMS strategy have both 

focused on managing chronic pain, but what are you doing to help promote more judicious 

prescribing among those who are not in the business of managing chronic pain? 

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Answer: 

Although the CDC Guideline focuses on the use of opioids to treat chronic pain, it does provide 

some guidance in the treatment of acute pain. Recommendation 6 in the Guideline states that 

long-term opioid use often begins with acute pain treatment, and when treating acute pain, 

clinicians should prescribe the lowest effective dose of immediate-release opioids and should 

prescribe no greater quantity than needed for the expected duration of pain severe enough to 

require opioids. Three days or less will often be sufficient; more than seven days will rarely be 

needed. More than a few days of exposure to opioids can significantly increase hazards and 

increase the likelihood of dependence. 

In addition, the CDC has released several resources for patients for the treatment of acute pain. 

These include: 

What You Need to Know outlines the differences between acute and chronic pain and 

also the facts that a patient needs to know when prescribed opioids for acute pain 

management. 

Get the Facts is an infographic that highlights important information about acute pain 

management for common conditions and injuries. 

Opioid Overdose Tip card is about preventing an overdose generally. It is also featured 

on our acute pain materials tab on the CDC website. 

Clinician Commitment Poster to Patient Prescription Safety [PDF-2MB] also addresses 

acute pain. 

Continuing Medical Education credits are being offered to healthcare providers for the 

training on the opioid guidelines. 

The National Safety Council is also sponsoring a systematic review of the evidence related to 

the management of acute musculoskeletal pain. The evidence review is currently underway by 

McMaster University and is expected to be completed by December 2018. A full guideline will 

follow, developed jointly by the American College of Physicians and American Academy of 

Family Physicians. A CDC representative serves on the technical review advisory panel for this 

effort. 

2. What are you doing to promote the delivery of preventive services that help to control acute 

pain and stop such pain from becoming chronic? 

Answer: 

CDC's Guideline provides guidance for the treatment of acute pain (see Recommendation 6 

described in the above response to question #1). In addition, CDC will serve on the technical 

review advisory committee for an acute pain guideline (see NSC work described above in the 

response to question #1). We also have released several communications materials 

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(referenced in the above question) that are supporting the delivery of preventive services. 

Finally, CDC's work through our funded states encourages the uptake and implementation of 

the CDC Guideline, which includes recommendations regarding acute pain management with 

opioids. 

The Honorable Gus Bilirakis 

I recently learned about a new initiative from the health insurance industry called the STOP 

Initiative that will help plans measure how individual providers in their networks are 

adhering to CDC guidelines for prescribing opioids for chronic pain using claims data to 

quantitatively track from results. It is my understanding that this is the first industry-wide 

initiative that will help to measure these guidelines. 

1. Can you please describe these measures and what they seek to do? 

Answer: 

America's Health Insurance Plans (AHIP) launched its Safe, Transparent Opioid Prescribing 

(STOP) Initiative, which is designed to support widespread adoption of clinical guidelines for 

pain care and opioid prescribing. The STOP Measure will be shared widely with health plans 

and initial results will be gathered throughout the coming months. As experience is gained, the 

initial version of the measure will be updated, revised, and validated. As part of the overall 

STOP Initiative, AHIP and an opioid work group will continue to introduce best practices as the 

health care industry works together to combat the opioid epidemic. 

The CDC was not engaged in the development of these measures included in STOP. However, 

CDC was made aware of these efforts by individuals representing AHIP. Based on information 

shared by AHIP with CDC, the four measures include: 1) Percentage of immediate-release 

opioids versus percentage of long-acting/extended-release opioids; 2) Percentage of opioids 

prescribed concurrently with benzodiazepines; 3) When and how often urine drug tests are 

performed for patients on opioid therapy; and 4) Dosage and days supply of opioid 

prescriptions. CDC perceives these four measures to correspond broadly to a few of the 12 

recommendations enumerated in the CDC Guideline. An initial assessment is that use of these 

measures may hold potential to track concordance with elements of the CDC Guideline at 

minimum. This voluntary initiative was launched on October 19, 2017, so it is too early to see 

the results. 

2. From your perspective, do you think this type of initiative is something that will help move 

the needle on the opioid epidemic? 

Answer: 

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While CDC cannot speak to the efficacy of this effort in particular given our cursory knowledge 

of this initiative, CDC is supportive of the development and use of measures to assess and 

encourage adherence to clinical recommendations, as well as to promote quality improvement 

efforts. Certain insurers are developing similar measures. CDC has been considering how to 

assist in coordination of this effort so that consistent measures can be developed. AHIP, as the 

association of some individual insurers/plans across the nation, is heading in this direction, 

which is noteworthy. 

3. Do you think more efforts like this are needed to generate tangible results when it comes to 

adoption ofthese guidelines? 

Answer: 

CDC is supportive of a comprehensive approach to operationalize and evaluate the 

recommendations contained in the Guideline to change the culture of clinical practice. One 

means for doing so is with efforts like the STOP Initiative. Under the STOP Initiative, A HIP has 

launched the STOP Measure, an evidence-based methodology health plans can use to measure 

how provider practices compare to the Centers for Disease Control and Prevention (CDC) 

Guidelines for Prescribing Opioids for Chronic Pain. This measurement aims to help health plans 

and providers collaborate to improve adherence with the CDC guidelines, thereby improving 

patient safety and reducing the risk of opioid misuse. CDC is supportive of the development 

and use of measures to assess and encourage adherence to clinical recommendations, as well 

as to promote quality improvement efforts. 

To encourage uptake and use of the Guideline, CDC developed a comprehensive 

implementation plan to move science into action. Since health care systems have the potential 

to improve pain management including safer use of opioids through guideline concordant care 

on a broad scale, CDC engaged external stakeholders to develop Quality Improvement (QI) 

measures based on the Guideline. These are voluntary Ql measures intended to support 

practice improvement for primary care practices by tracking opioid prescribing and providing 

feedback to clinicians through a data dashboard. CDC is recruiting large health care systems in 

which to pilot implementation of the Ql measures, track their progress, and to be part of a 12-

month Opioid Ql Collaborative. 

CDC's Ql-related work is one component of its overarching Guideline implementation strategy. 

Broadly stated, CDC's Guideline implementation effort is comprised of the following: 1) 

Communication and Dissemination; 2) Clinical education and training; 3) Insurer and Pharmacy 

Benefit Manager Strategies; and 4) Health System Strategies. 

Another way to improve uptake is to integrate the guideline into electronic health records 

(EHRs) or clinical decision support tools. CDC is collaborating with the Office of the National 

Coordinator to integrate Guideline recommendations, such as alerts for Morphine Milligram 

Equivalent (MME) thresholds, defaults on prescribing amounts for the initiation of opioids and 

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prompts to check the POMP, into EHRs. This work was piloted in three hospital systems (Yale 

New Haven Hospital, Carolinas Medical Group, and Houston Medical) and is currently being 

evaluated. The Carolinas HealthCare System successfully built an EHR alert to address opioid 

prescribing by providing critical information at the point of care. The following five objective 

criteria available in the EHR were programmed to "trigger" the alert: three or more 

prescriptions for an opioid in past 30 days; two or more onsite administration of opioids in past 

30 days; current prescription with 50 percent or more remaining ("early refills"); previous 

presentation for opioid overdose; and positive blood alcohol content or toxicology screen for 

cocaine or marijuana. 

The Honorable Chris Collins 

1. As POMPs have evolved in recent years, incorporating POMP data into a prescriber or 

pharmacist's clinical workflow seems to be the key to ensuring that the data is used 

effectively while also increasing efficiency and saving time for providers. What are the 

barriers currently preventing more states from incorporating POMP data into clinical 

workflow? 

Answer: 

Two main barriers are the costs and the lack of capacity (skilled staff) to implement the 

software. 

A POMP must also be easy to access, and the data must be accurate and timely. 

The most helpful, and arguably the most important, feature of a PDMP-EHR integration 

platform is ensuring that patient data is displayed in a simple and organized manner. Clinicians 

do not want the POMP data to be a simple laundry list of prescriptions that are not necessarily 

itemized by date. A well-built PDMP-EHR integrated platform provides the clinician/end user 

with PDMP data within clinical workflow in an easily accessible and readable format. Another 

helpful feature are the flags/alerts. Integrated PDMP-EHR platforms that provide clinicians/end 

users with easily accessible and organized data presented in clear manner with guideline 

concordant alerts/flags would facilitate increased POMP use and informed clinical decision 

making. 

2. We know that the "moment of clarity" when a patient realizes they need to go into 

treatment can be short-lived, and having resources in place to immediately connect patients 

to treatment is critical to the chances of recovery. When a POMP does indicate a patient has 

been "doctor shopping" and potentially has a substance use disorder, what policies are in 

place to direct them to treatment if they wish to go? If none exist, how could we help 

encourage them to access treatment at that time? 

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Answer: 

CDC's Prevention for States {PfS} program requires states to implement community-based or 

insurer interventions. In addition, states have the option to undertake evaluations of state 

policies or a rapid response project to address the rapidly changing epidemic. 

The best practices CDC has seen thus far are strategies to encourage referrals at the site of 

overdose reversal treatment and directing them to services. 

States have taken these opportunities to implement a variety of initiatives that support 

individuals suffering from substance use disorder and encourage them to access treatment. 

One example is the work of Maryland's PfS team. Maryland has a community-based 

intervention, the Overdose Survivors Outreach Program (OSOP). that enhances the hospital 

Screening, Brief Intervention, Referral to Treatment (SBIRT) model in six Baltimore city hospitals 

by adding community peer outreach post-discharge. These peer recovery specialists will 

conduct outreach to overdose survivors from 4 hospitals that have implemented SBIRT. In 

addition, some POMP platforms are developing tools that integrate the CDC guidelines into 

their platforms. These platforms create easy-to read reports for clinicians to use to assess 

patients risk factors and needs. In addition, these platforms are integrating alerts for patients 

in need of MAT treatment to local MAT treatment facilities. 

3. Some states such as Massachusetts have started using data as a weapon in the fight against 

opioids. They are combining data from prescription records, death records, medical 

examiners ... even prisons. For example, they found that a person who is released from jail in 

Massachusetts has a 56 times greater chance of dying from an overdose than the average 

person. They are using that information to make better policy decisions, as well as to identify 

specific individuals who are in need of services. States are supposed to be the laboratories of 

democracy. What has the CDC learned from states in their use of data analytics? Is there a 

plan to use data to fight the opioid crisis? 

Answer: 

Strengthening our understanding of the crisis through better public health data and reporting is 

an HHS priority and included in the Department's 5-point strategy to combat the opioid 

epidemic. Surveillance and data are key components in informing a public health response to 

the opioid epidemic and can come from multiple sources, such as a PDMP, vital records, or 

emergency departments. linking and analyzing data from these sources can help provide the 

best understanding of how the opioid crisis is affecting states. 

One means to shore up state capacity and to provide the needed level of scientific expertise to 

assist states in these efforts has been the creation of CDC's Enhanced State Opioid Overdose 

Surveillance (ESOOS) program. In its first programmatic year (2016). CDC funded 12 states to: 1) 

Improve the timeliness of reporting of nonfatal opioid overdoses using Emergency Department 

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(ED) and Emergency Medical Services (EMS) data; 2) Improve the timeliness of reporting of fatal 

opioid overdoses and associated risk factors so that these data can be used to inform public 

health response tactics within and across states; and 3) Disseminate findings to stakeholders to 

support prevention efforts. 

The program collects data on fatal opioid overdoses through the State Unintentional Drug 

Overdose Reporting System (SUDORS), which uniquely captures detailed information on 

toxicology, death scene investigations, and other risk factors that may be associated with a fatal 

overdose. For instance, SUDORS data have identified and tracked large increases in fentanyl 

analog deaths driven by carfentanil within one state's borders. Early findings from these data 

reinforce the need and urgency for more timely and comprehensive toxicology testing. 

ESOOS also improves innovative strategies around morbidity data, using EMS and ED data to 

provide a comprehensive picture around non-fatal opioid overdoses. The use of this data can 

act as an early warning system to detect sharp increases or decreases in overdoses. In addition, 

this data can help inform where more resources, such as naloxone or treatment capacity, are 

needed. 

The initial cohort of 12 states began program implementation on September 1, 2016, and CDC 

will rapidly disseminate findings as states provide data. The first report of ESOOS mortality 

data, "Deaths Involving Fentanyl, Fentanyl Analogs, and U-47700-10 States, July-December 

2016," was published as a Morbidity and Mortality Weekly Report (MMWR) Early Release on 

October 27, 2017. States completed data reports by August 31, 2017, and CDC published it less 

than two months later. 

With the increase in funds appropriated to CDC in Fiscal Year 2017, CDC expanded the ESOOS 

program to fund an additional 20 states and Washington, D.C., for a total of 32 states plus D.C. 

CDC also was able to provide supplemental funds to all ESOOS-funded states, with the 

expectation that a minimum of 60 percent of the supplemental funds were to go to medical 

examiners/coroners to primarily support comprehensive toxicology testing of opioid-involved 

deaths. 

States are also leveraging PDMP data to inform public health prevention responses around 

safer prescribing. Linking PDMP data to an electronic health record can help facilitate safer 

prescribing at the point of care. In addition, POMP data can also help identify high prescribing 

counties or localities in need of provider education, specifically academic detailing. 

In addition to more timely data, the ability to leverage data sources across agencies is beneficial 

in creating a full picture of the opioid overdose crisis. CDC is working with DEA to find ways to 

use law enforcement data to improve public health interventions. For example, DEA data 

available through the National Forensic Laboratory Information System (NFLIS), were used 

during a 2015 Epidemiological Assistance, or Epi Aid, in which CDC scientists responded to a 

request from the state of Ohio to assist in examining the ongoing increase in unintentional 

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fentanyl-related overdose deaths in their state, elucidate the population most at risk, and 

inform their public health response. In part, the Epi Aid explored whether changes in law 

enforcement fentanyl drug reports (from NFUS) could be used to estimate trends in fentanylrelated mortality. In analyzing data on fentanyl drug reports and fentanyl-related deaths, it was 

found that changes in reported fentanyl drug reports were predictive of changes in fentanylrelated deaths in Ohio, especially in 2014 as the epidemic began. 

States are at the forefront of using data to understand Neonatal Abstinence Syndrome (NAS). 

CDC, in partnership with March of Dimes, is working to protect mothers and babies through a 

pilot project in Illinois, New Mexico, and Vermont to explore ways to estimate the prevalence 

of NAS and support infants affected by NAS in the first year of life. Surveillance of NAS is 

important to inform a public health response that can quickly identify areas of need and target 

interventions to improve outcomes for these babies by connecting mothers to services and 

care. These pilot projects are also evaluating the health services needed through their first 

birthday, which will help prepare the health system to care for these babies. CDC, in 

partnership with March of Dimes, is supporting the Tennessee Department of Health in first 

look at the impact NAS may have on educational needs and services for children in the United 

States. It links Tennessee Medicaid (TennCare) and birth certificate data to Tennessee 

Department of Education data tracking special education outcomes during early childhood (3-8 

years of age). Preliminary findings indicate children with a history of NAS were significantly 

more likely to: 1) be referred for evaluation of an educational disability, 2) meet criteria for a 

disability, and 3) receive therapies or services. 

The Honorable Buddy Carter 

1. What type of education is available, or should be available, to providers on evidence based 

prescribing and clinical strategies for abuse-deterrent opioids and understanding when to 

prescribe immediate release (IR), extended release (ER), and long-acting (LA) opioids? 

Answer: 

The 2016 CDC Guideline for Prescribing Opioids for Chronic Pain addressed the use of abuse 

deterrent opioids, noting that "As indicated in FDA guidance for industry on evaluation and 

labeling of abuse-deterrent opioids (190), although abuse-deterrent technologies are expected 

to make manipulation of opioids more difficult or less rewarding, they do not prevent opioid 

abuse through oral intake, the most common route of opioid abuse, and can still be abused by 

non oral routes. The "abuse-deterrent" label does not indicate that there is no risk for abuse. No 

studies were found in the clinical evidence review assessing the effectiveness of abusedeterrent technologies as a risk mitigation strategy for deterring or preventing abuse. In 

addition, abuse-deterrent technologies do not prevent unintentional overdose through oral 

intake. Experts agreed that recommendations could not be offered at this time related to use of 

abuse-deterrent formulations." At this time, there is limited evidence to support use of specific 

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abuse deterrent opioids. Better evidence of benefits of abuse deterrent opioids is needed to 

inform education and training for providers. 

For extended-release/long acting {ER/LA) opioids, multiple trainings have been made available 

as part of FDA's Risk Evaluation and Mitigation Strategy (REMS) for ER/LA Opioid Analgesics, 

approved in 2012. These trainings were provided using unrestricted funds from opioid 

manufacturers. One example of a high-quality training produced for this REMS was Boston 

University's SCOPE of Pain. 

CDC offers free continuing education training on opioid prescribing for providers, including a 

webinar series and interactive online modules. A lecture on "Dosing and Titrating Opioids" in 

the webinar series addresses appropriate use of IR and ER/LA opioids. Other content in the 

webinar series and online modules addresses related topics including how to assess when 

benefits of opioids are likely to outweigh risks, nonopioid treatments for pain, and how to 

communicate with patients about opioid use. 

The Honorable Pete Olson 

1. Of the grant funding provided for in CARA, how much funding has been allocated to state 

prescription drug monitoring programs (PDMPs)? Do you think states need additional federal 

grant funding to improve their POMP or to fund clinical workflow integrations? 

Answer: 

CDC did not receive any funding through CARA. While CDC does fund states for improvements 

to PDMPs via the Overdose Prevention in States program, this was not through CARA. 

Funding to states is critical to enhance PDMPs, which includes making them real-time, actively 

managed, and easy to use and access. 

2. How does CDC work with federal partners, specifically law enforcement and public safety 

partners such as the DEA and ONDCP? 

Answer: 

CDC works closely with our Federal partners including the DEA and ONDCP to combat the 

opioid epidemic. CDC embedded a public health analyst within DEA for one year to better 

inform collaborative efforts and to assist in learning the cultures of each field, which can help 

increase communication across agencies. Within this personnel exchange, it was particularly 

useful to learn of and share information about the data sources that each agency uses. As a 

result of this personnel exchange, DEA and CDC established a data-sharing request process for 

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National Forensic Laboratory Information System (NFLIS). Although DEA publishes annual and 

semi-annual NLFIS reports to its website for public viewing, prior to this agreement, the sharing 

of raw data with CDC had been inconsistent DEA and CDC are currently in the process of 

establishing a formal data and information-sharing agreement. CDC and DEA are working 

together to find ways to use law enforcement data to improve public health interventions. DEA 

data systems, such as NFUS, can act as an early warning system for potential outbreaks or sharp 

increases in overdoses. 

As an example, NFLIS data were used during a 2015 Epidemiological Assistance, or Epi Aid, 

where CDC scientists responded to a request from the state of Ohio to assist in examining the 

ongoing increase in unintentional fentanyl-related overdose deaths in their state. In part, the 

Epi Aid explored whether changes in reported fentanyl drug-seizure rates (from NFLIS) could be 

used to estimate trends in fentanyl-related mortality. In analyzing data on fentanyl-related 

seizures and fentanyl-related deaths, it was found that changes in reported fentanyl-seizures 

were predictive of changes in fentanyl-related deaths in Ohio, especially in 2014 as the 

epidemic began. 

