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EXAMINING THE OPIOID EPIDEMIC: 

CHALLENGES AND OPPORTUNITIES 

HEARING 

BEFORE THE

COMMITTEE ON FINANCE 

UNITED STATES SENATE 

ONE HUNDRED FOURTEENTH CONGRESS 

SECOND SESSION 

FEBRUARY 23, 2016 

( 

Printed for the use of the Committee on Finance 

COMMITTEE ON FINANCE 

ORRIN G. HATCH, Utah, Chairman 

CHUCK GRASSLEY, Iowa 

MIKE CRAPO, Idaho 

PAT ROBERTS, Kansas 

MICHAEL B. ENZI, Wyoming 

JOHN CORNYN, Texas 

JOHN THUNE, South Dakota 

RICHARD BURR, North Carolina 

JOHNNY ISAKSON, Georgia 

ROB PORTMAN, Ohio 

PATRICK J. TOOMEY, Pennsylvania 

DANIEL COATS, Indiana 

DEAN HELLER, Nevada 

TIM SCOTT, South Carolina 

RON WYDEN, Oregon 

CHARLES E. SCHUMER, New York 

DEBBIE STABENOW, Michigan 

MARIA CANTWELL, Washington 

BILL NELSON, Florida 

ROBERT MENENDEZ, New Jersey 

THOMAS R. CARPER, Delaware 

BENJAMIN L. CARDIN, Maryland 

SHERROD BROWN, Ohio 

MICHAEL F. BENNET, Colorado 

ROBERT P. CASEY, Jr., Pennsylvania 

MARK R. WARNER, Virginia 

CHRIS CAMPBELL, Staff Director 

JOSHUA SHEINKMAN, Democratic Staff Director 

(II) 

C O N T E N T S 

OPENING STATEMENTS 

Page 

Hatch, Hon. Orrin G., a U.S. Senator from Utah, chairman, Committee on 

Finance .................................................................................................................. 1 

Wyden, Hon. Ron, a U.S. Senator from Oregon .................................................... 4 

WITNESSES 

Coukell, Allan, senior director, health programs, The Pew Charitable Trusts, 

Washington, DC ................................................................................................... 7 

Young, Nancy K., Ph.D., director, Children and Family Futures, Inc., Lake 

Forest, CA ............................................................................................................. 8 

Hart, David, Assistant Attorney-in-Charge, Health Fraud Unit/Consumer Protection Section, Oregon Department of Justice, Salem, OR ............................. 10 

ALPHABETICAL LISTING AND APPENDIX MATERIAL 

Casey, Hon. Robert P., Jr.: 

Prepared statement .......................................................................................... 35 

Coukell, Allan: 

Testimony .......................................................................................................... 7 

Prepared statement .......................................................................................... 36 

Responses to questions from committee members ......................................... 39 

Hart, David: 

Testimony .......................................................................................................... 10 

Prepared statement .......................................................................................... 41 

Response to a question from Senator Bennet ................................................ 43 

Hatch, Hon. Orrin G.: 

Opening statement ........................................................................................... 1 

Prepared statement .......................................................................................... 44 

Toomey, Hon. Patrick J.: 

Letters submitted for the record ..................................................................... 45 

Wyden, Hon. Ron: 

Opening statement ........................................................................................... 4 

Prepared statement .......................................................................................... 55 

Letters submitted for the record ..................................................................... 57 

Young, Nancy K., Ph.D.: 

Testimony .......................................................................................................... 8 

Prepared statement .......................................................................................... 63 

Responses to questions from committee members ......................................... 74 

COMMUNICATIONS

American Academy of Pain Management et al. .................................................... 93 

American Academy of PAs (AAPA) ........................................................................ 97 

American Pharmacists Association (APhA) ........................................................... 101 

City of Baltimore, MD ............................................................................................. 104 

DeWine, Mike ........................................................................................................... 111 

First Focus State Policy and Advocacy Reform Center (SPARC) ........................ 112 

National Association of Chain Drug Stores (NACDS) .......................................... 114 

National Community Pharmacists Association (NCPA) ....................................... 117 

(III) 

(1) 

EXAMINING THE OPIOID EPIDEMIC: 

CHALLENGES AND OPPORTUNITIES 

TUESDAY, FEBRUARY 23, 2016 

U.S. SENATE, COMMITTEE ON FINANCE, Washington, DC. 

The hearing was convened, pursuant to notice, at 10:10 a.m., in 

room SD–215, Dirksen Senate Office Building, Hon. Orrin G. Hatch 

(chairman of the committee) presiding. 

Present: Senators Grassley, Crapo, Thune, Burr, Portman, Toomey, Coats, Scott, Wyden, Schumer, Stabenow, Cantwell, Nelson, 

Menendez, Carper, Brown, and Bennet. 

Also present: Republican Staff: Chris Armstrong, Deputy Chief 

Oversight Counsel; Brett Baker, Health Policy Advisor; Chris 

Campbell, Staff Director; and Becky Shipp, Health Policy Advisor. 

Democratic Staff: David Berick, Chief Investigator; Laura Berntsen, Senior Advisor for Health and Human Services; Anne Dwyer, 

Health-care Counsel; Michael Evans, General Counsel; Elizabeth 

Jurinka, Chief Health Advisor; Matt Kazan, Health Policy Advisor; 

and Joshua Sheinkman, Staff Director. 

OPENING STATEMENT OF HON. ORRIN G. HATCH, A U.S. 

SENATOR FROM UTAH, CHAIRMAN, COMMITTEE ON FINANCE 

The CHAIRMAN. The committee will come to order. Today, we are 

here to discuss the very important issue of opioid abuse. 

Opioids are a powerful class of drugs prescribed to treat severe 

pain. When used appropriately, these drugs provide much-needed 

relief to patients after a surgical procedure or during treatment for 

cancer. Unfortunately, opioids also have qualities that make them 

addictive and prone to abuse. The goal of today’s hearing is to help 

us gain a better understanding of why opioid use has risen dramatically in the past 15 years and how we can best curtail abuse. 

Put simply, opioid abuse has become an epidemic and a significant public health problem. While it puts serious strains on our 

health-care system, including Medicare and other Federal programs, the most devastating consequence of opioid abuse is the 

human impact. Opioid abuse takes a major toll on families and 

children, often persisting for generations. 

The statistics are staggering. Opioids are prescribed in such 

quantities that every adult in the United States could have a 

month’s supply. Approximately 7,000 people show up in an emergency room each day for treatment of problems associated with prescription opioid abuse. One opioid-related death takes place in our 

country almost every 30 minutes. My home State of Utah has been 

2 

hard hit by this epidemic. In 2014 alone, 289 Utahans died due to 

opioid abuse, which is more than half of all drug overdose-related 

deaths in the State. The problem is even worse in other States. I 

am sure many of my colleagues will not only have numbers to 

share regarding their States, but have stories about individuals as 

well. 

The good news is that there is wide recognition of the problem 

and shared interest in trying to find solutions. A few weeks ago, 

the Senate Judiciary Committee unanimously reported the Comprehensive Addiction and Recovery Act legislation sponsored by 

Senator Portman. I think it is a good bill. I was pleased to vote for 

it in committee and hope the full Senate will pass it swiftly and 

without unnecessary delay. I compliment Senator Portman for his 

work on that, and others with him. 

Today’s hearing will focus on another good bill, one that is in the 

Finance Committee’s jurisdiction. As I mentioned, Medicare is not 

immune from the costs of opioid abuse. The Government Accountability Office, the Medicare Payment Advisory Commission, and 

others have identified it as a problem. Though only a relatively 

small number of beneficiaries are at risk, we owe it to those individuals, their families, and the Medicare program to do all we can 

to address this problem. 

Senators Toomey and Portman have a very thoughtful bipartisan 

bill with Senators Casey and Brown that would provide Medicare 

with an important tool in the fight against opioid abuse. The bill 

would allow Medicare Part D prescription drug plans to work with 

at-risk beneficiaries to identify one physician to prescribe opioids 

and one pharmacy to fill all the opioid prescriptions. Having opioids prescribed by one physician instead of multiple doctors will result in better patient care and reduced abuse. It will also make it 

more likely that a beneficiary with a problem gets the help they 

need. Nearly all Medicaid programs and private payers have such 

a prescription drug review and restriction or ‘‘lock-in’’ program. I 

look forward to hearing more today about the success of these programs in Medicaid and how the Toomey-Portman bill would have 

a similar impact in Medicare. 

The Toomey-Portman bill has bipartisan support on the committee, with both Senators Brown and Casey acting as strong proponents. Establishing a lock-in program in Medicare is also supported by President Obama, as it was first proposed in the administration’s budget proposal. I applaud Senators Toomey and 

Portman for their leadership on this legislation, and I hope we can 

move it very soon. 

Of course, the impact of the opioid epidemic stretches far beyond 

our health-care system, touching on virtually all parts of the social 

safety net. Today, in addition to discussing the impact on the 

health-care system, we will hear more about the implications of 

these substance abuse crises for our child welfare system. 

The current opioid epidemic is just the latest manifestation of an 

ongoing problem in child welfare. Whether it be the crack cocaine 

epidemic of the 1980s, the methamphetamine epidemic that has 

plagued many rural areas, or the current opioid crisis, we have 

seen time and again that the child welfare system is ill-equipped 

to deal with families struggling with substance abuse. Instead of 

3 

finding ways to get families affected by addiction the help and support they need to get and stay sober, the majority of Federal dollars in the child welfare system are spent on removing children 

from their homes and placing them into foster care, which most 

have acknowledged is the least-effective and most-expensive outcome. 

Children who are raised by the State in foster care face increased 

risks of substance abuse, homelessness, pregnancy, and other negative outcomes, both while they are in the system and when they 

transition out as adults. In cases of untreated addiction, the cycle 

of addiction can persist for generations. 

Senator Wyden and I have been working together on bipartisan 

legislation that would provide the States the flexibility to use Federal child welfare funds to address issues of substance abuse and 

other risk factors. We are also talking with our colleagues over in 

the House, and I hope that we will be able to get to a bipartisan, 

bicameral agreement on a path forward. Children and families are 

relying on us to take this important step. 

Let me conclude by saying that the opioid epidemic is a complex 

problem that needs a multifaceted solution. We will discuss at least 

opportunities to make a difference here today—the ToomeyPortman bill dealing with Medicare and our efforts with regard to 

child welfare. 

Of course, these are not the only ideas out there. If there are any 

others, I would be happy to hear about them and consider any 

ideas that might be within the Finance Committee’s jurisdiction, so 

long as they are constructive and do not take an overly simplistic 

view of this serious and complicated problem. 

Before I conclude, I want to take a moment and address some 

concerns that have been shared with the press about the scope of 

this hearing and the composition of today’s panel of witnesses. I 

have, in keeping with the traditions of this committee, always 

worked with the ranking member to select witnesses in order to ensure a balanced panel in each committee hearing. Today’s hearing 

is no different. Both Senator Wyden and I agreed and signed off 

on the witnesses for this panel. I will note, for example, that we 

have a high-ranking official from the ranking member’s home State 

here with us today. 

So it is difficult for me to imagine why anyone would be expressing disappointment over the balance of the witnesses, particularly 

at this point. We have a very distinguished group of experts before 

us today, one that I think will shed light on a wide variety of 

issues. 

So I hope that, rather than spending time on lamenting who is 

and who is not on the panel, my colleagues will focus on the witnesses before us, as well as their own thoughts on how to best address the opioid epidemic. 

With that, I would like to thank these witnesses for being here 

today to discuss this important topic. 

I will have to leave shortly to go over and introduce my Governor 

at the Judiciary Committee hearing, but, at this time, I will turn 

to Senator Wyden for his opening remarks. 

[The prepared statement of Chairman Hatch appears in the appendix.] 

4 

OPENING STATEMENT OF HON. RON WYDEN, 

A U.S. SENATOR FROM OREGON 

Senator WYDEN. Thank you very much, Mr. Chairman. I share 

your view that this opioid issue is another one where this committee can come together and work in a bipartisan way, and I look 

forward to working with you in that regard. As the committee that 

is required to pay for the most important health programs in the 

Nation, the Finance Committee must step up and do its part to address the opioid crisis. 

In the coming years, Medicare and Medicaid are expected to account for over a third of substance abuse-related spending. That 

amounts to billions and billions of dollars each year. Any solution 

that is going to stem this tide has to include the Finance Committee and our bedrock health-care programs. 

Americans today are paying for a distorted set of priorities. 

Americans are getting hooked on opioids, there is not enough treatment, and enforcement is falling short. That sounds like a trifecta 

of misplaced priorities to me, and the Finance Committee has the 

opportunity, working in a bipartisan way, to develop fresh policies 

to start righting the ship. 

As one listens to the current debate on opioids, there is a sense 

that somehow policymakers have to line up and choose one of two 

solutions. One approach is tough enforcement, which means cracking down on pill mills, fraudsters bilking Medicare and Medicaid 

with unneeded prescriptions, and unscrupulous abusers doctorshopping for the next bottle of pills. Others want to focus on more 

social services. My own view is what is needed is a fresh approach 

that focuses on three areas: better prevention, better treatment, 

and better and tougher enforcement. Real success is going to require that all three work in tandem. 

When it comes to preventing addiction, any discussion has to include how these drugs are prescribed in the first place. In Oregon 

last week, I discussed with my constituents what I call the prescription pendulum. Where doctors were once criticized for not 

treating pain aggressively enough, today they are being criticized 

for prescribing too many opioids to manage pain. So one of our 

challenges is to have policies that start getting that balance right. 

The Centers for Disease Control and Prevention is trying to 

break new ground with their guidelines for prescribing opioids. 

Along with better prescribing practices, there need to be more responsible marketing practices by opioid manufacturers. 

I am very pleased that we are joined today by David Hart. He 

is with the Oregon Attorney General’s office. He has background in 

both health care and law enforcement, and I think we are all going 

to benefit from Mr. Hart’s considerable experience in this area. 

I am also very troubled about the influence the manufacturers 

have on medical prescribing practices. I have sent an inquiry to 

Secretary Burwell to ensure that any potential conflicts of interest 

as a result of funding received from drug manufacturers have been 

properly disclosed for members of government panels who are evaluating the Centers for Disease Control guidelines. Doctors ought to 

have the best information on prescribing these powerful drugs 

without undue influence from the companies that manufacture 

them. 

5 

In my view, a key piece of the puzzle has to be more prompt and 

more effective treatment of those who are dealing with an addiction 

to opioids. A prerequisite for any lasting solution needs to include 

improving access to addiction treatment and mental health services, and that is especially important for rural and underserved 

communities. It is no coincidence these areas have some of the 

highest rates of abuse and overdose in the country. 

Mental health and treatment for addiction have also gotten short 

shrift for far too long, and it is time for changes here as well. For 

example, the Finance Committee could be taking a look at what is 

called the IMD exclusion, an out-of-date policy from the 1960s that 

says services, like rehab or some emergency mental health stays in 

an inpatient setting, cannot be covered by Medicaid. That is a big 

policy change. I believe it ought to happen, but I also think we are 

going to have to be acutely aware of the vast sums that would be 

needed to pay for these services, and that will be a unique challenge. 

So the Congress has some tough choices to make if we are really 

going to solve this crisis. If prevention and treatment are not addressed up front, the costs will be even higher: pregnant mothers 

giving birth to opioid-dependent babies, EMTs and emergency 

rooms dealing with overdose calls every night, county jails taking 

the place of needed substance abuse treatment, able-bodied adults 

in the streets instead of working in a family-wage job. America’s 

tax dollars should be spent more wisely, and the Finance Committee has an opportunity to find the right mix. 

I am going to close by saying that I believe we already have an 

opportunity in this committee, in a bipartisan way, to start the reforms that are needed in this area. Our committee has been working for some time on a bipartisan proposal to get parents and kin 

care providers the kind of help they need to keep children safely 

out of foster care when addiction strikes a family member. A parent’s drug addiction is becoming a growing reason for removing 

children from their homes and placing them in foster care. 

A recent Reuter’s investigation found, on average, a baby is born 

opioid-dependent every 19 minutes. Using hospital records, the reporters found that there were more than 27,000 drug-dependent 

babies born in 2013. Many of these babies are going to enter the 

foster care system. In fact, as the committee will hear from Dr. 

Young, infants made up the largest group of children placed in outof-home care in 2014, and growth in the share of infants entering 

care is a trend that has been increasing consistently over the past 

several years. Protecting these babies and their siblings is, in my 

view, going to require getting better help and treatment for the 

moms and dads who are suffering these afflictions. 

The chairman and I have engaged in a very active effort to address these daunting challenges. We have been calling it the Family First Act, and it would help prevent unnecessary foster care 

stays through programs like evidence-based substance abuse treatment, reducing unnecessary congregate care stays, and putting in 

place stronger protections so that kids in foster care are safe. It is 

about making sure the system works better for the children. 

I thank Chairman Hatch and all my colleagues on both sides of 

the aisle, because I hope we can pursue these reforms soon. 

6 

I spent last week getting to about every corner of my State, from 

Medford to Eugene to Portland; I was in eastern Oregon and central Oregon. The message whenever anybody asked about opioids 

was clear: this epidemic is carving a path of destruction through 

communities in every corner of America. 

Oregon has the dubious distinction of ranking fourth worst for 

abuse and misuse of opioids in the Nation. In my home State, citizens are not going to accept being fourth worst. I know from talking with my colleagues here—Republicans, Democrats—that every 

State is dealing with this crisis. 

Finally, one story of the many I heard was especially devastating, and it illustrates how dramatically this opioid crisis has 

unfolded across the country. I spoke with a parent who told me 

about high school athletes struggling with addiction to these medicines. 

When I went to school on a basketball scholarship, dreaming of 

playing in the NBA, there was never any talk in the locker room 

about opioids. Now, the next generation of young people are getting 

swept up in a crisis beyond their control. 

So I thank all of our witnesses. I think we are going to have a 

good panel. There are colleagues on the Democratic side, there are 

colleagues on the Republican side who want to work constructively 

on these issues. 

Finally, special thanks to David Hart. That is a long trek to come 

and testify. But he has expertise on the health-care side and on the 

enforcement side. We welcome all three. 

[The prepared statement of Senator Wyden appears in the appendix.] 

Senator WYDEN [presiding]. Chairman Hatch is going to have to 

be away for a few minutes. He asked me to introduce all of our witnesses. 

Our first witness will be Allan Coukell. He is with Pew Charitable Trusts. He is the senior director of health programs at Pew, 

where they do very good work on lots of issues. He focuses on prescription drugs and medical device issues. Prior to joining Pew, he 

practiced clinical pharmacy in the area of oncology and served as 

a writer and editor for medical journals and media outlets. 

Second, we are happy to have Dr. Nancy Young. She is the director of Children and Family Futures, an organization she founded 

in 1996. This organization is focused on improving the well-being 

of those impacted by substance abuse and mental health disorders. 

While she has been at the organization, she also helped to guide 

the efforts of government and private entities to achieve optimal 

outcomes from child welfare programs. 

As I indicated, our third witness will be Mr. David Hart. He is 

an Assistant Attorney General in the Oregon Department of Justice. He has been the lead attorney on health-care fraud and consumer protection issues in our State, focused on marketing practices related to drugs and devices. As I indicated, prior to his work 

at the Department of Justice, he has been a physical therapist in 

a variety of patient settings, including hospitals and hospice. 

So we are pleased to have all three of you here. We will make 

your prepared statements a part of the record in their entirety, 

7 

and, if you could take 5 minutes or so and summarize your principal views, that would be very helpful. 

Welcome. 

STATEMENT OF ALLAN COUKELL, SENIOR DIRECTOR, HEALTH 

PROGRAMS, THE PEW CHARITABLE TRUSTS, WASHINGTON, DC 

Mr. COUKELL. Ranking Member Wyden, thank you and Chairman Hatch and the committee for holding this hearing on the 

opioid epidemic. My name is Allan Coukell. I am a pharmacist and 

director of health programs at The Pew Charitable Trusts. We are 

an independent, nonprofit research and policy organization. 

We focus on prescription drug abuse, because it is one of the 

pressing public health problems of our time. You have already outlined some statistics, and suffice it to say that nearly all of us now 

know someone who has been affected, urban or rural, young or old; 

19,000 deaths a year, 50 a day, and that does not even begin to 

tell the whole story of the toll on people’s lives and jobs and families and on the fabric of our communities. 

And yet, these deaths and addiction are preventable. It will take 

a multifaceted approach, and today I will focus on one policy 

change in Medicare that will improve patient care and reduce the 

chance of overdose. The approach I am talking about is known as 

a patient review and restriction program, or PRR. These programs 

are used in nearly every Medicaid program and by commercial 

drug plans, but this very same tool is currently prohibited in Medicare. 

Fixing that is straightforward. It can be done now by passing S. 

1913, the Stopping Medication Abuse and Protecting Seniors Act of 

2015. Pew supports this legislation, and I would like to thank Senators Toomey and Brown and Portman and Kaine for their leadership as original cosponsors and the many additional bipartisan cosponsors on this committee. 

So what is a PRR program and how would it work? Basically, a 

PRR identifies people at risk of addiction or overdose and ensures 

that they get coordinated care through one doctor or one pharmacy. 

The patient is initially identified using specific criteria, things like 

multiple prescriptions from multiple doctors in a single month. 

Other risks include duplicate prescriptions, emergency department 

visits, and so on. 

When these initial criteria are found, a pharmacist or a nurse 

looks at the patient’s profile, and if the high use of opioids is warranted—the patient is in hospice or getting treated for cancer, for 

example—that is the end of the process. But if there is concern 

that the patient is doctor-shopping and at risk for overdose, the 

plan contacts them and works with them to identify just one physician or one pharmacist who will provide the pain medication that 

they need. That improves care coordination and reduces the risk of 

multiple prescribers not knowing what else the patient is on. 

As I mentioned, these programs are already in widespread use. 

In Tennessee, for example, individuals who enrolled in the Medicaid PRR had about a 50-percent decrease in controlled substance 

prescriptions. Minnesota achieved an estimated cost savings of $1.2 

million for 245 patients based on reduced prescriptions, but also 

fewer clinic visits and emergency department visits. 

8 

The CDC convened an expert panel that concluded these programs have the potential to save lives and lower health-care costs 

by reducing opioid use to safer levels. S. 1913 would allow Medicare Part D plans to operate PRRs, something they cannot now do 

under current law. 

We know there are substantial numbers of Medicare patients at 

risk. A CMS analysis identified about 225,000 beneficiaries who got 

potentially unsafe doses of opioids for at least 90 consecutive days. 

A GAO study found 170,000 Part D beneficiaries who obtained the 

drugs from at least five pharmacies and up to 87 physicians a year. 

Pew has worked with a range of stakeholders to develop key 

principals that should be in any PRR legislation, elements like an 

appeal process for beneficiaries and patient input into the selection 

of prescribers and pharmacies to ensure reasonable access. S. 1913 

contains these provisions, and there is substantial support to advance the legislation. 

A similar proposal has already passed the House with broad bipartisan support. This policy was included in the administration’s 

fiscal year 2016 and 2017 budget requests. The HHS Inspector 

General has included PRRs as one of 25 quality improvements that 

should be prioritized and implemented. 

So let me conclude by quoting Andy Slavitt, the Acting CMS Administrator. ‘‘A PRR proposal for Medicare,’’ he said, ‘‘makes every 

bit of sense in the world and would be very helpful in really taking 

a practical measure to stem abuse.’’ 

I thank you for your work on this important problem, and I welcome your questions. 

[The prepared statement of Mr. Coukell appears in the appendix.] 

Senator WYDEN. Thank you very much, Mr. Coukell. 

Dr. Young? 

STATEMENT OF NANCY K. YOUNG, Ph.D., DIRECTOR, 

CHILDREN AND FAMILY FUTURES, INC., LAKE FOREST, CA 

Dr. YOUNG. Chairman Hatch, Ranking Member Wyden, members 

of the Finance Committee, thank you for conducting this hearing 

about our Nation’s opioid epidemic and specifically your interest in 

the effects of parents with opioid use disorders on the child welfare 

system. 

There are three points I would like to cover today—they are more 

fully described in my written statement—first, what the data says; 

what we know works; and opportunities for systems reform to improve outcomes to reduce our longer-term costs. 

For data, I wish I could tell you that there is clear data documenting the effect of parental opioid use disorders on child welfare 

services. Unfortunately, we have been here before in both the cocaine and the methamphetamine epidemics, and we still do not 

have reliable data in child welfare systems to monitor alcohol and 

drug use among parents. 

I have provided State-specific data that comes from the AFCARS 

data set in my written statement. But there are a few things we 

do know. After a high point in 1999 of over 567,000 children in 

care, there were about 15 years of decreasing numbers of kids. 

That trend ended in 2013, and we are now seeing upticks in the 

9 

numbers. One of the troubling statistics underlying that trend is 

the number of babies: 45,000 infants were placed in protective custody in 2013–2014, twice as many as any other age group. 

Of course, we then wanted to see, with the States with the high 

rates of babies coming into care, if they were also the States with 

high rates of neonatal abstinence syndrome, or NAS. Rates of NAS 

vary a great deal across the country. Mid-south central States— 

Kentucky, Tennessee, Mississippi, and Alabama—have the highest 

rates of NAS, with New England coming in second. These are regions that do also have higher rates of infants coming into care, although the data does not display a consistent pattern in each of the 

regions across the country. Over the past 5 years, however, drug 

abuse by a parent as a reason for the child’s placement increased 

by nearly 20 percent, more than any other factor. 

My second point is that there is, in fact, some good news. Federal 

investments during the methamphetamine epidemic and regional 

partnership grants—we call them RPGs—and OJJDP’s and 

SAMHSA’s investment in family drug courts have paid off with increasing our knowledge about how to improve child safety and family outcomes. There are variations from place to place about what 

these programs look like, but there are seven common practice 

strategies that communities adopt when they have flexible grant 

dollars. I detailed those in my written statement. 

In the first round of regional partnership grants, over 25,000 

children and almost 18,000 parents were served. Five key outcomes 

emerged. In comparison to standard services, RPG families 

achieved what we now refer to as the five Rs: recovery, remaining 

safely at home, reunifying at higher rates, having substantially 

lower reoccurrence of maltreatment, and having substantially lower 

rates of reentry to foster care. 

These programs were implemented in a different drug epidemic 

than we are facing today, but they are important lessons for us. 

Timeliness of treatment access improves child welfare outcomes, 

and we know for these parents with opioid use disorders, having 

access to medications is critical. 

Yet, I was in Ohio for 3 days last week, in a small county at the 

border with Kentucky. The child welfare administrator told me 

that it takes about a month for a family drug court to get a parent 

into medication treatment. The State official told me that that is 

when there is a family drug court that is navigating that for a parent. Normally, it is about 3 to 4 months to get into medication 

treatment. 

So this raises some real questions about reasonable efforts. That 

is the legal standard we ask child welfare to meet, and in Native 

American communities, we demand that child welfare make active 

efforts to prevent removing a child and to reunify. When a parent 

has a life-threatening brain disease, are wait lists of 30 days, 60 

days, 90 days reasonable? 

There are three critical steps that I see. States are submitting 

very weak data in most cases, and we cannot solve what we cannot 

count. States need to be held accountable for counting these children and families better so we can protect them and getting willing 

parents through the services they need. 

10 

It is true that we are in the midst of the largest potential expansion of treatment funding in history through the Parity Act and 

Medicaid expansion in many States, but constraints on those resources to meet high demand for services mean that very little of 

that potential is being focused on these children and families. 

I was reminded yesterday that in about 1995, I sat with a colleague and made a list of the communities around the country that 

had put programs in place to address this issue. There were 12 

places on that list. The good news is that today there are hundreds, 

but continuing the idea that pilot programs and demonstrations are 

needed to show how to improve outcomes for these families, I believe, is misguided. 

Every generation of 20-somethings, at least in my professional 

career, has been impacted by another drug of abuse. It is time that 

we move from pilots and demonstrations into State system reforms. 

Solving today’s epidemic, as critical as that is, needs to provide the 

longer-term strategy to support States and communities so that 

children can stay safely at home and so we prevent future drug 

epidemics from having such a dramatic impact on our Nation’s children. 

We have the knowledge. We can no longer say we do not know 

what to do. 

[The prepared statement of Dr. Young appears in the appendix.] 

The CHAIRMAN. We will take your testimony, Mr. Hart. 

STATEMENT OF DAVID HART, ASSISTANT ATTORNEY-INCHARGE, HEALTH FRAUD UNIT/CONSUMER PROTECTION 

SECTION, OREGON DEPARTMENT OF JUSTICE, SALEM, OR 

Mr. HART. Good morning. 

The CHAIRMAN. Good morning. 

Mr. HART. I would like to thank Chairman Hatch, Ranking Member Senator Ron Wyden from Oregon, and members of the committee for allowing me this opportunity to testify. 

My name is David Hart, and I am the Assistant Attorney-inCharge of the Health Fraud Unit, Consumer Protection Section of 

the Oregon Department of Justice. For more than 15 years, I have 

led investigations relating to pharmaceutical marketing and promotion, both for the State of Oregon and for bipartisan, multistate 

coalitions of State Attorneys General. Under the leadership of Attorney General Ellen Rosenblum, I continue to pursue these cases, 

especially as they relate to the opioid epidemic. 

Prior to graduating from law school and joining the Oregon Department of Justice, I practiced as a physical therapist for 15 years 

at hospitals, nursing homes, home health agencies, and hospices. 

Over the years, I have worked with thousands of patients with 

acute and chronic pain, and that experience informed my investigations of the marketing and promotion of opioids. 

The causes of the opioid epidemic are many. While my testimony 

will focus on the effects of marketing and promotion, I do not want 

to minimize the existence of other factors that helped cause the 

epidemic. Because the causes were many, so too will be the solutions. 

My testimony today will also cover some of the things we are 

doing in Oregon to combat the epidemic. In 2007, Oregon was a 

11 

*State of Oregon v. Purdue Pharma L.P., Case No. O7C14241, 2007. 

member of the executive committee of a coalition of 26 State Attorneys General that reached a settlement with Purdue Pharma resolving allegations that Purdue violated State consumer protection 

law by misrepresenting OxyContin’s risk of addiction and by promoting OxyContin off-label for the long-term treatment of certain 

chronic pain conditions.* 

Before OxyContin was introduced in 1995, opioids were largely 

used to treat severe, acute pain and cancer pain. Physicians were 

reluctant to prescribe opioids on a long-term basis for common 

chronic conditions because of concerns about abuse and addiction. 

While this inhibition was starting to break down before OxyContin 

was introduced, afterward the breakdown accelerated greatly, 

fueled in part by Purdue’s aggressive promotion of the drug. 

While the 2007 settlement stopped the unlawful promotion, it did 

not require Purdue to take sufficient remedial action to correct misinformation endemic in the marketplace. At the time of the settlement, I did not fully appreciate the severity of the opioid epidemic 

and the long-lasting effects of Purdue’s promotion. Had I so known, 

I would have advocated for a settlement with more extensive remedial action. 

Since the Purdue settlement, Oregon has remained vigilant to 

monitor opioid promotion in our State. As part of that effort, we became concerned that Subsys, a sublingual fentanyl spray, many 

times more powerful than heroin, was being deceptively and unconscionably promoted. Pursuant to Oregon’s Unlawful Trade Practices Act, we issued investigative demands to Insys, the manufacturer of Subsys, obtained documents and information from the company, interviewed former sales representatives, and consulted with 

experts. 

After a comprehensive investigation, we issued a formal Notice 

of Unlawful Trade Practices which alleged that Insys provided improper financial incentives to doctors to increase prescriptions and 

deceptively promoted Subsys for treatment of chronic back pain, 

neck pain, mild pain, and even migraine, a condition for which 

Subsys is contraindicated. I was truly shocked that in 2015, when 

the scourge of the opioid epidemic was so widely known, that a 

manufacturer of a Schedule II drug would promote in such an unconscionable and irresponsible way. 

To avoid litigating Oregon’s allegations, Insys agreed to an Assurance of Voluntary Compliance which prohibited the misconduct 

identified in our investigation and required payment of more than 

two times Subsys sales in the State of Oregon. Oregon is the only 

government entity to have settled with Insys for this alleged misconduct. 

Much of the $1.1-million payment Oregon received from the 

Insys settlement is being used to fund efforts to address the opioid 

epidemic. This includes regional pain guidance groups that develop 

opioid prescribing practices and guidelines; facilitating coordination 

of care across specialties and developing regional action plans; addiction treatment training and addiction treatment tele-medicine 

consultation services; promoting disposal of used and expired opioids; building a State-wide pain guidance public education web 

12 

platform with regional resource pages; and expanding the availability of naloxone, a drug that reverses the lethal effects of an 

opioid overdose. 

It is our hope in Oregon that these programs will save lives. We 

look forward to working with our Federal congressional delegation 

on this important issue. 

This concludes my testimony. Thank you, Chairman Hatch, Senator Wyden, and the members of the committee, for this opportunity. 

[The prepared statement of Mr. Hart appears in the appendix.] 

The CHAIRMAN. Thank you. We appreciate your testimony, all 

three of you. 

Let us turn to the prime sponsors of this bill. Let us turn to Senator Toomey first and then we will go to Senator Wyden. He can 

take my place. 

Senator TOOMEY. Mr. Chairman, thank you very much for convening this hearing and for cosponsoring the bill, the Stopping 

Medication Abuse and Protecting Seniors Act. I want to thank the 

witnesses as well. 

We have all heard an enormous amount of testimony back in our 

States, as well as here today, about the magnitude of this enormous problem of opioid and particularly prescription drug and heroin abuse and the tragic results. Last October, I did a field hearing 

with Senator Casey in southwestern Pennsylvania to bring local experts and victims to testify, and I was shocked when there was a 

standing-room-only crowd in a very large auditorium. That is just 

how widespread this problem is. 

There is no doubt there are many things that we can and should 

do to try to address this. Senator Portman has outstanding legislation that has just been recently reported out of the Judiciary Committee, is my understanding, which will be very helpful. But there 

are two specific things that we can do that are the responsibility 

of this committee, and our bill addresses these things. 

Those two specific things are efforts to reduce over-prescribing 

and an effort to reduce the diversion of these powerful prescribed 

narcotics. The problem is a very real problem. The GAO has estimated that 170,000 Medicare enrollees have engaged in doctorshopping, where they go to multiple doctors, who then, typically 

unknowingly, write duplicative prescriptions, which are then filled 

at multiple pharmacies for the very same pain killers. 

This is fraud. That is what is happening in most of these cases. 

It is an easy way for people to find commercial-scale quantities of 

opioids which they can then sell on the black market. 

But there is also a subset of Medicare beneficiaries who are innocently getting duplicative opioid prescriptions from multiple doctors 

and pharmacies because there is insufficient coordination of their 

care. And that can lead to very, very bad health outcomes, including death, for these innocent seniors. 

