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




    WHAT IS THE FEDERAL GOVERNMENT DOING TO COMBAT THE OPIOID ABUSE 
                               EPIDEMIC?

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

                                HEARING


                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS


                                 OF THE


                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES


                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 1, 2015

                               __________

                           Serial No. 114-38


             
             
             [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]




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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

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

                                 7_____

              Subcommittee on Oversight and Investigations

                        TIM MURPHY, Pennsylvania
                                 Chairman
DAVID B. McKINLEY, West Virginia     DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
LARRY BUCSHON, Indiana               JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas                   YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana             JOSEPH P. KENNEDY, III, 
MARKWAYNE MULLIN, Oklahoma               Massachusetts
RICHARD HUDSON, North Carolina       GENE GREEN, Texas
CHRIS COLLINS, New York              PETER WELCH, Vermont
KEVIN CRAMER, North Dakota           FRANK PALLONE, Jr., New Jersey (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

                                  (ii)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     3
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................     5
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, prepared statement...................................     7
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, prepared statement........................     8

                               Witnesses

Michael P. Botticelli, Director, Office of National Drug Control 
  Policy.........................................................    10
    Prepared statement...........................................    13
    Answers to submitted questions...............................   138
Richard G. Frank, Ph.D., Assistant Secretary for Planning and 
  Evaluation, Department of Health and Human Services............    29
    Prepared statement...........................................    31
    Answers to submitted questions...............................   144
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse, 
  National Institutes of Health..................................    41
    Prepared statement...........................................    43
    Answers to submitted questions...............................   150
Douglas C. Throckmorton, M.D., Deputy Director, Center for Drug 
  Evaluation and Research, Food and Drug Administration..........    56
    Prepared statement...........................................    58
    Answers to submitted questions...............................   159
Debra Houry, M.D., M.P.H., Director, National Center for Injury 
  Prevention and Control, Centers for Disease Control and 
  Prevention.....................................................    71
    Prepared statement...........................................    73
    Answers to submitted questions...............................   164
Pamela S. Hyde, J.D., Administrator, Substance Abuse and Mental 
  Health Services Administration.................................    81
    Prepared statement...........................................    83
    Answers to submitted questions...............................   170
Patrick Conway, M.D., M.S., Deputy Administrator for Innovation 
  and Quality, and Chief Medical Officer, Centers for Medicare 
  and Medicaid Services..........................................    92
    Prepared statement...........................................    94
    Answers to submitted questions...............................   178

                           Submitted Material

Subcommittee memorandum..........................................   125
Article of April 30, 2015, ``Physician-Issued Opioids Associated 
  With Higher ED Use,'' by Alicia Ault, MedScape, submitted by 
  Mr. Murphy.....................................................   136

 
    WHAT IS THE FEDERAL GOVERNMENT DOING TO COMBAT THE OPIOID ABUSE 
                               EPIDEMIC?

                              ----------                              


                          FRIDAY, MAY 1, 2015

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:00 a.m., in 
room 2322, Rayburn House Office Building, Hon. Tim Murphy 
(chairman of the subcommittee) presiding.
    Members present: Representatives Murphy, McKinley, Burgess, 
Griffith, Bucshon, Flores, Brooks, Mullin, Collins, Upton (ex 
officio), DeGette, Schakowsky, Tonko, Clarke, Kennedy, Green, 
and Pallone (ex officio).
    Staff present: Noelle Clemente, Press Secretary; Jessica 
Donlon, Counsel, Oversight and Investigations; Brittany Havens, 
Oversight Associate, Oversight and Investigations; Charles 
Ingebretson, Chief Counsel, Oversight and Investigations; Alan 
Slobodin, Deputy Chief Counsel, Oversight; Sam Spector, 
Counsel, Oversight; Christopher Knauer, Democratic Oversight 
Staff Director; and Una Lee, Democratic Chief Oversight 
Counsel.

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

    Mr. Murphy. Well, good morning. Welcome here to the 
Oversight and Investigations Subcommittee hearing.
    I just want to say it's Mental Health Month, so it's 
fitting that we are here today on this issue. This is the third 
in a series of hearings examining the growing problem of 
prescription drugs and heroin addiction that is ravaging our 
country. This is our Nation's single biggest public health 
concern.
    Over the past 5 weeks, this subcommittee has heard from 
addiction experts working with local communities and our 
leading academic and research centers. Dr. Robert DuPont, the 
former White House Chief of Drug Control Policy and the first 
director of the National Institute on Drug Abuse, testified 
that Federal programs lack direction and standards on treating 
addiction as a chronic condition, and noted what is being done 
to follow up with patients to prevent relapses and put them on 
a path of real recovery? He challenged us to even ask the most 
fundamental question, ``What is recovery?''
    Dr. Anna Lembke of Stanford Medical School provided 
critical testimony on how we must revise our healthcare quality 
measures to reduce overprescribing, reform medical privacy 
regulations, and incentivize the use of prescription drug 
monitoring programs.
    We know that those with opiate addiction disorders need a 
broad range of treatment options and that many with substance 
abuse disorders have co-occurring psychiatric disorders, but we 
need to tear down Federal policy and funding barriers that keep 
us from treating both simultaneously.
    About 3 weeks ago, one of today's witnesses, Mr. Michael 
Botticelli, the Director of the Office of National Drug Control 
Policy, presented a slide--I'm going to show it here--at the 
National Rx Summit on major causes of death from injury from 
1999 to 2013. Quite a revealing slide. While the trends of 
other major causes of death, such as auto accidents went down, 
drug poisoning continued to go up 21 percent from 2008 till 
2013. In many States, these numbers are soaring at high double-
digit rate increases. As Mr. Botticelli has indicated to me 
privately and at the Rx Summit, we must do better, and we have 
much work to do.
    Today, we will hear from Federal agencies charged with 
providing guidance, direction, and leadership in our Nation's 
public health response to the opiate epidemic. No Federal 
agency is more central in this ongoing epidemic than the 
Department of Health and Human Services or HHS. HHS and its 
Substance Abuse and Mental Health Services Administration, also 
known as SAMHSA, are responsible for leading our Nation's 
public health response to the opiate heroin abuse and addiction 
crisis.
    SAMHSA regulates our country's 1,300 opiate treatment 
programs, and SAMHSA is responsible for certifying the 26,000 
physicians who prescribe the most commonlyused opiate 
maintenance medication, buprenorphine. According to testimony 
provided by SAMHSA before this subcommittee in April of last 
year, there were nearly 1.5 million people treated with these 
opiate maintenance medications in 2012, which is a fivefold 
increase in the last 10 years.
    Has SAMHSA defined the goal of recovery for what these 
federally subsidized treatment programs are supposed to 
accomplish? Is SAMHSA collecting and evaluating meaningful data 
at an individualized level that would hold grant recipients 
individually accountable for effective results? So far, 
preliminary examination indicates the answers are no. And when 
you don't define where you're going, every road you take still 
leaves you lost. So we're hoping we can get some direction 
today.
    The numbers indicate we are failing as a Nation, and we 
darn well better come to terms with that. The 43,000 lives lost 
last year, the thousands of babies born addicted to opiates 
tell us the terrible toll this epidemic has taken. You've heard 
my thoughts about the Government-sponsored promotion of what 
I've characterized as addiction maintenance, and I refer to 
buprenorphine as heroin helper, not because the medication is 
altogether lacking, because it is helpful, but rather, because 
infrastructure the Federal Government has created for the use 
of this highly potent and important medication is not fully 
working and, worse yet, in many cases, contributing to the 
growing problem. This has to be fixed, and I hope we'll find 
some solutions, and that is what we need to discuss today 
openly, honestly, and humbly.
    If we do not reverse the current trend, where is this going 
to end? How many millions of citizens do we want to have on 
opiate maintenance? How many more must die? And how many more 
lives and dreams must be shattered before we recognize the 
depth of this national scourge?
    Now, I don't believe in better living through dependency. 
And, again, please do not misconstrue this critique as a 
general indictment of opiate maintenance. It is not. For some 
people, opiate maintenance is the most appropriate bridge 
treatment, and there should be no shame or stigma associated 
with it. But opiate maintenance therapy should not be the only 
treatment offered to the opiate-dependent individuals, and it 
is not the only goal.
    What patients on opiate maintenance can be successfully 
transition off of these medications? What protocols are best 
for affecting this transition? What are the best practice for 
prevention of relapse for those patients who end opiate 
maintenance treatment? There are nonaddictive medications 
approved for this use, but are these medications widely 
available and how well do they work?
    The diversion of buprenorphine for illicit nonmedical use 
is a related problem, because this is how the opiate epidemic 
can be spread. According to the DEA, buprenorphine is the third 
most often seized prescription opiate by law enforcement today. 
Where is a call to modernize our existing opiate addiction 
treatment system to ensure that the right patient gets the 
right treatment at the right time? Why aren't we hearing about 
expanding access to nonaddictive narcotic treatments that have 
zero potential for abuse or diversion, such as Naltrexone and 
evidence-based counseling? These are all incredibly important 
tools, and we want to make sure HHS talks more about these.
    Last week, Dr. Westley Clark, the former Director of SAMHSA 
Center for Substance Abuse treatment and the man who oversaw 
the growth of buprenorphine over the past decade declared 
before the American Society of Addiction Medicine that many 
buprenorphine practices have become pill mills where doctors 
and dealers were increasingly indistinguishable and physician 
negligence and alleged laboratory fraud prevailed. The problem 
is not with buprenorphine, however. The problem lies with 
current practices, and this is what we need to discuss.
    I consider opiate maintenance as a bridge for those with 
addiction disorders to cross over in the recovery process. And 
as I said, it is not a final destination. We seek to lay out a 
vision for recovery that includes complete withdrawal from 
opiates as an option. For cancer, for diabetes, for AIDS, we 
want people to be free of the diseases, not just learn to live 
with it. We need to commit the same sorts of things through our 
research and clinical efforts that boldly declare what we must 
change here.
    I thank our witnesses for being here today.
    [The prepared statement of Mr. Murphy follows:]

                 Prepared statement of Hon. Tim Murphy

    Today we convene the third in a series of hearings 
examining the growing problem of prescription drugs and heroin 
addiction that is ravaging our country. This is our Nation's 
single biggest public health concern.
    Over the past five weeks, this subcommittee has heard from 
addiction experts working within local communities and our 
leading academic and research centers.
    Dr. Robert DuPont, the former White House Chief on drug 
control policy and the first director of the National Institute 
on Drug Abuse, testified that Federal programs lack directions 
and standards on treating addiction as a chronic condition and 
noted: What is being done to follow-up with patients to prevent 
relapses and put them on a path of real recovery? He challenged 
us to even ask the most fundamental question: what is recovery? 
Dr. Anna Lembke of Stanford Medical School provided critical 
testimony on how we must revise our healthcare quality measures 
to reduce over-prescribing, reform medical privacy regulations, 
and incentivize use of Prescription Drug Monitoring Programs. 
We know that those with opioid-addiction disorders need a broad 
range of treatment options, and that many with substance abuse 
disorders have a co-occurring psychiatric disorder--but we need 
to tear down Federal policy and funding barriers that keep us 
from treating both simultaneously.
    About three weeks ago, one of today's witnesses--Mr. 
Michael Botticelli, the Director of the Office of National Drug 
Control Policy--presented the following slide at the National 
Rx Summit on major causes of death from injury 1999-2013. While 
the trends of other major causes of death such as auto 
accidents went down, drug poisoning continued to go up 21 
percent from 2008 to 2013. In many States these numbers are 
soaring at high double digit rates of increase. As Mr. 
Botticelli has indicated to me privately and at the Rx Summit, 
we must do better and we have much work to do.
    Today, hear from the Federal agencies charged with 
providing guidance, direction, and leadership in our Nation's 
public health response to the opioid epidemic.
    No Federal agency has a more central role in this ongoing 
epidemic than the Department of Health and Human Services 
(HHS). HHS and its Substance Abuse and Mental Health Services 
Administration (SAMHSA) are responsible for leading our 
Nation's public health response to the opioid, heroin abuse and 
addiction crisis. SAMHSA regulates our country's 1,300 opioid 
treatment programs, and SAMHSA is responsible for certifying 
the 26,000 physicians who prescribe the most commonly used 
opioid maintenance medication: buprenorphine. According to 
testimony provided by SAMHSA before this subcommittee in April 
of last year, there were nearly 1.5 million people treated with 
these opioid maintenance medications in 2012--which is a 5-fold 
increase in the last 10 years. Has SAMHSA defined the goal of 
recovery for what these federally subsidized treatment programs 
are supposed to accomplish? Is SAMHSA collecting and evaluating 
meaningful data at an individualized level that would hold 
grant recipients individually accountable for effective 
results? So far, our preliminary examination indicates the 
answers are no. And when you don't define where you are going, 
every road you take still leaves you lost.
    The numbers indicate we are failing as a nation, and we 
darn well better come to terms with that. The43,000 lives lost 
last year, the thousands of babies born addicted to opioids 
tell us the terrible toll thisepidemic has taken.You have heard 
my thoughts about the Government-sponsored promotion of what I 
have characterized as''addiction maintenance.''
    I have referred to buprenorphine as a ``heroin helper'' not 
because the medication is altogether lacking,but rather, 
because the infrastructure the Federal Government has created 
for the use of this highly potentand important medication is 
not working and worse yet, contributing to the growing problem. 
It has to befixed, and that is what we need to discuss--
honestly, openly, humbly.
    If we do not reverse the current trend, where will it end? 
How many millions of citizens do we want tohave on opioid 
maintenance? How many more must die? How many more lives and 
dreams must beshattered before we recognize the depth of this 
scourge?
    I do not agree in ``better living through dependency.''
    Again, please do not misconstrue this critique as a general 
indictment of opioid maintenance. It isnot. For some people, 
opioid maintenance is the most appropriate bridge treatment and 
there should be no shame or stigma associated with it. But 
opioid maintenance therapy should not be the only treatment 
offered to opioid dependent individuals, nor the only goal.
    What patients on opioid maintenance can be successfully 
transitioned off of these medications? What protocols are best 
for effecting this transition?
    What are the best practices for the prevention of relapse 
for those patients who end opioid maintenance treatment? There 
are non-addictive medications approved for this use, but are 
these medications widely available?
    The diversion of buprenorphine for illicit, non-medical use 
is a related problem because this is how the opioid epidemic 
can be spread. According to the DEA, buprenorphine is the third 
most often seized prescription opioid by law enforcement today.
    Where is the call to modernize our existing opioid 
addiction treatment system to ensure that the right patient 
gets the right treatment at the right time? Why aren't we 
hearing about expanding access to nonaddictive, non-narcotic 
treatments that have zero potential for abuse or diversion, 
such as naltrexone and evidence-based counseling? These are 
incredibly important tools that are barely mentioned in the HHS 
plan.
    Last week, Dr. Westley Clark, the former Director of 
SAMHSA's Center for Substance Abuse Treatment, and the man who 
oversaw the growth of buprenorphine over the past decade, 
declared before the American Society of Addiction Medicine that 
many buprenorphine practices had become pill mills where 
``Doctors and Dealers'' were increasingly indistinguishable and 
``Physician Negligence'' and ``Alleged Laboratory Fraud'' 
prevailed. The problem is not with buprenorphine, however. The 
problem lies with current practice and this is what we need to 
discuss.
    I consider opioid maintenance as a bridge for those with 
addiction disorders to cross over in the recovery process. It 
is not a final destination. I seek to lay out a vision for 
recovery that includes complete withdrawal from opioids as an 
option. For cancer, diabetes, AIDS, we want people to be free 
of the disease, not learn to just live with it. We need to 
commit to research and clinical efforts that boldly declare 
that we must change.