CDC also works with ONDCP to address the regional nature of the opioid epidemic by 

collaborating on the Heroin Response Strategy (HRS) under the High Intensity Drug Trafficking 

Areas (HIDTAs) program, which is funded by ONDCP. The HIDTA HRS leverages strategic 

partnerships to target the organizations and individuals trafficking deadly drugs like heroin and 

illicit fentanyl so that overdoses are reduced and lives are saved. The HRS currently coordinates 

the efforts of 10 regional HIDTAs across 22 states. The HIDTA HRS is a collaborative public 

health/public safety model focused on coordinated data-driven approaches to reduce opioid 

overdose deaths. 

CDC scientists, working with HIDTA law enforcement experts, manage project planning and 

development for the HRS, which includes: 

• Program and communications systems 

Program evaluation 

• Initiative-wide project implementation 

• Regional coordination of Public Health Analysts 

In addition, CDC partners with the HIDTAs to manage the Public Health and Public Safety 

Network, which includes a public health analyst (PHA) and a drug intelligence officer (DIO) in 

each of the 22 states the HIDTA HRS covers. PHAs work collaboratively across sectors and 

agencies within each state to gather, analyze, and distribute drug-related public health data; 

develop and support data-driven policy and programming initiatives; facilitate interagency 

collaboration; and advance efforts in surveillance, treatment and prevention initiatives within 

their state. They bring a public health perspective to law enforcement efforts, and enhance 

public health efforts with law enforcement intelligence and relevant data. 

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One of the projects conducted under the HIDTA HRS is the Good Samaritan Project, which 

assesses law enforcement knowledge of and perspective about Good Samaritan laws (laws that 

offer legal protection to people who give reasonable assistance to those who are, or who they 

believe to be, injured, ill, in peril, or otherwise incapacitated) within their state, which is one of 

the strategies implemented as means to prevent drug overdose fatalities. 

Also, in support of this work, CDC has partnered with ONDCP to invest $2 million to support the 

piloting of community-level initiatives to further efforts to address the opioid epidemic in 

partnership with regional HIDTA programs. Under this initiative, 13 grants have been awarded 

in 10 different states to support implementation of innovative strategies within a targeted 

geographic area with the aim of building the evidence base for response activities that other 

communities can employ. 

Projects address topics such as post-overdose strategies to link people to care using patient 

navigators and recovery coaches; justice-involved populations and access to MAT; pre-arrest 

diversion; buprenorphine induction in the ED; neo-natal abstinence syndrome; and adverse 

child experiences. 

The Honorable Susan Brooks 

1. I have heard you say that preventing drug use before it begins is the most cost effective way 

to reduce drug use and its consequences. In your opinion, what are the characteristics of 

successful prevention intervention programs? Besides lack of resources, what are the barriers 

to implementing intervention programs? 

Answer: 

To respond to and curtail the opioid crisis, CDC applies scientific expertise and centers activities 

on surveillance and implementation of public health strategies, which includes addressing 

inappropriate prescribing of opioids as a key driver of the current epidemic. Given the levers 

that exist at the state-level, through its Overdose Prevention in States effort across three 

programs, CDC is partnering with 45 states and Washington, D.C., to provide resources and 

scientific expertise to maximize those levers with a specific focus on using data to drive action 

and preventing people from getting addicted in the first place through safer prescribing. Some 

of the key prevention aspects of our program are: 

1. maximizing the use of state Prescription Drug Monitoring Programs as both a public health 

surveillance and clinical decision support tool; 

2. implementing community and insurer interventions to have the biggest impact on 

populations; 

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3. evaluating state-level policies in place to continue to build the evidence base for strategies 

that hold promise. Underlying success in these endeavors is strong collaboration across 

different entities within the state to support a multi-sector response to this complex issue. 

Through these efforts, CDC has established strong partnerships with public health entities in the 

vast majority of states. In CDC's estimation, however, the next critical step to address existing 

barriers is to establish and strengthen efforts at the local level as well. CDC has learned from 

our funded states that the manifestation of the epidemic differs within different regions of the 

same state. While in some regions overdoses from prescription opioids are the primary 

concern, in others it is overdoses from illicit opioids. Given this, a suite of resources and 

response interventions applicable at a local level are needed. CDC currently is in the initial 

stages of developing a suite of interventions that localities can choose from to quickly 

implement a response based on the needs presented. CDC is partnering with the National 

Association of County and City Health Officials (NACCHO) to assess resources available, develop 

tools that address gaps, and to evaluate implementation of these strategies at the local level. In 

addition, CDC is working closely with HIDTA partners in 22 states to implement and evaluate 

pilot projects across a variety of communities to grow the evidence base about what works in 

real-world settings. Ongoing gaps that exist include tailoring local interventions that yield 

efficacy within the context of rural and tribal communities in particular. Both communities 

possess underlying challenges that are distinct from other regions; therefore, the need exists to 

assess and promote tailored public health response strategies to benefit these populations. In 

addition, an important component of prevention should be primary prevention among youth to 

stop the trajectory toward use in adulthood. CDC data suggest that the middle- school years 

present a strong opportunity for intervention. While it can be difficult to bridge education and 

public health agencies, CDC has experience in successfully supporting these connections to 

address health risks And works to implement health education, youth development, and 

screening and referral activities in schools to address high-risk behaviors such as substance use. 

Finally, CDC is collaborating with other components of HHS and with other Federal agencies to 

prevent drug use before it begins by addressing pain management. CDC is working on the HHS 

National Pain Strategy (NPS) Implementation Steering Committee, which is working to improve 

pain management in the U.S. using the strategies laid out in the NPS. 

The Honorable Markwayne 

1. According to the CDC, Native Americans have the highest rates of both opioid overdose 

deaths as well as HCV-related deaths. Does your department engage with these populations 

around risk factors associated with opioid abuse, including the spread of infectious diseases 

such as HIV and HCV? Do you currently have the ability to help tribal and public health 

systems develop programs to alert providers of care for opioid abuse to also test for 

concomitant infectious diseases and provide a pathway to treatment? Are you engaging in 

these activities currently, if so, can you please elaborate on these efforts and provide any 

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findings on the results? How could we strengthen the our public health system infrastructure 

to better respond to the opioid epidemic and its long term health consequences? 

Answer: 

CDC collaborates with states, counties, local, and tribal communities, as well as with the Indian 

Health Service (IHS), to prevent opioid overdoses and related harms. CDC has the ability to 

support tribal health programs via CDC's work with U.S. states. CDC does not currently directly 

fund tribal governments; however, funding awards for CDC's HIV prevention efforts stipulate 

that states must address and collaborate with tribal communities in their jurisdictions. 

CDC is working with IHS on an analysis of existing data sources that may inform IHS about 

regions and counties at potential risk for spread of HIV and HCV infection associated with 

injection drug use, in order to identify priority localities for HIV and HCV prevention and harmreduction interventions. CDC is also providing technical assistance to the Cherokee Nation to 

optimize care and move toward eliminating HCV among American Indians in the Cherokee 

Nation Health System. This includes supporting the planning, implementation, monitoring, and 

evaluation of efforts to bring together a coalition of public health, clinical care, and academic 

medicine partners. Successful completion will not only improve the health of the Cherokee 

Nation, but also inform similar programs to move toward eliminating HCV infection in other 

American Indian and non-American Indian populations. In 2015, a five-fold increase in testing 

occurred, from 3,337 persons initially tested to 16,772 in the Cherokee nation. Additionally, 

screening for Hepatitis C virus in the Indian Health Service, reports an increase in testing from 

8% to 33 percent nationwide among American Indian/Alaskan Native populations between 

2012 and 2015. 

The Honorable Gregg Harper 

1. CDC recently launched a communications campaign. Can you tell us about the campaign and 

how it is being rolled out? 

Answer: 

CDC publically released the Rx Awareness communications campaign in September. The 

campaign features real-life accounts of individuals living in recovery from opioid use disorder, 

and those who have lost someone to a prescription drug overdose. The campaign will increase 

awareness and knowledge among Americans about the risks of prescription opioids and deter 

inappropriate use. CDC is running digital, radio, and out-of-home campaign ads for 14 weeks in 

select states (OH, KY, MA, and NM) with broader release anticipated in 22 additional states 

funded through CDC's Opioid Prevention in States effort. 

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The Honorable leonard lance 

1. Can you tell us about CDC's opioid surveillance programs, especially in regards to fentanyl? 

How has CDC improved the timeliness of reporting? What gaps remain in data collection 

capabilities and how is CDC working to bridge those gaps? 

Answer: 

CDC now funds the Enhanced State Opioid Overdose Surveillance (ESOOS) program in 32 states 

and Washington D.C. In its first programmatic year, CDC funded 12 states to: 1) Improve the 

timeliness of reporting of nonfatal opioid overdoses using Emergency Department (ED) and 

Emergency Medical Services (EMS) data; 2} Improve the timeliness of reporting of fatal opioid 

overdoses and associated risk factors so that these data can be used to inform public health 

response tactics within and across states; and 3) Disseminate findings to stakeholders to 

support prevention efforts. 

The program collects data on fatal opioid overdoses through the State Unintentional Drug 

Overdose Reporting System (SUDORS). which uniquely captures detailed information on 

toxicology, death scene investigations, and other risk factors that may be associated with a fatal 

overdose. For instance, SUDORS data have identified and tracked large increases in fentanyl 

analog deaths driven by carfentanil within one state's borders. Early findings from these data 

reinforce the need and urgency for more timely and comprehensive toxicology testing. 

ESOOS also improves innovative strategies around morbidity data, using EMS and ED data to 

provide a comprehensive picture around non-fatal opioid overdoses. The use of this data can 

act as an early warning system to detect sharp increases or decreases in overdoses. In addition, 

this data can help inform where more resources, such as naloxone or treatment capacity, are 

needed. CDC released a Vital Signs in March, which will publish CDC's most timely data on drug 

overdoses given the near real-time reporting of this system. 

The initial cohort of 12 states began program implementation on September 1, 2016, and CDC 

will rapidly disseminate findings as states provide data. The first report of ESOOS mortality 

data, "Deaths Involving Fentanyl, Fentanyl Analogs, and U-47700-10 States, July-December 

2016," was published as a Morbidity and Mortality Weekly Report {MMWR) Early Release on 

October 27,2017. States completed data reports by August 31, 2017, and CDC published it less 

than two months later. CDC published a Vital Signs report and MMWR Early Release in March 

2018, which will include the timely data on drug overdoses given the near real-time reporting of 

this system. 

With the increase in funds appropriated to CDC in Fiscal Year 2017, CDC was able to expand the 

ESOOS program to fund an additional20 states and Washington, D.C. CDC also was able to 

provide supplemental funds to all ESOOS-funded states, with the expectation that a minimum 

of 60% of the supplemental funds were to go to medical examiners/coroners to primarily 

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support comprehensive toxicology testing of opioid-involved deaths. With the increase in funds 

appropriated to CDC in Fiscal Year 2018, CDC anticipates scaling up funding and technical 

support to enhance surveillance within all 50 states to improve the timeliness and 

comprehensiveness of fatal and nonfatal opioid overdose reporting. 

In terms of gaps, it is necessary to strengthen the Mortality Data Infrastructure (IT Systems). 

When a drug overdose death occurs, multiple data requestors ask toxicology and ME/C offices 

to provide data using tools that are not integrated with the laboratory information systems and 

case management systems that they use every day. This puts significant burden on these offices 

and contributes to the lag in the data. CDC will work closely with the Association of State Crime 

Lab Directors, Society of Forensic Toxicologists, and National Association of Medical Examiners 

to help enhance their capabilities so that they can help provide the data. Support is needed to 

enhance the lnteroperability of medical examiner/coroner case management systems and state 

electronic death reporting systems to improve timeliness and data quality. 

The Honorable Morgan Griffith 

1. Prescription drug monitoring programs (PDMPs) are an invaluable tool for preventing "doctor 

shopping" and diversion of opioid medications. We know that POMPs are regulated 

differently from state to state in terms of when/if a provider is required to check them, what 

information is included in a POMP, and who has access to this information. Some states also 

have agreements in place to allow access between their respective POMPs across state lines. 

What are ways in which POMPs can be better utilized to identify instances of addiction to 

opioids and prevent overdoses? What can be done to improve POMP sharing across state 

lines? 

Answer: 

The opioid crisis manifests differently in communities and states. To the extent that states have 

access to more data, including data that are more timely as well as data from other states, the 

better they are able to inform and tailor their response. 

PDMPs are a promising tool to address the epidemic and prevent opioid misuse, abuse, and 

overdose. Their utility as a public health resource and tool can be maximized through various 

means. For one, they can provide essential information to a clinician at the point of care as they 

are making that critical treatment decisions for their patient. This is what we mean when we 

say that PDMPs are a clinical decision-making tool. Just like any other part of a patient's 

medical history, the POMP provides essential information to inform decisions about care. 

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Another public health application is the use of POMP data to inform strategic prevention 

programming and resource allocation. This is what we mean when we talk about the POMP as 

a public health surveillance tool. PDMPs can tell us where prescribing is problematic, where we 

need to focus prescriber education efforts, and where overdoses may be more likely to occur so 

that we can ensure availability of naloxone and use health systems to connect people to 

treatment and care. 

PDMPs can also act as part of an early warning system to detect increases in prescribing in 

certain communities. Analyzing de-identified POMP data by geographic area, whether that be 

county, zip code, etc. can show trends in medical and non-medical use of prescription drugs. 

Ensuring that these public health applications of the POMP are maximized is a key and required 

component under our Prevention for States program and the enhanced component of our 

Data-Driven Prevention Initiative program. 

Every state POMP operates differently, so the challenges and barriers for each state will differ. 

Some states may be precluded from sharing data from a legislative or regulatory perspective. 

Other may have difficulties from a resource perspective, particularly if there are costs 

associated with data sharing and prove prohibitive to a state. Others may have technical 

challenges, such as integrating POMPs with EHRs. Finally, some states may have a different 

agency housing a POMP, requiring MOUs to share data with public health entities. 

Some of these challenges can continue to be addressed by the provision of technical assistance 

and resources from the federal level. Illinois will soon be implementing guideline concordant 

enhancements to their integrated POMP-EHR integrations that provides flags based on the 

active cumulative Morphine Milligram Equivalent (MME). There will be flags based on;:: 50 

MME and<: 90 MME. The POMP will also provide resources such as links to the CDC's 

prescribing guideline provider tools and resources based on the MME flags. These 

changes/enhancements were a result of TA provided by the Illinois CDC PfS state support team. 

In addition, the Illinois CDC PfS state support team has been working to provide technical 

assistance around the PfS second required strategy of implementing initiatives in the 

community and/or health systems. Through the CDC PfS team's monthly calls and site visit, the 

CDC and Illinois have developed and disseminated Illinois Prescription Monitoring Program 

County Profiles. 

CDC is also working with funded states for POMP and EHR (electronic health record) 

integration. This step is critical for ensuring the information from PDMPs are a part of clinical 

workflow and easy for providers to check while seeing patients. 

2. We often hear that not enough states are sharing PDMP data with other states. However, my 

understanding is that 45 states are now actively sharing POMP data. For states that are not, 

the barriers are primarily at the state legislative level and not technological. What are your 

views on the current state of interstate data sharing? Do you think that states have been 

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doing a better job in recent years of sharing data with their neighboring states (at a 

minimum) to prevent doctor shopping? 

Answer: 

States have made important strides to share data to prevent doctor shopping, inform strategic 

prevention programming and resource allocation, and understand regional trends in opioid 

prescribing to better inform physicians about their own prescribing patterns. Ensuring that 

these public health applications of the POMP are maximized is a key and required component 

under our Prevention for States program and the enhanced component of our Data-Driven 

Prevention Initiative program. CDC also provides important technical assistance through its 

grantee communities of practice, which allows peer-to-peer learning so that states can share 

best practices, lessons learned, and key successes in addressing challenges that may be similar 

among states. 

States have been working to share POMP data via data hubs such as the RxCheck and PM Pi. As 

of now, 48 states and Washington, D.C. are exchanging data via either the PM Pi or the RxCheck. 

The Honorable Ben Ray Lujan 

1. In 2015, 33,000 Americans died from opioids. According to the CDC, almost half of those 

deaths were from prescription opioids. The New York Times reports that in 2016, overdoses 

from all drugs was the leading cause of death of people under the age of 50. Drug overdoses 

now kill more Americans each year than at the height of the HIV epidemic and the worst year 

for auto accident deaths. The Times and drug use experts attribute the sharp rise in all drug 

overdose deaths to the rise of opioids. What we need to fight this epidemic is continued and 

reliable long-term investments in prevention, treatment, recovery, and monitoring. The 

President's budget proposal for fiscal year 2018, coupled with other administration 

initiatives, takes several steps back in the fight against opioid addiction, including a cut in 

funds for SAMHSA. Overall, the President's proposed budget cuts HHS by 16.2 percent, the 

CDC by 17 percent and NIH by 19 percent. It cuts funding for addiction research, treatment 

and prevention. Even the White House Office on National Drug Control Policy would take a 95 

percent hit. 

a. Deputy Director Schuch at, do you have all of the tools you need to stop the opioid epidemic? 

Answer: 

CDC received an increase in appropriation in both fiscal years 2016 and 2017 for opioid 

overdose prevention activities. With that funding, CDC is now able to fund 45 states and 

Washington, D.C. to implement prevention activities and to collect data on fatal and non-fatal 

overdoses. CDC is committed to continuing prevention activities with the resources we are 

appropriated. 

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b. Given the 17 percent cuts to CDC in the President's budget proposal, what programs relating 

to the opioid epidemic will be cut? Which programs would have been expanded that will now 

not be? 

Answer: 

CDC appreciates Congress's support and investment of our opioid prevention work. CDC is 

committed to continuing opioid overdose prevention and will continue to work with states in 

their overdose prevention programs and surveillance. 

The Honorable Paul Tonka 

1. Does the CDC have any data that specifically details overdose death rates or incidence for 

individuals leaving jail or prison? If not, is there a way for CDC to obtain this data? 

Answer: 

CDC does not have systematic access to data on overdoses for all individuals leaving jail or 

prison, but the Enhanced State Opioid Overdose Surveillance program, which seeks to improve 

the timeliness of data collection on fatal and non-fatal opioid overdoses, does capture some 

information on justice-involved populations. The State Unintentional Drug Overdose Reporting 

System (SUDORS), which uniquely captures detailed information on toxicology, death scene 

investigations, and other risk factors that may be associated with a fatal overdose, does collect 

information on recent release from an institution for all opioid overdose deaths. "Jail, prison, or 

detention facility" is one of the options for institutions. To qualify as a recent release, the 

decedent had to have spent one or more nights in the institution, within a month prior to 

death. SUDORS also captures information about deaths that occurred while the decedent was 

in custody, which could have been under arrest, in jail/prison, in a psychiatric institution, etc. 

This information could be used to track what proportion of opioid overdose decedents had 

recently been incarcerated, and what proportion died while incarcerated. 

