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





 
EXAMINING LEGISLATIVE PROPOSALS TO COMBAT OUR NATION'S DRUG ABUSE 
                                 CRISIS

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                          OCTOBER 8 & 20, 2015

                               __________

                           Serial No. 114-86


      Printed for the use of the Committee on Energy and Commerce
                        energycommerce.house.gov

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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

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

                         Subcommittee on Health

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

                                  (ii)
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                             C O N T E N T S

                              ----------                              

                            OCTOBER 8, 2015

                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     2
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     3
    Prepared statement...........................................     4
Hon. Susan W. Brooks, a Representative in Congress from the State 
  of Indiana, opening statement..................................     6
Hon. Joseph P. Kennedy, III, a Representative in Congress from 
  the Commonwealth of Massachusetts, opening statement...........     7
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, prepared statement...................................    72
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................    72
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, prepared statement........................    73

                               Witnesses

Michael P. Botticelli, Director, National Drug Control Policy, 
  Executive Office of the President..............................     9
    Prepared statement...........................................    11
    Answers to submitted questions \1\...........................    98
Richard Frank, Ph.D., Assistant Secretary for Planning and 
  Evaluation, Department of Health and Human Services............    24
    Prepared statement...........................................    26
    Answers to submitted questions...............................    99
Jack Riley, Acting Deputy Administrator, Drug Enforcement 
  Administration.................................................    35
    Prepared statement...........................................    37
    Answers to submitted questions \1\...........................   110

                           Submitted Material

H.R. 2536, the Recovery Enhancement for Addiction Treatment Act, 
  \2\ submitted by Mr. Pitts
H.R. 3014, the Medical Controlled Substances Transportation Act 
  of 2015, \2\ submitted by Mr. Pitts
H.R. 3537, the Synthetic Drug Control Act of 2015, \2\ submitted 
  by Mr. Pitts
H.R. 2872, the Opioid Addiction Treatment Modernization Act, \2\ 
  submitted by Mr. Bucshon
H.R. ___, the Improving Treatment for Pregnant and Postpartum 
  Women Act of 2015, \2\ submitted by Mr. Lujan
H.R. ___, the Co-Prescribing to Reduce Overdoses Act of 2015, \2\ 
  submitted by Mr. Sarbanes
H.R. 2805, the Heroin and Prescription Opioid Abuse Prevention, 
  Education, and Enforcement Act of 2015, \2\ submitted by Mrs. 
  Brooks
Statement of the American Association for the Treatment of Opioid 
  Dependence, October 8, 2015, submitted by Mr. Bucshon..........    74

----------
\1\ Mr. Botticelli and Mr. Riley did not answer submitted questions for 
the record by the time of printing.
\2\ Legislation referenced in the hearing has been retained in 
committee files and also is available at http://docs.house.gov/
Committee/Calendar/ByEvent.aspx?EventID=104047.
Letter of October 7, 2015, from James L. Madara, Executive Vice 
  President and Chief Executive Officer, American Medical 
  Association, to Hon. Charles W. Dent, a Representative in 
  Congress from the Commonwealth of Pennsylvania, submitted by 
  Mr. Pitts......................................................    78
Letter of October 7, 2015, from Grant Smith, Deputy Director, 
  National Affairs, Drug Policy Alliance, to Mr. Upton and Mr. 
  Pallone, submitted by Mr. Green................................    79
Letter of October 7, 2015, from Mr. Murphy, et al., to Hon. 
  Sylvia Burwell, Secretary, Department of Health and Human 
  Services, submitted by Mr. Murphy..............................    94

                            OCTOBER 20, 2015
                               Witnesses

Paul K. Halverson, Ph.D., Dean, Richard M. Fairbanks School of 
  Public Health, Indiana University..............................   112
    Prepared statement...........................................   114
Chapman Sledge, M.D., Chief Medical Officer, Cumberland Heights 
  Foundation.....................................................   119
    Prepared statement...........................................   121
    Answers to submitted questions \3\...........................   231
Robert Corey Waller, M.D., Chair, Legislative Advocacy Committee, 
  American Society of Addiction Medicine.........................   128
    Prepared statement...........................................   131
    Answers to submitted questions...............................   232
Kenneth D. Katz, M.D., Section of Medical Toxicology, Department 
  of Emergency Medicine, Lehigh Valley Health Network............   155
    Prepared statement...........................................   157
    Answers to submitted questions...............................   237
Allen F. Anderson, M.D., President, American Orthopaedic Society 
  for Sports Medicine............................................   166
    Prepared statement...........................................   168
    Answers to submitted questions...............................   241

                           Submitted Material

Statement of Sandra D. Comer, Ph.D., President, College on 
  Problems of Drug Dependence, submitted by Mr. Pitts............   188
Letter of October 20, 2015, from Jon Taets, Director, Government 
  Affairs, National Association of Convenience Stores, to Hon. 
  Charles W. Dent, a Representative in Congress from the 
  Commonwealth of Pennsylvania, submitted by Mr. Pitts...........   195
Letter of September 24, 2015, from Daniel E. Cooper, M.D., to Mr. 
  Pitts and Mr. Green, submitted by Mr. Pitts....................   196
Letter of October 14, 2015, from Chuck Canterbury, National 
  President, National Fraternal Order of Police, to Hon. Charles 
  W. Dent, a Representative in Congress from the Commonwealth of 
  Pennsylvania, submitted by Mr. Pitts...........................   199
Letter of October 20, 2015, from Larry Langberg, President, 
  Society of Former Special Agents of the FBI, to Hon. Charles W. 
  Dent, a Representative in Congress from the Commonwealth of 
  Pennsylvania, submitted by Mr. Pitts...........................   201
Statement of the American Medical Association, October 8, 2015, 
  submitted by Mr. Pitts.........................................   202
Letter of September 16, 2015, from Michael J. Gerardi, President, 
  American College of Emergency Physicians, to Hon. Charles W. 
  Dent, a Representative in Congress from the Commonwealth of 
  Pennsylvania, submitted by Mr. Pitts...........................   208
Letter of October 16, 2015, from the American Association of 
  Orthopaedic Surgeons, et al., to Mr. Upton, et al., submitted 
  by Mr. Pitts...................................................   209
Letter of October 19, 2015, from Michael C. Barnes, Executive 
  Director, and Karen L. Thurman, Senior Government Relations 
  Advisor, Center for Lawful Access and Abuse Deterrence, to Mr. 
  Pitts and Mr. Green, submitted by Mr. Pitts....................   211

----------
\3\ Dr. Sledge did not answer submitted questions for the record by the 
time of printing.
Statement of the American Academy of Physician Assistants, 
  October 20, 2015, submitted by Mr. Pitts.......................   213
Statement of the National Association of Chain Drug Stores, 
  October 20, 2015, submitted by Mr. Pitts.......................   216
Letter of October 20, 2015, from David E. Nichols, Ph.D., 
  Department of Medicinal Chemistry and Molecular Pharmacology, 
  College of Pharmacy, Purdue University, to Mr. Upton and Mr. 
  Pallone, submitted by Mr. Sarbanes.............................   229

   EXAMINING LEGISLATIVE PROPOSALS TO COMBAT OUR NATION'S DRUG ABUSE 
                             CRISIS--DAY 1

                              ----------                              


                       THURSDAY, OCTOBER 8, 2015

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:16 a.m., in 
room 2322 Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Guthrie, Shimkus, 
Murphy, Lance, Bilirakis, Bucshon, Brooks, Green, Engel, 
Butterfield, Sarbanes, Matsui, Lujan, and Kennedy.
    Also present: Representative Tonko.
    Staff present: Clay Alspach, Chief Counsel, Health; Gary 
Andres, Staff Director; Karen Christian, General Counsel; 
Noelle Clemente, Press Secretary; Carly McWilliams, 
Professional Staff Member, Health; Katie Novaria, Professional 
Staff Member, Health; Graham Pittman, Legislative Clerk; Chris 
Sarley, Policy Coordinator, Environment and the Economy; 
Adrianna Simonelli, Legislative Associate, Health; Sam Spector, 
Counsel, Oversight and Investigations; Heidi Stirrup, Policy 
Coordinator, Health; John Stone, Counsel, Health; Eric Flamm, 
Democratic FDA Detailee; Waverly Gordon, Democratic 
Professional Staff Member; Tiffany Guarascio, Democratic Deputy 
Staff Director and Chief Health Advisor; Una Lee, Democratic 
Chief Oversight Counsel; Samantha Satchell, Democratic Policy 
Analyst; and Kimberlee Trzeciak, Democratic Health Policy 
Advisor.

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

    Mr. Pitts. The subcommittee will come to order. I believe 
the clock is a little slow, so we will get started.
    And I want to start by mentioning we have a couple of 
distinguished alumni in the audience of this committee. Phil 
Gingrey, who was a member of our subcommittee, welcome. A very 
distinguished member, Mary Bono Mack, is here. Where is Mary? 
She often raised this issue with me. So welcome. We appreciate 
all of your interest and input as well.
    The Chair will recognize himself for an opening statement. 
Today's hearing will consider a number of proposals intended to 
address various aspects of our nation's drug abuse crisis. The 
Oversight and Investigations Subcommittee has held five 
hearings examining this public health epidemic and current 
efforts underway to combat prescription drug abuse. It is clear 
that, despite these efforts, the epidemic has continued to grow 
exponentially.
    Today is a good opportunity to better understand what 
Congress can do to help. I appreciate the administration 
witnesses being here and working with us on these complicated 
issues. I also look forward to the testimony of outside experts 
on these various bills in the near future. Prescription drug 
abuse does not discriminate: it is not limited by geography, 
income, or age. According to the National Institute on Drug 
Abuse, one in five Americans has used prescription drugs for 
nonmedical reasons.
    In 2011, the Substance Abuse and Mental Health Services 
Administration published a National Survey on Drug Use and 
Health and found that 1.7 million 12-to-25-year-olds abused 
prescription drugs for the first time, which amounts to more 
than 4,500 new initiates per day. These startling statistics 
should concern all of us. Unfortunately, only about 10 percent 
of people with substance abuse disorders will get any form of 
medical care. There are many of our constituents and their 
families that still need help, and I applaud my colleagues for 
working on legislation with that goal in mind.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    Today's hearing will consider a number of proposals 
intended to address various aspects of our Nation's drug abuse 
crisis. The Oversight and Investigations subcommittee has held 
five hearings examining this public health epidemic and current 
efforts underway to combat prescription drug abuse. It is clear 
that despite these efforts, the epidemic has continued to grow 
exponentially.
    Today is a good opportunity to better understand what 
Congress can do to help. I appreciate the administration 
witnesses being here and working with us on these complicated 
issues. I also look forward to the testimony of outside experts 
on these various bills in the near future.
    Prescription drug abuse does not discriminate; it is not 
limited by geography, income, or age. According to the National 
Institute on Drug Abuse, one in five Americans has used 
prescription drugs for non-medical reasons.
    In 2011, the Substance Abuse and Mental Health Services 
Administration published a National Survey on Drug Use and 
Health and found that 1.7 million 12-to-25-year-olds abused 
prescription drugs for the first time--which amounts to more 
than 4,500 new initiates per day.
    These startling statistics should concern all of us.
    Unfortunately, only about 10 percent of people with 
substance abuse disorders will get any form of medical care. 
There are many of our constituents and their families that 
still need help and I applaud my colleagues for working on 
legislation with that goal in mind.
    I will now yield to the distinguished gentleman from 
Indiana, Dr. Bucshon.

    Mr. Pitts. I now yield to the distinguished gentleman from 
Indiana, Dr. Bucshon.
    Mr. Bucshon. Thank you, Mr. Chairman. Congressman Womack 
and I introduced H.R. 2872 as a starting point that will 
eventually result in legislation that helps reverse the heroin 
and opioid epidemic. Over 100 years ago, Congress first began 
legislating opioid addiction treatment policies, and since that 
time, Congress has had to come together and pass such 
legislation time and time again. Given the worsening epidemic, 
it is time for Congress to act once more.
    H.R. 2872 is not a final product. To that end, Congressman 
Womack, Congressman Tonko, and I held the first Opioid 
Addiction Treatment Workgroup composed of the leading opioid 
addiction professional associations and other stakeholders to 
discuss our legislation. Our objective is to refine this 
legislation to become a bill that all the key stakeholders 
support.
    We can only reverse the opioid epidemic by effectively 
treating the underlying cause, and part of that underlying 
cause is our Federal Government's public health response to 
addiction. Clearly, what we are currently doing is not working 
well enough, and change is needed. We will need to treat 
addiction as the medical disease that it is, and confront the 
very real issues that prevent a person from receiving 
individualized care specific to his or her circumstances.
    We need to understand what the data is telling us, and we 
shouldn't allow the status quo to prevent a legitimate 
deliberation over what is the best path forward for addressing 
a crisis that is touching all of our communities. These are the 
challenges that we must overcome.
    [H.R. 2872 has been retained in committee files and also is 
available at  http://docs.house.gov/meetings/IF/IF14/20151008/
104047/BILLS-1142872ih.pdf.]
    Mr. Bucshon. At this point, I also ask unanimous consent to 
submit for the record a statement from the American Association 
for the Treatment of Opioid Dependence.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Bucshon. Thank you, Mr. Chairman. I yield back.
    Mr. Pitts. And I would like to ask unanimous consent to 
submit the following document for the record: a letter from the 
American Medical Association. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. The Chair now recognizes the ranking member, Mr. 
Green, 5 minutes for an opening statement.

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

    Mr. Green. Good morning, and thank each of you for being 
here today. As we know, the Centers for Disease Control and 
Prevention declared our nation's prescription drug abuse crisis 
an epidemic. In 2013, drug overdose was the leading cause of 
injury death in the United States. This is a battle we have 
waged for more than 100 years. When Congress first passed laws 
to confront the problems of heroin and opioid addiction, we 
once again face the challenges of controlling and combating 
this menace that is ravaging communities across the country.
    In the past few years, overdose deaths involving opioids 
increased fourfold and the number of heroin use has almost 
doubled. Cases of HIV and hepatitis C are on the rise. Despite 
universal recognition of the problem, our current efforts are 
not enough to meet the challenges of the crisis. The drivers of 
the problem are complex and there is no single silver-bullet 
solution. It is critical that we approach this challenge 
through a public health lens.
    Experts have documented serious impediments to widespread 
access to treatment, including a shortage of substance abuse 
providers, social and cultural stigmas, and lack of health 
coverage for such services. Current research suggests that a 
combination of medication-assisted treatment and behavioral 
treatment such as counseling and support services are the most 
effective way to treat opioid addiction.
    In 2013, medication-assisted treatments were available in 
only 9 percent of substance abuse treatment facilities. For 
example, in 2012, 96 percent of States and the District of 
Columbia had opioid abuse dependence rates higher than their 
buprenorphine treatment capacity rates. Thirty-eight States 
reported that at least 75 percent of the opioid treatment 
programs, also known as methadone clinics, were operating at a 
greater-than-80-percent capacity.
    Today, we are here to examine seven legislative proposals 
aimed at combating our nation's drug abuse epidemic. They build 
upon the hearings this committee has held and represent various 
approaches to improving prevention and treatment. Each is a 
product of thoughtful consideration and dedication from their 
sponsors, and I thank my colleagues for their efforts and the 
chairman for having this hearing. It is critical that we give 
law enforcement, health providers, and communities enhanced 
tools to address this epidemic. We need more resources and a 
coordinated effort to ensure the evidence-based treatment is 
available and diversion is stymied. The statistics are 
staggering. The need for action is clear. Again, thank you for 
being here.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Good morning and thank you all for being here today.
    As we know, the Centers for Disease Control and Prevention 
declared our nation's prescription drug abuses crisis an 
``epidemic.''
    In 2013, drug overdose was the leading cause of injury 
death in the United States.
    This is a battle we have waged for more than 100 years, 
when Congress first passed laws to confront the problems of 
heroin and opioid addiction.
    We are once again faced with the challenges of controlling 
and combatting this menace that is ravaging communities across 
the country.
    In the past few years, overdose deaths involving opioids 
increased four-fold, and the number of heroin users almost 
doubled.
    Cases of HIV and Hepatitis C are on the rise.
    Despite universal recognition of the problem, our current 
efforts are not enough to meet the challenges of this crisis.
    The drivers of the problem are complex, and there is no 
single silver bullet solution.
    It is critical that we approach this challenge through a 
public health lens.
    Experts have documented serious impediments to widespread 
access to treatment, including a shortage of substance abuse 
providers, social and cultural stigmas, and lack of health 
coverage for such services.
    Current research suggests that a combination of medication 
assisted treatment and behavioral treatments--such as 
counseling and support services--are the most effective way to 
treat opioid addiction.
    Yet, in 2013, medication assisted treatments were available 
in only 9 percent of substance abuse treatment facilities.
    We know there is a gap in the availability these 
treatments.
    For example, in 2012, 96 percent of States and the District 
of Columbia had opioid abuse dependence rates higher than their 
buprenorphine treatment capacity rates.
    Thirty-eight States reported that at least 75 percent of 
the Opioid Treatment Programs, also known as methadone clinics, 
were operating at greater than 80 percent capacity.
    Today, we are here to examine seven legislative proposals 
aimed at combatting our country's drug abuse epidemic.
    They build upon the hearings this committee has held, and 
represent various approaches to improving prevention and 
treatment.
    Each is the product of thoughtful consideration and 
dedication from their sponsors, and I thank my colleagues for 
their efforts and the chairman for having this hearing.
    It is critical that we give law enforcement, health care 
providers, and communities enhanced tools to address this 
epidemic.
    We need more resources and a coordinated effort to ensure 
that evidence-based treatment is available, and diversion is 
stymied.
    The statistics are staggering. The need for action is 
clear.
    Again, I thank you all for being here today and look 
forward to examining the legislative proposals before this 
subcommittee.
    I yield the remainder of my time to my colleague from 
Maryland, Representative Sarbanes, the sponsor of the Co-
Prescribing to Reduce Overdoses Act.

    Mr. Green. And I would like to yield 1 minute to 
Congressman Lujan.
    Mr. Lujan. Thank you, Mr. Chairman and Ranking Member, for 
scheduling this incredibly important hearing on a crisis that 
is plaguing our nation. This crisis touches everyone, from 
dense urban cities to rural States like New Mexico, for getting 
access to health services can often be a challenge. Most recent 
data from New Mexico's health department puts the accidental 
drug overdose rate at 24.3 per 100,000. That is more than 
double the national average. In two of the counties in my 
district, the overdose rate is more than five times the 
national average.
    Too many people are being forgotten and too many people are 
suffering. That is why I have introduced the Improving 
Treatment for Pregnant and Postpartum Women Act to strengthen 
efforts to ensure that some of our most vulnerable get the care 
they need. I want to thank my colleagues, Representative 
Matsui, Tonko, Clark, and Cardenas, for joining me in 
introducing this bill, and I look forward to today's discussion 
and getting this done. Mr. Chairman, the thoughtfulness behind 
all of this legislation is so important, and I just hope that 
we can get this done. Thank you, Mr. Chairman. I yield back.
    [The bill introduced by Mr. Lujan has been retained in 
committee files and also is available at  http://
docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=104047.]
    Mr. Green. Mr. Chairman, I yield another minute to 
Congresswoman Matsui.
    Ms. Matsui. Thank you very much. Thank you, Mr. Chairman, 
for holding this hearing today on such an important topic. 
There is a growing prescription drug epidemic plaguing this 
country that we can no longer ignore. Prescription drugs are 
the second-most abused category of drugs among young people, 
and sadly, these painkillers often serve as a gateway to 
cheaper street drugs like heroin.
    The abuse of both prescription painkillers and heroin is 
devastating families and undermining public health and safety 
in our communities. In order to address this epidemic, we need 
to engage the full range of players, including patients, 
providers, parents, and manufacturers, as they all can and 
should play a critical role in curbing the abuse of 
prescription drugs.
    Addressing this crisis should be a priority, and I am 
pleased that this committee is holding a hearing on this 
important issue. I look forward to hearing from other witnesses 
as we consider strategies for addressing this epidemic. Thank 
you, and I yield back.
    Mr. Green. Mr. Chairman, I yield the remainder of my time 
to Congressman Sarbanes, if he would like to make a very brief 
statement.
    Mr. Sarbanes. It will be brief indeed. Thank you for 
yielding. One of the bills we are going to be talking about or 
I will be referring to is the Co-Prescribing to Reduce 
Overdoses Act. This would allow for co-prescribing of naloxone 
when physicians are prescribing opioids in cases where the 
patient is at high risk for overdose, and it would allow for a 
demonstration project to support certain facilities in 
exploring this opportunity, training physicians on it, who in 
turn can train patients on how to self-administer this 
lifesaving drug. We have an epidemic across the country. 
Certainly, Baltimore, Maryland, is experiencing this, and we 
look forward to testimony today on topics of this kind. And I 
yield back. Thank you.
    [The bill introduced by Mr. Sarbanes has been retained in 
committee files and also is available at  http://
docs.house.gov/meetings/IF/IF14/20151008/104047/BILLS-114pih-
Co-PrescribingtoReduceOverdosesActof2015.pdf.]
    Mr. Green. Mr. Chairman, I would also like ask to place 
into the record a statement by the Drug Policy Alliance.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. The gentleman yields back. And now the Chair 
recognizes the gentlelady from Indiana, Mrs. Brooks, who is 
filling in for the chair of the committee.