    Mr. Murphy. And I now recognize the ranking member of the 
subcommittee, Ms. DeGette from Colorado, for 5 minutes.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you so much, Mr. Chairman.
    I think it's really important to hear from our witnesses 
today about the work the Federal Government is doing to address 
this serious public health issue, and I know all of the 
agencies represented before us do critical work to prevent and 
treat this epidemic.
    In March, Secretary Burwell announced an initiative to 
combat the opioid crisis. I applaud the Department's actions, 
and I'm gratified to hear that this is one of the Secretary's 
top priorities. I want to hear more about this initiative today 
and how all the agencies before us are working together to 
accomplish its goals. But at the same time, I have some hard 
questions about our approach to caring for those who have 
substance abuse disorders.
    Last week, we heard from a panel of medical experts who 
have vast experience in treating opioid addiction. 
Unfortunately, as the chairman said, they gave us a fairly 
bleak view of the opioid treatment landscape in this country. 
For example, one witness, Dr. Adam Bisaga, a psychiatrist at 
Columbia University and a research scientist at the New York 
State Psychiatric Institute, told the committee that the 
majority of patients being treated for opioid addiction 
received treatment that is both, ``outdated'' and ``mostly 
ineffective.'' He described this approach of rapid 
detoxification, followed by an abstinence-only method without 
the use of important treatment medications. Dr. Bisaga added 
that this is potentially dangerous because it raises the risk 
of an overdose if a patient relapses.
    As troubling as this testimony from our last hearing was, 
today we have Dr. Volkow on our panel, who is one of the 
world's top experts on addiction research. And she notes--I'm 
sure you'll talk more about this, Doctor--in her written 
testimony that, ``Existing evidence-based prevention and 
treatment strategies are highly underutilized across the United 
States.''
    Why is that, Mr. Chairman? Why do we have experts week 
after week telling us that the bulk of the treatment Americans 
are receiving for this devastating disease are ineffective, 
outdated, and not evidence based.
    We need to be asking ourselves some tough questions. For 
example, Dr. Westreich, the president of the American Academy 
of Addiction Psychiatry, told us last week, ``Patients and 
their families need to know that detoxification treatment and 
drug-free counseling are associated with a very high risk of 
relapse.'' Are patients enrolling in treatment getting 
sufficient data so they can make medically informed choices? 
Are families and loved ones being told what approaches have 
high failure rates before choosing an approach to treatment? 
Frankly, this is not a decision that should be taken lightly. 
Getting ineffective treatment may not only be financially 
costly, but it may result in a fatal relapse.
    Finally, Mr. Chairman, recent testimony, including some I 
saw in the written statements for today, raises important 
questions about whether taxpayer dollars should fund certain 
approaches for combating this opioid epidemic over others. This 
is an issue I've been talking about week after week. We all 
agree that we need the most effective treatment, and our 
experts agree that this treatment needs to be a broad menu of 
options that is different from patient to patient.
    So we might not have a silver bullet to cure opioid 
addiction at this point, but we do know what treatments work 
better than others. Evidence tells us--and all the medical 
experts we heard from last week agree--that for most patients a 
combination of medication-assisted treatment and behavioral 
treatment, such as counseling and other supportive services, is 
the most effective way to treat opioid addiction. If that's the 
case, we should pursue more policies that encourage this 
approach as a clear option and steer away from any efforts that 
are not evidence based. It's costly, and it's dangerous to the 
patient.
    So I hope we can all work together to fight this epidemic, 
and I do look forward to hearing from all of our witnesses. I'm 
glad Secretary Burwell and the department are devoting serious 
attention to addressing both the prevention and treatment sides 
of this problem.
    And, Mr. Chairman, this has been a really great series. I'm 
happy to have a whole investigation like this in this 
committee. There's one group that we haven't heard from yet, 
I'm hoping----
    Mr. Murphy. States.
    Ms. DeGette. Good. The States. We haven't heard from the 
States yet. It's critical we hear from them because that's 
where the rubber is hitting the road. We need to hear what the 
States are doing to address this problem and understand the 
reasoning behind some of the choices being made. Some States 
are picking effective treatment methods, and others are not.
    So I think we need a multifaceted approach that this is 
what our research has showed, and I know we can work together 
to continue this important investigation.
    I just want to add one more note. The witnesses and the 
audience may see members jumping in and running out. We have 
another hearing in Energy and Commerce Committee going on down 
on the first floor, so people will be coming and going. But I 
know certainly, from my side of the aisle, people recognize 
this is a very serious issue. Thank you.
    Mr. Murphy. Thank you. And I know that they'll be calling 
votes at 9:30 for first vote series.
    Ms. DeGette. I thought it was at 11:00
    Mr. Murphy. Something has changed. First and only vote 
series of the day. I'm here for the duration, so we want to 
hear from you and hopefully the members.
    And now we recognize Mr. Upton.
    Mr. Upton. We really are going to have votes at 9:30?
    Mr. Murphy. That's what it says now.
    Mr. Upton. Well, I'm going to submit my statement for the 
record then.
    Mr. Murphy. OK. All right.
    [The prepared statement of Mr. Upton follows:]

                 Prepared statement of Hon. Fred Upton

    Today we continue our important review of the opioid abuse 
epidemic. In recent weeks we have heard valuable testimony from 
academics and State and local leaders, including folks on the 
frontlines in Southwest Michigan, and today we will hear what 
the Federal Government is doing to combat this pressing issue.
    The abuse of painkilling opioids and heroin is a complex 
and growing public health crisis that has sadly been outpacing 
the Nation's efforts to reverse this epidemic. A lot of people 
are dying, and a lot of families are suffering. In Kalamazoo 
County, where the reality of heroin overdoses has hit hard, we 
remember two young women who were friends. In 2008, we lost Amy 
Bousfield at 18 years old. In 2012, her friend Marissa King 
died at 21 years old. Marissa began using heroin in 2009, 
despite having lost two friends to the drug. Marissa was 
diagnosed with bipolar disorder, had struggled with depression, 
and had abused prescription drugs before turning to heroin 
after graduating from high school.
    Every community has been hit by heartbreak. According to 
the Michigan Department of Community Health, ``Unintentional 
poisoning deaths in Michigan involving opioids comprise 20 
percent of unintentional poisoning deals in 2012, compared to 
11 percent in 1999. Unintentional poisoning deaths involving 
opioids increased more rapidly than those from any other 
drug.'' This subcommittee's diligent review of every 
perspective of this issue is important.
    Last week, we took an important step. The House approved 
bipartisan legislation coauthored by the full committee Vice 
Chairman Marsha Blackburn, and Representatives Tom Marino, 
Peter Welch, and Judy Chu to clarify language in the Controlled 
Substances Act and promote collaboration between agencies and 
stakeholders to ensure patients have access to medications.
    But this subcommittee's hearings have shined a light on how 
much more needs to be done. Our review has introduced us to 
many health professionals, scientists, community leaders, and 
public servants who are working their hearts out to make a 
difference and to help reduce this problem. There are a number 
of worthy ideas on how to strengthen the Federal response.
    To take on the enormous challenge posed by the opioid abuse 
epidemic, we need to be unified and find common ground. These 
hearings provide a foundation for this committee to proceed in 
a bipartisan fashion to take constructive and effective 
actions. I am ready to work with my colleagues on the committee 
on both sides of the aisle, the president, Secretary Burwell, 
and the rest of the administration to produce positive results 
in fighting this epidemic for the American people.
    We want to help. I welcome our distinguished Federal 
Government witnesses and look forward to their testimony.

    Mr. Upton. Yield back.
    Mr. Murphy. All right.
    Mr. Pallone, 5 minutes.
    Mr. Pallone. I'll do the same, Mr. Chairman, because we 
both have to go to the other hearing.
    Mr. Murphy. OK.
    Mr. Upton. It's his bill. It's his bill we're talking 
about.
    Mr. Murphy. See how much we get along?
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Mr. Chairman, thank you for holding this hearing today--the 
third in a series on the opioid abuse epidemic. This problem 
has affected every one of our districts, and I am glad this 
subcommittee is taking a serious look at this issue.
    Today's hearing gives us the opportunity to hear from 
Federal Government agencies about what they are doing to tackle 
the opioid addiction crisis. I am pleased to see that Secretary 
Burwell and the Department are taking important steps on both 
the prevention and the treatment of opioid abuse and I look 
forward to working with them on addressing this burgeoning 
crisis. To that end, it is critical also that we approach this 
problem on both sides of this issue--upstream, where 
overprescribing is occurring, and downstream, where better 
treatment across this country is desperately needed.
    The opioid addiction and abuse epidemic is inextricably 
tied to the overprescribing of these drugs for the treatment 
and management of chronic pain. I want to hear from you about 
how we can reduce the overprescribing of opioids and assist 
medical professionals in making informed prescribing decisions.
    On the treatment side, we need to focus our attention on 
what works. There is consensus in the medical community that 
medication-assisted treatment--or MAT--is an essential 
component of effective treatment. However, it is still not 
available in large parts of the country and as others have 
already told this committee, many Americans are receiving 
outdated and ineffective treatment. We need to understand why 
that is the case and how we can increase access to the most 
effective treatment protocols currently available.
    I also want to use today's hearing as an opportunity to 
hear from these Federal agencies about the implementation of 
the Affordable Care Act. When we passed the law, we took 
significant steps to expand access to health care for all 
Americans, including those with substance use disorders.
    For many, the lack of insurance or the cost of treatment 
presents an insurmountable barrier to receiving the treatment 
help they need. The Affordable Care Act addresses some of these 
problems by expanding insurance coverage and requiring that 
insurance cover the cost of substance abuse services. This will 
mean that millions of people will have access to the tools they 
need to break their addictions.
    Additionally, the Affordable Care Act provides us with a 
historic opportunity to transform a fragmented, underfunded 
system for treatinu substance abuse disorders into one that 
promotes coordinated, patient-centered care. I look forward to 
hearing from Dr. Frank and others about how the Affordable Care 
Act is transforming the landscape for behavioral health 
services, and what more needs to be done to truly inteurate 
behavioral health services into our broader healthcare system.
    Thank you again for holding this important hearing and to 
all our witnesses. I look forward to continuing our work on 
this issue.
    I yield my remaining time to Rep. Kennedy.

    Mr. Murphy. Is there anybody else on either side that needs 
recognition? Go right into this.
    OK. Let me find my----
    Ms. DeGette. No. Wait, wait. Mr. Kennedy.
    Mr. Pallone. Oh, he wanted a minute. Mr. Chairman, can I 
yield just 1 minute to Mr. Kennedy?
    Mr. Murphy. Yes. You can yield your minutes to Mr. Kennedy 
of Massachusetts.
    Mr. Kennedy. Thank you very much for the consideration. I 
yield back.
    Mr. Murphy. OK. All right. Let me now introduce the 
witnesses on the panel for today's hearing. We have the 
Honorable Michael Botticelli, the Director of the Office of 
National Drug Control Policy, which is part of the Executive 
Office of the President. Welcome here. Dr. Richard Frank, the 
Assistant Secretary For Planning and Evaluation at the U.S. 
Department of Health and Human Services; Dr. Nora Volkow, who 
is the Director of the National Institute on Drug Abuse with 
the National Institutes of Health; Dr. Douglas Throckmorton, 
who is the Deputy Director of the Center for Drug Evaluation 
and Research of the Food and Drug Administration; Dr. Debra 
Houry, the Director of the National Center for Injury 
Prevention and Control of the Centers for Disease Control and 
Prevention; the Honorable Pamela Hyde, the Administrator for 
the Substance Abuse and Mental Health Services Administration; 
and Dr. Patrick Conway, the Deputy Administrator for Innovation 
and Quality and the CMS Chief Medical Officer at the Centers 
for Medicare and Medicaid Services. Welcome.
    You are aware that--now swearing in the witnesses--the 
committee is holding an investigative hearing and, when doing 
so, has a practice of taking testimony under oath. Do you have 
any objection to testifying under oath?
    None of the witnesses have objection. So the Chair then 
advise you that under the rules of the House and the rules of 
the committee, you are entitled to be advised by counsel. Do 
any of you desire to be advised by counsel today? And none of 
the witnesses say so.
    So, in that case, please rise. Raise your right hand. I'll 
swear you in.
    Do you swear that the testimony you're about to give is the 
truth, the whole truth, and nothing but the truth?
    Thank you. All the witnesses answered in the affirmative, 
so you are now under oath and subject to the penalties set 
forth in title 18, section 1001 of the United States Code.
    You may now each give a 5-minute opening statement. Please 
stick to the 5 minutes. If you don't have to fill it, that's 
OK, too. We'd like to get through.
    Mr. Botticelli.