While CDC does not collect data related to individuals leaving jail or prison, in 2015, the 

Massachusetts Department of Public Health (MDPH) requested CDC's assistance with an 

epidemiological investigation (Epi-Aid). Massachusetts had experienced a surge of opioidrelated deaths, from 698 in 2012 to 1, 747 in 2015, and over 74 percent of the drug overdose 

deaths involved fentanyl. The key goal of the investigation was to understand the extent to 

which the sharply increasing supply of illicitly-made fentanyl (IMF) in Massachusetts from 2013 

through 2015 contributed to the surge in opioid-related overdose deaths. CDC worked closely 

with the MDPH, SAMHSA, and DEA to determine that illicitly-made fentanyl mixed with or sold 

as heroin was primarily responsible for the surge of deaths from 2014 to 2015. Eight out of ten 

fentanyl-related overdose deaths were suspected to involve illicitly-made fentanyl. Using the 

data obtained in the investigation, CDC provided recommendations for the MDPH related to 

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screening people for heroin and/or fentanyl use, expanding access to naloxone and providing 

training for overdose prevention, and implementing messaging and education around the 

dangers of fentanyl, especially in the cases of people who had recently been released from 

prison. 

Given the specific needs of justice-involved individuals as particularly vulnerable demographic, 

CDC has partnered with the National Governors Association (NGA) to assess different strategies 

and programs underway within states to address opioid use disorder while individuals are 

incarcerated and following their release. More specifically, NGA convened a Learning Lab for 

interested states to attend and learn about programs and strategies within a peer state to 

provide Medication-Assisted Treatment (MAT) and other services for justice-involved 

populations. In addition, NGA hosted a webinar to educate leadership within states about the 

efficacy of MAT and to highlight other innovative strategies that states can employ to prevent 

opioid misuse, abuse, and overdoes specific to this target population. 

The Honorable Frank Pallone, Jr. 

1. With 90 percent of addictions beginning in the teenage years, we know there is a critical need 

for effective drug prevention programming, especially during this current opioid crisis. In the 

past decade, our national prevention infrastructure has been decimated (including the 

elimination of funding for the National Youth Anti-Drug Media Campaign) and our ability to 

educate young people and prevent more teens from becoming addicted is hobbled. We need 

prevention messages to serve as a counterweight to the proliferation of pro-drug messaging 

in the media today. In order to convey the risk of opioid and other drug abuse and reverse 

the stark addiction and overdose trends that are creating heartbreak in families across the 

country, investment in prevention messaging is crucial. Regarding Section 102 in CARA- the 

National Awareness Campaigns provision, can you please tell us what the status of 

implementation and investment is? What do the various agencies plan to do to move forward 

with this provision and how can we help? 

Answer: 

Although CDC did not receive any funding to implement provisions in CARA, CDC has developed 

the Rx Awareness communications campaign which was released publicly in September. The 

campaign features real-life accounts of individuals living in recovery from opioid use disorder, 

and those who have lost someone to a prescription drug overdose. The campaign will increase 

awareness and knowledge among Americans about the risks of prescription opioids and deter 

inappropriate use. CDC is running digital, radio, and out-of-home campaign ads for 14 weeks in 

select states (OH, KY, MA, and NM) with broader release anticipated in 22 additional states 

funded through the CDC Opioid Prevention in States effort. 

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2. I would like to thank all of the witnesses for joining us. I am particularly interested in learning 

more about CDC efforts to improve the timeliness and comprehensiveness of the data 

available about the epidemic. 

a. Can you tell us about CDC's surveillance programs? 

Answer: 

CDC's surveillance programs strengthen our understanding of the crisis through better public 

health data and reporting which is a component of HHS's 5-point strategy to combat the opioid 

epidemic. 

The National Vital Statistics System (NVSS) is one of oldest and most critical surveillance 

systems at CDC for monitoring the impact (measured in lives lost) of the opioid epidemic. 

Through the NVSS data on all births, deaths, and fetal deaths are sent to the National Center for 

Health Statistics (NCHS), which has contracts with all 57 vital records jurisdictions to provide 

these data. From these data, CDC compiles annual national statistical data files and publishes a 

variety of reports. Annual mortality data are currently available through 2015 and 2016 data 

will be release before the end of the year. To address a need for even more timely data NCHS 

now releases quarterly provisional estimates based on a current flow of vital statistics data 

from the states vital records offices. To address specific request for timely information of drug 

overdose death, CDC recently began releasing monthly provisional drug overdose counts that 

provide the most timely information available on the overall numbers of drug overdose deaths 

and death involving specific drugs and drug classes by state. 

In addition, CDC has launched the Enhanced State Opioid Overdose Surveillance (ESOOS) 

program. In its first programmatic year, CDC funded 12 states to: 1) Improve the timeliness of 

reporting of nonfatal opioid overdoses using Emergency Department (ED) and Emergency 

Medical Services (EMS) data; 2) Improve the timeliness of reporting of fatal opioid overdoses 

and associated risk factors so that these data can be used to inform public health response 

tactics within and across states; and 3) Disseminate findings to stakeholders to support 

prevention efforts. 

The program collects data on fatal opioid overdoses through the State Unintentional Drug 

Overdose Reporting System (SUDORS), which uniquely captures detailed information on 

toxicology, death scene investigations, and other risk factors that may be associated with a fatal 

overdose. For instance, SUDORS data have identified and tracked large increases in fentanyl 

analog deaths driven by carfentanil within one state's borders. Early findings from these data 

reinforce the need and urgency for more timely and comprehensive toxicology testing. 

ESOOS also improves innovative strategies around morbidity data, using EMS and ED data to 

provide a comprehensive picture around non-fatal opioid overdoses. The use of this data can 

act as an early warning system to detect sharp increases or decreases in overdoses. In addition, 

this data can help inform where more resources, such as naloxone or treatment capacity, are 

needed. 

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The initial cohort of 12 states began program implementation on September 1, 2016, and CDC 

will rapidly disseminate findings as states provide data. The first report of ESOOS mortality 

data, "Deaths Involving Fentanyl, Fentanyl Analogs, and U-47700-10 States. July-December 

2016," was published as a Morbidity ond Mortality Weekly Report (MMWR) Early Release on 

October 27,2017. States completed data reports by August 31, 2017, and CDC published it 

within two months. 

With the increase in funds appropriated to CDC in Fiscal Year 2017, CDC was able to expand the 

ESOOS program to fund an additional 20 states and Washington, D.C. (for a total of 32 states 

and Washington, D.C.) CDC also was able to provide supplemental funds to all ESOOS-funded 

states, with the expectation that a minimum of 60 percent of the supplemental funds were to 

go to medical examiners/coroners to primarily support comprehensive toxicology testing of 

opioid-involved deaths. 

States are at the forefront of protecting mothers and babies by using data to understand 

Neonatal Abstinence Syndrome (NAS). With support from CDC and in partnership with March of 

Dimes, Illinois, New Mexico, and Vermont to explore approaches for improving the speed and 

accuracy of surveillance of Neonatal Abstinence Syndrome {NAS). Surveillance of NAS is 

important to inform a public health response that can quickly identify areas of need and target 

interventions to improve outcomes for these babies by connecting mothers to services and 

care. These pilot projects are also evaluating the health services needed through their first 

birthday, which will help prepare the health system to care for these babies. 

CDC's Pregnancy Risk Assessment Monitoring System (PRAMS) in 51 jurisdictions (47 states, the 

District of Columbia, New York City, Puerto Rico, and the Great Plains Tribal Chairmen's Health 

Board) collects state-specific, population-based data from women during the postpartum 

period on maternal attitudes and experiences before, during, and shortly after pregnancy. CDC 

is supporting 6 states (AK, ME, NM, NY, PA, WV) to collect supplemental data on maternal 

substance use through the PRAMS. 

b. How has CDC improved the timeliness of reporting? 

Answer: 

Timeliness of mortality reporting has improved significantly over the past several years. In 

2010, only about 7% of deaths were reported to CDC within 10 days of the death. This 

percentage has increased steadily over the past few years and today over 50% of deaths 

nationally are reported to CDC within 10 days. The introduction of electronic death registration 

(EDR) systems in most states has been a significant catalyst for these improvements and CDC 

has been actively involved in encouraging states to implement these systems and has funded 

special projects in many states to enhance and maximize these systems with specific timeliness 

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goals. As current EDR systems age resources will be needed to maintain and upgrade aging 

systems if improvements in timeliness are to be sustained. 

Capitalizing on the significant improvements in the timeliness of deaths being reported by the 

states, CDC launched the Vital Statistics Rapid Release (VSRR) program in 2015 with the first 

release of quarterly provisional mortality estimates, which included national estimates of 

overall drug overdose death rates. In August of 2017, the VSRR program was expanded to 

include monthly provisional counts of drug overdose deaths and death involving specific drugs 

and drug classes by state. The most recent monthly provisional report was released on 

November 13, 2017, and includes counts of drug overdose deaths through April2017. 

Reliable provisional estimates of death rates and counts for many causes of death can be 

released 3 months after the death occurred, but due to the additional time needed for 

toxicology drug overdose deaths are among the last reported to CDC, which means that reliable 

provisional rates and counts for these deaths can only be released 6 to 9 months after the 

death occurred. CDC is working closely with the state vital records offices and the ME/Coroner 

community on efforts to help minimize the time needed to report drug overdose deaths, 

including efforts to better integrate ME/Coroner case management systems with state EDRS. 

c. What gaps remain in data collection capabilities, including the effect of some of the 

surveillance programs not being implemented in all 50 states and DC, and how is CDC working 

to bridge those gaps? 

Answer: 

CDC's surveillance programs strengthen our understanding of the crisis through better public 

health data and reporting which is a component of HHS's 5-point strategy to combat the opioid 

epidemic. Though timely, high-quality data are critical to support a multi-sector response to the 

opioid epidemic, states remain at differing capacity with regard to opioid overdose surveillance. 

One means to shore up state capacity and to provide the needed level of scientific expertise to 

assist states in these efforts has been the creation of CDC's Enhanced State Opioid Overdose 

Surveillance (ESOOS) program. In its first programmatic year, CDC funded 12 states to: 1) 

Improve the timeliness of reporting of nonfatal opioid overdoses using Emergency Department 

(ED) and Emergency Medical Services (EMS) data; 2) Improve the timeliness of reporting of fatal 

opioid overdoses and associated risk factors so that these data can be used to inform public 

health response tactics within and across states; and 3) Disseminate findings to stakeholders to 

support prevention efforts. 

The initial cohort of 12 states began program implementation on September 1, 2016, and CDC 

will rapidly disseminate findings as states provide data. The first report of ESOOS mortality 

data, "Deaths Involving Fentanyl. Fentanyl Analogs, and U-47700-10 States, July-December 

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2016," was published as a Morbidity and Mortality Weekly Report (MMWR} Early Release on 

October 27, 2017. States completed data reports by August 31, 2017, and CDC published it 

within two months. 

With the increase in funds appropriated to CDC in Fiscal Year 2017, CDC was able to expand the 

ESOOS program to fund an additional 20 states and Washington, D.C. CDC also was able to 

provide supplemental funds to all ESOOS-funded states, with the expectation that a minimum 

of 60 percent of the supplemental funds received were to directly support comprehensive 

testing within each state. 

CDC is now funding 32 states and Washington, D.C. under the ESOOS program. 

3. Adverse effects and accidental overdoses from opioids have had a huge impact on our nation, 

however, there are also downstream health consequences of opioid use, especially IV opioid 

or heroin use, such as HIV, Hepatitis B and Hepatitis C that also affects our nation's health. In 

2015, there was an outbreak of HIV in a small town in Indiana, where nearly 200 individuals 

became infected with HIV due to injection of oxymorphone. I was particularly struck by 

statements from public health officials in a recent article in Politico. According to that article, 

health officials believe that the 2015 outbreak in Scott County is a harbinger of things to 

come as abuse of- painkillers, heroin, fentanyl, and other drugs- rages on. According to the 

Director of Public Health in Alaska, "[t]he nightmare that wakes me up at 3 a.m. is a Scott 

County -level HIV outbreak happening here in Alaska." 

a. Dr. Schuchat, do you share these concerns about the risk of additional infectious disease 

outbreaks as a result of the opioid abuse epidemic? 

Answer: 

The threefold increase in hepatitis C between 2010 and 2015and the 2015 HIV outbreak in 

Indiana are powerful evidence that persons who inject drugs are at high risk for both HIV and 

viral hepatitis, and that these infections can gain ground at any time unless the nation remains 

vigilant about prevention, testing, care. 

b. What are we currently doing to monitor and prevent these infections from IV drug use? 

Answer: 

last year, tens of thousands of viral hepatitis, HIV, and endocarditis (heart valve) infections 

occurred in the nation due to injection drug use. CDC is working to prevent these infections by: 

• Using data to monitor emerging trends and direct prevention activities; 

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• Providing up-to-date scientific information and strengthening state, local, and tribal 

capacity to respond and prevent injection drug use-associated infectious diseases; 

• Working with providers, health systems, and payers to implement effective prevention 

programs; and, 

Coordinating with public safety and community-based partners to rapidly link people to 

effective infectious disease (and substance use) treatment 

c. What suggestions do you have for improving prevention strategies? 

Answer: 

CDC aims to strengthen our understanding of the crisis through better public health data and 

reporting which is a component of HHS's 5-point strategy to combat the opioid epidemic. A 

comprehensive, multi-sectoral approach is needed to prevent infectious diseases attributed to 

opioid use disorder which includes: 

• Collaboration at the community level between public health, law enforcement, 

healthcare, education, substance abuse treatment providers, housing services, and faithbased stakeholders. 

• Coordination across multiple levels of the U.S. health care system. 

• Implementation of tailored community-based prevention services which include, but are 

not limited to, testing and treatment for HIV, viral hepatitis, and endocarditis, provision 

and disposal of sterile injection equipment (where legal and consonant with community 

support), provision of naloxone and overdose prevention training, and provision of or 

referral to addiction and mental health services, including medication-assisted 

treatment. 

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GHLG WALDEN, OREGON 

CHAIRMAN 

Dr. Nora Volkow 

Director 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JE;HSEY 

RANKING MEMBER 

Q.Congress' of tbe WnitdJ ~tates 

j!}oul)c of l\cprel)mtatibel) 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN Housr OFFICE BuiLDING 

WASHJNGTON, DC 20515-<3115 

November 17, 2017 

National Institute on Drug Abuse 

National Institutes of Health 

9000 Rockville Pike 

Bethesda, MD 20892 

Dear Dr. Volkow: 

Thank you for appearing before the Committee on Energy and Commerce on October 25, 2017, 

to testifY at the hearing entitled "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA 

and Other Initiatives." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name ofthe 

Member whose question you arc addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on December 5, 2017. Your responses should be mailed to Zack 

Dareshori, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washin!,>ton, DC 20515 and e-mailed in Word fonnat to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Committee. 

cc: The Honorable Frank Pallone, Jr., Ranking Member 

Attachment 
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UNITED STATES HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE 

FEDERAL EFFORTS TO COMBAT THE OPIOID CRISIS: A STATUS UPDATE ON 

CARA AND OTHER INITIATIVES 

WEDNESDAY, OCTOBER 25,2017 

Questions for the Record- Dr. Volkov 

The Honorable Fred Upton 

I. The 21st Century Cures Act promoted the importance of advancing precision 

medicine. NIH Director Francis Collins previously discussed the importance of 

knowing what medications work for what patients, iu what doses, and at what times. 

How can advances in precision medicine be used to assess risks associated with 

opioid use disorder and identify the most clinically appropriate treatments? What is 

the NIH doing to improve awareness of the treatment options for opioid use 

disorder and examining efficacy of different treatments? 

The 21st Century Cures Act provides support for the National Institute of Health's 

(NIH's) Precision Medicine Initiative (PM!) and the All of Us Research Program, which 

seeks to extend precision medicine to all diseases by building a national research cohort 

of one million or more U.S. participants. 1 This resource holds promise for understanding 

the lifestyle, environmental, and biological including genetic factors that may 

influence risk for addiction and treatment response to develop tailored therapies based on 

an individual's unique risk factors. Medical information related to substance use 

disorders (SUDs) may be subject to additional confidentiality protection under 42 CFR 

Part 2. In order to ensure that the All of Us cohort will be able to incorporate SUD 

treatment information, the National Institute on Drug Abuse (NIDA) program staff have 

been working closely with All of Us program staff to ensure that data that are subject to 

42 CFR Part 2 can be incorporated into this resource. 

Accelerating scientific research to address the ongoing opioid crisis is a top priority for 

NIH. To this end, NIDA has been part of a trans-NIH group coordinating with All of Us 

across all scientific domains, including Mentallleallh & Addiction and Sensm:v, Pain & 

Neurologic, with the long-term goal of creating precision approaches for both pain and 

opioid addiction treatment. 

In order to improve awareness of effective treatments for opioid use disorder, N!DA has 

published the report Medications to Treat Opioid Addiction2, providing a comprehensive 

overview of the current state of the science related to pharmacological treatments for 

1 https ://allofus.nih.gov /about/about-alI-us-research-program 2 https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioidaddiction/overview 

1 
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opioid use disorder (OUD). NIDA has also published data briefs to concisely present the 

evidence on the effective treatment options for opioid use disorder, including Effective 

Treatments for Opioid Addiction3 and Treating Opioid Use Disorder During Pregnancy.4 

Toward the goal of examining relative treatment efficacy of existing medications for 

OUD, the results of a NlDA-funded comparative effectiveness study are expected to be 

published in November 2017 in Ihe Lancet comparing buprenorphine/naloxone and 

extended release naltrcxone (XR-NTX). These results will complement findings from a 

smaller Norwegian study comparing outcomes for patients taking 

buprenorphinc/naloxone and those on XR-NTX. 5 

2. A recent study estimated that over half of the opioid prescriptions in the United 

States went to individuals with depression, anxiety and other mood disorders. 

According to the study, "after controlling for a wide array of other demographic 

and clinical risk factors ... having a mental health disorder [like depression or 

anxiety disorder] is associated with increased opioid use." Is it common for 

individuals with no prior history of substance abuse or comorbid psychiatric 

conditions to develop opioid use disorder? What research has the NIH performed to 

look into the possible connection between taking prescription opioids and the cooccurrence of opioid use disorder and mental health problems like depression or 

anxiety disorder? 