So the administration has been seeking the authority from Congress to allow Medicare to use the tool that Medicaid already uses, 

that private health insurers already use, to lock in beneficiaries 

who are abusing prescription opioids, either intentionally or unintentionally, to a single provider and a single pharmacy, and that 

is exactly what our bill does. It authorizes Medicare Advantage and 

13 

Part D plans to assign one prescriber and one pharmacy to those 

beneficiaries with a pattern of opioid abuse. As I say, Medicaid and 

commercial insurers already do this. 

This concept, lock-in, as it is called, for Medicare was one of the 

recommendations made over the weekend by the National Governors Association. 

I want to thank Senators Portman, Brown, Casey, and Kaine, 

whose offices and colleagues and staff met on many occasions with 

my staff and key stakeholders to get this bill drafted and get it 

right, and I think we have done that, Mr. Chairman. We have a 

solid bill that will help opioid-addicted seniors find treatment, will 

reduce the diversion of powerful narcotics to illegal black markets, 

will save taxpayer money, and will reduce overspending on opioids. 

It is nearly identical to legislation that was already passed in the 

House in the 21st Century Cures bill, and the bipartisan support 

that we have is very, very broad. It includes the President’s budget. 

It includes the CMS Acting Administrator, the CDC Director, the 

White House drug czar, the folks from Pew Trusts—and I appreciate their testimony today—and Physicians for Responsible Opioid 

Prescribing. 

Mr. Chairman, it is a very, very long list of important organizations that have weighed in in support of this legislation. I ask 

unanimous consent that letters of support from these organizations 

be included in the record. 

The CHAIRMAN. Without objection, we will include them. 

[The letters appear in the appendix beginning on p. 45.] 

Senator TOOMEY. And I would just say, look, this is overdue, but 

this is a chance for us to get this done now. There is more in this 

space that needs to be done. That is not a reason not to do what 

we can do. 

So I would like to just ask a couple of quick questions, starting 

with Mr. Coukell. The data that I have seen suggests that between 

1993 and 2012, the rate of hospitalizations for pain pill overdoses 

increased fivefold among people 45 to 85. Among people 55 to 64, 

the increase was sevenfold. 

Do you have any idea of why this is happening? 

Mr. COUKELL. Thank you for that question, and thank you, 

again, for your leadership on this important issue. 

I think the increase in hospitalizations and deaths that we see 

associated with opioids closely correlates with the increase in prescribing for the drugs. There is no doubt that there is an epidemic. 

CDC classifies it as an epidemic, and it peaks in late middle-age 

but affects all ages and, as you say, has been increasing. And the 

latest data suggest that it continues to increase. 

Senator TOOMEY. The Government Accountability Office and the 

Office of Inspector General have discovered many, many cases of 

large-scale fraud. My understanding is, your background is as a 

pharmacist. I want to read through, very briefly, some of the examples they discovered. 

One is a patient who obtained pain killers from 89 different providers in a single year. Another is a beneficiary who received, in 

1 year, a 490-day supply of hydrocodone from 22 different prescribers. A Midwestern pharmacy billed Medicare for over 1,000 

prescriptions each for two beneficiaries, and one doctor ordered alVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 R:\DOCS\23291.000 TIMD
14 

most all the prescriptions for each of these beneficiaries. Another 

beneficiary received prescriptions for a total of 3,655 oxycodone 

pills from 58 different prescribers. 

In your professional judgment, are these all cases of fraud? 

Mr. COUKELL. Well, I cannot comment on specific cases, Senator, 

but if my math is right, 89 prescriptions a year would be a new 

one every 4 days, and that would be very, very unusual. 

If we look at the whole pattern here of people getting multiple 

prescriptions—— 

Senator TOOMEY. And these prescriptions are all for multiple 

pills, typically 30 days’ worth. Every 4 days getting a supply like 

that strikes me as very likely—— 

Mr. COUKELL. Clearly, there is some component here that is 

fraud. I think it is also important to recognize that some of these 

people are just falling through the cracks in the system and not 

getting good care. Some of them are trying to get adequate pain relief, and they are going from prescriber to prescriber and whatever 

the cause, we owe it to them to get them into some kind of coordinated care so they are not at risk of dying or in the case of the 

elderly—I mean, this does not show up in the statistics, but use of 

opioids increases very substantially the chances of falling and 

breaking a hip. 

Senator TOOMEY. Right. So just on the front side for a moment— 

though, you would agree, I think, that the legislation that we are 

discussing today would dramatically reduce the chances that people 

could obtain multiple prescriptions from multiple providers and 

systematically and fraudulently purchase huge quantities. 

Mr. COUKELL. Absolutely. 

Senator TOOMEY. The last thing is, I know you looked at the specifics in this legislation, and one of the things that we are certainly 

very concerned about is that people who have a legitimate need for 

these medicines not be prevented from getting them. 

Are you confident that this legislation would not impinge upon 

a person’s legitimate needs for prescription opioids? 

Mr. COUKELL. Yes, sir. Again, the first thing to say is, this is not 

a new idea. Programs like this are already in widespread use in 

the commercial market and Medicaid. The patient has a number of 

protections built into this legislation. They get a strong voice in selecting the pharmacy or physician. There are protections for people 

who have to travel if there is not a supply available at their pharmacy, and so on. 

We know from data that people in these programs, while their 

use of prescription opioids goes down, for example, their use of 

other prescription drugs is not affected. So that is a sign that it is 

targeting the problem that we are trying to target. 

Senator TOOMEY. Thank you. Thank, you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator. 

Senator Wyden? 

Senator WYDEN. Thank you very much, Mr. Chairman. 

Thank you all. Mr. Hart, great work fighting these manufacturing abuses with my former law school classmate, our Attorney 

General, Ellen Rosenblum. I am so glad that you are here. 

15 

Here is what I want to ask first. When you do the lock-in and 

you limit access to opioids, it seems to me it is critical at the same 

time to step up treatment, because the addiction does not go away. 

Do any of you disagree with that statement? Let us just go right 

down the row. 

Mr. Coukell, do you disagree with that? 

Mr. COUKELL. No. I agree, sir. 

Senator WYDEN. Thank you. 

Dr. YOUNG. I agree. 

Mr. HART. I strongly agree. 

Senator WYDEN. I think that is important, because I want that 

to be a crucial part of this debate. We are going to otherwise separate out into two blocks, some people for enforcement and some 

people for treatment and prevention. The two areas must go in tandem to be successful, and I appreciate your stating that so specifically. 

The second question I want to ask deals with these manufacturers’ abuses. I am so glad that you have been pursuing this with 

Insys and fentanyl in the work that you are doing at home, Mr. 

Hart. 

If you were in our shoes, what would you be pursuing to rein in 

these kinds of abuses? 

Mr. HART. Well, first, I think we have to make sure that these 

companies disgorge all their ill-gotten gains. We have all heard 

about these massive settlements with hundreds of millions of dollars paid, but that really represents only a fraction of the profits. 

We have to get rid of the incentive. We have to dis-incentivize. 

We have to create a deterrent, and to do that, you have to get rid 

of all the profit. 

That is why in the Insys matter, we required them to give up 

two times their total sales in Oregon, and it is with that magnitude 

of punishment that you will have a truly effective deterrent. 

We also have to have more personal accountability of the executives who make these decisions. They cannot walk away with their 

stock options and their salaries, and, where appropriate, they 

should be criminally prosecuted. 

Finally, we need to have these companies clean up the messes 

they helped create. Now, in part, that is because there is a lingering effect of the misconduct. Even if you stop the unlawful marketing and promotion, there is a glide effect. Prescribing patterns 

do not change immediately, and there is a continuing benefit. 

So we should have these companies pay to fix the problem they 

helped create. 

Senator WYDEN. That sounds too logical. Go ahead, please. 

[Laughter.] 

Mr. HART. I will leave it at that. 

Senator WYDEN. Thank you. I think all three of the suggestions 

that you have given are certainly worth exploring, and we look forward to working with you. 

I have one last question, if I could, for you, Dr. Young, and it 

goes to the important work the chairman and I are trying to do 

with all of the committee members dealing with this foster care 

and child welfare issue. 

16 

You pointed out how long families are waiting to access substance abuse treatment, that month-long wait lists for treatment 

are the norm across the country. You testified, Dr. Young, that 

these wait times are especially problematic when children’s safety 

and well-being are at stake. Parents need to access treatment 

much faster than that. 

You have also said that parents involved in the child welfare system have a unique set of treatment needs that often do not align 

particularly well with American health care. In our view, allowing 

State child welfare programs to have a stronger role in building 

and paying for substance abuse treatment as a foster care prevention strategy could, in our view, address both of the issues you 

have been talking about. 

What do you think of that? Do you think giving States and counties flexibility to use their foster care dollars to really carve out the 

most effective substance abuse treatment programs would address 

both of the issues you are talking about? 

Dr. YOUNG. I think it is probably the most important thing that 

you could do in terms of the child welfare system. Keeping kids at 

home reduces the trauma to them of the removal. 

It makes sense financially. It is much less expensive to serve 

kids when they are in-home, and we have the demonstrations now 

that show how to do that. 

It is not always an easy population to serve. The engagement has 

to be pretty intense. But the majority of kids are in in-home cases, 

not the out-of-home cases, and being able to make sure that those 

cases get treatment and the other services that they need are the 

way to be able to prevent them from going into, if you will, the 

deeper end of the child welfare system. 

Senator WYDEN. Very good. Thank you all. 

The CHAIRMAN. Thank you. 

Senator Portman, we will turn the time over to you. 

Senator PORTMAN. Thank you, Mr. Chairman. I want to thank 

you and Ranking Member Wyden for holding this hearing and for 

bringing some focus on this issue. 

It was mentioned that the Comprehensive Addiction Recovery 

Act, CARA, was reported out of the Judiciary Committee by a 

unanimous vote last week. That does not happen often around 

here. And it did so because, one, it is bipartisan. We have worked 

on it for several years. We brought in all the experts to make sure 

that it actually addresses the problem. But also because all of us 

see this epidemic growing in our States, and we see the human toll. 

I have been all around our State. I have met with dozens of recovering addicts, some of whom, by the way, are on Medicare—and 

this is an issue that, of course, we ought to be addressing. 

So this broader bill called CARA does deal, as Senator Wyden 

talked about, with prevention, treatment, recovery—which is incredibly important—and enforcement. But this legislation that Senator Toomey has proposed is really important, because it says with 

regard to Medicare, let us be sure that we are not allowing people 

to do the kind of pharmacy-shopping and doctor-shopping that 

leads to abuse. 

So I thank you for your testimony this morning and talking 

about that. 

17 

I do think that this frequent abuser program also is going to help 

with regard to identifying people who need treatment. Senator Wyden’s question to you was, ‘‘Is treatment also important?’’ Of 

course, it is. In fact, this very legislation will help people get into 

treatment, because, once they are identified as a frequent abuser, 

they actually are given the information and a referral to treatment. 

So we need to be sure we are doing all of this, and it is incredibly 

important. And I thank all my colleagues for joining in this effort 

and Senator Hatch for being an original cosponsor of the CARA 

bill, and I am proud to be with Senator Toomey and Senator Brown 

and others on this legislation. 

My Attorney General back home, Mike DeWine, has submitted a 

letter for the record today that I would ask unanimous consent to 

include in supporting this legislation. He is on the front lines back 

there at home, and his point is very simple. This is a strong tool 

to reduce doctor- and pharmacy-shopping. 

But also, we have the National Governors Association, which recently talked about this legislation. They support it. The administration supports it. So I would hope this is one that we could move, 

and perhaps we can move it along with the CARA legislation. 

We have seen in our Medicaid program in Ohio, through this 

lock-in program, a 41-percent reduction in dosages for certain narcotics. So it works in Medicaid, and it certainly should be in the 

Medicare program as well. 

In your testimony, Mr. Coukell, you talk a lot about this legislation and the fact that it provides a balance. There are some people 

who have said, ‘‘Well, gosh, how can I be sure I can get the drugs 

that I need?’’ 

Can you briefly tell us, how does it allow beneficiaries to still 

have a choice in terms of the drugs that they need? 

Mr. COUKELL. Thank you for your question, and thank you for 

your leadership as well on this bill. 

The legislation requires patient input into the selection of both 

the pharmacy and the physician who would be the provider, and 

so they would be able to get those drugs from the provider, and the 

provider would ensure that they have adequate pain control. 

So that is the essence of the legislation. It allows the individual 

to appeal if they think that they should not be in the program. It 

allows them to change pharmacies down the road if they need to. 

So there are a number of provisions built in here that help ensure the patient gets the drugs they need. 

Senator PORTMAN. Thank you. And thanks for talking about the 

appeals process. I think that is important. 

Just today, we are talking about a lock-in program. I would like 

to ask your advice, as a pharmacist, on another topic. It is about 

lock-out rather than lock-in. 

Before me here is a pill bottle. It has an inexpensive plastic lock 

on it. It costs about $1. I am told that the kind of pills that might 

be inside of this, if they are opioids, might have a street value of 

$80 a pill. 

Do you think it would make sense for pharmacies to offer this 

as an option? This would allow those seniors we are talking about, 

if they do need opioids and they are going to this one pharmacy 

and one prescriber and it is appropriate, to protect their pills from 

18 

their grandchildren, their children, their children’s friends, their 

grandchildren’s friends accessing them, by a very simple mechanism costing $1 to lock these pill bottles? 

This is what I call the lock-out effect. What do you think? 

Mr. COUKELL. Having not studied the device or seeing data, Senator, I think I should not comment on it. 

Senator PORTMAN. Well, you can see it. It is right here, and it 

makes a lot of sense. [Laughter.] So I will just say that. 

By the way, the CARA legislation also authorizes the Pregnant 

and Postpartum Women’s Program, which creates a pilot grant program specifically for treatment for women who are pregnant or 

have young babies and are struggling with addiction to deal with 

the issue, Dr. Young, that you talked about. 

So that is in the CARA legislation, but you also talk about 

CAPTA, the Child Abuse Prevention and Treatment Act, and some 

of the concerns there. 

Can you tell us, because this is something—I have been at hospitals in Cincinnati and Cleveland and in Lima, just in the last 

couple months, seeing some of these addicted babies, seeing the incredible compassion and care that they are getting, as they take 

these babies literally through withdrawal. 

One question I have asked them—these physicians and nurses 

and some of these amazing caregivers and some of the mothers— 

is, what are the long-term impacts? And there are different answers I get. 

So I would ask you, as an expert, what research exists on the 

long-term effects of a child who is born with dependence on a substance like heroin or another opioid? 

Dr. YOUNG. I would be happy to follow up and give you the 

study. There was a meta-analysis that was done just a few years 

ago that looked at the whole body of research on the long-term effects of opioids. 

It is a bit mixed, but we still know that alcohol and tobacco, alcohol in particular, have more neuro-developmental effects than some 

of the other drugs. 

So it is hard to tease out, when you look at what is happening 

for that child by the time they are in school, was that also the fetal 

alcohol spectrum disorder, which was not manifested into a full 

FAS, but had neuro-developmental effects during that prenatal period? 

So it is still mixed, but as far as what I have been told, going 

into the primary grades, there are not effects that are teased out 

specific to opioids. 

Senator PORTMAN. We are seeing a big increase in Ohio and 

other States of this neonatal abstinence syndrome, and I do hope 

we can get some better research on that but, in the meantime, of 

course, do everything we possibly can to aid prevention and treatment to avoid those babies becoming addicted in the first place. 

Thank you very much. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator. 

Senator Stabenow? 

Senator STABENOW. Thank you very much, Mr. Chairman, and 

thank you to our witnesses. This is an incredibly important issue, 

19 

and I hope we are going to move forward. We have strong bipartisan support on this. So I commend everyone who is involved. 

I want to specifically focus on one thing. I support all of the 

things being talked about, certainly from a law enforcement standpoint and so on. But ultimately we have to have treatment in the 

community. 

Dr. Young, you were talking about the fact that we need to get 

beyond pilots and we need to have systems changed. We have mental health parity, we have substance abuse parity laws now, Medicaid expansion, but we do not have the systems change. 

So I want to just urge colleagues and invite colleagues to work 

with Senator Blunt and me on the next steps in behavioral health 

care in the community, because whether it is a chemical imbalance 

from inside the brain or one self-induced because of opioids or some 

other chemical, it ends up in the same place in terms of treatment 

for people. 

So we have begun the process of a behavioral health clinic status, 

like Federally Qualified Health Centers. We have now a new quality set of services, 24-hour psychiatric inpatient services, substance 

abuse detoxification, post-detoxification step-down services, residential services, that are all defined under something we passed a 

couple of years ago that we are beginning to implement. 

Right now, 24 States have stepped up and said, we want to do 

behavioral health center services. There is funding for eight States 

to be fully able to do that. We would like very much to have the 

24 States that have stepped forward to have the capacity to provide 

these services. But if we do not, then we are going to still be going, 

in my judgment, around and around and around with a lot of 

pieces that are important, but not the core of what happens in the 

community in terms of individuals asking for help or families being 

able to get help. 

As we know, folks are still going to end up in the emergency 

room or on the street or in the jail or some other facility. So I wonder if folks might just speak about services. I know one of the most 

powerful conversations I have had is with the Cook County Sheriff 

talking about the fact that in his jail, they have a psychiatrist, because at least a third of the people in his jail have mental health 

or substance abuse disorders. So that is where folks are ending up, 

and we know that that does not ultimately help anybody. 

So when we look at all of this, I wonder if you might just speak 

to the fact that, when we have identified people—we have drug 

courts, we have all these other law enforcement provisions—in the 

end, if we do not have services for what clearly are brain disorders 

ultimately in addiction, we are not going to truly be able to solve 

this for the long run. 

So I wonder if anyone would want to comment on that. Mr. Hart? 

Mr. HART. Treatment is necessary and additional treatment is 

necessary, and, as you say exactly, it is a brain disorder. It is a disease, and we have to get beyond the stigma associated with it and 

treat it as a disease. 

Among other things, we, for example, are funding additional 

training for physicians to prescribe buprenorphine, which is a 

treatment modality. It is a partial opioid agonist. But we have very 

few physicians who have the DEA waiver necessary to do that. So 

20 

providing that type of treatment, behavioral treatment—obviously, 

the medical treatment—without addressing that, we are not going 

to solve the problem. 

Senator STABENOW. Thank you. 

Dr. Young? 

Dr. YOUNG. I agree with you. I think one of the trends in the 

treatment system that needs to happen is the recognition that families are affected and children in particular are affected. 

So if there is quality health care, quality substance abuse treatment, we need to have a family focus and make sure that the children perhaps with prenatal substance exposure, but certainly with 

the post-natal family environment, have their own service—either 

developmental or mental health services, and clearly parenting 

that becomes so key. 

One of the things that was so important in a grant program operated by SAMHSA, called Children Affected by Methamphetamine, 

was really understanding what kinds of parenting programs needed to be put in place to really engage parents in treatment, as well 

as then understanding what were the needs of the children growing 

up in that environment. 

Senator STABENOW. I could not agree more. As co-chair of the 

Foster Care Caucus with Senator Grassley, I completely agree. I do 

not know if you might want to just, Mr. Coukell, say something 

briefly. I know I am out of time. 

Mr. COUKELL. Senator, I fully agree with you and with my 

friends on the panel that solving this will take a multi-factorial or 

multipronged approach and that all of these things, prevention and 

treatment, are all part of what we will need. 

Senator STABENOW. Thank you, Mr. Coukell. 

The CHAIRMAN. Thank you, Senator. 

Senator Coats? 

Senator COATS. Thank you, Mr. Chairman. 

Our State is not exempt from this scourge that is affecting every 

State across the country. I have, in the last several weeks, been 

talking to doctors, judges, law enforcement officials, emergency 

room docs and nurses, grieving parents, friends of loved ones. This 

clearly is a national crisis, and I share with my colleagues the need 

to do what we can, realizing that our government does not have a 

single-bullet solution, but there are some things that we can do in 

coordination with our States and local communities, with our enforcement people. 

But my question really goes to the ability of the drug industry 

to provide perhaps a better means of pain medication that is not 

addictive and to the medical device industry. 

I know, Mr. Coukell, that the Pew Foundation and you particularly have done some work in this area. I am wondering if you 

could just bring us up to date here about where the FDA is, where 

the industry is. Obviously, we have a whole range of treatment, enforcement, and prevention protocols to put in place, but can we get 

some help from the drug industry with non-addictive drugs? Can 

we get some help from the medical device industry to address this 

problem? 

Mr. COUKELL. Thank you for that question, Senator. 

21 

When I was a clinical pharmacist in oncology, managing pain 

was part of what we did, and these drugs were a mainstay, and 

they will continue to be important for the foreseeable future. But 

we do need research and alternatives to opioids for pain management. 

We need to ensure that we are using the drugs we have appropriately. 

Senator COATS. Is that going on? Is that research underway? 

Mr. COUKELL. I think there is some underway, but I think there 

is no time soon where we can envision not having opioids as a critical part of pain management. 

We also need better abuse deterrent formulations, although it is 

also important to recognize that most of the people whom we are 

talking about are swallowing the pills. They are not crushing them 

and snorting. So the problem is also not solved by better abuse deterrent formulations, although they would be valuable. 

Senator COATS. Does anybody else want to comment on that 

question? 

Mr. HART. There are alternatives to opioids for treatment of pain, 

and historically we would use multidisciplinary approaches. It became quicker and cheaper and easier to prescribe an opioid. But 

what we need to make sure is that physicians are empowered to 

use alternative treatment therapies and modalities other than 

opioids. This is very important for chronic pain. 

So, yes, it would be nice to have new treatments and new modalities, but we have to use the ones we already have. 

Senator COATS. My wife just went through a surgical procedure 

for a hip replacement, and I talked to Dr. Cassidy here, my fellow 

colleague, and said that this is what the doctors have prescribed, 

and he said, ‘‘For how long?’’ I said, ‘‘Well, it was 90 pills, so I 

guess it is fairly lengthy.’’ I said, ‘‘Are there alternatives to that?’’ 

My wife was asking that question, also, and he, as a doctor, outlined prescribing a prescription alternative that he thought could 

manage that pain. 

Now, I know that does not apply to everybody, and pain is different in every situation, and chronic pain is particularly an issue 

here. But it seems to me that we ought to be pursuing every possible alternative given the consequences of what we are facing now. 

I do think it is an all-hands-on-deck situation here, with public 

service announcements and everything else, maybe very graphic 

ones, that would hopefully scare younger people into not thinking 

they are immortal and do not need to worry about the consequences of these drugs. 

But it is something we have addressed before in other forums, 

and it is not easy. I appreciate all your help here and giving us 

some guidance in terms of how we ought to go forward. 

Thanks, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator. 

Senator Schumer? 

Senator SCHUMER. Thank you, Mr. Chairman. I very much thank 

you for holding this hearing, you and Senator Wyden. 

We all know this is now a crisis. It is an epidemic, and we had 

better get our hands on it quickly. America let crack cocaine get 

22 

its tentacles into our people and, unfortunately, nothing was done 

for years, and it took a decade to get those tentacles out. 

Well, prescription drug abuse, heroin abuse, has become an epidemic, and Medicaid and Medicare play a very big role. They are 

going to provide, by 2020, 33 percent of the total spending on substance abuse. 

Just to give you a few quick numbers: 198 deaths from heroin, 

884 from prescription opioid drugs in New York State in 2010; 3 

years later, 678 heroin deaths, 1,000 deaths due to opioid abuse. 

Both are going up, but the heroin abuse is going up more significantly, because the cost of pills is amazing. I mean, my doctors in 

New York State told me a pill, a Vicodin, an OxyContin, can cost 

$50 to $80, one pill, on the black market, and that is one of the 

reasons, we all know, heroin has now raised its ugly head. 

The drug dealers, these evil people, these bottom crawlers, realize that they can get kids to take heroin if they cannot afford the 

Vicodin or the OxyContin, and it is much cheaper. 

So there is a lot we have to do here. America has woken up, because this has now affected all corners of America. It has affected 

poor, middle-class, and rich. It has affected suburban, urban, rural. 

It has affected black and white and brown. Everybody. 

What do we do? The CARA bill, which was passed out of the Judiciary Committee—I am a cosponsor—is a good bill. It certainly 

does some good things, and I want to support those Senators who 

have done a very good job there in moving that bill forward. But 

it is necessary; it is not sufficient. The bottom line is, we need dollars. Sequestration, which my colleagues on the other side of the 

aisle supported, cut the money available to fight this scourge. Now, 

we do not have sequestration, so we need to increase the dollars. 

Senator Shaheen will introduce an emergency bill, a bill for emergency funding of $600 million, which goes to programs that 

have already worked—Byrne grants—which give the locality the 

ability to back up law enforcement and stop the drug dealers from 

coming in, and separate money for treatment. 

I was in Buffalo last week, at one of our best treatment providers, Horizon. The waiting lists are enormous. I have met parents whose kids have killed themselves while they were on a waiting list. 

So to say we have enough money for this problem when there are 

people who are desperate for counselors—and counseling works— 

we do not have enough money for those counselors, no. 

While being fully supportive of the CARA bill, a bipartisan bill, 

we must at least have an attempt, and hopefully a successful attempt, to add some money here on an emergency basis, as embodied in the Shaheen amendment. 

We are certainly open—I spoke with Senator Portman today—to 

some changes that the other side might want to propose, but this 

idea of not providing dollars that are needed, if you will, of talking 

the talk but not walking the walk, is not acceptable, certainly in 

this crisis. 

So my pitch to you is funding. We need funding. I would ask any 

of you just to comment on the shortage we have of treatment, with 

the overwhelming needs for treatment. 

Dr. Young? 

23 

Dr. YOUNG. I misspoke when I said that the county in Ohio last 

week was the small county on the Kentucky border. It was actually 

a mid-sized county that told me that it was 30 days to get into 

medication treatment in Ohio. 

The wait lists for residential treatment are, as you know, way too 

long. But it is not just the dollars when it comes to child welfare. 

It is critical that you can get treatment access and timely access. 

But child welfare also needs to have the ability to work with their 

substance abuse treatment agency and their court in new ways. 

Senator SCHUMER. Right. But we have a shortage of counselors 

right now. That is my point—— 

Dr. YOUNG. Yes. Yes. 

Senator SCHUMER [continuing]. Not what else has to be done, because we need to do other things. 

Do you agree, Mr. Coukell, that we have a shortage of counselors 

and treatment programs? 

Mr. COUKELL. I do, Senator. The whole adequacy of treatment 

and access to evidence-based therapy is something that we are 

looking at right now. 

Senator SCHUMER. How about you, Mr. Hart? 

Mr. HART. I agree, and it is particularly acute in rural areas of 

our State. 

Senator SCHUMER. Yes. 

Mr. HART. We have treatment available on the I–5 corridor, but 

not in eastern Oregon. As we know, the scourge is in rural areas 

as well. That is why we funded tele-medicine addiction training as 

part of our funding. 

Senator SCHUMER. Thank you, Mr. Chairman. My time is up. 

The CHAIRMAN. Thank you. 

Senator Carper? 

Senator CARPER. Thanks, Mr. Chairman. 

Welcome, to each of you today. 

Several years ago, sitting at the table where you are sitting 

today was former vice chairman of the Federal Reserve, a fellow 

named Alan Blinder, who teaches economics at Princeton these 

days, and we were talking about how to reduce our Nation’s budget 

deficit. And Dr. Blinder said the 800-pound gorilla in the room for 

deficit reduction was health-care costs. Our health-care costs on a 

GDP basis, we spend about twice as much for health care as they 

do in Japan with respect to GDP—health care as a percentage of 

GDP. 

When I asked him what we should do about that, he said, ‘‘Find 

out what works and do more of that.’’ Pretty good advice, and I 

have used that often in considering the challenges we face in the 

country. 

One of the things we think that works with respect to this particular challenge, opioid addiction, is the lock-in program that we 

have now in Medicaid. I am told it works reasonably well, not perfectly, but it works reasonably well. It is helpful. 

There are those who want to extend that approach, as you heard, 

to Medicare. There are differences and there are similarities between Medicaid and Medicare, as you know, but my sense is that 

a lock-in program might work in Medicare Advantage. I am not 

sure that it works well in fee-for-service. 

24 

Mr. Coukell, would you take that on? And anyone else who cares 

to comment on that, please do so. 

Mr. COUKELL. Thank you for that question. I think it is an important question. The first thing to say perhaps is that the commercial drug plans are operating patient review programs now. So 

that is, in many ways, analogous to a Part D plan. And plans that 

are operating them have told us that they are confident they will 

be able to operate. 

While fee-for-service does not see or hold both the medical benefit 

and the drug benefit for the same patient, which Medicare Advantage does, you can still, from a patient’s drug profile, get a very 

good sense of their clinical situation and certainly whether they are 

getting drugs from multiple sources and then working with the patient to identify a provider and notify that provider. 

One of the things that we find is that, once the provider finds 

out that their patient is getting these drugs from multiple providers—they often do not know that—they sort of become the point 

for prescribing, then the patient is at reduced risk of getting multiple drugs from multiple providers. 

Senator CARPER. Dr. Young, Mr. Hart, is there anything you 

want to add to that? 

Mr. HART. No, Senator. This is not an area of my expertise. 

Senator CARPER. Senator Wyden has already asked this question, 

and some others have asked variations of it. I oftentimes try to 

drill down on root causes, not just the symptoms or problems. 

Lock-in, as good as it is in Medicaid, we are just addressing a 

symptom of the problem. Root causes—just talk to us a little bit 

about root causes here and maybe, if you were in our shoes, what 

you would be doing about addressing the root causes. 

Mr. Hart, do you want to lead off? 

Mr. HART. Thank you very much for that question. We need to 

improve prescribing. Most medical schools historically did not cover 

treatment of pain in their curriculum, and even now most do not. 

We need to improve prescribing through academic counter-detailing. 

Senator CARPER. What does that mean? 

Mr. HART. That means, instead of having sales representatives 

teach doctors how to prescribe, we have pharmacists, we have experts who are independent and unbiased sources of information. 

We need to have CME, continuing medical education, that is not 

industry-funded, and now that is who pays for it. Purdue Pharma 

paid for 20,000 CMEs, and even if you follow the guidelines, the 

Accreditation Council for Continuing Medical Education guidelines, 

and do not have direct control by choosing what is funded and 

what is not, you are not going to control the message. 

So we need independent messaging. I think that is key. We have 

already talked about addiction treatment—of course, that is important—but also providing alternative treatments to opioids for 

chronic pain conditions specifically. 

Doctors are under a lot of pressures. We need to provide them 

with clinical guidelines, for example, especially for chronic pain, so 

that docs who want to do the right thing can have support for their 

decisions and also to help reduce some of the misinformation out 

there in the marketplace. 

25 

So we need to improve prescribing. We also need to get rid of 

some of the drugs that are in the marketplace. For example, I 

know DEA recently changed rules that allowed pharmacies to take 

back drugs, but few pharmacies actually do so. There is paperwork, 

there are expenses. So we need to facilitate that process, maybe 

have the drug companies who sold the drugs pay for their removal 

when they are not needed anymore. 

Senator CARPER. My time has expired. Let me just ask the other 

witnesses. Do you agree with everything that Mr. Hart has just 

said? 

Dr. YOUNG. That particular aspect is not my area of expertise. 

Senator CARPER. So you do not. 

Dr. YOUNG. No. I agree with what he said, but I did not have 

anything to expand on that. 

Senator CARPER. Mr. Coukell? 

Mr. COUKELL. I agree, Senator, that to address this epidemic, it 

needs a multipronged approach, which includes reducing the problem before it starts, identifying folks who are at risk, and, once 

people have a problem, making sure that they get out of that situation and get effective therapy. 

Senator CARPER. Our thanks to all three of you. 

The CHAIRMAN. Thank you. 

Senator Thune? 

Senator THUNE. Thank you, Mr. Chairman, for holding this hearing today and examining how we can address this ongoing epidemic. 

As Dr. Young noted in her testimony, heroin use has risen at the 

same time that prescription opioid abuse has, and, as access to prescription opioids is tightened, there is also a concern that this could 

lead more people toward heroin. 

I wanted to, Mr. Hart, ask you, from your experience, what are 

the most effective ways to ensure that there is coordination between State health officials with law enforcement to ensure that 

there is not an increased turn toward heroin? 

Mr. HART. My area of expertise is not in terms of non-prescription drugs and heroin. So I am sorry, I do not think I can really 

offer anything on that. 

Senator THUNE. Your law enforcement does not coordinate with 

the State? 

Mr. HART. Our law enforcement does coordinate with State officials. I just do not participate in that process and do not have— 

I would be happy to get back with you—— 

Senator THUNE. Okay. 

Mr. HART [continuing]. Consult with some of our folks and give 

you a written report on that. 

Senator THUNE. That is fine. I would appreciate it, if it is something you are not familiar with. 

There are lots of new—I should not say new, but there are, I 

think, some different proposals for combating the opioid epidemic, 

and I am wondering—and this would be to anybody on the panel— 

if there are any current programs that you think are effective in 

combating opioid abuse and what are the traits of those programs 

if we were looking for things that we could do? What models exist 

that are, in your view, effective? 

26 

Dr. Young? 

Dr. YOUNG. In my area of children who are affected by parents 

with opioid use disorders, there are a few places that have put in 

concentrated efforts, one that we wrote a case study about because 

we were so impressed with what they had done in Burlington, VT 

with identifying moms with opioid use disorders during the prenatal period: bringing the community together to understand what 

the family’s needs were, making sure that before the baby is born, 

there is a plan of safe care so that at the time of the birth, there 

is an understanding about who will have custody of the child, if the 

child can go home after a period in the hospital, or who will be caring for that child. 

The important part, I think, someone said to me is, what we 

have done by this effort is reduced the crisis at birth, the expense 

of child welfare, of everyone who comes together, and this crisis 

mode of ‘‘what do we do now?’’ is eliminated when you have put the 

effort in to understanding what the family’s needs are and what 

the plan of safe care is for the child before the child is born. 

Senator THUNE. Anybody else on that? Mr. Coukell? 

Mr. COUKELL. One thing that we are looking at now, Senator, is 

something that has been shown in numerous, multiple, randomized 

controlled trials to improve treatment success, which is the use of 

medication-assisted therapy as an adjunct to counseling and behavioral therapy. And we know that access across the spectrum to 

MAT is still very low. So that is something that we are looking at 

now, but clearly it is important in the health-care system and possibly also in corrections. 

Senator THUNE. States like South Dakota have permitted properly trained law enforcement officers and first responders to carry 

naloxone. I am wondering what more can be done at the Federal 

level to encourage more States to increase access to this life-saving 

drug. 

Mr. Hart? 

Mr. HART. Recently, in Oregon, as part of our funding, we funded 

increased availability of naloxone, and now there is an intranasal 

variant available on label which should decrease the pricing, making it available in schools. We have made it available to our first 

responders as well. We have been distributing naloxone in Multnomah County and Clackamas County with needles to the drug 

abuse community, because they are the ones who are there. 

We also have to make sure that there are good Samaritan laws 

in place so that people are cared for by their fellow abusers who 

do not run and leave them but can provide that acute assistance. 