OPENING STATEMENT OF HON. SUSAN W. BROOKS, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF INDIANA

    Mrs. Brooks. Thank you, Mr. Chairman. I would like to thank 
the committee for bringing attention once again to this 
important topic. Sadly, Indiana is leading the country but not 
in a way we would like. Unfortunately, according to our State 
Public Health Commissioner, Dr. Adams, Indiana is one of 13 
States where the prescribers write enough prescriptions that 
every citizen in our State has a paying prescription.
    Unsuspecting addicts get hooked on opioids, but oftentimes, 
they switch to heroin, not only for the high but because now it 
is less expensive, and it is actually easier to get. And heroin 
on our streets is cheaper, stronger, and thanks to the 
synthetic add-ins, more unpredictable in its results than in 
the past. From '99 to 2009 Indiana health officials have seen a 
500-percent increase in the rate of drug overdose death, and in 
fact, overdose deaths now surpassed motor vehicle-related 
deaths in our State.
    And it is not just the overdoses, but in this past year, as 
this committee has already heard, Indiana has seen a drastic 
spike in hepatitis C and HIV due to opioid and heroin 
infusions, with the most recent figure at 183 confirmed cases 
of HIV in one small rural county alone.
    Now, we have held lots of roundtable discussions with 
providers and with prescribers and with law enforcement, but 
tragically, it is the families of the addicts and of those who 
have died who have become the real experts in this field. The 
consistent thread in the debate is that 80 percent of heroin 
use starts with prescription for pain meds, and many 
prescribers are unaware they may be a major part of the 
problem.
    So there is no silver bullet to fix it, but that is why I 
am very pleased that Congressman Kennedy and I have introduced 
H.R. 2805, the Heroin and Prescription Opioid Abuse Prevention, 
Education, and Enforcement Act of 2015. Yes, it is a 
comprehensive approach to solving the problem. It incorporates 
law enforcement, medical providers, educators, and first 
responders.
    I am thankful to my colleagues for participating in today's 
hearing and I look over to working with them in the coming 
weeks to advocate not only for passage of this bill, but the 
many thoughtful solutions being proposed by this committee. I 
yield back.
    [H.R. 2805 has been retained in committee files and also is 
available at  http://docs.house.gov/meetings/IF/IF14/20151008/
104047/BILLS-1142805ih.pdf.]
    Mr. Pitts. The Chair thanks the gentlelady. And now the 
Chair recognizes the gentleman from Massachusetts, Mr. Kennedy, 
filling in for the ranking member of the full committee.

      OPENING STATEMENT OF HON. JOSEPH P. KENNEDY, III, A 
   REPRESENTATIVE IN CONGRESS FROM THE STATE OF MASSACHUSETTS

    Mr. Kennedy. Thank you, Mr. Chairman. I appreciate the 
opportunity. And I want to thank the witnesses for coming to 
testify today, and for your extraordinary dedication to these 
issues and your service to our country.
    The other day, I asked some of my constituents to tell me 
about their experience with opiate abuse and drug addiction, 
whether it was their own personal struggle or the battle of a 
loved one. Their responses were heartbreaking: a grandmother 
who lost her 25-year-old grandson over the summer, a father 
whose 56-year-old son battled mental illness late in life and 
eventually fell victim to cocaine addiction, a young woman who 
just lost her cousin to an overdose 2 weeks ago, a mother whose 
son was denied entrance into a treatment program last month 
because he was already in detox after overdosing. So she gave 
him the money he needed to buy drugs and test positive. The 
themes of each story were unique, but every constituent ended 
their message the same way, by calling on Congress to act.
    Many of the bills we are considering today will help us 
began to answer those calls, including one I was proud to 
introduce with my colleague, Congresswoman Brooks, earlier this 
year. Chairman Pitts and Ranking Member Green, thank you for 
your continued commitment to this issue. I look forward to 
listening to the conversation today and discussing some 
bipartisan solutions.
    I would like to yield the balance of my time to 
Representative Tonko.
    Mr. Tonko. And I thank the gentleman for yielding. I am 
pleased that we are holding this legislative hearing today on 
bills that aim to ease the burden of our nation's growing 
opioid epidemic. I am here today in support of the Recovery 
Enhancement for Addiction Treatment Act, also known as the 
TREAT Act, on which I joined with my fellow upstate New 
Yorkers, Representatives Higgins, Katko, and Hanna, to 
introduce.
    This legislation would lift the current caps in place on 
the number of patients that doctors can serve while prescribing 
buprenorphine, a medication-assisted treatment for opioid 
addiction. Under current laws, if every opioid treatment 
program and DATA 2000-waivered physician treated the maximum 
number of patients, that would still be roughly 1 million 
opioid-addicted individuals unable to secure treatment.
    The hope with this bill is that we can lessen this gap 
between individuals seeking treatment and our inadequate 
treatment capacity. While this legislation is not a cure-all 
and we still need to examine measures to ensure the highest 
quality care, I believe the TREAT Act will go far in helping to 
alleviate our acute treatment capacity issues and put more 
people on the path to recovery. I urge our committee to take 
swift action on this bill so that we can turn the tide on this 
epidemic. And with that, I thank you and yield back to 
Representative Kennedy.
    Mr. Kennedy. Unless there is another member of the minority 
that wants time, I yield back.
    Mr. Pitts. The Chair thanks the gentleman. That concludes 
the opening statements. As usual, all written opening 
statements of the members will be made a part of the record as 
well. We have two panels for this hearing. We are going to take 
one today, the second, the week of October 20 when we come back 
from break. But I would like to thank our first panel here 
today, and I will introduce them in the order of their 
testimony.
    First, we have Mr. Michael Botticelli, Director of the 
National Drug Control Policy, Executive Office of the 
President; secondly, Dr. Richard Frank, Assistant Secretary for 
Planning and Evaluation, Health and Human Services; and 
finally, Mr. Jack Riley, Deputy Administrator, Drug Enforcement 
Administration.
    Thank you very much for coming today. Your written 
testimony will be made part of the record. You will be each 
given 5 minutes to summarize. We have a series of three little 
lights. Green will be on for 4 minutes, yellow a minute, and at 
minute number 5 the red will come on. We ask you to wrap it up 
if you could, and then we will go to questions and answers. So 
thank you very much for coming. And, Mr. Botticelli, you are 
recognized for 5 minutes for your summary.

 STATEMENTS OF MICHAEL P. BOTTICELLI, DIRECTOR, NATIONAL DRUG 
  CONTROL POLICY, EXECUTIVE OFFICE OF THE PRESIDENT; RICHARD 
FRANK, PH.D., ASSISTANT SECRETARY FOR PLANNING AND EVALUATION, 
DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND JACK RILEY, ACTING 
     DEPUTY ADMINISTRATOR, DRUG ENFORCEMENT ADMINISTRATION

               STATEMENT OF MICHAEL P. BOTTICELLI

    Mr. Botticelli. Thank you, Chairman Pitts, Ranking Member 
Green, and members of the subcommittee, for the opportunity to 
appear here today to discuss the administration's response to 
the epidemic of opioid abuse, particularly the rise in 
nonmedical prescription opioid and heroin use, overdose deaths, 
and the use of new psychoactive substances.
    The Office of National Drug Control Policy produces the 
National Drug Control Strategy, which is the administration's 
primary blueprint for drug policy. This strategy treats our 
nation's substance use problems as a public health issue, not 
just a criminal justice issue.
    Using ONDCP role as the coordinator of Federal drug control 
agencies, in 2011 our administration released a plan to address 
the sharp rise in prescription drug misuse. This plan contains 
items categorized in four areas: education of prescriber and 
patients, increased prescription drug monitoring programs, 
proper medication disposal, and law enforcement efforts.
    The administration has also convened at Congress' urgence 
an interagency Heroin Task Force co-chaired by ONDCP and the 
Department of Justice to more closely examine our strategies as 
it relates to heroin use in the United States. The task force 
will release its strategic plan later this year.
    There has been a stark increase in the number of people 
using heroin over recent years and the number of overdose 
deaths involving heroin. As communities and law enforcement 
struggle with an increasing number of overdose deaths, heroin 
use, and increased heroin trafficking, it is important to note 
that plentiful access to opioid drugs via medical prescribing 
and easy access to diverted opioids for nonmedical use is 
feeding our opioid drug use epidemic.
    Even though data indicate that over 95 percent of 
prescription opioid users do not initiate heroin use, four out 
of five new heroin users have experience as nonmedical 
prescription drug users. Given this interrelationship, the 
public health response to heroin use must be part of the 
response to nonmedical prescription opioid use.
    A further complicating factor in addressing this epidemic 
is law enforcement reporting of heroin that is laced with 
fentanyl, an opioid drug that is estimated to be 100 times more 
potent than heroin. This increased potency has resulted in more 
overdose deaths in many parts of the country.
    We have seen overdose deaths from prescription opioid level 
off, but unfortunately, this is coupled with a dramatic 39 
percent increase in heroin-involved overdose deaths in 1 year, 
from 2012 to 2013. To address the overdose death issue, we are 
working to increase access to naloxone for first responders and 
individuals close to those with an opioid drug use disorder, 
and to promote Good Samaritan laws so witnesses to an overdose 
will take steps to help save lives.
    First responders nationwide are rising to this challenge of 
addressing the increase in opioid use in overdose deaths, but 
the medical establishment also needs to increase access to 
treatment for individuals with opioid use disorders before they 
become chronic or result in other public health consequences 
such as infectious diseases or neonatal abstinence syndrome.
    Given that little to no time in graduate medical education 
programs is devoted to the identification or treatment of 
substance use disorders and given that very few physicians have 
availed themselves of voluntary training options, our 
administration continues to press for mandatory prescriber 
education tied to controlled substance licensure.
    Evidence shows that medication-assisted treatment with FDA-
approved medications, when combined with behavioral therapies 
and other recovery supports, has shown to be the most effective 
treatment for opioid use disorders. Our administration 
continues to pursue a wide variety of ways to increase access 
to these lifesaving medications. But since some of these 
products are subject to diversion, it is essential that this 
expansion be done in a way that promotes high-quality care and 
minimizes the opportunity for diversion.
    It is also important to continue our efforts to educate the 
public about the risks and consequences of nonmedical 
prescription opioid and heroin use and the availability of 
options for treatment for opioid use disorders to help improve 
and save lives. To help with all of these efforts, the 
administration's fiscal year 2016 budget proposal includes $133 
million in new funding to reduce opioid misuse, abuse, and 
overdose deaths.
    Lastly, a few comments about the use of new psychoactive 
substances, or NPS. The administration's activities to reduce 
the use, availability of NPS include data collection, research, 
prevention, treatment, domestic and foreign law enforcement 
actions, and international cooperation to reduce the 
manufacture and distribution of these serious life-endangering 
substances.
    The health risks of NPS can be significant, including 
serious injury and even death. The contents and effects of 
synthetic cannabinoids and synthetic cathinones are 
unpredictable due to a costly changing variety of chemical 
compounds used in manufacturing processes that are devoid of 
quality control and regulatory oversight. These substances also 
contain toxic impurity byproducts, and the potency can vary 
significantly from batch to batch.
    In conclusion, this administration will continue our work 
with Congress and our Federal, State, and local partners on 
public health and public safety issues resulting from the 
epidemic of the nonmedical prescription opioid and heroin use, 
as well as new psychoactive substances.
    Thank you.
    [The prepared statement of Mr. Botticelli follows:]
    
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    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Dr. Frank, 5 minutes for your summary.

                   STATEMENT OF RICHARD FRANK

    Dr. Frank. Thank you, Chairman Pitts, Ranking Member Green, 
and members of the subcommittee. I appreciate the opportunity 
to speak with you about addressing the misuse and abuse of 
opioids.
    We at HHS share your sense of urgency to take action to end 
this epidemic. Secretary Burwell has made halting the opiate 
epidemic a top priority.
    The numbers on the epidemic are stark. In 2014, more than 
10 million people reported nonmedical use of prescription 
opioids, and nearly a million reported use of heroin. Moreover, 
it is estimated that more than 2 million people have an opioid 
use disorder. These disorders tear apart families, increase 
crime, and kill too many of our neighbors.
    When Secretary Burwell arrived at HHS a little over a year 
ago, she directed our senior leadership to develop and 
implement an initiative to address the opioid problem. She 
insisted that it be department-wide, focused, and evidence-
based so as to produce maximum impact. That effort resulted in 
the strategy that consists of three elements: first, improving 
prescribing practices for opioid pain medications; second, 
expanding the use of medication-assisted treatment for opioid 
use disorder; and third, expanding the use and distribution of 
naloxone to reverse overdoses.
    In the time I have with you today, I want to focus on our 
efforts to expand the use of medication-assisted treatment, or 
MAT. MAT is a treatment that combines medication, behavioral 
interventions, recovery support services, and careful patient 
monitoring. There are three FDA-approved medications used in 
MAT: methadone, buprenorphine, and naltrexone. MAT, using each 
one of these, has been shown to be effective in clinical trials 
and in public health interventions. It is in fact the most 
effective approach to treating opioid use disorders. Yet MAT is 
woefully underused. Provision of MAT faces unique barriers in 
part because methadone and buprenorphine are controlled 
substances.
    In addition, stringent medical management techniques are 
used to control utilization, and in the case of buprenorphine, 
the number of opioid use disorder patients a certified 
physician can treat is limited to 100 at any one time.
    Our approach to expanding the use of MAT is guided by, 
first of all, the recognized need to expand the use of MAT; 
two, the fact that effective use of MAT means delivering the 
full package of services: pharmaceuticals, counseling, recovery 
supports, and monitoring for a patient's adherence; and third, 
that the capacity be expanded in a way that minimizes the risk 
of drug diversion. This approach is supported by the American 
Society of Addiction Medicine's recent guidelines on 
appropriate use of MAT.
    Given these guardrails, I want to share with you the steps 
we are taking to expand MAT that we believe have much in common 
with proposed legislation that has already been mentioned today 
such as the TREAT Act.
    Following Secretary Burwell's recent announcement, we are 
engaging in rulemaking related to expanding access to 
buprenorphine-based MAT. Our Health Resources and Services 
Administration, or HRSA, recently announced a competition for 
$100 million to expand the use of MAT in community health 
centers. SAMHSA recently awarded $11 million per year for 3 
years to 11 States across the Nation to increase MAT, and is 
proposing an additional 25.1 million for this purpose to go to 
22 States for fiscal year 2016.
    CMS recently issued a letter to State Medicaid Directors 
describing opportunities and authorities that States can use to 
provide a continuum of care to beneficiaries suffering from 
substance use disorder, including opioid use disorder.
    We are also exploring ways to expand education and training 
for providers in the treatment of opioid use disorders. We are 
committed to tracking and evaluating our efforts, that we make 
the best use of public resources, and in the end, we will 
measure our success by the impact we have on families, people, 
and communities touched by the opioid crisis.
    Thank you.
    [The prepared statement of Dr. Frank follows:]
    
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    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Mr. Riley, 5 minutes for your opening statement.

                    STATEMENT OF JACK RILEY

    Mr. Riley. Chairman Upton, Chairman Pitts, Ranking Member 
Pallone, Ranking Member Green, and members of the subcommittee, 
I want to thank you for this opportunity to testify this 
morning about our nation's most pervasive drug issues: the 
continuing opioid epidemic and the rise of synthetic drugs.
    DEA's single mission is enforcing the Controlled Substances 
Act, and we are honored to work closely with our counterparts, 
including those in education, enforcement, research, recovery 
field, as well as partners in the supply chain.
    Sadly, today, 120 Americans will die as a result of drug 
overdose. Heroin and prescription drugs cause over half of 
those fatalities. Accordingly, DEA views the opioid addiction 
epidemic as the number one drug threat to our country.
    I spent my entire career in law enforcement. Having been an 
agent with the DEA for over 30 years, I have to tell you I have 
never seen it this bad. Prescription drug abuse has increased 
tremendously in the last 15 years. The abuse of prescription 
drugs and resulting addiction has fueled a spike in the use of 
heroin. In fact, four out of five new heroin users have misused 
prescription painkillers.
    Increases in heroin purity, its low cost on the streets, 
the expanding role of violent Mexican organized crime groups, 
and the toxic business relationship with violent urban street 
gangs has also played a significant role in the resurgence of 
heroin. DEA is addressing this evolving threat by targeting the 
highest-level traffickers and the vicious organizations they 
run.
    I have personally spent the bulk of my career chasing the 
man I consider to be the most dangerous heroin dealer in the 
world, El Chapo Guzman. He and his Sinaloa Cartel clearly 
dominate the U.S. heroin market, as the map I have brought with 
me today depicts.
    Just as we cannot separate violence from drugs, we cannot 
separate controlled prescription drug abuse from heroin. As a 
result, DEA established highly effective tactical diversion 
squads, 66 in total, to target the critical nexus between the 
diversion of prescription drugs and heroin. DEA has also 
addressed the threat posed by the drugs that are in our 
medicine cabinets through our National Take-Back, the latest 
one being just 2 weeks ago. We have removed over 5-1/2 million 
pounds of unused and unwanted drugs. However, DEA drug disposal 
is still a problem to us and we can't solve it on our own.
    DEA promulgated a regulation last year to allow the drug 
supply chain to become authorized collectors. At present, we 
have 500 registrants. It is simply not enough. This is one 
important way in which we can step up as partners in our effort 
to curb prescription drug abuse.
    Lastly, I want to address the growing synthetic issue that 
we are facing. Some of these designer drugs are referred to as 
synthetic THC and marketed with similar effects. Nothing could 
be further from the truth. Last year, there was a 229-percent 
spike in calls to Poison Control Centers for synthetics. The 
physical reaction to even one use of a synthetic drug varies 
widely, and in some cases, has resulted in death.
    DEA has identified literally hundreds of synthetic drugs 
that have been encountered during Federal, State, and local law 
enforcement operations. Manufactured in overseas laboratories, 
these drugs are unregulated, have no medical use, and are not 
tested for safety. This means that those who misuse these 
products--most likely teens and adolescents--are really 
unwittingly allowing themselves to become guinea pigs.
    Law enforcement has been encountering these substances more 
and more. According to the National Forensic Laboratory 
Information System, substances identified as synthetic 
cannabinoids by Federal, State, and local forensic laboratories 
have increased from 52 reports in 2009 to over 49,000 reports 
just last year.
    DEA has made several enforcement operations targeting this 
problem, including Operation Log Jam, Project Synergy I and II, 
which have collectively resulted in 377 arrests and over $80 
million in cash seized, and literally tons of synthetic drugs 
taken off our streets. These operations demonstrate the scope 
of the problem, but I believe they are really just the tip of 
the iceberg.
    I want to thank you for your partnership. DEA and I look 
forward to continuing to work with this subcommittee and 
Congress on these important issues.
    [The prepared statement of Mr. Riley follows:]
    