Many individuals who develop opioid use disorder do not have a prior history of mental 

illness or substance usc disorder. However, mental illness can contribute to the 

development of substance use disorders, and vice versa, and the same risk factors can 

impact both mental health and substance use. Because mood disorders increase 

vulnerability to drug use and addiction, the diagnosis and treatment of the mood disorder 

can reduce the risk of subsequent drug use. Because the inverse may also be true, the 

diagnosis and treatment of drug use disorders may reduce the risk of developing other 

mental illnesses and, if they do occur, lessen their severity or make them more amenable 

to effective treatment. Detailed information on the link between mental illness and 

substance use disorders is available in the NIDA Research Report entitled Comorbidity: 

Addiction and Other Mentallllnesses. 6 

It is important to note that many childhood risk factors for substance usc also increase 

risk for other psychiatric and behavioral problems, including conduct disorder, 

3 https://www.drugabuse.gov/publications/effective-treatments-opioid-addiction/effectivetreatments-opioid-addiction 

4 https://www.drugabuse.gov/publications/treating-opioid-use-disorder-duringpregnancy/treating-opioid-use-disorder-during-pregnancy 

5 Tanum, L., eta!. (2017), "The Effectiveness of Injectable Extended-Release Naltrexone vs 

Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Non inferiority 

Trial." JAMA psychiatry. 6 NIDA Research Report: Comorbidity: Addiction and Other Mental Illnesses, Available at: 

https://www.drugabuse.gov/sites/defaultlfiles/rrcomorbidity.pdf 

2 
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depression, and delinquency. 7 Shared genetic or biological risk factors may contribute to 

the emergence of mental illness and substance use, and symptoms of one may influence 

the development of the other. Prevention interventions often target these shared risk 

factors and have been shown to reduce risk for both substance use and addiction, as well 

as a range of behavioral health problems. 8 

NIDA, along with multiple NIH Institutes, Offices, and Centers, in pminership with the 

Centers for Disease Control and Prevention (CDC), is currently funding the Adolescent 

Brain Cognitive Development (ABCD) Study which is the largest long-term study of 

brain development and child health in the U.S, and the longitudinal nature of the study 

will help answer these questions. Because the ABCD Study is also collecting 

information about youth substance use, mental health, physical health, brain 

development, as well as cognitive and academic performance, scientists will be able to 

gain new insight into the connection between mental health and substance use disorders. 

The Honorable Bill Johnson 

1. The NIH has launched some initiatives to improve pain management education 

in medical, nursing, pharmaceutical, and dental schools. Can you give an update on 

the efforts of the Centers of Excellence in Pain Education (CoEPEs)'! 

The NIH Pain Consortium's Centers of Excellence in Pain Education (CoEPEs) program 

was first funded in the spring of2012. NIH is currently funding 11 academic institutions 

in the US that act as hubs for the development, evaluation and distribution of pain 

curriculum resources for medical, dental. nursing, pharmacy and other health professional 

schools to enhance and improve how health care professionals are taught about pain and 

its treatment. Case-based scenarios form the backbone of the curriculum resources and 

11 modules contain interactive digital elements to guide learners through with questions 

and answers, videos, and problem solving. There are currently six published case studies 

with five additional cases in the final stages of production. The CoEPEs facilities are 

now working on putting together proposals for eleven additional case studies for 2018. 

The CoEPE modules arc available through the NIH Pain Consortium Webpage 

(https://painconsortium.nih.gov/Funding Research/CoEPEs). Further, the Department of 

Health and Human Services (Dl-IHS) National Pain Strategy (NPS) provider education 

7 National Research Council (US) and Institute of Medicine (US) Committee on the Prevention 

of Mental Disorders and Substance Abuse Among Children, Youth, and Young Adults: Research 

Advances and Promising Interventions; O'Connell ME, Boat T, Warner KE, editors. Preventing 

Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities. 

Washington (DC): National Academies Press (US); 2009. Available from: 

https://www.ncbi.nlm.nih.gov/books/NBK32775/ doi: 10.1722611248 8 NIDA. Principles of Substance Abuse Prevention for Early Childhood. 2016. Available from: 

https://www.drugabuse.gov/publications/principles-substance-abuse-prevention-earlychildhood/index. 

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effort, which is in the process of implementation, proposes to use the CoEPEs as the basis 

of a larger national pain education effmi. 

2. Alternative, non-addictive analgesics could prevent addiction before it starts. I 

understand that NIH is conducting research into potential opioid alternatives. Can 

you talk about the work being done and how it might help combat the opioid crisis? 

In 2016 NIH spent $483 million on pain research ranging from cell and molecular 

mechanisms of acute and chronic pain to safe, effective therapy development, to large 

scale clinical trials. The portfolio includes many projects that address the pressing need 

to develop new non-opioid, non-addictive pain treatments. Studies range from earlystage drug target discovery focused on molecular pathways of pain signaling including 

exploration of receptors and channels as potential non-addictive analgesic targets to 

testing in behavioral models. A number of targets identified through NIH basic science 

research, such as the nerve growth factor receptor and pain-related ion channels, are now 

being pursued in industry sponsored clinical trials of non-addictive treatments. 

NIH is developing opioids with reduced risk of addiction and misuse. NIH-supported 

investigators arc developing new compounds that exhibit novel properties as a result of 

their combined activity at different opioid receptors (mu, delta, and kappa). Compounds 

with combined activity at the mu and delta receptors or at all three receptors can induce 

strong analgesia without producing tolerance or dependence in animal models. In 

addition, discovery of adjunct medications that can be combined with opioids to reduce 

the needed dose, promise to result in lower potential for dependence and addiction. 

Innovative methods are being explored for drug delivery to increase specificity and 

efficacy and to reduce analgesic side effects, as well as modified formulations to enhance 

delivery. 

NIH supports an initiative called the Blueprint Neurotherapeutics Program for small 

molecule drug discovery and development. For example, the National institute of 

Neurological Disorders and Stroke (NINDS) funds studies through this program that aims 

to develop non-addictive kappa opioid receptor antagonists for migraine and a safe, nonopioid analgesic that can be taken orally to reduce diabetic nerve pain. 

Other non-pharmacological approaches show promise for pain management. A tissuebased tool for screening potential migraine drugs is under development and a library of 

small molecules is being leveraged to screen for candidates for optimization as 

analgesics. Tissue engineering and regeneration to create tissue scaffolding and 

microcnvironments to promote wound healing and joint cartilage and intervertebral disc 

replacements is being applied to relieve pain. Neural stimulation technologies for 

chronic intractable pain are being improved. For example, wearable ultrasound devices 

and implantable micro-stimulators are being tested for peripheral and central nervous 

system targets to relieve pain. 

Evaluation and dissemination of complementary and integrative health approaches are a 

crucial component of quality pain management. NIH supported studies include 

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mechanism-based clinical studies on cognitive behavior therapy, exercise, yoga, 

acupuncture, massage and fitness, and mindfulness practices that are important 

components of the NIH federal pain research portfolio. 

The Honorable Chris Collins 

1. Despite the staggering overdose reports from my district's coroners and the CDC, 

opioids are still primarily used for the treatment of pain. It is estimated that around 

250 million Schedule II prescriptions are filled across the country each year. 

However, there arc other effective options for pain management. For example, 

several academic peer-reviewed journals have found that states that have legalized 

the use of marijuana for medical purposes had significantly lower state-level opioid 

overdose mortality rates ... and found that it was an effective form of pain 

management. Alternatively, anesthesia is utilized in various surgical and nonsurgical procedures to improve perioperative [preoperative, intraoperative, and 

postoperative) pain control while minimizing systemic opioid consumption. 

a. Under the Opioid State Targeted Response (STR) grants, are states using 

funds to educate physicians and providers on utilizing non-opiate treatment 

for pain? 

(SAMHSA Primary) 

2. CARA established the Pain Management Best Practices Inter-Agency Task Force to 

provide advice and recommendations for development of best practices for pain 

management and prescribing pain medication. The Task Force is also expected to 

develop a strategy for disseminating such best practices to relevant federal agencies [the 

Department of Veterans Affairs, Department of Defense, and Department of Health and 

Human Services] and the general public. 

a. What is the current status of the nominations process? As this is an advisory 

committee, to what degree do you expect providers to adopt these practices? Please 

explain. 

The Pain Management Best Practices Inter-Agency Task Force is being established by the 

Secretary of the Department of Health and Human Services in cooperation with the Secretary 

of V ctcrans Affairs and Secretary of Defense. The Office of the Assistant Secretary for 

Health (OASII) released a call for nominations for individuals to serve on the Task Force 

through the Federal Register on August 28, 2017. It is our understanding that the Office 

received hundreds of applications from qualified individuals, reflecting the high-level of 

interest in serving and indicating the significant attention directed to the task force. A careful 

and comprehensive tiered evaluation process was established for selection of the candidates. 

The breadth and quality of expertise of the nominees ensures that the membership 

requirements for balance and knowledge as outlined in CARA will be met. It is our 

understanding that OASH expects to complete the selection and approval process by the end 

of 2017 and to convene the first meeting of the committee early in 2018. 

The pain and opioid crises have highlighted the important role of this task force and 

generated intense interest in the committee's role and potential impact on pain management, 

including opioid prescribing practices. The committee can draw from the 2016 National Pain 

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Strategy which outlined a comprehensive program for pain management in the United States. 

Providers, especially those in primary care where most pain patients seek care, clearly are 

seeking better and more comprehensive clinical practice guidance for their patients with 

unmet needs for pain relief. It is expected therefore, that the task force recommendations will 

be disseminated and implemented broadly by the pain care community. 

3. NIDA's Principles of Drug Addiction Treatment was created to address 

addiction to a wide variety of drugs, including nicotine, alcohol, and prescription 

drugs. It was first printed in October 1999 and revised in December 2012. 

(a) Considering that robust new research has been published since that time, 

docs NIDA have plans to produce a fourth edition? 

(b) It has come to my attention that this document is not utilized by all 

health care providers and families with afflicted loved ones across the 

country. What can NIDA or Congress do to ensure that these types of 

resources are available to all stakeholders? 

NIDA is currently in the process of creating a Principles of Opioid Addiction Treatment 

guide, summarizing the current state of the science on medications and evidencesupported behavioral therapies for opioid use disorder. It is expected to be completed by 

the fall of2018. To ensure that information on evidence-based treatment is available to 

all stakeholders, NIDA also recently developed a Research Report on Medications for 

Opioid Addiction9 (released May 2017) and brief fact sheets for policymakers, hcalthcarc 

providers, and other stakeholders on the state of the science of medications for opioid 

addiction. 10 NIDA, along with the National Institute on Alcohol Abuse and Alcoholism 

(NIAAA) and SAMHSA, also helped support the development of the American Society 

of Addiction Medicine's ASAM Standards of Care, which was released in 2014. 

The Honorable Buddv Carter 

1. NIH is currently undertaking a public-private initiative to develop new nonopioid therapies. That initiative is designed to bring to market less-addictive options 

for patients. 1. Dr. Volkow, I know that NIH is currently working on a publicprivate initiative. What do you currently have in the pipeline as non-addictive 

alternatives'! 

Addressing the opioid crisis is a top priority for the Trump Administration and the 

Depatiment of Health and Human Services, including the National Institutes of Health 

(NIH). NIH supports a broad portfolio of research to develop and test strategies for the 

prevention and treatments of opioid use disorder (OUD). In addition, NIH is exploring a 

public-private collaborative research initiative to address the opioid crisis. The initial 

plan for this initiative was recently described by Drs. Collins and Volkow in the New 

England Journal of Medicine and includes three major areas for advancement: (I) safe, 

more effective, and non-addictive strategies for chronic pain management to prevent 

9 https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioidaddiction/overview 

10 https://www .drugabuse.gov /pub! ications/finder/t/902/pol icy-briefs 

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misuse of and addiction to prescription opioids; (2) new and innovative opioid addiction 

treatments to reduce drug use and support recovery; and (3) overdose reversal 

interventions to reduce mortality and promote access to treatment. 11 

To identify the scientific strategies with the greatest potential, NIH brought together 

innovative experts from government, industry, and academia for a series of three cuttingedge science meetings. Plans are underway to develop a draft strategy for collaborative 

activities including major goals of the initiative, action steps, key partners, deliverables, 

timeline, and resources (in-kind and financial costs) to fully carry out the proposed action 

steps. The Foundation for the National Institutes of Health will solicit input on the final 

draft from participants including Federal partners as well as other relevant stakeholders. 

Upon final approval ofthe plan, it will be posted on the NIH website at: 

https://www.nih.gov/opioid-crisis 

In 2016 NIH spent $483 million on pain research ranging from cell and molecular 

mechanisms of acute and chronic pain to safe, effective therapy development, to large 

scale clinical trials. The portfolio includes many projects that address the pressing need 

to develop new non-opioid, non-addictive pain treatments. Studies range from earlystage drug target discovery focused on molecular pathways of pain signaling including 

exploration of receptors and channels as potential non-addictive analgesic targets to 

testing in behavioral models. A number of targets identified NIH basic science, such as 

the nerve growth factor receptor and pain-related ion channels, are now being pursued in 

industry sponsored clinical trials of non-addictive treatments. 

NIH is developing opioids with reduced risk of addiction and abuse. NIH-supported 

investigators are developing new compounds that exhibit novel properties as a result of 

their combined activity at different opioid receptors (mu, delta, and kappa). Compounds 

with combined activity at the mu and delta receptors or at all three receptors can induce 

strong analgesia without producing tolerance or dependence in animal models. In 

addition, discovery of adjunct medications that can be combined with opioids to reduce 

the needed dose, promise to result in lower potential for dependence and addiction. 

Innovative methods are being explored for drug delivery to increase specificity and 

efficacy and to reduce analgesic side effects, as well as modified formulations to enhance 

delivery. 

NIH supports an initiative called the Blueprint Neurotherapeutics Program for small 

molecule drug discovery and development. For example, the National Institute of 

Neurological Disorders and Stroke (NINDS) funds studies through this program that aim 

to develop non-addictive kappa opioid receptor antagonists for migraine and a safe, nonopioid analgesic that can be taken orally to reduce diabetic nerve pain. 12 

11 Volkow, N.D. and F. S. Collins (2017). "The Role of Science in Addressing the Opioid 

Crisis." New England Journal of Medicine 377(4): 391-394. 12 

https :/I pro j ectrepo rter .nih. gov /project_ info_ descri ption.cfm ?ai d=93 25 694& i cde=36 5 286 5 8&ddp 

aram=&ddvalue=&ddsub=&cr=3&esb=default&cs=ASC&pball= 

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Other non-pharmacological approaches show promise for pain management. For 

example, new molecules arc being developed as analgesics and new tissue-based 

engineering tools are being used to develop microenvironments that promote wound 

healing. Additionally, joint cartilage and intervertebral disc replacements are being 

applied to relieve pain and neural stimulation technologies are being improved for 

chronic pain. For example, wearable ultrasound devices and implantable microstimulators are being tested for peripheral and central nervous system targets to relieve 

pain. 

Evaluation and dissemination of complementary and integrative health approaches are a 

crucial component of quality pain management. NIH supported studies include 

mechanism-based clinical studies on cognitive behavior therapy, exercise, yoga, 

acupuncture, massage and fitness, and mindfulness practices that are important 

components of the NIH federal pain research portfolio. 

2. Who are you currently working with and what's the timeline? Does there need to 

be a legislative fix to speed these alternatives to market? 

To fight the opioid crisis, an all hands-on deck strategy is needed. NIH is enlisting 

partners across government and the private sector to develop scientific solutions to this 

public health crisis. NIH is currently in the process of partnering with pharmaceutical 

companies, but the list of partners is not yet finalized. Regarding any legislative fixes, 

the Department of Health and Human Services is undergoing a department-wide process 

to identify what authorities or changes in statute would be helpful. 

The Honorable Susan Brooks 

l. I have heard you say that preventing drug usc before it begins is the is the most 

cost-effective way to reduce drug use and its consequences. In your opinion, what 

are the characteristics of successful prevention intervention programs? Besides lack 

of resources, what are the barriers to implementing intervention programs? 

The National Institute on Drug Abuse (NIDA) continues to fund a robust prevention 

portfolio that builds upon solid epidemiological findings and insights from genetics and 

neuroscience research, applying this knowledge to develop effective strategies to prevent 

initiation of drug use and escalation of use to addiction among youth. Highly effective 

evidence-based drug use prevention interventions and drug addiction treatment 

approaches have been developed and tested. These are well detailed in the Surgeon 

General's Report on Alcohol, Drugs and Health. 13 NIH's current prevention portfolio 

encompasses a broad range of research to (I) increase our understanding of the factors 

including genetic, psychological, and environmental that enhance or mitigate an 

13 Surgeon General's Report on Alcohol, Drugs, and Health. 2016. at 

https://addiction.surgeongeneral.gov/ 

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individual's risk for drug use and substance use disorders; and (2) develop and testing 

intervention strategies targeted to high-risk populations. 

For example, KEEP SAFE is a family-based and skill-focused program designed to 

prevent substance use and other related health risking behaviors among youth in foster 

care. Research indicated that the intervention significantly reduced substance use in 

foster youth at 18 months post-baseline and that the intervention influenced substance use 

through two processes: youths' improved quality of relationships with caregivers at 

6 months post-baseline and fewer associations with deviant peers at 12 months postbaseline. This suggests that these two processes may be important targets in substance 

use prevention programs for foster youth. 

Broad adoption of evidence-based prevention interventions has been limited due to 

implementation challenges that span financial, regulatory, geographic, attitudinal, and 

logistical issues. Ongoing research is working to develop strategies to translate evidencebased practices in a way that confers population-level impact, 14 including for developing 

implementation capacity, and implementation and sustainability of evidence-based 

practices across systems and settings. For example: 

Organizational and system supports for evidence-based implementation 

• Work-foree development and training 

• Ongoing fidelity monitoring 

• Continuous quality improvement 

• Financing 

In addition, NIH supports basic research to understand the impact of drug use during 

adolescence on brain development. Adolescence is a period of intense brain and 

cognitive development. During this time, one's environments, experiences, and 

exposures shape brain structure and function, and ultimately adult identity. Brain 

research, particularly in the last decade, has opened new windows to understanding the 

adolescent brain, but there is much we still do not know about the normal trajectory of 

brain development during adolescence and the many experiences that may enhance or 

disrupt it, such as substance use. To address this gap, Nil I, in partnership with the 

Centers for Disease Control and Prevention (CDC), is funding the landmark Adolescent 

Brain Cognitive Development (ABCD) Study 15 , a multi-site, longitudinal investigation of 

l 0,000 children from ages nine and ten into early adulthood. As of October 2017, over 

6,500 youth have enrolled in the study. The actionable information coming out of this 

study will be a foundation upon which to develop and refine substance use prevention 

and treatment as well as other health promotion interventions that are rooted in a deep 

understanding of the neurobiological and psychosocial factors that influence adolescent 

health and wel!ness to optimize the wellbeing and success of our Nation's children. 

14 Spoth R, Rohrbach LA, Greenberg M, eta!. Addressing core challenges for the next 

generation of type 2 translation research and systems: the translation science to population 

impact (TSci Impact) framework. Prev Sci 20 13; 14:319-51. 15 http://abcdstudy.org/indcx.html 

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In particular, more research is needed to improve strategies for prevention of risky drug 

use among those aged 18-30, and to develop evidence-based strategies for the prevention 

of opioid misuse that preserve access to effective pain management. In addition, more 

research is needed to develop strategies for transforming health systems and other public 

and private service platforms for successful integration of sustainable, evidence based 

drug usc prevention interventions. 

Finally, NIH would like to note that this year, a new study called the Advancing Clinical 

Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) will evaluate treatment 

options and improve clinical care of infants with Neonatal Abstinence Syndrome 

(NAS)/NOWS. The study is a collaboration between the Eunice Kennedy Shriver 

National Institute of Child Health and Human Development's (NICHD's) Neonatal 

Research Network (which has 30 years of experience in conducting clinical trials with 

newborns) and the new IDeA States Pediatric Clinical Trials Network (within the NIH 

Office of the Director's Environmental Influences on Child Health Outcomes (ECHO) 

Program), with sites located in rural and medically underserved communities. This joint 

research effort will use the reach of both networks to assess the prevalence ofNAS, 

understand current approaches to managing NOWS cases (including nonpharmacological approaches), and develop protocols for conducting large scale studies 

across the country to inform clinical care for affected infants. 