So you are absolutely correct. Naloxone is a life saver. It is the 

Lazareth drug, we call it. 

Senator THUNE. My time has expired. So thank you all very 

much. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you. 

Senator Brown? 

Senator BROWN. Thank you, Mr. Chairman. And thanks to the 

witnesses for sitting for a couple of hours listening to questions and 

sharing your insight and wisdom. 

27 

Yesterday I was in Warren, OH, a working-class city north of 

Youngstown, near the Pennsylvania border, with a group of 25 or 

so people all concerned about this issue and what it means to this 

community of high unemployment and high numbers of foreclosures, on top of one thing after another. 

They are pretty overwhelmed. They talk in terms of how important it is to have additional resources and a multipronged approach. We need to make sure that health-care providers have the 

tools they need to manage patients who are being seriously harmed 

and may even die from addiction. 

One woman spoke whose son was 14 and became addicted, in 

part, because someone in the home had been dying and some morphine was left around. And he has been addicted for 12 years on 

and off, and she called it a chronic disease, as you would call it. 

Patient review and restriction programs, the PRR programs, are 

one of these tools that are so important. Despite their success in 

State Medicaid programs and commercial plans, PRR programs are 

not available in Medicare under current law, as you know. It 

makes no sense. We have one proven tool that could help patients 

suffering from addiction, and Medicare is not even allowed to use 

it. 

My colleague, Senator Toomey, and I have been working together, as Mr. Coukell knows, for several years on a legislative proposal to help address the epidemic, the Stopping Medication Abuse 

and Protecting Seniors Act. Our legislation would allow Medicare 

to utilize PRR programs by creating a framework for at-risk beneficiaries to get their opioids from one prescriber, reducing the risk, 

obviously, of overdose. Our legislation incorporates important consumer protections to ensure patients who need pain medications 

can get them. 

Mr. Coukell, describe how these PRR programs balance patients’ 

legitimate need for pain medications and the goal of protecting vulnerable patients from becoming addicted or potentially overdosing, 

and talk briefly about how the programs have been successful in 

Medicaid and commercial plans and what their potential could be 

in Medicare. 

Mr. COUKELL. Thank you, Senator, and thank you for your leadership on this bill. S. 1913, the legislation you mention, contains 

a number of important protections. The first is that, in identifying 

patients who are at risk, it takes into consideration, are they in 

hospice, are they in long-term care, are they being treated for cancer, and those patients would not be locked in. 

Then someone, a clinician, a nurse, or a pharmacist, looks at 

their profile and makes a judgment about how much risk they are 

at, what is the behavior we are seeing there. And then the patient 

has input into what provider or what pharmacy they will go to. 

They have the opportunity to appeal their inclusion in the program 

not once, but twice. If they need to, they can, down the road, 

change their provider if they need to do that. 

So there are a number of protections that are built in here so 

that we ensure patients get access that they need and that we do 

not have a false positive. 

You also asked about the evidence from Medicaid programs, and 

I can just touch quickly on a number of States. In Tennessee, we 

28 

saw that an assessment looking at patients before and after their 

enrollment in the program saw a 33-percent decrease in prescribers 

visited and a 46-percent decrease in the number of controlled substance prescriptions; in Minnesota, very similar data also, with reductions in service utilization found there. 

In the Oklahoma PRR program, pharmacies visited fell by more 

than half, and the number of prescriptions was reduced. In other 

States, we have seen reduced emergency department and clinic visits and so on. So there is quite a long list, and you probably do not 

want me to go through the whole thing. 

Senator BROWN. Thank you for that. It is clear that implementing a program in Medicare will help, but not solve the problem. It is a small piece in the puzzle. 

What we should be focusing on too, Mr. Chairman, is increasing 

access to treatment for individuals struggling with addiction, ensuring those who need help have community resources. What yesterday in Warren, OH taught me, in part, was how resources are 

so scarce: not enough providers, not enough treatment homes, if 

you will. 

We have a good group of witnesses. I am thankful and grateful 

that all three of you are here. But there are significant gaps in expertise. There is no one on today’s panel from the administration 

who could discuss programs in both Medicaid and Medicare that 

exist to help individuals overcome their addiction or witnesses to 

speak for additional legislation to improve government programs as 

needed. There is no one with a background in addiction treatment 

who can discuss what more we need to do from that side and that 

standpoint to ensure that beneficiaries who are struggling receive 

the treatment they need to address their addiction. 

That is disappointing, understanding that it costs money, understanding that this is a Congress where most of its members have 

taken pledges to lobbyists saying they will never come up with any 

revenues, and it ties our hands and puts too much of a straightjacket on responding to one of the great public health crises of this 

decade. 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator Brown. 

Well, let me ask you, Dr. Young, just one—— 

I am sorry. Senator Scott, you go ahead of me. 

Senator SCOTT. Thank you, sir. Are you sure? 

The CHAIRMAN. Sure. 

Senator SCOTT. Sounds good. I always want to follow the chairman and the would-be NBA basketball star down there. [Laughter.] 

Mr. Coukell, just a couple questions for you. Senator Brown 

touched on the topic of the Medicaid success in the lock-in programs. 

I know that one of the things that has worked really well in 

South Carolina is the ability to create 20 criteria that allow for the 

HHS in South Carolina to figure out who needs to be a part of the 

program. 

How do we make sure that the customization and the flexibility 

that is necessary and has been successful in South Carolina in 

Medicaid would also be built into Medicare Part B? 

29 

Mr. COUKELL. Thank you, Senator. I think it is an important 

question, and what we have seen over time is increasing sophistication in how we identify patients who are at risk; so, starting with 

straight number of prescriptions over a certain number of days, increasingly taking in things like dosage and emergency department 

visits and other factors which suggest risk. 

This legislation I think strikes the appropriate balance between 

requiring the Secretary to work with the plans to establish criteria, 

building in some specific exclusions, but still gives the plans the 

flexibility to identify criteria that are going to work for them and 

their population and their data. 

Senator SCOTT. So you see that as a State-by-State opportunity 

for Medicare Part D as well? 

Mr. COUKELL. As the legislation is written, it would be some Federal guidance, followed by customization by plan rather than by 

State. 

Senator SCOTT. Speaking of the Toomey legislation, those in hospice and long-term care facilities are exempt from these lock-in programs. How do you think the authority to exempt the individuals, 

which is left to the Secretary, will be exercised, particularly for 

folks with cancer or rare diseases, like sickle cell, which we have 

a high incidence of in South Carolina? Which individuals have the 

State Medicaid programs commonly excluded? 

Mr. COUKELL. Thank you for that. It is difficult to generalize 

across Medicaid programs, because the criteria are various. But 

some of the categories you have mentioned are ones that should be 

taken into account, and, under the Federal legislation, the Secretary will work with the stakeholders to identify appropriate exclusions. 

Senator SCOTT. As you know, many folks with opioid abuse 

issues are struggling with mental illness, and in South Carolina, 

I think it is one out of three seeking treatment, either selfreporting mental illness or doctors determining that the individuals 

had a mental health problem in addition to their substance abuse 

problem. 

There seems to be a high co-morbidity between mental illness 

and substance abuse. Given this, when locking patients into one 

physician for the opioid prescriptions, what can we do to ensure 

that there is a coordination of care with all of their other doctors, 

but particularly with the physician treating their mental illness 

issues, since they are intrinsically related? 

Mr. COUKELL. They are, and one thing the legislation does is, it 

requires that the patient be notified of available services, such as 

substance abuse treatment and so on, at the point that they are enrolled in the program. 

I do not think that is a full solution for the nexus of mental 

health and substance abuse that you are talking about. It is one 

thing that I think is valuable in the context of these programs, but 

it is a bigger issue. 

Senator SCOTT. Do you have any specific examples of perhaps 

positive outcomes from that coordination that we have seen: mental 

illnesses with the prescriptions? 

Mr. COUKELL. I do not have a specific example right now. 

Senator SCOTT. Thank you, Mr. Chairman. 

30 

The CHAIRMAN. Senator Menendez? 

Senator MENENDEZ. Thank you, Mr. Chairman. Thank you to our 

panelists. I got to read your testimony when I was sitting in the 

Senate Foreign Relations Committee with Secretary Kerry. 

I want to thank you and the ranking member for holding this 

hearing on the increasing crisis of opioid addiction and death. However, I am troubled, and I hope maybe some future hearings might 

consider this, by the fact that we do not have any witnesses here 

today to speak specifically on the issues of addiction treatment and 

recovery or to the policies this committee should be working on to 

address the needs of those struggling with an opioid addiction and 

to be able to help them find and receive the timely, effective help 

that they need to survive. 

As I mentioned when Secretary Burwell was here during a hearing on the President’s budget earlier this month, I recently held a 

listening session with key addiction treatment stakeholders in New 

Jersey to address this growing crisis. To a person, the issue that 

came up as the most substantial barrier to addiction treatment was 

the limitation on a provider’s ability to conduct medication-assisted 

treatment. These limitations include things like restrictions on the 

number of patients a physician can treat and the number of qualified providers available to treat people seeking treatment to get 

clean. 

So I was pleased that Secretary Burwell committed to taking all 

possible administrative steps to address these limitations, but I 

fear that will not be enough, and we have to act to provide the legislative tools necessary to properly address the crisis. 

So with that as a preface, Mr. Coukell, would you agree that including expanded access to treatment, including medicationassisted treatment, is a critical component to any comprehensive 

effort to stem the tide of opioid abuse? 

Mr. COUKELL. Senator, this is something that I think is very important, and we have been looking at it as an organization. Now, 

it is quite clear that medication-assisted treatment is an area 

where the evidence of effectiveness is very strong and where it is 

underused really across the board. 

So we, I hope, will soon be in a position to make strong recommendations on that. We are looking at it right now. 

Senator MENENDEZ. Let me ask anyone else on the panel this 

question, in a different context. As I think we all know, deaths associated with opioids have quadrupled over the last 12 years to an 

astounding 78 deaths a day. In addition to the issue of prescription 

opioids that has been a focus of this and other committees, an increasingly pressing issue is the major increase in heroin use. 

This increased heroin issue is, somewhat ironically, in my mind, 

the result of making access to prescription opioids more difficult. 

Meanwhile, access to cheap, highly potent heroin on the streets has 

become, by comparison, very cheap and easy. 

In fact, while opioid prescribing per patient in New Jersey is 

among the lowest in the country, we saw a 160-percent increase in 

heroin deaths since 2010, and we suffered more than 1,200 overdose-related deaths. These statistics, again, point to the need to 

provide access to treatment as part of a comprehensive approach 

to combating the opioid and heroin epidemics. 

31 

So I would like to hear from you, if any of you have ideas. What 

steps can we take to ensure that, as we make illegitimate access 

to prescription opioids more difficult, we do not just push people to 

use drugs like heroin? 

Mr. Hart? 

Mr. HART. If I might, and if I could just back up to your prior 

question—— 

Senator MENENDEZ. Sure. 

Mr. HART [continuing]. Which had to do with what we could do 

to improve medication-assisted treatment. I heard earlier mentioned how we are trying to train more physicians in Oregon to use 

buprenorphine, especially in rural areas where it is not available. 

It just also strikes me as odd that mid-level providers can prescribe 

fentanyl, but they cannot prescribe buprenorphine. So that is something to consider, because we have significant shortages in rural 

areas of medical providers. 

Regarding what can be done, while we have been talking about 

it this morning, one thing to consider is, how can we provide alternatives to opioids for people suffering from chronic pain so then 

they do not have to turn to opioids and then inadvertently become 

addicted? 

So providing alternative therapies, providing multidisciplinary 

treatments, where physicians are not just paid for the 15 minutes 

to write a prescription, could actually create a care plan that would 

involve behavioral therapists, social workers, psychologists, physical therapists, occupational therapists. That is one proposal I 

would make. 

Senator MENENDEZ. Dr. Young? 

Dr. YOUNG. We have been talking about the wait lists, and, from 

the child welfare perspective, we know that timely access is key. 

Many of the other funding sources do not necessarily have child 

safety and child well-being as their outcomes. 

So without a funding source that provides treatment for the child 

welfare system, it is a referral to a wait list in far too many cases. 

Mr. COUKELL. Along with what my friends on the panel have 

said, I think recognizing that, at some point, if a proportion of this 

population that starts out getting the drugs through the medical 

system goes out and starts to seek heroin, we have to identify the 

problem further upstream. So if we can find these folks when they 

are visiting multiple doctors, multiple pharmacies, and at that 

point say, ‘‘Hey, stop, we need to get you into effective care, we 

need to manage your pain,’’ before it crosses over from seeking 

medical treatment into a full-blown addiction, then we will have intervened further upstream. 

Senator MENENDEZ. Thank you. 

Mr. Chairman, I would just say that a referral to a wait list, to 

me, is probably a pathway to heroin if that wait list is awfully long. 

So this is one of the critical elements I hope that the committee 

under your leadership can look at as we deal with that. Because 

if I am already, unfortunately, addicted to opioids that I had been 

prescribed and now I can get, for a fraction of the cost to take care 

of that addiction, heroin instead of moving to a substance abuse entity that can help me permanently kick the addiction, then the reVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00035 Fmt 6633 Sfmt 6633 R:\DOCS\23291.000 TIMD
32 

ality is, if that wait list is very long, then we are on a path to a 

destructive course. 

Thank you very much. 

The CHAIRMAN. Good point. 

Let me just ask one question of you, Dr. Young. That is, as you 

pointed out, the Congress has acted in response to various substance abuse crises. As you note, in response to the methamphetamine epidemic, Congress enacted the Regional Partnership Grant 

Program. Additionally, States have access to title IV–B funds and 

the TANF and Social Services block grant to fund the types of prevention activities you testified about to keep children safely at 

home. 

Do you believe these existing funding streams are sufficient to 

address the current opioid crisis? Why or why not? 

Dr. YOUNG. Regrettably, those funding streams are not sufficient, 

as we have been talking about with the wait lists and the other 

priorities that those funding streams have. If you were to take 

those funding streams and allocate them to paying for treatment 

for child welfare families, you would just be moving other priorities 

and other populations from one funding source to this one. 

So, it is the fact that there are wait lists that speaks for itself. 

Only 10 percent of the people in the country who need treatment 

get into treatment. 

In the regional partnership grants, at their peak, there were 

about 5,000 children in a year, which pales in comparison to the 

number of children in the child welfare system who need treatment 

and the number of infants who are born with prenatal substance 

exposure. 

The CHAIRMAN. Well, thank you so much. 

Senator Wyden has a question. 

Senator WYDEN. Thank you very much, Mr. Chairman. 

I wanted to come back, because this has been such an important 

hearing. We have heard from all our colleagues, and I am walking 

out of here prepared to make sure that everybody in the Senate understands that when you do the lock-in, when you actually restrict 

access to opioids, it is absolutely critical, it is crucial that you step 

up treatment, because everybody in health care is telling us that 

the addiction is not just automatically going away. 

I was very pleased that the three of you all agreed with that 

proposition, and I can tell you I am just going to be hammering 

that point away again and again as we talk in the days ahead 

about how to tackle this. I think the fact that all of you were unanimous in that judgment was just enormously helpful as we try to 

build a bipartisan coalition for fighting opioid addiction in the right 

way. 

Just one last question, if I might, Mr. Chairman. The Oregon Attorney General, Ellen Rosenblum, and 37 other Attorneys General 

have written letters to the Centers for Disease Control in support 

of the CDC’s proposal to issue opioid prescribing guidelines. 

I would just ask unanimous consent that they be put in the 

record. 

The CHAIRMAN. Without objection. 

[The letters appear in the appendix beginning on p. 57.] 

33 

Senator WYDEN. And one last question, if I might. Mr. Hart, as 

I indicated, you all have been doing very good work with your settlement funds—as a result of some of these abuses by the manufacturers—to help Oregon develop prescribing guidelines. 

I think it would be helpful for us, as we wrap up, for you to give 

us your sense of why these sort of prescribing guidelines are so important. You come from a health background, from a law enforcement background, so you give us some special perspective. 

Why, in your view, are these prescribing guidelines so important? 

The CHAIRMAN. Well, before you answer, I have to leave. So I am 

going to have Senator Wyden close this down. 

I just want to personally express my gratitude to all three of you 

for being here today, and I want to thank my colleagues for their 

participation. This is serious stuff, and this hearing has been helpful in shedding light on the serious nature of the opioid problem 

and providing thoughts on how to move forward. 

So we owe it to the individuals, their families, and our programs 

to tackle these problems. 

I would ask that any written questions for the record be submitted by Tuesday, March 8, 2016. 

With that, I will turn the remaining time over to you, Senator. 

Forgive me. 

Senator WYDEN [presiding]. Thank you, Mr. Chairman. I look 

forward to working with you on this. 

Our last question then. How appropriate that an Oregonian is 

going to respond to the last question with respect to why these prescribing guidelines are so important. 

Mr. HART. Thank you for the question. In your opening comments, you mentioned how we need to get the balance right for prescribing. 

Senator WYDEN. Right. 

Mr. HART. Not too much, but we also want to make sure patients 

who are appropriate get treated, and that is why guidelines are 

necessary to help get the balance right. 

Now, there is misinformation in the marketplace, and they can 

help correct that, but also, let us remember, most of the prescribing 

is not being done by specialists. It is primary-care providers. 

Frankly, what we recently found is that in Oregon, for the top 

50 OxyContin prescribers, they were not even physicians. I mean, 

half—half of the top 50 OxyContin prescribers were mid-level providers. They were nurse practitioners, they were physician assistants. 

So these folks would benefit from guidance. Again, it helps people do the right thing. Doctors and prescribers are under a lot of 

pressure to prescribe. It is quicker, it is easier. So if you have a 

guideline, it will help change that. 

Finally, it might support alternative treatments, because thirdparty payers have to pay for what might be initially a more expensive alternative treatment than writing a prescription, and if you 

have guidelines that support examining and using those alternatives, perhaps we will be more likely to have third-party payers 

pay for them. 

Senator WYDEN. I think it is also important for all who are following this to understand that these are optional guidelines. This 

34 

is not the Federal Government coming in with sort of a one-sizefits-all mandate and requirement and the like. These are optional 

guidelines, and I appreciate what you are talking about. 

I will tell you, Mr. Hart, one of the most striking aspects of last 

week, as I held these forums with Senator Merkley and Congressman Blumenauer and got around the State, was the comments that 

we got with respect to what I have come to call the prescription 

pendulum. 

It was very clear that 5 to 10 years ago, there was a great deal 

of hesitancy with respect to prescribing medicine for pain, even 

when the evidence warranted that was the right thing to do. Now 

there is a sense that we have gone the other way, that just automatically there is prescribing for pain, and too many pills are made 

available. Perhaps there ought to be ways in which a person gets 

a more limited number of pills at the outset and then there is an 

arrangement to come back as needed. 

I think Oregon has really done pioneering work, you and Attorney General Rosenblum and our health specialists, in trying to 

help right that prescription pendulum. My sense is that this is not 

an exact science, just as you said. This is a challenge for doctors 

and patients and health-care providers, but I think we are starting 

to get a sense of what it is going to take to get the right balance 

of the pendulum. 

So a big thanks to you, Mr. Hart, and your colleagues. You both 

have, in addition to Mr. Hart, been very, very helpful, and, again, 

I appreciated the unanimity on this panel, people who have come 

from different walks of life, in saying that enforcement and treatment and prevention have to go forward in tandem. You have given 

us an opportunity to get that message out, and I thank you. 

With that, the Finance Committee is adjourned. 

[Whereupon, at 12 p.m., the hearing was concluded.] 

(35) 

A P P E N D I X 

ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD

PREPARED STATEMENT OF HON. ROBERT P. CASEY, JR., A U.S. SENATOR FROM PENNSYLVANIA

Thank you, Chairman Hatch and Ranking Member Wyden, for holding a hearing 

on heroin and prescription opioid abuse. This hearing is timely, given the way the 

opioid abuse crisis is engulfing communities throughout the United States, and in 

my own state of Pennsylvania. According to the Drug Enforcement Agency, Pennsylvania ranks ninth highest for drug overdose deaths in the Nation, at a rate of 18.9 

per 100,000 people. According to the Centers for Disease Control and Prevention, 

more Pennsylvanians now die from drug overdoses than car accidents. 

Although it is clear that the opioid abuse epidemic has had a terrible impact on 

the lives of many adults, we should not overlook the equally tragic impact that it 

has had on thousands of children. Nationally, the number of children entering care 

who were removed with parent drug abuse reported as a reason increased 42.5 percent from 2009 through 2014. It is almost certain that opioid addiction played a role. 

This increase can be particularly challenging for child welfare systems to handle, 

as the children of adults with a substance abuse problem often stay in the system 

longer and require extra services and counseling. In Pennsylvania, the number of 

births covered by Medicaid of children with opioid dependence rose from 883 in 2010 

to 1,122 in 2012, according to my state’s Department of Public Welfare. These children suffer from a condition known as Neonatal Abstinence Syndrome, which can 

include seizures, fever, tremors and dehydration. The long-term health effects for 

these children may not be fully known. 

There is no simple solution or law that Congress can pass to fix this problem, but 

there are commonsense steps that we can take to identify and attack the roots of 

the opioid crisis in this country, as well as to help mitigate some of its effects. I 

am pleased to support the Family First Act, bipartisan legislation that is being developed by the Finance Committee to make title IV–E funding available, for a limited time, for family preservation services, including substance abuse treatment. By 

helping to keep families together, and by expanding access to treatment, this legislation will lead to better outcomes and save the federal government money. I appreciate the efforts that Chairman Hatch and Ranking Member Wyden have put into 

developing this legislation, and I hope that the Finance Committee will vote on it 

soon. 

I am also a cosponsor of several pieces of legislation that would move us in the 

right direction, including the TREAT Act, introduced by Senator Markey, that would 

expand access to Medication Assisted Treatment; the Treatment and Recovery Investment Act, also introduced by Senator Markey, which would increase funding for 

the Substance Abuse Prevention and Treatment Block Grant; the so-called ‘‘heroin 

supplemental,’’ introduced by Senator Shaheen, which would appropriate $600 million in emergency funding to address the heroin and prescription opioid epidemic; 

and legislation introduced by Senators Toomey and Brown that would prevent doctor and pharmacy shopping for at-risk Medicare beneficiaries. 

Congress has already taken one important step by passing the Protecting Our Infants Act, which I introduced with Senate Majority Leader Mitch McConnell. This 

legislation, which was signed into law last year, requires the Department of Health 

and Human Services to develop a strategy to address research and program gaps 

on prenatal opioid use and Neonatal Abstinence Syndrome. Although passage of this 

legislation is a critical achievement for helping infants born in withdrawal, I am 

36 

1 Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. 

Compressed Mortality File 1999–2014.http://www.cdc.gov/nchs/data/health_ policy/AADR_ 

drug_ poisoning_involving_OA_Heroin_US_2000-2014.pdf. 

also aware of ongoing concerns around states’ implementation of Plans of Safe Care 

for these infants under the Child Abuse Prevention and Treatment Act. I am looking 

into ways to address this matter. 

Far too many of our local communities are struggling against the rising tide of 

prescription opioid and heroin abuse, and far too many families are being torn 

apart. I look forward to hearing from the witnesses on how we can combat opioid 

abuse, protect our children and help keep families together. 

PREPARED STATEMENT OF ALLAN COUKELL, SENIOR DIRECTOR, HEALTH PROGRAMS, THE PEW CHARITABLE TRUSTS

Chairman Hatch, Ranking Member Wyden, and members of the Senate Committee on Finance, thank you for holding this hearing on the pressing public health 

problem of prescription drug abuse. My name is Allan Coukell. I am a pharmacist 

and I direct health programs for The Pew Charitable Trusts. Pew is an independent 

nonpartisan research and policy organization that works to develop and support 

policies that will help reduce the inappropriate use of prescription drugs while ensuring that patients with medical needs have access to effective pain management. 

Nearly all of us have been touched by the epidemic of prescription drug abuse or 

have heard the horrific personal stories of its effects on peoples’ lives. It is a problem cities and rural states, of rich and poor, of old and young. This is a public 

health crisis across the nation, and the statistics are staggering. Almost 19,000 

Americans died in 2014 from prescription opioid overdoses. This is the equivalent 

of 52 people a day, and represents a 16 percent increase in deaths from the year 

before.1 What is particularly tragic is that these deaths are preventable. 

The epidemic is a public health crisis that requires a multi-faceted response. We 

need strategies to prevent drug abuse and addiction. We need to identify patients 

who are at risk. We need to prevent people from overdosing. We need to educate 

providers about how to prescribe opioids responsibly. And we need to ensure that 

people who do become addicted get the help they need. We must also not lose sight 

of the importance of providing adequate pain management to people who need it. 

Today, I would like to focus on one policy that will improve patient care and reduce the chance of overdose by ensuring that patients who are at risk of harm from 

multiple opioid prescriptions get their pain medications from one doctor or one pharmacy. These programs, known as patient review and restriction (PRR) programs, 

are in wide use in Medicaid and commercial plans. But they are prohibited in Medicare. Senators Toomey, Brown, Portman and Kaine have shown great leadership by 

introducing the Stopping Medication Abuse and Protecting Seniors Act of 2015, 

which would allow Medicare to use this important tool to protect seniors. Pew applauds their work on this important legislation. 

PATIENT REVIEW AND RESTRICTION PROGRAMS

PRRs are a tool to identify individuals at risk of overdose and other harms, and 

to ensure they receive coordinated care. PRRs specifically identify patients who are 

receiving these drugs from multiple healthcare providers, assigning them to designated pharmacies and prescribers to obtain their controlled substance prescriptions. Through this mechanism, PRRs allow plan sponsors and providers to improve 

care coordination and prevent inappropriate access to medications that are susceptible to abuse. 

Let me explain in detail how these programs work. First, potentially at-risk patients are identified based on specific, predetermined criteria, which may include the 

number of different prescribers and pharmacies visited to obtain controlled substance prescriptions. Other risk criteria may include duplicative therapies, emergency room visits and total daily dosage of the drugs. Once patients have been identified, a clinical review is performed, usually by a medical professional, to determine 

if the beneficiary’s prescription drug use is inappropriate. Patients, such as those 

in hospice or receiving treatment for certain cancers, are typically excluded from 

these programs. The beneficiary is then notified of his identification as at risk and 

his subsequent enrollment in a PRR. The beneficiary is provided the right to appeal 

the decision and the choice to submit provider preferences. 

37 

2 Centers for Medicare and Medicaid Services (2013), Supplemental guidance related to improving drug utilization controls. Correspondence from Cynthia G. Tudor, director, Medicare 

Drug Benefit and C and D Data Group dated Sept. 6, 2012. Available at http://www.cms.gov/ 

Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/HPMSSupple 

mentalGuidanceRelated-toImprovingDURcontrols.pdf. 3Medicare Payment Advisory Commission (2015). Medicare and the Health Care Delivery System, Report to the Congress. Chapter 5. Available at http://www.medpac.gov/documents/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf?sfvrsn=0. 4Government Accountability Office (GAO) (2011) Medicare Part D: Instances of questionable 

access to prescription drugs, Report to Congressional Requesters. Available at http:// 

www.gao.gov/assets/590/585424.pdf. 

Forty-nine Medicaid programs currently operate PRRs, and Pew has researched 

outcomes from these programs. Tennessee’s Medicaid program evaluated patients 

who were enrolled into the PRR program during the fourth quarter of 2010. An assessment of controlled substance use, which was measured immediately prior to and 

at least 6 months after PRR enrollment, demonstrated a 51 percent decrease in 

pharmacies visited, a 33 percent decrease in prescribers visited, and a 46 percent 

decrease in number of paid prescriptions among those patients enrolled in the PRR 

(n=96). From a 2014 report, Minnesota’s Medicaid PRR estimated cost savings of 

$1.2 million in the first year of patient enrollment based on reductions in prescriptions, emergency room utilization, and clinic visits that resulted in an average savings of $4,800 per patient (based on projected enrollment of 245). Additional reductions in service utilization and costs were realized during the second year of program enrollment. In 2008, Oklahoma’s Medicaid PRR reported decreases pre- and 

post-enrollment in the mean monthly average for narcotic claims (from 2.16 to 1.32), 

emergency department visits (from 1.26 to 0.81), number of pharmacies visited 

(from 2.05 to 0.89), and number of prescribers seen (from 2.48 to 1.63) for PRR patients with at least 1 month of eligibility in both the pre- and post-enrollment periods (n=52). 

Outcomes information from commercial plans, including CVS Health and 

BlueCross BlueShield of Massachusetts, suggest that PRR programs could improve 

public health. An expert panel convened in 2012 by the Centers for Disease Control 

and Prevention concluded that these programs have the potential to save lives—and 

healthcare costs—by reducing opioid usage to safer levels. 

PRRS IN MEDICARE

PRRs have shown effectiveness in Medicaid and the private sector, but these programs are currently prohibited in Medicare. A statutory change will be required to 

authorize their use. 

It is clear that substantial numbers of Medicare patients are at risk. A Centers 

for Medicare and Medicaid Services (CMS) analysis identified approximately 

225,000 beneficiaries who received potentially unsafe opioid dosing (the equivalent 

of 120mg or more of daily morphine for 90 or more consecutive days).2

A Medicare Payment Advisory Commission (MedPAC) analysis of 2012 prescription drug event data found that 12.3 million Medicare beneficiaries filled at least 

one prescription for an opioid, corresponding to about 36 percent of Part D enrollees 

and ranging from a low of approximately 23 percent in Hawaii to a high of approximately 50 percent in Alabama. Arkansas, Georgia, Kentucky, Louisiana, Oklahoma, 

and Tennessee were all at 40 percent or higher (see Appendix A). The vast majority 

of these individuals (87% of the 12.3 million) received the drugs for conditions not 

associated with cancer treatment or hospice care. In 2012, the beneficiaries with the 

highest use of opioids filled, on average, 23 opioid prescriptions at a cost of $3,500 

per beneficiary.3

Medicare beneficiaries are all too often getting opioid prescriptions from multiple 

providers. According to the same 2012 MedPAC analysis, among the subset of beneficiaries with the highest use of opioids for these indications, 32 percent obtained 

these prescriptions from four or more prescribers or three or more pharmacies. An 

evaluation of 2008 claims data conducted by the Government Accountability Office 

identified 170,000 Medicare Part D beneficiaries who visited at least 5, and as many 

as 87, medical professionals in a year to obtain prescriptions for opioids or other 

drugs from 14 classes of abusable drugs.4

Data from these evaluations highlight the need for PRR programs as a mechanism to achieve the balance of ensuring access to pain management while preventing overdoses and other harms associated with prescription drug abuse in the 

Medicare population. 

38 

5The Pew Charitable Trusts. Pew Urges Congress to Authorize Patient Review and Restriction Programs in Medicare, http://www.pewtrusts.org/en/research-and-analysis/speeches-andtestimony/2015/05/pew-urges-congress-to-authorize-patient-review-and-restriction-programs-inmedicare. 6 21st Century Cures Act, H.R. 6, 114th Cong. (2015), Prescription Drug Abuse Prevention and 

Treatment Act of 2015, S. 1431, 114th Cong. (2015); Department of Health and Human Services, 

‘‘HHS FY 2016 Budget in Brief’’ (2015), http://www.hhs.gov/about/budget/budget-in-brief. 7Office of the Inspector General, ‘‘Compendium of Unimplemented Recommendations’’ (2015), 

http://oig.hhs.gov/reports-and-publications/compendium/files/compendium2015.pdf. 8 Healthcare Co-ops: A Review of the Financial and Oversight Controls. Senate Finance Committee Hearing, (2016)(statement of Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services), http://www.finance.senate.gov/hearings/healthcare-co-ops-a-review-of-the-financial-and-oversight-controls. 

THE STOPPING MEDICATION ABUSE AND PROTECTING SENIORS ACT

In May 2015, Pew, along with health plan sponsors, managed care pharmacy providers and public policy organizations worked together to develop key principles 

that should be included in PRR legislation to ensure that these proposals provide 

patient protections while also ensuring that they work as intended to minimize potential harms from prescription drug misuse and abuse.5 Patients in long-term care 

and hospice should be excluded from enrollment in a PRR. Beneficiaries should also 

have the ability to appeal their enrollment in a PRR. In addition, PRR program design should also allow for patient input on the selection of prescribers and pharmacies to ensure reasonable access that considers geographic location, cost-sharing, 

travel time, and multiple residencies. 

Pew supports the Stopping Medication Abuse and Protecting Seniors Act because 

it includes the key principles described above, to ensure both patient safety and access to care. 

This legislation achieves an appropriate balance in allowing identification of doctor shopping and at-risk patients, and providing access to effective pain management. It includes the beneficiary protections outlined above and allows for broad 

stakeholder input on the development of criteria that will be used to enroll patients. 

The legislation also requires plan sponsors to contact the beneficiary’s physicians 

prior to patient enrollment to verify whether the prescribed medications are appropriate given the beneficiary’s medical condition. Beneficiaries will help select providers. An appeals process is also included. Finally, plans will be required to provide 

enrollees with information on resources to address prescription drug abuse, such as 

substance use disorder and addiction treatment services, when possible. 

SUPPORT FOR THE LEGISLATION

There is substantial support to advance the Stopping the Medication Abuse and 

Protecting Seniors Act as an effective tool to decrease opioid abuse and improve patient safety. A similar proposal has already passed the House of Representatives 

with broad bipartisan support as part of the 21st Century Cures Act, and President 

Barack Obama proposed this policy in his FY 2016 and 2017 Budget requests for 

the Department of Health and Human Services.6 The Office of the Inspector General also included PRRs in the 2015 Compendium of Unimplemented Recommendations as one of 25 quality improvements that should be prioritized and implemented.7

We agree with CMS acting administrator, Andy Slavitt, who said a PRR proposal 

‘‘makes every bit of sense in the world, and we completely agree that that’s the kind 

of authority that would be very helpful in really taking a practical measure to stem 

abuse.’’ 8 Once again, we thank Senators Toomey, Brown, Portman and Kaine for 

introducing this legislation, as well as the many cosponsors of the legislation who 

sit on this Committee. We urge the Senate to help address the nation’s prescription 

drug abuse epidemic by passing the Stopping Medication Abuse and Protecting Seniors Act of 2015, which would expand use of the PRRs to ensure that these programs 

can be used to prevent prescription drug abuse in Medicare. 

39 

QUESTIONS SUBMITTED FOR THE RECORD TO ALLAN COUKELL

QUESTIONS SUBMITTED BY HON. CHUCK GRASSLEY

Question. You have testified that patient review and restriction programs (PRR) 

are in wide use in Medicaid and commercial plans. How many Medicaid programs 

currently operate patient review and restriction programs? 

Answer. Based on research conducted by Pew, 48 states and the District of Columbia operate PRR programs for their Medicaid fee-for-service population, managed care population, or both. Twenty-eight states operate PRRs in both Medicaid 

FFS and managed care environments; 16 states administer PRRs only in Medicaid 

FFS; and three states administer a PRR only in Medicaid managed care. Two other 

states also operate a FFS PRR, but we were unable to confirm whether Medicaid 

managed care plans in these states have active PRRs. 