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    Mr. Pitts. The Chair thanks the gentleman. That concludes 
the opening statements of the witnesses. We will now begin 
questioning. I will recognize myself for 5 minutes for that 
purpose. Dr. Frank, and then Mr. Botticelli, in your view, what 
are the most significant obstacles at the present time 
preventing more individuals with opioid use disorders from 
receiving the most effective treatments?
    Dr. Frank. I think there are several factors. I think 
supply of treatment is certainly one important factor. The 
second one is stigma and the shame that comes from seeking 
treatment, the attitude of friend to neighbors. And then third, 
I think we are still working on our payment and coverage 
arrangements as we implement our parity legislation, and as we 
move towards expanding our parity regulations.
    Mr. Pitts. Mr. Botticelli?
    Mr. Botticelli. As you indicated, only about 20 percent of 
people who have substance use disorder get care and treatment, 
and the factors that are often cited in those surveys, as Dr. 
Frank alluded to, is, one, insurance status. And we know that 
either not having insurance, or not having insurance that 
appropriately covers a spectrum of substance use disorder 
services is particularly challenging.
    As he also talked about, stigma plays a role. We know that 
in national data, and I hear it time and time again reflected 
in people's stories, that it keeps them from asking for help, 
or delaying their care.
    And the third aspect, particularly as it relates to opioid 
use disorders, as we have been discussing here, is the really 
dramatic underutilization of medication-assisted therapies not 
only in our treatment programs but in our correctional 
facilities. We know we have many parts of the country that 
don't have a dedicated treatment program, and looking at, and I 
think particularly, the Secretary's initiative, focusing on 
increasing access to community health centers--becomes 
particularly important. So we know that not having dedicated 
treatment in a local community is really, really important.
    Mr. Pitts. Would the two of you expand on that, on the role 
that you think medication-assisted therapy should play?
    Mr. Botticelli. I will start and----
    Mr. Pitts. Yes, go ahead.
    Mr. Botticelli [continuing]. Have Doctor-- again, I think 
there is common agreement and that all of the studies are 
really very crystal clear that, by far, people with opioid use 
disorders do better on medication-assisted treatment when done 
in a high-quality way that includes other behavioral therapies 
and supports, bar none. So we know that not only do people do 
better, they don't die, they don't get infectious disease as it 
relates to it. And part of our efforts on the administration 
level, both at ONDCP in conjunction with HHS, is to ensure that 
people have adequate access.
    In addition to grants and other activities, we have also 
been strengthening our Federal contracting language to ensure 
that those programs that get Federal dollars that support 
treatment include the entire spectrum of FDA-approved 
medications for opioid use disorders.
    Mr. Pitts. Dr. Frank, do you want to add to that?
    Dr. Frank. The one point I would add to that is that it is 
not only important that we have people out there able to 
conduct medication-assisted treatment, but they have to do it 
in a way that is evidence-based, that is, having all of the 
components in place, the counseling, the recovery supports, the 
patient monitoring. You need the whole package for it to work. 
But clearly, when you have that, it is the most effective 
treatment out there.
    Mr. Pitts. Thank you. Mr. Riley, I appreciate DEA's 
willingness to work with the committee to ensure that 
veterinarians can travel with and administer pain medication to 
their animal patients. Athletic team physicians also have an 
inherently mobile practice, yet as was the case with the vets, 
the statute prohibits them from administering appropriate 
medication to their patients outside of their physical office. 
Will you commit to working with the committee and Chairman 
Sessions on a responsible solution to this important issue?
    Mr. Riley. Well, yes, sir, we will and we are. This is a 
difficult balancing act, in terms of making sure that the 
supply is there to legitimate patients given by legitimate 
caregivers, but we also want to make sure that the ability of 
diversion in these situations are as limited as much. So I look 
forward to working with the committee, and I know we already 
are.
    Mr. Pitts. Thank you. I also appreciate DEA's efforts to 
combat the recent influx of incredibly dangerous synthetic 
drugs hitting communities across the country, yet I understand 
that due to no fault of your own, the criminals are a step or 
two ahead of you. Can you explain how Congressman Dent's bill 
would help in this regard?
    Mr. Riley. Well, first of all, I want to say thank you to 
the leadership in this issue because it really is an issue for 
us. As I look across the country today, what keeps me up at 
night is clearly the heroin issue, the opioid addiction issue, 
various organized crime groups. But second that is the growth 
of synthetic drugs primarily targeting our young people. I 
personally witnessed this where people have lost their lives. 
So from a cop's point of view, sir, and that is what I am, 
anything that could help us as a tool to make sure we can move 
quicker, we would welcome. And again, we are going to work with 
the committee to get it done.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the ranking member, Mr. Green, 5 minutes for 
questions.
    Mr. Green. Thank you, Mr. Chairman. Current research 
suggests that the most effective treatment to combat opioid 
addiction is a combination of medication and counseling. 
Methadone, which was approved nearly 50 years ago, is a 
synthetic opioid. Methadone is also a DEA Schedule II drug. 
Director Botticelli, could you talk a little bit about the 
evidence base regarding methadone and how it impacts patients' 
retention and treatment, transmission of infectious disease, 
and other health outcomes?
    Mr. Botticelli. So methadone is one of the most highly 
evaluated treatments for opioid use disorders. It has been 
around for over 50 years. And so not only have we seen kind of 
remarkable results in terms of treatment engagement and 
retention, and reduction in infectious disease but also 
reduction in criminal behavior, increase in full-time 
employment. It is one of the highly effective medications that 
we have as it relates to opioid use disorders.
    I think the bright spot that we do have with the opioid use 
epidemic is a growing armamentarium of highly effective 
medications, and when done in a quality way, methadone 
treatment programs wrap not only medication but look at 
addressing other medical conditions but also ensure that people 
have access to behavioral therapies and other recovery 
supports.
    Mr. Green. OK. Dr. Frank, what are the advantages and 
disadvantages of using methadone to treat opioid addiction?
    Dr. Frank. Thank you for the question. As Director 
Botticelli said, first and foremost, it is extraordinarily 
effective, and that is a huge advantage. It is administered in 
a highly structured environment that provides testing, support, 
and therefore has a very low probability of diversion. Now, 
this structured setting is there because of the way methadone 
is metabolized, and careful attention to dosing is necessary 
early in the treatment because of the increased risk of 
mortality. And a disadvantage is that methadone is particularly 
prone to stigma.
    Mr. Green. OK. Another drug used for opioid addiction is 
buprenorphine. This drug is a synthetic opioid and a DEA 
Schedule III drug. Buprenorphine can be prescribed by 
physicians who receive a DATA waiver. They are only permitted 
to treat a maximum of 100 patients at a given time. Dr. Frank, 
can you talk about the evidence base for buprenorphine and its 
impact on overdoses and other health outcomes?
    Dr. Frank. Yes, thank you. There have been 16 clinical 
trials on buprenorphine. It is impossible to pronounce, isn't 
it?
    Mr. Green. Oh, it is very, although we are learning.
    Dr. Frank. Buprenorphine----
    Mr. Green. People who think Members of Congress can't learn 
are so off.
    Dr. Frank. So there have been 16 trials of buprenorphine-
based medication-assisted treatment. They consistently show 
strong effectiveness in treatment retention and reduced illicit 
opioid use. They also show improved maternal and fetal outcomes 
in pregnancy, relative to placebo trials, and they also have 
some mortality benefits. So they also have been highly 
effective.
    Mr. Green. I understand that an injectable drug called 
Vivitrol also has been approved by FDA to treat opioid 
addiction. Vivitrol is an opioid antagonist, meaning it blocks 
opioid receptors. It is neither a narcotic nor a DEA-scheduled 
drug. Director Botticelli or Dr. Frank, can you comment on the 
evidence base regarding the use of Vivitrol in the treatment of 
opioid addiction?
    Mr. Botticelli. Once again, there is significant study to 
show that injectable naltrexone is highly effective in terms of 
dealing with opioid addiction. I think the premise here is we 
have three really highly effective medications that are 
underutilized. But it is also, I think, important to understand 
that, as in any disease, you want as many highly effective 
medications as possible, to make sure that we are matching the 
right treatment with the right person, and that if one fails, 
you have another option to be able to use for people. So, you 
know, again, I think our approach is to ensure that people have 
access to all of the three FDA medications that we have.
    Mr. Green. Is there a problem with diversion of either of 
those drugs? Because I know you said earlier in the testimony 
that methadone wasn't a diversion on these two drugs?
    Mr. Botticelli. You know, clearly, and I think it would be 
disingenuous to say that there is not a diversion issue, 
particularly with buprenorphine. However, what we see when it 
is done in a high-quality way, when it is done with sufficient 
patient monitoring, that it is particularly effective in terms 
of the work that we see.
    Mr. Green. OK. Mr. Chairman, finally, buprenorphine, I 
think I can get that done.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from Indiana, Dr. Bucshon, 5 minutes 
for questions.
    Mr. Bucshon. Thanks, Mr. Chairman. As background, I was a 
practicing cardiovascular surgeon for 15 years, and my wife is 
an anesthesiologist so I have a little bit of experience 
prescribing and seeing patients on these medications. And now I 
kind of get my medical knowledge through my wife, and as an 
anesthesiologist, when patients come to surgery these days, it 
is amazing the number of people who are already on prescription 
narcotics for a variety of reasons, it is just striking, as 
well as others like benzodiazepines. But we are addressing the 
opioids today.
    The other thing is this does go across socioeconomic class; 
it goes across ages. For example, the number one prescribed 
medication under Medicare Part D is a prescription opioid pain 
medicine. That is seniors. So this is really a problem we need 
to address, and it really is something that I am really happy 
that we have chosen to have this hearing, amongst many others 
today and in the past and future.
    But enhanced provider education is another priority for 
reversing the current epidemic--as a provider, I can say that 
that is true--by really reducing inappropriate prescriptions of 
opioids. So what steps should be taken to strengthen prescriber 
training and primary care, outpatient opioid treatment, and 
methadone clinics for the use of non-opioid methods of managing 
pain, and also non-opioid things like Vivitrol and other 
medicines in the recovery of opioid addiction? Mr. Botticelli, 
you can start that.
    Mr. Botticelli. Maybe I will start, and I will let Dr. 
Frank talk about HHS efforts in this domain. As the 
Congresswoman from Indiana pointed out, a 2012 study by the CDC 
showed that we are prescribing enough pain medication in the 
United States, not just in Indiana, to give every adult 
American 75 pain pills. And while we clearly want to make sure 
that pain is treated in the United States, when you look back 
over the past 10 years, all of the morbidity and mortality is 
directly correlated to the increase in prescribing. So we know 
that giving people good education is important. That is why we 
continue to pursue mandatory prescriber education. And I will 
yield to Dr. Frank to talk about HHS efforts in those domains.
    Dr. Frank. Let me mention four things that we think are 
important. First is continue bringing prescription drug 
monitoring programs into the clinical world so that we can 
track prescribing patterns as part of routine medical practice 
and can do so across States and across settings. That is one 
thing.
    Second thing is we are in the process of developing 
guidelines for prescribing, particularly for non-cancer pain. 
And we have accelerated that effort and should be putting those 
guidelines out early next year. We have just had a set of 
public meetings where we have rolled out some initial ideas and 
gotten public feedback on it.
    Third is we are engaging with a variety of medical 
societies and specialty groups to find ways and to partner with 
them to up the amount of training that is done within each of 
their organizations. And then finally, for the second year in a 
row, we have brought together the 50 States to compare best 
practices for helping to improve prescribing and monitoring of 
prescriptions.
    Mr. Bucshon. And I think that is really important. I can 
tell you in my own medical training in medical school and 
honestly 7 years of residency, I never had a specific month or 
week even directed at how to manage pain, and that is a person 
who is a surgeon. So we really learn how to manage pain almost 
on the go, so to speak, and I think addressing that issue 
probably with accrediting agencies that accredit medical school 
training or residency training is another avenue.
    But I can tell you, as a physician, it takes months or 
maybe even years to understand how to manage pain, whether that 
is nonsurgical, whether that is related to injury, and top that 
off with managing people that already have significant issues 
with using prescription medication and trying to manage their 
pain, that we clearly need to address training, probably all 
the way back to medical school moving forward, and that may 
take us a generation to fix. So I yield back. Thank you.
    Mr. Pitts. The Chair thanks the gentleman, and now the 
Chair recognizes the gentleman from North Carolina, Judge 
Butterfield, 5 minutes for questions.
    Mr. Butterfield. Thank you very much, Chairman Pitts, and 
thank the witnesses for your testimony today. Let's see. Where 
do I start? All of you are right. All of my colleagues are 
right. All of the witnesses are right. We have a crisis in this 
country, and it is preventable, in my opinion. And so it is 
therefore incumbent upon all of us to address the opiate 
epidemic that has claimed too many, too many victims in my 
district and in your districts and all across the country.
    Opiate addiction doesn't discriminate. It does not 
discriminate. Black, white, rich, or poor, anyone can succumb 
to opiate addiction. And that presents a very difficult 
challenge to finding ways to curb the epidemic. My home State 
of North Carolina has seen a 300-percent death increase due to 
opiate poisoning since 1999. Our emergency officials where I 
live in Wilson, North Carolina, respond to overdose calls every 
other day on average. In March, police in the city of 
Greenville, North Carolina, responded to six heroin overdoses 
in a single day.
    This is real. It is a real problem which reaches each and 
every community in our country from the most urban to the most 
rural and across every demographic. There is much that we can 
and should do in response to this significant problem. 
Recently, I received a letter from our attorney general, Mr. 
Roy Cooper, and 37 other State Attorneys General urging Members 
to support legislation to assist with recovery from opiate 
addiction. One of the provisions important to my State included 
in that legislation is funding to increase access to naloxone 
for first responders. This drug is a lifesaving treatment which 
can counteract some of the damages of narcotic overdoses.
    And so I appreciate the convening of this hearing to 
consider some of the policy options to combat this dangerous 
national epidemic. While some of these pieces of legislation 
are steps in the right direction, we must consider increasing 
access to naloxone--and I may be pronouncing that wrong--for 
law enforcement.
    It is also clear that we cannot do this alone. The private 
sector is a key stakeholder and is stepping up to the plate. 
From abuse-deterrent formulations to injectable and implantable 
treatments, the future of medicine can help reduce prescription 
drug abuse and diversion.
    But let me underscore the urgency of doing it now. From 
2001 to 2013 there was a threefold increase in deaths from 
opiates, and the doctors in the room, I appreciate you helping 
to put a spotlight on this problem. There has been a threefold 
increase in deaths from opiates. These are our nation's mothers 
and fathers and sisters and brothers. This is a crisis. To 
Director Botticelli, thank you for your testimony. Are abuse-
deterrent formulations having an impact here in the United 
States?
    Mr. Botticelli. One of the areas that we continue to 
evaluate is how abuse-deterrent formulations will diminish 
people's use. I think we are continuing to work with FDA to 
look at the evaluation strategies. But clearly, we know that 
this is a prime strategy that we have been putting forth in our 
Prescription Drug Abuse Plan to really look at the impact that 
abuse-deterrent formulations will continue to play in reducing 
prescription drug use issues.
    I think as you discussed that abuse-deterrent formulations 
are one part of a larger strategy that we have to employ in 
terms of dealing with this issue. Clearly, we don't want people 
just switching from one drug to another. We want to use that as 
an opportunity to get people into care and treatment. So this 
is obviously a prime part of our strategy, an important part of 
our strategy, but it has to be linked to other things to ensure 
that people get interventions and get good, high-quality care.
    Mr. Butterfield. While I have your attention, let me talk 
about manufacturers just for a moment. Can you describe whether 
we should be doing more to encourage opiate manufacturers to 
convert their medicines to abuse-deterrent formulations?
    Mr. Botticelli. And I probably can't speak as eloquently as 
the FDA can on this issue, but clearly, they have signaled 
their strong preference for approving abuse-deterrent 
formulations as part of their overall goal and work that they 
are doing. And again, it has been clearly part of our overall 
prescription drug abuse strategy to continue to promote abuse-
deterrent formulations.
    Mr. Butterfield. Thank you. Now, I will go to my far right. 
And we don't use that word, do we? All right. Go to the right. 
All right. Deputy Administrator Riley, as a representative from 
an area which has withstood some of the strongest storms in our 
nation's history, I am concerned. I am interested in the 
Medical Controlled Substances Transportation Act of 2015. I 
know you recognize that. Can you describe whether this 
legislation would increase access of potentially lifesaving 
treatments to those in need in federally declared disaster 
areas?
    Mr. Riley. Well, clearly, in situations unfortunately the 
Carolinas are going through now----
    Mr. Butterfield. Yes.
    Mr. Riley [continuing]. It is an important aspect. While I 
don't know the specifics of the bill, I can tell you that we 
are working with the committee on this. We recognize this is an 
issue that really needs attention, and I give you my word we 
are going to come to some agreement here. We can work it out.
    Mr. Butterfield. Mr. Chairman, you have been very patient 
with me. Thank you. I yield back.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from Florida, Mr. Bilirakis, 5 minutes 
for questions.
    Mr. Bilirakis. Thank you so much. I appreciate it. Thanks 
for your testimony, panel. I have a question for Mr. Riley. 
Recently, as many of you discussed in your testimonies, heroin 
deaths have been increasing across the country at an alarming 
rate, unfortunately. Both Pinellas and Hillsborough Counties in 
Florida, which I represent--I represent a portion of both of 
those counties--they have seen heroin deaths rise in some cases 
by more than 700 percent over the course of a year. 
Unbelievable. Mr. Riley, what can we do to best address not 
only how to control the supply side of prescription drug abuse, 
but also address the demand issue so that this population 
doesn't turn to illicit drugs?
    Mr. Riley. Thank you for the question, sir. Well, I think 
you hit it on the head. While I have been in law enforcement 
for 30 years, I do recognize we cannot arrest our way out of 
this. This is an issue that can be found in every corner of 
this country in cities large and small, rural and urban. And we 
have got to get everybody's help, from law enforcement to 
policymakers, to educators, faith-based organizations, clearly 
treatment, and the registrants that handle prescription drugs. 
So it is an educational fight as much as it is I think a law 
enforcement fight.
    Now, on the law enforcement side, I also have to tell you 
we have never seen organized crime--and I will use the Sinaloa 
Cartel. We have never seen in my 30 years a criminal entity so 
well financed, vicious, and willing to do anything to make a 
buck. What keeps me up at night, sir, is the growing 
relationship between American street gangs, urban street gangs, 
and the toxic business relationship that they have formed with 
Mexican organized crime. That in itself I think has fostered 
the spread of heroin across the country.
    Today's heroin is not what it was 5 years ago. It is 
cheaper, it is more pure, it can be smoked and snorted. So it 
has really attracted a completely different user base. So 
everybody in this room plays a role in our success, and that is 
why I applaud this committee for even bringing this up.
    But I can tell you DEA around the world, working with our 
partners, it is the number one priority. One of the things that 
we are doing better, sir, that we haven't done before, is we 
are communicating. The bad guys for years have counted on the 
cops not sharing information, not sharing intelligence 
information. We are doing that better now than we have ever 
done it, even with our foreign counterparts.
    I have spent quite a bit of time on the border and also in 
Mexico. I have to tell you we have never seen the exchange of 
information with the Mexican law enforcement authorities as 
good as it is. Our ability to share information and for them to 
share information back for domestic cases is at an all-time 
high. So I am optimistic on the law enforcement front that we 
are moving forward. But clearly, everybody has a piece of this.
    Mr. Bilirakis. Thank you. That is good to know. Mr. 
Botticelli, you mentioned a steep rise in the number of babies 
born with neonatal abstinence syndrome. Counties within my 
district were found to be suffering from some of the highest 
number of babies born addicted to opiates in the country. What 
do you see as the greatest obstacle to ensuring access to 
services, and how can these challenges be addressed?
    Mr. Botticelli. So, again, this is, I think, an opportunity 
for us to work with Congress on additional issues, particularly 
the Protecting Our Infants Act that was passed in the House, 
and I think it is a really great opportunity to expand our 
efforts.
    So clearly we, you know, as you have indicated, have seen a 
dramatic increase in the rise of pregnant women and neonatal 
abstinence among babies who are born here in the United States. 
You know, obviously, our overall efforts to focus on reducing 
prescription drug misuse and heroin use play a big role, but 
also making sure that pregnant women have good access to care 
and treatment, we have effective medications, again, for the 
use in this and that moms have particularly good access to a 
wide variety of treatment services. So this becomes really 
important for us to look at this.
    We also want to ensure that we are not putting additional 
stigma on pregnant women in terms of their ability to seek 
care, and we hear that time and again. Dr. Frank talked about 
the role that stigma plays, but that is particularly true with 
pregnant women, and we don't want to do anything to further 
enhance that, particularly among pregnant women in terms of 
their ability to seek care.
    Mr. Bilirakis. Thank you, sir. Would you be willing to come 
to my district and participate in a roundtable on this 
particular issue?
    Mr. Botticelli. Absolutely. I----
    Mr. Bilirakis. I am in the Tampa Bay area.
    Mr. Botticelli. Great. I would be happy to do that. I have 
had the opportunity, as I have traveled, to talk and visit many 
neonatal intensive care units, had the opportunity to talk to 
practitioners. I think we have further work to do, and this is 
where we are looking forward to working with Congress on making 
sure that we have good standardized protocols for the treatment 
of pregnant women, that we have good surveillance. And so 
again, I think this is another area where administration 
priorities and congressional priorities are aligned.
    Mr. Bilirakis. Absolutely. Thank you very much. I yield 
back, Mr. Chairman.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from New Mexico, Mr. Lujan, 5 minutes 
for questions.
    Mr. Lujan. Thank you very much, Mr. Chairman. I appreciate 
this important hearing today. And, Mr. Chairman, my questions 
began with Dr. Frank. Looking specifically at the legislation 
that I have introduced, Assistant Secretary Frank, to see what 
we can do in, especially rural States like New Mexico, where it 
is hard to get to some of these areas and families are being 
separated because of the challenges of substance abuse, which 
is compounded by these distances and healthcare shortages, what 
are we doing to ensure that those in need of help are getting 
it? How do we make sure people don't have to wait 3 months to 
be able to get access to this care? And how do we make sure 
that rural communities are not left behind?
    Dr. Frank. Thank you for that question. As you probably 
know, Secretary Burwell, being from a rural area herself in 
West Virginia, where the opioid abuse and mortality rates are 
very high, is extraordinarily sensitive to these issues. And 
one of the things that is behind our new grant program putting 
$100 million into community health centers to increase access 
to buprenorphine is to actually get more services, more people 
trained into the areas of high need and low availability. And 
so that is a major thrust of what we are doing there.
    The other is to sort of revisit our rulemaking on access to 
buprenorphine and other medication-assisted treatments so that 
we can increase the number of doctors, potentially increase the 
physician capacity to treat opioid use disorder.
    Mr. Lujan. And, Dr. Frank, can you quickly touch on the 
importance of how we should consider giving States flexibility 
when it comes to treatment programs? There is a program in a 
little community in my district in Espanola called Inside Out 
that talks about the length of time that it takes to get 
treatment. And many judges in New Mexico are requiring 6-month 
treatment programs. There aren't very many 6-month treatment 
programs, and the only ones available are if you get 
incarcerated. So we are spending money to put someone in jail 
and not putting that money into treatment for these individuals 
that are addicts.
    Dr. Frank. Yes, thank you for that question. Actually, I 
have been there, and I think that it is important. And in fact, 
the reason that we are using grant mechanisms is in part to 
allow us to kind of match the interventions and match the 
strategies to the local needs, and in particular, making sure 
that the patient is at the center of what we do, and their 
circumstances kind of dictate the way we put the treatment in 
place.
    Mr. Lujan. Inside Out also makes the important point, as we 
have talked about, naloxone or Narcan, that -- what can we do 
to make sure that that is readily available? It is about the 
safest substance, as we talk about these treatments, that 
someone can take. Is there a push or can Congress do something 
to make that available over-the-counter, as opposed to not 
being a prescription mechanism? Because of some of these 
addicts, you know, when there is an emergency or an issue, you 
have to go try to get a prescription. They need it then and now 
to save their lives. What are your thoughts, sir?
    Mr. Botticelli. As you indicated, increasing access to 
naloxone by anyone who is in a position to reverse an overdose 
has been a particularly important priority for us. We have been 
working with law enforcement across the country, have really 
been heartened to do that. We have been significantly heartened 
by the number of States, including New Mexico, that have passed 
naloxone distribution efforts.
    We are continuing to support, and will in the President's 
fiscal year 2016 budget, a naloxone purchase. SAMHSA sent out a 
letter to States saying that some of the existing grant 
structures can be used to support naloxone purchase. So that 
will continue to be a priority for us to look at how we 
increase the capacity for naloxone and look at supporting grant 
programs to look at increased naloxone purchase.
    Mr. Lujan. And, Mr. Riley, I am trying to do the math here. 
Everything that I read suggest that 90 percent of the poppies 
in the world are grown in Afghanistan, or the opioids are 
produced in Afghanistan. So that leaves 10 percent for the rest 
of the world, and it is grown in lots of places. Ninety percent 
of the heroin coming to the United States is attributed to 
Colombia and Mexico, with 50 percent going to one cartel. So am 
I to understand that with less than 10 percent production, or a 
fraction of that production, Mexico and Colombia are growing 
their own poppies that lead to 90 percent of heroin that is 
coming to the United States? Or is there opium coming from 
Afghanistan to Mexico and to Colombia that is making its way to 
the United States? And if that is the case, how do we stop it?
    Mr. Riley. Well, I can tell you that the majority of the 
opium and heroin produced in the Afghanistan theater is 
destined for China, Russia, and Europe. We see as little as 5 
percent in the United States. But clearly, between the 
Colombians' criminal organizations and the Mexican criminal 
organizations, they control virtually all of the heroin 
available across our country.
    And what are we doing to ensure that--I go back to the 
cooperation that we have, sharing intelligence information, 
making sure that we work on organizations. For us to be 
successful, we have to stop the street level, which leads to 
violence, but at the same time, we have to ensure that we 
follow those cases wherever they take us, whether it is into 
Central/South America, working with our counterparts overseas, 
our agents on the ground to stop it at the source, and at the 
same time, to go after the reason they are in business, and 
clearly that is the profit. And that is just as important a 
part of what we are doing. So are we getting better? I 
certainly feel we are, but as I said before, this is a 
marathon, not a sprint. We are in it for the long haul, but we 
need everybody's help.
    Mr. Pitts. The gentleman yields back. The Chair recognizes 
the gentlelady, Mrs. Brooks, from Indiana, 5 minutes for 
questions.
    Mrs. Brooks. Thank you, Mr. Chairman. And thank you all for 
your work on this issue. Mr. Botticelli, as I mentioned in my 
opening and as you also talked about, we have an issue with 
respect to the prescribing practices beginning with medical 
school education, or not just with med schools because it is 
not just physicians who are prescribers, there are a whole 
category of healthcare providers who are prescribers.
    In ONDCP's 2011 report 4 years ago, it was epidemic, 
responding to America's prescription drug crisis, and one of 
the issues in that report was that we were going to encourage 
medical and health professional schools to continue expanding 
their continuing education programs to include instruction on 
measuring pain and prescribing to treat it. What efforts have 
been made since 2011, if not before, with our medical education 
schools? Because I talked to our med school in Indiana just a 
couple of months ago and still yet less than 5 hours, if even 3 
hours, of education is dedicated to those who are prescribing. 
What is the resistance? Why are our medical education 
providers, not just for physicians, but for nurses and for 
nurse practitioners and others, what is the resistance, and why 
haven't we gotten that done?
    Mr. Botticelli. There are two issues that you and Dr. 
Bucshon have articulated, and I think one is getting to the 
root cause about how do we make sure that healthcare providers, 
not just physicians but nurses, have embedded in their training 
programs good information on substance use disorders and safe 
prescribing? We have actually been working with the American 
Board of Addiction Medicine and all of the specialty medical 
societies and the AMA, as well as the deans of medical schools 
to look at embedding good medical education as part of----
    Mrs. Brooks. OK.
    Mr. Botticelli [continuing]. Their curriculum.
    Mrs. Brooks. Excuse me for interrupting, but why hasn't it 
been done yet, when we have known for now a number of years 
this has been a problem? You all identified it at least in 
2011, if not before. What is their resistance in embedding it 
in their curriculum this academic year? Why isn't it there yet?
    And what do we need to do with our State medical 
associations, with the medical school associations, and so 
forth, what do we need to do to get it embedded in education 
initially? Healthcare providers don't want to be helping cause 
the problem, but yet when they give a 30-day prescription for a 
pain med after a minor procedure when you might need 4 to 6 or 
7 days--I don't know, I'm no doctor--why do we give 30 days of 
prescription? Why are the med schools resistant?
    Mr. Botticelli. Having been doing this for quite a while, I 
think there has been just an overall hesitancy and resistance 
to think about substance use disorders as part of someone's 
overall health conditions, and not seeing the impact of what we 
are seeing. You know, when we look at referrals to treatment, 
only 7 percent of referrals to treatment are coming from our 
healthcare providers. And I think we will continue to pursue 
opportunities not just to embed medical education but look at 
the testing requirements of those medical educations to make 
sure that we are having competencies as part of medical 
examinations.
    And this is why I think, you know, being into this epidemic 
why we have been calling at least for mandatory education. We 