2. Please describe the NIDA-supported research that is investigating how to 

improve access to treatment for incarcerated individuals. How is NIDA working 

with state and local communities on this particular problem? 

NJDA's Juvenile Justice Translational Research on Interventions for Adolescents in the 

Legal System (.JJ-TR!ALS) cooperative was established in 2013 and is composed of six 

research centers and one coordinating center. The main study is a randomized trial that 

involves 36 sites in seven states and aims to test the eftectivencss of two implementation 

strategies for promoting system-wide change to improve the continuum of substance use 

services for juvenile offenders under community supervision. 16 JJ-TRIALS has led to the 

development of the Juvenile Justice Behavioral Health Services Cascade, a framework 

for measurement of unmet substance use treatment needs that can be used to identify 

services delivery needs and develop strategies to address them. 17 

Beyond juvenile populations, NlDA currently is funding research to test the feasibility 

and utility of depot formulations of buprenorphine and naltrexonc to prevent relapse to 

16 Knight DK, Belenko S, Wiley T, eta!. Juvenile Justice-Translational Research on 

Interventions for Adolescents in the Legal System (JJ-TRIALS): a cluster randomized trial 

targeting system-wide improvement in substance use services. Implementation Science : IS 

2016;11:57. 

17 Bclenko S, Knight D, Wasserman GA, eta!. The Juvenile Justice Behavioral Health Services 

Cascade: A new framework for measuring unmet substance use treatment services needs among 

adolescent offenders. Journal of Substance Abuse Treatment; 74:80-91. 

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opioid usc and recidivism in incarcerated opioid-dependent individuals. 18 Barriers to 

care also are being investigated, with research specific to the difficulties that justiceinvolved veterans have in accessing medications for Opioid Use Disorder (OUD) 19 and 

development of eLearning tools to improve attitudes toward medications in drug and 

felony courts.20 

The period of transition from incarceration to community living can cause disruption in 

care for substance use disorders and for associated health conditions such as HIV and 

Hepatitis C. NIDA funds research to identify barriers and facilitators of linkage to care 

following incarceration, along with research to develop interventions to improve care 

continuity, reduce overdose risk, and identifY factors specific to vulnerable subpopulations. This research includes: 

Development of an intervention to support initiation of buprcnorphine or 

methadone treatment following release from incarceration21 •

22 ; 

• Evaluation of pre-release initiation of extended-release naltrexone (XR-NTX) 

followed by post-release home visits for XR-NTX injection delivery23; 

• Development of a program to optimize HIV treatment outcomes for women under 

community correctional supervision2

\ and 

• Development and testing of behavioral interventions to reduce risky behaviors 

and improve treatment adherence post-release. 25.26 

3. In your opinion, what are the most pressing gaps in data collection that must be 

addressed in order to stem the tide on this crisis? We hear a lot about the 

underreporting of overdose deaths- what are the contributing factors that lead to 

underreporting and inaccurate reporting and what is NIDA doing to address that? 

(CDC Primary) 

18 4UOIDA034743-04-DEPOT PHARMACOTHERAPIES FOR OPIOID-DEPENDENT 

OFFENDERS: OUTCOMES AND COSTS 19 1 R21DA041489-0 1 A I-IMPROVING ACCESS TO PHARMACOTHERAPY FOR OPIOID 

USE DISORDER AMONG JUSTICE INVOLVED VETERANS 20 5R34DA038799-03-FACILITATING MAT ACCEPTANCE & IMPLEMENTATION IN 

PROBLEM SOLVING & FELONY COURTS 21 5K23DA034541-06-BUPRENORPHINE FACILITATED ACCESS AND SUPPORTIVE 

TREATMENT IN FORMER INMATES 22 5K24DA022112-l0-HIV AND ADDICTIONS AMONG CRIMINAL JUSTICE-INVOLVED 

POPULATIONS 

23 5RO!DA040636-02- LONG-ACTING NAL TREXONE FOR PRE-RELEASE PRISONERS: 

A RANDOMIZED TRIAL OF MOBILE TREATMENT 24 4K23DA033858-05- EVALUATING AND IMPROVING HIV OUTCOMES IN 

COMMUNITY-BASED WOMEN WHO INTERFACE WITII 25 5ROIDA025885-09-SUSTAINABLE HIV RISK REDUCTION STRATEGIES FOR CJ 

SYSTEMS 

26 I R36DA043393-0 I A 1- ADDRESSING OVERDOSE RISK AMONG RECENTLY 

INCARCERATED PEOPLE LIVING WITH HIV/AIDS 

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4. Please describe any current or planned programs in which NIDA would 

collaborate with state governments to scale-up evidence-based research in 

prevention or treatment. 

NIDA-funded researchers are partnering with states to examine the strategies that are 

being used to increase access to opioid use disorder medications through the SAMHSA 

State Targeted Response to the Opioid Crisis Grants that were funded through the 21st 

Century Cures Act. Five NIDA-funded research projects will help evaluate: 

• The creation and deployment of the Patient Decision Aid for Medication-Assisted 

Treatment (PtDA- MAT), a patient-centered decision tool to promote the use of 

medications, assess patient values and preferences, and incorporates scientific 

evidence to increase patients' understanding of possible medication risks, benefits, 

alternatives, and their associated outcomes. 27 

• The Recovery Initiation and Management after Overdose (RIMO) protocol for 

individuals who are revived from an opioid overdose. The protocol is initiated 

within a week of nonfatal overdose and includes assertive recovery supports and 

facilitates linkage with evidence-based treatment for OUD using medications. 28 

• Planned Outreach, Intervention, Naloxone, and Treatment (POINT), an 

emergency department-based outreach program for engaging opioid overdose 

survivors in Indiana with treatment. Recovery coaches are deployed to 

emergency departments to assist patients with accessing medication-assisted 

treatment after discharge from the emergency departmcnt. 29 

• A Rhode Island initiative is focused on expanding the medication assisted 

treatment workforce by developing and testing a pharmacist-delivered 

intervention for the management of patients who are stable on medications. This 

model will also be relined and tested to provide continuity in medication assisted 

treatment for patients who are being released from incarceration. 30 

• The Hub & Spoke model for provision of medication assisted treatment in 

primary care settings. This model is being tested in Washington state with a study 

that focuses on adults with OUD who are covered by Medicaid. 31 

In addition, NIDA has partnered with states and several other federal agencies to address 

the opioid crisis in rural U.S. regions, issuing funding opportunities to help communities 

27https://projectreporter.nih.gov/projcct info description.cfm?aid=95 13338&icde=36846083&d 

dparam=&ddvalue=&ddsub=&cr= I &csb=default&cs=ASC&pball= 28https://projectreporter.nih.gov/project info description.cfm?aid=95 11 074&icde=36846!31 &d 

dparam=&ddval ue=&ddsu b=&cr= 1 &csb=default&cs= ASC&pba II= 29https://projectreporter.nih.gov/project info description.cfm?aid=95 13197&icde=36846207&d 

dparam=&ddvalue=&ddsub=&cr= 1 &csb=defau lt&cs= ASC&pball= 30https://projectreporter.nih.gov /proiect info description.cfm?aid=95 13201 &icde=36846245&d 

dparam=&ddvalue=&ddsub=&cr=4&csb=default&cs=ASC&pball= 

3 1https://projectreporter.nih.gov/projcct info description.cfm?aid=95 13139&icde=36846292&d 

dparam=&ddvalue=&ddsub=&cr=2&csb=default&cs=ASC&pball= 

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develop ways to comprehensively prevent and treat Substance Usc Disorder (SUD), 

overdoses, and infectious disease transmission related to injection drug use. These 

projects support the work of state and local communities in developing best-practice 

responses that rural public health systems can implement. The grants are co-funded by 

the Appalachian Regional Commission, the Centers for Disease Control and Prevention 

(CDC), and the Substance Abuse and Mental Health Services Administration 

(SAMHSA). 

The Honorable Ben Ray Lnjan 

In 2015, 33,000 Americans died from opioids. According to the CDC, almost half of 

those deaths were from prescl'iption opioids. The New York Times reports that in 

2016, overdoses from all drugs was the leading cause of death of people under the 

age of 50. Drug overdoses now kill more Americans each year than at the height of 

the HIV epidemic and the worst year for auto accident deaths. The Times and drug 

use experts attribute the sharp rise in all drug overdose deaths to the rise of opioids. 

What we need to fight this epidemic is continued and reliable long- term 

investments in prevention, treatment, recovery, and monitoring. 

The President's budget proposal for fiscal year 2018, coupled with other 

administration initiatives, takes several steps back in the fight against opioid 

addiction, including a cut in funds for SAMHSA. Overall, the President's proposed 

budget cuts HHS by 16.2 percent, the CDC by 17 percent and NIH by 19 percent. It 

cuts funding for addiction research, treatment and prevention. Even the White 

House Office on National Drug Control Policy would take a 95 percent hit. 

1. Director Volkow, do you have all of the tools you need to stop the opioid 

epidemic? 

To fight the opioid crisis, an all hands-on deck approach is needed. NIH is enlisting 

partners across government and the private sector to deliver scientific solutions to this 

public health crisis. Regarding tools we may need, the Department of Health and Human 

Services is undergoing a department-wide process to identify what authorities or changes 

in statute would be helpful. 

2. Given the 19 percent cuts to NIH in the President's budget proposal, what 

programs relating to the opioid epidemic will be cut? Which programs would have 

been expanded that will now not be? 

Addressing the opioid crisis is a top priority for the Department of Health and Human 

Services, including Nlll. We will prioritize research to develop solutions for this crisis 

and strive to accelerate progress as quickly as available resources will allow. 

The Honorable Frank Pallone, Jr. 

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1. Dr. Volkow and Dr. McCance-Katz I would like to ask you a few questions 

related to treatment approaches for opioid use disorder. I have been particularly 

struck by stories of individuals with opioid use disorder and families who have been 

targeted and referred to low quality and non-evidence-based treatment services. As 

I'm sure you're aware, in many cases, this has led to tragic consequences upon 

leaving such programs. 

(a) Dr. Volkow and Dr. McCance-Katz- I understand that the evidence is 

clear that medication-assisted treatment is the gold standard of opioid use 

disorder treatment. What are some of the barriers of widespread uptake for 

this treatment approach? 

(b) What is the difference between this and other chronic conditions as far as 

uptake of evidence-based medical care? And could you dispel some of the 

stigma that exists about the use of medications to treat this chronic condition 

that doesn't exist for the use of medications to treat like diabetes or heart 

disease? 

(c) What are you doing to increase awareness among the general public and 

the medical community about these evidence-based approaches to opioid use 

disorder? 

(a) Medication-Assisted Treatment (MAT) has been adopted in less than half of privatesector treatment programs, and even in programs that do offer MAT, only 34.4 percent of 

patients with opioid use disorder (OUD) receive itY The barriers are many, including a 

limited number of trained prescribers and settings in which people with OUD can obtain 

treatment; negative attitudes and misunderstandings about MAT held by the public, 

providers, and patients; and policy and regulatory barriers. Although there are currently 

over 45,000 DEA-registercd Data Waive practitioners and over l ,600 DEA-registered 

narcotic treatment programs throughout the U.S., those are mainly focused on highlypopulated, metropolitan areas and limited access still exists in more scarcely-populated 

areas of the country. 

In the past, the only medication available to treat opioid addiction was methadone and it 

was available only through opioid treatment programs, which were separate from the rest 

ofhealthcare. With the approval ofbuprenorphine in 2002 and then naltrexone in 2010, 

MAT became available from office-based physicians. However, clinicians may 

administer buprcnorphine only if they hold special waivers. There remains a shortage of 

qualified, waivered physicians able to deliver buprenorphine. 

For decades, a common concern was that maintenance therapy (methadone and, more 

recently, buprenorphine) "substitutes one addiction with another," a legacy of older, 12-

step models of recovery that avoided all use of medications. Despite common myths, 

when someone is treated with methadone or buprenorphine the dosage of medication 

used docs not produce euphoria, it helps to control cravings and withdrawal symptoms in 

32 Knudsen HK, Abraham AJ, Roman PM. Adoption and implementation of medications in 

addiction treatment programs. J Addict lvfed. 2011 ;5(1 ):21-27. 

doi: I 0.1097/ADM.Ob013c318ld4lddb. 

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opioid-dependcnt patients, thus enabling them to function at work, in family life and 

relationships, and participate in treatment. These medications restore balance to the brain 

circuits that have been dysrcgulatcd by addiction, allowing the patient's brain to heal 

while they work towards recovery. Unfortunately, provider skepticism still contributes to 

low adoption of MAT; this skepticism also contributes to systematic prescription of 

inadequate doses or inadequate duration of treatment. ll 

Other impediments have to do with public and private insurance coverage. Most 

commercial insurance plans cover some opioid-addiction medications-most commonly 

buprenorphine-and Medicaid can cover buprcnorphine and methadone in every state. 

However, even when MAT is covered, insurers (including Medicaid programs or their 

managed-care organizations) may impose limits on dosages prescribed, annual or lifetime 

medication limits, initial authorization and reauthorization requirements, minimal 

counseling coverage, and "fail first" criteria requiring that other therapies be attempted 

first 34 These structural impediments synergizc with attitudinal ones, for instance by 

encouraging insufficient dosing/duration, which causes treatment to fail, which leads to a 

perception that MAT is not effective. Also, few private insurance plans cover extendedrelease naltrcxone, and most do not cover methadone provided through opioid treatment 

programs. 

(b) Although cost of medication may sometimes constitute impediments to obtaining 

high-quality treatment for other diseases, no other common, devastating health condition 

has so many barriers to care that in one way or another come down to stigma-against 

the disease and against the idea of treating it as a medical condition. Abundant research 

has made clear that MAT, when delivered at a clinically appropriate dose, reduces illicit 

opioid usc, risk of relapse and overdose, risk of infectious disease transmission, and 

associated criminality. 

(c) To dispel misconceptions about MAT and educate the public and providers about 

MAT's effectiveness in treating OUD, the National Institute on Drug Abuse (NIDA) has 

produced a range of web-based materials on MAT including a Research Report on 

Medications for Opioid Use Disorder35 (released May 2017) and brieffaet sheets for 

policymakers, healthcarc providers, and other stakeholders on the state of the science of 

medications for opioid addiction. 36 NIDA has also published extensively on the need for 

expanded access to MAT in professional publications and the popular press. NIDA has 

also partnered with other federal agencies to promote access to MAT, for instance the 

2016 Surgeon General's Report on Alcohol, Drugs, and Health, and SAMHSA's 

upcoming Principles of Mental Health and Substance Use Disorder Treatment for 

Criminal Justice Populations. 

33 http://www.nejm.org/doi/ref/1 0.1 056/NEJMp 1402780#t=references 34 Clark RE, Baxter JD. Responses of state Medicaid programs to buprenorphine diversion: 

doing more harm than good? JAMA Intern Med 2013; 173:1571-1572. 35 https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioidaddiction/overview 

36 https://www.drugabuse.gov/publications/finder/t/902/policv-briefs 

15 
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GREG WAtDEN. OREGON 

CHJ\IRM!\N 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW ,IEHSEY 

RANKING MEMBEB 

((ongress of tbe 'mlnttel:J i->tates 

;1!)otu.ir of l\tprt!itntatibeli 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

Mr. Neil Doherty 

Deputy Assistant Administrator 

Office of Diversion Control 

Drug Enforcement Administration 

8701 Morrissette Drive 

Springfield, VA 22152 

Dear Mr. Dohe11y: 

M~)ontv (20ll ns~::i'9n 

M<ntl!H\1 \2D2l275-::l641 

November 17,2017 

Thank you for appearing before the Subcommittee on Health on October 25, 2017, to testify at 

the hearing entitled "Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other 

Initiatives." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (I) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on December 5, 2017. Your responses should be mailed to Zack 

Dareshori, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office 

Building, Washington, DC 20515 and e-mailed in Word format to zack.dareshori@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Committee. 

Sincerely, 

Chainnan 

awi!~ 

cc: The Honorable Frank Pallone, Jr., Ranking :vtcmber 

Attachment 
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Office of the Assistant Attorney General 

The Honorable Greg Walden 

Chairman 

Committee on Energy and Commerce 

U.S. House of Representatives 

Washington, DC 20515 

Dear Mr. Chairman: 

U.S. Department of Justice 

Office of Legislative Affairs 

Washington, D.C. 20530 

MAY 0 7 2018 

Enclosed please find responses to questions for the record arising from the appearance of 

Neil Doherty, Deputy Assistant Administrator of the Office ofDivcrsion Control for the Drug 

Enforcement Administration, before the House Committee on Energy and Commerce on October 

25,2017, at a hearing entitled "Federal Efforts to Combat the Opioid Crisis: A Statos Update on 

CARA and Other Initiatives." We hope that this information is of assistance to the Committee. 

Please do not hesitate to contact this office if we can be of additional assistance regarding 

this or any other matter. The Office of Management and Budget has advised us that there is no 

objection to submission of this letter from the perspective of the Administration's program. 

Enclosure 

cc: The Honorable Frank Pallone 

Ranking Minority Member 

Sincerely, 

Prim 

17~&~ F. Escalona 

Principal Deputy Assistant Attorney General 
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QUESTIONS FOR THE RECORD 

NEIL DOHERTY 

DEPlffY ASSISTANT ADMINISTRATOR 

OFFICE OF DIVERSION CONTROL 

DRUG ENFORCEMENT ADMINISTRATION 

DEPARTMENT OF JUSTICE 

HOUSE COMMITTEE ON ENERGY AND COMMERCE 

HEARING ON 

"FEDERAL EFFORTS TO COMBAT THE 0PIOID CRISIS: A STATUS UPDATE ON CARA AND OTHER 

INITIATIVES" 

OCTOBER 25, 2017 

Questions Posed by Representative Adam Kinzinger 

!. With respect to Prescription Drug Monitoring Programs, what issues should we be aware 

of regarding PDMP access by law enforcement personnel? 

RESPONSE: As you know, prescription drug monitoring programs (PDMPs) are 

state-run electronic database systems used by practitioners, pharmacists, medical 

and pharmacy boards, and, where permitted, law enforcement, but access varies 

according to state law. These programs are established through state legislation and 

are tailored to the specific needs of each state. The Drug Enforcement 

Administration (DEA) strongly supports robust PDMPs and encourages medical 

professionals to use this important tool to detect and prevent doctor shopping and 

other forms of diversion. Currently, 49 states have an operational PDMP. Missouri 

will become the sotb state to have an operational PDMP, pursuant to the Governor's 

Executive Order in July 2017. As of January 2018,40 of these 49 states with 

operational PDMPs require controlled substance prescribers to use the state's PDMP 

prior to prescribing a controlled substance in certain circumstances as mandated by 

each state's legislation. 1 The DEA encourages all practitioners and pharmacists to 

use their state PDMPs. 