   STATEMENTS OF MICHAEL P. BOTTICELLI, DIRECTOR, OFFICE OF 
    NATIONAL DRUG CONTROL POLICY; RICHARD G. FRANK, PH.D., 
ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, DEPARTMENT OF 
  HEALTH AND HUMAN SERVICES; NORA D. VOLKOW, M.D., DIRECTOR, 
   NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF 
HEALTH; DOUGLAS C. THROCKMORTON, M.D., DEPUTY DIRECTOR, CENTER 
FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION; 
DEBRA HOURY, M.D., M.P.H., DIRECTOR, NATIONAL CENTER FOR INJURY 
    PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL AND 
  PREVENTION; PAMELA S. HYDE, J.D., ADMINISTRATOR, SUBSTANCE 
 ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION; AND PATRICK 
 CONWAY, M.D., M.SC., DEPUTY ADMINISTRATOR FOR INNOVATION AND 
 QUALITY, AND CHIEF MEDICAL OFFICER, CENTERS FOR MEDICARE AND 
                       MEDICAID SERVICES

               STATEMENT OF MICHAEL P. BOTTICELLI

    Mr. Botticelli. Thank you, Chairman Murphy, Ranking Member 
DeGette, and members of the subcommittee for the opportunity to 
provide testimony to you today about the administration's 
efforts to address the opioid epidemic in the United States.
    Mr. Chairman, as you recognized, in 2013 almost 44,000 
Americans died of a drug overdose. That's one drug overdose 
death every 12 minutes. Using ONDCP's role as the coordinator 
of the Federal Drug Control agencies, in 2011, we published the 
administration's Prescription Drug Abuse Prevention Plan to 
address the sharp rise in prescription opioid drug abuse in 
this country since 1999. As you know, the plan consists of 
action items categorized under four pillars: Education of 
patients and prescribers; increased prescription drug 
monitoring; proper medication disposal; and informed law 
enforcement.
    With the work of our HHS partners here today, and other 
Federal partners as part of the Interagency Prescription Drug 
Work Group convened by ONDCP, we have made some strides in each 
of these areas, but there is much more to be done.
    Since time in graduate medical education programs devoted 
to the identification of treatment of substance abuse disorders 
is rare, we have worked with our Federal partners to develop 
continuing education programs about substance abuse, managing 
pain appropriately, and treating patients using opioids more 
safely. Many prescribers in Federal agencies, including HHS, 
are receiving this important training. Despite this, a large 
percentage of prescribers have not availed themselves of this 
training. Therefore, the administration continues to press for 
mandatory prescriber education tied to controlled substance 
licensure. I am pleased that Secretary Burwell has expressed 
her support for working with Congress to set requirements for 
specific training for opioid prescribers.
    Today, all States but one, Missouri, have prescription drug 
monitoring programs that allow prescribers to check on drug 
interactions as well as alert them to the signs of dependence 
on opioids. Missouri is also working to authorize a PDMP 
program. With almost all States implementing PDMPs, we are 
focusing on improving State-to-State data sharing, and 
improving access to PDMP data within the health record systems 
providers use every day.
    In October, the Drug Enforcement Administration's final 
regulation on controlled substances disposal became effective. 
ONDCP and our Federal partners and stakeholders have begun to 
inform the public about these regulations and look to ways to 
stimulate more local disposal programs in partnerships with 
pharmacies, local government, community groups, and local law 
enforcement.
    And the work of our law enforcement partners at the 
Federal, State, and local levels is ongoing. Those engaged in 
fraud across the drug control supply chain are being 
investigated and prosecuted.
    Recent data shows we are seeing an overdose from 
prescription opioids leveling off in this country, but a 
dramatic 39 percent increase in heroin overdoses from 2012 to 
2013. This is creating an additional need for treatment in a 
system where a well-known gap between treatment capacity and 
demand already exists. Therefore, we must redouble our efforts 
to address people who are misusing prescription opioids, since 
we know this is a major risk factor for subsequent heroin use.
    Earlier this week, the administration held the inaugural 
meeting of the congressionally mandated interagency Heroin Task 
Force. Mary Lou Leary, our Deputy Director for State, Local, 
and Tribal Affairs, is one the cochairs for this committee. In 
addition, the President's FY '16 budget request includes $99 
million in additional funding for treatment and overdose 
prevention efforts.
    We have also been working to increase access to the 
emergency opioid overdose reversal drug, naloxone, and to 
promote Good Samaritan laws so that witnesses can take steps to 
help save lives. Many police and fire departments have already 
trained and equipped their personnel with this life-saving 
drug, and loved ones of people with opioid drug use disorders 
are equipping themselves as well.
    And while law enforcement and other first responders have 
an important role to play, the medical establishment also must 
become more engaged to identify and treat heroin and 
prescription opioid use disorders. Every day, these people 
appear in our emergency departments and other medical settings, 
and more models and interventions are needed to get these 
individuals engaged in care.
    We also need to expand availability of evidence-based 
opioid use disorder treatments. Medication-assisted treatment, 
which uses FDA-approved medications, combined with behavioral 
and other recovery supports, has been shown to be the most 
effective treatment for opioid use disorders. Decisions about 
the most appropriate treatment options and their duration need 
to be agreed upon by both the patient and the treatment 
provider.
    We must also provide community supports, such as access to 
housing, employment, and education, to give patients the 
functional tools they need to lead healthier lives and fully 
integrate into the community as part of their recovery process.
    While we support multiple pathways to recovery, the 
literature shows that short-term treatment, such as 
detoxification alone, is not effective and carries risk of 
relapse and overdose death. Because of the lack of availability 
of evidence-based maintenance treatments and the strong 
connection between injection of opioid drugs and infectious 
disease transmission, we also promote the use of public health 
strategies that will help prevent the further spread of 
infectious disease. The HIV and hepatitis C outbreak in Scott 
County, Indiana, is a stark reminder of how opioid use can 
spread other diseases, how comprehensive public health 
strategies, such as syringe exchange programs, need to be part 
of the response to the opioid use epidemic, and how rural 
communities that have limited treatment capacity may experience 
additional public health crises.
    Finally, we are continuing our efforts to address neonatal 
abstinence syndrome. Research published just yesterday shows 
that the incidence of NAS has grown nearly fivefold between 
2000 and 2012 and that 81 percent of the 2012 hospital charges 
for NAS were attributed to Medicaid. We must consider that the 
best interest of babies with NAS is often served by best 
addressing the interests of the mother. Therefore, we need to 
provide safe harbor for pregnant and parenting women seeking 
prenatal care and treatment.
    In conclusion, we look forward to working with Congress and 
our Federal partners on the next stage of action to address 
this epidemic. Thank you.

    [The prepared statement of Mr. Botticelli follows:]
    
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    Mr. Murphy. Thank you.
    Dr. Frank, we're going to try and get your testimony and 
then we're going to run off and vote, and we'll be back. Go 
ahead.

                 STATEMENT OF RICHARD G. FRANK

    Dr. Frank. OK. Chairman Murphy, Ranking Member DeGette, and 
members of the subcommittee, thank you for the opportunity to 
discuss how the Department of Health and Human Services is 
addressing the opioid abuse epidemic.
    Containing the abuse and misuse of prescription opioids and 
heroin is a high priority for the HHS leadership team, and 
we're pleased to be here with you today. I would like to use my 
time today to give you an overview of how we view the challenge 
and describe how we are working to develop a multifaceted 
solution to this problem. It's going to take a lot of 
collaboration, and we are pleased to work with you and other 
stakeholders on this issue.
    Addiction to and abuse of opioids, including both 
prescription painkillers and heroin and the terrible outcomes 
associated with them, are growing at an alarming pace. Just 
over a third of drug overdose deaths in 2012 and 2013 were from 
prescription opioids, while heroin-related deaths have spiked 
dramatically, almost tripling since 2010.
    The sharp increase in the misuse and abuse of opioids 
places a great burden on the health system. There were 259 
million prescriptions filled for opioids in the U.S. in 2012, a 
large increase over just a few years prior. The Medicare 
program under part D spent $2.7 billion on opioids overall in 
2011, 1.9 billion of that total, or 69 percent was accounted 
for by the top 5 percent of opioid users. Those spending 
patterns on these drugs reflect some of our concerns.
    The cost of abuse and misuse of opioids shows up in 
preventable use of very expensive health care. Heroin presents 
an equally troubling, but different abuse and overdose pattern. 
We saw increases between 2002 and 2009 in a number of people 
using heroin, but that number has held fairly steady since 
2009.
    The striking new trend is that there's an increasing share 
of the users that are dying from heroin overdoses. So what I'm 
telling you is that we have a opioid prescribing problem, 
sitting alongside a drug abuse and misuse problem.
    Secretary Burwell is committed to aggressively addressing 
the epidemic. She's driving us towards two main goals: One, 
reducing opioid overdoses and overdose-related mortality; and 
two, decreasing the prevalence of opioid use disorder. She 
directed us to use the best science and to focus on the most 
promising levers that can make a difference for the people who 
struggle with opioid addiction and their families.
    HHS agencies have been collaborating on this problem for 
some time, and we hope you will agree after today that the 
whole is greater than the sum of the parts.
    Our actions informed by the evidence and discussions with 
States and other stakeholders fall into three general 
categories: One, addressing opioid prescribing practices; two, 
expending the use of naloxone; and three, promoting medication-
assisted treatment.
    Let me outline the plan in a bit more detail. First, PDMPs. 
We're increasing investments in prescription drug monitoring 
programs, which are among the most promising clinical tools to 
curb prescription opioid abuse. We're investing it through 
State grants and technical assistance and supporting best 
practices to maximize the impacts of PDMPs.
    Second, naloxone, which is the life-saving drug that can 
reverse overdose from both prescription opioids and heroin. 
We're supporting the development of user-friendly formulations 
and delivery mechanisms and are working with State and local 
governments to support training and other measures that get 
naloxone into the hands of those that are in a position to 
reverse overdoses.
    Finally, we have plans to support the appropriate use of 
medication-assisted treatment, or MAT. The enactment of the 
Mental Health Parity and Addiction Act opens up new 
opportunities to expand access to these evidence-based 
treatments.
    We are also working on identifying best practices in 
primary care settings, increasing access to MAT through SAMHSA 
grant support and potentially increasing the supply of MAT 
providers by reviewing the policy and regulations that limit 
the types of individuals certified to prescribe. Our commitment 
to halting this complex public health epidemic is set out in 
the President's 2016 budget that includes a $99 million 
increase for parts of our initiative.
    Finally, evaluation will help us identify the most 
effective activities, allow us to continuously learn, and 
inform future policy making in order to address this public 
health concern.
    So, in closing, this is critical for HHS and for the 
Nation, and we can't do it alone. We need help. Thank you for 
encouraging an open discussion of this today, and we are 
committed to turning the tide on this scourge that has become 
the opioid epidemic.

    [The prepared statement of Mr. Frank follows:]
    
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    Mr. Murphy. Thank you, Doctor.
    Now, for the members--so votes are in progress. And even 
though time is running out, just to let you know, I think only 
about 20 people voted so far. So, apparently, this is throwing 
everybody off in their schedules.
    I apologize. This is what happens on Capitol Hill. But 
we're committed to hear from you. We know how important this is 
and we value your testimony. So we're probably going to be back 
in a little under an hour. So we look forward to hearing from 
you then and getting the rest of this testimony. Thank you.
    [Recess.]
    Mr. Murphy. All right. Thank you for being patient.
    All right. Dr. Volkow, you're recognized for 5 minutes.

                  STATEMENT OF NORA D. VOLKOW

    Dr. Volkow. Good morning, Chairman Murphy, Ranking Member 
DeGette, and other members of the subcommittee. I want to thank 
you for organizing and inviting me to participate in this 
important hearing.
    The nonmedical use of prescription pain relievers is a 
particular public health challenge, for it demands solutions, 
on the one hand, to prevent their diversion and misuse, while 
at the same time, it demands so many solutions that will not 
jeopardize access to these medications for those that need 
them.
    Opiate medications are probably among the most effective 
painkillers that we have for the management of acute severe 
pain, and the proper use can actually save lives. They act by 
activating opioid receptors that are located in the areas of 
the brain that perceive pain, but there are very high 
concentration of opioid receptors in brain reward regions, and 
hence, the problem. Activation of these receptors is what is 
associated with their addiction potential.
    There are also high levels of receptors in areas of the 
brain that regulate breathing, which is why their use is 
associated also with a high risk of death from overdose.
    We have heard the devastating consequences from the 
escalation of the abuse of prescription medications in our 
country, the overdose deaths and transition to injection of 
heroin and associated infections with HIV and hepatitis C, and 
increasing numbers that we are seeing for the neonatal 
abstinence syndrome.
    NIDA's role in helping solve this epidemic is to support 
the research that will help develop solutions to prevent and 
treat abuse of prescription medications that could be 
implemented now, while, at the same time, funding research that 
in the future will provide transformative solutions.
    There are already evidence-based practices that have been 
shown to be effective in the prevention of overdose death that 
include the use of medications for opioid addiction and the use 
of naloxone to reverse opioid overdoses.
    There are three medications currently available to treat 
opioid addiction: methadone, buprenorphine, and naltrexone, 
which, when used as part of a comprehensive addiction treatment 
plan, have been shown to facilitate abstinence and reduce 
overdoses and HIV infections. Also, when coupled to prenatal 
care in pregnant women addicted to opioids, these medications 
reduce the risk of obstetrical fetal and neonatal 
complications. Yet, despite the strong evidence, less than 40 
percent of those receiving treatment for opioid addiction get 
treated with these medications. Toward this end, NIDA is 
funding research on implementation strategies that facilitate 
the use of medications for opioid addiction in the healthcare 
system.
    Another key component to decrease the overdose deaths is to 
expand the use of naloxone, so NIDA has partnered with 
pharmaceutical companies to develop user-friendly, effective 
delivery systems for naloxone that will facilitate their use by 
those that have absolutely no medical training.
    In addition, NIDA supports research on the treatment of 
pain and on the treatment of opioid addiction that will offer 
new solutions for the treatment of these two disorders. 
Examples for the management of pain include the development of 
drug combinations or new formulations with less addiction 
potential, the development of analgesics that do not rely on 
the opioid system, and the development of nonmedication 
interventions, such as the use of transcranial magnetic or 
electrical brain stimulation for pain management.
    Examples of research on the treatment of opioid addiction 
include the development of slow-release formulations that need 
only once-a-month or once-every-6-months dosing--which will 
facilitate compliance and use--and the development of vaccines 
against heroin, which will prevent the delivery of the drug 
into the brain, hence, interfering with its rewarding effects 
and adverse consequences.
    Because the epidemic of prescription drug abuse resulted 
from a lack of knowledge by healthcare providers, the 
importance of developing curriculum to train both in pain and 
in substance abuse disorders is another priority which NIDA has 
developed in partnership with the other institutes and NIH 
Centers of Excellence.
    There were over 24,000 deaths from opioid overdoses in 
2013. Twenty-four thousand. This highlights the urgency to 
address this epidemic. Solutions are already available. The 
challenge is the implementation. This requires strong 
integration of efforts, and NIDA will continue to work closely 
with other Federal agencies, community organizations, and 
private industries to address this complex challenge.