Question. What protections are in place to allow access to needed pain medication 

for patients with certain medical conditions? 

Answer. By coordinating the use of controlled substance prescriptions, PRR programs aim to protect patients from harmful amounts of opioids while also ensuring 

patients receive needed pain medications. Based on results of a survey Pew conducted of 38 Medicaid fee-for-service PRR programs, PRR staff (typically a pharmacist or registered nurse) perform a clinical review after identification of patients 

potentially at risk for prescription misuse or diversion. Patients, such as those receiving treatment for certain types of cancer, in hospice, or in long-term care, may 

be automatically excluded from PRR programs. Further, most programs allow patients to provide input on the selection of their designated providers and to appeal 

their identification as at-risk and enrollment in a PRR. 


022316.001
40 

The Comprehensive Addiction and Recovery Act, section 705, which passed the 

Senate on March 10, 2016, would require that the Secretary, in consultation with 

plan sponsors and other stakeholders, develop screening criteria to identify beneficiaries at risk for prescription drug misuse or diversion. These criteria are to be 

based on clinical factors indicating misuse of prescription drugs, including dosage, 

quantity, duration of use, number of prescribers, and number of pharmacies visited 

to obtain such drugs. Certain patient populations are excluded from PRR enrollment, including individuals receiving hospice care, residents in long-term care facilities, and others that the Secretary elects to treat as exempt. Further, the legislation 

provides the right for the beneficiary to appeal identification and placement in the 

PRR program. It also requires that the plan provide the beneficiary an opportunity 

to submit input on provider selection. Finally, the legislation requires the Comptroller General to conduct a post-program analysis to assess any barriers that may 

impede access to prescription medications and to evaluate the effectiveness of the 

reasonable access protections included in the legislation. 

Question. In your opinion, is there a need for a patient review and restriction program in Medicare? 

Answer. A patient review and restriction program in Medicare would help protect 

beneficiaries and reduce prescription drug abuse. A Centers for Medicare and Medicaid Services analysis identify approximately 225,000 beneficiaries who received potentially unsafe opioid dosing (the equivalent of 120 mg or more of daily morphine 

for 90 or more consecutive days) in 2011. An evaluation of 2008 claims data conducted by the Government Accountability Office identified 170,000 Medicare Part D 

beneficiaries who visited at least 5, and as many as 87, medical professionals in a 

year to obtain prescriptions for opioids or other drugs from 14 classes of abusable 

drugs. According to a 2012 Medicare Payment Advisory Commission analysis, 

among the subset of beneficiaries with the highest use of opioids for conditions not 

associated with cancer treatment or hospice care, 32 percent obtained these prescriptions from four or more prescribers or three or more pharmacies. Data from 

these evaluations highlight the need for PRR programs as a mechanism to achieve 

the balance of ensuring access to pain management while preventing overdoses and 

other harms associated with prescription drug misuse in the Medicare population. 

QUESTIONS SUBMITTED BY HON. MICHAEL F. BENNET

Question. The Colorado Plan to Reduce Prescription Drug Abuse is working to 

educate prescribers and providers. It will also increase public awareness, strengthen 

the Colorado Prescription Drug Monitoring Program, and expand access to the overdose reversal drug, Naloxone. To date, there are 39,000 fewer Coloradoans who misused prescription drugs since the program was implemented. As we consider policy 

options to reduce opioid drug abuse, how can the federal government partner with 

states to advance the work that has been done? 

Answer. The Colorado Plan to Reduce Prescription Drug Abuse is working to educate prescribers and providers. It will also increase public awareness, strengthen the 

Colorado Prescription Drug Monitoring Program, and expand access to the overdose 

reversal drug, Naloxone. To date, there are 39,000 fewer Coloradoans who misused 

prescription drugs since the program was implemented. As we consider policy options to reduce opioid drug abuse, how can the federal government partner with 

states to advance the work that has been done? 

The federal government should continue to support states’ efforts to curb prescription drug abuse. Federal grants programs, such as the Centers for Disease Control 

and Prevention (CDC) Prevention for States and the Substance Abuse and Mental 

Health Services Administration’s Medication-Assisted Treatment for Prescription 

Drug and Opioid Addiction, are examples of programs that have allowed states to 

enhance prescription drug monitoring programs, support community and health system interventions to prevent abuse, and expand the use of medication-assisted treatment in combination with psychosocial services, recovery support services, and coordination of medical care for HIV and hepatitis C. 

Question. In Colorado, drug overdoses are more prevalent in our rural areas. 

Those areas lack services, treatment, and access to transportation so patients can 

obtain services. How can we find a solution that takes into account the unique needs 

of our rural families? 

Answer. Individuals in rural areas of Colorado and many other states face substantial barriers in accessing substance use disorder (SUD) treatment. These chalVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00044 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
41 

lenges include the limited number of healthcare providers who can prescribe 

buprenorphine, which is an effective therapy for SUD. Use of buprenorphine is especially beneficial in rural areas where opioid treatment programs (OTPs) are scarce. 

Yet, too few buprenorphine prescribers exist in these areas. A study published by 

Rosenblatt et al. in Annals of Family Medicine in January 2015 found that 10 percent of the U.S. population (30 million people) lives in a county where there are no 

authorized buprenorphine prescribers. Of these counties with no prescribers, 80 percent are in rural areas. Nurse practitioners and physician assistants may be more 

readily available in these areas, but legislation is needed to provide these healthcare 

professionals with the authority to prescribe and manage patients who could benefit 

from this medication. 

Question. Given that over 20% of pregnant women on Medicaid filled a prescription for an opioid during pregnancy, what can we do to aid mothers-to-be and improve outcomes for infants who are born in withdrawal? 

Answer. A CDC study published in National Health Statistics Reports in July 

2012 found that approximately two in five U.S. pregnancies are unplanned, thus 

prescribers should assess opioid medication use among all women of reproductive 

age (15 to 44 years). Women on Medicaid may be at increased risk because of differences in opioid prescribing, differences in coverage of health care services, or differences in the prevalence of underlying health conditions. As recommended by the 

Association of State and Territorial Health Officials (ASTHO), key strategies for 

states include: patient education; universal substance use screening; Medicaid reimbursement for substance use screening during preventive care, preconception, and 

prenatal visits; provider education and training; and access to substance abuse 

treatment services. 

Infants born with neonatal abstinence syndrome (NAS) are at increased risk of 

complications in the neonatal period, including respiratory complications and seizures. ASTHO recommends that birthing hospitals develop written policies that 

standardize evaluation and treatment protocol for NAS to decrease biases in screening and testing of mothers-to-be. Infants born with withdrawal respond best when 

mother-baby bonding is encouraged, and when mothers receive parental support and 

teaching. To improve outcomes for both mother and baby, mothers may need additional supports (e.g., home-based services; family treatment drug courts) to enhance 

attachment and reduce the risk of child abuse or neglect. 

PREPARED STATEMENT OF DAVID HART, ASSISTANT ATTORNEY-IN-CHARGE, HEALTH

FRAUD/CONSUMER PROTECTION SECTION, OREGON DEPARTMENT OF JUSTICE

Good morning. I’d like to begin by thanking Chairman Hatch, Ranking Member 

Ron Wyden and members of the committee for allowing me the opportunity to testify on this important issue. My name is David Hart, and I am the Assistant Attorney-in-Charge of the Health Fraud Unit/Consumer Protection Section of the Oregon 

Department of Justice. For more than 15 years I have led investigations relating 

to pharmaceutical marketing and promotion, both for the State of Oregon, and for 

bipartisan multistate coalitions of state Attorneys General. Now, under the leadership of Oregon Attorney General Ellen Rosenblum, I pursue cases related to Oregon’s growing—and painful—opioid abuse epidemic. Prior to graduating from law 

school and joining the Oregon Department of Justice, I practiced as a physical therapist for 15 years at hospitals, nursing homes, home health agencies and hospices. 

In that time period, I worked with thousands of patients with acute and chronic 

pain. That experience informed my investigations of the marketing and promotion 

of opioids which is the subject of my testimony this morning. 

The causes of the opioid epidemic are many. While my testimony will focus on 

the effects of opioid marketing and promotion, I do not want to minimize the existence of other factors that helped cause the epidemic. Because the causes are many, 

so too will be the solutions. My testimony today will also cover some of the things 

we are doing in Oregon to combat the epidemic that were funded in part with settlement funds from our cases. If the Federal Government wants to take action to stop 

the opioid abuse, I would urge members of this committee to consider adopting the 

model approach we have taken in Oregon. 

In 2007, Oregon was a member of the Executive Committee of a multistate coalition of state Attorneys General that reached a settlement with Purdue Pharma 

(‘‘Purdue’’) to resolve allegations that Purdue violated state consumer protection law 

by misrepresenting OxyContin’s risk of addiction and by promoting OxyContin ‘‘offVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00045 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
42 

1 4.0 per 100,000 in 2013; 1.4 per 100,000 in 2000. 

2http://www.samhsa.gov/data/sites/default/files/NSDUHStateEST2012-2013-p1/Change 

Tabs/NSDUsaeShortTermCHG2013.htm. 3 Unpublished Oregon PDMP data. 

label’’ for long term treatment of certain chronic pain conditions. OxyContin, an extended release formulation of oxycodone, was first introduced in 1995. Until that 

time, opioids were largely used to treat acute pain and cancer pain. Many physicians were reluctant to prescribe opioids on a long-term basis for common chronic 

conditions because of concerns about abuse and addiction. However, while this inhibition was already breaking down before OxyContin was introduced, after its introduction, this breakdown accelerated, fueled in part by Purdue Pharma’s aggressive 

marketing and promotion of the drug. Attached as Exhibit 1 to my written testimony is a copy of the complaint the Oregon Department of Justice filed against Purdue in May of 2007. Virtually identical complaints were filed by 26 other state Attorneys General. In short, our complaints alleged that although OxyContin is a 

Schedule II narcotic with an abuse profile and addictive qualities similar to morphine, Purdue aggressively promoted OxyContin to doctors, nurses and consumers 

as a first-choice analgesic for treatment of a wide variety of pain symptoms. While 

it expanded the market for OxyContin, Purdue avoided and minimized the known 

risks of OxyContin abuse, addiction and diversion. Purdue failed to adequately warn 

doctors or consumers of OxyContin’s significant risks and failed to take reasonable 

steps to guard against OxyContin abuse and diversion, instead striving to ‘‘educate’’ 

doctors and consumers that concerns over abuse, addiction and diversion of OxyContin were misplaced. Purdue’s aggressive promotion of OxyContin led to a dramatic increase in OxyContin prescriptions which in turn furthered an increase in 

OxyContin abuse and diversion from legitimate users to illicit use of OxyContin. 

The 2007 multistate consumer protection settlement with Purdue required cessation of unlawful promotion, and required Purdue to identify and stop promoting 

OxyContin to doctors who improperly prescribed opiates. Attached as Exhibit 2 to 

my written testimony is a copy of the multistate settlement. However, the settlement did not require Purdue to take sufficient remedial action to correct misinformation that was endemic in the marketplace. At the time of the multistate settlement, I did not fully appreciate the severity of the opioid epidemic and the long lasting effects of Purdue’s OxyContin promotion. Had I so known, I would have advocated for a settlement which would have required more extensive remedial action 

by Purdue to correct the inappropriate prescribing patterns for opioids that Purdue’s 

marketing helped create. 

Oregon, like the rest of the nation, has continued to struggle with overprescribing 

and misuse of prescription opioids. Between 2000 and 2013, there were 2,226 deaths 

in Oregon due to prescription opioid drug overdose. The mortality rate associated 

with prescription opioid overdose increased 364% between 2000 and 2006, and 

though it has decreased since then, it remains 2.9 times higher than in 2000.1 Results from the 2013–2014 National Survey on Drug Use Health tie Oregon for 4th 

place among all states in non-medical use of prescription pain relievers, down from 

1st among all states in the same 2010–2011 survey.2 In 2013, 3.6 million prescriptions for opioid painkillers were dispensed in Oregon, enough for 925 opioid prescriptions for every 1,000 residents.3

To ensure that unlawful drug promotion does not further contribute to this problem, the Oregon Department of Justice has been vigilant to monitor opioid marketing and promotion in our state. As part of that effort, we became concerned about 

the marketing and promotion of Subsys, a sub-lingual fentanyl spray that is more 

than 50 times more powerful than heroin and is only approved for breakthrough 

cancer pain. We believed this powerful drug was being deceptively and unconscionably promoted in Oregon. Pursuant to Oregon’s Unlawful Trade Practices Act, we 

issued Investigative Demands to Insys, the manufacturer of Subsys, obtained documents and information from the company, interviewed former sales representatives 

and consulted with experts. Our comprehensive investigation revealed several patterns of alleged misconduct, including reports that the company provided improper 

financial incentives to doctors to increase prescriptions, aggressively promoted 

Subsys to doctors not qualified to prescribe the drug, and deceptively promoted 

Subsys for treatment of mild pain. After our investigation, we issued a formal Notice of Unlawful Trade Practices which lays out the allegations. In short, Oregon 

was the first state in the country to allege that Insys promoted Subsys ‘‘off-label’’ 

for non-cancer pain such as back pain and neck pain, uses for which Subsys is neither safe nor effective. We also outlined allegations that Insys unconscionably tarVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00046 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
43 

geted problem doctors who misprescribed opiates with aggressive Subsys promotion 

and that Insys facilitated prescribing of Subsys for contraindicated uses. Not only 

did Insys target problem opiate prescribers, it hired those doctors to teach other doctors about Subsys. I was truly shocked that in 2015, when the scourge of the opioid 

epidemic was so widely known, that a manufacturer of a schedule II drug would 

promote a powerful opioid such as Subsys in such an unconscionable and irresponsible way. Attached to my written testimony as Exhibit 3 is a copy of Notice of Unlawful Trade Practices which describes this conduct in greater detail. 

To avoid a lawsuit that would litigate our allegations, Insys agreed to an Assurance of Voluntary Compliance which prohibits the misconduct that we identified in 

our investigation and required Insys to pay Oregon more than two times the total 

Subsys sales in the state. Oregon was also the first government entity to settle with 

Insys for this alleged misconduct. Attached to my written testimony as Exhibit 4 

is a copy of the Assurance of Voluntary Compliance. 

Fortunately, much of the $1.1 million dollar payment the Oregon Department of 

Justice received from the Insys settlement is now being used to fund efforts to address the opioid epidemic in Oregon. This includes: 

• Funding regional pain guidance groups to develop opioid prescribing practices 

for their communities and to facilitate coordination of care across specialties; • Funding development of regional action plans to prevent opioid abuse; • Funding addiction treatment training to increase the number of Oregon physicians in underserved communities with the waiver necessary to treat opioid 

dependent individuals with agonist and partial agonist medications in an office based setting; • Funding to support addiction treatment telemedicine consultation services to 

expand access to treatment for Oregonians with substance abuse disorders in 

the communities where they live; • Funding to promote disposal of unused and expired opioids by helping pharmacies become licensed disposal locations; • Funding to expand the use of naloxone, a drug that reverses the lethal effects 

of an opioid overdose; and • Funding to build a statewide pain guidance public education campaign web 

platform with regional resource pages to help providers, patients and family 

members make informed choices. 

It is our hope in Oregon that these programs and initiatives will save lives. We 

also hope that other states, and the Federal government, will consider programs like 

the one in Oregon that take a holistic—and realistic—approach to fighting our country’s opioid epidemic. 

This concludes my testimony. Again, thank you Chairman Hatch, Ranking Member Ron Wyden and members of the committee for inviting me today. I am available 

to answer questions. 

QUESTION SUBMITTED FOR THE RECORD TO DAVID HART

QUESTION SUBMITTED BY HON. MICHAEL F. BENNET

Question. In recent months, a Colorado hospital’s former employee stole narcotic 

pain medication and was found to have possibly exposed up to 2,900 patients to viruses including hepatitis B, hepatitis C, and HIV. A similar case occurred in 2009 

involving a surgical technician that diverted narcotic pain medication and left behind dirty syringes. In other instances, stolen narcotics have been sold illegally in 

the community. As we discuss solutions for the opioid epidemic, how can we combat 

narcotic drug diversion in hospitals that not only adds to the epidemic but may put 

hospitalized patients at risk of contracting diseases? 

Answer. Senator Bennet asks an excellent question. However, I am not the best 

person to answer it. Diversion of narcotics by addicted health care professionals is 

a serious problem that can impact thousands of patients. The events in Colorado, 

where surgical technicians diverted narcotics intended for post-surgical pain relief, 

was likely the result of insufficient procedures, or a failure to comply with existing 

procedures. Whether there should have been better screening of the technicians, or 

more robust monitoring and control of the drugs themselves, is outside of my area 

of expertise. My suggestion is to consult with groups such as the American Society 

of Health System Pharmacists, The American Society of Anesthesiologists, and professional licensing boards, who have expertise in this area, for greater insight into 

44 

what can be done to prevent diversion of narcotics by health care professionals in 

the hospital setting. 

PREPARED STATEMENT OF HON. ORRIN G. HATCH, 

A U.S. SENATOR FROM UTAH

WASHINGTON—Senate Finance Committee Chairman Orrin Hatch (R–Utah) today 

delivered the following opening statement at a hearing examining the opioid abuse 

epidemic and its effect on Medicare and the child welfare system: 

Today, we are here to discuss the very important issue of opioid abuse. Opioids 

are a powerful class of drugs prescribed to treat severe pain. When used appropriately, these drugs provide much-needed relief to patients after a surgical procedure or during treatment for cancer. 

Unfortunately, opioids also have qualities that make them addictive and prone to 

abuse. The goal of today’s hearing is to help us gain a better understanding of why 

opioid use has risen dramatically in the past 15 years and how we can best curtail 

abuse. 

Put simply, opioid abuse has become an epidemic and a significant public health 

problem. 

While it puts serious strains on our health care system, including Medicare and 

other federal programs, the most devastating consequence of opioid abuse is the 

human impact. Opioid abuse takes a major toll on families and children often persisting for generations. 

The statistics are staggering. 

Opioids are prescribed in such quantities that every adult in the United States 

could have a month’s supply. Approximately, 7,000 people show up in an emergency 

room each day for treatment of problems associated with prescription opioid abuse. 

One opioid-related death takes place in our country almost every 30 minutes. 

My home state of Utah has been hard hit by this epidemic. In 2014 alone, 289 

Utahns died due to opioid abuse, which was more than half of all drug-overdose related deaths in the state. 

The problem is even worse in other states. I am sure many of my colleagues will 

not only have numbers to share regarding their states, but have stories about individuals as well. 

The good news is that there is wide recognition of the problem and shared interest 

in finding solutions. 

A few weeks ago, the Senate Judiciary Committee unanimously reported the Comprehensive Addiction and Recovery Act, legislation sponsored by Senator Portman. 

It is a good bill. I was pleased to vote for it in Committee and hope the full Senate 

will pass it swiftly and without unnecessary delay. 

Today’s hearing will focus on another good bill—one that is in the Finance Committee’s jurisdiction. 

As I mentioned, Medicare is not immune from the costs of opioid abuse. The Government Accountability Office, the Medicare Payment Advisory Commission, and 

others have identified it as a problem. Though only a relatively small number of 

beneficiaries are at risk, we owe it to those individuals, their families, and the Medicare program to do all we can to address this problem. 

Senators Toomey and Portman have a very thoughtful bipartisan bill with Senators Casey and Brown that would provide Medicare with an important tool in the 

fight against opioid abuse. The bill will allow Medicare Part D prescription drug 

plans to work with at-risk beneficiaries to identify one physician to prescribe opioids 

and one pharmacy to fill all the opioid prescriptions. Having opioids prescribed by 

one physician instead of multiple doctors will result in better patient care and reduced abuse. It will also make it more likely that a beneficiary with a problem gets 

the help they need. 

Nearly all Medicaid programs and private payers have such a prescription drug 

review and restriction, or ‘‘lock-in,’’ program. I look forward to hearing more today 

about the success of these programs in Medicaid and how the Toomey-Portman bill 

would have a similar impact in Medicare. 

45 

The Toomey-Portman bill has bipartisan support on the Committee, with both 

Senators Brown and Casey acting as strong proponents. Establishing a lock-in program in Medicare is also supported by President Obama as it was proposed in the 

Administration’s budget proposal. 

I applaud Senators Toomey and Portman for their leadership on this legislation 

and I hope we can move it very soon. 

Of course, the impact of the opioid epidemic stretches far beyond our health care 

system, touching on virtually all parts of the social safety net. Today, in addition 

to discussing the impact on the health care system, we’ll hear more about the implications of these substance abuse crises for our child welfare system. 

The current opioid epidemic is just the latest manifestation of an ongoing problem 

in child welfare. Whether it be the crack cocaine epidemic of the 1980s, the methamphetamine epidemic that has plagued many rural areas, or the current opioid crisis, we have seen time and again that the child welfare system is ill-equipped to 

deal with families struggling with substance abuse. 

Instead of finding ways to get families affected by addiction the help and support 

they need to get and stay sober, the majority of federal dollars in the child welfare 

system are spent on removing children from their homes and placing them into foster care, which most have acknowledged is the least effective and most expensive 

outcome. 

Children who are raised by the state in foster care face increased risks of substance abuse, homelessness, teen pregnancy, and other negative outcomes both 

while they’re in the system and when they transition out as adults. And, in cases 

of untreated addiction, the cycle of addiction can persist for generations. 

Senator Wyden and I have been working on bipartisan legislation that would provide states the flexibility to use federal child welfare funds to address issues of substance abuse and other risk factors. We’re also talking with our colleagues over in 

the House, and I hope that we’ll be able to get to a bipartisan/bicameral agreement 

on a path forward. Children and families are relying on us to take this important 

step. 

Let me conclude by saying that the opioid epidemic is a complex problem that 

needs a multi-faceted solution. We will discuss at least opportunities to make a difference here today—the Toomey-Portman bill dealing with Medicare and our efforts 

with regard to child welfare. 

Of course, these are not the only ideas out there. I am would be happy to hear 

about and consider any other ideas that might be within the Finance Committee’s 

jurisdiction, so long as they are constructive and do not take an overly simplistic 

view of this serious and complicated problem. 

I’d like to thank our witnesses for being here today to discuss this important to 

topic. 

LETTERS SUBMITTED FOR THE RECORD BY HON. PATRICK J. TOOMEY

Supporters of Patient Review and Restriction Programs 

Prepared by the Office of Senator Pat Toomey (R-PA) 

CMS Acting Administrator Andy Slavitt, Senate Finance Committee Hearing, January 21, 2016. 

‘‘Thank you for your leadership on this very challenging issue. I know from work 

we’ve done with you, and your office in western Pennsylvania, how personally involved you have been, and of course we are dealing with the effects of this every 

day as well. 

‘‘We think a lock-in proposal makes every bit of sense in the world, and we completely agree that that’s the type of authority that would be very helpful in really 

taking a practical measure to stem abuse.’’ 

Statement of Michael P. Botticelli, Director of National Drug Control Policy, HSGAC Field Hearing, September 15, 2015. 

Director Botticelli on the President’s FY16 budget includes support for a lock-in proposal stating, ‘‘The Budget also proposes to establish a program in Medicare Part 

D to prevent prescription drug abuse by requiring that beneficiaries at risk for preVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00049 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
46 

scription drug misuse obtain controlled substances only from specified providers and 

pharmacies, similar to many state Medicaid programs.’’ 

CDC Director Tom Frieden, Press Conference, November 1, 2011. 

Dr. Frieden stated in 2011 that, ‘‘Prescription pain killers are meant to help people 

who have severe pain. They are, however, highly addictive. . . . There are specific 

things that can be done to drastically reduce the number of prescription overdoses, 

of deaths and people who become addicted. . . . One means of taking that effective 

action is through patient review and restriction policies which identifies problem patients or patients who have had a problem with drugs and limits them to one doctor 

to prescribe narcotics and one pharmacy to fill those narcotic prescriptions.’’ 

HHS Budget Request 

The President’s FY 2016 and FY 2017 budget request, ‘‘proposes to establish a program in Medicare Part D to prevent prescription drug abuse by requiring that highrisk beneficiaries only obtain controlled substances from specified providers and 

pharmacies.’’ 

Office of Inspector General Reports 

In a report issued in August 2014, the Department of Health and Human Services, 

Office of the Inspector General ‘‘has found that Part D is vulnerable to fraud, waste, 

and abuse’’ and ‘‘found that a number of beneficiaries received . . . drugs from extremely high numbers of pharmacies or prescribers.’’ In order to prevent this abuse 

of the Part D Program, OIG recommended that ‘‘CMS should seek legislative authority, if necessary, to restrict certain beneficiaries to a limited number of pharmacies or to a limited number of prescribers, a practice commonly referred to as 

‘lock-in.’ ’’ 

In a report issued in June 2015, HHS OIG stated, ‘‘As a means to more appropriately manage prescription drug utilization by beneficiaries, CMS should seek 

statutory authority to restrict certain beneficiaries to a limited number of pharmacies or prescribers when warranted by excessive or questionable billing patterns. 

This practice is commonly referred to as ‘lock-in’ and has been successfully implemented by some State Medicaid programs.’’ 

MedPAC 

When discussing potential policy options focused on opioids, MedPAC stated on 

April 2, 2015 that pharmacy and/or prescriber lock-in was an option that had potential to cut down on the opioid epidemic. 

Government Accountability Office 

In a September 2011 report the GAO recommended, ‘‘that the Administrator of CMS 

. . . consider additional steps such as a restricted recipient program for Medicare 

Part D that would limit these beneficiaries to one prescriber, one pharmacy, or both 

for receiving prescriptions. CMS should consider the experiences from Medicaid and 

private sector use of such restricted recipient programs, including weighing the potential costs and benefits of instituting the control. CMS could consider piloting such 

a program with a focus on hydrocodone and oxycodone, the two drug classes where 

[GAO] identified the largest potential doctor shopping activity.’’ 

In a July 2015 report the GAO ‘‘identified about 16,000 individuals [in the Medicaid 

program] whose visits to multiple prescribers for antipsychotics and respiratory 

medications raise questions.’’ To prevent this from occurring, the GAO concluded 

that, ‘‘Lock-in programs are an important tool that can be used to address doctor 

shopping by locking beneficiaries who have abused the Medicaid program in to one 

prescriber, one pharmacy, or both for receiving prescriptions.’’ 

ACADEMY OF MANAGED CARE PHARMACY

February 22, 2016 

The Honorable Orrin G. Hatch The Honorable Ron Wyden 

Chairman Ranking Member 

Senate Finance Committee Senate Finance Committee 

219 Dirksen Senate Office Building 219 Dirksen Senate Office Building 

Washington, DC 20510 Washington, DC 20510 

Re: Senate Finance Committee Hearing—‘‘Examining the Opioid Epidemic: Challenges and Opportunities’’ 

47 

1Proceedings of the AMCP Partnership Forum: Breaking the Link Between Pain Management 

and Opioid Use Disorder J Manag Care Spec Pharm 2015 Dec;21(12):1116–1122. 2Theresa R.F. Dreyer, Thomas Michalski, and Brent C. Williams. Patient Outcomes in a Medicaid Managed Care Lock-In Program. J Manag Care Spec Pharm, 2015 Nov;21(11):1006–1012. 3 Centers for Disease Control and Prevention. Prescription painkiller overdoses in the U.S. November 2011. Available at: http://www.cdc.gov/vitalsigns/painkilleroverdoses/. Accessed on 

August 25, 2015. 4 Roberts A.W., Cockrell Skinner A. Assessing the Present State and Potential of Medicaid 

Controlled Substance Lock-in Programs. J. Manag. Care Pharm. 2014;20(5):439–46. 5 CDC; National Center for Injury Prevention and Control. Beneficiary review and restriction 

programs. Lessons learned from state Medicaid programs (2012), http://www.cdc.gov/home 

andrecreationalsafety/pdf/PDO_beneficiary_review_meeting-a.pdf. Accessed on August 25, 2015. 6 North Carolina Department of Health and Human Services. 2.3 million pills off the streets, 

$5.2 million saved by narcotics lock-in. May 14, 2012. 

Dear Chairman Hatch and Ranking Member Wyden: 

The Academy of Managed Care Pharmacy (AMCP) appreciates the opportunity to 

submit comments for the record on the hearing titled ‘‘Examining the Opioid Epidemic: Challenges and Opportunities’’ scheduled for February 23, 2016. AMCP supports a holistic, comprehensive, and multi-stakeholder approach among health care 

providers and patients that truly addresses the opioid epidemic.1 On the federal 

level, AMCP supports drug management programs for the population of Medicare 

at-risk beneficiaries. Adoption of federal legislation on this issue is one opportunity 

to better manage opioid addiction in Medicare and therefore AMCP strongly supports S. 1913—The Stopping Medication Abuse and Protecting Seniors Act that 

would allow for the expansion of drug management programs to Medicare Part D 

beneficiaries and allow these patients to benefit positively from these programs. 

AMCP is a professional association of pharmacists and other practitioners who serve 

society by the application of sound medication management principles and strategies to improve health care for all. The Academy’s 8,000 members develop and provide a diversified range of clinical, educational, medication and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. 

Rates of prescription drug abuse related to emergency department visits and treatment admissions have reached epidemic levels in the United States. According to 

the Centers for Disease Control and Prevention (CDC), deaths associated with prescription medications have increased more than 300 percent since 1998, while prescribing rates for these drugs quadrupled between 1999 and 2010. Deaths connected 

to prescription drug misuse now exceed those from heroin and cocaine combined.2

Moreover, the economic costs of prescription drug abuse are substantial. The nonmedical use of controlled substances results totals $72 billion in unnecessary costs 

annually, including lost productivity, costs to the criminal justice system, and health 

care expenditures.3

Managed care organizations have well-established techniques for limiting the abuse 

or diversion of opiates or other controlled substances for patients who have a history 

or suspicion of inappropriate utilization, diversion, or abuse of these agents. However, one tool commonly used by the private sector and Medicaid markets that the 

Medicare Part D program does not permit is the use of a drug management plan 

(DMP) by prescription drug plans (PDPs) and Medicare Advantage prescription drug 

plans (MA–PD) to limit patients with a history of abuse to a single prescriber and/ 

or pharmacy (or chain of pharmacies). Members of Congress, the Centers for Medicare and Medicaid Services (CMS), the Drug Enforcement Administration (DEA), 

and the Department of Health and Human Services (HHS) Office of Inspector General have all acknowledged the need and expressed support for this type of program. 

Forty-six states have successfully implemented DMPs through state Medicaid programs with positive results.4 An evaluation of state Medicaid DMPs, performed by 

a CDC expert panel, concluded that these programs have the potential to reduce 

opioid usage to safer levels and thus save lives and lower health care costs.5

• In 2012, the State of North Carolina, announced $5.2 million in savings from 

their state Medicaid DMP program.6

48 

7SoonerCare Pharmacy Lock-in Program Promotes Appropriate Use of Medications. September 9, 2009 [press release]. http://okhca.org/about.aspx?id=10973. Accessed on August 25, 

2015. 8Theresa R.F. Dreyer, Thomas Michalski, and Brent C. Williams. Patient Outcomes in a Medicaid Managed Care Lock-In Program. Journal of Managed Care and Specialty Pharmacy 2015 

21:11, 1006–1012. 9Sarah G. Kachur, Alyson B. Schuster, Yanyan Lu, Elizabeth Patton-LeNoach, Hugh Fatodu, 

Peter J. Fagan, and Chester W. Schmidt. Impact of a Single-Provider Lock-In Program for Opiates in a Managed Medicaid Population. Johns Hopkins University School of Medicine, Baltimore, MD. 10 Alexander G.C., Frattaroli S., and Gielen A.C., eds. The Prescription Opioid Epidemic: An 

Evidence-Based Approach. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD: 

2015. 11 Announcement of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and 

Medicare Advantage and Part D Payment Policies and Final Call Letter. Centers for Medicare 

and Medicaid Services, April 2, 2012. Available at http://www.amcp.org/WorkArea/ 

DownloadAsset.aspx?id=15078. Accessed September 4, 2015. 

• In 2009, the Oklahoma Medicaid department found that its lock-in program reduced doctor shopping, utilization rates of controlled substances, and emergency 

room visits with a savings of $600 per person in costs.7

• Florida reported 1,315 individuals had been placed into their Medicaid DMP between October 2002 and March 2005. During this time period, cumulative savings for medical and pharmaceutical expenses topped $12.5 million. 

A recent study evaluating the clinical outcomes of drug management programs for 

Medicaid patients found that the proportion of stable patients increased from 31% 

at 6 months to 78% at 36 months.8 In addition, a study evaluating the impact of 

a single-prescriber and single-pharmacy drug management program on health care 

utilizations and costs within a Medicaid Managed Care Organization in Maryland 

found that enrollment in a drug management program decreased opioid prescriptions and associated costs among health plan members who exhibited signs of opioid 

overuse.9 Therefore, AMCP supports the ability for patients identified as at-risk for 

opioid overutilization to be entered into a DMP to reduce incidence of doctor or 

pharmacy shopping. 

As noted above, DMPs have successfully been used by state Medicaid programs and 

commercial plans for years but are currently prohibited under Medicare Part D. 

Opioid misuse by elderly patients, the primary population covered by the Medicare 

Part D program, is a growing concern in the United States and it is unfortunate 

that DMPs, along with other clinical and psychosocial interventions, may not be 

used to allow these individuals to receive the help they need. Furthermore, Medicare beneficiaries who are disabled and under 65 are at the greatest risk for overutilization or inappropriate utilization of opioids thereby strengthening the need for 

DMPs under Medicare Part D. In addition, a recent consensus document released 

by the Johns Hopkins Bloomberg School of Public Health highlights the benefits of 

DMPs and recommends expansion of the DMPs to Medicare Part D beneficiaries.10

Given the success and experience using DMPs, AMCP urges you to support S. 1913. 

This legislation would allow PDPs and MA–PDs to proactively identify individuals 

at risk for controlled substance abuse, misuse or improper utilization. Once identified beneficiaries have appeal rights and can submit their preference for a specific 

DMP prescriber and pharmacy. The use of DMPs may improve continuity of care 

among at-risk beneficiaries, while ensuring beneficiaries with legitimate medical 

needs have continued access to effective pain control. 

A 2012 CMS study found that less than 1% of beneficiaries would be targeted for 

a DMP. The study examined the use of potentially unsafe doses of prescription 

opioids for 90 days. Beneficiaries in hospice or those with a diagnosis of cancer were 

excluded. The study further found that only 0.7% of Medicare Part D beneficiaries 

received opioids from at least 4 prescribers and 4 or more pharmacies.11 Under S. 

1913, at-risk beneficiaries are still able to receive non-controlled prescriptions at 

network pharmacies of their choice. 

AMCP appreciates that under your leadership that the Finance Committee is identifying challenges and opportunities on this important issue. AMCP will continue to 

work on this issue and offers our support to you in your efforts. If you have any 

questions regarding AMCP’s comments or would like further information, please 

contact me at 703–683–8416 or scantrell@amcp.org. 

