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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 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California7 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

DORIS O. MATSUI, California 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

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. lll, the Improving Treatment for Pregnant and Postpartum Women 

Act of 2015, 2 submitted by Mr. Luja ́n 

H.R. lll, 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 

1Mr. Botticelli and Mr. Riley did not answer submitted questions for the record by the 

time of printing. 2Legislation 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. 

Page

IV 

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 

3Dr. Sledge did not answer submitted questions for the record by the time of printing. 

Page

V 

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 

(1) 

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, Luja ́n, 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 adVerDate Mar 15 2010 09:27 Aug 26, 2016 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X86DRUGABUSEASKOK082516\114X86DRUGABUSELEGREVD
2 

dress 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. 

3 

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 

4 

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. 

5 

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 

Luja ́n. 

Mr. LUJA ́ N. 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. Luja ́n 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 

6 

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-CoPrescribingtoReduceOverdosesActof2015.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 

7 

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. 

8 

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. 

9 

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 

10 

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 FDAapproved 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 

25 

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 

36 

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. 

51 

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 behavVerDate Mar 15 2010 09:27 Aug 26, 2016 Jkt 037690 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X86DRUGABUSEASKOK082516\114X86DRUGABUSELEGREVD
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ior, 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 

53 

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 nonopioid 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 patVerDate Mar 15 2010 09:27 Aug 26, 2016 Jkt 037690 PO 00000 Frm 00059 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X86DRUGABUSEASKOK082516\114X86DRUGABUSELEGREVD
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terns 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 

55 

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 abusedeterrent 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 

56 

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 

57 

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. Luja ́n, 5 minutes for questions. 

58 

Mr. LUJA ́ N. 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. LUJA ́ N. 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. LUJA ́ N. 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 

59 

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. LUJA ́ N. 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 

60 

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. 

61 

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. Luja ́n 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? 

62 

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, socalled 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. 

63 

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 

64 

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 

65 

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. 

66 

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 coVerDate Mar 15 2010 09:27 Aug 26, 2016 Jkt 037690 PO 00000 Frm 00072 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X86DRUGABUSEASKOK082516\114X86DRUGABUSELEGREVD
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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? 

68 

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 doctorshopping, 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, 

69 

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 

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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 diverVerDate Mar 15 2010 09:27 Aug 26, 2016 Jkt 037690 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X86DRUGABUSEASKOK082516\114X86DRUGABUSELEGREVD
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sion 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 

72 

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. 

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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 Luja ́n 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. 

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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 

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tionally, 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 policylevel 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. 

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[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, notfor-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 insurancedependent, 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. 

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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 efVerDate Mar 15 2010 09:27 Aug 26, 2016 Jkt 037690 PO 00000 Frm 00134 Fmt 6633 Sfmt 6633 F:\114THCONGRESS\114X86DRUGABUSEASKOK082516\114X86DRUGABUSELEGREVD
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ficacy of these medications is not new. There are now eight largescale, 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. 

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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. 

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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 

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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:] 

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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. 

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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? 

174 

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? 

175 

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. 

176 

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 

177 

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—— 

178 

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. 

179 

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? 

180 

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. 

181 

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 

182 

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, 

183 

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? 

184 

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. 

185 

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. 

186 

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. 

187 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 5:12 p.m., the subcommittee was adjourned.] 

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