    [The prepared statement of Dr. Volkow follows:]
    
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    Mr. Murphy. Thank you.
    Dr. Throckmorton, 5 minutes.

              STATEMENT OF DOUGLAS C. THROCKMORTON

    Dr. Throckmorton.  Mr. Chairman, Ranking Member DeGette, 
and members of the subcommittee, I am Dr. Douglas Throckmorton, 
Deputy Director for Regulatory Programs within FDA's Center for 
Drug Evaluation and Research. Thank you for the opportunity to 
be here today to discuss FDA's role in combating opioid abuse 
and encouraging the safe use of these important drugs.
    Our goal is to find the balance between needing to treat 
patients with pain, including the use of opioids where 
appropriate, and needing to reduce opioid drug abuse. This work 
is being done together with other parts of the Federal 
Government, and we know that a successful and sustainable 
response must include Federal and State Government, public 
health officials, opioid prescribers, addiction experts, 
researchers, manufacturers, and patient organizations.
    For our part, FDA plays a central role in the regulation 
and use of drugs from their discovery and throughout their 
marketing. For example, when FDA reviews a drug for possible 
marketing, we also approve drug labeling, which includes 
information about approved uses about the medicine, as well as 
information about potential safety risks. FDA also carefully 
follows drugs after they are marketed, including opioid drugs. 
Where necessary, this enables us to take a variety of actions 
to improve their safe use, such as changes to approved 
labeling.
    The first area of FDA activity I'd like to highlight is our 
work to support the development of abuse-deterrent formulations 
that make opioids harder or less rewarding to abuse. While this 
is not a silver bullet that will prevent all abuse, FDA 
believes abuse-deterrent opioids can help reduce opioid abuse. 
To incentivize their development, FDA recently issued final 
guidance on abuse-deterrent formulations, guidance we are using 
now to meet with sponsors interested in developing them.
    To date, FDA has received some 30 investigational new drug 
applications from manufacturers. In addition, we have approved 
four opioid drugs with abuse-deterrent claims in their 
labeling.
    Overall, then, while we are in the early stages of 
development, I am encouraged by this level of work. FDA 
envisions a day not far in the future when the majority of 
opioids in the marketplace are in effective, abuse-deterrent 
forms.
    Next, with regards to prescribing opioids, we know that 
they are powerful medicines, and FDA believes that it is 
critically important to ensure that prescribers have high 
quality education about how to use them in pain management.
    Over the past several years, FDA has done several things to 
improve educational materials on opioids. For example, we 
recently finalized required changes to the approved labels of 
extended-release, long-acting opioids, changing their 
indication to inform prescribers that these drugs should only 
be used for pain severe enough to require daily around-the-
clock treatment when alternative treatments would not work.
    At the same time, FDA strengthened significantly the safety 
warnings on these opioids. We want prescribers to use them with 
care, and today, the labels for extended-release, long-acting 
opioids are among the most restrictive of any drugs that we 
have in the center, and have clear language that calls 
attention to their potentially life-threatening risks.
    FDA's also working to improve the information available for 
prescribers in other ways. Under certain circumstances, FDA can 
require manufacturers, as a part of a risk evaluation and 
mitigation strategy, to address safety concerns such as opioid 
abuse. In 2012, FDA required manufacturers to fund the 
development of unbiased continuing education programs on opioid 
prescribing practices for prescribers. In the first year since 
that program has been in place, approximately 6 percent of the 
320,000 prescribers, around 20,000 prescribers of extended-
release and long-acting opioids, have completed one of those 
courses. We believe this training for prescribers is important. 
We also support mandatory education for prescribers of opioids, 
as called for by the administration in the 2011 Prescription 
Drug Abuse Prevention Plan, and reemphasized in the 2014 
National Drug Control Strategy.
    Finally, FDA has been working with many other stakeholders, 
including the agencies here today, to explore the best ways to 
prevent overdose deaths by the expanded use of naloxone. As 
others have said, it can and does save lives. FDA is working to 
facilitate the development of naloxone formulations that could 
be easier to use by anyone responding to an overdose. First, 
FDA meets with manufacturers whenever needed and is using 
whatever tools we can to expedite product development. We 
recently approved the first auto-injector formulation of 
naloxone, which is intended to be administered by people 
witnessing an overdose, such as family members and caregivers. 
We completed that review and approved this product in 15 weeks.
    Going forward, we continue to work on how best to use 
naloxone. As a part of this work, FDA, and many of the others 
agencies at this table, are planning a public meeting in July 
to bring together key stakeholders to deal with questions of 
access, coprescribing of naloxone, and State and local best 
practices.
    In conclusion, as a society, we face an ongoing challenge 
and a dual responsibility. We must balance efforts to address 
opioid drug misuse, abuse, and addiction against the need for 
access to appropriate pain management. These are not simple 
issues and there are no easy answers. FDA is taking important 
actions we hope will achieve this balance. We welcome the 
opportunity to work with Congress, our Federal partners, the 
medical community, advocacy organizations, and the multitude of 
interested communities and families to turn the tide on this 
devastating epidemic.
    Thank you for this opportunity to testify. I look forward 
to answering any questions that I can.

    [The prepared statement of Dr. Throckmorton follows:]
    
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    Mr. Murphy. Thank you, Doctor.
    Dr. Houry.

                    STATEMENT OF DEBRA HOURY

    Dr. Houry. Chairman Murphy, Ranking Member DeGette, I would 
like to thank you for inviting me here today to discuss this 
very important issue. I would also like to thank the committee 
for your continued interest in prescription opioid abuse and 
overdose. My name is Dr. Debra Houry, and I am the director of 
the National Center for Injury Prevention and Control at the 
CDC.
    As a trained emergency room physician, I have seen 
firsthand the devastating impact of opioid addiction on 
individuals and their families, as well as the importance of 
prevention. Together, we have witnessed a deadly epidemic 
unfolding in States and communities across the country. The 
overdose epidemic is driven, in large part, by fundamental 
changes in the way healthcare providers prescribe opioid pain 
relievers. Enough prescriptions were filled in 2012 for every 
American adult to have their own bottle of pills. As the amount 
of opioids prescribed increased, so has the number of deaths.
    In alignment with the Department's initiative, I want to 
highlight CDC's work in developing evidence-informed opioid 
prescribing guidelines for chronic pain and providing direct 
support to States to implement multi-sector prevention 
programs.
    CDC is currently developing guidelines for the prescribing 
of opioids for chronic noncancer pain. This undertaking is 
responsive to a critical need in the field. These new 
guidelines will redefine best practices around opioid 
prescribing for chronic pain and make important advances in 
protecting patients. The audience for these guidelines are 
primary care practitioners, who account for the greatest number 
of prescriptions for opioids compared to other specialties. The 
guidelines process is underway, and our goal is to share a 
draft for public comment by the end of this year. We have plans 
in place to encourage uptake and usage of the guidelines among 
providers, which is key for improving prescribing practices.
    The second activity I would like to highlight is our major 
investment in State-level prevention. States are at the front 
lines of this public health issue, and CDC is committed to 
equipping them with the expertise they need to reverse the 
epidemic and protect their communities. Utilizing the newly 
appropriated $20 million, we recently published a new funding 
opportunity called Prescription Drug Overdose: Prevention for 
States. It builds upon existing CDC-funded State programs and 
targets States that have a high drug overdose burden and those 
that demonstrate readiness needed to combat the epidemic. It 
requires collaboration across sectors for a truly comprehensive 
response.
    The goals for this program are to make prescription drug 
monitoring programs more timely, easier to use, and able to 
communicate with other State PDMPs, to implement Medicaid or 
Workers' Compensation interventions to protect patients at 
risk, and to bring data-driven prevention to the communities 
struggling with the highest rates of drug abuse and overdose. 
States also will be given the flexibility to use the program to 
respond to emerging crises and develop innovative interventions 
so they know what works to reduce overdose and save lives in 
their community.
    The development of opioid prescribing guidelines and our 
State prevention program are two key ways that CDC's broad work 
on the epidemic contributes to the Department's initiative.
    We are also examining the increase in heroin use and 
overdose. Heroin overdose deaths have more than doubled since 
2010, and prescription opioid abuse, a key risk factor for 
heroin use, has contributed significantly to this rise in 
heroin use and overdose. We will leverage our scientific 
expertise to improve public health surveillance of heroin and 
evaluate effective strategies to prevent future heroin 
overdoses.
    Addressing this complex problem requires a multifaceted 
approach and collaboration among a variety of stakeholders, but 
it can be accomplished, particularly with the ongoing efforts 
of all of the organizations represented here on this panel.
    CDC is committed to tracking and understanding the 
epidemic, supporting States working on the front lines of this 
crisis, and providing healthcare providers with the data, 
tools, and guidance they need to ensure safe patient care.
    Thank you again for the opportunity to be here with you 
today and for your continued work and support of us protecting 
the public's health. I look forward to your questions.

    [The prepared statement of Dr. Houry follows:]
    
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    Mr. Murphy. Thank you, Doctor.
    Pamela Hyde, welcome back.

                  STATEMENT OF PAMELA S. HYDE

    Ms. Hyde. Good morning, Chairman Murphy, Ranking Member 
DeGette, and members of the subcommittee. Thank you for 
inviting SAMHSA to be part of this hearing, and thank you for 
your interest in this important public health issue.
    According to SAMHSA's National Survey on Drug Use and 
Health, the prevalence rate of nonmedical use of prescription 
opioids is high, approximately 4.5 million individuals in 2013. 
Heroin use is much lower, About 289,000 individuals reporting 
past month use, but that's doubled in 5 years.
    Fortunately, the nonmedical use of pain relievers has 
actually decreased some from 2009 to 2013, especially among 
young people 12 to 17. However, as you know, overdoses and 
overdose-related deaths from both prescription drugs and heroin 
have risen dramatically among all ages. And as you've heard, 
few who need treatment are receiving the comprehensive 
community-based services they need to live lives in recovery, 
free of addiction.
    SAMHSA believes prevention is the priority and recovery is 
the goal. SAMHSA's programs, data, practice improvement, public 
education, and regulatory efforts are all designed to prevent 
addiction and overdoses, help provide the treatment and 
services needed for people with substance abuse disorders to 
achieve recovery, support their families, and foster supportive 
communities.
    SAMHSA funds the American Academy of Addiction Psychiatry, 
together with six other medical societies, to train prescribers 
in the best approaches to pain management. SAMHSA also educates 
physicians on medication-assisted treatment for opioid 
addiction. SAMHSA's Addiction Technology Transfer Centers 
provide training and materials on opioid use disorders, and are 
cofunded with NIDA to distribute research-based best practices 
to the field of addiction treatment.
    To help prevent opioid-overdose-related deaths, SAMHSA 
alerted States last year that substance abuse treatment block 
grant funds may be used to purchase and distribute naloxone and 
increase education and training on its use. Also in 2014, 
SAMHSA updated its opioid overdose prevention toolkit to 
educate individuals, families, first responders, and others 
about steps to prevent and reverse the effects of opioid 
overdoses, including the use of naloxone. This toolkit's one of 
the most downloaded resources on SAMHSA's Web site.
    The President's 2016 budget includes $12 million in 
discretionary grants for States to purchase and distribute 
naloxone, equip first responders in high risk communities, and 
support education on the use of naloxone and other overdose 
prevention strategies.
    SAMHSA also supports medication-assisted treatment as part 
of a recovery-oriented, person-centered care model. Medication-
assisted treatment is not meant as a standalone approach, but 
rather is designed to include medication, counseling, 
behavioral therapies, and recovery supports.
    In March 2015, SAMHSA issued revised Federal guidelines for 
opioid treatment programs which highlight this recovery-
oriented care model, and encouraged the use of any of the three 
FDA-approved medications for the treatment of opioid use 
disorder based on an assessment of each individual's unique 
needs.
    SAMHSA's also taking an integrated clinical care approach 
as part of a new 2015 grant program to expand and enhance the 
availability of medication-assisted treatment and other 
clinically appropriate services in States with the highest 
rates of opioid admissions. The President's 2016 budget 
proposes to double this program.
    In collaboration with DOJ and ONDCP, SAMHSA added language 
to its 2015 treatment drug court grant requirements to ensure 
that drug court clients will not be compelled to stop or be 
prevented from using medication if it is prescribed or 
dispensed consistent with a licensed prescriber's 
recommendation, a valid prescription, or as part of a regulated 
opioid treatment program.
    SAMHSA regulates opioid treatment programs, which are 
expected to provide a full range of services for their 
patients. In collaboration with the Drug Enforcement 
Administration, SAMHSA provides waivers to physicians wishing 
to treat opioid use disorders with buprenorphine in a practice 
setting other than an opioid treatment program.
    SAMHSA also funds efforts to help prevent prescription 
opioid misuse and heroin use. For example, in 2014, SAMHSA's 
Strategic Prevention Framework--Partnerships for Success 
program, made preventing and reducing heroin use one of its 
focus areas, along with prescription drug misuse and abuse, and 
underage drinking. For 2016, the President has proposed $10 
million for the Strategic Prevention Framework Rx, or SPF Rx, 
to help States use data, including PDMP data, to identify and 
assist communities at high risk for the nonmedical use of 
prescription drugs.
    We want to thank you, again, for taking on this issue and 
for allowing SAMHSA an opportunity to share some of its efforts 
with you. We look forward to answering your questions.

    [The prepared statement of Ms. Hyde follows:]
    
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    Mr. Murphy. Thank you, Ms. Hyde.
    Dr. Conway, you're recognized for 5 minutes.