PDMPs are valuable tools for prescribers, pharmacists, and law enforcement 

agencies to identify, detect, and prevent nonmedical prescription drug use and 

diversion. Law enforcement access to request, view, and utilize PDMP data in 

support of ongoing investigations in a manner that protects personally identifiable 

information (PII) is vital. Access to information in support of active state and 

federal investigations varies widely from state to state, with some states requiring a 

court order in order for law enforcement to obtain data. These requirements can 

hinder DEA's investigations of those who are operating outside of the Controlled 

1 PDMP Center ofExceltence, Brandeis University. hlln.:!/~~J?.9JTIP~~Q_r_g[m!.(!Mund.\it9JY ..... QJ,lf!:.'L.._Cgn_Qjtiqns_~illaOl02.ruif retrieved March 6. 2018. 
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Substances Act (CSA) and may affect DEA's ability to effectively protect the public 

health and safety. 

Ouestjons Posed by Representative Bill Flores 

2. A serious problem in the opioid epidemic is synthetic drugs. The DEA released its 2017 

National Drug Threat Assessment Monday. One of the findings was, and I quote, 

"Overdose deaths, already at high levels, continue to rise. The increased mixing of 

heroin with analogues of the highly-potent synthetic opioid fentanyl and other synthetic 

opioids has exacerbated this situation." 

Our colleague, Mr. Katko of New York, testified before this committee earlier this 

month about a bill he has that help protect our communities from synthetics and 

analogues. Now, there is still work to be done on his proposal- which has passed the 

Judiciary Committee, I should note. 

• Mr. Doherty, has the DEA focused any attention on providing technical 

comments on the Katko bill, titled the Stop the Importation and Trafficking of 

Synthetic Analogues Act- or SITSA for short? 

RESPONSE: Yes. The Department of Justice (the Department) and DEA have 

provided extensive technical assistance on SITSA to both the House and the Senate. 

The Department and DEA welcome any additional tools that Congress can provide 

to assist DEA in combating the opioid epidemic. In the interim, DEA will continue to 

utilize all available tools, including temporary scheduling of substances as authorized 

by 21 USC Sll(h). In fact, on November 9, 2017, the Department and DEA 

announced that we intended to take immediate action against the flow of illicit 

fentanyl analogues into this country and the alarming increase in overdose deaths 

linked to synthetic opioids by scheduling all fentanyl-related substances on an 

emergency basis. The "notice of intent" was published in the Federal Register on 

December 29, 2017. The final order was published in the Federal Register on 

February 6, 2018, and made effective on that date. Pursuant to this final order, 

anyone who possesses, imports, distributes, or manufactures any illicit fentanyl 

analogue will be subject to criminal prosecution in the same manner as for fentanyl 

and other controlled substances. This critical scheduling action will make it easier 

for federal prosecutors and agents to prosecute traffickers of all forms of fentanylrelated substances. 

3. Are there tools that the DEA has requested from Congress to help combat synthetics? 

RESPONSE: DEA and the Department have provided technical assistance to both 

the House and Senate regarding SITSA, which would be a useful tool to combat the 

proliferation of synthetic analougues. As mentioned in the response to the previous 

question, DEA continues to utilize its regulatory authority to place many synthetic 

substances into Schedule I of the CSA pursuant to the aforementioned temporary 

scheduling authority. 

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4. I understand Jaw enforcement desires additional scheduling authorities, while 

researchers have concerns with how this may unintentionally impact the scientific 

community's ability to study compounds for groundbreaking medications. 

• Is there a way we can strike a balance of scheduling these rapidly-multiplying 

analogues in a timelier manner while also protecting the important work being 

done by scientific researchers? 

RESPONSE: The introduction of new drugs of abuse is causing unprecedented 

harm to our communities and scheduling is an important tool DEA uses to protect 

the public from the trafficking and diversion of these harmful substances. It bears 

repeating that scheduling does not prevent DEA-registered researchers from 

conducting research on the substances. DEA agrees that it is important for the 

research community to have access to these novel psychoactive substances and 

DEA strongly supports research with controlled substances, including those in 

schedule I of the CSA. This research informs regulatory and policy decisions. 

Indeed, the process of drug scheduling requires the Department of Health and 

Human Services (HHS) to evaluate the research and provide DEA with a binding 

recommendation regarding the control of a substance. The scientific evidence 

remains critical to both the drug scheduling and the approval process. As a 

provider of this binding control recommendation and a primary source for 

funding, HHS should continue to maintain a robust role. The procedures that 

must be followed to apply for a DEA registration to conduct research with a 

schedule I controlled substance are set forth in 21 C.F.R. 1301.18. 

DEA has taken steps to simplify the research application process, including 

the introduction of a new electronic system through which applications can be 

submitted, and will continue to work with the research community to ensure 

applications arc processed in a timely manner. DEA has granted every application 

received for bona fide research with a schedule I controlled substance, and as of 

March 18, 2018 there are 601 DEA-registered schedule I researchers. 

DEA worked with the Department to provide formal technical assistance on 

SITSA. During that time, DEA and HHS engaged extensively in order to 

understand its concerns related to permanent scheduling and research under 

SITS A. 

Ouestjons Posed bv Representative Chris CoUins 

5. As PDMPs have evolved in recent years, incorporating PDMP data into a 

prescriber or pharmacist's clinical workflow seems to be the key to ensuring that 

the data is used effectively while also increasing efficiency and saving time for 

providers. What are the barriers currently preventing more states from 

incorporating PDMP data into clinical workflow? 

RESPONSE: DEA agrees that integrating PDMP data into electronic health 

records to better inform the prescriber and pharmacist before a prescription 

3 
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is dispensed is a best practice. However, DEA is not aware of barriers that 

are currently preventing states from incorporating POMP data into clinical 

workflow and respecfully defers to HHS. 

6. We know that the "moment of clarity" when a patient realizes they need to go into 

treatment can be short-lived, and having resources in place to immediately connect 

patients to treatment is critical to the chances of recovery. When a POMP does indicate a 

patient has been "doctor shopping" and potentially has a substance use disorder, what 

policies are in place to direct them to treatment if they wish to go? If none exist, how 

could we help encourage them to access treatment at that time? 

RESPONSE: DEA is not aware of any policies aimed at directing patients to 

treatment and would respectfully defer to the Bureau of Justice Assistance 

(BJA) or HHS. Although there arc no policies mandating referral to 

treatment, DEA is not aware of anything to prohibit health professionals who 

currently have access to POMP information to engage in intervention and 

referral to treatment. DEA defers to the Substance Abuse and Mental Health 

Services Administration (SAMHSA) to explore the expanding practice of 

screening, brief intervention, and referral to treatment among health 

professionals. Additionally, DEA plays a role in supporting effective drug 

treatment of persons with opioid use disorders through providing waivers and 

certifications to physicians, physician assistants, and nurse practitioners to 

dispense/administer medications approved by the U.S. Food and Drug 

Administration (FDA) for addiction treatment- buprenorphine, naltrexone, 

and methadone in certain settings. 

7. a. Some states such as Massachusetts have started using data as a weapon in the fight 

against opioids. They are combining data from prescription records, death records, 

medical examiners ... even prisons. For example, they found that a person who is released 

from jail in Massachusetts has a 56 times greater chance of dying from an overdose than 

the average person. They are using that infonnation to make better policy decisions, as 

well as to identify specific individuals who are in need of services. States are supposed to 

be the laboratories of democracy. What has the CDC learned from states in their use of 

data analytics? 

RESPONSE: DEA respectfully defers to the Centers for Disease Control and 

Prevention (CDC) for a response. 

b. Is there a plan to use data to fight the opioid cri~i~? 

RESPONSE: DEA uses data when pursuing actions against those who violate the 

CSA. For example, the Automation of Reports,and Consolidated Orders System 

(ARCOS) is the electronic system in which manufacturers and distributors report 

the manufacture, sale, purchase, loss, or other disposition of certain controlled 

substances. ARCOS is an important tool in both DEA's law enforcement mission 

and its regulatory mission. DEA field elements use ARCOS to assist investigators 

with accountability audits during onsite regulatory investigations and also to review 

4 
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and verify specific registrant's activities and reporting accuracy. A unit within the 

Diversion Control Division's Pharmaceutical Investigations Section uses aggregated 

ARCOS data to identify patterns and trends in the flow of narcotic controlled 

substances through the closed system of drug distribution created by the CSA. This 

unit performs quality control reviews of ARCOS data and then uses validated 

ARCOS data to detect anomalies and identify leads. This unit is now proactively 

preparing reports for each of DEA's 22 Field Divisions to prioritize DEA's limited 

resources in furtherance of criminal, civil, and regulatory investigations. DEA 

shares ARCOS data with its federal, state, local, and trihallaw enforcement and 

regulatory counterparts who have a need to know and are operating in coordination 

with DEA for investigative purposes. In addition to ARCOS data, DEA registrants 

are required under current regulations to report the theft or significant loss of 

controlled substances. Each report is fully investigated and this data also informs 

DEA's decision making and resource prioritization. 

In addition to data that is collected by DEA pursuant to the CSA, we are also 

engaging with both federal and state partners on data sharing agreements to 

enhance our efforts. DEA is currently working with a coalition of States Attorneys 

General (Coalition) to develop an information-sharing agreement in support of 

ongoing investigations that the Coalition has initiated. This information sharing 

agreement will include the sharing of ARCOS data with States and in return, those 

States who can, will share data from PDMPs in support of active DEA 

investigations. DEA has also been working with HHS on an information sharing 

agreement. HHS's Office of Inspector General (OIG) has been sharing with DEA 

information from HHS's OIG analytics for the Medicare Program. DEA has 

already received data from HHS regarding the Part D prescription program that is 

being utilized alongside additional data in support of ongoing matters. 

Finally, in line with the Department's Opioid Fraud and Abuse Detection Unit 

(a Department pilot program announced in August, 2017), the Department, DEA, 

Federal Bureau oflnvestigation (FBI), and counterparts at HHS are utilizing 

advanced data-analytics to combat the opioid crisis. As part of this program, the 

Department has dedicated experienced prosecutors for a three-year term in twelve 

districts, who will focus solely on investigating and prosecuting health care fraud 

related to prescription opioids, including pill mill schemes and pharmacies that 

unlawfully divert or dispense opioids for illegitimate purposes. 

Questions Posed by Representative Buddy Carter 

8. Under CARA, prescribers can write up to three 30-day prescriptions without any 

refills. You can look into how pharmacists could play a larger role and ways to 

address prescriber behavior. 

Additionally, you can ask questions about limiting prescriptions for acute pain needs, 

such as dental work or minor surgeries with the possibility for a limited refill. 

Mr. Doherty, under CARA, prescribers were allowed to write up to three 30-day 

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prescriptions for a patient but no refills. While CARA took some great steps forward, I 

think it's worth taking another look at its progress and ways to improve the program. 

One area I'd like to raise would be limiting prescriptions for acute pain procedures and 

needs. As a pharmacist, I've seen people come in with 30 day prescriptions for minor 

dental procedures. Have you looked in to that possibility and what would be the DEA's 

outlook on such a move? 

RESPONSE: DEA bas reviewed CARA and could not locate a provision 

authorizing prescribers to write up to three 30-day prescriptions for a patient with 

no refills. The question may be referring to a final rule on the "Issuance of 

Multiple Prescriptions for Schedule II Controlled Substances," which DEA 

published in the Federal Register on November 19, 2007. (72 FR 64929) This rule 

allowed prescribers to issue three sequential prescriptions at one time for a 

schedule II controlled substance, effectively allowing a patient to be issued 

prescriptions for a 90-day supply of controlled substances. 21 C.F.R. 1306(b). 

DEA does not dictate what quantities of controlled substances constitute a 30-day 

supply, as DEA does not regulate the practice of medicine. 

With regard to limiting prescriptions for acute pain, DEA notes that the 

CDC published guidance to prescribers suggesting that three days or less of an 

opioid medication will often be sufficient for acute pain. DEA does not dictate the 

amount of a controlled substance that a prescriber should authorize as these 

clinical decisions are the direct result of the doctor's clinical training and the result 

of his/her evaluation of the patient's particular needs. 

Finally, DEA provided technical assistance on the provision in CARA that 

authorized prescribers and patients to request a partial fill of a prescription for a 

schedule II controlled substances. This provision authorizes a patient or 

practitioner to request that the pharmacist only dispense a portion of the quantity 

prescribed, and be/she may request the remainder of the quantity prescribed to be 

dispensed within 30 days. This provision was intended to reduce the amount of 

unused and unwanted opioids outside of the drug supply chain, i.e., in people's 

homes. 

9. Would the DEA be willing to look at reducing the number of prescriptions for opioids 

and allowing for one, limited refill of the prescription? I believe it could help to reduce 

the amount in circulation as well as address some of these accessibility needs we've 

brought up through take-back programs. 

RESPONSE: It is not clear bow authorizing one limited refill of a schedule II 

controlled substance would result in a reduction in the number of prescriptions 

written and the amount of controlled substances in circulation. The refilling of a 

prescription for a controlled substance listed in schedule II is prohibited under 

Federal law. 21 USC §829(a). 

I 0. October 28th is the 14th National Drug Take-Back Day. During your tenure in the state 

legislature, you helped create the program that turned in 9,63 0 pounds of unwanted 

6 
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medications during the April drive in Georgia. 

• How would the DEA approach a national mail-in take-back program across 

the country? What sort of security concerns and guidelines would need to be 

addressed to make it effective? 

RESPONSE: A mail in take-back program is one of several acceptable options 

authorized under current DEA regulations. 21 C.F.R. 1317.70. On September 9, 

2014, DEA issued a final rule, titled "Disposal of Controlled Substances." These 

regulations implement the Secure and Responsible Drug Disposal Act of 2010 and 

expand upon the previous methods of disposal by including disposal at drop-boxes 

in pharmacies and law enforcement agencies, mail back programs and drug 

deactivation systems if they render the product irretrievable. Through these 

regulations, DEA continues to focus its national attention on the issue of the misuse 

of prescription drugs and related substance use disorders (SUDs), and promotes 

awareness that one source of these drugs is often the home medicine cabinet. 

According to the 2016 National Survey on Drug Use and Health, approximately 

half of persons aged 12 or older who misused pain relievers in the past year bought 

or took the pain relievers from a friend or relative, or received it free from a friend 

or relative. These regulations provide a safe and legal method for the public to 

dispose of unused or expired controlled prescription drugs (CPDs). As of January 

9, 2018, a total of3,214 DEA registrants have become "authorized collectors." 

11. On top of those concerns, would a nominal fee paid by the patient be able to cover the 

costs of such a program? 

RESPONSE: Per 21 C.F.R. l317.70(c), "collectors or law enforcement that 

conduct a mail-back program shall make packages available (for sale or for free)" 

for the collection of controlled substances via mail. Collectors set their own fee 

should they choose to do so. It should be noted that 21 C.F.R.1317.70(c)(4) states 

that "the cost of shipping the package shall be postage paid." 

Ouestjons Posed by Representative Pete Olson 

12. Of the grant funding provided for in CARA, how much funding has been allocated to 

state prescription drug monitoring programs (PDMPs)? Do you think states need 

additional federal grant funding to improve their PDMP or to fund clinical workflow 

integrations? 

RESPONSE: DEA does not have grant making authority and is therefore unaware 

of how much funding has been allocated to state prescription drug monitoring 

programs as a result of CARA. 

7 
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Questions Posed by Representative Susan Brooks 

13. I have heard you say that preventing drug use before it begins is the most cost-effective 

way to reduce drug use and its consequences. In your opinion, what are the 

characteristics of successful prevention intervention programs? Besides lack of 

resources, what arc the barriers to implementing intervention programs? 

RESPONSE: It is true that preventing drug use before it starts is the most costeffective way to reduce drug use and its related consequences. Interventions that 

prevent substance misuse and substance use disorders can yield a greater economic 

return than the services that treat them. For instance, a study of prevention 

programs estimated that every dollar spent on effective, school-based programs to 

delay onset of use of alcohol, tobacco, and illegal drugs may save an estimated $18 

in costs related to problems later in life such as lost productivity and diminished 

quality of life.z 

Effective research-based programs share the following core elements: 

structure--how each program is organized and constructed; content-how the 

information, skills, and strategies are presented; and delivery-how the program is 

selected or adapted and implemented, as well as how it is evaluated in a specific 

community. When adapting programs to match community needs, it is important 

to retain these core elements to ensure that the most effective parts of the program 

stay intact.3 

While it is important to note that prevention strategies must be tailored to the 

individual setting, thereby avoiding a "cookie-cutter" approach, successful 

prevention approaches share a variety of characteristics. For instance, they are 

data-driven, in that data is compiled and used to guide all prevention-related 

decisions, from determining which drug abuse issues to address to choosing the 

most appropriate way to address those problems. Also, they focus on populationlevel change, which means implementing multiple strategies that address the 

identified risk and protective factors related to drug abuse iu a given community. 

l<"urthermore, they are comprehensive, combining a variety of strategies rather 

than relying on a singular strategy. Lastly, they rely on a team approach. An 

effective prevention approach needs- and greatly benefits from- the participation 

of diverse partners. These individuals and institutions may change over time, but 

the need for prevention partners is constant. 4 

Besides a lack of resources, which continues to be a significant barrier to 

implementing prevention and intervention programs throughout the government, 

other barriers include insufficient training and technical assistance opportunities 

2 Miller, T., & Hendrie, D. (2008). Substance abuse prevention dollars and cents: A cost-benefit analysis. (DHHS-Pub. 

No. (SMA) 07-4298). Rockville, MD: Substance Abuse and Mental Health Services Administration, Center for 

Substance Abuse Prevention.) 

'www.drugabuse.gov/publicationslpreventing-drug-abuse-among-children-adolescents-in-brieC/chapter-3-

appJying~prevention-principles-to-drug-abuse-prcvention-programs/what-are 

4 www.samhsa.gov/capt/applying-strategic-prevention-framework 

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for community coalitions and others across the nation working to prevent drug 

abuse, workforce shortages in the drug abuse prevention field, a lack of conformity 

to implementing evidence-based programs as designed, and apathy about drug 

abuse prevention in general. 

Questions Posed by Representative Markwayne Mullin 

14. I introduced H.R.3528, the Every Prescription Conveyed Securely Act, with Katherine 

Clark (D-MA), to require e-prescribing of controlled substances (EPCS) under Medicare 

Part D. As you may know, the President's Commission on Opioids recommended that 

the use of e- prescribing of opioids should be encouraged. Since the DEA relaxed its 

prohibition of e-prescribing for controlled substances in 2010, e-prescribing has 

expanded for Medicare beneficiaries and six states have mandated its use specifically for 

controlled substances. 

Does the DEA have a position on this legislation? Please explain the DEA's position and 

any concerns it may have with EPCS. 

RESPONSE: Thank you for your work on this important issue. The 

Administration has not taken a position on this legislation. DEA supports theeprescribing of controlled substances through its issuance of an interim final rule on 

EPCS, which was published in the Federal Register in March 2010. This rule 

clarifies the criteria by which DEA-registered practitioners may electronically 

issue controlled-substance prescriptions and by which DEA-registered pharmacies 

may receive and archive those prescriptions. It also creates an authentication 

procedure to ensure the prescriptions are not forgeries. The goal of this interim 

rule is to reduce the number of errors caused by illegible written prescriptions and 

help hospitals integrate prescription records into other medical files. As a result of 

this interim final rule, DEA received a number of comments and subsequently has 

met with stakeholders as it drafts a final rule. DEA will continue to work towards 

the publication of this final rule. 