have seen States--about 10 States have passed medical education 
laws as it relates to pain prescribing, and we are seeing some 
remarkable results.
    Mrs. Brooks. Excellent. Could you please provide us with 
the list of which 10 States have done that? Because that is 
something that I would like to explore further.
    Mr. Botticelli. Happy to do that.
    Mrs. Brooks. Mr. Riley, I want to thank you for your many 
decades of service with the DEA. I am a former U.S. attorney 
from 2001 to 2007. Crack cocaine was the epidemic of the day in 
the '80s, '90s, and early 2000s, but it has obviously shifted. 
And I am curious, because the synthetic drugs that are coming 
into this country, you said in your written testimony, is 
primarily from China. And while we have this unprecedented--I 
am curious about the unprecedented cooperation with Mexico. 
Really? I would like to know a little bit more about why is it 
so much better now than it was 5 years ago? And how is China 
cooperating with us with respect to synthetics?
    Mr. Riley. Thank you, ma'am. In terms of China, we are 
beginning to make inroads there. It has been a tough road. Many 
of the synthetic drugs that are seized here are very difficult 
to origin, and that is by design. But we have made inroads. We 
have had several high-level meetings with the Chinese on this 
issue, dating back, I think, several years ago. So this is an 
ongoing dialogue.
    Part of our issue there, as it has been in Mexico, is to 
make sure both the Mexican authorities and the Chinese 
authorities understand the damage that it is doing in the 
United States. In terms of our Mexican partnerships, I was the 
agent in charge of El Paso in the mid-2000s when Juarez was 
aflame, thousands of drug-related homicides.
    We have really developed a working relationship with part 
of the Mexican authorities, not all of them, unfortunately. But 
we have developed a working relationship that is based off 
trust, that is based off productivity, and I think they 
understand the importance that they can play, in both their own 
country and around the world. Our extraditions continue to be 
strong. Just a couple of weeks ago we were able to pull out two 
very high-level targets that, I got to tell you, 5 years ago I 
don't think they would have even consider doing it.
    So it is an ongoing process, ma'am. It is what keeps me up 
at night. I am really 35 years old, but this is what it has 
done to me. And I give you my word, around the world, our guys 
24/7 are on it, because it truly is the new face of organized 
crime.
    Mrs. Brooks. Mr. Chairman, before I yield back, I just want 
to commend the agents of the DEA who I have worked with for 
quite some time, and they do remarkable work. There just aren't 
enough of them, and I don't think we give them all the tools 
they need. And with that, I yield back.
    Mr. Pitts. The Chair thanks the gentlelady, and now 
recognizes the gentleman from Massachusetts, Mr. Kennedy, 5 
minutes for questions.
    Mr. Kennedy. Thank you, Mr. Chairman. Mr. Riley, a couple 
of questions to start with. Mrs. Brooks and Mr. Lujan touched a 
little bit on the origins of the opium trade and heroin trade 
internationally, and I was wondering if you could quantify, to 
the best of your ability, the total dollar figure, if you will, 
between the U.S. and Mexico for heroin.
    Mr. Riley. Well, that is very difficult to do, but I can 
tell you it is in the billions.
    Mr. Kennedy. Order of magnitude? Just so -- and I don't 
mean to pin you down too much, but a billion, 10 billion, 100 
billion?
    Mr. Riley. Definitely close to 50 billion. And I quantify 
that by saying just in Chicago, where I was the agent in charge 
and heroin has exploded in the last several years, it was 
billions of dollars when we really drilled down on it. And I 
think that is what is really important. And if you look at New 
England in particular, you are seeing this spread of violent 
organized crime, urban, in terms of street gangs, and their 
ability to interface almost as unwitting contractors with 
Mexican organized crime to put heroin on the street, to make it 
available and obviously causing violence. I mean, the way these 
organizations regulate themselves, sir, is with the barrel of a 
gun. And I think it has caused tremendous damage across the 
country.
    Mr. Kennedy. And, Mr. Riley, thank you, and thank you for 
your service. I want to touch on two other things. I just 
commend you briefly for bringing back, first off, the take-back 
days, and one day back on April 26 of 2014 Massachusetts 
residents alone, in a single day, dropped off nearly 23,000 
pounds of drugs. And I believe nationally the figure was 390 
tons in a single day. I think they are a tremendous asset for 
our country, and I appreciate you bringing them back.
    I also want to thank you for your work with New England 
around the HIDTA designation, the high-intensity drug 
trafficking area. It has helped with critical resources for law 
enforcement in the region, and I want to thank you and commend 
you for that.
    Mr. Frank, I wanted to touch base with you a little bit if 
I can somewhat briefly, my apologies. There are three FDA-
approved medications for treatment of opioid dependence: 
methadone, buprenorphine, and naltrexone. I am interested in 
learning a little bit more from you about methadone, if you 
will. So could you describe a little bit about how methadone is 
used to treat individuals with opiate dependence?
    Dr. Frank. So methadone is a very powerful drug. It is a 
controlled substance. It is provided in a very controlled 
setting, so-called OTP, opioid treatment programs, that are 
very comprehensive. They provide the dose in person on the day. 
They provide counseling, they provide drug testing, they 
provide patient monitoring. And I think I said earlier that the 
reason that this is done is because the dosing and the 
management of methadone, particularly at the beginning of a 
treatment episode, must be done very carefully or risk 
mortality.
    Mr. Kennedy. And there are special restrictions on the 
ability to prescribe methadone?
    Dr. Frank. Yes, there is.
    Mr. Kennedy. And what are they, briefly, if you can?
    Dr. Frank. They have to be done within those programs, 
those certified programs.
    Mr. Kennedy. And are those requirements applied to 
treatment of individuals with opiate dependence with naltrexone 
or buprenorphine, or is the regulatory schema different?
    Dr. Frank. Yes, the regulatory schemes are quite different. 
The naltrexone sort of operates under the rules of DATA 2000 
and -- did I say naltrexone? I meant buprenorphine. And 
naltrexone is not a controlled substance, and so it can be 
prescribed by any physician.
    Mr. Kennedy. And is there a medical rationale to separate 
the way that those drugs are actually regulated?
    Dr. Frank. I think there is. As I said, I think there are 
unique risks, in, particularly, the early stages of methadone 
treatment. Buprenorphine, as we have noted, is a drug that is a 
controlled substance, and there is diversion of that drug. And 
because naltrexone is not a controlled substance, it can be 
more broadly prescribed. So I think there is a logic to it.
    Mr. Kennedy. So if I could squeeze one last question in 
here, do you think -- does that separation of that different 
regulatory environment make sense, or do you think bringing it 
all together and putting it under one -- basically abolishing 
the stovepipe regulations there makes sense, or is there 
rationale for keeping them separate?
    Dr. Frank. I think that even if you brought them together, 
you would see many of the same restrictions in place. I think 
that what we are trying to do is to particularly focus on 
buprenorphine right now, because I think that is an opportunity 
we have to rethink those rules so that we can expand access to 
MAT.
    Mr. Kennedy. Thank you very much, sir.
    Thank you, Mr. Chairman. I yield back.
    Mr. Pitts. The Chair thanks the gentleman. Because Dr. 
Murphy is chairing a hearing downstairs, Mr. Guthrie is 
yielding him his 5 minutes. Dr. Murphy, you are recognized.
    Mr. Murphy. Thank you, Mr. Chairman. I appreciate that. I 
wanted to be here because, although downstairs we are having a 
hearing on Volkswagen and devices put in cars that affect 
emissions testing, this is a life-and-death matter, so I wanted 
to be here.
    The first thing I wanted to ask, Mr. Chairman, I ask 
unanimous consent that this letter, signed by multiple members 
of the Energy and Commerce Committee, be submitted into the 
record. It was sent today to HHS and calls for a comprehensive 
review and additional rules on buprenorphine providers before 
HHS unilaterally lifts the DATA provider cap.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Murphy. Thank you.
    Now, I just want to make sure none of you are physicians, 
none of you are people who are involved in the treatment of 
people with addiction disorders. Am I correct?
    Mr. Botticelli. [Nonverbal response.]
    Dr. Frank. [Nonverbal response.]
    Mr. Riley. [Nonverbal response.]
    Mr. Murphy. OK. But you are involved with policymaking on 
these issues, correct?
    Mr. Botticelli. [Nonverbal response.]
    Dr. Frank. [Nonverbal response.]
    Mr. Riley. [Nonverbal response.]
    Mr. Murphy. OK. I am a psychologist. I have dealt with 
people with addiction disorders. And I want to start off by 
saying one of the problems we have in this country is that 
money that is sent to States that is being used for mental 
health funding for block grants and substance abuse block 
grants are not allowed to be used together. The serious problem 
that comes with that is many people with substance abuse 
disorders also have mental health disorders,, and yet we create 
a barrier there.
    Now, we are talking about increasing the number of 
prescriptions a physician can write. Dr. Frank, do you know how 
many--so we are talking about someone going from like 30 or so 
a month, a week, a day? What is it? Up to----
    Dr. Frank. Thirty patients at any one time.
    Mr. Murphy. Up to 100, and they can potentially go beyond 
that. Do you see a maximum with that?
    Dr. Frank. Right now, there is a limit to 100 after a year.
    Mr. Murphy. Right, but after that, they are looking to do 
more, to lift that cap, right?
     Mr. Frank. We are in the process of sort of reviewing the 
best way to expand access, and we are going to do it very 
cautiously.
    Mr. Murphy. I understand that. To what number?
    Dr. Frank. We don't have a number yet.
    Mr. Murphy. OK. Now, throughout this process -- and you 
recognize that buprenorphine is the third-most diverted drug. 
That is people get it and they sell it, and they make money and 
then they will go out and buy heroin or something else. What 
attention is being given to make sure that doesn't happen?
    Dr. Frank. That is exactly why we are taking a careful 
approach, because of that concern. But let me give you an 
additional concern. So we want to expand access. We are 
concerned that too often you don't get the full package of 
services, the counseling, the supports, and in the testing and 
monitoring, and so we want to make sure that the evidence-based 
package is in place and that the risks of diversion are 
minimized. And so what we are trying to do is to collect 
evidence about where are the places, and under what conditions 
are you most likely to be able to significantly expand capacity 
while minimizing the risks of diversion, and maximizing the 
probability that evidence-based treatment will be provided.
    Mr. Murphy. So let me ask about some of those. How much 
time do you think the average amount of time is that one of the 
physicians who is prescribing will actually be face to face 
with a patient?
    Dr. Frank. I think that----
    Mr. Murphy. Well, let me put it this way: Is that something 
that will be assessed?
    Dr. Frank. Yes. Well, we want to consider sort of what it 
takes and what are the environments that get you combination of 
treatments, so that means you have to have the counseling, you 
have to have the----
    Mr. Murphy. Right. Well, let me go into just a couple 
things. I talked to one clinic and they said the average amount 
of time physicians may spend actually discussing and 
prescribing is about one and a half minutes. Now, during that 
amount of time, you have to assess those very things. Is this a 
diversion issue? Is the person in recovery? Are they seeing a 
counselor or therapist? Are they really engaged in treatment?
    And also then in many of these cases the person who is 
perhaps the addictions counselor does not even communicate with 
the physician, except maybe to write a note in the chart in 
treatment. Or they may have someone there in some places where 
it is a nurse or someone sitting in the waiting room, and while 
people are there waiting for their prescription, they have a 
chat and they write that down as group therapy. You are aware 
that some of these things take place. Knowing you, I would 
assume you would be as distressed as anyone to say that is not 
tolerable, that is not treatment. And such people not only 
should not have expanded prescription privileges, they should 
have zero.
    Dr. Frank. I completely share your concerns, but even more 
importantly, Secretary Burwell shares those concerns.
    Mr. Murphy. Yes, she does.
    Dr. Frank. And she has emphasized sort of a careful 
approach to make sure that both the evidence-based treatment 
and the risk of diversion are addressed carefully.
    Mr. Murphy. One more final thing in my final seconds here, 
I know Secretary Burwell is dedicated to this, too, but I am 
also concerned that the amount of training that these 
physicians get, deal with addictions, is minimal. Very few of 
them are actually addictions counselors, addiction trainers, 
and many times other people there have minimal training.
    In my area of southwestern Pennsylvania I have heard 
proctologists, plastic surgeons, pediatricians, and others who 
do not have extensive board certification in these things. I 
think it is a dangerous issue for something that is growing as 
a deadly issue in America. And I hope we can continue our 
conversation. I want to work with you on this, but we are all 
concerned that just expanding the number of prescriptions can 
be written without total assurances of other things is a 
dangerous issue. Thank you. And I yield back.
    Dr. Frank. And we thank you for your support and agree.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes 
for questions.
    Mr. Sarbanes. Thank you, Mr. Chairman. I want to thank all 
of you for being here today. I have introduced the Co-
Prescribing to Reduce Overdoses Act, which would create a 
demonstration project to encourage co-prescribing opioid 
overdose reversal drugs like naloxone.
    So let me talk a little bit about the need first, which you 
all are very familiar with. Over 100 Americans every day are 
dying from preventable drug overdose, and that kind of fatality 
is now the leading cause, the leading cause of accidental death 
in the country. In 2013, more than 16,000 people died due to 
prescription opioids overdose, and an additional 8,000 died 
from heroin overdose. In Maryland, we are having the same 
experience. We had 192 heroin overdoses in the City of 
Baltimore, in Anne Arundel County, which I also represent. 
There were 49 fatal overdoses from opioids, and that was part 
of 360 overdoses overall that occurred.
    So this is an epidemic. There is no question about it. And 
we have to put real resources behind it. We have to put it 
behind workable and strategic solutions that we can identify. I 
will mention that, today, the State of Maryland released a 
$680,000 grant from the U.S. Department of Justice to help 
address this epidemic in our State.
    Let me talk about naloxone now. It is a drug that safely 
and effectively reverses both opioid and heroin-induced 
overdoses if administered in time. It has been used by 
nonmedical personnel with only minimal training for over 15 
years and has been proven to reduce lower overdose mortality by 
almost 50 percent. More people need access to lifesaving 
medication, obviously.
    And while efforts to distribute naloxone to first 
responders and community organizations are important, and we 
have talked about that today, it is critical that we also take 
a more proactive approach. One idea, one part of that proactive 
approach is the idea of co-prescribing naloxone to patients who 
are taking opioids and are at high risk of overdose. And this 
is supported by the American Society of Addiction Medicine, the 
American Medical Association, the Veterans Health 
Administration.
    The bill that I have introduced, the Co-Prescribing to 
Reduce Overdoses Act, would create a demonstration project for 
federally qualified health centers, opioid treatment centers, 
and other providers to encourage co-prescribing naloxone. Funds 
could be used for training to purchase opioid overdose reversal 
drugs, to offset copays, and to conduct community outreach and 
raise awareness to connect patients who have experienced a drug 
overdose with appropriate treatment, and track individuals that 
are participating in the program. And all grant recipients, of 
course, would be required to evaluate the outcomes of the 
program.
    A second program would allow States or local health 
departments to develop guidelines on co-prescribing opioid 
overdose reversal drugs like naloxone. So there is no question 
that opioid overdose is a public health epidemic. I believe 
strongly that increased access to naloxone, particularly this 
co-prescribing opportunity to patients at high risk of 
overdose, is a key element of any approach to successfully 
decrease prescription drug and heroin overdoses.
    I would like to get the thoughts of the three members of 
the panel, certainly Mr. Botticelli and Dr. Frank, on this 
question of whether co-prescribing naloxone is an effective 
strategy that we should try to encourage and support going 
forward.
    Mr. Botticelli. Thank you for your leadership on this 
issue. I don't think we could agree with you more in terms of 
the opportunities that we have for supporting co-prescribing in 
a wide variety of settings, and particularly for people who are 
at highest risk.
    We share your goals. We have actually continued to take 
action to support co-prescribing. We have hosted webinars with 
the American College of Emergency Rooms Physicians to support 
co-prescribing. We continue to work with our treatment programs 
to encourage co-prescribing. So this is, I think, a 
particularly important area for people who are at high risk.
    Our overall policy goals are to ensure that anyone who is 
at high risk for an overdose also has access to naloxone. It 
has been truly remarkable in terms of its ability to save lives 
and actually motivate many people to go seek care and 
treatment. So we would love to continue to work on that to look 
at that legislation.
    Mr. Sarbanes. Dr. Frank, I have 15 seconds if you have a 
comment. Yes.
    Dr. Frank. Yes. I obviously am not going to say what he 
said, but there are some things that you need to do to go along 
with co-prescribing and other measures to really expand supply 
here, and one of them is making sure that we have user-friendly 
versions of naloxone so that non-medically trained people can 
administer it. Two, I think we need to make sure that once 
somebody gets naloxone, they get the treatment. Just recovering 
and walking away isn't the right thing to do. We have to get 
them to see----
    Mr. Sarbanes. No, it is the first step is what you are 
saying.
    Dr. Frank. It is the first step, and it is an important 
first step----
    Mr. Sarbanes. Yes.
    Dr. Frank [continuing]. But we would like to complement 
that with links to treatment.
    Mr. Sarbanes. Great. Thank you. I yield back.
    Mr. Pitts. The Chair thanks the gentleman. The Chair 
recognizes Mr. Lance, 5 minutes for questions.
    Mr. Lance. Thank you, and good morning to the panel. And, 
Mr. Riley, did you say you are 35 years old? Is that what you 
said?
    Mr. Riley. Yes.
    Mr. Lance. Yes, I am 35 as well, but what keeps me up at 
night is leadership elections. You discussed challenges in 
carrying out a criminal prosecution pursuant to the Federal 
Analogue Act. It is my understanding that there is a very high 
burden of proof to establish that a compound is in fact a 
controlled substance analogue. Could you please elaborate on 
that standard and what changes can be made to the Analogue Act 
that would make it more effective as a tool in combating the 
spread of synthetic drugs?
    Mr. Riley. Well, first of all, just the mere amount of 
these synthetic drugs that we are encountering is mind-
boggling, and our ability to test those through our scientific 
arm and get an identifier on them sometimes is very prolonged. 
So what we are doing now is we are really trying to look at how 
can we be effective? What is the best possible way that we can 
move this process along? But I have got to be honest with you. 
We are not one step behind the bad guys, we are three steps 
behind the bad guys.
    Mr. Lance. Thank you. Is there anyone else on the 
distinguished panel who would like to comment on this?
    Mr. Botticelli. I completely agree. I think it has been a 
challenge from both a prevention standpoint and a scientific 
standpoint to stay ahead of the chemical tweaks that 
manufacturers make to do that. I think that opportunities to 
lower the burden of proof around scheduling, around these 
analogues are important. I think despite Congress and States' 
best attempts to deal with this issue, that look at expediting 
the scheduling and thinking about the criteria with which we 
schedule those drugs is particularly important.
    Mr. Lance. Thank you. Director Botticelli, as you mentioned 
in your testimony, New Jersey, where I live, is one of a 
handful of States that requires greater use by prescribers of 
the State's Prescription Drug Monitoring Program. Specifically, 
Governor Christie recently signed into law a requirement for 
prescribers to check the program and patients returned for a 
second resale on a prescription opiate. What is your office 
doing to ensure that both State officials and prescribers are 
able to utilize effectively their Prescription Drug Monitoring 
Programs?
    Mr. Botticelli. So I will start, and I know that this is an 
important initiative for the Secretary, too, so there is more 
action.
    Mr. Lance. Certainly.
    Mr. Botticelli. When this administration started, we had 20 
PDMP programs, 20 States. Today, I am happy to report that we 
have 49 States that have Prescription Drug Monitoring Programs. 
We continue to focus opportunities on increasing the interstate 
operability so that we can share information across State lines 
but also increase the utility and usability of these programs. 
And I will defer to Dr. Frank on that.
    But one of the things that I think we are seeing promising 
practice, and particularly in States that require some level of 
mandatory check of their Prescription Drug Monitoring Program, 
we are seeing a decrease--in Florida, we saw a significant 
decrease in overdose deaths, and we have seen a significant 
decrease in doctor-shopping, people going from one doctor to 
another to get their medications when we have good, robust 
Prescription Drug Monitoring Programs.
    Mr. Lance. Thank you. Dr. Frank?
    Dr. Frank. Thank you. This here, we are investing $20 
million in State grants really to focus on improving 
Prescription Drug Monitoring Programs in the States. We have a 
proposal in for 2016 to put in 45 million in order to bring it 
to all 50 States. And we are hoping to build off the progress 
of some very successful pilots in addition that have integrated 
Prescription Drug Monitoring Programs in clinical health 
information technology.
    Mr. Lance. Thank you very much. And, Mr. Chairman, I yield 
back the balance of my time.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from New York, Mr. Engel, 5 minutes 
for questions.
    Mr. Engel. Thank you, Mr. Chairman. You know, gentlemen, 
first of all, thank you all for excellent testimony. Really, 
all of you have just been terrific. And, you know, through my 
perch on the Foreign Affairs Committee when I was chairman of 
what we called the Western Hemisphere Committee, which dealt 
with Latin America, and we did a lot of work involving the drug 
trade in Mexico and some of the other places. And we fund money 
for treatment programs and we fund a lot of money to go after 
the bad guys, but so much of the consumption comes from us that 
I have always felt that we didn't do enough in terms of 
education, and in terms of that side of it rather than going 
after the bad guys after they have done it.
    And the one thing that is stark for me is that there are so 
many people in this country that use drugs. I mean it is just 
mind-boggling. And young people, because when you are young, 
you think you are going to live forever and you think nothing 
is going to happen to you and so you are more likely to 
experiment, but this is an epidemic. I mean, this is just 
beyond the pale. You know, I don't make judgments on anybody, 
but I just know that we can't continue like this. I mean, we 
have got to do a better job of educating people and letting 
them understand that this is a life-ruining situation.
    And you have really driven the point home, all three of 
you, about it. I mean I have some other questions to ask, but 
in general, I think, you know, if you could expand on that 
because it is really just shocking, the extent of the abuse. 
And so not only are we keeping these criminal enterprises 
going, but we are destroying lives of American citizens.
    Mr. Botticelli. I will start. Thank you, Congressman, for 
your comments. I think, yes, what you have described is the 
entire approach, the Obama administration's view of drug policy 
that, while supply reduction and law enforcement has a big role 
to play, that we need and will continue to pay more attention 
to prevention, treatment, and recovery efforts for people here 
in the United States. If you look at our entire drug control 
budget, we are actually spending now more on those public 
health strategies than we have had during the entire time of 
our office, so this is particularly important.
    I will say, however, that I think our heroin situation is a 
good example between the nexus of supply and demand, that 
because of the purity levels, because of the price, because of 
the widespread availability of heroin that we have, it really 
does combine both a public health and public safety approach. 
And I have really been heartened, as I travel around the 
country, to see law enforcement and police wanting to partner 
with public health to really come up with holistic strategies, 
knowing that arrest and incarceration are really ineffective in 
dealing with this issue.
    Mr. Engel. You know, every time I see a young person smoke 
a cigarette, a regular cigarette, I think to myself, you know, 
why are they doing this? Because we have evidence now that we 
didn't have maybe when I was a kid that regular smoke just is 
terrible for your health. And you think, well, why would a 
young person do that? We are not getting through. And of course 
when you take it a notch up and you are talking about heroin or 
prescription drugs, it is that much worse. So we are failing as 
a society, and it is just shocking.
    So let me ask you, Dr. Frank. The bill proposed by 
Congresswoman Brooks and Congressman Kennedy tasks an 
interagency coalition with developing best prescribing 
practices, and it is certainly needed. My district -- New 
York's Lower Hudson Valley contains a portion of my district, 
and according to the New York State Office of Alcoholism and 
Substance Abuse Services, the number of New Yorkers admitted to 
hospitals on account of heroin skyrocketed 136 percent between 
2004 and 2013, and in 2013 alone, nearly 90,000 New Yorkers 
were admitted to hospitals for heroin and prescription opioid. 
This is shocking. It is absolutely, absolutely shocking.
    So given how varied the populations affected by this 
epidemic are, how would you, Dr. Frank, suggest that we ensure 
that any best practices created as a result of this bill or 
other bills will suit physicians and patients from contrasting 
backgrounds? You know, I worry about a one-size-fits-all 
approach. Do we need to tailor best practices to different 
populations?
    Dr. Frank. Thanks for that question. Our approach is very 
much aimed at two things. One is matching policies to context, 
locally, but also matching patients to actual treatments, and 
we want to do both. And so, for example, just a couple weeks 
ago we had a 50-State convening where we brought all the States 
together, all 50 States and the District of Columbia together, 
to talk about how to share best practices.
    And what we did is we had breakout sessions where we had 
regional breakouts, so in fact people who bordered one another 
could talk about sort of common approaches that met their 
particular circumstances. Likewise, we try to have a full 
armamentarium of treatments available so that we can match 
patients and their circumstances in the best possible way, and 
our mechanism for doing this is largely grant support through 
the States.
    Mr. Engel. Thank you. Thank you all. And, Mr. Riley, thank 
you for all you do.
    Mr. Pitts. The Chair thanks the gentleman. The gentleman 
yields back. Without objection, the Chair recognizes Mr. Tonko, 
a member of the full committee, who wishes to ask questions for 
5 minutes.
    Mr. Tonko. Thank you, Mr. Chair. As I mentioned in my 
opening statement, access to effective addiction treatment is 
the biggest obstacle we face today in preventing more deaths in 
this epidemic. We know that nearly 80 percent of persons with 
an opioid addiction do not receive treatment. While the reasons 
for these gaps are multifaceted, it is clear that capacity in 
our current treatment system play some role.
    A study published recently in the American Journal for 
Public Health estimated a gap between treatment need and 
treatment capacity between 1.3 and 1.4 million individuals in 
the year 2012. This is why I joined with my colleagues in 
introducing the TREAT Act, which would raise the arbitrary cap 
on buprenorphine prescribing for certain providers and allow 
physician assistants and nurse practitioners the ability to be 
waivered providers.
    As such, I was very encouraged by Secretary Burwell's 
announcement to start the rulemaking process to address opioid 
addiction and specifically addressed treatment hurdles such as 
the DATA 2000 caps. Dr. Frank, what is the expected time line 
and process for this rulemaking change?
    Dr. Frank. You are not going to like this answer, but we 
are going to move as fast as we can. But I can guarantee you 
that this is extraordinarily high on my office's agenda and the 
Secretary's agenda, and literally, we are meeting every week to 
kind of get this pushed through.
    Mr. Tonko. Thank you. And, Director Botticelli, we have 
heard a number of concerns expressed today over the diversion 
of buprenorphine. Is that the most commonly diverted opioid?
    Mr. Botticelli. I will defer to my DEA partners on this in 
terms of diversion. I would suspect that probably 
pharmaceutical opioids are far more diverted than----
    Mr. Tonko. Pharmaceutical?
    Mr. Botticelli [continuing]. Buprenorphine diversion.
    Mr. Tonko. OK. And what actions does the administration 
recommend to address that diversion?
    Mr. Botticelli. Part of, I think, what we need to look at--
and I have to be careful not to get ahead of the HHS rulemaking 
authority here--but I think that looking at how we can continue 
to support access to buprenorphine and other medications but 
also being mindful of ensuring quality treatment and minimizing 
diversion become really important. And I think you have heard a 
willingness on the part of the administration to work with 
Congress on how do we strike that balance as we move forward, 
thinking about how many people who can prescribe, what is the 
quality care setting that we can do it. I have seen models 
across this country where we have been able to expand the 
number of people who get access to medications through a wide 
variety of, I think, really innovative State practice. And I 
think we can use some of that thinking and some of that 
guidance to help with the process about how we go forward.
    Mr. Tonko. Let me ask you, Director Botticelli, why do you 
think we make it so much harder for individuals to get the 
treatments that help them recover than the drugs that get 
people addicted in the first place?
    Mr. Botticelli. I think there is a wide variety of -- you 
know, both as a person in recovery and as someone who has been 
doing this for a long time, I think stigma plays a huge role. 
And I think, quite honestly, that we had viewed people with 
addictive disorders and their families as less deserving of 
care, and I think for a long time public policy has reflected 
that. And I think now with the opioid epidemic I think we are 
finally understanding some of the long-standing issues that we 
have had in this country as it relates to how we have treated 
people with addictive disorders. I think that is why our jails 
and prisons, quite honestly, unfortunately, our de facto 
treatment programs, that we viewed people with addictive 
behaviors as morally flawed or bad people. And I don't think we 
have seen them as deserving as a response, as people with a 
disease.
    Mr. Tonko. Well, I think all of you gave powerful 
testimony, and it reminds us that we need to see addiction as a 
disease. And until we do, we won't get the results we require. 
And finally, Director, does the administration support 
mandatory prescriber education on pain management and substance 
use, prior to an individual being able to prescribe controlled 
substances?
    Mr. Botticelli. We do and we look forward to working with 
Congress in terms of how we might make that happen.
    Mr. Tonko. And there are things that Congress can do to 
help with that effort?
    Mr. Botticelli. Absolutely.
    Mr. Tonko. And you will direct us?
    Mr. Botticelli. And we look forward to working with you on 
that.
    Mr. Tonko. Absolutely. I thank you all again for your 
testimony. It, I think, was very instructive. And with that, 
Mr. Chair, I will yield back the balance of my time.
    Mr. Pitts. The Chair thanks the gentleman. That concludes 
the questioning of members present. We have had members going 
in and out all morning because we have another hearing on 
Energy and Commerce being conducted downstairs, so I apologize 
for that.
    But I want to thank the first panel of witnesses. This is a 
very important issue and we look forward to working with each 
of you as we proceed on the legislation. And we will have some 
follow-up questions, so we will send those to you in writing. 
We ask that you please respond promptly. I remind members that 
they have 10 business days to submit questions for the record. 
Members should submit their questions by the close of business 
on Thursday, October 22. I have a U.C. request, a statement for 
the record, on behalf of the Opioid Treatment Program 
Consortium. Without objection, so ordered.
    Mr. Pitts. The subcommittee will stand in recess until the 
week of October 20, when we will convene our second panel on 
this issue.
    The subcommittee stands in recess.
    [Whereupon, at 12:02 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