                  STATEMENT OF PATRICK CONWAY

    Dr. Conway. Chairman Murphy, Ranking Member DeGette, and 
members of the subcommittee, thank you for inviting me to 
discuss the CMS's work to ensure that all Medicare and Medicaid 
beneficiaries are receiving the medicines they need, while also 
reducing and preventing prescription drug abuse.
    As we have heard from other witnesses, opioid analgesics 
have increasingly been implicated in drug overdose deaths over 
the last decade. As a practicing physician, I understand the 
importance of this issue.
    CMS recognizes our responsibility to protect the health of 
Medicare and Medicaid beneficiaries by ensuring that 
appropriate safeguards are in place to help prevent overuse and 
abuse of opioids, while ensuring that beneficiaries can access 
needed medications and appropriate treatments for substance 
abuse disorder.
    Since its inception in 2006, the Medicare part D 
prescription drug benefit has made medicines more available and 
affordable, leading to improvements in access to prescription 
drugs and better health outcomes.
    Despite these successes, part D is not immune from the 
nationwide epidemic of opioid abuse. CMS has broadened its 
initial focus of strengthening beneficiary access to prescribed 
drugs to also address potential fraud and drug abuse by making 
sure part D sponsors implement effective safeguards and provide 
coverage for drug therapies that meet safety and efficacy 
standards.
    We believe that broader reforms that result in better 
coordinated care will help protect beneficiaries from the 
damaging effects associated with prescription drug abuse and to 
prevent and detect overutilization related to prescription 
drugs.
    A centerpiece of our strategy is to strengthen CMS's 
monitoring of part D plan sponsors' drug utilization management 
programs, to prevent overutilization of these medications. To 
accomplish this goal, the Medicare part D overutilization 
monitoring system, or OMS, was implemented in 2013. Through 
this system, CMS provides reports to sponsors on beneficiaries 
with potential opioid overutilization identified through 
analysis of prescription drug event data and through 
beneficiaries referred by the CMS Center for Program Integrity. 
Sponsors are expected to utilize various drug utilization 
monitoring tools to prevent continued overutilization of 
opioids. Recent data has shown that from 2011 to 2014, the OMS 
has reduced the number of potential opioid over-utilizers by 
appropriately 26 percent.
    CMS also utilizes the Drug Integrity Contract, or MEDIC, 
which is charged with identifying and investigating potential 
fraud and abuse, and developing cases for referral to law 
enforcement agencies. In 2013, CMS directed the MEDIC to 
increase its focus on proactive data analysis in part D. CMS 
has also used our rule-making authority to create new tools to 
take action against problematic prescribers and pharmacies. We 
recently finalized a provision that requires prescribers of 
part D drugs to enroll or have a valid opt-out affidavit on 
file, and establishes a new revocation authority for abusing 
prescribing patterns.
    State Medicaid agencies have also taken action to tackle 
the opioid abuse epidemic. Efforts include expanding the 
Medicaid benefit to include behavioral health services for 
those with addiction to prescription drugs and pharmacy 
management review programs. Although CMS does not determine 
what services are provided in each Medicaid program to prevent 
and treat opioid abuse, we are encouraged by the increasing 
efforts by States to develop effective strategies for designing 
benefits for this population.
    We recently launched the Medicaid Innovation Accelerator 
Program, or IAP, to provide States with technical assistance 
and other types of support to address this important issue.
    CMS, in coordination with CDC, SAMHSA, and NIH, issued an 
informational bulletin on medication-assisted treatment for 
Substance Abuse Disorder in the Medicaid program. This guidance 
outlines that a combination of medication and behavioral 
therapies is the most effective combination of treatment. We 
issued a similar bulletin focused on these services in the 
pediatric and youth population.
    CMS is dedicated to providing the best possible care to 
beneficiaries with opioid addiction, and is working with part D 
sponsors and State Medicaid programs to implement effective 
safeguards to prevent opioid abuse and treat patients 
effectively with substance abuse disorders.
    CMS has made progress, but there is more work to be done. 
CMS is undertaking multiple policy initiatives and 
interventions to reduce the rate of opioid addiction and 
overdoses in both Medicare and Medicaid.
    In previous testimonies, I've never had family here or the 
time to thank them, so I do want to thank my mother, Diane 
Conway, is here and my son, Jack, who's out of school, as well 
as my wonderful wife, Heather, and daughters Alexa and 
Savannah. And without their love and support, I would not be 
able to work on issues like this that are critically important 
to our Nation. So thank you.

    [The prepared statement of Dr. Conway follows:]
    