Sincerely, 

49 

Susan A. Cantrell, RPh, CAE 

Chief Executive Officer 

cc: The Honorable Senator Pat Toomey 

AMERICA’S HEALTH INSURANCE PLANS (AHIP) 

601 Pennsylvania Avenue, NW 

South Building 

Suite 500 

Washington, DC 20004 

202–778–3200 

February 19, 2016 

The Honorable Patrick Toomey The Honorable Sherrod Brown 

U.S. Senate U.S. Senate 

248 Russell Building 713 Hart Building 

Washington, DC 20510 Washington, DC 20510 

The Honorable Rob Portman The Honorable Tim Kaine 

U.S. Senate U.S. Senate 

448 Russell Building 388 Russell Building 

Washington, DC 20510 Washington, DC 20510 

Dear Senators Toomey, Brown, Portman, and Kaine: 

On behalf of America’s Health Insurance Plans (AHIP), I am writing to thank you 

for introducing S. 1913, the ‘‘Stopping Medication Abuse and Protecting Seniors 

Act.’’ 

Our members appreciate your leadership in proposing thoughtful steps to prevent 

prescription drug abuse and improve patient safety in the Medicare Part D prescription drug program. Your bill directly addresses concerns about the harmful impact 

of prescription drug fraud and abuse on the health and well-being of Medicare beneficiaries. Health plans are strongly committed to promoting the safe use of pharmaceuticals among Part D enrollees and the broader population, and have implemented a range of strategies to address this priority. Your bill seeks to add important tools to support fraud prevention. We look forward to working with you to further improve patient safety in this critically important area. 

Thank you again for bringing attention to this issue with your bipartisan legislation. 

Sincerely, 

Marilyn B. Tavenner 

President and CEO 

BLUE CROSS BLUE SHIELD ASSOCIATION (BCBSA) 

1310 G Street, NW 

Washington, DC 20005 

202–626–4800 

www.bcbs.com 

February 23, 2016 

The Honorable Pat Toomey The Honorable Sherrod Brown 

Committee on Finance Committee on Finance 

U.S. Senate U.S. Senate 

Washington, DC 20510 Washington, DC 20510 

The Honorable Rob Portman The Honorable Tim Kaine 

Committee on Finance Committee on Finance 

U.S. Senate U.S. Senate 

Washington, DC 20510 Washington, DC 20510 

Dear Senators Toomey, Brown, Portman, and Kaine: 

On behalf of the Blue Cross Blue Shield Association (BCBSA), I am writing in support of the Stopping Medication Abuse and Protecting Seniors Act of 2015 (S. 1913). 

BCBSA is the national federation of 36 independent, community-based and locally 

operated Blue Cross and Blue Shield companies that collectively provide healthcare 

coverage for 105 million members. Many Blue Cross and Blue Shield Plans contract 

with the Centers for Medicare and Medicaid Services (CMS) to sponsor coverage opVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00053 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
50 

tions in both the MA and Part D programs. We serve more than 4 million members 

in these 2 important programs. 

BCBSA commends your efforts to enable Medicare Advantage and Part D plans to 

prevent prescription drug abuse and increase patient safety. S. 1913 will help to advance this critical goal by authorizing plans to establish drug utilization management programs that limit beneficiaries who are documented high-risk users of controlled substances to one or more authorized prescriber and one or more designated 

pharmacy. 

Thank you for your bipartisan leadership to address the overutilization of controlled 

substances which in turn will help combat prescription drug and opioid abuse and 

addiction. BCBSA and its member Plans look forward to working with you to advance this important public health policy. 

Sincerely, 

Alissa Fox 

Senior Vice President, Office of Policy and Representation 

Blue Cross and Blue Shield Association 

MAJOR CITIES CHIEFS ASSOCIATION

February 18, 2016 

The Honorable Pat Toomey 

248 Russell Senate Office Building 

Washington, DC 20510 

Dear Senator Toomey, 

On behalf of the Major Cities Chiefs Association, representing the largest local law 

enforcement agencies in the Nation, I am writing to voice support for S. 1913, the 

Stopping Medication Abuse and Protecting Seniors Act. 

Our officers see the real life impact of drug abuse everyday as they patrol the 

streets of the communities we are sworn to protect. Studies show that after marijuana, prescription drugs are the most commonly abused substance by Americans 

14 and older. S. 1913 will provide the authority to enact effective fraud prevention 

and information sharing practices which are important measures in the fight to regulate dangerous medications and prevent prescription drug abuse. By establishing 

safe pharmacy access programs, the ability to suspend payments pending investigation of fraud allegations, and increased electronic monitoring this legislation will 

provide strong Nation-wide tools to combat a trend that is destroying lives throughout the country. 

We value your leadership in the fight against opioid abuse, and all that you do to 

support the enforcement of our Nation’s laws. We appreciate the chance to be a part 

of this important conversation and look forward to swift action by your colleagues 

in the Senate to pass this bill. 

Sincerely, 

J. Thomas Manger 

Chief of Police 

Montgomery County Police Department 

President, Major Cities Chiefs Association 

PENNSYLVANIA STATE CORONERS ASSOCIATION

Secretary/Treasurer President 

Dennis J. Kwiatkowski Jeffrey R. Conner 

110 Franklin St., Suite 500 Vice President 

Johnstown, PA 15901 Charles E. Kiessling Jr. 

(814) 535–6222 Assistant Secretary/Treasurer 

(814) 539–9057 Fax Kenneth A. Bacha 

August 20, 2015 

The Honorable Pat Toomey 

U.S. Senate 

Washington, DC 20510 

51 

Dear Senator Toomey: 

On behalf of the Pennsylvania State Coroners Association, we are writing this letter 

in support of S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 

2015. According to data collected by the Association nearly seven persons a day are 

dying in Pennsylvania from drug related deaths. Of those deaths approximately two 

of those persons daily are over 50 years of age. (A copy of the 2014 Report has been 

previously sent to your office.) 

While we know that many of these drug related deaths can be attributed to the use 

of illegal drugs, such as heroin and cocaine, many of these deaths are complicated 

by the use or misuse of prescription drugs. And, even in the absence of prescription 

drugs in the person’s toxicology at the time of death, it has been well-established 

that the use of prescription drugs may be the gateway to the cheaper substitute of 

illegal drugs. Many times an individual may have a deadly combination of different 

opioids, anti-depressants, benzodiazepines, antihistamines, antipsychotics, anticonvulsants, muscle relaxers, barbiturates and hypnotics along with heroin or cocaine used at the same time. Even prescription drugs at therapeutic levels, when 

combined with other prescription drugs can be deadly. 

PSCA has supported the State’s passage of a PMP which allows Coroners and Medical Examiners access to prescription data of the deceased as a means of assisting 

in the investigation into the cause and manner of death. To be sure, the PMP provides other benefits in reducing doctor shopping and reducing a patient’s unknowingly accessing incompatible prescription drugs for use. 

PSCA supports the legislation’s establishment of drug management programs for 

Medicare recipients. These programs can play an important role in preventing prescription drug abuse and misuse by assigning at risk patients to pre-designated 

pharmacies and prescribers to obtain these drugs. 

If you have any concerns or questions, please feel free to be in further contact with 

Susan M. Shanaman, Solicitor at 717–412–0002 or shanaman1@comcast.net. 

Sincerely, 

Jeffrey R. Conner 

President 

PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION (PCMA) 

325 7th Street, NW, 9th Floor 

Washington, DC 20004 

www.pcmanet.org 

February 22, 2016 

The Honorable Pat Toomey The Honorable Sherrod Brown 

248 Russell Senate Office Building 713 Hart Senate Office Building 

Washington, DC 20510 Washington, DC 20510 

The Honorable Rob Portman The Honorable Tim Kaine 

448 Russell Senate Office Building 231 Russell Senate Office Building 

Washington, DC 20510 Washington, DC 20510 

Dear Senators Toomey, Brown, Portman, and Kaine: 

As the Senate Finance Committee investigates ways to stem prescription opioid 

abuse, PCMA believes that a Medicare Part D ‘‘lock-in’’ pharmacy provision could 

help curb prescription drug fraud, waste, and abuse. 

A pharmacy ‘‘lock-in’’ provision, which would authorize Part D plans to identify atrisk beneficiaries and limit their opioid prescription fills to one or more specific 

pharmacies, would help prevent inappropriate prescriptions from crossing the pharmacy counter. S. 1913, the Stopping Medication Abuse and Protecting Seniors Act, 

recognizes that this approach is one step toward addressing the prescription drug 

abuse epidemic. 

The key to stopping ‘‘drugstore shopping’’ is preventing improper prescriptions from 

being filled in the first place. Currently, Medicare Part D plans are unable to ‘‘lockin’’ at-risk beneficiaries to a particular pharmacy in order to fill prescriptions for 

certain controlled substances. This practice is an important and widely used tool in 

commercial health plans. The creation of this type of program in Medicare Part D 

would allow health plans and at-risk beneficiaries to agree upon which pharmacy 

52 

a beneficiary will use for the dispensing of his or her controlled substance prescriptions. 

We appreciate your efforts to promote legislation enabling Medicare Part D plans 

to establish these types of programs and we look forward to working with you to 

strengthen the Part D program’s ability to combat prescription drug fraud, waste, 

and abuse. 

Sincerely, 

Kristin Bass 

Senior Vice President—Policy and Federal Affairs 

PENNSYLVANIA DISTRICT ATTORNEYS ASSOCIATION

2929 North Front Street 

Harrisburg, PA 17110 

(717) 238–5416 

FAX (717) 231–3912 

FOUNDED 1912 

February 18, 2016 

The Honorable Pat Toomey 

U.S. Senate 

Washington, DC 20510 

Re: Stopping Medication Abuse and Protecting Seniors Act (S. 1913) 

Dear Senator Toomey: 

Pennsylvania’s prosecutors write in support of the Stopping Medication Abuse and 

Protecting Seniors Act (S. 1913). This legislation comprises a common sense measure in the fight against prescription drug abuse. 

Requiring beneficiaries that are known to be abusing prescription opioids to select 

a single pharmacy for dispensing such drugs will help to control diversion and reduce fraud. The scourge of prescription drug abuse exists in every corner of the 

Commonwealth and the problem is worsening. With the GAO estimating 170,000 

Medicare enrollees diverting medication, this measure will result in improved quality of care and quality of life for seniors. 

Authorizing Medicare prescription drug plans to adopt the ‘‘lock-in’’ tool to require 

an addicted beneficiary to use a single doctor and/or a single pharmacy to get 

opioids should substantially curtail pharmacy and/or doctor shopping. This expanded use of the ‘‘lock-in’’ tool will provide protections for seniors currently available to those participating in Medicaid or commercial plans. 

Our membership recognizes and appreciates the important privacy protections and 

beneficiary appeal rights included in the bill. 

The insidious nature of prescription drug abuse demands a comprehensive strategy 

in opposition. This act comprises an important piece of such a strategy by helping 

to limit access to opioids by those most vulnerable. We appreciate the efforts of your 

fellow members of Congress and you in working to provide the tools to fight prescription drug abuse in Pennsylvania and across the nation. If our association can 

be of further assistance in this fight please let us know. 

Sincerely, 

David J. Arnold, Jr. 

President 

PHYSICIANS FOR RESPONSIBLE OPIOID PRESCRIBING (PROP) 

164 West 74th Street 

New York, NY 10023 

www.supportprop.org 

T 347–396–0369 

F 347–396–0370 

February 19, 2016 

The Honorable Pat Toomey The Honorable Rob Portman 

U.S. Senate U.S. Senate 

Washington, DC 20510 Washington, DC 20510 

53 

1Leadership Council of Aging Organizations (LCAO), ‘‘Medicare Part D ‘Lock-In’ Proposals 

Must Include Beneficiary Protections,’’ (November 2014), available at: http://www.lcao.org/ 

files/2014/11/FINAL-LCAO-LockIn-Part-D-Brief.pdf. 

The Honorable Sherrod Brown The Honorable Tim Kaine 

U.S. Senate U.S. Senate 

Washington, DC 20510 Washington, DC 20510 

Dear Senators Toomey, Portman, Brown and Kaine, 

On behalf of Physicians for Responsible Opioid Prescribing (PROP), I am writing to 

express our strong support for the Stopping Medication Abuse and Protecting Seniors Act, which authorizes the use of drug management programs in Medicare. 

PROP represents physicians from diverse specialties including Pain, Addiction, Primary Care, Public Health and Emergency Medicine. Our mission is to reduce morbidity and mortality caused by overprescribing of opioid analgesics. 

PROP supports patient review and restriction programs (PRRs) because we understand the important role they play in reducing prescription drug overdose deaths. 

PRRs allow plan sponsors to better coordinate patient care and prevent inappropriate access to medications that are especially dangerous when prescribed to individuals suffering from a substance use disorder. 

Evidence suggests that PRRs in Medicaid programs can effectively reduce opioidrelated harms caused by overuse. PRRs are urgently needed in Medicare, where the 

problem of opioid overuse is especially serious in Medicare Part D beneficiaries. We 

are supporting the Stopping Medication Abuse and Protecting Seniors Act because 

it authorizes the use of PRRs in Medicare and will help reduce opioid-related harms 

while ensuring access to medication for patients with legitimate medical needs. We 

urge the Senate to appropriately respond to the epidemic of opioid addiction and 

overdose deaths by passing this legislation. 

Your bipartisan efforts to address this urgent public health crisis are greatly appreciated. We look forward to working with you in your efforts to address the opioid 

addiction epidemic. 

Sincerely, 

Andrew Kolodny, M.D. 

MEDICARE RIGHTS CENTER

February 22, 2016 

The Honorable Pat Toomey The Honorable Rob Portman 

U.S. Senate U.S. Senate 

Washington, DC 20510 Washington, DC 20510 

The Honorable Sherrod Brown The Honorable Tim Kaine 

U.S. Senate U.S. Senate 

Washington, DC 20510 Washington, DC 20510 

Dear Senator Toomey, Senator Brown, Senator Portman, and Senator Kaine: 

On behalf of the Medicare Rights Center (Medicare Rights), I am writing to express 

support for the Stopping Medication Abuse and Protecting Seniors Act of 2015 (S. 

1913). Medicare Rights is a national, nonprofit organization that works to ensure 

access to affordable health care for older adults and people with disabilities through 

counseling and advocacy, educational programs, and public policy initiatives. Our 

organization provides services and resources to over 2 million beneficiaries, family 

caregivers, and professionals annually. 

This bipartisan legislation would establish a Patient Review and Restriction (PRR) 

program to identify Medicare beneficiaries at risk for prescription drug misuse. The 

PRR program would allow Part D plan sponsors to limit enrollees with questionable 

prescription drug utilization patterns to one prescriber and one pharmacy for a 

given medication. As this bill and similar legislation was developed in the U.S. 

House of Representatives, we advised Congress to design PRR programs with adequate consumer protections to ensure no unintended harm comes to those with a 

legitimate medical need for pain medications or other commonly misused prescriptions.1

54 

As such, we appreciate that S. 1913 incorporates several critical beneficiary protections, including: a clinically-determined criteria for targeting at-risk beneficiaries; 

advance, written notification outlining beneficiary rights, resources, and the opportunity to choose a pharmacy and prescriber; exemptions for hospice beneficiaries 

and those residing in long-term care facilities; required plan audits and monitoring, 

including a report by the Department of Health and Human Services on opportunities to improve the Part D appeals process; and engagement with diverse stakeholders, including beneficiaries and consumer advocates. 

To further strengthen the legislation, we continue to encourage stronger emphasis 

on provider education, specifically to limit inappropriate prescribing of frequently 

misused medications, which may lead to addiction and overuse. We look forward to 

working with you on this issue and other advancements to strengthen Medicare for 

today’s beneficiaries and for future generations. If you have questions, please contact Stacy Sanders, Federal Policy Director, at ssanders@medicarerights.org or 202– 

637–0961. Thank you. 

Sincerely, 

Joe Baker 

President 

Medicare Rights Center 

MAJOR COUNTY SHERIFFS’ ASSOCIATION (MCSA) 

February 23, 2016 

The Honorable Pat Toomey 

U.S. Senate 

248 Russell Senate Office Building 

Washington, DC 20510 

Dear Senator Toomey, 

As Vice President of Government Affairs for the Major County Sheriffs’ Association 

(MCSA), an association of elected sheriffs representing our nation’s largest counties 

with populations of 500,000 people or more serving over 100 million Americans, I 

write to express our support for S. 1913, the Stopping Medication Abuse and Protecting Seniors Act of 2015. 

Prescription drug abuse and diversion have become among the largest contributing 

factors to crime in our communities and our sheriffs are on the front line combating 

this growing epidemic and associated crime. According to the National Institute on 

Drug Abuse, from 2001 to 2014 prescription drug deaths increased 2.8 fold translating to over 25,000 deaths in 2014 alone. 

Your legislation would address this problem head on by stopping the epidemic 

where it starts—at the pharmacy counter. S. 1913 would give Medicare the same 

authority as Medicaid and the commercial market to prevent prescription drug 

fraud and abuse. Through fraud prevention, information sharing and increased electronic monitoring measures, thousands of lives will be saved and our communities 

will be safer. 

We appreciate the opportunity to weigh in on this important issue and applaud your 

commitment to fighting our nation’s prescription drug abuse epidemic. 

Very Respectfully, 

Michael J. Bouchard, Sheriff, Oakland County (MI) 

Vice President—Government Affairs, Major County Sheriffs’ Association 

CVS HEALTH

February 22, 2016 

The Honorable Pat Toomey The Honorable Sherrod Brown 

U.S. Senate U.S. Senate 

248 Russell Senate Office Building 713 Hart Senate Office Building 

Washington, DC 20510 Washington, DC 20510 

The Honorable Rob Portman The Honorable Tim Kaine 

U.S. Senate U.S. Senate 

55 

1 Centers for Disease Control and Prevention; National Center for Injury Prevention and Control. Patient review and restriction programs. Lessons learned from state Medicaid programs 

(2012). Available at http://www.cdc.gov/homeandrecreationalsafety/pdf/PDO_patient_review_ meeting-a.pdf. 

448 Russell Senate Office Building 388 Russell Senate Office Building 

Washington, DC 20510 Washington, DC 20510 

Dear Senators Toomey, Portman, Brown, and Kaine: 

CVS Health applauds your efforts to prevent prescription drug abuse by your work 

on S. 1913, Stopping Medication Abuse and Protecting Seniors Act of 2015. This bill 

would permit the use of drug-management programs in Medicare and require patients at risk of drug abuse to utilize designated pharmacies and prescribers to obtain controlled substances. 

These drug management programs, which are also known as Patient Review and 

Restriction programs (PRRs), are a critical tool for addressing the nation’s prescription drug abuse epidemic. A Centers for Disease Control and Prevention expert 

panel evaluation found that PRRs used in state Medicaid programs have reduced 

narcotic prescriptions, abuse, and visits to multiple doctors and emergency rooms, 

while also generating cost savings.1 These programs are used in state Medicaid as 

well as in commercial plans, but authorization is needed by Congress to permit the 

use of PRRs in Medicare. The legislation would authorize the use of PRRs in Medicare, potentially improving continuity of care by providing improved drug therapy 

management while simultaneously ensuring patients with legitimate medical needs 

continue to have access to effective pain control. 

There is support to advance these drug management programs as an effective tool 

to decrease opioid abuse. The policy has been proposed in the FY 2017 Budget request for the Department of Health and Human Services, and the House of Representatives authorized these programs in the 21st Century Cures Act, which 

passed the House of Representatives with broad bipartisan support on July 10, 

2015. We urge the Senate to join in efforts to address the Nation’s ongoing prescription drug abuse epidemic by advancing the Stopping Medication Abuse and Protecting Seniors Act of 2015 to authorize the use of PRRs in Medicare. 

Thank you for your careful consideration of this important matter. We welcome the 

opportunity to work with you to ensure the final legislation brings the proven benefits of PRRs to Medicare beneficiaries. If you have any questions, please feel free 

to contact Ann Walker at 202–772–3503. 

Sincerely, 

Melissa Schulman 

Senior Vice President, Government Affairs 

PREPARED STATEMENT OF HON. RON WYDEN, 

A U.S. SENATOR FROM OREGON

Thank you, Chairman Hatch. As the committee that’s required to pay for the most 

important health programs in the nation, the Finance Committee needs to do its 

part to address the opioid crisis. In the coming years, Medicare and Medicaid are 

expected to account for over a third of substance abuse-related spending. That 

amounts to billions and billions every year. Any solution that’s going to stem this 

tide needs to include the Finance Committee and our bedrock health programs. 

Americans today are paying for a distorted set of priorities—people are getting 

hooked on opioids, there’s not enough treatment, and enforcement is falling short. 

That sounds like a trifecta of misplaced priorities to me, and the Finance Committee 

has the opportunity to develop fresh policies to start righting the ship. 

As one listens to the current debate on opioids, there is a sense that policymakers 

will have to choose between two solutions. One approach is tough enforcement, 

which means cracking down on pill mills, fraudsters bilking Medicare and Medicaid 

with unneeded prescriptions, and unscrupulous abusers doctor-shopping for their 

next bottle of pills. Others want to focus on more social services. My own view on 

what’s needed is a better approach that includes three things: more prevention, better treatment, and tougher enforcement. True success will require all three to work 

in tandem. 

56 

When it comes to preventing addiction, any discussion has to include how these 

drugs are prescribed in the first place. In Oregon last week, I heard about the ‘‘prescription pendulum’’—where doctors were once criticized for not treating pain aggressively enough, and today they are being criticized for prescribing too many 

opioids to manage pain. So let’s look at how to get that balance right. 

The Centers for Disease Control and Prevention is trying to break new ground 

with their guidelines for prescribing opioids. Along with better prescribing practices, 

there needs to be more responsible marketing practices by opioid manufacturers. I’m 

pleased that we’re joined today by David Hart, with the Oregon Attorney General’s 

office, who will able to discuss his considerable experience in this area. 

I am also concerned about the influence the manufacturers have on medical prescribing practices. I’ve sent an inquiry to Secretary Burwell to ensure any potential 

conflicts of interest have been properly disclosed for members of government panels 

who are evaluating CDC’s guidelines, as a result of funding they receive from drug 

manufacturers. Doctors ought to have the best information on prescribing these 

powerful drugs without undue influence from the companies that are manufacturing 

them. 

In my view, a key piece of the puzzle has to be prompt and effective treatment 

of those who are dealing with an addiction to opioids. A prerequisite for any lasting 

solution needs to include improving access to addiction treatment and mental health 

services—something that’s very important for rural and under-served communities. 

It’s no coincidence these areas have some of the highest rates of abuse and overdose 

in the country. 

Mental health and treatment for addiction have gotten short shrift for too long, 

and it’s high time for a change. For example, the Finance Committee could also be 

taking a look at what’s called the IMD exclusion—an out-of-date policy from the 

1960s that says services, like rehab or some emergency mental health stays in an 

inpatient setting, can’t be covered by Medicaid. That’s a big policy change that 

should happen, but finding the vast sums needed for these services will be uniquely 

challenging. 

So Congress has to make some tough choices to solve this crisis. If prevention and 

treatment aren’t addressed up front, the costs to come will be even higher: pregnant 

mothers giving birth to opioid dependent babies. EMTs and emergency rooms dealing with overdose calls every night. County jails taking the place of needed substance abuse treatment. Able-bodied adults in the streets instead of working at a 

family-wage job. America’s tax dollars should be spent more wisely, and it’s my hope 

the Finance Committee can take the lead to find the right mix. 

There is an example of how to do this right. The Committee is working in a bipartisan way on a proposal to get parents and kin care providers the kind of help they 

need to keep children safely out of foster care when addiction strikes a family member. 

A parent’s drug addiction is becoming a growing reason for removing children 

from their homes and placing them in foster care. A recent Reuters investigation 

found that on average, a baby is born opioid-dependent every 19 minutes. Using 

hospital records, the reporters found there were more than 27,000 drug-dependent 

babies born in 2013. 

Many of these babies will enter the foster care system. In fact, as the Committee 

will hear from Dr. Young, infants made up the largest group of children placed in 

out-of-home care in 2014, and growth in the share of infants entering care is a trend 

that has been consistently increasing over the past several years. Protecting these 

babies and their siblings is, in part, going to mean getting better help, and treatment, for the moms and dads in these situations. 

The Chairman and I are engaged in a very active effort to address these daunting 

challenges with our Family First Act which would help prevent unnecessary foster 

care stays through programs like evidence-based substance abuse treatment, reduce 

unnecessary congregate care stays, and put in place stronger protections to keep 

kids in foster care safe. It’s about making sure the system works better for the children, and I hope the committee is able to act soon. 

As I spent the last week travelling around my home state—from Medford to Eugene to Portland, the message on opioids was clear: this epidemic is carving a path 

of destruction through communities all across the country. Oregon has the dubious 

distinction of ranking fourth worst for abuse and misuse of opioids in the country. 

57 

1http://www.samhsa.gov/data/sites/default/files/NSDUHStateEST2012-2013-p1/Change 

Tabs/NSDUsaeShortTermCHG2013.htm. 2 Unpublished Oregon PDMP data. 

In my home state, citizens will not accept being fourth worst. And I know from talking with many of my colleagues that every state is dealing with this crisis as well. 

One story out of the many I heard was especially devastating. I spoke with a parent who told me about high school athletes struggling with addiction to these medicines. When I played basketball in my younger years, there was never any talk in 

the locker room about ‘‘opioids.’’ Now, the next generation of young people are getting swept up in a crisis beyond their control. 

Thank you to our witnesses for coming before the committee today, and in particular I want to thank David Hart for flying all the way out from Oregon to speak 

about some of the important work he’s done to curb improper marketing practices 

and help establish a comprehensive program to deal with this epidemic in our state. 

LETTERS SUBMITTED FOR THE RECORD BY HON. RON WYDEN

ELLEN F. ROSENBLUM FREDERICK M. BOSS 

ATTORNEY GENERAL DEPUTY ATTORNEY GENERAL

OREGON DEPARTMENT OF JUSTICE 

Justice Building 

1162 Court Street, NE 

Salem, Oregon 97301–4096 

Telephone: (503) 378–4400 

January 11, 2016 

Dr. Debra Houry, M.D., M.P.H. 

Director, National Center for Injury Prevention and Control 

Centers for Disease Control and Prevention 

4770 Buford Highway NE, Mailstop F–63 

Atlanta, GA 30341 

RE: Docket CDC–2015–0112 

Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain 

Dear Dr. Houry: 

I write in support of the work done by the Centers for Disease Control and Prevention (‘‘CDC’’) in preparing the draft Guideline for Prescribing Opioids for Chronic 

Pain (‘‘Guideline’’). I urge the CDC to finalize the Guideline as soon as possible. 

Oregon has been devastated by the opioid epidemic. Between 2000 and 2013, 

there were 2,226 deaths in Oregon due to prescription opioid drug overdose. The 

mortality rated due to prescription opioid overdose increased 364% between 2000 

and 2006, and though decreasing since then, remains 2.9 times higher than in 2000 

(4.0 per 100,000 in 2013; 1.4 per 100,000 in 2000). Results from the 2012–2013 National Survey on Drug Use Health tie Oregon for 2nd place among all states in nonmedical use of prescription pain relievers, down from 1st among all states in the 

same 2010–2011 survey.1 In 2013, 3.6 million prescriptions for opioid painkillers 

were dispensed in Oregon, enough for 925 opioid prescriptions for every 1,000 residents.2

My office is committed to combating this epidemic. For example, in 2015, the Oregon Department of Justice created a nearly $600,000 fund from an Unlawful Trade 

Practices settlement involving the promotion of a fentanyl product which will be 

used to fund projects to combat the opioid epidemic throughout Oregon, including 

distribution of naloxone, disposal of disused prescription drugs, community-based 

adoption of prescribing guidelines, and improved access to medication assisted treatment for opioid addiction. However, to effectively combat the epidemic, we need 

highly respected organizations like CDC to provide the health care community with 

clear guidance for safer opioid prescribing, especially for chronic pain, so health care 

providers can better meet the needs of their patients while still protecting the 

health and safety of the community. 

58 

Thank you for your work to address this public health crisis. Please do not hesitate to contact my office if we can be of any assistance. 

Very truly yours, 

Ellen F. Rosenblum 

Attorney General 

DELAWARE DEPARTMENT OF JUSTICE 

820 NORTH FRENCH STREET 

WILMINGTON, DELAWARE 19801 

MATTHEW P. DENN PHONE (302) 577–8400 

ATTORNEY GENERAL FAX (302) 577–2610 

January 12, 2016 

Veronica Kennedy, Acting Executive Secretary 

National Center for Injury Prevention and Control 

Centers for Disease Control and Prevention 

4770 Buford Highway NE 

Mailstop f–63 

Atlanta, GA 30341 

Attn: Docket CDC–2015–0112 

Re: CDC Guideline for Prescribing Opioids for Chronic Pain—2016 

Dear Ms. Kennedy: 

I am writing to offer comments on the CDC’s Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain. 

Delaware has a particularly strong interest in the issue of opioid prescriptions, 

because empirical evidence suggests that opioids are being prescribed in Delaware 

at rates that exceed those in most other states, with often tragic results. Delaware’s 

Prescription Drug Advisory Committee found in 2013 that Delaware: 

• Had the nation’s ninth highest drug overdose rate; • Had a significantly higher percentage of its residents engaging in non-medical 

use of prescription opioids than the national average; • Had the nation’s fifth highest overall rate for opioid sales; 

More recently, the state’s Division of Public Health reported that Delaware’s medical providers ranked highest in the country in high-dose opioid pain relievers per 

100 people, and second highest in the country in long-acting/extended relief opioid 

pain relievers per 100 people. 

Although real-time statistics are not publicly available and Delaware has been 

making efforts to address opioid prescription, additional steps are clearly necessary. 

Delaware is attempting at the state level to more rigorously regulate the prescription of opioids. The state’s Controlled Substance Advisory Committee recently proposed a set of standards for such prescriptions, and my office made a number of suggestions that are under consideration as to how those standards could be further 

strengthened. 

The CDC’s Proposed 2016 Guideline covers some of the same areas as the proposed standards issued by Delaware’s Controlled Substance Advisory Committee, 

but in some instances the CDC guidelines are more specific than the proposed state 

standards. As such, the CDC guidelines are a useful supplement to the state’s impending mandatory rules, offering physicians a set of non-mandatory expert guidelines to ensure that opioids are prescribed only when necessary, and only in the 

amounts necessary, for proper patient care. 

The process for adopting these proposed guidelines has, by the CDC’s own admission, been an imperfect one. Process is important to reaching a sound medical conclusion, and I am confident that the CDC will review the thousands of comments 

it has received and make any changes to the proposed guidelines that are reasonably prompted by those comments. The comment deadline does not expire until tomorrow, but to date I have not seen any substantive objections to the proposed 

guidelines issued by any medical organizations that are not largely funded by the 

pharmaceutical industry. 

59 

1 National Center for Health Statistics, National Vital Statistics System, Mortality File, at 

http://www.cdc.gov/nchs/data/health_ policy/AADR_drug_ poisoning_involving_OA_Heroin_US _2000-2014.pdf. 

2 New York State Department of Health, Poisoning Deaths Involving Opioid Analgesics in 

New York State, 2003–2012, at https://www.health.ny.gov/statistics/vital_statistics/docs/poisoning_deaths_opioid_analgesics.pdf. 3 Susan Okie, A Flood of Opioids, a Rising Tide of Deaths, New England Journal of Medicine 

(November 18, 2010). 4 New York City Department of Health and Mental Hygiene, Health Department Data Show 

Increase In Opioid Prescription Painkiller Deaths In New York City (May 14, 2013), at http:// 

www.nyc.gov/html/doh/html/pr2013/pr013-13.shtml. 

I applaud the CDC for taking the initiative to issue these guidelines, and I encourage the CDC to finalize them after thoughtfully reviewing public comments and 

formally issue them as soon as possible. We have lost too many Delawareans to 

opioid abuse and the heroin addiction that so often follows it, we cannot delay in 

employing every tool at our disposal to combat this problem. 

Sincerely, 

Matthew P. Denn 

Attorney General 

STATE OF NEW YORK

OFFICE OF THE ATTORNEY GENERAL

120 BROADWAY, NEW YORK, NY 10271 • PHONE (212) 416-6305 • FAX (212) 416-8034 • www.ag.ny.gov 

ERIC T. SCHNEIDERMAN DIVISION OF SOCIAL JUSTICE

ATTORNEY GENERAL HEALTH CARE BUREAU

January 13, 2016 

Dr. Debra Houry, M.D., M.P.H. 

Director, National Center for Injury Prevention and Control 

Centers for Disease Control and Prevention 

4770 Buford Highway NE, Mailstop F–63 

Atlanta, Georgia 30341 

RE: Docket CDC–2015–0112, 

Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain 

Dear Dr. Houry: 

Thank you for your agency’s efforts in developing the draft Guideline for Prescribing Opioids for Chronic Pain (the ‘‘Guideline’’), which may represent an important tool in battling the epidemic of prescription drug abuse affecting our nation. 

New York has been a leader in fighting the abuse of prescription opioids, and I 

strongly encourage CDC to adopt the Guideline. 

As you know, drug overdose rates are at a historic high. Most alarming is the rise 

in heroin and opioid overdoses. As data released last month by CDC data reflects, 

18,893 people in the U.S. died from opioid pain reliever overdoses in 2014, a 16% 

increase from 2013.1 In New York, from 2003 to 2012, deaths involving opioid analgesics increased four-fold, from 186 deaths in 2003 to 914 deaths in 2012.2 At the 

core of this opioid overdose epidemic is the fact that physicians are writing more 

prescriptions for opioid pain relievers than ever before. As a result, the use of prescription opioids has increased ten-fold over the past 25 years in the United States.3

The experience in New York mirrors that of the nation as a whole. In New York 

City, between 2008 and 2011, the number of opioid painkiller prescriptions filled by 

New York City residents increased by 31%, from approximately 1.6 million to approximately 2.2 million.4

The Guideline is addressed to primary care providers treating chronic pain outside of active cancer treatment, thus squarely focusing on an important segment of 

the medical community. Primary care physicians are the top prescribers of opioid 

pain medication in the United States. Nevertheless, research suggests that some 

PCPs may lack a sufficient understanding of how opioid pain medications can result 

in abuse and addiction. A recent study by the Johns Hopkins Bloomberg School of 

Public Health suggests that this may be contributing to the ongoing epidemic of preVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00063 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
60 

5 Catherine S. Hwang et al., Primary Care Physicians’ Knowledge and Attitudes Regarding 

Prescription Opioid Abuse and Diversion, Clinical J. of Pain (Jun. 22, 2015). 6 Id. 