                 Prepared statement of Hon. Fred Upton

    Today we will discuss several important bipartisan 
legislative proposals aimed at addressing the drug abuse crisis 
that is sadly unfolding in communities in my home State of 
Michigan as well as across the country. These bills and this 
hearing build upon the solid foundation laid by the Oversight 
and Investigations Subcommittee, which has held several 
hearings and meetings and heard from two dozen witnesses, 
including from the Federal Government, our partners in the 
States, and a wide range of health professionals and addiction 
specialists. They spoke about the root causes as well as the 
consequences of our nation's complex and growing opioid 
epidemic and about potential solutions.
    In addition to the O&I hearings, many of my colleagues on 
both sides of the aisle have participated in numerous 
discussions back home with impacted constituents and local 
leaders about the devastating effects this public health crisis 
is having on our communities. In August I participated in an 
event in St. Joe, Michigan, with various local leaders to 
discuss the devastating effects of prescription drug and heroin 
abuse that was gripping our community.
    There were 13 suspected overdoses in Kalamazoo in the first 
quarter of 2013, up from 9 in the first quarter of 2012. 
Opiate-related overdoses have recently become the number one 
cause of injury related death in Michigan and nationwide. This 
sad reality has hit hard at home in Kalamazoo County. In 2008, 
we lost Amy Bousfield, 18 years old and a graduate of Portage 
Central High School. In 2012, Marissa King died at 21 years 
old. She began using heroin in 2009, despite having lost two 
friends to the drug, including Amy Bousfield. This crisis does 
not discriminate between large and small, rural and urban, rich 
and poor. Now it is time to take what we have learned and begin 
making changes to help.
    We have learned that while addiction is not easy to treat, 
it is treatable, and we need to rise to this challenge for the 
sake of the American family. Mr. Botticelli sitting before the 
committee today is an example that this disease is beatable. He 
is a champion of the patient community. We thank you for your 
continued efforts.
    I commend those of you who have worked diligently on the 
legislation being discussed today and I look forward to 
continuing to learn about and work on these various bills. As 
we move forward, we must harmonize our efforts with the efforts 
already underway at the Federal and State levels, in order to 
take constructive and effective action, and I am committed to 
doing just that.

                 Prepared statement of Hon. Joe Barton

    Mr. Chairman, I am pleased that we will be marking up H.R. 
8, the North American Energy Security and Infrastructure Act of 
2015, H.R. 3242, the Child Nicotine Poisoning Prevention Act 
and reconciliation recommendations today.
    The reconciliation recommendations include three important 
parts. Section one repeals the Prevention and Public Health 
Fund, often referred to as the ``Obamacare slush fund'', which 
will result in a savings of $12.7 billion over 10 years. 
Section two prevents Federal Medicaid dollars from going to 
private entities that perform abortions, such as Planned 
Parenthood, for 1 year. Section three redirects these Medicaid 
dollars to Community Health Centers. We all support funding for 
quality and widely accessible women's health centers, and I 
believe this reconciliation recommendation will ensure women 
have access to care while protecting the unborn.
    I am pro-life because I believe that all life is precious 
and should be respected and I back that up with my vote. As a 
lawmaker, I have a constitutional and moral obligation to 
protect those who do not have the power to protect themselves. 
I will continue to fight in Congress for the unborn.
    In addition, I am glad that we are marking up HR 8 as well. 
As the chairman of the Conference on the 2005 Energy Bill, I 
appreciate all the hard work it has taken to get to this point. 
While I may not agree with every provision, I know that getting 
into conference is the only path to the President's desk. I 
hope that all my colleagues on both sides of the aisle feel 
that creating sound energy policy is in the best interest of 
our country and will support this process moving forward.

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you, Mr. Chairman, for calling today's hearing. I 
want to start by sharing a story from one of my constituents 
from Old Bridge, New Jersey. She has already lost one son to 
the drug abuse crisis and she is fighting to save her remaining 
son's life as he suffers from his own opiate dependence. Her 
younger son overdosed at the age of 21 and her older son--who 
was struggling with addiction when his brother died--continues 
that struggle.
    No mother should have to endure this tragedy--having 
grieved the loss of one son and being overwhelmed with worry 
that she could lose another to the opiate epidemic. I know such 
stories are not unique to New Jersey or my District. 
Unfortunately, most of us have heard similar stories from 
constituents, family members, or friends. Each day we are 
losing 44 people in the U.S. from overdose of prescription 
painkillers. We must take action to combat this epidemic.
    That is why I am pleased that we are holding this hearing 
on several bills to combat this drug abuse crisis. I strongly 
support efforts to expand access to substance abuse treatment 
services, increase access to overdose reversal medication, 
improve provider education, and increase public awareness of 
the problems of substance abuse.
    That is why I support H.R. 2536, H.R. 2805, H.R. 3680, H.R. 
3691, and I would like to thank Representatives Tonko, Kennedy, 
Sarbanes, and Lujan for their leadership on this issue. I 
briefly want to mention that I have concerns with the remaining 
substance abuse treatment bill--H.R. 2872, the Opioid Addiction 
Treatment Modernization Act. While I support the goal of 
expanding access to all FDA-approved medications for the 
treatment of opiate dependence and I support efforts to 
increase provider education and training generally--I believe 
we must pursue those goals in a way that does not undermine our 
efforts to expand access to substance abuse treatment services. 
I don't think H.R. 2872 strikes the right balance and, as a 
result, could harm access to care.
    There are also another two bills we will discuss today. 
H.R. 3537, which would place a number of synthetic drug 
substances on Schedule I of the Controlled Substances Act. Use 
of synthetic drugs has led to numerous overdoses and deaths, 
primarily among young adults. More must be done to eliminate 
the availability of these substances, and enable DEA to take 
appropriate enforcement action as H.R. 3537 strives to do. I am 
concerned, however, about whether the broad list of chemicals 
in the bill might include chemicals that can have legitimate 
research uses for developing important medical therapies.
    The other bill, H.R. 3014, would allow registered 
physicians to transport controlled substances away from their 
registered practice locations to other locations, such as team 
physicians traveling to a game out of State, or physicians 
responding to a disaster in a neighboring State. I hope to work 
with stakeholders to ensure that the proper safeguards are in 
place to address this problem and maintain access to drugs for 
patients only when needed.
    I look forward to hearing from all of our witnesses, and 
continuing the conversation about how to address the issue of 
substance abuse moving forward.

    [H.R. 2536, H.R. 3014, and H.R. 3537 have been retained in 
committee files and also are available at  http://
docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=104047.]