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    Mr. Murphy. Thank you, Doctor. And thank you for 
recognizing Take Your Family to Testifying Day. Apparently 
everybody else did not get the memo.
    I just want to start out by saying if talent and dedication 
alone could solve this crisis, we'd be there with the testimony 
of today and other days, but obviously, we still have problems. 
So let me start off with asking a few questions.
    First, for Director Botticelli, for the Office of National 
Drug Control Policy, or ONDCP, uses the term ``recovery,'' does 
it mean to include patients with opioid addiction in a 
buprenorphine or methadone treatment program and still using 
heroin or other illicit drugs, or would you say that's not 
recovery?
    Mr. Botticelli. So I think, you know, from our perspective, 
and also as a person in recovery, clearly we want to make sure 
that people are continuing to progress in their recovery, and 
that kind of freedom from substances is the ultimate goal of 
recovery programs, and I think everyone would agree on that, 
but we also know that substance use, and particularly opioid 
use disorders, are a significant chronic disorder, and that 
oftentimes, and even my own experience show me, that people 
often will experience relapse and will often, I think, need 
multiple attempts at treatment to get to that final goal of 
long-term recovery and long-term abstinence.
    And so we really want to make sure that we're continuing to 
engage with patients, that we're moving them toward better 
health, better recovery, and being free from substance abuse as 
part of long-term recovery.
    Mr. Murphy. Well, let me ask in context of this, because we 
also heard from testifiers last week they felt there was not a 
uniform definition of recovery, but, I mean, this is the talent 
pool here, you're the ones that do these. Do you all meet on a 
regular basis to talk about these issues? And when was the last 
time you all got together to talk about policy issues? Was it 
within the last--can someone answer that? Pam? Pam Hyde?
    Mr. Botticelli. So let me start.
    Mr. Murphy. Oh, you will start? OK.
    Mr. Botticelli. Let me start with that, because it's 
actually part of our statutory authority----
    Mr. Murphy. OK.
    Mr. Botticelli (continuing). That we set in conjunction 
with, not just our HHS partners, but with all of the Federal 
agencies that have a role in substance use, and particularly in 
opioid use disorders. We have been engaged with the DOD and the 
VA and the Bureau of Prisons.
    Mr. Murphy. So you all meet regularly?
    Mr. Botticelli. We actually do meet regularly. So we have 
quarterly meetings to focus on where we are.
    Mr. Murphy. Well, let me move on that too, because that's 
going to be important.
    Ms. Hyde, let me ask you a question here in your response 
to our bipartisan letter of March 18 concerning the National 
Registry of Evidence-Based programs, you noted that, quote, 
``new submission and review procedures will improve the rigor 
of the registry and bring NREPP into closer alignment with 
other registries of evidence-based programs in the Federal 
Government.''
    Now, prior to entering into this July 2014 contract, did 
SAMHSA feel that the scientific basis of the rigor of NREPP 
needed to strengthened, yes or no? I mean, do you feel it 
needed to be strengthened?
    Ms. Hyde. Thank you for the question. We thought the 
process that we used for determining what practices were 
reviewed needed to be strengthened, and in the process, we have 
also increased the rigor with which we look at them.
    Mr. Murphy. Can you get us a list, not today, but can you 
get us a list of what you consider to be some of the models 
within the Federal registry that we can review as part of that, 
as evidence-based programs?
    Ms. Hyde. Certainly.
    Mr. Murphy. OK. Thank you.
    Your response also indicates an outside contractor will 
assume the role of gatekeeper for NREPP, determining which 
studies and outcomes are reviewed in the screening and review 
of an intervention, with the aim of preventing bias in favor of 
the intervention developers.
    Was SAMHSA's prior system for vetting and selecting 
interventions to be included in the NREPP prone to any kind 
developer bias or conflict of interest? Was that a concern?
    Ms. Hyde. Yes, Mr. Murphy, it was a concern. It was pretty 
much developer driven. So a developer had to want their 
practice to be reviewed, and then they had some control over 
what research we looked at. We have changed that with the new 
contract, which began last year, and we will help decide 
priorities together with the public input, but the contractor 
will help us look more objectively at evidence.
    Mr. Murphy. Thank you. I just pulled up here--I just got a 
note, actually an article that, was this one of your 
constituents, Dr. Frank, from eastern Colorado? I don't want to 
take all your Colorado thunder, but it was fascinating article, 
because it made reference to the increased use of emergency 
departments associated with opiates. And it's interesting, they 
said that the reasons for this is--first of all, they said 
there's 10-1/2 million estimated people with this, it's 
probably an underestimate, that people go to the emergency 
rooms for treatment for withdrawal, but also many trying to get 
more opiates; and that when you have users with opiate 
prescriptions from more than one physician, they're more likely 
to be involved in riskier practices.
    I wonder if any of you could comment on if that's an area 
that we're trying to address. I think, Dr. Volkow, you were 
also talking about issues with regard to prescribing practices, 
and Dr. Frank. Can some of you comment on those issues?
    Dr. Volkow. Yes. And I think that that article, I think, 
that you're referring to the New England Journal of Medicine 
article that shows that there's been a very significant, 
quadruple number of cases of neonatal abstinence syndrome in 
the intensive care units, and this does reflect the fact that 
many women are actually being prescribed opioid medications 
during the pregnancy itself. And, actually, based on another 
study, it was estimated that 21 percent of women that are 
pregnant are going to receive an opioid medication, which, 
again, highlights the need to enforce better that the 
guidelines on the management of pain need to be enforced in 
better ways. And this is also recognized by studies that have 
actually evaluated the extent to which physicians are following 
guidelines by the main medical organizations as it relates to 
the management of pain. So that is an area where there needs to 
be an aggressive increase in the education and enforcement of 
guidelines.
    Mr. Murphy. Thank you. I'm out of time. I'd just ask 
unanimous consent that I can submit this research article for 
the record.
    [The information appears at the conclusion of the hearing.]
    Mr. Murphy. Ms. DeGette, you're recognized for 5 minutes.
    Ms. DeGette. Thank you, Mr. Chairman.
    Dr. Volkow, as I mentioned in my opening statement, you're 
one of the world's top experts on the issue of treating 
addiction. Briefly, what does the body of scientific evidence 
show regarding the effectiveness of methadone and buprenorphine 
in this treatment of opioid abuse disorders?
    Dr. Volkow. What the research has shown--and it has shown 
it not just for methadone and buprenorphine, but a more recent 
medication, naltrexone--is that these medications when used as 
part of a comprehensive program for the treatment of opioid 
addiction are quite effective, and they significantly improve 
the outcomes of individuals being able to stay, on the one 
hand, abstinent from the drug or to decrease the likelihood of 
relapsing, but it also protects them against the adverse 
outcomes, such as overdoses.
    Ms. DeGette. So in light of those studies, you also said in 
your testimony that existing evidence-based prevention and 
treatment strategies are highly underutilized across the United 
States. And last week we had an expert tell our panel that very 
few patients with opioid addiction today receive treatments 
that have been proven most effective. He was talking about this 
rapid detox followed by abstinence-based treatment.
    I'm wondering, Dr. Volkow, if you can help understand this. 
Why do we have a situation where people are not getting 
evidence-based treatment?
    Dr. Volkow. Well, one of the problems has been--and it's a 
complex problem and there are many reasons why they're not 
getting the correct treatment, including the fact of adequate 
education as it relates to the proper screening and management 
of substance abuse disorder, including the healthcare system. 
Then you have a whole infrastructure that has developed because 
addiction is stigmatized, so, therefore, the likelihood of 
people accessing that medical care is much lower. And then, of 
course, there is a difference between States in the way that 
they implement the treatment. So all of these factors account 
for the current situation.
    Ms. DeGette. Dr. Frank, do you have anything to add to 
that?
    Dr. Frank. Yes, I do. I think that one thing that's very 
important to remember is that overall, we treat 10 percent of 
the people with these disorders, so it's not surprising that 
people aren't getting evidence-based treatment, because they're 
not getting treatment, period.
    Second part is why aren't they getting evidence-based 
treatment among those who do? And I think that there are 
insurance dynamics that hopefully we're fixing, there are, as 
Dr. Volkow said, access to trained professionals who are 
trained in the best things, and then there's, in a sense, 
trying to kind of get the systems and the infrastructures 
aligned so that they support the best practices.
    Ms. DeGette. And, Dr. Houry, several of our witnesses, 
including you, mentioned the role of the States in this. Can 
you talk about that for a minute?
    Dr. Houry. Absolutely. I think States have different 
populations, different issues, different prescription drug 
monitoring programs, and so tailoring these programs for States 
so they can best identify, whether it's their State Medicaid 
program, other high-risk programs or patients and how to best 
target them, and that's why the program at the CDC is really 
helpful, because we have the higher level view to work across 
the States for this.
    Ms. DeGette. And do you think the States have work to do in 
terms of implementing these programs that are science-based and 
that work?
    Dr. Houry. You know, I think we're starting to do that. 
Like, our program itself has only been in existence for 6 
months, but we're seeing great progress. And if you look at 
some of the policies that States are implementing, we're seeing 
reductions in what we call doctor shopping and patients going 
to different doctors, because of utilizing prescription drug 
monitoring programs. So although it's early in the stage, I'm 
very optimistic that we are making progress in the States.
    Ms. DeGette. OK. Dr. Volkow, I want to come back to you. 
One of our other experts last week said patients and their 
families need to know that detoxification treatment and drug-
free counseling are associated with a very high risk of 
relapse.
    I'm wondering if you can tell us what the science shows. Is 
this type of treatment generally effective or less effective? 
What does the research show?
    Dr. Volkow. The research has shown that in general, fast 
detoxification of patients is associated with increased 
mortality, like what you just mentioned. And this reflects the 
fact that addiction is a chronic disease and the changes that 
occur in the brain persist months, years after you've stopped 
taking the drug.
    So what they do in this fast detoxification is just remove 
the physical dependence and assume that the addiction is cured, 
and these are two independent processes, and as a result of 
that, the patient feels that they are safe and then they 
relapse because they are still addicted----
    Ms. DeGette. Thank you.
    Dr. Volkow (continuing). And many times they overdose.
    Ms. DeGette. Thank you.
    Thank you very much, Mr. Chairman.
    Mr. Murphy. I now recognize Mr. Collins for 5 minutes.
    Mr. Collins. Thank you, Mr. Chairman. This is truly a 
fascinating topic we're discussing, and it's obvious there's no 
very easy solution. I mean, we've heard it's a chronic disease, 
10 percent are seeking treatment. I guess my question maybe for 
Ms. Hyde at SAMHSA is, you know, certainly with pregnant women 
that may have young kids at home, and inpatient treatment might 
be the preferred, and we just can't let perfect be the enemy of 
good, what other options are you looking at for people who 
can't get in, I mean, they're just not going to enter 
inpatient, so they may be part of the 90 percent not getting 
treatment at all? Some treatment better than no treatment, as 
frustrating as that might be? What are your comments to the 
young mother that's got kids at home and she's pregnant and 
she's dependent and she just can't go into an inpatient center? 
What do we do for that patient?
    Ms. Hyde. Thank you for the question. The issue of pregnant 
and parenting women is a big one in our field. We do have a 
small program to address that issue, but you're right, it's a 
residentiallybased program.
    We have increasingly been looking at ways to take what we 
learn in that program about the best ways to treat pregnant and 
parenting women and take it into other settings, so whether 
it's our opioid treatment programs or the training that we do 
for physicians who are using medication-assisted treatment to 
deal with pregnant and parenting women. So we're trying in 
every way that we can to make those services available to those 
women.
    Mr. Collins. So, again, with pregnant women, and we're 
looking at other treatments, I guess, whether that's 
buprenorphine or methadone, are there studies that show whether 
that has an impact on the fetus and the baby?
    Ms. Hyde. You're right to be concerned about the child. 
What we see is that this prevents death, it prevents addiction 
of the baby, it prevents a lot of other issues that may come 
with allowing the young woman to continue with the illicit drug 
use or the prescription opioid misuse. So definitely providing 
treatment helps both the woman and the child.
    Mr. Collins. Now, as you've counseled these women, what 
kind of reaction are you getting? Are they recognizing--and you 
would think the genuine concern they have for the baby. I mean, 
there's very much a complicated balancing act going on here. 
What kind of reactions are you getting from the women 
acknowledging the problem and wanting to treat it?
    Ms. Hyde. You know, most pregnant and parenting women 
really want to do the best thing for their babies, and they 
want to do the best thing for themselves, but as you've heard, 
addiction is a chronic disease and it's very difficult; changes 
the brain, changes the ability to make decisions.
    The women who are in the programs that we provide support 
for find it a very helpful program with the kind of supports, 
because we provide a range of programs, and we've recently 
introduced medication-assisted treatment into those programs as 
well.
    Mr. Collins. So are these women finding you on their own, 
or are their physicians guiding them to you?
    Ms. Hyde. The women who come to our programs come from a 
variety of places; some from the correctional system, some from 
physicians, some from family, some from self-referral. So they 
come from a number of places, and we don't make a distinction 
between where they come from in terms of providing the care.
    Mr. Collins. Well, it's something this committee's very 
concerned with. And, again, Mr. Chairman, thank you for holding 
this hearing and for all of your testimony. I wish there was an 
easy solution. There just doesn't appear to be one. So this is 
going to have to be addressed on a lot of fronts. And with 
that, I yield back.
    Mr. Murphy. Mr. Tonko, you're recognized for 5 minutes.
    Mr. Tonko. Thank you, Mr. Chairman. And let me join in 
welcoming the Conway family to the hearing, and let me 
compliment the Honorable Michael Botticelli for having the 
roots, origins in the 20th Congressional District of New York. 
So welcome all.
    One of the biggest concerns I hear from individuals and 
families struggling with addiction is the difficulty they have 
accessing treatment. As you know, with the Mental Health Parity 
and Addiction Equity Act, as well as with our Affordable Care 
Act, millions more people have gained access to mental health 
and substance use services. However, recent reports have laid 
bare the fact that these new treatments as options sometimes 
exist on paper only.
    So my question first to Assistant Secretary Frank, Dr. 
Frank, what is HHS planning to do to increase the public 
disclosure of the Medicaid management practices insurers use 
both on the commercial side and on Medicaid and CHIP so that 
consumers can truly evaluate their health plans to make sure 
they are in compliance with parity?
    Dr. Frank. Thank you for the question. We, too, view the 
Mental Health Parity Act as an incredibly important opportunity 
to increase the use of evidence-based practice and access to 
treatment.
    We are doing a number of things. We work with both the 
Department of Labor on the ERISA side of the commercial health 
insurance side. We've trained the ERISA investigators in how to 
detect deviations from parity arrangements within insurance, 
and so they are out there fully trained now working on these 
issues. We have a group within HHS who regularly provides 
technical assistance to State insurance commissioners and works 
with them to resolve complaints as they arise. And we've 
continued a series of forums and technical assistance around 
the country. And we're working with stakeholders, some of whom 
are in this room today, to improve our ability to ask for 
disclosure and to offer up consumers the opportunity to really 
make that evaluation that you referred to.
    Mr. Tonko. Thank you, Assistant Secretary.
    And Director Botticelli, I would like to talk about another 
barrier to treatment for some patients. And press accounts have 
suggested that some States are denying patients access to drug 
courts if they are receiving medication-assisted treatments, or 
MATs. I understand this has been a problem in Kentucky, at 
least according to some press accounts. So, Director, can you 
explain what is going on here? Given the importance of MATs, 
why are some judges attempting to cut patients off of medicines 
that can actually help them recover?
    Mr. Botticelli. Thank you, Congressman. And as many of my 
colleagues have talked about today, increasing access to 
medication-assisted treatment along with other behavioral 
therapies is the best course of treatment for people with an 
opiate use disorder. Unfortunately, one of the access issues 
that we find in addition to issues around payment has been 
particularly lack of access within the criminal justice system, 
and we know that many people with opioid use disorders are 
ending up in our system.
    Drug courts, some drug courts have not adapted policies 
that the National Association of Drug Court Professionals 
endorse in terms of ensuring that people who do have an opioid 
use disorder get access to those medications, as well as not 
predicating their participation that they get off these 
medications.
    Part of what we've been doing on the Federal level is using 
our Federal contracting standards to ensure that people with 
opioid use disorders, whether it's in a drug court or a 
treatment program or in other venues, are offered access to 
medication-assisted treatment and are not denied participation 
based on the fact that they are on physician-prescribed 
medication.
    Mr. Tonko. Dr. Volkow, on that same issue, do you agree 
with the assessment?
    Dr. Volkow. Yes, I agree very much. And at the same time, 
we are developing alternatives that may be more amenable for 
the criminal justice system, like prison or jail, like the 
naltrexone antagonist, so there is no reason why they should 
not get access to medication.
    Mr. Tonko. OK. And another barrier that patients face is 
the lack of available treatment providers who can prescribe 
MATs. Director Botticelli, can you comment on this dearth of 
providers who can prescribe buprenophrine, for example, what 
are some of the reasons for the shortage and what can we do to 
address it?
    Mr. Botticelli. One of the other opportunities that we have 
is ensuring that all of our treatment programs either offer 
medication-assisted treatment or to refer to programs that have 
medication-assisted treatment. An analysis of our treatment 
programs show that a very low percentage of them have 
incorporated medication-assisted therapies into their programs. 
Some of this, Congressman, quite honestly, has been by myth and 
misunderstanding and this divide between abstinence-based care 
and medication-assisted treatment, which I think is really 