Questions Posed by Representatjve Ben Ray Lujan 

15.1n the U.S., we still have too few locations to drop off unwanted and expired medication 

-some of which can be dangerously addictive or fatally lethal in even small doses -like 

fentanyl. According to the 2017 National Drug Threat Assessment, in 2015, over half 

of people who misused prescription pain relievers, like opioids, got them from a friend 

or relative while roughly 34% got them from one doctor. 

• Administrator Doherty, what is the DEA doing to combat the misuse of pain 

relievers that are given by, bought from, or stolen from family friends? 

RESPONSE: On September 9, 2014, DEA issued a final rule, titled "Disposal of 

Controlled Substances:' These regulations implement the Secure and Responsible 

Drug Disposal Act of 2010 and expand upon the previous methods of disposal by 

including disposal at drop-boxes in pharmacies and law enforcement agencies, 

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mail back programs and drug deactivation systems if they render the product 

irretrievable. Through these regulations, DEA continues to focus its national 

attention on the issue of the misuse of prescription drugs and related SUDs, and 

promotes awareness that according to the 2016 National Survey on Drug Use and 

Health, one source of these drugs is often the home medicine cabinet, as 

approximately half of persons aged l2 or older who misused pain relievers in the 

past year bought or took the pain relievers from a friend or relative, or that friend 

or relative gave it to the user for free. These regulations provide a safe and legal 

method for the public to dispose of unused or expired CPDs. As of January 9, 

2018, a total of 3,214 DEA registrants have become "authorized collectors." 

Since 2010, DEA has held its National Drug "Take Back" Initiative (NTBI) 

to provide a convenient and safe option to dispose of unused, expired and/or 

unwanted prescription drugs. DEA's most recent NTBI was held on April25, 

2018. As a result of all fifteen National Take Back Days, DEA, in conjunction with 

its state, local, and tribal law enforcement partners, has removed a total of nearly 

10 million pounds (4.98 tons) of medications from circulation. The sixteenth 

National Drug Take Back Day is scheduled for October 2018. 

Education is a key piece of combatting the opioid epidemic, including the 

misuse of pain relievers that are given by, bought from, or stolen from family friends. 

DEA initiated and continues to expand upon its 360 Strategy. The strategy leverages 

existing Federal, state, local, and tribal partnerships to address the problem on three 

different fronts: law enforcement, diversion control, and demand reduction. Our 

enforcement activities are directed at the violent cartels and drug trafficking gangs 

responsible for feeding the heroin and prescription drug epidemic in our 

communities. We are also enhancing our diversion control efforts and working with 

community partners for them to implement evidence-based programs and efforts 

designed to reduce demand and to prevent the same problems from resurfacing. 

As part ofthe 360 Strategy, DEA has partnered with Discovery Education, a 

division of Discovery Communications, to develop and distribute a prescription 

opioid and heroin education curriculum to middle and high school students, their 

teachers, and parents. We are calling it Operation Prevention and have started 

nationwide development of this program. Our goal is to educate children about the 

science of addiction and the true danger of prescription opioids and heroin, and to 

"kick start" life-saving conversations in the home and classroom. This awardwinning program is available at no cost to schools nationwide and includes resources 

such as standards-aligned lesson plans, interactive student activities, parent 

resources and more- all available through an online portal. Operation Prevention 

launched in October 2016 with a virtual field trip, viewed live by more than 200,000 

students, in all 50 States and in seven foreign countries. The program has reached 

more than 1.1 million students to date, will run for at least three consecutive school 

years (through spring 2019), and will be free for all law enforcement, prevention, 

treatment, and community groups to use and distribute. 

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Since launching the 360 Strategy in 2016, it has been implemented in eight 

cities: Louisville, Kentucky; St. Louis, Missouri; Pittsburgh, Pennsylvania; 

Milwaukee, Wisconsin; Dayton, Ohio; Albuquerque, New Mexico; Charleston, West 

Virginia; and Manchester, New Hampshire. DEA is expanding this program to 

additional locations including the announcement of the Salt Lake City, Utah location 

in September 2017. Our enforcement efforts will continue across the United States 

with our law enforcement and community partners. 

16. What is the DEA doing to make it harder to misuse of prescription drugs attained directly 

from doctors? 

RESPONSE: DEA cannot control if ultimate users will misuse prescription drugs 

obtained directly from doctors. With that said, DEA works to prevent the 

diversion of controlled prescription drugs from doctors. DEA Tactical Diversion 

Squads (TDSs) investigate suspected violations of the CSA and other federal and 

state statutes pertaining to the diversion of controlled substance pharmaceuticals 

and listed chemicals. These unique groups combine the skill sets of Special Agents, 

Diversion Investigators, and a variety of state and local law enforcement agencies. 

They are dedicated solely towards investigating, disrupting, and dismantling those 

individuals or organizations involved in diversion schemes (e.g., "doctor shoppers," 

prescription forgery rings, and DEA registrants who knowingly divert controlled 

substance pharmaceuticals). Between March 2011 and the present, DEA increased 

the number of operational TDSs from 37 to 77. In addition, we established two 

mobile TDSs that can deploy quickly to "hot spots" in furtherance of tbe Diversion 

Control Division's mission. 

Additionally, please see the discussion ofDEA's National "Take-Back" 

Initiative discussed above in response to question 1. This program, along with the 

authorized disposal methods in the Secure and Responsible Drug Disposal Act of 

2010 and 21 C.F.R. 1317, is intended to reduce the amount of unwanted and 

unused controlled prescription drugs in peoples' homes such that they cannot be 

misused by the ultimate user or others. 

17 .I'm aware of private sector organizations such as CVS and Walgreens that are working 

diligently to provide more drop-off locations in their stores and local communities. 

What would it take to have drop-offlocations for controlled substances in every 

community in the United States? What is the public sector doing to aid the private sector 

in these efforts? 

RESPONSE: The DEA cannot mandate nor does it offer an incentive to a DEAregistered pharmacy, hospital or clinic to become an "authorized collector" 

pursuant to the September 2014 final order that establishes rules for this activity. 

DEA strongly encourages its approximately 90,000 registrants in these classes to 

consider becoming authorized collectors so that families have safe and convenient 

opportunities to dispose of unused and unwanted controlled prescription drugs 365 

days per year. 

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The GAO recently studied this issue in its report entitled, Preventing Drug 

Abuse: Low Participation by Pharmacies and Other Entities as Voluntary Collectors 

of Unused Prescription Drugs (GA0-18-25, published October 12, 2017). 

18. Addressing the opioid epidemic is going to require a multi-faceted approach. We cannot 

cure opioid addiction through law enforcement or treatment alone. We must also work 

to address the problem at the start. This means we should also be adopting policies and 

practices to reduce the amount of opioids that are available in circulation, and educating 

health care providers on opioids, pain management, and non-opioid pain alternatives. 

Approximately 80 percent of the legal global opioid supply is consumed in the United 

States. Based on 2015 sales, the top five opioid products were made by Purdue Pharma, 

Johnson & Johnson, Insys Therapeutics, Mylan and Depomed, according to sales. A 

2016 survey by the National Safety Council revealed that about 99 percent of 

physicians exceed the recommended three-day dosage limit, with a quarter of them 

writing prescriptions for a full month and thus overprescribing these types of 

medications. 

Members of this Committee have called for additional prescriber education and training 

to this effect and I want to learn more about what role FDA and DEA can play in this 

process. 

• Mr. Doherty, as you know, a number of stakeholders have called for mandatory 

prescriber training on opioids to be a requirement of DEA registration. What role 

do you see prescriber education playing in addressing the opioid crisis, and what 

role has, or can, DEA play in ensuring health care practitioners are properly 

informed about the benefits and risks of opioids and the role appropriate 

prescribing can play in addressing the opioid epidemic? 

RESPONSE: DEA believes that all entities in the controlled prescription drug 

supply chain benefit from having the most information possible regarding the 

benefits and risks of opioids, as well as the role that appropriate prescribing can 

play in addressing the opioid epidemic. DEA supports the CDC's Guideline for 

Prescribing Opioids for Chronic Pain. DEA is encouraged to see that the total 

prescriptions dispensed for the opioid analgesic class has trended downward from 

a high of approximately 290 million prescriptions in 2014 to approximately 240 

million prescriptions in 2017.5 

Additionally, in 2018, DEA has initiated a nationwide program to offer 

training to individual practitioners on the important role they play in preventing 

diversion of these controlled substances. This program will be modeled after, and 

will follow upon, the success of the 97 Pharmacy Diversion Awareness Conferences 

that DEA held throughout the country, culminating in Octoher2017. DEA trained 

over 13,100 pharmacists, pharmacy technicians, and others on the important role 

they play in ensuring that valid prescriptions for controlled substances are filled. 

~ Information obtained by DEA pursuant to its contract with Quintiles. IMS Health's for statistical infonnation from its National Prescription Audit 

databa'ie. Information obtained on 1216/l?. 

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19. In 2015, 33,000 Americans died from opioids. According to the CDC, almost half of 

those deaths were from prescription opioids. The New York Times reports that in 2016, 

overdoses from all drugs was the leading cause of death of people under the age of 50. 

Drug overdoses now kill more Americans each year than at the height of the HIV 

epidemic and the worst year for auto accident deaths. The Times and drug use experts 

attribute the sharp rise in all drug overdose deaths to the rise of opioids. What we need to 

fight this epidemic is continued and reliable long- term investments in prevention, 

treatment, recovery, and monitoring. 

The President's budget proposal for fiscal year 20!8, coupled with other administration 

initiatives, takes several steps back in the fight against opioid addiction, including a cut 

in funds for SAMHSA Overall, the President's proposed budget cuts HHS by 16.2 

percent, the CDC by 17 percent and NIH by !9 percent. It cuts funding for addiction 

research, treatment and prevention. Even the White House Office on National Drug 

Control Policy would take a 95 percent hit. 

• Deputy Assistant Administrator Doherty, do you have all of the tools you need to 

stop the opioid epidemic? 

RESPONSE: With four out of five new heroin initiates reporting that they previously 

misused prescription pain relievers,6 the efforts ofDEA's Diversion Control Division 

have never been more critical. The DEA has a wide array oftools to ensure its more 

than l. 7 million registrants are in compliance with the CSA. These include outreach 

to industry, medication disposal, regulatory oversight, administrative actions, civil 

penalties, and criminal charges, among others. DEA has and will continue to use all 

available tools to combat the opioid epidemic. 

Outreach to Industry 

Due to the complexity of DEA's regulatory program, the Diversion Control 

Division has worked aggressively to improve its communication and cooperation with 

its more than 1.7 million registrants, who represent medical professionals, 

pharmaceutical drug manufacturers, and those in the drug supply chain. DEA works 

with its registrant population by: (1) hosting Pharmacy Diversion Awareness · 

Conferences (PDACs) throughout the country; (2) administering the Distributor 

Initiative Program with a goal of educating distributors on how to detect and guard 

against diversion activities; and (3) maintaining an open dialogue with various 

national associations such as the National Association of Boards of Pharmacy (NABP), 

American Medical Association (AMA), and Federation of State Medical Boards 

(FSMB), and other groups to address diversion problems and educate the medical 

community on improving prescribing practiccs.7 As of November 2017, DEA will 

have hosted 100 PDACs in aliSO states (as well as the District of Colombia and Puerto 

6 Substance Abuse and Mental Health Serviet>s Administration. Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use m the 

United States. Department of Health and Human Services, August 2013. available at: 

https:/lwww.samhsa.govfdatalsites/defaultffites!OR006/DR006Jnonmedical~pain-reliever~usc~2013.htm 

7 In FY20 17 alone, Diversion has participated in 1,407 outreach efforts 

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Rico) resulting in the training of more than 13,300 pharmacists, pharmacy 

technicians, and others on the important role they play in ensuring that valid 

prescriptions for controlled substances are filled. In May 2018, DEA plans to initiate 

a nationwide program to offer similar training to individual practitioners. 

Medication Disposal 

On September 9, 2014, DEA issued a final rule, titled "Disposal of Controlled 

Substances." These regulations implement the Secure and Responsible Drug Disposal 

Act of 2010 and expand upon the previous methods of disposal by including disposal 

at drop-boxes in pharmacies and law enforcement agencies, mail-back programs and 

drug deactivation systems if they render the product irretrievable. Through these 

regulations, DEA continues to focus its national attention on the issue of the misuse of 

prescription drugs and related SUDs, and promotes awareness that one source of 

these drugs is often the home medicine cabinet, as 53% of persons aged l2 or older 

who misused pain relievers in the past year bought or took the pain relievers from a 

friend or relative, or that friend or relative gave it to the user for free8• These 

regulations provide a safe and legal method for the public to dispose of unused or 

expired CPDs. As of November 30, 2017, 2,948 DEA registrants have become 

"authorized collectors." 

Since 2010, DEA has held its National Drug "Take Back" Initiative (NTBI) to 

provide a convenient and safe option to dispose of unused, expired and/or unwanted 

prescription drugs. DEA's most recent NTBI was held on April25, 2018, which 

collected another record-setting 949,046 pounds-474.5 tons--of potentially 

dangerous expired, unused, and unwanted prescription drugs for disposal at more 

than 5,800 collectimi sites. As a result of alliS National Take Back Days, DEA, in 

conjunction with its state, local, and tribal law enforcement partners, has removed 

nearly 10 million pounds (4,982 tons) of medications from circulation. The sixteenth 

National Drug Take Back Day is scheduled for October 2018. 

Prescription Drug Monitoring Programs 

PDMPs are state-run electronic database systems used by practitioners, 

pharmacists, medical and pharmacy boards, and law enforcement, but access varies 

according to state law. These programs are established through state legislation and 

are tailored to the specific needs of each state. DEA strongly supports robust PDMPs 

and encourages medical professionals to use this important tool to detect and prevent 

doctor shopping and other forms of diversion. Currently, 49 states have an 

operational PDMP. Missouri will become the 501

b state to have an operational PDMP, 

pursuant to the Governor's Executive Order in July 2017. As of August 2017,24 of 

8 Substance Abuse and Mental Health Services Administration. (2017). Key substance use and mental health indicators in the United States: Results 

from the 2016 National Survey on Drug Use and Health (HHS Publication No. SMA 17-5044, NSDUH Series H-52). Rockville, MD: Center for 

Rehavioral Health Statistics m1d Quality, Substance Abuse and Mental Health Services Administration. Retrieved from 

h!Jns:l/www.samhsa.gov/data!. 

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these 49 states with operational PDMPs require controlled substance prescribers to 

use the state's PDMP prior to prescribing a controlled substance in certain 

circumstances as mandated by each state's legislation.9 DEA encourages all 

practitioners and pharmacists to use their state PDMPs. 

Production Quotas (or Schedule II Opioids 

The Diversion Control Division is responsible for setting Aggregate Production 

Quotas (APQs) every year. These APQs are the "total quantity of each basic class of 

controlled substance listed in schedule I or II necessary to be manufactured during 

the following calendar year to provide for the estimated medical, scientific, research, 

and industrial needs of the United States, for lawful export requirements, and for the 

establishment and maintenance of reserve stocks. The APQs are determined after 

consideration of certain statutory factors, described in 21 C.F.R. § 1303.11 (b), which 

include: 

1. Total net disposal (e.g. domestic sales, exports, waste) of the substance by all 

manufacturers during the current and two preceding years; 

2. Trends in the national rate of net disposal of the substance; total actual (or 

estimated) inventories of the substance and of all substances manufactured 

from that substance, and trends in inventory accumulation; 

3. Projected demand as indicated by procurement quotas requested in 

accordance with DEA regulations; and 

4. Other factors affecting medical, scientific, research, and industrial needs in 

the United States and lawful export requirements, as the Administrator 

finds relevant, including changes in the currently accepted medical use in 

treatment with the class or the substances which are manufactured from it, 

the economic and physical availability of raw materials for use in 

manufacturing and for inventory purposes, yield and stability problems, 

potential disruptions to production (including possible labor strikes), and 

recent unforeseen emergencies such as floods and fires. 

Since 2014, DEA has observed a decline in prescriptions written for certain 

schedule II opioids. These declines have led to overall reductions in licit demand 

which, in turn, have directly impacted the factors DEA considers when establishing 

the APQs for schedule II opioids. In October 2016, DEA announced a 25 percent 

reduction (or more) in the 2017 APQs for many prescription opioids, including 

oxycodone, hydrocodone, fentanyl, hydromorphone, and morphine. Hydrocodone 

was reduced to 66 percent of the previous years' (2016) level. The 2018 APQs result 

in a nearly 20 percent reduction from the 2017 levels. These reductions include the 

aforementioned opioids, as well as oxymorphone, codeine, and meperidine. These 

decreases can be attributed to local, state, and federal agencies creating new 

partnerships, enforcing current regulations, and issuing updated guidance documents, 

including the Centers for Disease Control and Prevention's 2016 publication entitled, 

CDC Guideline for Prescribing Opioidsfor Chronic Pain. In addition, we are 

9 PDMP Center of Excellence, Brandeis University. http:/lwww.pQ~2LQ!g/pdf/Mandato~G9nditions 20l70824,pdf 

retrieved October 19, 2017. 

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encouraged that more states have enacted and enforced laws mandating the use of 

prescription drug monitoring programs by medical providers and pharmacists which 

provides prescribers with valuable information to guide their medical decisions. 

DEA 'S 360 Strategv and Operation Prevention 

To counter the opioid crisis, DEA continues to expand its 360 Strategy, a 

comprehensive three-pronged approach tackling the cycle of violence and addiction 

generated by the link between drug cartels, violent gangs, and the rising problem of 

prescription opioid misuse and heroin use in U.S. cities. The 360 Strategy features: 

coordinated law enforcement actions against drug cartels and heroin traffickers in 

specific communities; diversion actions against DEA registrants operating outside the 

law and long-term engagement with pharmaceutical drug manufacturers, wholesalers, 

pharmacies, and practitioners; and community outreach through local partnerships 

that empower communities to take back affected neighborhoods after enforcement 

actions and prevent the same problems from cropping up again. In 2016, DEA 

implemented its strategy in: Louisville, Kentucky; Milwaukee, Wisconsin; St. Louis, 

Missouri and Pittsburgh, Pennsylvania. In 2017, DEA implemented its strategy in 

Dayton, Ohio; Albuquerque, New Mexico; Charleston, West Virginia and 

Manchester, New Hampshire. In 2018, DEA is implementing this program in Salt 

Lake City, Utah; Northern and Southern New Jersey; and Philadelphia, 

Pennsylvania. 

As part of the 360 Strategy, DEA has partnered with Discovery Education, a 

division of Discovery Communications, to develop and distribute a prescription opioid 

and heroin education curriculum to middle and high school students, their teachers, 

and parents. We are calling it Operation Prevention and have started nationwide 

development of this program. Our goal is to educate children about the science of 

addiction and the true danger of prescription opioids and heroin, and to "kick start" 

life-saving conversations in the home and classroom. This award-winning program is 

available at no cost to schools nationwide and includes resources such as standardsaligned lesson plans, interactive student activities, parent resources and more all 

available through an online portal. Operation Prevention launched in October 2016 

with a virtual field trip, viewed live by more than 200,000 students, in aliSO States and 

in seven foreign countries. The program bas reached more than 1.1 million students 

to date, will run for at least three consecutive school years (through spring 2019), and 

will be free for all law enforcement, prevention, treatment, and community groups to 

use and distribute. 