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   EXAMINING LEGISLATIVE PROPOSALS TO COMBAT OUR NATION'S DRUG ABUSE 
                             CRISIS--DAY 2

                              ----------                              


                       TUESDAY, OCTOBER 20, 2015

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 4:00 p.m., in 
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Guthrie, Shimkus, 
Blackburn, Bucshon, Brooks, Sarbanes, and Pallone (ex officio).
    Also present: Representative Tonko.
    Staff present: Clay Alspach, Chief Counsel, Health; Sean 
Bonyun, Communications Director; Leighton Brown, Press 
Assistant; Katie Novaria, Professional Staff Member, Health; 
Graham Pittman, Legislative Clerk; Chris Sarley, Policy 
Coordinator, Environment and the Economy; Adrianna Simonelli, 
Legislative Associate, Health; Sam Spector, Counsel, Oversight 
and Investigations; Heidi Stirrup, Policy Coordinator, Health; 
John Stone, Counsel, Health; Jeff Carroll, Democratic Staff 
Director; Eric Flamm, Democratic FDA Detailee; Tiffany 
Guarascio, Democratic Deputy Staff Director and Chief Health 
Advisor; Samantha Satchell, Democratic Policy Analyst; and 
Kimberlee Trzeciak, Democratic Healthy Policy Advisor.
    Mr. Pitts. Ladies and gentlemen, if you can take your 
seats, the subcommittee will come order.
    We are reconvening this hearing. We had the first panel a 
week ago, couple weeks ago, and this will be the second panel. 
So welcome back.
    For those of you just joining us today, today is the second 
day of our hearing to examine legislative proposals to combat 
our Nation's drug abuse crisis. On the first day of the 
hearing, which took place on October 8, we heard testimony from 
a panel of Federal witnesses representing DEA, HHS, and the 
Executive Office of the President. Today, we will hear from a 
number of distinguished doctors with a wide variety of 
expertise.
    On our panel today we have--and I will introduce them in 
the order of their presenting their testimony--first, Dr. Paul 
Halverson, Dean, Indiana University's Richard M. Fairbanks 
School of Public Health.
    Welcome.
    Secondly, Dr. Chapman Sledge, Chief Medical Officer, 
Cumberland Heights.
    Welcome.
    Third, Dr. Robert Corey Waller, Chair of the American 
Society of Addiction Medicine's Legislative Advocacy Committee.
    Welcome.
    Then, Dr. Kenneth Katz, Department of Emergency Medicine, 
Section of Medical Toxicology, Lehigh Valley Health Network.
    Welcome.
    And I don't see Dr. Allen Anderson yet, President of the 
American Orthopaedic Society for Sports Medicine.
    So thank you for coming. Your written testimony will be 
made a part of the record. You will each have 5 minutes to 
summarize your testimony, and after opening statements we will 
do the questioning.
    So, Dr. Halverson, you are recognized for 5 minutes for 
your summary.

   STATEMENTS OF PAUL K. HALVERSON, PH.D., DEAN, RICHARD M. 
FAIRBANKS SCHOOL OF PUBLIC HEALTH, INDIANA UNIVERSITY; CHAPMAN 
    SLEDGE, M.D., CHIEF MEDICAL OFFICER, CUMBERLAND HEIGHTS 
   FOUNDATION; ROBERT COREY WALLER, M.D., CHAIR, LEGISLATIVE 
  ADVOCACY COMMITTEE, AMERICAN SOCIETY OF ADDICTION MEDICINE; 
     KENNETH D. KATZ, M.D., SECTION OF MEDICAL TOXICOLOGY, 
DEPARTMENT OF EMERGENCY MEDICINE, LEHIGH VALLEY HEALTH NETWORK; 
 AND ALLEN F. ANDERSON, M.D., PRESIDENT, AMERICAN ORTHOPAEDIC 
                  SOCIETY FOR SPORTS MEDICINE

                 STATEMENT OF PAUL K. HALVERSON

    Dr. Halverson. Thank you, Mr. Chairman.
    Chairman Pitts, Ranking Member Green, Representative 
Brooks, thank you for the opportunity to testify today.
    I come before you today as both the founding dean of the 
Indiana University Richard M. Fairbanks School of Public Health 
at IUPUI as well as the former State health officer of Arkansas 
to discuss a very important and far-reaching public health 
issue: the heroin and prescription drug abuse epidemics and the 
deleterious effects which we are experiencing across the 
country and in my home State of Indiana.
    We know addiction is a tragedy not for the addicted person 
alone but also for families, employers, and entire communities. 
Addiction is often at the root of myriad social, physical, 
mental, and public health problems. It harms all in its path, 
even the most innocent among us.
    Newborns who have been exposed to opioids in utero are 
often born with a condition called neonatal abstinence 
syndrome. In the last 15 years, the number of affected babies 
is five times higher, mirroring the surge in opioid abuse over 
the same time period.
    The financial costs of drug addiction for health care, 
criminal justice, and education are staggering. In my State of 
Indiana alone, the costs are estimated at over $7.3 billion 
annually. Hospital charges for babies born with NAS were over 
$1.5 billion nationally in 2013.
    Opioid abuse is particularly pernicious because it is often 
a precursor to heroin use. SAMHSA found that nearly four out of 
five new heroin users took nonmedical prescription pain 
medication before taking up heroin.
    The end result: People are dying. CDC notes that 44 people 
die each day in our country from an overdose of pain 
medication. Nationally, heroin-related deaths have escalated 
over 39 percent between 2012 and 2013. And although mortality 
rates are up in many States in the country, Indiana is one of 
only four States where the rate of overdose deaths has 
quadrupled in 14 years.
    Indiana made the national news this past spring with its 
public health crisis related to opioid abuse. Scott County, a 
population of less than 25,000 people, had an unprecedented 
outbreak of HIV related to needle sharing among intravenous 
drug users injecting prescription opioids. To date, the number 
of new confirmed cases of HIV for 2015 exceeds 180 people. This 
numberis particularly alarming since the entire southeastern 
region of Indiana has never had more than five new cases 
annually prior to this year.
    In addition, significant cuts in already chronically 
underfunded public health infrastructure nationwide make 
communities even more vulnerable and frequently leaves them 
without important public health services, such as education on 
how to protect themselves against life-threatening diseases and 
access to confidential HIV testing and treatment, among other 
important services like epidemiology and outbreak investigation 
capacity. Indiana's public health system is particularly 
vulnerable, with our overall health ranking at 41 and our 
funding of public health services at 47 out of the 50 States.
    Between 2009 and 2013, this small, rural county led the 
entire State in both drug overdose deaths and nonfatal 
emergency department visits due to opioid overdose. It is also 
important to point out that there are numerous counties in 
Indiana and, frankly, throughout the country that are 
strikingly similar by virtue of their social and demographic 
characteristics as well as the fragile public health system 
capacity that exists.
    We are grateful to colleagues from the CDC for assisting 
our State health department, under the leadership of Dr. Jerome 
Adams, as they responded to and supported local public health 
and community leaders; and to Governor Pence for recently 
establishing an executive branch task force to focus State 
government agencies on the system issues surrounding substance 
abuse.
    In addition, our attorney general's longstanding 
Prescription Drug Task Force has been focused on the 
coordination and oversight of Indiana's prescription drug 
monitoring program, and its insight has been instrumental in 
developing legislative and policy-level recommendations.
    Lastly, I would like to acknowledge the support that the 
Richard M. Fairbanks School of Public of Health has provided, 
primarily through the leadership of Dr. Joan Duwve, who has 
tirelessly led and supported these efforts in our State.
    In spite of these important State efforts, though, 
additional national legislative efforts are needed. We are 
grateful to Representative Brooks and other members of the 
committee for shedding light on the very serious problems with 
opioid abuse and heroin use, which are becoming more pervasive 
with each passing day. It is clear we need to effectively 
attack these problems from a system perspective to prevent 
further destruction of our public's health.
    I applaud your efforts, and I am grateful for your 
dedication in addressing this important public health issue.
    Thank you, sir.
    [The prepared statement of Dr. Halverson follows:]

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    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Dr. Sledge for 5 minutes for your summary.

                  STATEMENT OF CHAPMAN SLEDGE

    Dr. Sledge. Thank you, Mr. Chairman. I want to thank this 
committee for holding this important hearing on legislative 
solutions to combat the worsening drug crisis in our country. 
Like all of us, I am deeply concerned as to what I see 
happening in regards to the opioid epidemic in particular, and 
I am grateful to have this opportunity to share my thoughts and 
experience.
    I am chief medical officer of Cumberland Heights, a 
private, not-for-profit addiction treatment center on the banks 
of the Cumberland River in Nashville, Tennessee. I previously 
served as medical director of addiction treatment services at 
Pine Grove Behavioral Health in Hattiesburg, Mississippi, and 
have been practicing addiction medicine for over 26 years.
    I am certified by the American Board of Addiction Medicine. 
I am a fellow of American Society of Addiction Medicine, and, 
from 2005 to 2009, I represented Mississippi, Alabama, Florida, 
Tennessee, and Kentucky on the board of directors of ASAM and 
served as secretary of the organization until 2011.
    Cumberland Heights has a 50-year tradition of treating 
addiction. We provide treatment to adult men and women as well 
as adolescents. Most of our patients are working-class and 
insurance-dependent, but we treat a fair number of patients 
with resources to self-pay, and we treat a fair number of 
patients dependent upon scholarships to provide their 
treatment.
    A watershed moment in my career as an addiction medicine 
specialist came around 2006 on a Saturday morning. I was making 
rounds on a detox unit with 25 beds, and I realized that every 
single one of those patients had a diagnosis of opioid 
dependence, and that was new to me. Some of those patients had 
other diagnoses, as well, but every single one of them had a 
diagnosis of opioid dependence. And, in fact, every single one 
of those patients was dependent upon prescription opioids.
    Our most common diagnosis at Cumberland Heights of the 
1,500 admissions per year has been opioid dependence, 
particularly in young adults. Tennessee leads the Nation in 
prescriptions for opioids per capita. And heroin addiction has 
become more and more prevalent as access to prescription 
opioids becomes limited through less abusable formulations, 
monitoring of controlled substance prescription databases, as 
well as education.
    The Tennesseean, Nashville's local newspaper, ran a cover 
story on the opioid epidemic last month. To quote, ``At least 
1,263 Tennesseeans died last year from opioid overdose, up 97 
deaths from 2003--a staggering statistic that points to growing 
abuse despite an array of measures to stem addiction. More 
people died in 2014 from opioid overdose in Tennessee than by 
car accidents or gunshots.''
    My expertise is based in direct patient care; I am an 
expert in what my patients disclose to me face-to-face in my 
office. Almost all of our patients admitted to Cumberland 
Heights for treatment of opioid dependence have some experience 
with buprenorphine, either by prescription or by buying the 
medication off the street. Over the years, I have been amazed 
at stories of diversion and abuse of buprenorphine among 
patients presenting to Cumberland Heights for treatment.
    Buprenorphine is sometimes used under the tongue, as it is 
designed. It can be used intranasally or even injected. 
Motivations for illicit use of buprenorphine include to get 
high as well as to treat withdrawal. Of course, some patients 
with buprenorphine diversion and abuse take it with the 
motivation to stop using other opioids.
    A typical 8-milligram dose of buprenorphine costs $20 in 
middle Tennessee when obtained illicitly and, in east 
Tennessee, as much as $40 per 8-milligram dose. The street 
value supports my observation as to the level of diversion and 
abuse of buprenorphine. In fact, buprenorphine has been 
identified as the third-most-diverted medication in the U.S. by 
the DEA.
    At a 2008 meeting of the American Society of Addiction 
Medicine's Medical Scientific Conference in Miami, I was asked 
by a colleague if I use buprenorphine to treat opioid 
dependence. I replied that we utilize buprenorphine to detox 
from opioids. He remarked that he had never seen a patient 
recover without buprenorphine, and I told him that I had 
recovered from opioid dependence without buprenorphine. He 
said, ``Yes, but you weren't using intravenously.'' He appeared 
incredulous when I told him that I had recovered from IV opioid 
addiction without buprenorphine or methadone.
    I cringe when an addiction medicine treatment provider 
makes a recommendation based on his or her personal experience 
in treatment and recovery; that is not what I am saying. But my 
experience indicates that there are multiple paths to recovery. 
There is no one-size-fits-all.
    At Cumberland Heights, we promote abstinence after detox, 
we provide psychosocial treatment, and we use a long-acting 
opioid blocker, Vivitrol, as well as incorporation of a 
spiritual basis of recovery through 12-step facilitation. We 
completely understand that addiction is a chronic illness, and 
ongoing recovery requires ongoing treatment. No one is claiming 
that detox from opioids alone will result in recovery.
    And I thank you for the opportunity to speak.
    [The prepared statement of Dr. Sledge follows:]
    
    
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    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Dr. Waller, 5 minutes for your opening statement.

                STATEMENT OF ROBERT COREY WALLER

    Dr. Waller. Thank you, Chairman Pitts and Ranking Member 
Green. Thank you very much for inviting me to participate in 
this important hearing. I am grateful to you and the other 
members of the subcommittee for your leadership in addressing 
the epidemic of opioid addiction currently ravaging our 
country.
    My name is Dr. Corey Waller, and I am the chair of the 
Legislative Action Committee of the American Society of 
Addiction Medicine, also known as ASAM. This testimony is 
offered on behalf of ASAM, myself as a practicing addiction 
specialist physician, and my patients who are unable to speak 
before this committee themselves.
    I am board-certified in both addiction medicine and 
emergency medicine. I am the medical staff chief of pain 
medicine to the Spectrum Health Hospital System as well as the 
substance use disorder medical director at a regional community 
mental health organization based in Grand Rapids, Michigan.
    My testimony today will focus on the following three facts: 
Addiction is a chronic disease of the brain that leads to 
characteristic biological, psychological, and social 
manifestations; addiction involving opioid use can be 
successfully treated with a combination of medications and 
psychosocial interventions; and we have published guidelines 
that detail best practices for the use of these medications.
    There are significant barriers to access to these effective 
medications, resulting in a significant addiction treatment gap 
in our country. This is, without question, a chronic 
neurobiological disorder that starts with a genetic risk, is 
informed by the environment, and is solidified by the culture 
surrounding it. Not unlike diabetes or hypertension, we can 
effectively manage the disease, but stopping that treatment 
prematurely costs us lives.
    We are here today to provide recommendations on how best to 
respond to the epidemic of prescription opioid and heroin 
misuse, addiction, and related overdose deaths. According to 
the Centers for Disease Control, we have reached epidemic 
levels in our country. We have all seen the data and heard the 
shocking statistics, but what is not said or heard enough is 
that the 2.3 million people who need treatment for opioid 
addiction have a chronic disease of the brain. While we need to 
prevent other Americans from developing addiction, these 2.3 
million people need treatment now.
    There are currently three medications that are FDA-approved 
to treat opioid addiction: methadone, which has been used in 
highly regulated opioid treatment programs since the 1960s; 
buprenorphine, which has been used since 2002 by physicians who 
complete a special training in their offices; and naltrexone, 
which is not a controlled substance and can be administered by 
any licensed prescriber.
    All of these medications have proven to be clinically 
effective. A 2013 review of the scientific literature found 
substantial, broad, and conclusive evidence for the 
effectiveness of all three medications and for methadone in 
particular. Notably, the literature on efficacy of these 
medications is not new. There are now eight large-scale, 
rigorously conducted reviews of the literature on these 
medications since the early 1980s. All FDA medications have 
been shown to reduce mortality.
    Finally, we have a clear and comprehensive guideline for 
how to use these medications effectively in the clinical care 
of persons with addiction. However, despite the strong, 
evidence-based use of these medications and the clinical 
guidance available, very few eligible patients are offered 
medication to help treat their disease. Less than 30 percent of 
treatment programs offer medications, and less than half of 
eligible patients in those programs receive medications. 
Indeed, a study published just last week in the Journal of the 
American Medical Association found that 80 percent of Americans 
with opioid addiction don't receive treatment.
    This treatment gap is attributable to many factors, some 
more complex than others. Research has demonstrated significant 
access barriers to methadone, including waiting lists for 
treatment entry, limited geographic coverage, limited insurance 
coverage, and the requirement that many patients receive 
methadone at an OTP daily.
    DATA 2000 was intended to expand access to addiction 
treatment across geographies and populations by integrating it 
into the general medical setting. In recent months, my practice 
has had to turn away patients due to the 100-patient limit for 
buprenorphine, and this includes pregnant patients as well as 
the children of my friends, and has resulted in at least 2 
overdose deaths that we can track.
    If I am out of town or unavailable, my physician assistants 
are unable to see patients who need an urgent intake due to the 
restrictions on PAs and nurse practitioners writing for 
buprenorphine, which exists even if they are under the guidance 
of a physician who is board-certified in addiction.
    It is important to note that the entire purpose of DATA 
2000 was to make opioid treatment available outside an OTP, in 
traditional physician's offices, both to increase access in 
areas where OTPs may be physically inaccessible and to reduce 
the stigma and patient burden associated with visiting an OTP 
for treatment on a daily basis.
    Still, because diversion and quality of care remain 
legitimate concerns, ASAM has proposed a gradual and limited 
lifting of the DATA 2000 limits. By coupling a lifting of the 
patient limit with increased training requirements and 
accountability for those physicians treating large numbers of 
patients, we feel we can expand access while also ensuring a 
certain quality of care.
    Still, this single strategy should be just one part of a 
broader Federal effort to ensure safe prescribing of opioids 
for pain, alternative pain therapy options, and early 
identification and treatment of addiction.
    Pain and addiction education should be required curriculum 
in medical school and encouraged as continuing medical 
education throughout a physician's career. Communities should 
have the resources to educate their citizens about these issues 
and the outreach and surveillance resourcesnecessary to better 
understand the unique issues and needs.
    Thank you again for the opportunity to present here today. 
ASAM and myself look forward to a continued collaboration on 
this and other addiction-related issues.
    [The prepared statement of Dr. Waller follows:]
    
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    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Dr. Katz, 5 minutes for your summary.

                  STATEMENT OF KENNETH D. KATZ

    Dr. Katz. The drug epidemic confronting this Nation has 
exploded in recent years due to the accessibility of cheaply 
made, mass-produced deadly synthetic drugs. As a physician on 
the front line, I have witnessed how these dangerous compounds 
have directly led to violence, hospitalizations, and deaths. 
For example, in both the adult and pediatric intensive care 
units in Allentown, Pennsylvania, this spring, I spent 
countless hours at the bedside caring for many patients 
suffering from the toxic effects of synthetic marijuana which 
ripped through eastern Pennsylvania, leaving in its wake 
multiple patients in emergency departments, hospitals, and, 
unfortunately, morgues.
    Mr. Chairman and members of the subcommittee, my name is 
Dr. Kenneth Katz, and I am board-certified in emergency 
medicine, medical toxicology, and internal medicine. Thank you 
for allowing me to testify today on behalf of the American 
College of Emergency Physicians to discuss the dangers posed by 
synthetic drugs and to advocate for enactment of H.R. 3537, the 
Synthetic Drug Control Act of 2015.
    In every community across the Nation, my colleagues and I 
are treating more and more patients who have experienced 
synthetic drug toxicity or poisoning. It is important to 
understand that the term ``synthetic drugs'' we are using here 
today describes substances that are primarily manufactured in 
clandestine Chinese laboratories and actually represents a 
nimiety of chemical combinations that are designed to mimic the 
effects of illegal chemicals with stimulant, depressant, or 
hallucinogenic properties. They are nonorganic, chemically 
synthesized, unsafe recreational drugs that produce 
psychoactive or mind-altering effects.
    Many of these substances are marketed as innocuous 
products, such as incense, plant fertilizer, or air freshener 
and then sold in convenience stores, gas stations, or online. 
Because of their commercial availability, many users presume 
they must be safe. However, the public should not be fooled. 
Even though these products may be hiding in plain sight, they 
are colorfully packaged poison.
    Unlike most illicit drugs, synthetics can contain a vast 
array of different chemicals with varying potencies. For 
example, synthetic marijuana may contain compounds 2 to 500 
times more powerful than THC. In many cases, the manufacturer's 
only goal is to alter the chemical compound in such a way as to 
technically create a new compound, allowing them to circumvent 
legislative and regulatory bans.
    This modification process poses increasing risk to users, 
who are unaware of the reactions the new chemicals or 
formulation may cause. It is not until these substances are 
ingested or inhaled that some or all of the following symptoms 
can occur: hyperthermia; elevated blood pressure and pulse; 
severe, uncontrollable agitation; seizures; coma; muscle 
breakdown; kidney injury; and, ultimately, death. 
Unfortunately, at that point, it may be too late for either my 
emergency medicine colleagues or even me, as a medical 
toxicologist, to save them.
    While there is an increasingly expanding array of synthetic 
drugs being manufactured, of particular concern to ACEP is the 
availability and high use of synthetic marijuana. Whether it is 
the data from SAMHSA's Drug Abuse Warning Network, DEA's 
National Forensic Laboratory Information System, or Poison 
Control Centers, it is clear: Synthetic marijuana use has 
increased exponentially since it first appeared in the United 
States a few years ago.
    For example, according to NFLIS, there were 21 reported by 
2009. By 2012, that number grew to more than 29,000, an 
increase of more than 1,400 percent. Through the first 6 months 
of 2014, there were already close to 20,000 synthetic marijuana 
drug reports. My home State of Pennsylvania has been especially 
hit hard by the increasing use of synthetic marijuana, trailing 
only New York, Mississippi, and Texas in the number of reported 
exposures this year.
    Currently, all 50 States have banned some cannabinoids and 
cathinones, with the majority doing so through legislation. 
Since synthetic compounds are easily manipulated to make new 
drugs, many States have passed laws targeting entire classes, 
substances, or used broad language to describe the prohibited 
drugs.
    Federal statues must also be updated to meet this 
constantly evolving challenge and restrain these dangerous 
products. The Synthetic Drug Control Act of 2015, sponsored by 
Representatives Charlie Dent and Jim Himes, would amend the 
Analogue Act so that a substance can be treated as an analogue 
if it is chemically similar or produces a similar clinical 
effect. In addition, the bill would add more than 200 known 
synthetic drugs to Schedule I of the CSA.
    This legislation is targeted to the manufacturers and 
distributors of synthetic drugs, not the end users. H.R. 3537 
would amend the Analogue Act so that it would only apply to the 
sale, manufacture, import, and distribution of drugs, not 
simple possession.
    The easy access to and thoughtless use of synthetic drugs 
by those who are unaware of their dangerous toxicities not only 
places their health and lives at risk but can have a profound 
impact upon my ability to care for all my patients. When users 
of synthetic drugs need emergency medical attention, they are 
utilizing precious resources such as ambulances, emergency 
department beds, hospital personnel, and limited healthcare 
dollars.
    It is both my opinion and that of the American College of 
Emergency Physicians that this critical issue must be addressed 
through the enactment of H.R. 3537 and supplemented by a 
national campaign to educate Americans about the dangers of 
using synthetic drugs.
    Thank you.
    [The prepared statement of Dr. Katz follows:]
    
    
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    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes Dr. Anderson, 5 minutes for your summary.