unfortunate that we have here, so we really want to make sure 
that if a client is entering a treatment program that has 
particularly Federal funding needs to offer, by way of its own 
offering or through referral, medication-assisted treatment.
    Mr. Tonko. All right. Thank you very much. And thank you to 
the entire panel for guiding us in this crisis situation.
    Mr. Murphy. I just want to ask as a clarification for the 
question you were asking about the drug courts and the use of a 
medication-assisted treatment. So you're recommending 
medication-assisted treatment as part of an option package, 
although you say obviously we want to get people free from 
drugs all together, does it require a recommended practice from 
your agencies to get drug courts to do that? Does it require 
regulatory changes from one of your agencies to do that? Or 
does it require a legislative solution from us to do that?
    Mr. Botticelli. And other panelists could add--this is--
we've actually been doing that as a condition of their 
Federal----
    Mr. Murphy. OK.
    Mr. Botticelli (continuing). Drug court language.
    Mr. Murphy. OK.
    Mr. Botticelli. You know, again, we want this to be decided 
by an expert in addiction services in consultation with the----
    Mr. Murphy. OK.
    Mr. Botticelli (continuing). But we just didn't want to 
have categorical denial.
    Mr. Murphy. Ms. Hyde, are you adding to that question?
    Ms. Hyde. I did mention in consultation with ONDCP and also 
with the Department of Justice, we have changed the language in 
our request for applications for drug courts so that they can't 
require that someone either get off of or not be on medication-
assisted treatment if it is prescribed appropriately by a 
physician or a certified program.
    Ms. DeGette. So I just wanted to add, though, what you can 
do, you can make the Federal funding contingent on full 
programs, but we can't force the States or whatever regulatory 
agency is setting up the drug courts to offer this. They just 
can't get Federal money if they don't offer it.
    Mr. Botticelli. And this is where I'm glad the committee is 
actually going to be talking at State level, because as a 
former State administrator, States do play a crucial role. 
There are many, many programs out there that actually don't 
receive Federal funding, or drug courts that don't receive 
Federal founding. We hope that our policies and procedures are 
adopted by those nonfederally funded programs, but States play 
a key role in licensing treatment programs.
    Mr. Murphy. Thank you.
    Mr. Botticelli. And they, I think, can look at the 
opportunities of increasing or ensuring that State licensing 
treatment programs also the have same kind of language.
    Mr. Murphy. Thank you. Speaking of States, go to the 
gentleman from West Virginia, Mr. McKinley, for 5 minutes.
    Mr. McKinley. Thank you very much, Mr. Chairman, and thank 
you again for these hearings that we've been having on this 
topic.
    As an engineer, I need to see things in perspective, and so 
I guess we've been following this over the last 4 years in 
Congress, and especially on this committee, been trying to look 
at this issue, and I think at one of the last meetings we just 
had, I tried to put it in perspective by saying from--
Botticelli, you said there were 44,000 overdose deaths. I want 
people to understand, that's more than died in Vietnam in 
combat. I don't know that the American public understands that. 
And every day on the news, NBC or whatever, they had body 
counts and they had that, and people were outraged over that.
    I'm not getting the sense of outrage over every year we 
lose as many people to drug overdose as we did in a 10-year war 
in Vietnam. I'm concerned when I had affirmed that in West 
Virginia, one in five babies born in West Virginia, and I'm 
sure it may be one in four in other States or so, but one in 
five babies, they've been affected with drugs. I keep thinking 
this in perspective by saying in Europe, the overdose rate is 
approximately 21 per million; in America, it's seven to 10 
times that amount.
    Now, I get a little on the verge of outrage. You know, I'm 
the father of four and grandfather of six, and I see these are 
what we're giving our kids, this is what the future is. And I 
hear this testimony from this panel of seven and the seven 
before that and the seven before that, and quite frankly, I get 
confused, because I don't known what the priority is.
    From the business community and you all here in Washington, 
everyone loves to plan, but they don't carry out. Now, that may 
be insulting, and I don't mean it in an insulting fashion, but 
we still have 44,000 people who will die between now and next 
year because we don't have a prior--I'd like to think that we 
could come up with one plan, one way, if you had at least one, 
prioritize it, what's the one thing, and then let's put 
everything we have into it, that Manhattan-type project, go 
after that one solution and see if that doesn't start the ball 
rolling in the right way, and then we can do two, three and 
four with it, but a focus; but I don't see a focus. I didn't 
see a focus from you. I heard seven, eight different ways that 
we might be able to approach this problem, because the 
planning--everyone loves to plan, but the implementation falls 
short.
    So, since you're meeting on a regular basis, couldn't you 
come up with one--one idea to where we ought to begin to where 
we can really--the metrics, we get the optics and everything, 
we can really dig into that, and then we can have plan B, C and 
D, but let's achieve one instead of continuing to melt down as 
we do at this. I don't want to see another statistic of 44,000 
more people die of overdose.
    So I hesitate to ask, can you come up with an idea today in 
the time frame, is there one, just one idea that we should 
focus on? What's the best way? Is that in the drug use, is that 
in real-time on purchasing the prescription drugs that it's a 
national database, is that the number one thing we should do? I 
mean, my God, the Federal Government just changed the 
sentencing guidelines for heroin and they said if you're caught 
with 50 hits of heroin, you get probation. What are we doing? 
Are we fighting heroin or not? I'm really frustrated with this, 
so I really--give me some more guidance on plan one.
    Mr. Botticelli. So, Congressman, I appreciate your 
attention to this. And, you know, myself and many of our 
colleagues have been doing this work for a long time and, I 
think, are filled with a sense of tragedy in terms of where we 
are, and know that we can do better and know that we can work 
with Congress.
    You asked for one. I think there are three areas, and some 
of these are articulated in the Secretary's plan, that we've 
got to do. We've got to change prescribing patterns in this. We 
are prescribing way too much medication, and that's starting 
the trajectory. We need to increase our capacity to treat the 
disease so that people who go down that path have adequate 
access. And the third is that we really need to focus on 
reducing overdose deaths.
    Those are three areas that I think we can work with 
Congress on to really look at how do we increase our efforts.
    Dr. Frank. Let me add on to that on behalf--it seems that 
people from West Virginia all sort of think alike that way. And 
our Secretary, who shares the same experience you do has pushed 
us to focus and to take action in those three areas. And, you 
know, with it--this year we more than quadrupled our funding in 
those areas, and we're going to triple that again if our plan 
goes through, and these are in those three focused areas, 
because that's where the evidence says we should be doubling 
down, and that's sort of what is guiding us.
    Mr. Murphy. Thank you. Is the Secretary asking for 
legislation on this, then, to facilitate the answer to that 
question?
    Dr. Frank. There are some legislative proposals, and some 
of it is just increasing some of the use of our discretionary 
funds, and we got some additional appropriations this year, and 
then in the President's budget, we have sort of some 
legislative proposals for----
    Mr. Murphy. Could you please let this committee know if 
there's enabling language we have, and that would help address 
Mr. McKinley's question?
    Dr. Frank. Yep.
    Mr. Murphy. Thank you.
    Ms. Clarke of New York, you're recognized for 5 minutes.
    Ms. Clarke. I thank you very much, Mr. Chairman, and our 
ranking member, and thank you to all of our witnesses for 
giving the committee the benefit of your expertise and 
experience today.
    I'd like to focus my questions on the prevention side of 
the equation, how do we prevent opioid addiction in the first 
place. So, Dr. Volkow, picking up actually on a point that Mr. 
Botticelli made just a moment ago about way too many 
prescriptions, this is to you: Why are so many prescriptions 
being written for opioids? Are physicians not getting the 
appropriate level of training and education in pain management 
for responsible opiate prescribing practices? What would you 
say?
    Dr. Volkow. There are both. Actually, what had happened is 
we have to recognize that there's another epidemic, of chronic 
pain in our country, estimated at 100 million people, according 
to the Institute of Medicine. As a result of the pressure of 
needing to address this problem, the joint accreditation 
require that hospitals and physicians in hospitals ask 
questions about pain and treat them. This was in 2000. And the 
problem was that that was not associated with the education 
required in order to be able to properly screen pain, but also 
to manage it, and to manage it and use opioid medications 
adequately. So there was a big gap between the need to 
implement better treatment for pain, but an inadequate 
education of that system, so that is a major problem.
    I think that in terms of prevention, we have to recognize 
two aspects of this epidemic that are different from the 
others. One of them, we do have individuals that start 
diverting and they get the medications because they want to get 
high, but then there's the other element that is as important, 
of individuals that are properly prescribed the medication 
because they have pain. And in the past, it was believed that 
if you got an opioid and you had pain, you would never become 
addicted. Now the data shows us that that's not correct. We 
don't exactly know what percentage of individuals that will be 
treated for their pain will become addicted. The range goes 
enormously from none to something like 40/60, so we have no 
real idea. And that's why I highlighted the notion of, we need 
to be very aggressive in the education of healthcare providers 
on the screening and management of pain, but also be very 
aggressive on the education of healthcare providers for the 
recognition of substance abuse disorder so that they can 
determine who's vulnerable, and when a person that's properly 
being treated is transitioning, and how to intervene.
    Ms. Clarke. Very well. Thank you very much.
    Director Botticelli, does ONDCP believe that the Federal 
Government should mandate continuing medical education on 
responsible opioid prescribing practices as a precondition of 
DEA registration to prescribe controlled substances? And can 
you elaborate on how that would work if that's the case?
    Mr. Botticelli. Sure. We do support mandatory prescriber 
education. I think for all of the evidence that you've heard 
today, it's very clear that if we really want to prevent both 
prescription drug misuse and heroin use and overdoses, we need 
to stop prescribing these medications so liberally.
    There was a recent GAO report that showed that physicians 
get little to no pain prescribing, and actually veterinarians 
get more pain prescribing than physicians in the United States. 
So we don't think that it's overly burdensome to require 
physicians in this epidemic to have education.
    I think, as you talked about it, we'd have to work with the 
legislature to look at changes to the Controlled Substances Act 
to ensure that a certified continuing medical education program 
would be linked to the DEA licensure or relicensure process, 
and that we would oversee those courses that we believe have 
the core competencies that we think are important and monitor 
who takes those.
    Ms. Clarke. Very well. Thank you very much.
    Dr. Throckmorton, manufacturers of opioid pain relievers 
are currently required to offer free voluntary education to 
physicians or responsible opioid prescribing practices. 
However, as I understand it, physician participation rates for 
these voluntary educational courses are fairly low. Is that 
correct?
    Dr. Throckmorton. We do have those programs in place. They 
were put into place about 18 months ago, and so the initial 
year was spent putting into place a process to allow the 
education to be available, prescribers to make use of it. 
During that time, we saw about 20,000 prescribers that are 
using extended-release, long-acting opioids sign up for one 
course. That's true, 20,000 out of 320,000 prescribers that 
prescribe these medicines is not a large fraction. It is 
progress. What we hope is in the second year, which will end in 
July of this year, we'll see a larger increase in terms of 
uptake and use of this education. We have been working with the 
continuing education community to make better use of it, make 
it more available. We're optimistic. We hope that we'll see 
more use.
    It's one of two pillars of education, from our perspective. 
Combined with the mandatory education that Mr. Botticelli just 
spoke about, we believe both of these things provide important 
opportunities to educate prescribers.
    Ms. Clarke. Very well. I yield back. Thank you very much.
    Mr. Murphy. Thank you.
    Mrs. Brooks of Indiana, 5 minutes.
    Mrs. Brooks. Thank you, Mr. Chairman, for continuing the 
focus on this critical subject for our country.
    I want to start with you, Dr. Volkow. We talked about how 
the opioid addiction facing the country is, in large part, due 
to chronic pain. And you mentioned that 100 million people 
suffer from chronic pain. I've heard up to one in three 
Americans actually possibly suffer from chronic pain.
    And one of the goals of this hearing is to try to focus on 
evidence-based treatment and new treatments in trying to find 
out what it is that is working. And, obviously, one treatment 
doesn't work for everyone, as we've heard.
    But I learned about, in the course of examining this, that 
there are some technologies that are new, not completely new, 
but one being--I was told about spinal cord stimulation, which 
targets nerves with electrical impulses rather than drugs, and 
that clinical studies have shown it to be safe: 4,000 patients 
have received this stimulator. And so it obviously is a device, 
a technology that can actually stop that stimulation and can 
help hopefully end that addiction, but yet NIH hasn't included 
that in its draft pain strategy. It didn't mention technologies 
like SCS.
    Can you talk at all about why it wouldn't be promoting this 
FDA-approved type of technology? And are there other 
technologies we ought to be talking about other than medication 
for chronic pain?
    Dr. Volkow. Yes. Thanks for the question.
    And this is an area that is rapidly evolving. And if it's 
not mentioned, it's because many of the findings are way too 
recent. And the one that you're commenting on in terms of 
stimulation is one of the strategies in which we're also 
promoting research. And the same strategy can be utilized to be 
able to actually inhibit the emotional centers of the brain 
that react to pain.
    So researchers are utilizing a wide variety of tools and 
technologies that have evolved as part of our initiative to 
understand the brain. That, again, highlights--but it brings up 
something that, I think, is facing us in this epidemic: the 
need that we have to develop better strategies for the 
management of chronic pain, because the physicians are forced--
patients in great suffering, they don't know what to do, and 
they give an opioid even though the evidence does not really 
show us they are very effective for the management of chronic 
pain. But there are not many out there.
    So recognizing that this is an area where we are required 
to invest resources for having alternatives for patients 
suffering from chronic pain is an extremely important part of 
an initiative of addressing the opioid epidemic.
    Mrs. Brooks. How would you recommend we increase, then, 
patient access and educate more physicians about this type of 
technology?
    Dr. Volkow. Well, this is a new technology, some of them. 
Actually, the evidence is just emerging. It will have to be 
submitted to the FDA for approval. And then physicians, as part 
of their training, should be exposed to them. And I would say--
I am just highlighting in the notion because Michael Botticelli 
very clearly delineated, I also think it's important that 
medical students, as part of their basic training, have an 
understanding of these technologies because pain is part of 
every medical condition, almost of every medical condition.
    Mrs. Brooks. Thank you very much.
    I'd like to ask you, Mr. Botticelli, my State, State of 
Indiana, recently passed a law allowing physicians to prescribe 
the naloxone to parents and to others and friends, giving them 
greater access to the reversal heroin drug.
    Would you speak as to what's known about the impact of the 
naloxone programs and whether you have concerns about whether 
the naloxone might encourage actually more risk-taking? Because 
I met with law enforcement who said they had given naloxone, 
had saved their lives and, a couple weeks later, saved their 
life again with the naloxone. And so I am somewhat concerned--
and I absolutely want to save lives, and we must. And we know 
there aren't enough treatments. This is obviously a huge 
problem.
    But might that encourage an addict, if they knew their mom, 
dad, or friend had the save right there? Can you talk to us 
about these naloxone programs?
    Mr. Botticelli. Sure. So, to your first question, 
obviously, naloxone distribution by as many people who have the 
potential to witness an overdose is particularly important. And 
law enforcement, particularly in rural counties, also play a 
key role in that effort.
    I will tell you, by way of--when I was in Massachusetts, we 
significantly increased access to naloxone and actually did a 
peer-reviewed study that showed when you introduced naloxone 
into a community, overdose rates go down. And the more naloxone 
you introduce, the better the scale effect.
    You know, one of the pieces that we are concerned about--
but there is absolutely no evidence to show that naloxone 
distribution actually increases drug use. Some of the issues 
that you mentioned become critically important, that overdoses 
are often seen as a significant motivator for people to seek 
care. But having treatment on demand is a particular issue. 
Treatment on demand, particularly in some of our rural 
communities, is particularly an issue.
    Interventions that are emergency departments to get people 
into care become critically important. So while we know that 
addiction is a chronic disease, and some people do continue to 
use, when you have these adverse events, but we also need to 
know we have to have a comprehensive response, not just saving 
someone's life.
    Mrs. Brooks. Thank you. I completely agree, and I certainly 
hope the results in Indiana prove out to be the same as in your 
State.
    And I yield back. Thank you.
    Mr. Murphy. Gentlelady yields back.
    Mr. Mullin from Oklahoma, you're recognized for 5 minutes.
    Mr. Mullin. Thank you, Mr. Chairman.
    Before I get to some questions, I have got a followup 
question for Ms. Hyde. The last time that you were in front of 
this committee, which I really appreciate you coming back, we 
had discussed your Web sites and if they were an effective use 
of taxpayer dollars. At that time, you stated that you were all 
in the process of evaluating that. Have you finished that 
process yet?
    Ms. Hyde. That process continues. Thank you for asking the 
followup question. The process continues. I think the Web site 
that you indicated most concerns about was one of the Web sites 
that we were in the process of reviewing. It was originally 
developed based on data and knowledge from NIDA.
    Mr. Mullin. Right. And which----
    Ms. Hyde. And we have----
    Mr. Mullin. Well, that was for the 3- to 6-year-old for 
suicide prevention. Have you finished that one yet?
    Ms. Hyde. Yes. Building blocks----
    Mr. Mullin. Right.
    Ms. Hyde (continuing). I think is the one you were 
concerned about. We have worked with our colleagues at NIDA and 
determined that the Web site hadn't been updated in a while, so 
it needed to be updated. So we have taken it down and are in 
the process of updating it.
    Mr. Mullin. Could you give me some process reports on that, 
just so I can kind of know where you guys are at? We just want 
to make sure that taxpayer dollars are being used in an 