Significant Enforcement Efforts 

In addition to the actions of the Diversion Division, DEA continues to 

aggressively combat the opioid epidemic through a variety of enforcement and 

partnership efforts. The DEA Special Operations Division (SOD) Heroin/Fentanyl 

Task Force (HFTF) Working Group consists of several agencies using a joint "whole 

of government" approach to counter the fentanyVopioid epidemic in the United States. 

The HFTF consists of personnel from DEA, U.S. Immigration and Customs 

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Enforcement, Homeland Security Investigations (HSI) and Customs and Border 

Protection (CBP); supplemented by the FBI and the U.S. Postal Inspection Service. 

HFTF utilizes every resource available, including support from the multi-agency 

Organized Crime Drug Enforcement Task Forces (OCDETF) and the OCDETF 

Fusion Center (OFC), the Department's Criminal Division, the Department of 

Defense (DOD), the Intelligence Community (I C), and other government entities, and 

provides field offices from all agencies with valuable support in their respective 

investigations. 

These relationships have led to several large enforcement actions, including 

two separate OCDETF investigations centered in North Dakota and Southern 

Mississippi that resulted in the first-ever indictments in September 2017 of two 

Chinese nationals responsible for tbe manufacturing, importation, and distribution of 

fentanyl in the United States. In addition, SOD played an integral role in the July 

2017 seizure ofthe largest criminal marketplace on the Internet, AlphaBay, which 

operated for over two years on the dark web and was used to sell deadly illegal drugs, 

stolen and fraudulent identification documents and access devices, counterfeit goods, 

malware and other computer hacking tools, firearms, and toxic chemicals throughout 

the world. The international operation to seize AlphaBay's infrastructure was led by 

the United States and involved cooperation and efforts by law enforcement authorities 

in Thailand, the Netherlands, Lithuania, Canada, the United Kingdom, and France, as 

well as the European law enforcement agency Europol. Multiple OCDETF 

interagency investigations into AlphaBay revealed that numerous vendors sold 

fentanyl and heroin, and there have been multiple overdose deaths across the country 

attributed to purchases on the site. 

Automated Reporting and Consolidated Orders Svstem (ARCOS) Data 

DEA's Diversion Control Division has also taken numerous steps to examine 

sales and monitoring processes. For example, Diversion Control utilizes various 

reports and records to monitor trends or determine anomalous transactions, which 

can then be developed into investigative leads. A unit within the Diversion Control's 

Pharmaceutical Investigations Section uses aggregated ARCOS data to identify 

patterns and trends in the flow of narcotic controlled substances through the closed 

system of drug distribution. This unit is now proactively preparing quarterly threat 

assessment reports for each of DEA's 22 Field Divisions to prioritize DEA's limited 

resources in furtherance of criminal, civil and regulatory investigations. DEA is 

working collaboratively with a coalition of States Attorneys General to provide nonpublic, law enforcement sensitive ARCOS data to support their active investigations 

against certain manufacturers and distributors. 

Diversion Enforcement Actions 

DEA uses a wide array of diversion enforcement tools to ensure its more than 

1.7 million registrants are in compliance with the CSA. These include administrative 

actions, civil penalties, and criminal charges. Within DEA's administrative 

authorities, there are multiple actions that may lead to an individual or entity having 

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a registration revoked, which include orders to show cause (OTSC), immediate 

suspension orders (ISO), and voluntary surrenders. Upon a registrant surrendering a 

registration for cause, or DEA obtaining a suspension/revocation of the registration, 

the registrant can no longer dispense, prescribe or administer controlled 

substances, which DEA deems to be a success. Since FY 2011, these combined actions 

result in an average of roughly 980 registration revocations per year. Of the total 

registration revocations, ISOs have historically made up a small portion, averaging 

less than three percent annually. Additionally, combined ISO and OTSC actions in 

2017 more than doubled since 2014. 

Working with the United States Attorneys' Offices, DEA has pursued civil 

actions against some of the nation's largest drug distributors. Over the last decade, 

opioid distributors nationwide have paid nearly $390 million in civil penalties and 

DEA has entered into Memoranda of Agreement (MOAs) with the distributors to 

ensure their future compliance. In Fiscal Year 2017, distributors paid more than $194 

million in civil penalties, which is more than the previous seven years combined (close 

to $148 million). 

Since 2010, DEA has re-prioritized its criminal investigators and embedded 

them with diversion investigators into enforcement groups called tactical diversion 

squads (TDS). TOSs investigate suspected violations of the CSA and other federal 

and state statutes pertaining to the diversion of controlled substance pharmaceuticals 

and listed chemicals. These unique groups combine the skill sets of Special Agents, 

Diversion Investigators, and a variety of state and local law enforcement agencies. 

They are dedicated solely towards investigating, disrupting, and dismantling those 

individuals or organizations involved in diversion schemes (e.g., "doctor shoppers," 

prescription forgery rings, and DEA registrants who knowingly divert controlled 

substance pharmaceuticals). Between March 2011 and present, DEA increased the 

number of operational TOSs from 37 to 77. In addition, DEA established two mobile 

TDS groups that can deploy quickly to "bot spots" in furtherance of the Diversion 

Control Program's mission. For example, one mobile TDS team recently deployed to 

Charleston and Clarksburg, West Virginia. Each ofthese groups focuses primarily 

on criminal enforcement and the results of their work often lead DEA registrants to 

surrender their DEA registration for cause. Over the last seven years, these TDS 

groups have initiated an average of more than 1,500 cases per year and made an 

average of more than 2,000 arrests per year. 

Supporting Effective Drug Treatment 

Additionally, DEA plays a role in supporting effective drug treatment of 

persons with opioid use disorders through providing waivers and certifications to 

physicians, physician assistants, and nurse practitioners to dispense/administer 

medications approved by the FDA for addiction treatment- buprenorphine, 

naltrexone, and methadone in certain settings. 

20. How will the DEA allocate its 3.7 percent boost in funding in the President's budget 

proposal to fight the opioid epidemic? 

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RESPONSE: DEA appreciates the U.S. House of Representatives mark of the FY 

2018 budget, which is consistent with the President's budget request. DEA has 

developed proposals that identify priorities that focus on anticipated program needs 

and that will allow DEA to continue to target the most significant drug trafficking 

threats including CPOTs, PTOs, and other significant DTOs. The FY 2018 

President's Budget request will provide DEA resources to build upon our success 

and to continue to address the scourge of heroin and controlled prescription drug 

abuse. Enhancement requests include the following: 

I. Heroin Enforcement: $8.5 million in support of coordinated Law Enforcement 

actions that aim to sever the ties between cartels and the violent gangs which 

supply deadly opioids to our communities. 

2. Transnational Organized Crime: $6.5 million for investigative activities 

focusing on the TCOs responsible for large quantities of drugs arriving in U.S. 

cities. DEA will enhance overseas investigative capabilities and the Sensitive 

Investigative Units (SIU) Program. 

3. Violent and Gun-Related Crime Reduction Task Force: $5.9 million to tackle 

the violence generated by drug cartels and street gangs. DEA appreciates the 

U.S. House of Representatives mark of the FY2018 budget, which is consistent 

with the President's budget request. This request includes $21 million to 

combat the opioid epidemic and violent crime (10 agents) in support of the 

disruption and dismantlement of the individuals and organizations responsible 

for the illicit manufacture and distribution of pharmaceutical controlled 

substances in violation of the CSA. 

4. Opioid Training, Enforcement, and Drug Disposal: $20 million in support of 

actions against individuals and organizations operating outside the law. 

Additionally, long-term education and training engagements with 

pharmaceutical drug manufacturers, wholesalers, pharmacies, and 

practitioners will he conducted. 

5. Diversion Investigators and Tactical Diversion Squads: $9;4 million will provide 

55 positions (to include 10 Special Agents and 28 Diversion Investigators) to 

create new and enhance current Diversion Groups while solidifying existing 

TDSs to conduct criminal enforcement activities involved in diversion schemes 

(i.e. pill mills, prescription forgery rings, and rogue internet pharmacies). 

21. Opioid addiction is not a new problem. Misuse of and addiction to pharmaceuticals has 

existed for centuries, ever since morphine was heralded in the 1850s as a solution to our 

opium addiction problem- until it, in tum, morphine became a larger problem, as did 

heroin, and then methadone. Today, we understand the importance of pain relieving 

agents, but as my constituents continue to perish at alarming rates due to these drugs, we 

need to be working together to address the crisis. The public and private sectors can and 

should work together to swiftly address the opioid epidemic. The Reagan-Udall 

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Foundation for the FDA is an independent 50l(c)(3) not-for-profit organization created 

by Congress for the purpose of advancing regulatory science that is necessary to helping 

the FDA accomplish its mission. The Foundation was created by Congress in the Food 

and Drug Administration Amendments Act of 2007 (FDAAA) to address regulatory 

science challenges of the 21st century. The central focus of the Foundation is to assist in 

the creation of new, applied scientific knowledge, tools, standards, and approaches the 

FDA needs to evaluate products more effectively, predictably, and efficiently, and 

thereby enhance the agency's ability to protect and promote the health of the American 

public. 

• Understanding what we know now about this issue, what further information or 

support do you need from pharmaceutical manufacturers to more aggressively 

combat this crisis? 

RESPONSE: As the U.S. Food and Drug Administration (FDA) is the agency with 

a regulatory obligation to ensure that only safe and effective drugs are approved 

for marketing in the United States, DEA respectfully defers to the FDA on what 

additional measures pharmaceutical manufacturers should take to address the 

opioid epidemic. 

22. Stopping the flow of opioids into the U.S. will require a decrease in demand. People 

who are at highest risk of overdose use prescription opioids nonmedically for 200 or 

more days a year. These highest-risk users are approximately four times more likely 

than the average user to buy the drugs from a dealer or other stranger. From a supply 

perspective, the ways for illicit opioids and heroin to enter the U.S. are ever-changing 

and creative, driven by the rise of e-commerce and outpacing our current abilities to 

monitor what enters across our borders. 

Opioids and heroin illicitly enter the U.S. through the U.S. Postal Service and 

traditional drug smuggling charmels. Illicit synthetics are largely manufactured in 

China and smuggled into the United States via traditional charmels and through the 

U.S. Postal Service. Fentanyl is a synthetic opioid that Americans can order online 

through illicit drug marketplaces. Online ordering of counterfeit prescription drugs is 

possible viae-commerce websites and through dark web markets on the Tor network. 

Because fentanyl is potent, it is easy to hide in letters and small packages that are sent 

by post. Overseas labs in China are mass-producing fentanyl and fentanyl-related 

compounds and marketing them to drug trafficking groups in Mexico, Canada, and the 

United States. Mexico often serves as a transshipment point for fentanyls shipped from 

China. In 2017, fentanyl is being trafficked through Mexico into the U.S. alongside 

heroin and cocaine, though it is largely produced in Asia. Customs and Border 

Protection officers search packages entering the U.S. through the John F. Kennedy 

International Airport mail center for fentanyl and other synthetic opioids using an old 

X-ray machine, a borrowed handheld laser that can peek into packages, and a dog 

trained to detect fentanyl. In fiscal year 2016, the CBP team at JFK airport seized 

seven fentanyl packages. This year, they have seized 64 as of September 17,2017. 

Not all illicit synthetics enter the U.S. from other countries. A DEA intelligence brief 

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published in July 2016 noted that people within the U.S. are also making and selling 

fentanyl pills. In January 2016, DEA agents seized 6,000 fentanyl pills made to look 

like oxycodone from a dealer who was manufacturing them in his New York residence. 

A similar pill pressing operation was discovered in Los Angeles in March 2016. 

Heroin consumed in the U.S. comes mainly from Afghanistan and Mexico, according 

to the UN's International Narcotics Control Board (!NCB). As much as 94 percent of 

the heroin entering America comes from Mexico, estimated William R. Brownfield, 

assistant secretary of the Bureau of International Narcotics and Law Enforcement 

Affairs. 

• Why can't the U.S. stop and dramatically reduce trafficking of opioids and heroin 

into the U.S.? 

RESPONSE: DEA is diligently working by taking a whole of government approach 

with our federal partners to reduce the trafficking of opioids and heroin into the 

United States. There are many current initiatives aimed at combatting this 

problem, some of which are listed below. 

Significant Enforcement Efforts 

The DEA Special Operations Division (SOD) Heroin/Fentanyl Task Force 

(HFTF) Working Group consists of several agencies using a joint "whole of 

government" approach to counter the fentanyVopioid epidemic in the United States. 

The HFTF consists of personnel from DEA, U.S. Immigration and Customs 

Enforcement Homeland Security Investigations (HSI) and Customs and Border 

Protection (CBP); supplemented by the FBI and the U.S. Postal Inspection Service. 

HFTF utilizes every resource available, including support from the multi-agency 

Organized Crime Drug Enforcement Task Forces (OCDETF) and the OCDETF 

Fusion Center (OFC), the Department's Criminal Division, the Department of 

Defense (DOD), the Intelligence Community (I C) and other government entities, 

and provides field offices from all agencies with valuable support in their respective 

investigations. 

The HFTF mission aims to: 

• Identify, target, and dismantle command and control networks of national 

and international fentanyl and New Psychoactive Substances (NPS) 

trafficking organizations. 

• Provide case coordination and de-confliction on all domestic and foreign 

investigations to ensure that multi-jurisdictional, multi-national, and multiagency investigations and prosecutions have the greatest impact on 

targeted organizations. 

• Provide direct and dynamic operational and investigative support for 

domestic and foreign field offices for all agencies. 

• Identify new foreign and domestic trafficking, manufacturing, importation, 

production and financial trends utilized by criminal enterprises. 

• Analyze raw intelligence and documented evidence from multiple resources 

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to develop actionable leads on viable target(s) involved in possible illicit pill 

production and/or distribution networks. 

• Educate overall awareness, handling, trafficking trends, investigative 

techniques and safety to domestic and foreign field offices for all law 

enforcement, DOD, IC and governmental agencies. 

• Facilitate, coordinate and educate judicial districts during prosecutions of 

fentanyl and other NPS related cases. 

AlphaBav "Dark Market" Shutdown 

In July 2017, the Department announced the seizure of the largest criminal 

marketplace on tbe Internet, AlpbaBay, which operated for over two years on tbe 

dark web and was used to sell deadly illegal drugs, stolen and fraudulent 

identification documents and access devices, counterfeit goods, malware and other 

computer backing tools, firearms, and toxic chemicals throughout the world. The 

international operation to seize AlphaBay's infrastructure was led by the United 

States and involved cooperation and efforts by law enforcement authorities in 

Thailand, the Netherlands, Lithuania, Canada, the United Kingdom, and France, as 

well as the European law enforcement agency Europol. Multiple OCDETF 

interagency investigations into AlphaBay revealed that numerous vendors sold 

fentanyl and heroin, and there have been multiple overdose deaths across the 

country attributed to purchases on the site. 

Mexico: Partnership to Reduce Supply oflllicit-Narcotics 

DEA, through its partnership with the U.S. Department of State, helps 

Mexican government officials to improve capacity to interdict and seize illicit 

narcotics. DEA routinely engages with Mexico through the bilateral drug policy 

working group with the Office of the Attorney General (PGR) in Mexico City. 

These efforts were instrumental in constructive policy changes such as Mexico's 

decision to schedule the two primary fentanyl precursors, ANPP and NPP in mid2017. 

China: Government Action and Cooperation 

DEA, through its leadership in the United States and its country office in 

Beijing, has maintained an ongoing relationship with government officials of the 

People's Republic of China for years, and has been able to leverage this relationship 

to combat the rising threat from NPSs and their precursors. Engagement has been 

occurring at the leadership level through interagency working groups that operate 

under the U.S.-China Joint Liaison Group (JLG) framework co-chaired by the 

Department of State's Bureau of International Narcotics and Law Enforcement 

Affairs, DEA, and DHS, including the Counternarcotics Working Group led by the 

Department of Justice, and the Bilateral Drug Intelligence Working Group led by 

DEA. 

On March 1, 2017, China's National Narcotics Control Commission 

announced scheduling controls against four fentanyl-class substances: carfentanil; 

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furanyl fentanyl; valery! fentanyl; and, aery! fentanyl. This announcement was the 

culmination of ongoing collaboration between DEA and the Government of China, 

and reaffirms an expanding collaborative commitment to countering illicit fentanyl. 

Over the past year, DEA and Chinese officials have met regularly to discuss 

mutual interests and shared responsibilities in countering the threat from fentanyl 

class substances. Representatives from the China National Narcotics Laboratory, 

the Narcotics Control Bureau, and the Ministry of Public Security met with DEA 

(along with Department of Justice and Department of Homeland Security) officials 

to exchange information on emerging substances' scientific data, trafficking trends, 

and sample exchanges. This continued dialogue is anticipated to foster a bilateral 

information exchange related, but not limited to, the identification of new 

substances of abuse that may then be considered for national control. The meeting 

also deepened professional contacts between relevant technical and legal experts. 

A key moment in enhanced cooperation on synthetic drugs came in October 

2015, when, following similar discussions, China decided to implement domestic 

controls on 116 NPS, which included a number offentanyl analogues, and 

streamlined its procedures to control additional substances with no known 

medicinal use. In total, China has scheduled 138 different NPS, including 128 since 

October 2015. 

Finally, as this threat bas increased, law enforcement cooperation at the street 

level has been very productive, particularly on fentanyl cases. DEA will continue to 

collaborate with the Government ofthe People's Republic of China as the threat 

from fentanyl continues to evolve. 

Class Wide Scheduling o(Fentanvls 

As stated in previous responses, the Department of Justice and DEA 

announced on November 9, 2017, that DEA intended to take immediate action 

against the flow of illicit fentanyl analogues into this country and the alarming 

increase in overdose deaths linked to synthetic opioids by scheduling all fentanylrelated substances on an emergency basis. The "notice of intent" was published in 

the Federal Register on December 29, 2017. The final order was published in the 

Federal Register on February 6, 2018, and made effective on that date. Pursuant to 

this final order, anyone who possesses, imports, distributes, or manufactures any 

illicit fentanyl analogue will be subject to criminal prosecution in the same manner 

as for fentanyl and other controlled substances. This scheduling action will make it 

easier for federal prosecutors and agents to prosecute traffickers of aU forms of 

fentanyl-related substances. 

23. If Congress was to allow for international drug importation writ large, does that have the 

potential to impact either positively or negatively the ability for nefarious actors to 

increase illegal opioid trafficking in the US? 

RESPONSE: Any such authorization would require changes to the CSA and DEA 

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is not in a position to comment on a hypothetical issue without knowing how 

Congress might seek to make those statutory changes. DEA notes that its mission 

is to enforce the controlled substances laws and regulations of the United States, 

which would include preventing the importation and distribution of illegal drugs, 

as well as preventing the diversion of controlled prescription drugs from the 

legitimate drug supply chain. DEA is willing to review any draft legislation 

proposed by Congress on this matter. 

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