                 STATEMENT OF ALLEN F. ANDERSON

    Dr. Anderson. Good afternoon. I am Dr. Allen Anderson, an 
orthopedic surgeon specializing in sports medicine, and I am 
also the president of the American Orthopedic Society for 
Sports Medicine, or AOSSM. It is a nonprofit organization made 
up of 3,400 orthopedic surgeons specializing in the care of 
athletic injuries at every level of competition.
    Eighty percent of AOSSM members are team physicians, and 60 
percent of our members take care of high-contact collision 
sports, where serious injury can occur. A team physician has 
unique responsibilities and qualifications. He or she must have 
fundamental knowledge of on-field emergency care and treatment 
of musculoskeletal injuries and medical conditions.
    Today, I will discuss the need for a team physician to be 
able to carry controlled substances when traveling with the 
team and the problems with current law; the fact that 
workarounds are not practical; and why H.R. 3014, the Medical 
Controlled Substances Transportation Act, will enable team 
physicians to provide the best quality medical care to our 
injured athletes.
    In emergencies or disasters where there is significant 
trauma, it is critical that a physician have immediate access 
to controlled substances. There are times, such as during air 
travel or on a bus, when the team physician is the only medical 
person available. There are documented cases of players having 
seizures after concussions on a flight home, and, in such 
situations, controlled substances are needed to stop the 
seizure and perhaps save the athlete's life. Additionally, it 
is humane care to allow a player to take a pain pill if he or 
she has a broken bone, dislocated shoulder, or torn ACL.
    As you watch your favorite team on Saturdays, one or more 
athletes is significantly injured in almost every game. These 
players are your constituents from every State. The team 
physician, who is probably a member of AOSSM, is there on the 
sideline to render aid and take responsibility for the 
athlete's wellbeing. This aid is being severely restricted by 
current law.
    The current law prohibits the transportation and storage of 
controlled substances away from the site of storage that is 
registered with the DEA. This makes it illegal for team doctors 
to transport a limited quantity of critical medications that 
are needed for pain control or emergency management. This is 
highly problematic for athletic team physicians, who need the 
ability to maintain a limited supply of controlled substances 
if a player is injured at an away game. The current law also 
precludes controlled substances from being transported within 
the same State or across State lines.
    The current workarounds are problematic. Current options 
include predispensing medications to every member of the team 
prior to travel. That would be 80 members on a football team. 
This would create a logistical nightmare.
    Delegating the dispensing of controlled substances to the 
home medical staff in the State of entry. This is also a 
problem. The opposing team physicians can provide medications, 
but they have to independently examine the patient, and they 
have limited time due to demands to treat their own team. This 
would be create malpractice concerns for that physician of 
prescribing medications and not following that patient.
    There are also privacy concerns. The local physician is 
generally caring for the competing team. This would be 
unacceptable for the coaching staff to enter the training room.
    H.R. 3014 would address these concerns. It allows the 
physician who is traveling with a team the ability to 
appropriately manage the injury in a similar fashion to when 
they are in their home facilities. It does not diminish the 
need or requirement for controlled substances to be monitored 
at the current level.
    Records of controlled substances dispensed are maintained 
and subject to inspection by the DEA at any time. The team 
physician will be responsible for the security of the 
controlled substances throughout the entire time the team will 
be traveling, and the duration of transport is limited to 72 
hours.
    Military flight surgeons and rural large-animal 
veterinarians have an exemption to carry these medications. 
Contact sports can be much more perilous than noncombat 
military maneuvers. It is also hard for me to believe that 
horses and, potentially, cows could get better medical 
treatment than our athletes.
    This legislation would also benefit patients and physicians 
who donate their time in declared disaster areas in their 
States or other States.
    Therefore, we urge you to support H.R. 3014, the Medical 
Controlled Substances Transportation Act, so that we can 
provide the highest level of care for our injured athletes.
    Thank you for giving me this opportunity to testify, and I 
am happy to take questions.
    [The prepared statement of Dr. Anderson follows:]
    
  [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]  
   
   
    