7 Id. 

8Food and Drug Administration, Abuse-Deterrent Opioids: Evaluation and Labeling Guidance 

for Industry (April 2015), at http://www.fda.gov/downloads/Drugs/GuidanceCompliance 

RegulatoryInformation/Guidances/UCM334743.pdf. 9Marc R. Larochelle, et al., Opioid Prescribing After Nonfatal Overdose and Association with 

Repeated Overdose, Ann. of Intern. Med. (Jan. 5, 2016). 10 Id. 11https://www.governor.ny.gov/news/governor-cuomo-announces-progress-states-efforts-crackdown-prescription-drug-abuse. 

scription opioid abuse and addiction in the United States.5 Notably, nearly half of 

the internists, family physicians, and general practitioners surveyed mistakenly believed that ‘‘abuse-deterrent’’ opioid pills were less addictive than their standard 

counterparts.6 One-third of these practitioners said they believed that most prescription drug abuse is by means other than swallowing the pills as intended.7 According 

to the Food and Drug Administration, however, swallowing capsules or tablets is in 

fact the most common route of abuse of prescription opioids.8 Further highlighting 

the issue, another recent study found that over a median follow-up of 299 days, physicians dispensed opioids to 91% of patients after an overdose, 7% of whom experienced another overdose shortly thereafter.9 Proper prescribing practice suggests 

that adverse events, such as overdose, are compelling reasons to cease prescription 

opioids.10 Consequently, inconsistencies between proper practice and real-world conduct accentuate the need for health care practitioners to receive more guidance on 

how to properly prescribe opioid pain medications. While other factors may play a 

role in the concerning misuse and mismanagement of opioids, health care providers 

would benefit from stronger and more uniform national guidance on how to properly 

prescribe opioid pain medication—as set forth in the Guideline. 

The nonbinding Guideline is based on solid clinical evidence and contains recommendations that promote the effective treatment of pain and may prevent inappropriate prescribing of opioids, thus saving lives. In particular, Recommendation 9 

encourages health care providers to review their patients’ history of controlled substance prescriptions using state prescription drug monitoring program (‘‘POMP’’) 

data to determine whether the patient is receiving opioid dosages that put him or 

her at high risk for overdose. Many states have created PDMPs, and some, such as 

New York, require prescribers to consult the database before prescribing controlled 

substances. New York’s historic Internet System for Tracking Over Prescribing (‘‘I– 

STOP’’) legislation was signed into law on August 27, 2012. This law made New 

York the first state in the nation to ensure every prescription for a controlled substance is tracked in a real-time database accessed by both prescribers and pharmacists. New York’s I–STOP program, which became mandatory in 2013, has helped 

reduce prescription drug abuse, decreasing doctor shopping by almost 75%.11

Thank you for the opportunity to comment on the draft Guideline, and for your 

commitment to the promotion of public health in our state. 

Sincerely, 

Eric T. Schneiderman 

New York Attorney General 

THE COMMONWEALTH OF MASSACHUSETTS

OFFICE OF THE ATTORNEY GENERAL

ONE ASHBURTON PLACE

BOSTON, MASSACHUSETTS 02108 

MAURA HEALEY TEL: (617) 727–2200 

ATTORNEY GENERAL www.mass.gov/ago 

January 11, 2016 

Tom Frieden, M.D., M.P.H. 

Director, Centers for Disease Control and Prevention 

Debra Houry, M.D., M.P.H. 

Director, National Center for Injury Prevention and Control 

61 

1Massachusetts Department of Public Health, Data Brief: Fatal Opioid-related Overdoses 

among Massachusetts Residents (Oct. 2015). 2SAMHSA, CBHSQ: Associations of Nonmedical Pain Reliever Use and Initiation of Heroin 

Use in the United States (Aug. 2013). 3Massachusetts Department of Public Health, Board of Health Care Safety and Quality, Report (Nov. 5, 2015). 4 CDC/NCHS, National Vital Statistics System, Mortality File, available at http:// 

www.cdc.gov/nchs/data/health_ policy/AADR_drug_ poisoning_involving_OA_Heroin_US_2000- 

2014.pdf. 5 Rose A. Rudd et al., Increases in Drug and Opioid Overdose Deaths—United Sates, 2000– 

2014, 64 Morb. Mortal. Wkly. Rep. 1 (Dec. 18 2015). 6DMP Center of Excellence at Brandeis University, Briefing on PDMP Effectiveness at 3 

(Sept. 2014). 

United States Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329–4027 

RE: Docket CDC–2015–0112, 

Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain 

Dear Drs. Frieden and Houry, 

I write to commend the work of the Centers for Disease Control and Prevention 

(‘‘CDC’’) in preparing the draft Guideline for Prescribing Opioids for Chronic Pain 

(‘‘Guideline’’) and urge the CDC to finalize the Guideline as soon as possible. The 

Guideline will provide much-needed information to primary care providers across 

the country about when and how opioids should be prescribed for chronic pain. 

While there have been various efforts from state officials and other organizations 

to memorialize best practices for opioid prescribing, the Guideline would provide 

prescribers with a single, nationwide, evidence-based standard. 

The opiate epidemic has had a devastating impact in Massachusetts, as in so 

many other parts of the country. Deaths from opioid-related overdoses more than 

doubled in Massachusetts between 2011 and 2014, with more than 1,250 people believed to have died here in 2014.1 According to SAMHSA, four out of five recent heroin initiates report having previously used a non-medical prescription pain reliever.2

In Massachusetts alone, there were 4,664,391 prescriptions for Schedule II and III 

opioids in 2014.3 That is a prescription for nearly every adult in Massachusetts. 

Our national opioid-related overdose deaths are the result of years of overprescribing of prescription pain killers. To significantly impact the trajectory of this epidemic, we need to change this country’s culture around opioid prescribing. In the 

United States, we consume 80% of the world’s opioid supply. In 2014, the CDC reported that 18,893 people died from prescription opioid overdoses, a 16% increase 

from 2013.4 This is not just a heroin epidemic. There are more than three times 

as many Americans struggling with prescription opioid dependence or addiction as 

there are dealing with heroin addiction. 

I strongly agree with CDC’s conclusion that ‘‘[t]o reverse the epidemic of opioid 

drug overdose deaths and prevent opioid-related morbidity, efforts to improve safer 

prescribing of prescription opioids must be intensified.’’5 The draft Guideline is an 

important step toward intensifying those efforts. In particular, the Guideline makes 

clear that opioids should not be the initial treatment for chronic pain and should 

only be used where their benefits outweigh the risks. See Guideline No. 1. Equally 

important, the Guideline advises prescribers to evaluate the benefit and harms of 

opioid treatment within weeks of the initial dose and re-evaluate the patient at least 

every 3 months. See Guideline No. 7. Furthermore, ‘‘there are recent indications 

that prescription drug overdose deaths are declining in some jurisdictions, for instance Florida and Kentucky , likely due in part to the promulgation and increased 

use of PDMPs,’’6 as indicated in Guideline No. 9. If finalized, the Guideline will provide much-needed information to prescribers nationwide. 

62 

1See Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999–2008; 

Morbidity and Mortality Weekly Report, Nov. 4, 2011. 

Thank you for your continued work to address this public health crisis and help 

save lives. Please do not hesitate to contact Assistant Attorney General Eric Gold 

(617–963–2663) in my office if I can provide any additional information. 

Very truly ours, 

Maura Healey 

NATIONAL ASSOCIATION OF ATTORNEYS GENERAL

2030 M Street, NW 

Eighth Floor 

Washington, DC 20036 

Phone: (202) 326–6000 

http://www.naag.org/ 

January 13, 2016 

Tom Frieden, M.D., M.P.H. 

Dockets Management 

Centers for Disease Control and Prevention 

United States Department of Health and Human Services 

1600 Clifton Road 

Atlanta, GA 30329 

Re: Docket No. CDC–2015–0112 

Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain 

Dear Dr. Frieden: 

As attorneys general whose states and residents have been affected by the epidemic 

of opioid abuse, addiction, diversion, overdose, and death, we write to urge the 

speedy adoption of the CDC’s Proposed 2016 Guideline for Prescribing Opioids for 

Chronic Pain (the ‘‘Guidelines’’). 

As statewide public officials who work collaboratively with law enforcement, we are 

regularly confronted with the problems caused by opioid abuse. While some states 

have reduced the number of deaths due to opioid drug overdose, overall deaths from 

overdoses continue to rise in our nation. Unfortunately, the opioid overdose deaths 

and emergency room visits continue to increase in proportion to the increase in prescribed opioids.1 In order to reduce these deaths and injuries, we must provide clear 

guidance for prescribers to assess the appropriate balance between the potential 

harms and benefits of opioid use. 

The increase in overdose deaths has made the efforts to improve informed prescribing both a law enforcement and public safety issue. Unfortunately, many prescribers, particularly primary care and family physicians, note they can lack clear 

and practical guidance in deciding when and how to prescribe opioids. Some are 

afraid to prescribe opioids at all, for fear that they will jeopardize their patients— 

or even their licenses. Others provide their patients with opioids when alternative 

treatments may serve as a more effective long term method of care. 

We recognize that the Guidelines are just that. The Guidelines provide a foundation 

for practice, recognizing that doctors will need to adapt them to meet the individual 

needs of their patients. But the core message—that many patients can be treated 

with lower doses or alternative treatment methods, provides much-needed direction 

to doctors. It gives doctors the knowledge and confidence to prescribe opioids when 

appropriate, and to more safely manage patients on opioids. The Guidelines also recognize that opioids remain an important tool for responding to extreme or intractable pain. 

By better informing and guiding prescribers, these Guidelines will not only provide 

a strong framework for providers, but they will also improve the access to opioids 

for patients for whom they are the best choice. For these reasons, we urge the CDC 

to promptly adopt these Guidelines. 

Respectfully submitted, 

Pam Bondi Joseph A. Foster 

Florida Attorney General New Hampshire Attorney General 

63 

Leslie Rutledge Karl A. Racine 

Arkansas Attorney General District of Columbia Attorney General 

Samuel S. Olsen Doug Chin 

Georgia Attorney General Hawaii Attorney General 

Lawrence Wasden Lisa Madigan 

Idaho Attorney General Illinois Attorney General 

Greg Zoeller Andy Beshear 

Indiana Attorney General Kentucky Attorney General 

Jeff Landry Janet Mills 

Louisiana Attorney General Attorney General 

Brian Frosh Maura Healey 

Maryland Attorney General Massachusetts Attorney General 

Jim Hood Chris Koster 

Mississippi Attorney General Missouri Attorney General 

Tim Fox Douglas Peterson 

Montana Attorney General Nebraska Attorney General 

Adam Paul Laxalt John Hoffman 

Nevada Attorney General New Jersey Attorney General 

Hector Balderas Eric T. Schneiderman 

New Mexico Attorney General New York Attorney General 

Roy Cooper Wayne Stenehjem 

North Carolina Attorney General North Dakota Attorney General 

Mike DeWine Scott Pruitt 

Ohio Attorney General Oklahoma Attorney General 

Kathleen Kane Peter F. Kilmartin 

Pennsylvania Attorney General Rhode Island Attorney General 

Alan Wilson Marty J. Jackley 

South Carolina Attorney General South Dakota Attorney General 

Herbert H. Slatery, III Sean Reyes 

Tennessee Attorney General Utah Attorney General 

Willian H. Sorrell Robert W. Ferguson 

Vermont Attorney General Washington Attorney General 

Patrick Morrisey Brad Schimel 

West Virginia Attorney General Wisconsin Attorney General 

PREPARED STATEMENT OF NANCY K. YOUNG, PH.D., DIRECTOR, 

CHILDREN AND FAMILY FUTURES, INC. 

Chairman Hatch, Ranking Member Wyden, and Members of the Finance Committee, thank you for conducting this hearing on our nation’s opioid epidemic and 

the effects of opioid and other substance use disorders on our nation’s child welfare 

and foster care system. There are three primary points I would like to emphasize 

in this statement for the record: 

(1) In the past 3 decades, our country has experienced at least three major 

shifts in substances of abuse that have had dramatic effects on children and 

families. However, the increase of opioid misuse has been described by longtime child welfare professionals as having the worst effects on child welfare 

systems that they have seen. 

(2) The current environment has at least two major differences from our prior 

experiences, first that young people are dying at astonishing rates and 

many states report that infants are coming into protective custody at alarming rates. 

(3) Federal investments over the past decade testing strategies to improve outcomes for families in child welfare affected by substance use disorders have 

generated a knowledge base that allows us to clearly state that we can no 

longer say we don’t know what to do. 

64 

1 Nonmedical use of prescription drugs includes using medications that are not prescribed for 

them or using them for the effect or feeling rather than the medical purpose for which they were 

prescribed. 

BRIEF SUMMARY OF THE DATA

Data from SAMHSA’s National Survey on Drug Use and Health show that between 2007 and 2014, the numbers of persons who misuse prescription drugs, new 

users of heroin and people with heroin dependence increased significantly 

(SAMHSA, 2014). As shown in this graph, rates of dependence on heroin has doubled and overdose deaths increased 286 percent between 2002 and 2013 (Leonard, 

2015). 

According to the 2014 National Survey on Drug Use and Health:

• 10.3 million person non-medically used prescription painkillers in 2014 1

• Approximately 1.9 million met criteria for prescription painkillers use disorder 

• 4.8 million people have used heroin at some point in their lives 

• 212,000 people aged 12 or older used heroin for the first time within the prior 

12 months 

• Approximately 435,000 people were regular (past-month) users of heroin 

The pattern of initiating heroin use has changed over the past decade. Approximately three-quarters of persons who use heroin report prior nonmedical use of prescription opioids, as well as current abuse or dependence on additional substances 

such as stimulants, alcohol and marijuana. Conversely a small percentage, approximately 4 percent, of persons with nonmedical use of prescription drugs become regular users of heroin. However given the 10.3 million persons who reported nonmedical use of prescription drugs in 2014, this small percentage of conversion to heroin 

generates 200,000 new heroin users in a year and 435,000 regular heroin users 

(Compton, Jones and Baldwin, 2016). 

Among pregnant women, the highest rates of use continues to be the legal substances which have known detrimental effects on the neurodevelopment of the fetus. 

Among pregnant women aged 15 to 44, 5.4 percent were current illicit drug users 

based on data averaged across 2012 and 2013. This was lower than the rate among 

women in this age group who were not pregnant (11.4 percent). In the most recent 

year for which the data on specific substances are available, among pregnant women 

in 2011–2012, 18% reported using cigarettes, 9.4% used alcohol and 5% used illicit 

drugs; heroin use was reported by .2% of pregnant women and .9% non-medically 

used prescription drugs (SAMHSA, 2012). 

There are two aspects of parental opioid use that affect the child welfare system: 

(1) prenatal opioid and other substance use exposure when it is determined that 

there are immediate safety factors resulting in the newborn being placed in protecVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00068 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD

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2The exact language is that ‘‘. . . such notification shall not be construed to—(I) establish 

a definition under Federal law of what constitutes child abuse or neglect; or (II) require prosecution for any illegal action.’’ 

tive custody and (2) post-natal use that affects parents’ ability to safely care for 

their children. 

Congress has been specific that hospital notification of cases of prenatal substance 

exposure is not substantiated child abuse or neglect.2 Rather, when these children 

come to the attention of the child welfare system, assessment of risk and safety are 

to be conducted and plans of safe care instituted to ensure the newborn’s well-being. 

Unfortunately, as the recent Reuters series made clear, often this is not happening 

(Wilson and Shiffman, 2015). 

Neonatal abstinence syndrome (NAS) occurs in about half of babies with exposure 

to opioids during pregnancy. At this time, there are not clear data as to why babies 

do or do not experience the withdrawal syndrome. In a national study on the use 

of methadone and buprenorphine during pregnancy, researchers found that NAS did 

not appear to be related to the dose of these medications that are used to treat 

opioid dependence. But there were data suggesting that experiencing NAS was related to mothers who also smoked during pregnancy (Jones, 2015). 

Dr. Stephen Patrick and colleagues (2016) have analyzed Medicaid claims data to 

monitor the trend of infants who are diagnosed with Neonatal Abstinence Syndrome. There is variation across regions in rates of NAS with the north-east and 

mid-south central regions experiencing the highest rates of diagnosed cases in Medicaid claims data. 

While there is not a clear relationship of rates of NAS and the dramatic increase 

of infants being placed in protective custody, the trend of younger children in care 

and particularly the number of infants is alarming. After a decade of decreasing the 

number of children in out-of-home care, that trend began to reverse in 2012–2013. 

The total number of children in care are both new intakes as well as children who 

are remaining longer in care. 

Of the nearly 265,000 children who entered care in 2014, the largest group were 

infants. The data are not available on the percentage of those infants who also experienced prenatal substance exposure, since they are not collected at the federal level 

nor by the majority of states. One might suggest however, that there are few underlying factors other than a parent’s substance use disorder that would disrupt the 

ability of a parent to care for their infant—particularly in areas of the country that 

are experiencing a profound opioid epidemic. 


022316.003
66 

These trends are resulting in an increasing shift toward younger children making 

up a larger percentage of children in out-of-home care with children under 6 representing nearly 40% of children in care. These data indicate a short window of time 

for intervention with these children and families. This alarming rate of young children coming into care is especially troubling, as children ages 0–3 are especially vulnerable. Infancy and toddlerhood is a time of rapid development across all domains 

of functioning. The brain of a newborn is about one-quarter the size of an adult’s 

and by the age of three, the brain has developed to about 80 percent of its adult 

size (Nowakowski, 2006). It is imperative that the development of that child take 

place in a stable environment with a caregiver who fosters mutual attachment with 

the child. 

Unfortunately, I cannot report reliable data that would indicate to what extent 

parental opioid or other substance use disorders are associated with the number of 

children in out-of-home care. The nation’s data system to monitor these factors does 

not require collection of parental substance use as factors in child removal, since 

those are voluntary collection items in the data system. However, our agency has 

been monitoring the available data for 15 years, and there has been a steady increase in reports of removals due to substance use by parents. The graph on the 

following page shows that since 2009, states report a 19.4 rate of increase in parental alcohol or drug use as factors in the child’s removal. 


022316.004 022316.005
67 

However, we have been to all but one state in the country and asked child welfare 

professionals if they believe these data represent the prevalence of parental substance use in their cases. Not a single state believes these data accurately reflect 

their experience and tell us that these numbers greatly understate that the vast 

majority of cases in which a child is placed in protective custody are related to parental substance use disorders. 

As shown in the graph on the following page, these data vary substantially across 

states. We do not believe that these data reflect true variation in incidence, rather 

they reflect states’ systems of identification and specifics of how these data are recorded in each state’s automated data system. Only a handful of states have a 

standardized screening tool that is used to detect parental substance use disorders 

during investigations of child abuse and neglect. Very few states have consistent 

policy and protocols on how the results of investigations regarding parents’ substance use are to be recorded in the automated information system. 

Among all reasons for child removal, drug abuse by parents was the largest rate 

of increase over the past 5 years. Child welfare professionals often tell us that neglect is the category that is checked in the data system but that neglect is almost 

always associated with parents’ substance use disorder. 

These data are reflected in statements by child welfare agency professionals from 

around the country. Last week I spent 3 days in Ohio. I was told by a child welfare 

administrator from a county that borders Kentucky that 2015 was the first time 

ever that there were more children whose parents’ rights were terminated than 

were reunified. That small county had 70 terminations attributed to parents’ opioid 

use disorders. Child welfare officials reported that this trend is evident across the 

state. They report that over the past 5 years parents with opioid use disorders have 

increased the number of children placed in care at the same time that overall resources to serve families have decreased. 

To summarize 

• Infants are the largest age group of children entering foster care, they are at 

least twice the number of children of other ages. 

• Removals of children due to parental substance abuse has increased significantly as reported by the states. 


022316.006
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022316.007
69 

• Child welfare professionals across the country, particularly in the north-east 

and Appalachian states, report that parental opioid use disorders are having 

a major impact on increasing child removals, preventing reunification and increasing termination of parental rights. 

WHAT WORKS FOR FAMILIES AFFECTED BY OPIOID AND

OTHER SUBSTANCE USE DISORDERS

Families and child welfare agencies have been affected by multiple drug epidemics 

over the past several decades—cocaine in the late 1980s, methamphetamine in the 

early 2000s and now opioids. In the cocaine epidemic, Congress enacted legislation 

to expand specialty treatment programs for women and their children and required 

that the Substance Abuse Prevention and Treatment Block Grant prioritize treatment admissions for pregnant and parenting women. 

During the methamphetamine epidemic, Congress made the largest ever investment through demonstration grants to find out what works to improve outcomes for 

these families and ensure child safety, permanency in caregiving relationships, and 

their well-being. A key shift in policy was that many of the communities that received these grants worked to prevent removal of children by providing services to 

children and their families while the children remained safely at home. States use 

different labels to refer to these ‘‘in-home’’ cases—protective supervision for example. But they represent the majority of the caseload of families in child welfare services, often about 70% of the state’s caseload. 

Across child welfare programs, approximately 85% of children stay home, or go 

home, or in the case of children who are not reunified, they find home when they 

age out of foster care or become adults and access their adoption records. These realities make evident the imperative that child welfare service agencies, substance 

abuse treatment providers, and community partners work together to address the 

needs of parents to prevent placement, reunify with their children or potentially 

play another supportive role in their child’s life. 

The demonstration grants included the Regional Partnership Grant program 

(RPG) and SAMHSA’s Children Affected by Methamphetamine Program (CAM). The 

RPG and CAM programs documented a set of common ingredients and strategies 

leading to positive outcomes for families affected by substance use disorders. These 

strategies include: 

1. Identification: A system of identifying families in need of substance use 

disorder treatment. 

2. Timely Access: Timely access to substance use disorder assessment and 

treatment services. 


022316.008
70 

3. Recovery Support Services: Increased management of recovery services 

and monitoring compliance with treatment. 

4. Comprehensive Family Services: Two-generation family-centered services 

that improve parent-child relationships. 

5. Increased Judicial Oversight: More frequent contact with parents with a 

family focus to interventions. 

6. Cross-Systems Response: Systematic response for participants based on 

contingency contracting methods. 

7. Collaborative Structures: Collaborative non-adversarial approach grounded in efficient communication across service systems and the courts. 

Implementation of these common strategies for collaborative policy and practice 

has shown five core outcomes, the 5Rs: 

1. Recovery: Parental recovery from substance use disorders. 

2. Remain at Home: More children remain in the care of parents. 

3. Reunification: Increased number and timeliness of parent-child. 

4. Reoccurrence: Decreased incidence of repeat maltreatment. 

5. Re-entry: Decrease number of children re-entering out-of-home care. 

REGIONAL PARTNERSHIP GRANTS

The Child and Family Services Improvement Act of 2006 reauthorized the Promoting Safe and Stable Families program and provided a competitive grant program 

with funding over a 5-year period to implement regional partnerships in states, 

tribes and communities to improve outcomes for children and families who were affected by parental substance use disorders. 

In October 2007, the Administration on Children Youth and Families (ACYF), 

Children’s Bureau (CB) awarded grants to 53 partnerships across the country, including 7 tribes. Family Drug Courts were part of the initiative in 21 of the grantees. The outcomes of the grants were measured in a performance measurement system focused on documenting child safety, permanency, and well-being; systems improvement; and treatment-related outcomes such as timeliness of treatment access, 

length of stay in treatment, and parents’ recovery. 

RPG grantee OnTrack is located in Medford, Oregon. They developed an 

alternative to children being placed in foster care by creating emergency 

shelters and residential treatment in which parents and children could stay 

together. Of families who participated in the program, 98% of kids were reunified with families within 10 months. 

After 1 year of program completion, only 6% of families had a subsequent 

removal, compared 28% of families receiving standard services—comparison 

group children were four times more likely to experience subsequent removal. 

In September 2012, ACYF/CB awarded 17 new RPGs and 2-year extension grants 

to 8 of the 53 original grantees. This was made possible by Child and Family Services Improvement and Innovation Act (Pub. L. 112–34) signed into law in September 

2011. In September 2014, four additional 5-year grants were awarded. 

The original 53 grantees served a total of 17,820 adults, 25,541 children and 

15,031 families. Key positive outcomes across sites include: 

• Parents achieved timely access to substance abuse treatment (36.4% entered 

treatment within 3 days), stayed in treatment (65.2% stayed in treatment 

more than 90 days), and reported reduced substance use. 

• The majority of children at risk of removal remained in their parent’s custody—92.0% of children who were in custody of their parent or caregiver at 

the time of RPG program enrollment remained at home through RPG program case closure. The percentage of children who remained at home significantly increased through program implementation from 85.1% in Year 1 to 

96.4% in Year 5. 

• Most children in out-of-home placement achieved timely reunifications with 

their parent(s). 

• 83.0% of children discharged from foster care were reunified. 

71 

• 63.6% reunified within 12 months. 

• 17.9% were reunified in less than 3 months. 

• 72.7% of infants reunified within 12 months. 

• After returning home, very few children re-entered foster care. 

• Only 4.2% of children had a substantiated maltreatment within six months 

versus 5.8% subsequent maltreatment rate based on state data. 

The RPG in the State of Kansas implemented the evidence-based Strengthening Families Program (SFP) with 367 Children and 473 adults. On average, the SFP child participant spent 190 fewer days in out-of-home care 

than their non-SFP counterparts. For example, at the 360-day point from 

start of SFP, almost half (45.0 percent) of the SFP children were reunified, 

compared to 27.0 percent of the comparison children. The evaluation conducted by University of Kansas researchers found that SFP saved approximately $16,340 per child in State and Federal out-of-home care costs 

(McDonald and Brook, 2013). 

CHILDREN AFFECTED BY METHAMPHETAMINE GRANTS

Funded through the Substance Abuse and Mental Health Services Administration 

(SAMHSA), the Children Affected by Methamphetamine (CAM) Grant Program focused on expanding and enhancing services to children and their families who are 

affected by methamphetamine and other substance use disorders. The Public Health 

Service Act of 2000 section 509 provided funding from 2010–2014 to 12 Family Drug 

Courts to improve the well-being, permanency, and safety outcomes of children, who 

were in, or at-risk of out-of-home placement as a result of a parental methamphetamine or other substance abuse. The primary focus of the grant program was to provide services directly to the children and to provide supportive services for parents, 

caregivers, and families. 

The Sacramento County CAM Project (known as Children in Focus) 

served children and families in the Dependency Drug Court (DDC) and the 

Early Intervention Family Drug Court (EIFDC). The DDC serves families 

in which children have been removed from parental care and the EIFDC 

serves children, primarily infants, who are in the care of their birth parents. The CAM grant supported family-centered services including an evidenced-based specialized parenting program for parents in recovery called 

Celebrating Families (CF) and the use of Recovery Specialists who conduct 

active engagement based on motivational interviewing and monitoring activities with parents. The project also linked participants to family resource 

centers and other community resources to provide recovery support during 

CF participation and beyond program completion. 

Outcome data shows that 97.8% of children who were at home at the time 

of enrollment remained at home, saving an estimated $34,494 per child in 

placement costs. Within 6 months of program entry, only 1.5% of children 

experienced maltreatment reoccurrence. Higher reunification rates and 

shorter times in out-of-home care compared to standard services saved an 

estimated $12,254 per child. 

Outcome data from across all 12 sites indicated that children enrolled in the CAM 

program services were kept safe with lower rates of repeat maltreatment than in 

the general child welfare population. Outcomes included: 

• More than 90% of children remained in their home with their parent/caregiver throughout program participation and the majority of children exiting 

out-of-home care were discharged to reunification. 

• Over two-thirds (68.2%) of CAM children were reunified in less than 12 

months. 

• Less than 6% of reunified children re-entered foster care within 12 months 

after being returned home. This is about a third of the national average with 

standard services. 

The CAM grantees experience increased our knowledge about the timing and type 

of parenting classes that should be delivered to parents in early recovery. These 

grantees experimented with when to start and what type of parenting classes these 

families need. They found that they could increase retention in treatment when they 

engaged parents early in their recovery in parenting programs specifically developed 

for parents with substance use disorders, focusing on teaching effective parenting 

72 

skills, and providing opportunities for children and parents to repair their relationship. 

The other good news about these projects is that they saved money. Not only in 

reduced foster care costs, but in keeping parents in treatment long enough for treatment to have a lasting effect. And in the long term, these programs are keeping children out of higher-end, higher-cost mental health, special education, and juvenile 

justice programs when they get older. These programs proved that they could save 

millions of dollars, justifying the increase in enhanced services for children and 

their parents. 

Although these grant programs operated in different drug epidemics than the current opioid wave, there is much that can be applied to today’s crisis. We do know 

that access to medication-assisted treatment is imperative for success in today’s population. But, as important as access to effective treatment has proven to be in prior 

eras, access to medication-assisted treatment for this population is not being provided on a timely basis. For example, months of wait lists for treatment are the 

norm across the country. 

In Ohio last week, I was told that in a FDC model that includes facilitating treatment access, it still takes approximately 1 month to get access to medication assisted treatment. Without participation in the specialized drug court docket, it takes 

at least 3 months to access medications. When children’s safety and well-being are 

at stake, parents need to access treatment much faster than that. 

While some states have access to Medicaid funding for some families involved 

with child welfare, it’s important to recognize that the health-related criteria for accessing treatment and the outcomes measured in the health care system may not 

always relate to the needs of families in child welfare. Medical criteria to access a 

certain level of care with Medicaid or private insurance does not include the safety 

or impact on the child as criteria for residential or intensive out-patient levels of 

care. Similarly, outcomes for substance abuse treatment for adults in the Medicaid 

or private insurance system do not typically count in their performance measures 

family safety and child well-being. Rather, these outcomes are the responsibility of 

the child welfare system in collaboration with substance abuse treatment agencies 

and courts. 

We would suggest that referral to a wait list does not meet child welfare’s legal 

standard of reasonable efforts, and in the case of Native American children the 

higher standard of active efforts, to prevent placement and to reunify children. 

Rather, facilitating access to treatment and ensuring treatment availability is needed. 

In summary, we can no longer say we don’t know what to do. We can build on 

the track record of dozens of fine, smaller-scale programs in your states and communities. That’s a big difference in this epidemic, compared with prior eras. We can 

take what works into system change approaches, instead of helping only a few families at a time. 

OPPORTUNITIES TO TAKE WHAT WORKS INTO SYSTEM-WIDE REFORM

The impact of opioids on children and families in the child welfare system must 

be placed in context of the history of parental substance use disorders, how to comprehensively address the current epidemic, and to mediate the effects of future 

shifts in drug use patterns from severely impacting children and their families. The 

effort should focus on how to build on lessons from prior federal investments, resolve the current gap in timely treatment access, focus on improving data collection 

and monitoring, and prevent future crises and costs as substance use patterns 

change over time. 

In addition to the key programmatic strategies implemented to prevent child 

placement, there are system changes that are also needed to effectively monitor effects over time, ensure staff are prepared to work effectively with these families, 

state-specific financing strategies need to be developed to maximize recent changes 

in substance use disorder treatment, fill gaps in treatment access for these families, 

and build collaborative efforts that cross agency boundaries and support communities. Specific system reforms that are needed include: 

• Improve data collection and reporting to monitor the effects of parental substance use disorders on the child welfare system and the 

outcomes achieved by addressing treatment needs. This should happen 

by resolving states’ information technology challenges to include alcohol and 

73 

drug use factors in case records, require standardized reporting of alcohol and 

drug use factors in federal child welfare reporting systems and require existing outcome monitoring to report on the differential child welfare outcomes 

for children and families due to parental substance use disorders. 

• Improve access to quality substance use disorder treatment. The need 

for access to substance abuse treatment cannot be over-emphasized. When we 

refer parents to treatment as a condition of keeping or reunifying with their 

children, we must make sure that the treatment is state-of-the-art, comprehensive, meets the needs of the entire family, and that treatment, including medications for opioid use disorders, are available and timely. 

• Improve collaborative practice. This can be achieved through implementation of practical strategies, such as staff development and training programs and cross-systems communication protocols. Ensuring that these strategies include a focus on infants with prenatal substance exposure will develop 

a workforce that is prepared to work in today’s environment. Staff training 

and communication protocols must provide concrete and pragmatic information, such as guidance in developing comprehensive plans of safe care that 

keep infants with birth families whenever possible and provide interventions 

to address the needs of both the infant and mother. 

When we ensure timely access to effective treatment, families recover, 

kids stay safe at home, and we save money. Now we can and must move 

beyond pilots and demonstration grants and take these lessons to into systemic changes across agencies to help children and families. 

REFERENCES

Compton, W.M., Jones, C.M. and Baldwin, G.T. (2016). Relationship between nonmedical prescription-opioid use and heroin use. New England Journal of Medicine, 

374(2), 154–163. 

Jones, H. (2015). Treatment of Opioid Use Disorder in Pregnancy and Infants Affected by Neonatal Abstinence Syndrome. A Webinar presented for the SAMHSA 

Women’s Health Week. May 15, 2015. Accessed February 20, 2016, http:// 

www.cffutures.org/files/webinars. 

Leonard, K. (2015). Heroin Use Skyrockets in U.S. U.S. News and World Report. 

July 7, 2015. Accessed February 21, 2016, http://www.usnews.com/news/blogs/ 

data-mine/2015/07/07/heroin-use-skyrockets-in-us-cdc-says. 

McDonald, T. and Brook, J. (2013). Description of the State of Kansas Regional 

Partnership Grant and Evaluation Findings. Accessed February 21, 2016, http:// 

www.cffutures.org/files/rpgprofiles/ArrayofServicesCluster/KansasDepartmentof 

SocialandRehabilitationServices.pdf. 

Nowakowski, R.S. (2006) Stable neuron numbers from cradle to grave. Proceedings 

of the National Academy of Sciences of the United States of America. 

103(33):12219–12220. 

Patrick, S.W., Davis, M.M., Lehmann, C.U. and Cooper, W.O. (2015). Increasing incidence and geographic distribution of neonatal abstinence syndrome: United 

States 2009 to 2012. Journal of Perinatology, 35(8): 650–655. 

Substance Abuse and Mental Health Services Administration, Results from the 2013 

National Survey on Drug Use and Health: Summary of National Findings, 

NSDUH Series H–48, HHS Publication No. (SMA) 14–4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014. 

Substance Abuse and Mental Health Services Administration, Center for Behavioral 

Health Statistics and Quality (2015). Behavioral Health Trends in the United 

States: Results from the 2014 National Survey on Drug Use and Health, HHS Publication No. SMA 15–4927, NSDUH Series H–50. Retrieved from http:// 

www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1- 

2014.pdf (accessed February 19, 2016). 

Wilson, D. and Shiffman, J. (2015). Helpless and Hooked. A Reuters Investigation. 

December 7, 2015. Accessed February 21, 2016, http://www.reuters.com/investigates/special-report/baby-opioids/. 

74 

QUESTIONS SUBMITTED FOR THE RECORD TO NANCY K. YOUNG, PH.D. 

QUESTIONS SUBMITTED BY HON. ROBERT P. CASEY, JR. 

Question. In your testimony, you note that the opioid epidemic is having a worse 

effect on youth than previous drug abuse epidemics, particularly because young people are dying at a much higher rate and because they are coming into protective 

custody at a higher rate. Why is the opioid epidemic having a much more substantial impact on young people than previous substance abuse epidemics? 