effective way.
    Ms. Hyde. Certainly.
    Mr. Mullin. To get to the questions, Dr. Throckmorton, just 
a simple yes or no. Does the FDA recommend that methadone be 
used as a first line of therapy for chronic pain?
    Dr. Throckmorton. Methadone is approved for use for pain, 
yes.
    Mr. Mullin. But I am specifically speaking to the first 
line, for a first line of defense, basically.
    Dr. Throckmorton. It's one of the medications that we have 
approved for pain. I will say, however, that if you look at 
methadone, if you look at the labeling that we have for 
methadone, it calls it out as far as a product that has 
particular characteristics that make it challenging to use for 
pain.
    Mr. Mullin. So that would be a no for the first line.
    What is your recommendation for first line?
    Dr. Throckmorton. Our recommendation is prescribers think 
very carefully before using methadone. There are things that 
make it a challenging product to use. It is approved for use in 
that setting, but I hope doctors think very carefully before 
they do it.
    Mr. Mullin. Well, the FDA put out a warning about the drug 
safety and basically said that you guys--that insurers should 
not--should not be referred as a preferred therapy, unless 
special instructions and education was put onto it. So I would 
take that as the FDA would, by this statement, that it'd be a 
no, that you wouldn't recommend it unless there's a lot of 
consideration taken.
    Dr. Throckmorton. Personally, what I just said is where I 
would be.
    Mr. Mullin. OK.
    Dr. Throckmorton. I need to look at the statement and get 
back with you about the specifics of it.
    Mr. Mullin. OK.
    Dr. Throckmorton. But it is a drug that has a very long 
half life that is variable patient to patient. It has unique 
cardiac toxicities. There are other drugs that are useful for 
pain that don't have those characteristics and I----
    Mr. Mullin. Sure. All I'm really looking for is a yes or no 
because I'm really trying to get further on down the line for 
questions. I do appreciate you being here. And I like the last 
name; that's my sister's last name. And I got some beautiful--
--
    Dr. Throckmorton. A very good last name.
    Mr. Mullin. I know. I've got three beautiful nieces. But 
the spelling usually gets messed up.
    Dr. Houry, what about the CDC? Do you guys consider this 
methadone as being a first line of defense for pain?
    Dr. Houry. At CDC, we just focus really on the primary 
prevention and not as much of the care, so I would defer to the 
sister agencies on that.
    Mr. Mullin. Which would be?
    Dr. Houry. The panelists here. FDA.
    Mr. Mullin. Well, Dr. Throckmorton kind of gave his 
personal opinion. But the statement of FDA you heard about. So 
would you follow the statement, I'm assuming?
    Dr. Houry. I would follow his statement. I don't have a 
personal opinion on methadone for pain. It's not something I 
did in my prior practice.
    Mr. Mullin. OK. Dr. Conway--by the way, I'm always jealous 
when people have their family with them. I have got five 
wonderful kids. And if you ever want to see me cry, that's 
about the only thing that will make me cry. I miss them.
    Mr. Murphy. How are your kids doing?
    Mr. Mullin. Thanks. I appreciate that. I will take a deep 
breath and wipe the tear away.
    Are you aware that methadone accounts for 30 percent of 
overdose deaths while only accounting for about 2 percent of 
the prescriptions that are prescribed for chronic pain?
    Dr. Conway. I am aware that it's a higher percentage of 
deaths compared to prescriptions because of the long half-life 
and risks described.
    Mr. Mullin. Would you personally recommend it as a first 
line of defense for pain?
    Dr. Conway. So I'm a practicing physician. I do not, as a 
practicing physician, typically use methadone as a first 
defense. However, I think it depends on the individual patient 
characteristics and would defer to the physician's judgment 
with that individual patient.
    Mr. Mullin. Well, according to the Pew research, they put 
out a deal that said methadone is available in low-cost generic 
form and is considered a preferred drug in many States by the 
Medicaid programs, despite FDA warnings about the drug safety 
and the statements by the American Academy of Pain Medicine 
that insurers should not be preferred this therapy unless it's 
especially educated and provided to the individual.
    I just kind of wonder if--overall, I would think, we're 
considering it not being there. Why is this still listed as a 
first line with Medicaid, I mean, when we're seeing so many 
deaths? It almost makes you think, is the cost of a life not 
more valuable than the cost of a low drug?
    Dr. Conway. So I'd make a few points. Statutorily, the 
Medicaid programs have the ability to set their preferred drug 
list. However, we have taken a couple of actions that I think 
to try to address this issue. One, working with SAMHSA, NIH, 
and others on this panel, we have put out an informational 
bulletin to the Medicaid programs talking about this issue and 
a complete array of pain, both on the medication side, the 
risks of methadone, and the other options and, also, 
importantly as others have said, the importance of both 
behavioral treatment and medication treatment.
    I'd also call out, in our Medicaid Innovation Accelerator 
Program, the first area we're working on is substance abuse 
disorders. We have over 30 States involved, and they're taking 
a comprehensive approach to the Medicaid program to appropriate 
substance abuse treatment, including appropriate use of 
medications and also other therapies.
    Mr. Mullin. Dr. Conway, appreciate it.
    Mr. Chairman, I yield back.
    Mr. Murphy. Mr. McKinley has a followup question. Then I 
have a followup question, too.
    Mr. McKinley. Thank you for the opportunity just to follow 
up because one of the questions or statistics I was giving you 
in talking about prospector is the model or the situation that 
they're facing in Europe. What do we have there in Europe? The 
average is 21 per million. And I was just looking at--that's 
the average.
    Italy is below that. Latvia, Netherlands, Belgium, Greece, 
France, Poland, Portugal, Bulgaria, the Czech Republic, 
Slovakia, Hungary, Turkey, Romania, all have less than that, 
significantly less. What are they doing right? What are they 
doing differently in Europe than we are in America? Are we 
learning anything from them?
    Dr. Volkow. There is something that we're doing very 
differently. And, actually, you picked up exactly on the point. 
If you look at the United States, for some of the medications 
we may be consuming 95 percent of the total production in the 
world.
    So the question is, Are we a Nation that is so much in pain 
that we require these massive amounts of opiate medications? Or 
is there something that we are doing in terms of their access 
to them that is inadequate?
    And I want, again, to reiterate the notion that, yes, we 
are overprescribing opiate medications, on the one hand. But, 
at the same time, which is not exclusionary, sometimes we are 
undertreating patients with pain. So we are in a situation that 
we have it bad in both ways. Overprescribing, making these 
drugs available, which then can be easily diverted, and 
prescribing them to those that don't need them can also result 
in adverse consequences. You don't see that level of 
prescriptions in any of the European countries.
    Mr. McKinley. So what's the--why not? What are they doing? 
Are their doctors more sensitive to this issue than our doctors 
in America? Are they concerned about the trial lawyers? What's 
the difference between it?
    If there are 10 to 15 times more people dying in America 
than there are in Europe, something is wrong. They're doing 
something differently, and I'd like to know what it is.
    Dr. Volkow. And that's exactly the way that I say we have 
to aggressively institute the education of the healthcare 
providers on the proper screening and management of pain--
that's a crucial component--while also educating them about the 
adverse effects as it relates to substance abuse disorders.
    And we need to face the fact that we need to also provide 
alternative treatments for the management of chronic pain that 
are effective.
    Mr. McKinley. OK.
    Yield back.
    Thank you very much for that.
    Mr. Murphy. Ms. Brooks, you have a quick question?
    Mrs. Brooks. Thank you. Actually, I realize Mr. Botticelli 
mentioned it in his opening, and I wanted to have an unrelated 
follow-up if I might, Mr. Chairman.
    Mr. Murphy. Yes, you may.
    Mrs. Brooks. You mentioned--and we are having a crisis in 
Indiana in Scott County, a community of 4,300 people, an 
outbreak of HIV due to needle exchange. And I would simply 
like--and I hope that many of you have been following what has 
been happening and the number of citizens in Indiana who now 
have contracted HIV because of their, in all likelihood, heroin 
addiction, right.
    Mr. Botticelli. Prescription drug.
    Mrs. Brooks. Or prescription drug addiction and possibly 
heroin addiction as well.
    I am very curious, since I have this incredible panel of 
experts here, what you might say to our State and to the health 
professionals, our public health professionals who are dealing 
with this crisis, to our State and local government officials, 
what advice and thoughts do you have for our State? And I 
truly, if we could, this is a crisis in our State that I think 
could be in any State in the country.
    Mr. Botticelli.
    Mr. Botticelli. Sure.
    Mrs. Brooks. And then anyone else who might comment, 
please.
    Mr. Botticelli. So, first of all, just about the staff from 
all of the agencies on this table coordinate on a daily basis 
in tight coordination with the Indiana Health Department to 
make sure that we are giving Scott County the resources they 
need to do that.
    Mrs. Brooks. Thank you. And I'm sure Dr. Adams appreciates 
that.
    Mr. Botticelli. You're absolutely right that while we're 
seeing huge--I think we're over 145 cases of HIV now--one of 
the consequences we've seen nationally is increases in viral 
hepatitis as it relates to sharing needles. And I think it also 
points to some issues that we need to include about access to 
treatment services.
    So I think what's happening in Indiana in Scott County is 
emblematic of the potential that we could see in other parts of 
the country but points to some of the issues that we've been 
talking about today in terms of making sure that people have 
access to good care, both infectious disease care and substance 
abuse care; they have adequate access to clean syringes so that 
they are not increasing infection in this most poignant case of 
what we need; and that they're having timely access to 
treatment services, I think, are all areas to do that.
    We'll continue to engage with folks in Scott County to make 
sure that whatever we can do on the Federal side can help 
alleviate the situation.
    Dr. Houry. And I'd just like to add to that I'm really 
proud of all of the efforts CDC is doing on the ground in 
Indiana and in conjunction with agencies here, I agree 
completely with Director Botticelli about the access to 
medication-assisted treatment as well as the HIV therapy.
    The other thing I would add is Indiana is number nine in 
the Nation for prescribing, and so there's a lot that can be 
done when you're looking at, again, trying to stop the epidemic 
before it even happens. So looking at, again, using the 
Prescription Drug Monitoring Programs, having better 
prescribing guidelines, so that people don't get addicted to 
opioids, then inject them. So that's the third component, I 
think, we really need to add.
    Mrs. Brooks. Dr. Volkow----
    Dr. Volkow. Yes.
    Mrs. Brooks. Or, I'm sorry, and Administrator Hyde. Maybe 
Dr. Volkow and then Administrator Hyde.
    Dr. Volkow. I mean, we got caught by surprise with the 
Indiana epidemic of HIV, and I heard Tom Frieden say this is 
the fastest growing incidence of HIV cases that we've had since 
HIV entered the United States.
    But there's been an extraordinary advance on HIV that has 
emerged really over the past 2 or 3 years, which is that if you 
initiate someone on antiretroviral therapy, not only are you 
going to be improving their outcome, but you are actually going 
to dramatically decrease their infectivity.
    So, in looking forward--one of the things I would have 
suggested to do is once you start to see a case, you 
immediately treat them with antiretroviral therapy. They'll do 
better, and their infectivity will dramatically decrease. So 
this is another aspect, which actually relates to the issue of 
giving good infectious disease care to these individuals 
jointly with the interventions for substance abuse treatment.
    Mrs. Brooks. Thank you.
    Ms. Hyde. So I just wanted to add that we are working 
collectively on this issue and that we understand there may be 
some legal barriers that we've been talking to Indiana about in 
terms of developing opioid treatment programs, and there's not 
a lot of waivered physicians able to provide buprenorphine. I 
think the closest opioid treatment program is about 40 miles 
away. There may be some transportation barriers and some cost 
barriers and other things. So we're collectively working with 
the State to try to help develop alternatives.
    Mrs. Brooks. Thank you, Mr. Chairman, for allowing me to 
give that voice.
    Mr. Murphy. Thank you.
    I have two quick followup questions. First, Ms. Hyde, last 
week, the subcommittee heard testimony from Dr. Anna Lembke, 
the program director of the Stanford University Addiction 
Medicine Program that the 42 CFR part 2 is an artifact of the 
past. She told us the law's consent requirements are so 
stringent that two doctors seeking to treat the same patient 
for opioid addiction can't communicate with each other about 
the patient's medical condition. In fact, she cited that the 
subcommittee--and we received subcommittee reports. The rule 
was based upon a 1972 law, and it's causing havoc in the age of 
electronic records. I guess sometimes the police would actually 
raid a methadone clinic and arrest people there.
    So she has strongly recommend that we change that so we are 
not overprescribing people and a physician can know who is in 
treatment.
    Now my understanding is that SAMHSA is contemplating new 42 
CFR part 2 rules. And I just want to know if you're committed 
that these rules will reflect the concerns that have been 
repeatedly voiced by so many in the medical community who treat 
patients with substance abuse who want nothing more than to 
make sure patients aren't given double doses, so they can 
really communicate. Is that what SAMHSA is going to be working 
on?
    Ms. Hyde. I really appreciate that question. It is a 
complex issue. And you're right; these laws and regs are 
decades old, before we had electronic health records, before we 
had collaborative care models and other things that we are now 
considering part of the practice.
    We, a couple of years ago, put together some subregulatory 
guidance to try to help this issue, but that wasn't sufficient. 
So, last year, we held a listening session for stakeholders and 
have taken those pieces of input and are trying to balance the 
privacy concerns with the need for access to data. We hope that 
we will have something available for public input yet this year 
to try to address some of these issues.
    Mr. Murphy. And please let the committee know. Thank you.
    And, Mr. Botticelli, I wanted to follow up on this Kentucky 
drug court issue. Could the drug courts' decisions relate to 
the issue of diversion? I mean, at a previous hearing, we heard 
testimony from witnesses that Suboxone mills are popping up in 
Kentucky and West Virginia and these are high problematic 
States. And, when entering the drug court system, it's nearly 
impossible to determine if the Suboxone is from an illicit 
source or prescribed by a doctor.
    Could this be part of the issue and that the drug courts 
could really work and perhaps have some flexibility to deal 
with this on a case-by-case basis?
    Mr. Botticelli. So I think there are a number of issues. 
The National Association of Drug Court Professionals actually 
did a survey of drug courts in the United States. And for those 
drug courts that were not referring, it was actually more about 
judicial bias than it was about fear of diversion that kept 
people from doing that.
    I think the second piece that any treatment, whether it's 
medication-assisted treatment or residential treatment, 
requires a level of collaboration and relationship between the 
court and the provider to ensure that courts who are referring 
to treatment are referring to high-quality treatment.
    You know, we do need to pay attention to diversion. And 
drug courts, I think in combination with treatment programs, 
can ensure that these are appropriately prescribed and 
appropriately monitored medications. And they need to make sure 
that they're partnering with physicians who are implementing 
and dispensing medications in a high-quality way.
    Mr. Murphy. Now, part of this--I just got an article that 
was--I'm not sure what newspaper it is. But it was talking 
about in some of these courts, they're using Vivitrol and for 
people in and out of incarceration trying to keep them off by 
maintaining Vivitrol.
    So I just want to make sure I understand. They want to keep 
these people, after they're released from prison, drug-free. 
And so could you please clarify: Are you saying that unless 
they have some synthetic opiates, they're going to have Federal 
funding cut, or they can still maintain Federal funding and 
then Vivitrol would be acceptable as another part of the 
program?
    Mr. Botticelli. So we don't dictate to drug courts what 
medications. That actually should be a decision between the 
treatment provider and the patient.
    I think our work here was just to make sure that there 
weren't categorical prohibitions for drug courts either to not 
offer medication-assisted therapies and, if someone was on a 
recommended course of treatment, that they not have to get off 
the medications to do that.
    We actually don't dictate what medications courts use to be 
able to do that. I think, like any treatment, you want to have 
an arsenal of medications.
    Mr. Murphy. Dr. Frank, could you also respond to the 
Vivitrol question, too? Did you hear that? I'm just wondering 
as that as an option for States as a diversion to be using 
Vivitrol, that that could be part of what we could be----
    Dr. Frank. Well, I think that we are trying to have the 
full armamentarium available to the treating providers who are 
trying not to get between the provider and the patient as long 
as there is the opportunity to offer the richest menu of 
evidence-based treatments that are available.
    Mr. Murphy. Mr. DeGette, do you have a followup?
    Ms. DeGette. Mr. Chairman, Mr. McKinley asked the witnesses 
what one thing would you recommend that we could do to try to 
start reversing this epidemic and this problem. He got as far 
as Dr. Frank when he ran out of time. So I just ask unanimous 
consent, if we can ask each one of the other witnesses----
    Mr. Murphy. Yes, please.
    Ms. DeGette (continuing). To supplement their testimony. 
They don't have to say it right now.
    Mr. Murphy. Get back to us. Thank you.
    Ms. DeGette. But if you can get back to us with that 
recommendation. We recognize there is a problem, and we are 
really struggling with the issue of what we do as a Congress to 
remedy it. Thank you.
    Mr. Murphy. And I think what you're also talking about, a 
partnership with the States--says we should be looking at 
Kentucky and some others--Indiana----
    Mrs. Brooks. Indiana.
    Mr. Murphy (continuing). Colorado, of course, and see what 
else is going on.
    I want to thank this panel. We will follow up with the 
questions because we heard a number of recommendations from 
you, so we will ask for more clarifications of this.
    Look, I want to thank you. As I said last time, too, you 
know, if this was about a single airplane crash, this room 
would be filled with media. But we have had more people die in 
the last year from drug overdose deaths than the combination of 
every airplane crash in North America from 1975 to the present. 
And we have to make sure we keep this on the front page. This 
is a serious crisis and one, whether it's education of 
physicians, mandatory education, whether it's options out 
there, we want to make sure the evidence-based care and that 
Federal funding is going in the right direction.
    So I'd like to thank all the witnesses and members that 
participated in today's hearing.
    I remind members they have 10 business days to submit 
questions for the record, and I ask that all the witnesses 
agree to respond promptly to the questions.
    With that, this committee is adjourned. Thank you.
    
    [Whereupon, at 12:20 p.m., the subcommittee was adjourned.]
    
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