    Mr. Pitts. The Chair thanks the gentleman.
    That concludes the opening statements of our second panel.
    I have a UC request. I would like to submit the following 
documents for the record: statements from the College on 
Problems of Drug Dependence; the National Association of 
Convenience Stores; Dr. Cooper, head team physician of the 
Dallas Cowboys; the Fraternal Order of Police; the Society of 
Former Special Agents of the FBI; the American Medical 
Association; the American College of Emergency Physicians; the 
American Association of Orthopaedic Surgeons; the Center for 
Lawful Access and Abuse Deterrence; the American Academy of 
Physician Assistants; and the National Association of Chain 
Drug Stores.
    Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. I will begin the questioning and recognize 
myself 5 minutes for that purpose.
    Dr. Halverson--and, Drs. Sledge and Waller, you can respond 
here, too--do you all agree that patients addicted to opioids 
should receive treatment based on their individual clinical 
needs?
    Dr. Halverson?
    Dr. Halverson. Yes, sir.
    Mr. Pitts. Dr. Sledge?
    Dr. Sledge. Absolutely.
    Mr. Pitts. Dr. Waller?
    Dr. Waller. Yes.
    Mr. Pitts. How would you each advise HHS to take this 
principle into account when considering how to responsibly 
implement Secretary Burwell's recent announcement to expand the 
use of medication-assisted therapy?
    Dr. Halverson?
    Dr. Halverson. Since I am not a physician, I would like to 
defer to my colleagues here.
    Mr. Pitts. OK. All right.
    Dr. Sledge?
    Dr. Sledge. And I think that prescribing physicians should 
be trained in all modalities of medication-assisted therapy as 
well as other options, particularly psychosocial treatment, 
with abstinence as an option.
    Mr. Pitts. Dr. Waller?
    Dr. Waller. So we have looked at this very closely in the 
area that I treat. I am in charge of a seven-county area with 
patients and figuring out how to treat that seven-county area. 
We have been able to delineate two separate groups of patients 
which we have good data for: those that started very early in 
life and started earlier, in their adolescence, which have a 
different brain disease than started later in life. Those 
groups of patients actually separate us out a little bit, as 
far as how treatment works.
    So I have many patients in my clinic that are physicians, 
pilots, and lawyers who I don't give any medication to because 
generally it is not indicated. And we have wonderful outcomes 
without any medication-assisted treatment for those groups 
because of many other factors.
    My groups, which are 92 percent of my patients, which are 
Medicaid patients or those without insurance, I find that it is 
a perilous journey to try to treat them without buprenorphine. 
And the data backs that up, with a high mortality rate 
associated with this group of patients specifically.
    And so Dr. Sledge and I are saying the same thing. It is 
absolutely the right treatment for the right patient at the 
right time, and making sure that we allow for an expansion of 
use of these medications that save lives in the hands of those 
people who are trained best to use them.
    Mr. Pitts. All right.
    You have touched on this, but expand a little bit more on 
how should differences in certain types of patients and 
treatment settings and therapeutic options be addressed.
    Dr. Waller. Well, currently, we have guidelines that 
directly do address the utilization of the medications. These 
are the first guidelines that look at all three of the FDA-
approved medications, and it does speak to the behavioral and 
psychosocial therapies without medications within there.
    Generally, the medication treatment has been done in a 
cohort of patients that do not represent a physician or pilot 
or a lawyer, which, in general, we have programs within States 
that surround them that are different than the general 
programatic treatment pathways.
    And so utilizing the guidelines that we have delineated 
with the appropriate education to back that up would be the way 
that I would say.
    Mr. Pitts. Dr. Sledge?
    Dr. Sledge. An overarching principle identified by the 
Institute of Medicine for successful treatment included patient 
self-determination. And I think that H.R. 2872, the Opioid 
Addiction Treatment Modernization Act, brings patient self-
determination back to the equation.
    Mr. Pitts. And, in your opinion, what are the most 
significant obstacles at the present time preventing more 
individuals with opioid use disorders from receiving the most 
effective treatments?
    Dr. Sledge. I think that one-size-fits-all treatment is 
very detrimental to addressing the opioid epidemic. I think 
that an assessment of each individual patient, with 
recommendation and referral based on their individual needs, is 
essential for successful treatment.
    Mr. Pitts. Any other significant obstacles, Dr. Waller?
    Dr. Waller. I think the legal obstacles to be able to 
obtain the appropriate medications for patients if we deem it 
is the right medication for them, such as specifically 
buprenorphine for my patients.
    I treat all of the pregnant patients in that seven-county 
area, and I am out of space. And so I have to turn people away 
to areas that are either less than optimal for them or, you 
know, try our best with what we can do, but, unfortunately, 
that doesn't turn out very well.
    Mr. Pitts. Can each of you comment on the role nurse 
practitioners and physician assistants play in providing 
office-based opioid treatment?
    Dr. Sledge. I am not a provider of office-based opioid 
treatment, so I will defer to Dr. Waller.
    Mr. Pitts. Dr. Waller?
    Dr. Waller. Without the utilization of my physician 
assistants, my office doesn't run. We have the capability to 
see patients in volume because we have well-trained physician 
assistants and nurse practitioners that work directly with 
board-certified people in their other specialties, whether this 
is a neurosurgeon or an orthopedic surgeon or an addiction 
specialist. And, in this case, an addiction specialty--you 
know, coupling my physician assistants along with behavioral 
therapists with my patients works out really well, and we have 
great outcomes from this.
    And this is a model that has been adopted in the medical 
home model of care and is relatively standardized throughout 
medicine. And so to eliminate this as a possibility for this 
specific disease doesn't make sense from a monetary standpoint 
nor a patient delivery standpoint.
    Mr. Pitts. Thank you.
    I am out of time, but, Dr. Katz, you talked about synthetic 
drugs. And with the movement towards legalization of medical 
marijuana, is synthetic marijuana considered medical marijuana, 
or are the advocates trying to include that in medical 
marijuana?
    Dr. Katz. Not that I am aware of. No, I think we are 
talking about two different things.
    Mr. Pitts. Yes. It is completely synthetic.
    Dr. Katz. Yes.
    Mr. Pitts. Yes. That is what I thought.
    Thank you.
    And, at this time, the Chair recognizes the gentleman from 
Maryland, Mr. Sarbanes, filling in for Ranking Member Green.
    Mr. Sarbanes. Thank you, Mr. Chairman.
    Before I ask my question, I would ask unanimous consent to 
enter a letter from the Purdue University College of Pharmacy, 
Dr. Nichols, which provides some additional perspective on this 
issue of adding certain synthetic drugs to the Schedule I CSA 
and the implications of that for scientific research.
    Mr. Pitts. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Sarbanes. Thank you.
    I appreciate the testimony, everybody.
    The first question I wanted to ask was--and maybe, Dr. 
Halverson, from your, sort of, public health perspective, and 
Dr. Waller, but others, as well--the word ``epidemic'' is 
getting used a lot to describe this. And I, frankly, myself, 
didn't appreciate that by the CDC definition of ``epidemic'' we 
have actually gotten to that point.
    Can you comment on--because, you know, ``epidemic,'' that 
is kind of used in the vernacular to just describe something 
that is sort of out of hand and serious. But, you know, if you 
are talking about ``epidemic'' where it could be, you know, 
analogous to a SARS epidemic or a MERS epidemic or an Ebola 
epidemic, whatever, that is of a difficult scale and degree. 
And if you could speak to that, any of you.
    Yes?
    Dr. Halverson. ``Epidemic'' is used in large part because 
of the fact that we don't see an easily controllable end, that 
we experience the phenomenon, whatever it might be, an epidemic 
of flu or an epidemic related to any disease where the disease 
is raging beyond our ability to control it, and the disease has 
the potential to have profound impact.
    And so, under those definitions, we certainly have seen an 
epidemic of opioid abuse, of deaths. And the reality is that we 
do have an idea of how to address the epidemic, but, at our 
current point in time, we haven't reached the point where we 
can actually say it is controlled.
    Mr. Sarbanes. Any other perspectives on that?
    Dr. Waller. So the two components of an epidemic is 
susceptibility to something and then to be able to come into 
contact with that something and have it spread.
    We have seen exactly that pattern with heroin. If it shows 
up in a community, those people who have susceptibility from a 
genetic predisposition and then have already been started on 
opioids or, in the case, unfortunately, of many areas, young 
people who this is the first drug they touch, in some cases in 
early high school, and then they have access and a genetic 
risk, it grows just like the disease that we look at on 
outbreak, where it just covers the map.
    And that is what we are seeing. It kills more people in my 
State than anything else. And it is all people that are young 
and healthy as compared to other diseases that affect a whole 
different population of people.
    Mr. Sarbanes. So let's say tomorrow you were appointed the 
opioid addiction czar, in the same way that we had an Ebola 
czar----
    Dr. Waller. I accept.
    Mr. Sarbanes. OK--and you could take whatever steps you 
thought were necessary, describe what the first two or three 
things would be, both ones that would require additional 
resources, would be resource-dependent, as well as, it seems, 
ones that maybe are not resource-dependent, like lifting some 
of the caps on the number of patients that can be treated and 
so forth. What would your steps be?
    Dr. Waller. Well, I think the first step would be a re-
education of the population about what the disease of addiction 
is, that this is a chronic neurobiological disorder that has 
more data about the brain-disease aspect than any other mental 
health disease in the history that we have ever looked at----
    Mr. Sarbanes. So is that PSAs? I mean, what is that? How do 
you get that word out?
    Dr. Waller. This is a Surgeon General's report, this is 
public messaging, this is rebranding of a disease that has been 
maligned in the face--and we have been treating this with an 
emotional context, rather than a science context, for years. So 
that has to be the first place.
    Mr. Sarbanes. OK.
    Dr. Waller. The second piece is access to all treatments. 
And the third place is to build a structure around those 
treatments so that they are delivered with high fidelity and 
low risk.
    Mr. Sarbanes. OK. Thank you.
    I am interested because I have a piece of legislation on 
this topic of this idea of encouraging coprescribing of 
Naloxone at the time that a physician is prescribing a certain 
kind of opioid.
    And, you know, there would be some demonstration projects 
around this to test the potential of this and to look at the 
particular circumstances under which that would be 
appropriate--the kind of patient, you know, their particular 
vulnerabilities, and the likelihood of a potential overdose, et 
cetera.
    Can you just speak to your perspective on whether that 
would be a useful step?
    Dr. Waller. Well, first, Congressman Sarbanes, I appreciate 
that piece of legislation. It is very impactful.
    I carry Naloxone in my backpack. It is sitting behind me in 
a ready, injectable pen, because it is something that we can 
do--it is an anti-death serum. And so, to have this available 
in a coprescribing way to family members and to patients alike 
and to make sure that they are trained in the utilization of 
this is no different than having an automatic defibrillator on 
a wall in a gym. I mean, this is something that should be 
publicly available, and this is a great step toward that. We 
definitely support that. I personally support this, as well as 
with ASAM as well.
    I think the biggest issue with this--we need to make sure 
and dispel the myth that somehow adding an antidote changes 
patients' behavior to use more and more often. That has been 
found through research to not be true. In the areas with which 
we have allowed this to be legalized and given to police 
officers and community members and made it available to 
patients, we have seen nothing but a decrease in mortality. We 
have not seen an increase in utilization. We have not seen an 
increase in amount of utilization per person per time they use. 
That is just not true.
    And when you reverse somebody, that is one more time that 
they are not dead, and, two, we have an opportunity to get them 
into treatment.
    Mr. Sarbanes. So you have to bring all the other measures 
to bear and view that as kind of a first step back to that 
opportunity.
    Dr. Waller. Absolutely.
    Mr. Sarbanes. Yes.
    Thank you very much. I yield back.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the vice chair of the subcommittee, Mr. Guthrie, 5 
minutes for questions.
    Mr. Guthrie. Thank you very much.
    And, first, as a comment to Dr. Anderson, I know you got up 
here early. I saw you on the airplane, I believe, coming out of 
Nashville this morning.
    And I appreciate--and I am also working with your--not your 
organization, but people that practice in your area, not just 
for opioids that they are talking about being able to carry, 
but, also, a friend of mine is an emergency room physician in 
Auburn, Alabama, and so he traveled to Kentucky last Thursday 
night with the Auburn Tigers to watch over the team while they 
were playing our beloved Wildcats. And there is a licensing 
issue, too, back and forth about a physician licensed in 
Alabama to come travel with the team into Kentucky. We need to 
fix that, as well, and that is something that we are looking 
forward to doing.
    Second thing, a lot of my good friends back in the 
legislature in Kentucky, former colleagues of mine, were very 
aggressive on OxyContin and prescription drugs and put forth 
ways to manage prescription drug abuse and seemed to be very 
successful with it. And I know some of the physicians were 
really having to manage it very closely. And we thought, wow, 
we really are getting a big handle on the supply of the 
problem--which, supply is still a problem. You have to attack 
supply all the way. And, all of a sudden, heroin became a big 
component in Kentucky.
    And somebody told me--I had lunch yesterday with one of our 
drug task force leaders, and he said it is easier to get heroin 
now than prescription drugs in Kentucky--I mean, illegal 
prescription drugs, use of prescription drugs. And so we have 
to attack the demand for it, as well, in what you guys do.
    And so one of the questions I have for those of you who 
practice in this area--I know, Dr. Halverson, I have a question 
for you, too, but I don't think you are--you said you are not 
an M.D. But anyone who would like to answer.
    I know there are caps on what practices can use for 
buprenorphine. And the question is, do you think the current 
caps should be lifted? And if not, why? And if so, how?
    So, any of you who practice in this area, I would love for 
you to answer that question.
    Dr. Waller. So I can address it initially.
    The short answer is: Yes, but safely.
    We have identified that this medication is diverted and, in 
some cases, abused. I have patients that I treat for 
buprenorphine abuse. They show up, and I treat them for that.
    And now that we have the abuse-deterrent versions, the 
inadvertent utilization of it through snorting or injection has 
significantly declined, to the point where we generally don't 
use the mono drug, the buprenorphine by itself, at all in my 
clinic.
    Mr. Guthrie. Do the caps put limits on you that you look at 
it and say, wow, I could treat more people if I didn't have 
this cap?
    Dr. Waller. I have a 7-month waiting list, and it is purely 
waiting on slots.
    Mr. Guthrie. Because of the cap.
    Dr. Waller. Because of the cap. And I have no one else in 
my community of 1.3 million people that has any space on their 
cap that is a specialist in this area.
    Mr. Guthrie. Do the other--both of you practice in this 
area, I believe, as well.
    Dr. Sledge, do you have the same issues with the caps?
    Dr. Sledge. Well, again, I don't practice office-based----
    Mr. Guthrie. OK.
    Dr. Sledge [continuing]. Opioid treatment. And there 
certainly is not a cap involved with extended-release 
naltrexone and its incorporation as a medication-assisted 
therapy.
    And, again, with the issue of diversion and abuse, I do 
think that there needs to be diversion protection in whatever 
measures are taken to increase----
    Mr. Guthrie. Let me ask you a question, Dr. Sledge. So, in 
your comments earlier, you talked about psychosocial should be 
added to the--that you can't just treat through, like, 
buprenorphine and those kinds of things. Why is that important?
    Dr. Sledge. Why is that important?
    Mr. Guthrie. Uh-huh.
    Dr. Sledge. You know----
    Mr. Guthrie. I want you to state the obvious. I want you to 
say it for the record, why that is important.
    Dr. Sledge. OK. Absolutely.
    And I think just prescribing the medication is not going to 
effect much of a change in the course of this chronic disease. 
It is a chronic brain disease that affects not only with 
biological manifestations but physiatric, physiological, 
spiritual, and social manifestations. And all of those areas 
have to be addressed for ongoing recovery.
    I think that medication is uni-dimensional. When it is used 
alone, it addresses the biological manifestations of the 
disease. But the disease is multifaceted, and all of those 
areas must be addressed for recovery.
    Mr. Guthrie. I have one more question. If anybody wants to 
add to that?
    If not, thanks for doing that.
    And, also, I guess this is really for the record, too, Dr. 
Halverson, because I think a lot of us understand this. But 
aside from the chronic health impacts of addiction and death 
from overdose, what other public health or social impacts are 
associated, in Indiana and nationally--in your role, I know you 
see this nationally--with opioid use disorders?
    Dr. Halverson. Right.
    So one of the things that we experienced in Indiana with 
the overdose patients were related to infections that occurred 
as a result of intervenous drug use.
    So, again, part of the issue is people overdose on drugs 
for a number of different reasons. They frequently will also be 
affected by infections as well as actual other diseases that 
weren't intended as part of the effect that they were trying to 
get from the medication.
    But, additionally, there are a number of other issues that 
are related to the community's overall health. And the ability 
for the community to be resilient around this kind of disease 
is important to take into consideration.
    In part, there is, I think, a general lack of understanding 
around drug abuse in particular. I think one of the questions 
that was asked earlier was related to what would you do to 
address the community awareness, and part of that is helping 
people to understand the scientific basis of this disease. It 
is, indeed, a chronic disease, and we need to begin to treat it 
in that manner and approach it from a scientific perspective. 
There still are number of people, unfortunately, that believe 
that people ought to just quit that, they just ought to stop 
this. And they don't recognize the fact that this is a disease 
that needs to be treated.
    We have to also make sure that people have access to 
treatment, which is--in our State as well as others, there are 
some problems getting access----
    Mr. Guthrie. Thank you. I am kind of over my time, but I 
appreciate you answering. I know I am over my time, and the 
chairman needs to move on, but I appreciate your answer.
    Thank you. I yield back.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the ranking member of full committee, Mr. Pallone, 5 
minutes for questions.
    Mr. Pallone. Thank you, Mr. Chairman.
    My questions are of Dr. Waller.
    As you know, or you mentioned, there are three FDA-approved 
medications for the treatment of opioid dependence. There is 
methadone, buprenorphine I guess you have been talking about, 
and naltrexone. And I am interested in hearing more about 
methadone.
    Could you briefly describe how methadone is used to treat 
individuals with opiate dependence? And are there special 
requirements to treat individuals with methadone in a substance 
abuse context?
    Dr. Waller. Yes, sir. So methadone is a full agonist 
medication, which means it resembles medications like oxycodone 
and hydrocodone, morphine, in that way.
    So for patients who have traditionally a heroin addiction 
and specifically injecting heroin, we have great data that 
states that utilizing this medication in a fully inclusive 
biopsychosocial environment, not just the medication itself but 
then specifically adding all of these, the biopsychosocial 
aspects with that, significantly decreases craving for a drug 
and, by doing that, allows them to continue to show up and have 
a very high retention and treatment rate.
    So about 75 percent of patients will be retained in 
treatment on methadone as compared to buprenorphine, where you 
will retain at about 65 percent. And then for new onset with 
naltrexone, it is lower than that. That number hasn't been 
fully vetted. But when we look at the----
    Mr. Pallone. I guess what I am trying to be find out is why 
buprenorphine should not be regulated like methadone. That is 
what I am trying to get you to respond to.
    Dr. Waller. So the basics are that the regulations around 
methadone are significant. And for a primary care physician to 
onboard the regulations, it would be a minimum of about 
$150,000 immediately, with the paperwork, the accreditation 
through the joint commission, the accreditation through CARF.
    And then, at that point, you have to actually--there are 
specific issues with almost all States where you would have to 
then par with a community mental health, which requires a 
request for proposals, which requires a hearing. It almost 
completely negates the capability for a primary care doctor to 
deliver this medication at all.
    Mr. Pallone. But, again--I think you were getting at it, 
but I still don't understand. What are the medical reasons to 
justify why methadone comes with different requirements than 
the other two drugs?
    Dr. Waller. Well, one, those are historic, because that is 
how it was started, and it has been very regulated since it was 
initially utilized in this manner since the 1960s. Two, it does 
have a higher potential for abuse than buprenorphine. Three, it 
has a higher overdose risk than buprenorphine.
    And so all of those are much lower in buprenorphine, which 
is why it is Schedule III and able to be utilized in an OTP, 
opioid treatment program.
    Mr. Pallone. OK.
    One of the bills that we are discussing today, H.R. 2872, 
proposes bringing the regulations for physicians who prescribe 
buprenorphine in their offices more in line with the 
regulations governing methadone.
    How would this proposal affect patients' access to 
buprenorphine, or how would this proposal affect our ability to 
treat special populations like pregnant women who are opiate-
dependent?
    Dr. Waller. It would completely negate my ability to see my 
patients, and I would have 200 people without treatment 
immediately in my clinic.
    If you look at this from a national perspective, we would 
shut down any extension or expansion of this pathway, given the 
amount of money that it takes to get into the pathway and in 
the amount of regulations surrounding it.
    So I think that it would be a--not just me. This is pretty 
well understood that if that happened it would be catastrophic, 
and the mortality rate would sky rocket.
    Mr. Pallone. So, basically, it would profoundly affect our 
ability to respond to the current opioid crisis, in your 
opinion.
    Dr. Waller. Unfortunately, yes.
    Mr. Pallone. All right.
    Now, another major access to--well, patients already face a 
number of barriers in accessing medication-assisted treatment, 
or MAT. And one major barrier to access MAT appears to be 
cultural, social stigma surrounding the use of these 
medications. Although there is strong evidence supporting the 
use of MATs, many people, even within the treatment field, 
continue to believe that using MATs is merely replacing one 
addiction with another.
    Can you comment on this perception? Are patients on MATs 
merely replacing one opioid addiction with another?
    Dr. Waller. The short answer is no.
    But, very specifically, if we look at what we are trying to 
do, the part of the brain that has been injured is the area 
that releases a specific chemical called dopamine. These 
medications re-regulate that so that we can add the beneficial 
psychotherapies that then stabilize that for long-term.
    Unfortunately, we have found that some patients who have 
used this for an extended period of time, opioids and alcohol, 
and at very high doses, they injure that part of the brain 
permanently and that they may require stabilization of those 
chemicals for a very long time and then sometimes lifetime.
    We find that we don't keep all of our patients in my clinic 
on this. We are able to wean a good number of them, but it 
takes time. And the data is very clear that, at minimum, it is 
18 months to 2 years before the brain begins to heal in that 
setting.
    Mr. Pallone. All right. Thanks a lot.
    Thanks, Mr. Chairman.
    Mr. Pitts. The Chair thanks the gentleman and now 
recognizes the gentleman from Indiana, Dr. Bucshon, 5 minutes 
for questioning.
    Mr. Bucshon. Thank you, Mr. Chairman. I appreciate it.
    Thank you to all the witnesses for being here. Very much 
appreciate it. This a big problem, obviously, that all of us 
want to help solve.
    I was a practicing cardiovascular and thoracic surgeon 
prior to coming to Congress. And we are talking today primarily 
about treatment, but we all know we also have to probably 
address this on the front end with training of physicians, 
beginning in medical school and residency. I can tell you, the 
amount of training that I had, even as a surgeon, specifically 
on pain management and the use of narcotics to manage pain was 
really minimal other than, essentially, on-the-job training 
during residency. And I think we nee to address that moving 
forward.
    I had a nice conversation with Michael Botticelli about an 
hour ago, as you probably know, the Director of the Office of 
National Drug Control Policy. And I guess President Obama will 
be commenting on this specific subject in West Virginia 
tomorrow, and I will be looking forward to his comments and 
what they are planning to do to help all of us address this 
situation.
    I also want to comment on what Mr. Sarbanes said about 
Naloxone. I think that it is important that especially first 
responders and law enforcement and probably family members of 
people who have these issues, as well as maybe the people 
themselves, have access, with the appropriate training. I have 
used Naloxone myself many times, primarily in intensive-care 
units when we felt patients were overnarcotized. But there are 
ramifications of using it, and we just need to make sure 
everyone has the training. But I really agree with what Mr. 
Sarbanes said.
    The other thing is I think we need to recognize this goes 
across age groups. For example, in 2013, the most commonly 
prescribed drug under Medicare Part D was the generic version 
of Vicodin--not an antibiotic, but a narcotic.
    So, with that said, you know, I really appreciate all of 
your comments today. And I agree with the team doctor, Dr. 
Anderson, also. We need to address that situation going 
forward.
    Dr. Sledge, can you expand on your experience treating this 
problem with the available current medications that are out 
there? I mean, you obviously use other methods other than 
medication treatment, but your experience at Cumberland also, 
using those options also?
    Dr. Sledge. Sure. And I appreciate the question. During the 
assessment process, you know, we offer options as patients come 
in, very clear with the course of treatment that we would 
recommend at the time of the assessment. There are a myriad of 
referents in the Nashville area if they choose to utilize a 
different approach.
    But we use buprenorphine, typically, to detox, to get the 
patient opioid-free. And with a sufficient period of time, 
which is very difficult to achieve in an outpatient setting, 
but in a residential setting, with a sufficient period of time 
of abstinence, we can begin to use a pure opioid antagonist or 
an opioid blocker, if you will, naltrexone, and administer that 
in an extended-release formulation that lasts for 30 days in 
conjunction with their biopsychosocial----
    Mr. Bucshon. OK. And Dr. Waller, I was interested in your 
comments about 2872, since I am one of the ones that is working 
on it. And thank you. With that we are still working through 
this, trying to make sure, actually, we expand access to 
treatment for patients, and we have a process we are going 
through that we need to continually work on.
    The one thing, though, I do, maybe slightly disagree on is, 
that we should consider history, and we should consider money, 
as part of a reason why to do or not to do things as it relates 
to drug treatment. I understand the practical aspects of that.
    So, I mean, what might you suggest? What would your 
suggestions be to expand, really access to outpatient treatment 
for these problems? Because, clearly, as you know, what we have 
now, we have methadone, buprenorphine, and Naloxone--well, 
naltrex--I keep confusing the two. You know what I am talking 
about.
    Dr. Waller. I do. Yes.
    Mr. Bucshon. Vivitrol. I mean, we are trying to expand 
access. If you don't think that we should make sure that 
everyone is able to offer all of the options for treatment 
medically, what should we do?
    Dr. Waller. Well, no. I think that I may have misspoke or 
been misunderstood. I think all three should be available for 
sure. I use all three----
    Mr. Bucshon. Yes.
    Dr. Waller [continuing]. On a regular basis. I have a 
number of patients on long-acting naltrexone, and we use it at 
the time in which it is right for the patient. For some people, 
it is right at the beginning. For my population in general, 
though, it is toward the end of treatment as we stabilize them 
on these other medications and let the psychosocial aspects 
really start to work.
    So the biggest thing that I think we have to do is make 
sure that those of us who have access, and knowledge, and extra 
training, and board certification in this area, much like you 
did in your training, you wouldn't want a general surgeon doing 
cardiothoracic surgery. You know, just like we want to be able 
to help our colleagues in primary care by stabilizing these 
complex patients and helping them to maintain them over a 
period of time, and then in that fashion.
    So I think bolstering the capability for the people who are 
board certified and trained and focused on this illness to be 
able to deliver services to a higher number of people, with all 
of the medications, is of the utmost importance.
    Mr. Bucshon. OK. Thank you. I yield back.
    Mr. Pitts. The Chair thanks the gentleman, now recognizes 
the gentlelady from Indiana, Mrs. Brooks, 5 minutes for 
questions.
    Mrs. Brooks. Thank you, Mr. Chairman, for holding this 
hearing. And thank you all of the witnesses for coming today.
    I specifically would like to thank Dr. Halverson for being 
here. Welcome to Washington. It is an honor to have you before 
the panel and always nice to have a fellow Hoosier in the 
Nation's Capitol. And I have to admit, your experience--State 
health director, CDC, now at IU Fairbanks School of Public 
Health--we are very fortunate to have in you Indiana.
    And in fact, I want to thank you, because Dr. Halverson 
convened a roundtable, at IUPUI with prescribers, pharmacists, 
members of HHS and VA, and we discussed the challenges Indiana 
was facing then. As, unfortunately, one of the States leading 
the country in prescription opioid and heroin drug abuse. And 
we had quite a discussion that day, and we actually also had 
someone from the med school who attended, and we appreciated 
his participation.
    But one thing that ONDCP, they released a report in 2011 
that cited their intent to encourage medical and health 
professional schools, such as Fairbanks, to continue expanding 
the continuing education programs for prescribers. More 
instruction on measuring pain and prescribing to treat it. Now, 
that was 4 years ago. I think we are still really struggling in 
the country with getting our medical schools and our continuing 
medical education programs, embracing this concept. And could 
you please discuss not only your efforts, but I would be 
curious from the panel, what are we doing wrong? Why can we not 
get our med schools and our continuing medical education and 
other health educators to focus on the prescribing practices?
    Dr. Halverson, would you please start. Because this is not 
a new issue. ONDCP said it in 2011, so what challenges, 
obstacles, what do we need to do to get our prescribers onboard 
with this?
    Dr. Halverson. Well, thank you, Representative Brooks. We 
appreciate your interest specifically in this matter. I would 
also say that the need is clear. It is my understanding we are 
constantly looking at curriculum, and this is an important 
issue. I have had conversations with our medical school dean 
about this issue, but I also know that there are a whole lot of 
other issues that are also in competition for that time. But I 
also don't think there is any question about the importance of 
this education.
    Certainly, as we look in Indiana around issues of 
continuing education and the need to inform all of the 
prescribers around this issue, continuing education is not in 
dispute. I think, really, it has been in the implementation, 
particularly as it relates to reimbursement, and just the 
logistics around getting it in place. But I don't think there 
is any disagreement around the importance of the education.
    Mrs. Brooks. Well, I have been involved in higher education 
before coming to Congress, and I understand the curriculum 
committees. There is a lot of discussion and a lot of work that 
goes into providing curriculum. However, when our med schools 
are saying they get 3 to 5 hours, possibly, in med school on 
pain, it is just simply not enough. And at this point, to come 
up with one set curriculum, I think, is a problem. Let's do 
more.
    And I am curious, do we need to be requiring it? Does it 
need to be mandatory? Should there be certain hours that all 
prescribers are required to take a year?
    I am a lawyer. We have continuing legal education credits 
that we are required to have every year. There are some 
requirements--what do the other panelists think? This is very 
troublesome for me. Not just for physicians, but nurses, 
dentists, others who are prescribers. What should we be doing?
    Any ideas of what can we do to fix this problem? Because we 
have been talking about it far too long and our educators 
haven't resolved the issue.
    Dr. Waller. So, two very practical possible solutions, and 
one is to consolidate the efforts of adding to the curriculum 
for pain and addiction based on the governing body for the 
national medical schools rather than having a heterogeneous 
group of medical schools come up with their own curriculum.
    This curriculum has already been developed by SAMHSA as 
well as CMS, and has put out there as a recommended curriculum. 
It is there, access to it online for free is available in many 
locations, so you don't even have to have your own specialist. 
But you need to have the mandate within the medical schools 
that this is a part of the curriculum. It is currently not.
    Mrs. Brooks. And unlike my colleague, Dr. Bucshon, who went 
to med school, I did not, so I don't know what is mandated. Are 
there other parts in the medical education that are mandated, 
or is it all left up to each individual med school? I am 
certain there must be a lot of mandatory curriculum items. Can 
you give us a couple of examples of a couple of them, and why 
wouldn't this be one of them?
    Dr. Waller. Well, a specific example is, every medical 
student has to rotate through the core curriculum, and the core 
curricula hasn't changed, in 100 years almost. I mean, when you 
look at it, it is internal medicine; it is general surgery, and 
then it is the connections between all of those. Pediatrics, 
and then you rotate through the critical care, the inpatient 
care, and the outpatient care of each of those. Adding on the 
specialties has always been an option. And they have seen 
addiction medicine and pain medicine as a high-end specialty 
for which many don't have access to rotate.
    So until you mandate it as a part of the clinical 
curriculum so they actually stand next to somebody doing this, 
there is no way for them to glean from a book how hard it is to 
talk to some of these patients who have had a horrible early 
life, and they have to see it. And if you mandate that, they 
will find it, because there are people everywhere, there is a 
medical school. There is someone who is board certified in pain 
or addiction to do this.
    And then, I am sorry, my friends are not going to like me 
for this, but I think that physicians who prescribe controlled 
substances should be mandated to have ongoing, you know, CME, 
period. And ASAM agrees with that.
    Mrs. Brooks. I would be curious--and I see that my time is 
up, but, Mr. Chairman, if I could just ask the panel, I would 
be curious if anyone on the panel disagrees with that notion?
    Dr. Sledge. No.
    Dr. Katz. No, absolutely not.
    Mrs. Brooks. Sir?
    Dr. Anderson. I don't disagree.
    Mrs. Brooks. Thank you. With that, I yield back, Mr. 
Chairman.
    Mr. Pitts. The Chair thanks the gentlelady.
    Now, without objection, the gentleman, Mr. Tonko, a member 
of the full committee, is recognized for 5 minutes for 
questions.
    Mr. Tonko. Thank you, Mr. Chairman.
    Thank you for the thoughtful discussion by the panelists 
and to the many in the room who make it their passion to end 
this epidemic.
    I understand that the Drug Addiction Treatment Act of 2000, 
or DATA 2000, was passed to expand access to addiction 
treatment, across geographic boundaries, and populations by 
integrating it into the general medical setting.
    So for Dr. Waller, can you describe how DATA 2000 expanded 
access to addiction treatment services in the United States?
    Dr. Waller. Yes, sir. And, again, Congressman Tonko, thank 
you for all your hard work in this area. It is greatly 
appreciated.
    Mr. Tonko. Well, we have good partners, so----
    Dr. Waller. So one of the things that it has done, is it 
has allowed for clinics such as mine, which I work for a 
medical system. I am an employee of a hospital system, to be 
able to open our doors and see patients based on a referral, in 
an outpatient setting, and then deliver the highest quality of 
care. So it allows for a specialist like me to work in a 
standard medical setting and deliver care to patients, both for 
pain and addiction, and all of the psychosocial aspects.
    From a primary care aspect, it does allow them to treat in 
place. And especially in our rural areas of America, which is 
the largest part of America, there are no methadone clinics. 
There are no inpatient treatment facilities for hundreds of 
miles in many places. And in my home State, Michigan, we have 
an Upper Peninsula that is devoid of treatment. They don't have 
a buprenorphine prescriber in the entire Upper Peninsula now. 
This is a large portion of the population that is left without.
    So, being able to not make this feel like a criminal act to 
write this medication for patients, not be fearful of the DEA 
walking into your office while you are seeing a patient for 
hypertension to write buprenorphine, and then the availability 
of the medication to prescribe in a thoughtful, safe way is 
key. It is expanded in many areas, but we still have a lot to 
go, and it is for all of those reasons I just stated.
    Mr. Tonko. Well I say this in terms of expanding it, the 
law expanded access to buprenorphine in some ways, but the law 
did set certain limits. And it is clear from the current opioid 
crisis that we have outgrown those rules. And as you know, in 
2012, 96 percent of our States and the District of Columbia had 
opioid abuse or dependence rates higher than their 
buprenorphine treatment capacity rates.
    So I am concerned that the opioid crisis has outgrown those 
rules. Could you explain how the current cap of 100 patients, 
Dr. Waller, has limited our ability to respond to the current 
opioid epidemic?
    Dr. Waller. Yes. We have two areas that we have dug in 
pretty deeply above the national level, and me at the local 
level. One is the first year, you can only see 30. You take 
your 8 hours of education and make sure that you finish the 
test and then you get your certification to see 30 patients. 
The next year you can apply for 100. For that, those of us who 
were specialty trained capped out at 100 pretty quickly, 
because the vast majority of the patients funnel to us. And so 
we capped very early within our areas.
    In primary care, we have a large percentage of doctors who 
have chosen not to write for this medication, despite having an 
X license. And so what it looks like is we have a large amount 
of capacity. Well, we have 423 primary care doctors in my 
medical group, and I have talked to over 300 of them to find 
out why they won't write this medication in their practice.
    And it is consistent. They don't feel like they have the 
training. They don't feel like they have the support to 
evaluate and initiate treatment in patients and then stabilize 
them. They feel comfortable with the maintenance as long as 
they know they have backup. But the reason that we don't see a 
lot of primary care doctors raising that, you know, seeing up 
to 100 patients, or seeing the 30, is because they don't feel 
like they have the appropriate knowledge and backup. When we 
have offered that, we have seen, they do a really good job with 
this. I mean, once they learn about the disease, their ability 
to treat it is really good.
    But it needs to be stabilized in a specialty setting and 
then handed off. Therefore, raising the cap for people who do 
this as a specialty, and have board certifications then it 
would allow us to then hand some of our patients off to primary 
care over time but then allow us to not have a barrier, in my 
case, a 7-month waiting list to see patients.
    Mr. Tonko. And do you have an opinion on the current 
prohibition of certain--other professionals that might assist 
here, prohibition on nonphysician providers prescribing 
buprenorphine, including nurse practitioners, physician 
assistants? Does that limit patient access?
    Dr. Waller. It absolutely does. I have two PA, physicals 
assistants, in my office who are the backbone of my patient 
evaluation. They are seeing patients as I am sitting here. But 
we are limited in what they can do. So if I had an urgent 
intake, they are frozen. They can't see a new patient and start 
them on buprenorphine, even if they are under my supervision. I 
can't pick up a phone, they don't have the legal right to write 
that prescription.
    So, starting this in a way in which is appropriately 
supervised and so that they have somebody to go to for the 
difficult patients and can onboard this knowledge and training 
is very important. But the access for them to be able to write 
these from a practical standpoint, it really just has to 
happen. They are really moving forward the biggest part of our 
healthcare system.
    Mr. Tonko. Thank you. With that, I yield back. Mr. Chair, 
thank you very much.
    Mr. Pitts. The Chair thanks the gentleman. That concludes 
the questions of the members who are present. There will be 
other members who have questions and follow-ups that we will 
send you in writing. We ask that you would please respond 
promptly. Members should submit their questions by the close of 
business on Tuesday, November the 3rd. So members have 10 
business days to submit the questions for the record.
    Very informative and important issues we are dealing with. 
Thank you for your expert testimony. It will help us as we 
proceed to move the legislation, the subject of the hearing. 
And I want to thank each of you for coming and presenting the 
expert testimony today.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 5:12 p.m., the subcommittee was adjourned.]
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