Answer. Prior epidemics did not provide the wide access to over-prescribed prescription drugs that many ‘‘pill mills’’ and unscrupulous physicians provided; fentanyl use and uncertain dosages have worsened effects; and the respiratory effects 

of opioids have more severe consequences for their users. In addition, many child 

welfare agencies are not prepared for how to handle families with an infant who 

goes through a withdrawal syndrome. Too many states, counties and workers make 

those conditions an automatic placement in foster care rather than understanding 

family safety and risk factors and how to ensure the infant and family receive best 

practice. 

Question. Your testimony covers some of the policies and programs that were established in response to previous substance abuse epidemics, and how they worked 

to help adults recover and keep families together. Are there any policies or efforts 

that did not work, and that should be modified or abandoned as a result? 

Answer. Punitive responses that criminalize prenatal use and separate mothers 

from newborns have not succeeded in achieving recovery or good parenting practices. I would also emphasize the importance of devoting proportionate attention to 

the different substances, rather than over-emphasis on any one substance as we 

have done in past cycles of increases in specific drugs. The chart bellows shows the 

proportionate effects on newborns, and makes clear that the legal drugs still have 

the highest prevalence rates and we know from decades of research create the greater harm for the neurodevelopment of the child. 

Question. Thank you for noting the fact that many states do not seem to be in 

compliance with their Plan of Safe Care requirements under CAPTA. My office has 

been actively investigating the best course of action to resolve this situation. What, 

if any, changes do you feel need to be made to CAPTA in order to encourage compliance with this provision? Do you feel there is a danger that some states may begin 

to turn down CAPTA funding if reporting requirements such as this are enforced? 

Answer. The recent passage of the CARA legislation which included changes in 

CAPTA implementation by improving these provisions, requiring HHS to provide 

best practice guidance to states on these requirements and ensuring that the caregivers of infants are included in the plan of safe care referenced in CAPTA are critical. I have attached a suggested approach to the plan of safe care that our organization has drafted. As to states that may refuse their CAPTA funding due to these 


022316.009
75 

1 For state specific information, see: http://khn.org/news/nearly-half-of-u-s-births-are-covered-by-medicaid-study-finds/. 

requirements, if federal agencies annually report on CAPTA numbers and practices 

for each state, there would be increased accountability for those states that comply 

with CAPTA reporting-and those that do not. Of course, it is urgent that the Family 

First Prevention Services Act is passed by the Senate to ensure that families with 

an infant with prenatal substance exposure can access prevention services including 

substance use disorder treatment, mental health treatment and in-home parenting 

supports. 

QUESTIONS SUBMITTED BY HON. MICHAEL F. BENNET

Question. Given that over 20% of pregnant women on Medicaid filled a prescription for an opioid during pregnancy, what can we do to aid mothers-to-be and improve outcomes for infants who are born in withdrawal? 

Answer. (1) Promote and support strategies that facilitate safe practices in the 

prescribing of opioids. 

• The Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 (March 15, 2016) 

summarizes 12 recommendations. The recommendations include use of nonpharmacologic and non-opioid pharmacologic therapies to manage chronic 

pain. When opioid medications are necessary, the guidelines provide strategies to identify and address risk factors, such a history of misusing prescription opioids or of a substance use disorder, and strategies to address identified risk factors, such as referral to evidence-based substance use treatment. 

• The guidelines include information on prescribing opioids to pregnant 

women—women should be informed of the potential risks related to opioid 

use during pregnancy and an assessment of risk and benefit is necessary. 

During pregnancy, withdrawal from opioids is not recommended, primarily 

due to the high relapse potential and resultant impact on the fetus. Medication-assisted treatment (MAT) in conjunction with counseling and other behavioral interventions for opioid use disorders is recommended. Pregnant 

women undergoing MAT should give birth at a hospital prepared and 

equipped to address the woman’s needs and to care for an infant with neonatal abstinence syndrome (NAS). 

• Additional information on opioid prescribing guidelines for pregnant women 

is available on pg. 32 of the Guidelines document. 

• On March 22, 2016, the Federal Drug Administration (FDA) announced new 

requirements for labeling of prescription opioid medications. The requirements include a new warning about the serious risks of misuse, abuse, addiction, overdose and death; and a precaution that chronic maternal use of 

opioids during pregnancy can result in NAS. 

(2) Promote and support strategies that improve early identification of opioid and 

other substance use disorders during pregnancy and access to, and engagement in, 

MAT and other evidence-based substance use treatment. 

• Approximately half of U.S. births are covered by Medicaid (Markus, et al., 

2013; Curtin, et al., 2013).1 There is wide variation in state Medicaid regulations on whether prenatal care providers are required to screen for opioid and 

other substance use disorders. Adoption of The American College of Obstetricians and Gynecologists (ACOG) guidelines in universal Medicaid regulations 

would result in enhanced identification of prenatal exposure to opioids and 

other substances. The ACOG guidelines state, ‘‘Screening for substance abuse 

is a part of complete obstetric care and should be done in partnership with 

the pregnant woman. Both before pregnancy and in early pregnancy, all 

women should be routinely asked about their use of alcohol and drugs, including prescription opioids and other medications used for nonmedical reasons 

(ACOG, 2012).’’ 

• The ACOG guidelines also state ‘‘. . . to optimize care of patients with substance use disorder, obstetrician-gynecologists are encouraged to learn and 

appropriately use routine screening techniques, clinical laboratory tests, brief 

interventions and treatment referrals (ACOG, 2015).’’ Yet, a national study 

76 

found that medical residency programs that require formal training on substance use disorders widely ranges from 31% to 95%, with only 39% of OB/ 

GYN programs including curricula on substance use disorders (Isaacson, et 

al., 2000). The OB/GYN substance use curricula included an average of 3 

hours of training. 

• Enhancing training requirements for OB/GYNs and other medical professionals will help address the range of challenges related to identifying opioid 

and other substance use during pregnancy and in ensuring access to treatment. These challenges include (Terplan, 2015; ACOG 2015): 

• Screening Tool: Evidence-based screening tools, such as the 4Ps Plus, are 

available. Yet there is wide variation in whether prenatal care providers 

use these evidence-based tools. 

• Reimbursement: While Medicaid regulations vary, screening for substance 

use during pregnancy is a Medicaid reimbursable service. 

• Referral to Treatment for Opioid and Other Substance Use Disorders: Prenatal care providers and substance use treatment providers are often in different health networks. A common barrier for obstetricians in screening for 

substance use during pregnancy is the lack of access to follow-up care 

should a pregnant women need further assessment and treatment. This can 

be complicated, since making a referral to a substance use treatment provider outside of the Medicaid managed care network of the obstetrician may 

require different insurance processes. 

• Stigma: Misunderstanding of opioid and other substance use disorders. 

Fear and concern that identifying substance use during pregnancy will result in criminal prosecution of the woman and automatic removal of the infant with prenatal exposure at the time of birth, without regard for mothers’ willingness to enroll in treatment. 

(3) Promote and support strategies that encourage evidence-based treatment for 

infants with NAS. 

• According to ACOG, ‘‘NAS is an expected and treatable condition that follows 

prenatal exposure to opioid agonists (2012).’’ NAS is the term used to represent the pattern of effects that are associated with opioid withdrawal in 

newborns (Hudak and Tan, 2012). NAS symptoms are affected by a variety 

of factors, including: 

• Type of opioid the infant was exposed to; 

• Point in gestation when the mother used the opioid; 

• Genetic factors; and 

• Exposure to multiple substances, particularly tobacco (Wachman, et al., 

2013). 

• Non-pharmacological treatment (e.g., swaddling, breastfeeding, provision of a 

calm environment) is the standard of care for an infant with NAS and should 

begin at birth and continue throughout the infant’s hospitalization and beyond (Velez and Jansson, 2008). The goal of both non-pharmacological and 

pharmacological treatment (e.g., methadone, buprenorphine, morphine) is to 

soothe the infant’s NAS symptoms, while encouraging the mother-infant 

bond. Other supportive strategies, such as having the mother and infant room 

together, are also necessary. 

(4) Supporting development of partnerships across health networks and other systems involved in the care of pregnant women with opioid and other substance use 

disorders and their infants. 

• Supporting the development of this partnership will facilitate access to: 

• Evidence-based treatment for opioid and other substance use disorders; 

• Evidence-based treatment of NAS; and 

• The range of additional social, health and safe housing services needed by 

pregnant women and their infants. 

(5) Ensure implementation of provisions in the Child Abuse Treatment Act related to hospitals’ notification to Child Protective Services of infants identified as 

affected by illegal substance use, withdrawal symptoms, or a fetal alcohol spectrum 

disorder and monitor that states and communities are implementing plans of safe 

care that support the infant and caregiver prior to the infant’s and mother’s discharge from the hospital. 

• We note that the House Education and Labor Committee recently passed out 

of committee a bipartisan and bicameral bill to improve the CAPTA legislaVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00080 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
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tion in regard to monitoring implementation of these provisions, providing 

best practice guidance to states on these requirements and ensuring that the 

caregivers of infants are included in the plan of safe care. We anticipate that 

the bill will be taken up by the Senate Health, Education, Labor and Pensions (HELP) committee. 

In summary, support of the following five approaches are necessary to improve 

outcomes for pregnant women with opioid and other substance use disorders and 

their infants: 

(1) Safe practices in the prescribing of opioids. 

(2) Improving early identification of opioid and other substance use disorders 

(particularly the co-occurrence of opioid, alcohol and nicotine use disorders) 

during pregnancy and providing access to and engagement in MAT and 

other evidence-based substance use treatment. 

(3) Improving use of evidence-based treatment including fostering mother-infant bonding and non-pharmacological treatment as well as medication as 

needed for infants with NAS. 

(4) Developing partnerships across health networks and other systems involved 

in the care of pregnant women with opioid and other substance use disorders and their infants. 

(5) Improving provisions in the CAPTA legislation in regard to better monitoring of the implementation of the law and to ensure that plans of safe care 

are provided to infants and their caregivers. 

Question. Thank you for highlighting in your written testimony the importance of 

keeping children at home and recovery support services for parents who are affected 

by opioid and substance abuse disorders. Nearly 40% of Colorado children removed 

from their homes are removed due to parental substance abuse. What do you think 

is the most immediate step that must be taken to ensure that parents have the help 

they need and keep children safely in the home? 

Answer. (1) Take advantage of the lessons learned from prior federal investments 

in demonstration programs and title IV–E waivers to ensure child welfare agencies 

and community partners implement proven strategies to prevent child placement in 

out-of-home care and improve family outcomes. 

After more than a decade of testing strategies to improve outcomes for these families, there are seven key components of services that have been implemented in 

demonstration grants and Title IV-E waivers that are associated with preventing 

child removal, decreasing costs, and providing better family outcomes. These strategies are more fully described in my prior written statement submitted to the Finance Committee Hearing in February. In brief, successful communities and interagency collaboratives: 

• Implement a system of identifying families in need of substance use disorder 

prevention and treatment such as establishing standardized screening protocols in child welfare practice and in prenatal care; 

• Ensure early access to assessment and treatment services such as securing 

expert consultation on cases involving substance use disorders, conducting 

outreach and methods to engage and retain parents in treatment, and provide 

priority access to assessment and treatment of child welfare-involved families 

affected by substance use disorders; 

• Increase management of treatment and recovery services and monitoring 

compliance such as co-location of services, specialized recovery case management services; ensuring comprehensive family treatment programs are tailored to individual parent and child needs; 

• Ensure access to family-centered services including effective parenting programs focused on enhancing the parent and child relationship and the prevention needs of children; 

• Provide appropriate judicial oversight including providing more frequent judicial or administrative reviews of treatment access and compliance with case 

plans regarding participation in substance use disorder treatment; 

• Have a system in place that appropriately responds to participants’ behavior 

such as proven contingency management approaches; 

• Improve their collaborative approach across service system and courts including: 

• Cross training of staff; 

• Data collection and information systems capable of monitoring the progress 

and outcomes of children and families receiving services from the child welfare and treatment systems; 

78 

• Arrangements for addressing confidentiality and sharing of information; 

• Identification by the State agencies or Indian tribal agencies of funding barriers and how Federal, State, and local resources are being used to sustain 

programs of these agencies; 

• Consultation with community members and persons in recovery to ensure 

programmatic approaches reflect their consultation and advice; and 

• Identifying how infants with prenatal substance exposure are specifically 

included in the efforts of States or Tribes to monitor and reduce infant fatalities. 

As Senator Bennet represents the State of Colorado, we note that efforts are underway in the State of Colorado to implement these strategies. The Office of Juvenile Justice and Delinquency Prevention (OJJDP) provided grant funds to Colorado 

and four other states in 2014 to conduct cross-system planning and to test methods 

to implement these strategies in a collaborative effort among the administrative 

agencies and the juvenile court. Colorado’s efforts include pilot testing of universal 

screening of child welfare-involved families for substance use and mental health 

issues. There are eight pilot counties that are geographically representative of the 

State. The first cohort of counties continues to refine and develop practice and protocols through routine information sharing, data collection and analysis to prepare for 

statewide implementation in the Fall of 2016. Lessons learned from the first cohort 

are informing the second cohort. Both groups are now testing strategies to ensure 

that the following are developed into policies and protocols for statewide implementation: 

(1) Universal screening for substance use and mental health; 

(2) Improved and earlier access to shorten timeframes between screening and 

assessment for substance use disorder and mental health; 

(3) Use of a multidisciplinary team staffing model to integrate substance use 

disorder and mental health assessments and to consider, simultaneously, 

the child’s safety and risk assessments; and 

(4) Compel court’s case management to be responsive to treatment needs. 

The project has developed a data collection, management and analysis plan that 

entails development of a shared database to measure the efficacy of the pilots and 

to ensure continued quality improvement in the statewide implementation. The 

project has drafted and operationalized shared outcomes across partners in a data 

dictionary. 

(2) The need to improve the identification of families who need assistance and the 

information systems to better record and monitor the impact of parental substance 

use and mental disorders on child welfare services. 

We understand that the Adoption and Foster Care Analysis and Reporting System 

(AFCARS) data regarding the prevalence of parental alcohol or drug use are factors 

in cases of children being placed in protective custody in Colorado. However, under 

various technical assistance engagements in Colorado over the past dozen years, no 

one we have interacted with in Colorado believes that the 40% prevalence rate is 

accurate. They generally believe it is a much higher percentage. In the written 

statement to the Committee, we detailed some of the reasons for the under-recognition of parental substance use disorders. In addition, as noted by Seay it has been 

more than a decade since a study on the prevalence of substance use in child welfare agencies has been published (Seay, 2015). 

Solutions to the under-reporting of parental substance use and mental health 

issues as reasons for child removal seem more urgent than ever. As any potential 

changes in the financing of child welfare services are being discussed, it will be increasingly important to determine the prevalence of substance use. In our view, the 

mandated Statewide Automated Child Welfare Information System (SACWIS) for 

child welfare agencies and proposed changes in the AFCARS system reporting on 

foster care do not adequately address the wide variation among states in reporting 

removals of children to foster care that involved parental drug and alcohol use. 

States range from near-zero to the high 50% level, which underscores the underreporting. Unless reporting on indicators of parental substance use is made mandatory, states will continue to under-report, based on our discussions with state and 

local officials. States that have done the best job with this reporting could be given 

incentives to spotlight their efforts as a form of peer-to-peer technical assistance. 

In closing, while we now understand ‘‘What to Do,’’ based on these strategies, the 

most urgent need is to change the financing mechanisms in child welfare to support 

strategies that broaden access to substance use treatment services for child welfareVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00082 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
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1Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H–48, 

HHS Publication No. (SMA) 14–4863. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2014. Retrieved from http://www.samhsa.gov/data/sites/default/files/ 

NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.pdf. 

involved families so that prevention of child placement becomes a clear priority by 

providing the substance use treatment and mental health services that are needed 

by parents and children. 

The Role of Plans of Safe Care in Ensuring the Safety 

and Well-Being of Infants with Prenatal Exposure, 

Their Mothers and Families 

A Discussion Draft in Development of 

A Technical Assistance White Paper 

March 26, 2016 

Updated July 27, 2016 

Prepared by: Children and Family Futures 

Strengthening Partnerships, Improving Family Outcomes 

25371 Commercentre Drive 

Lake Forest, CA 92692 714–505–3525 

This white paper is intended to generate discussion among State and local policymakers and practitioners. The ideas are framed by Children and Family Futures 

staff and informed by our work with numerous communities across the nation on 

the public policy issues affecting children of parents with substance use disorders. 

The views do not reflect the official position or agreement with these ideas from any 

of the funding organizations of Children and Family Futures. 

The Need 

More than 500,000 infants are born each year to mothers who used tobacco (13.4 

percent), alcohol (9.3 percent), or illicit drugs (5.3 percent) during pregnancy.1 The 

number of infants exhibiting the narrower criteria of ‘‘affected by illegal substance 

abuse or withdrawal symptoms or a fetal alcohol spectrum disorder’’ is unknown. 

For many of these children, this exposure has lifelong effects. 

Many Federal and State programs aim to reduce substance use during pregnancy 

as well as the potential effects on infants and children, but there is no single Federal agency that is charged with responding to these risk factors or to coordinate 

a response across the multiple agencies. Legislation and administrative guidelines 

on risks to infants and young children involve more than a dozen Federal agencies, 

and dozens more at State and local levels. These agencies and professionals include 

health care, social services, treatment for substance use disorders, mental health, 

child welfare, developmental disabilities, home visiting, education, and more. 

The Role of the Child Abuse Prevention and Treatment Act (CAPTA) in 

Meeting the Need 

In the child welfare system, the Keeping Children and Families Safe Act of 2003 

(amended in 2010) created new conditions for States to receive State grant allocations under the Child Abuse Prevention and Treatment Act (CAPTA). The changes 

were intended to provide the needed services and supports for infants, their mothers, and their families and to ensure a comprehensive response to the effects of prenatal exposure. 

The legislative intent was to improve the likelihood of mothers obtaining treatment 

for their substance use disorder, not to mandate that prenatal exposure would automatically result in a substantiated case of child abuse or neglect. In referring to 

needed services, the CAPTA language makes clear that child welfare is only one of 

the agencies that must be involved. Since child welfare does not have responsibility 

80 

2 H.R. 14, Keeping Children and Families Safe Act of 2003. Retrieved from https:// 

www.congress.gov/bill/108th-congress/house-bill/14/text?q=%7B%22search%22%3A%5B%22HR 

+14+keeping+children+and+families+safe+act+2003%22%5D%7D&resultIndex=4&overview=open 

#content. Signed into Public Law (P.L. 108–36; S. 342, Keeping Children and Families Safe Act 

of 2003) on June 25, 2003. Retrieved from https://www.congress.gov/bill/108th-congress/senate-bill/342?q=%7B%22search%22%3A%5B%22HR+14+keeping+children+and+families+safe+act 

+2003%22%5D%7D&resultIndex=5. 3 Christian, Steve, Substance Exposed Newborns: New Federal Law Raises Some Old Issues, 

National Conference of State Legislatures: Children’s Policy Initiative, September 2004, pg. 3. 4Signed into Public Law (P.L. 111–320, CAPTA Reauthorization Act of 2010) on December 

20, 2010. Retrieved from https://www.congress.gov/bill/111th-congress/senate-bill/ 

3817?q=%7B%22search%22%3A%5B%22P.L.+111-320%22%5D%7D&resultIndex=1. 5Wilson, D. and Shiffman, John, ‘‘Helpless and Hooked,’’ December 7, 2015, http:// 

www.reuters.com/investigates/special-report/baby-opioids/. 

for intervening prior to the birth event, other agencies and providers must be responsible for identifying such infants during the prenatal period or at birth and providing mothers the treatment services that are needed. 

The committee report on H.R. 14 (2003) the House version of the Keeping Children 

and Families Safe Act, stated that the requirement was intended to ‘‘identify infants 

at risk of child abuse and neglect so appropriate services can be delivered to the 

infant and mother to provide for the safety of the child.’’ The authors of this bill 

called for . . . 

‘‘the development of a safe plan of care for the infant under which consideration may be given to providing the mother with health services (including 

mental health services), social services, parenting services, and substance 

abuse prevention and treatment counseling, and to providing the infant 

with referral to the statewide early intervention program funded under part 

C of the Individuals with Disabilities Education Act for an evaluation for 

the need for services provided under part C of such Act.2’’ 

Thus, the law intended that the function of Child Protective Services (CPS) is protecting a child who may be at increased risk of maltreatment, regardless of whether 

the State had determined that the child had been abused or neglected as a result 

of prenatal exposure.3

In 2010, the law was amended again to include the needs of infants born with and 

identified as being affected by illegal substance abuse or withdrawal symptoms resulting from prenatal drug exposure, or a Fetal Alcohol Spectrum Disorder.4 Recent 

attention generated in part by the nation’s current prescription drug and opioid epidemic has focused state agencies on the requirement that a Plan of Safe Care be 

implemented for these infants.5

On July 22, 2017, H.R. 4843, Infant Plan of Safe Care was signed into law under 

Title V, Section 503, of S. 524, Comprehensive Addiction and Treatment Act of 2016. 

The legislation requires the Plan of Safe Care to address the needs of both the infant and parent(s) while also increasing States’ accountability through monitoring 

by the U.S. Department of Health and Human Services (HHS) to better ensure 

States are complying with the CAPTA provisions. 

The changes in the law are highlighted on page 82. 

Defining Drug- and Alcohol-Affected 

One of the complicating factors in implementing the CAPTA provisions is that, at 

present, there is no clear definition of the term ‘‘affected by illegal substance abuse.’’ 

It is certainly easier to make that determination when an infant experiences a withdrawal syndrome. Yet, infants exposed to stimulants or alcohol without the full expression of Fetal Alcohol Syndrome may be ‘‘affected by’’ that exposure as evidenced 

by impaired growth, prematurity, or subtle neurodevelopmental signs that are more 

difficult to define in the newborn and infancy stages. 

We would suggest that States need to offer clarity on and define through State legislation or administrative policy how they are to define, identify, intervene and ensure 

the safety of infants and their families with prenatal substance exposure in the immediate post-partum period and through-out infancy. 

The language in the CAPTA legislation calls for a response to drug- and alcoholaffected infants, but does not specify how this should be defined. That leaves the 

definitional task up to States at this point. In the section of this paper on developing 

a Plan of Safe Care that follows, we reference assessment tools that were created 

81 

6McPherson M., Arango P., Fox H., et al., A new definition of children with special health 

care needs. Pediatrics. 1998;102(1 pt 1):137–140 [PubMed]. 7Many of the characteristics cited in this list are adapted from Messinger, D. and Lester, B., 

‘‘Prenatal Substance Exposure and Human Development’’ in Fogel, A. and Shanker, S. (2005) 

(Eds.), Human Development in the 21st Century: Visionary Policy Ideas from Systems Scientists. 

Council on Human Development, Bethesda, MD. 8The Encyclopedia of Children’s Health, Fetal Alcohol Syndrome. Accessed March 20, 2016 

from: http://www.healthofchildren.com/E-F/Fetal-Alcohol-Syndrome.html. 9Kocherlakota, P. (2014), Neonatal Abstinence Syndrome. Pediatrics 134(2). Accessed March 

25, 2016 from: http://pediatrics.aappublications.org/content/134/2/e547. 

in the late 1980s during the cocaine epidemic that are excellent tools to adapt as 

States define these issues. 

We would suggest the following definition for State policymakers’ and practitioners 

to refine: 

An alcohol- or other drug-affected infant is one in which there is any detectable physical, developmental, cognitive, or emotional delay or harm that is 

associated with parental action involving substance use or abuse. 

States may want to consider the use of medical fragility or Medically Fragile Infants 

when defining this population of infants, as this is consistent with the Maternal and 

Child Health Bureau definition of children with special health care needs (CSHCN); 

children who have or are at increased risk of a chronic physical, developmental, behavioral, or emotional condition and require health care and related services of a 

type or amount beyond that required by children generally.6 Appropriate interventions, including family-centered services and care coordination, should be considered 

in the context of this definition. 

Similar to the current CAPTA language, we do not suggest that this definition is 

grounds for substantiating child abuse or neglect. Specifically, a mother participating in medication-assisted treatment is not grounds for substantiated child abuse 

or neglect. 

Rather, a definition is warranted to assure that the full spectrum of intervention 

and supports are provided to ensure the safety of the infant and mother. Further, 

in the absence of immediate safety concerns, the supports are provided to the mother, infant and family to maintain the mother/infant bond. 

We would suggest pediatricians and other medical professionals are consulted for 

establishing the State’s definition. The following factors may be taken into account 

in developing that definition.7

In conjunction with known substance use during pregnancy: 

1. Signs of prenatal exposure detectable at birth and early infancy are assessed including: 

a. Facial characteristics of fetal alcohol syndrome 8

b. Withdrawal as defined by neonatal abstinence syndrome 9

c. Irritability 

d. Irregular and rapid changes in state of arousal 

e. Low birth weight 

f. Prematurity 

g. Difficulties with feeding due to a poor suck 

h. Irregular sleep-wake cycles 

i. Decreased or increased muscle tone 

j. Seizures or tremors 

2. Evidence through prenatal screening of mother’s substance use including alcohol, 

tobacco, illegal drugs, prescription drugs used non-medically, or legal use of marijuana in States with legal use, at any time during pregnancy or screening of the 

mother and infant at the time of birth. 

3. Mothers’ participation in a treatment program using medications as prescribed 

for an opioid use disorder or medical marijuana in those States in which medical 

marijuana is legal (again, inclusion of this group of mothers is to identify infants 

with possible prenatal substance exposure effects to ensure needed supports are 

provided to the family, not to classify this group of mothers as perpetrators of 

child abuse or neglect). 

Additional factors, such as previous child welfare history that indicates unresolved 

substance use issue and other potential risk factors, such as co-occurring mental 

82 

10 Child Abuse Prevention and Treatment Act, Reauthorization Act of 2010: https:// 

www.acf.hhs.gov/sites/default/files/cb/capta2010.pdf https://www.congress.gov/111/plaws/ 

publ320/PLAW-111publ320.pdf. 

health concerns, can be considered in developing the Plan of Safe Care. Refer to pg. 

16 for additional information. 

The bold-face text represents proposed changes from H.R. 4843, ‘‘Infant Plan of Safe 

Care Improvement Act’’ 

Section 103. NATIONAL CLEARINGHOUSE FOR INFORMATION RELATING TO 

CHILD ABUSE. [42 U.S.C. 5104] 10

a. ESTABLISHMENT.—The Secretary shall through the Department, or by one or 

more contracts of not less than 3 years duration let through a competition, establish a national clearinghouse for information relating to child abuse and neglect. 

b. FUNCTIONS.—The Secretary shall, through the clearinghouse established by 

subsection (a)— 

(5) maintain and disseminate information about the requirements of 

section 106(b)(2)(B)(iii) and best practices relating to the development of plans of safe care as described in such section for infants 

born and identified as being affected by illegal substance abuse 

or withdrawal symptoms, or a Fetal Alcohol Spectrum Disorder. 

Section 106. GRANTS TO STATES FOR CHILD ABUSE OR NEGLECTION PREVENTION AND TREATMENT PROGRAMS. [42 U.S.C. 5106a] 

A State plan . . . shall contain a description of the activities that the State will 

carry out using amounts received under the grant to achieve the objectives of this 

subchapter, including—. . . 

(B) an assurance in the form of a certification by the Governor of the State that 

the State has in effect and is enforcing a State law, or has in effect and is 

operating a statewide program, relating to child abuse and neglect that includes— 

(ii) policies and procedures (including appropriate referrals to child protection service systems and for other appropriate services) to address the 

needs of infants born with and identified as being affected by illegal 

substance abuse or withdrawal symptoms resulting from prenatal drug 

exposure, or a Fetal Alcohol Spectrum Disorder, including a requirement that health care providers involved in the delivery or care of such 

infants notify the child protective services system of the occurrence of 

such condition of such infants, except that such notification shall not 

be construed to— 

(I) establish a definition under Federal law of what constitutes child 

abuse or neglect; or 

(II) require prosecution for any illegal action; 

(iii) the development of a plan of safe care for the infant born and identified as being affected by illegal substance abuse or withdrawal symptoms, or a Fetal Alcohol Spectrum Disorder to ensure the safety and 

well-being of such infant following release from the care of 

healthcare providers, including through— 

(I) addressing the health and substance use disorder treatment needs of the infant and affected family or caregiver; 

and 

(II) the development and implementation by the State of monitoring systems regarding the implementation of such 

plans to determine whether and in what manner local entities are providing, in accordance with State requirements, referrals to and delivery of appropriate services 

for the infant and affected family or caregiver. 

(iv) procedures for the immediate screening, risk and safety assessment, 

and prompt investigation of such reports; . . . 

(xxi) provisions and procedures for referral of a child under the age of 3 

who is involved in a substantiated case of child abuse or neglect to 

early intervention services funded under part C of the Individuals 

with Disabilities Education Act (20 U.S.C. 1431 et seq.); . . . 

(d) ANNUAL STATE DATA REPORTS.—Each State to which a grant is made 

under this section shall annually work with the Secretary to provide, to the 

maximum extent practicable, a report that includes the following: 

83 

(15) The number of children referred to a child protective services system 

under subsection (b)(2)(B)(ii) [Note: this section is above related to notification to CPS and referrals to other appropriate services] 

(16) The number of children determined to be eligible for referral, and the 

number of children referred, under subsection (b)(2)(B)(xxi), to agencies 

providing early intervention services under part C of the Individuals 

with Disabilities Education Act (20 U.S.C. 1431 et seq.). 

(17)(A) The number of infants identified under subsection 

(b)(2)(B)(iii). 

(B) The number of infants for whom a plan of safe care was developed under subsection (b)(2)(B)(iii); 

(C) The number of infants for whom a referral was made for appropriate services, Including services for the affected family 

or caregiver, as may be necessary under subsection 

(b)(2)(B)(iii). 

Section 114. MONITORING AND OVERSIGHT. 

The Secretary shall conduct monitoring to ensure that each State that receives a grant under section 106 is in compliance with the requirements of 

section 106(b), which— 

(1) shall— 

(A) be in addition to the review of the State plan upon its submission 

under section 106(b)(1)(A); and 

(B) include monitoring of State policies and procedures required 

under (ii) and (iii) of section 106(b)(2)(B); and 

(2) may include— 

(A) a comparison of activities carried out by the State to comply with 

the requirements of section 106(b) with the State plan most recently approved under section 432 of the Social Security Act; 

(B) a review of information available on the Website of the State relating to its compliance with the requirements of section 106(b); 

(C) site visits, as may be necessary to carry out such monitoring; and 

(D) a review of information available in the State’s Annual Progress 

and Services Report most recently submitted under section 

1357.16 of title 45, Code of Federal Regulations (or successor regulations). 

The Need for Multi-Agency Support in Implementing CAPTA 

It is clear that child welfare agencies cannot be charged with the sole responsibility 

for responding to prenatal substance exposure and infants who are affected by prenatal substance use. In fact, while data are largely incomplete, only a small percentage of these families are identified and are referred to the child protection system. 

Child welfare agencies typically cannot intervene until birth, and many do not receive timely notifications of drug- or alcohol-exposed births from hospitals and medical providers. This occurs even though for a State to receive a CAPTA grant, the 

governor assures that the State is enforcing a complying State law or that the child 

welfare agency operates a program that ensures that health care professionals notify Child Protective Services when such infants are identified. 

A five-stage framework, set forth in a 2009 SAMHSA publication and included in 

the 2012 White House Office of National Drug Control Policy, specifies five stages 

which need to be part of comprehensive reform to effectively respond to pregnant 

women, their families and infants with prenatal exposure: 

(1) Pre-pregnancy public education to reduce substance use during pregnancy including tobacco, alcohol, and other drugs; 

(2) Prenatal screening and engagement of pregnant women in treatment when indicated; 

(3) Universal screening at birth to both deter substance use and to ensure infants 

who may be at increased risk and their families receive the intervention and 

supports that are needed to ensure their safety and well-being; 

(4) Screening, assessment and intervention during infant and toddler stages (0– 

3 years) to remediate any developmental concerns and early identification and 

support for pre-school developmental care and education (3–5); and 

84 

11 Young, N.K., Gardner, S., Otero, C., Dennis, K., Chang, R., Earle, K., and Amatetti, S. 

(2009), Substance-Exposed Infants: State Responses to the Problem. HHS Pub. No. (SMA) 09– 

4369, Rockville, MD: Substance Abuse and Mental Health Services Administration. 12Social Policy Report Volume 29, Number 1, 2015, ISSN 1075–7031, www.srcd.org/publications/social policy-report. 13Mental Health and Substance Abuse Essential Benefits. Accessed March 20, 2016 from 

https://www.healthcare.gov/coverage/mental-health-substance-abuse-coverage/. 14 Center for Medicaid and Medicare Services. The Mental Health Parity and Addiction Equity 

Act. Accessed March 24, 2016 from: https://www.cms.gov/CCIIO/Programs-and-Initiatives/ 

Other-Insurance-Protections/mhpaea_factsheet.html. 15There are several estimates on the gap between treatment need and receipt of treatment; 

most are in the range that 10–11% of persons who need treatment receive it. State of Health 

(2014), Despite Obamacare, Big Gap in Substance Abuse Treatment. Accessed March 25, 2016 

from: http://ww2.kqed.org/stateofhealth/2014/04/11/despite-obamacare-big-gap-in-substanceabuse-treatment/. 

(5) Ongoing support and age-appropriate interventions for children and adolescents (5–18) who may have neurodevelopmental or other effects.11

There is more than $400 billion of Federal expenditures that benefit children, which 

is allocated across many agencies.12 That array of resources underscores the critical 

roles that could be played by many agencies and providers at all five stages of this 

framework. Despite these resource allocations and potential expansion of substance 

use disorder treatment through the Affordable Care Act 13 and parity legislation requiring substance use and mental health treatment benefits on par with medical 

care provisions,14 there remains a dramatic gap in substance use disorder treatment,15 particularly for family-centered care and for medications needed to treat 

opioid use disorders. Therefore, States need a two-pronged approach to achieve a 

multi-agency response to prenatal exposure: 

(1) A State-level strategic plan that sets forth broad system policies and practices, 

addresses barriers to multi-agency responses, sets and monitors benchmarks 

to improve outcomes for these families, and ensures the support of agencies’ 

leadership. 

(2) Local-level implementation plans to ensure the necessary policies, practice and 

communication protocols are in place that ensure a continuum of services, including Plans of Safe Care for infants, their mothers, and their families. 

A State-level authority, reporting directly to the governor and charged with convening authority to work across agencies and providers, is needed to develop a strategic, multi-year response to the problems of prenatal substance exposure. The characteristics of that plan have been set forth below: it must be based on shared resources and cross-agency outcomes, rather than the province of a single agency. Its 

efforts must be monitored by legislative oversight and accountability to the governor’s budget authority. Clarifying the role of each participating agency requires 

measurable outcomes and specific timelines. 

At the local government level, a multi-disciplinary approach is needed that draws 

on professional expertise across agencies and includes an initial response and triage 

process that assesses risk and protective factors but does not presume child abuse 

or neglect. This multi-disciplinary approach includes the development of a team 

comprised of partnering agencies, including, but not limited to, hospitals, private 

medical providers, maternal and child health, including home visiting, substance 

abuse and mental health services, and early intervention services. 

The development of the Plan of Safe Care for each family must involve an assessment of the strengths of and challenges for the mother, her infant and her family. 

The plans are based on a preference that infants, mothers, and families can remain 

together. Reasons for placing an infant in protective custody would be based on immediate risk and safety concerns that are present and not mitigated by sufficient 

familial protective factors to provide for the infant’s safety. If the mother and infant 

are residing in or enter a residential treatment program, which can mitigate immediate safety concerns, removal of the infant from the mother’s care can be avoided. 

Regardless of the immediate placement decisions, the Plan of Safe Care must include specific follow up plans that support the family and focus on the longer-term 

well-being of the infant, mother and family. 

The following criteria may go beyond provisions in current CAPTA laws. Yet, it is 

the experience of Children and Family Futures staff and our recommendations that 

they are needed in developing and implementing Plans of Safe Care. Setting the 

State’s policy context for an approach to families affected by substance use disorders 

85 

is critical in providing guidance to local jurisdictions on the development and implementation of Plans of Safe Care. 

State Level Strategic Plans 

Charge to the Governor’s Council—A Governor’s interagency council could be 

charged with developing a comprehensive State Plan for implementation of Plans 

of Safe Care (PSC) to focus on reducing prenatal substance exposure and responding 

effectively to the needs of infants who are affected by prenatal substance exposure, 

to their mothers with substance use disorders and to their families. The charge of 

such entity is to develop, coordinate and support the child and family-focused service delivery system, emphasizing prevention, early intervention, and an array of 

community-based treatment services. The Governor’s Council would be tasked with 

evaluating the State’s existing legislation, policies and procedures that govern the 

State-wide implementation of the CAPTA provisions and determining if changes are 

needed in State laws or administrative rules. The Council would also be able to 

issue guidance to local jurisdictions that are charged with developing an effective 

response and Plan of Safe Care for infants and their families. 

Membership of the Governor’s Council—This council could include the Departments of Health, including Public Health and Maternal and Child Health (including 

Home Visiting Division), Substance Use Disorder prevention and treatment, Mental 

Health, Social Services (Child Abuse Prevention and Protection Services), Early 

Intervention (IDEA Part C), Developmental Disabilities, Administrative Office of the 

Courts, State Department of Education, Department of Budget and Finance, the 

Medicaid Director, as well as representatives from the State Hospital Association, 

State branches of the American College of Obstetricians and Gynecologists (ACOG) 

and State branches of the American Academy of Pediatrics (AAP) and the Insurance 

Commissioner’s office who has oversight of private health insurers in the State. Previously existing councils at the state level such as Children’s Cabinets or Early 

Childhood Councils could be tasked with this role if given adequate emphasis and 

greater priority to the issues of responding to prenatal exposure and its effects. 

Tasks of the Governor’s Council—At a minimum the plan could include: 

Prevention of Infants with Prenatal Substance Exposure 

• Strategies for raising awareness about the risks associated with alcohol, tobacco 

and other substance use during pregnancy. Specific strategies are developed to engage young women of childbearing age, including the adolescent and foster care 

population. 

• Strategies that focus on changing the culture regarding substance use during 

pregnancy so that women and families are supported to make healthy decisions 

and to receive appropriate intervention and treatment when needed. 

Screening, Assessment and Intervention during Pregnancy, at Birth and 

Childhood 

• Implementing universal screening for substance use during pregnancy using an 

evidence-based reliable tool. 

• Medicaid and private insurer requirements for coverage of screening during pregnancy and the minimum insurance benefit and payment rates (e.g., determining 

factors such as screening during prenatal care as a billable item in the Medicaid 

plan and at what rate and who can bill for that service) for treatment in accordance with Federal parity legislation and the Affordable Care Act. 

• Demonstrate that policies and protocols for the notification to CPS of an infant 

with prenatal substance exposure to CPS are developed with hospitals and medical providers responsible for the delivery of such infants. 

• A lead agency (e.g., a substance abuse treatment agency or the public health authority) is designated to ensure that multi-disciplinary and comprehensive assessments with the pregnant woman are conducted. However, the Medicaid agency, 

for example, may be charged with monitoring implementation of the assessments 

by determining that claims for routine prenatal care include billing codes for substance use disorder screening and assessments. 

• A lead agency must also be designated that has the responsibility to ensure that 

a Plan of Safe Care is implemented for infants identified with prenatal exposure, 

their mothers and families. While signs and symptoms of neurological effects of 

prenatal exposure would not be evident during pregnancy or in some cases at 

birth, the intent of designating which agency is responsible is to ensure that a 

plan is developed and that follow up with the family occurs to reduce longer-term 

effects and to foster the child’s development. 

86 

• A continuum of services for pregnant, post-partum and parenting women that acknowledges women’s treatment needs for evidence-based, family-centered and 

trauma-informed services and addresses barriers to accessing services for pregnant and parenting women. Steps to ensure that continuum include determining 

gaps in the availability of these services and the development of strategic plans 

to create such a continuum in States and communities. 

• Practice protocols for women in treatment, particularly those receiving medication-assisted treatment, to ensure effective communication between substance use 

disorder treatment agencies and physicians providing medications. 

• Policy and procedures to ensure home visiting or other programs that provide follow up to high risk infants include this population in their services and that all 

such infants receive those follow up services, regardless of their placement following discharge from the hospital (e.g., with mother and family or an out-of-home 

care placement). 

• A policy for automatic referral to and assessment of need by IDEA Part C providers for infants born affected by substance use disorders as specified by CAPTA 

for substantiated child welfare cases under the age of 3; exposed to and affected 

by illegal substance abuse or withdrawal symptoms resulting from prenatal drug 

exposure, or a fetal alcohol spectrum disorder. 

• The provision of evidence-based training to personnel across multiple domains, 

agencies, and disciplines to educate them on issues related to prenatal alcohol exposure and the diagnosis of fetal alcohol syndrome and the broad spectrum of associated disorders that fall within FASD. Criteria for diagnosing individuals who 

were exposed to alcohol and have neurodevelopmental deficits without any physical indicators of exposure have been presented in the DSM5 and should be communicated to health care providers. 

Data Collection and Monitoring 

• Identifying and resolving barriers to data collection and information sharing 

across agencies and systems; 

• Establishing state-wide performance measures and benchmarks with annual monitoring of the numbers, including the data points sufficient to monitor Plan of Safe 

Care implementation: 

• the prevalence of substance use during pregnancy; 

• pregnant women who screen positive for substance use; 

• the number of treatment admissions for pregnant women; 

• infants born with prenatal substance exposure; 

• notifications to child welfare of infants with prenatal exposure; 

• the number of infants and families with implemented Plans of Safe Care; 

• average hospital stays and costs for infants and mothers; 

• infants with prenatal exposure who remain at home and those placed in custody 

of the State; 

• the number of families receiving home visiting interventions or other on-going 

supportive services, including those covered by Plans of Safe Care; and 

• referrals to and receipt of early intervention services through IDEA Part C. 

• Assessment of data from hospitals and CPS on the needs of children and families 

to make appropriate policy updates. 

• State policies on the appropriate follow-up time frames for collecting the data 

needed to monitor child and family benchmarks based upon an agreed-upon set 

of outcomes and indicators. 

• Methods for evaluating costs of the continuum of care involved with Plans of Safe 

Care, including cost avoidance, in hospitals, child welfare, special education and 

other agencies. 

The Community Level Plan of Safe Care for an Individual Infant, Mother 

and Family 

Charge to the Community Team—A Community’s interagency team is charged 

with implementing the Governor’s Interagency Council’s decisions by developing a 

comprehensive practice protocol to focus on reducing prenatal substance exposure 

and responding effectively to infants who are affected by prenatal substance exposure, to their mothers with substance use disorders and to their families. The 

charge of such entity is to develop specific practice and communication protocols 

that coordinate the child and family-focused service delivery system, emphasizing 

prevention, early intervention, and an array of community-based treatment and support services for infants, children, and their families. 

Membership of the Community Team—This team would include, at a minimum, 

representatives from the Departments of Health, including Public Health and MaVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00090 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
87 

ternal and Child Health and Home Visiting Services, Substance Use Disorder Prevention and Treatment, Mental Health, Social Services (Child Abuse Prevention and 

Protection Services), Early Intervention Services, Developmental Disabilities, Juvenile/Dependency Courts, Office of Education as well as representatives from the 

Local Hospital Association, local representatives of the American College of Obstetricians and Gynecologists (ACOG) and local representatives of the American Academy of Pediatrics (AAP). These representatives should have decision-making authority to approve or provide needed services to children and families. 

Tasks of the Community Team—At a minimum the Community Team would establish community goals that: 

(1) Implement an interagency memoranda of agreement that codifies agency roles 

and responsibilities in reducing prenatal exposure and responding to its effects. 

(2) Focus on changing the culture regarding substance use during pregnancy so 

that women and families are supported to make healthy decisions and to receive appropriate intervention and treatment when needed. 

(3) Implement a continuum of care that ensures infants, mothers and families can 

remain safely together with any needed community supports focused on their 

well-being. 

(4) Ensure appropriate placement for infants who cannot stay in the custody of 

their birth mother with preference for kin providers when possible. 

(5) Ensure coordination and avoid duplication of services for infants, mothers and 

families. 

(6) Identify resources, barriers to care and gaps in services including availability 

of appropriate resources and the effects of current eligibility criteria. 

(7) Identify and address information and data sharing barriers including aggregating, monitoring and changing practice and policies based on the data. 

Practice Protocol Specific Tasks Include: 

• Developing efficient methods for health care providers to identify and notify specific personnel in the CPS agency in accordance with provisions in CAPTA or the 

prevailing State’s law that implements the CAPTA requirements. 

• Ensuring a prompt assessment of families for whom notifications are received by 

CPS to determine if there are immediate safety concerns and risk of future harm 

to the infant. 

• Determining which infants require a Plan of Safe Care. Options may include 

those with positive results on the universal implementation of the screening tool 

during prenatal care and repeating that measure in the month prior to the expected due date and at birth. A Plan of Safe Care should be triggered by positive 

results on the screen or a positive toxicological screen 30 days prior to birth or 

at birth, or enrollment of an infant under the age of one year in the substantiated 

child abuse and neglect caseload who may have not been detected at birth as experiencing prenatal substance exposure. 

• Establishing a procedure that assures families are included in the ‘‘assessment 

track’’ in communities with differential response or methods to assess for immediate safety concerns with the preference for maintaining the infant and mother 

bond. 

• Developing methods for the assessments to be conducted by and coordinated with 

relevant agencies and service providers. This coordination may take the form of 

a family team meeting in which multiple disciplines work with the family to ensure a comprehensive assessment of strengths and needs of the infant’s and mother’s physical, social-emotional health and safety needs. 

• Determining whether the community’s existing safety and risk assessment and 

intervention protocols are appropriate and sufficient for this group of families and 

enhancing those assessment tools and procedures as needed. 

• Making determinations on how to support infants and families for whom medication assisted treatment is being used in accordance with the mother’s treatment 

plan. 

• Determining the process for and content of an individual Plan of Safe Care which 

addresses the needs of the infant, mother and other family members identified by 

the multidisciplinary, comprehensive assessments. 

• Ensuring other caregivers receive medical information, training and support to 

appropriately care for infants with prenatal exposure prior to discharge from the 

hospital when such infants will not be released to the care of his/her mother and 

family. 

• Determining the appropriate timing for the development of the Plan of Safe Care 

with a preference that plans are developed with families prior to the infant’s birth 

88 

so that the family is supported and there is communication among health providers, substance use disorder treatment agencies, child welfare and other community supportive agencies. 

• Ensuring Plans of Safe Care are consistent with the individual family support 

plans that are required for all children accepted by early intervention services 

under Part C of the Individuals with Disabilities Education Act (IDEA). 

• Developing the process for ensuring that families who are determined to have insufficient protective capacity to ensure the safety of the baby with prenatal substance exposure receive prompt investigation services by CPS. 

• Implementing policies that ensure the infant’s safety plan includes a safety and 

risk assessment of the home environment, community and family support, mother’s recovery status and ongoing treatment needs (including her need and receipt 

of medication assisted treatment) as well as other health care needs in appropriate medical homes, and infants’ health, developmental, well-being and safety 

needs. 

Plans of Safe Care 

Specific definition on what was to be included and who was to develop, implement 

and monitor Plans of Safe Care were not specified in the 2003 and 2010 amendments to CAPTA. While legislative intent in those changes to CAPTA included care 

for the infant’s mother, recognizing that her care and safety of the infant are intertwined, in practice, it does not seem that Plans of Safe Care have been consistently 

implemented. 

Guidance on these questions was provided in the Children’s Bureau’s Child Welfare 

Policy Manual, in response to a question that was posed on September 27, 2011. 

The question states: 

Which agency is responsible for developing the plan of safe care and what 

is a plan of safe care, as required by section 106(b)(2)(B)(iii) of the Child 

Abuse Prevention and Treatment Act (CAPTA)? 

Answer: The statute does not specify which agency or entity (such as hospitals or community-based organizations) must develop the plan of safe 

care; therefore, the State may determine which agency will develop it. The 

plan of safe care should address the needs of the child as well as those of 

the parent(s), as appropriate, and assure that appropriate services are provided to ensure the infant’s safety. There may be Federal confidentiality restrictions for the State to consider when implementing this CAPTA provision. 

(http://www.acf.hhs.gov/cwpm/programs/cb/laws_ policies/laws/cwpm/ 

qacumm.jsp) 

Legal and Related References*Child Abuse Prevention and Treatment Act 

(CAPTA), as amended (42 U.S.C. 5101 et seq.) section 106(b)(2)(B)(iii). 

As proposed in 2016 legislation, Plans of Safe Care are specifically intended to provide the needed services and supports for infants, their mothers, and their families. 

The 2016 proposed changes to CAPTA specifically state that services for the mother 

and family are included in the Plan of Safe Care. 

At the time of birth, assessing risk to determine if the infant can go home safely 

is paramount and is a critical component of the comprehensive assessment process 

(safety factors generally included in CPS investigations are clarified below). 

However, the Plan of Safe Care moves beyond seeking information to substantiate 

allegations of child abuse or neglect. It specifically incorporates the mother’s (and 

potentially the father’s) need for treatment for substance use and mental disorders, 

appropriate care for the infant who may be experiencing neurodevelopmental or 

physical effects or withdrawal symptoms from prenatal substance exposure, and 

services and supports that strengthen the parent’s capacity to nurture and care for 

the infant and to ensure the infant’s continued safety and well-being. The plan also 

ensures a process for continued monitoring of the family and accountability of responsible agencies such as substance use disorder treatment, home visiting, public 

health, health care providers for the infant and mother. 

The Plan of Safe Care would: 

(1) Be based on the results of a comprehensive, multidisciplinary assessment 

that is coordinated across disciplines to determine the infant’s and mother’s 

89 

16 An example of a comprehensive assessment instrument is modeled after the Newborn Assessment developed in Kansas City and adapted by Los Angeles County which can be found at: 

http://ican4kids.org/documents/CANProtocol/ap15.Hospital.pdf. The Kansas City, MO example can be located at: https://dss.mo.gov/cd/info/cwmanual/section2/ch6/sec2ch6sub2.htm. 

physical, social-emotional health and safety needs, as well as the mother’s 

strengths and parenting capacity.16

(2) Assess immediate safety factors and risk of future maltreatment, including: 

• Safety: Deciding if a child is in danger of being hurt right now (Decision 

to remove). 

• Risk: Determining the possibility that a child may be hurt in the future 

(Decision to open a child welfare investigation case). 

• Strengths: Assessing the family’s positive qualities and resources available 

to care for the child. 

• Protective Capacities: Determining if the parent has the ability or support 

system available to provide an environment that keeps children free from 

harm. Factors to consider when assessing safety and risk include: 

• Mothers’ or fathers’ child welfare-related history that indicates unresolved 

substance use disorders related to a prior case of child abuse or neglect: 

• Prior abuse and/or neglect reports related to substance use. 

• Siblings’ substance exposure prenatally or in the family environment. 

• Evidence of co-occurring mental health concerns that may affect immediate parenting capacity such as post-partum depression and substance 

use. 

• Mother’s willingness to seek treatment and parenting instruction. 

• Family environmental challenges related to parental substance use disorders. Access to sufficient income and resources, employment history, and 

lack of health access to a medical home can all interact with substance use 

disorders, and can result in effects on infants in the home, including neglect. It is clear that poverty alone does not connote an immediate safety 

concern, rather it is the family’s access to sufficient resources in combination with substance use disorders that may place an infant at higher risk. 

For additional information, see Factors Commonly Included in Assessments 

Conducted by Child Protective Services on pg. 20. 

(3) Be completed when possible prior to the birth of the infant to facilitate engagement of parent(s), and communication among providers; or, when not 

possible, prior to discharge of the infant from the hospital; 

(4) Designate a lead agency responsible for oversight and monitoring of the plan 

including both needs of the infant and needs of the mother including treatment, mental health and other services; 

(5) Be both child- and parent-focused, recognizing that parents’ ability to do 

their part in carrying out such a plan will be as equally important as any 

role for public or private services; 

(6) Specify with whom the child will be discharged and ensure protective capacity of the parents and/or other family members are sufficient to care for the 

infant; 

(7) Include provisions for frequency and the entity responsible for follow up with 

families including providing home visiting services for all families with a 

Plan of Safe Care; 

(8) Specify a timeline for follow-up and monitoring; 

(9) Specify the details of referral of the child to developmental intervention; and 

(10) Be available online to relevant agencies with the appropriate privacy safeguards. 

Plans of Safe Care should include the provision of services and supports that address the infant’s and mother’s physical, social-emotional health and safety needs, 

and foster the mother’s and family’s capacity to nurture and safely care for the infant. Many of the factors to be included in the plan are identified by various professionals throughout the mothers’ pregnancy, at the time of birth and at discharge 

from the hospital. For example, a mother’s post-partum care would typically be included in the hospital discharge plan. It is clear that many of the factors included 

in assessments, case planning and treatment plans are included in a Plan of Safe 

Care and are included in processes conducted in communities at present. 

Yet, at present there is not sufficient communication among professionals to ensure 

that families of infants with prenatal substance exposure have sufficient supports 

and that infants with prenatal substance exposure have follow-up services to ensure 

90 

17 Adapted from the American Humane Association, Breakthrough Series on Risk and Safety. 

Accessed March 20, 2016 from: http://www.americanhumane.org/assets/pdfs/children/practice-cards/bsc-defining-safety-and-risk-1.pdf. 

their safety. Thus the plan requires the collaborative effort among community agencies and the family that ensures efficient communication across service systems, 

agencies and professionals. 

Several key aspects differentiate a Plan of Safe Care for an infant with prenatal 

substance exposure, the mother and family from a typical safety plan developed by 

child welfare services which assesses for factors that have already occurred in a 

family and have been brought to the attention of the child welfare agency. Clearly, 

if it is determined that immediate safety factors are present and protective capacity 

is not clear to provide for the infant, the family should be moved into the investigation caseload of child protective services. In such instances, it is imperative that the 

infant’s caregivers (e.g., kin, foster parents) also be involved in discharge planning 

and caring for an infant with any medical concerns, as is likely for infants with Neonatal Abstinence Syndrome or Fetal Alcohol Syndrome. 

In the following table, the assessments conducted to develop the Plan of Safe Care 

are delineated followed by the risk and protective factors that would be considered 

for families in which the child is not able to safely remain in the family’s custody.17

COMPONENTS OF PLANS OF SAFE CARE FOR INFANTS, MOTHERS AND FAMILIES AFFECTED BY 

PRENATAL SUBSTANCE EXPOSURE SERVICES AND SUPPORTS 

DOMAINS 

Mother 

Health • Pregnancy and Post-partum care 

• Medical home is designated that is consistent with the family’s insurance plan and has 

responsibility for the primary care needs for the mother and family; Medical homes are 

often designated in States with Medicaid managed care plans 

• Medication management is assessed and the Medical Home provider has responsibility 

to oversee including liaison with methadone or other medications used in assisting 

treatment 

• Pain management 

• Contraception and pregnancy prevention 

• Support with breastfeeding 

Substance Use and Mental 

Disorders Prevention, Intervention and Treatment 

• Timely access to treatment is ensured by referrals and appropriate feedback across 

agencies 

• Engagement and retention outreach services and on-going recovery supports 

• Appropriate treatment (gender-specific, family focused, accessible, medication assisted 

treatment, trauma) 

• Mental health services including symptoms of depression and anxiety 

• Intervention for domestic partner and family violence 

• Substance use and mental health treatment for partner and other family members 

Parenting/Family Support • Coordinated care management 

• Home visiting follow-up services are provided including infant care, parent/infant bonding, nurturing parenting guidance and skill development, safe sleep practices, and maternal support 

• Child care in developmentally appropriate programming when needed by the family 

• Income support and safety net benefits eligibility determination and employment support 

• Safe and stable housing determinations are made 

• Need for transportation is assessed 

Infant 

Health • Linkage to a medical home for infant primary health care is provided 

• Need for high-risk infant follow-up care is determined 

• Referral to specialty health care as needed 

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COMPONENTS OF PLANS OF SAFE CARE FOR INFANTS, MOTHERS AND FAMILIES AFFECTED BY 

PRENATAL SUBSTANCE EXPOSURE SERVICES AND SUPPORTS—Continued 

DOMAINS 

Infant 

Development • Developmental screening and assessment 

• Referral to developmental pediatrician as needed 

• Referral to early intervention services for assessment, services and follow up 

• Early care and education program to ensure developmental intervention and supports 

are provided by a program with expertise in young children who experienced prenatal 

substance exposure 

Factors Commonly Included in Assessments Conducted by Child Protective Services * 

Immediate Safety Factors • Physical harm or threat of children in the home 

• Previous maltreatment of other children 

• Sexual abuse allegations of other children in the home 

• Failure to protect older children from harm 

• Questionable explanation of injuries 

• Refuses access to monitor the child or threatens to take the child out of the CPS agency’s jurisdiction; immediate needs of child not met 

• Hazardous living conditions 

• Impairment by substance abuse and parent is not active in treatment or recovery 

• Domestic violence 

• Child is danger to self/others 

• Emotional/developmental/cognitive Impairment 

Risk of Child Neglect Factors • Current complaint includes neglect of other children in home 

• Prior investigations 

• Household has previously received CPS 

• Number of children involved in the child abuse/neglect incident 

• Age of younger child in household 

• Primary caretaker provides physical care inconsistent with child needs 

• Primary caretaker has a past or current untreated mental health problem 

• Primary caretaker has historic or current alcohol or drug problems and is not actively in 

treatment or recovery 

• Characteristics of children in the household 

• Unsafe housing 

Risk of Child Abuse Factors • Current complaint is for child abuse of other children in the home 

• Number of prior abuse investigations 

• Household has previously received CPS 

• Prior injury to a child resulting from child abuse or neglect 

• Primary caretaker’s assessment of incident 

• Domestic violence in the household in the past year 

• Primary caretaker characteristics 

• Primary caretaker has a history of abuse or neglect as a child 

• Secondary caretaker has historic or current alcohol or drug problem and is not actively 

in treatment or recover 

• Characteristics of children household 

* Adapted from the American Humane Association (2016). 

(93) 

COMMUNICATIONS

AMERICAN ACADEMY OF PAIN MANAGEMENT ET AL. 

975 Morning Star Dr., Suite A, Sonora, CA 95370 

T: 209–533–9744 F: 209–533–9750 E: aapm@aapainmanage.org W: www.aapainmanage.org 

March 2, 2015 

Senate Committee on Finance 

Rm. SD–219 

Dirksen Senate Office Bldg. 

Washington, DC 20510–6200 

Re: Examining the Opioid Epidemic: Challenges and Opportunities; hearing held 

February 23, 2016 

Dear Chairman Hatch, Ranking Member Wyden, and Honorable Members of the 

Committee: 

On behalf of the American Academy of Pain Management, and with the full support 

of the undersigned organizations, this letter is in response to the Committee’s hearing held on February 23, 2016 entitled ‘‘Examining the Opioid Epidemic: Challenges 

and Opportunities.’’ Collectively, we recognize the challenges involved in addressing 

two major public health crises, namely, inadequate treatment for pain, and prescription medication abuse, and to that end, have been heavily involved in both national 

and state-level efforts to address both health concerns. We thank you for addressing 

these issues, and respectfully offer the following list of possible ways that the Centers for Medicare and Medicaid Services (CMS) could address these dual issues in 

a balanced and thoughtful approach that aims to improve care for those with pain 

and other chronic conditions while improving safety for all Americans. 

To date, policy solutions to address the opioid crisis have focused on opioid misuse, 

focusing on prescription practices and treatments for people after they have become 

addicted to opioids. These issues are important and deserve attention; however, a 

long-term solution to the opioid epidemic will fall short unless policies are broadened to address the underlying public health crisis of chronic pain. Policy solutions 

to reduce the supply of opioids, will not by themselves end this crisis—we must also 

address why there is a demand for the use of addictive medications in the treatment 

of chronic pain at all. This was highlighted in the last month by the President declining to endorse a sweeping proposal by our nation’s governors to limit the amount 

of opioid medication that doctors can prescribe, saying such a policy would be unfair 

to rural Americans who don’t have easy access to integrated pain care or addiction 

treatment programs. 

The country’s current state of pain care, research, education and prevention is woefully inadequate, as highlighted by the 2011 Institute of Medicine study, Relieving 

Pain in America. The study found that more than 100 million American adults suffer from chronic pain, at a cost of approximately $600 billion annually in direct medical expenses and lost productivity. Yet, our federal agencies continue to invest poorly in chronic pain research, which averaged just 4 cents per patient in 2015. The 

result is that the field of chronic pain treatment is ‘‘strikingly deficient’’ of highquality evidence to assess benefits and risks, according to the Food and Drug Administration, leaving clinicians with little evidence for making informed decisions 

for effective treatment for patients’ chronic pain. It is extremely common for patients to spend months to years consulting multiple clinicians and experimenting 

with a host of treatments to find solutions that will help to reduce painful symptoms 

without intolerable side effects. 

94 

1Department of Health Care Policy and Financing. Summary of the Second Annual Evaluation Report for HCBS–SCI Waiver. 2014. Print. 

Prescription medications play a crucial role in treating and curing illness, alleviating pain, and improving quality of life for millions of Americans. Unfortunately, 

these medications can also be abused—and policies to address this abuse often adversely impact those who truly require these medications in order to live full, 

healthy, and productive lives. A balance is necessary to ensure that individuals who 

legitimately need prescription medications for pain and other conditions receive 

them, but that such medications are not diverted for improper purposes. The following suggestions provide a balanced response to both epidemics: chronic pain and 

prescription medication abuse. 

Opportunities to Reduce Prescription Medication Misuse, Abuse, and Diversion While 

Improving Care: Eleven Recommendations 

1. In order to provide methods and measures to guide progress towards 

achieving improved prevention and management of pain in the United 

States, CMS should fund research that evaluates longitudinal pain outcomes among Medicare, Medicaid, and other beneficiaries. A core responsibility of public health agencies is assessing the significance of health problems 

in the population. At present, data are needed on the prevalence, onset, course, 

impact, and outcomes for most common chronic pain conditions in order to guide 

policies and initiatives of federal and state governments, and of health care organizations and insurers. Improvement in data methods and measures will (1) 

guide efforts to reduce the burden of chronic pain through more accurate estimates of the prevalence and impact, (2) provide standard methods for analysis 

of electronic health care data related to pain treatment, and (3) develop a system of metrics for tracking changes in pain prevalence, impact, treatment, and 

costs over time that will enable assessment of progress, evaluation of the effectiveness of interventions at the population health level. This is one of the key 

long-term recommendations of the National Pain Strategy, which was developed 

by six federal agencies and more than 80 well-respected experts from the medical-scientific, public, private, federal, patient, and advocacy communities, under 

the direction of the Department of Health and Human Services. If we are to 

adequately address prescription overdose deaths and substance use disorder in 

America, we must not ignore the millions of people who need better pain care. 

We must develop safer and more effective ways to treat pain. Given the availability of de-identified medical data through electronic medical records, CMS 

has the opportunity to further this goal by funding longitudinal studies that examine the use of non-pharmacological treatments by Medicare receipts, and the 

impact of those treatments on subsequent care. 

2. The Center for Medicare and Medicaid Innovation (CMMI) should be required to set aside certain funds to establish demonstration projects related to interdisciplinary and integrated pain care. An example of a demonstration project highlighting the benefits of integrative care can be found in 

Colorado. Since 2009, the Colorado Department of Health Care Policy and Financing has been tasked with creating and evaluating a Home and Community 

Based Services Waiver for the Persons with Spinal Cord Injury (SCI Waiver) 

Pilot Program. According to the department, there are initial signs of positive 

trends regarding cost-saving, but without additional research, larger sample 

sizes, and changes to the evaluation methodology, the evidence remains anecdotal. Personal stories from participants include describing minimal use or complete abstinence from previously used medications for pain, due to the addition 

of massage, acupuncture, and chiropractic care. The department is in support 

of the renewal of the SCI Waiver and believes that additional time combined 

with waiver modifications will significantly improve the data available; further, 

with additional program experience and some modifications to the evaluation 

methodology, future reports will provide more insight and actionable recommendations regarding the SCI Waiver program and its benefits.1 Colorado’s 

legislature agreed to continue support of this promising pilot program with the 

passage of CO SB 11 (2015), extending the repeal date of the pilot program to 

2020. CMMI could greatly improve the outcomes of this study and many more 

like it, and thus improve health care and cost-savings, by funding additional, 

and larger, demonstration projects measuring the impact of the type of integrated pain care called for by the 2011 IOM report and the draft National Pain 

Strategy. 

95 

3. CMS should allow a greater number of physical and occupational therapy sessions annually, and should allow patients to access physical and 

occupational therapy without first acquiring a referral or prior authorization. Physical and occupational therapies are extraordinarily effective at 

preventing and treating musculoskeletal pain syndromes, in particular, and 

chronic pain conditions in general. Medicare’s coverage for these therapies is inadequate in terms of the number of sessions covered, and requires that a physician serve as a gatekeeper. Physical and occupational therapists are highly 

trained professionals who are capable of evaluating a patient’s likelihood of benefitting from the treatments they offer. Requiring a gatekeeping appointment 

with a physician or a prior authorization process only delays a patient’s access 

to treatment and, in some cases, may deny that patient access to an effective 

and cost-effective treatment that minimizes the need for opioid analgesics. Removing those barriers seems to us to be a logical step. 

4. CMS should provide total reimbursement—and collect long-term efficacy and cost data—for at least the following five non-pharmacologic 

treatments: chiropractic and osteopathic manipulation, acupuncture, 

massage therapy, biofeedback, and yoga. Nearly every recent effort to reduce prescriptions of opioid analgesic medications has been accompanied by a 

provision which urges the use of alternative treatments to treat pain. However, 

many people cannot access these treatments due to lack of insurance coverage. 

This is true for Medicare, which provides only limited coverage for chiropractic 

and osteopathic manipulations from the list above. These five key treatments 

are recognized by the Department of Defense and the Veterans Health Administration as effective treatments for chronic pain, are included in the DoD/VHA 

pain management guidelines, and are covered services in DoD/VHA facilities. 

5. CMS should provide reimbursement to providers of behavioral health 

services for the prevention, treatment, or management of physical 

health problems. As noted above, many efforts to reduce prescriptions of 

opioid analgesic medications have been accompanied by language that urges the 

use of alternative treatments to treat pain. Behavioral health care providers are 

well-equipped to teach patients skills and techniques in how to better manage 

and cope with pain; however, these practitioners are often not reimbursed for 

their services when they use proper diagnoses and Current Procedural Terminology (CPT) codes. We urge that CMS be required to reimburse these practitioners for these services utilizing the behavior assessment and intervention reimbursements codes 96150 to 96154, or their successor codes, under the CPT 

coding system. 

6. Medical residencies funded by Medicare and Medicaid should include 

adequate content on pain and substance abuse. Pain consistently ranks as 

the top reason that people visit a health care provider, and undertreated and 

mistreated acute pain often causes patients to develop chronic pain. Yet, most 

health care providers have received little to no formal education in pain management. Substance use disorders also are relatively common, and coverage of 

that topic in medical training is likewise lacking. The 2011 Institute of Medicine 

(IOM) report, Relieving Pain in America, documented that the median medical 

school content on pain management is only 9 hours, while a recent survey of 

medical schools by the Association of American Medical Colleges found a median of only 5 hours dedicated to substance use disorders. Through its support 

of medical residencies, CMS has the unique opportunity to provide the health 

care providers of tomorrow with tools that will help them to properly and effectively treat pain and reduce substance abuse and overdose deaths as they treat 

patients over the course of their careers, producing hugely positive effects on the 

public welfare. 

7. To improve education for providers already in practice, CMS should require completion of the three hour Risk Evaluation and Mitigation 

Strategy (REMS) program related to extended release and long-acting 

opioid analgesic medications as a condition of participation in Medicare. While the Food and Drug Administration (FDA) mandated that 3 hour 

REMS courses be offered to prescribers a number of years ago, there was no 

corresponding mandate for prescribers to take the REMS course. Consequently, 

completion rates have been low. These REMS courses have the potential to arm 

health care providers with much needed strategies for preventing and addressing substance abuse, but they cannot do so if no one is taking them. This effort 

to educate prescribers would be simple to implement for three reasons: (1) the 

REMS programs have already been developed and implemented; (2) CMS is in 

96 

2Twillman, R., PAINS Project. 2013. Prescription Monitoring Programs. (Policy brief 2). Retrieved from 

http://www.painsproject.org/wp/wp-content/uploads/2014/04/pains_policy_brief_2.pdf. 

the same department as FDA, which oversees REMS programs; and (3) this requirement could be implemented by a change in rules and regulations, and 

would not require legislation. The other mechanism that has been discussed as 

a means of mandating REMS education is linking REMS completion to Drug 

Enforcement Administration (DEA) registration renewal, but doing that would 

require legislation and would involve a law enforcement agency in the regulation of medical education, a change that would be unprecedented and, we believe, inappropriate. 

8. Medicare should contact known prescribers and dispensers in the event 

that a patient overdoses on any controlled substance. It recently came to 

light that in nearly all cases in which a patient has experienced an opioidrelated overdose, patients were, shortly thereafter, given additional prescriptions for opioid analgesic medications. This is due, in large part, to the fact that 

prescribers were completely unaware that the overdose event had occurred. 

While overdoses can occur for numerous reasons, some having nothing to do 

with substance abuse, it is vital that the overdose victim’s health care provider 

is made aware of an overdose to enable completion of a thorough evaluation of 

the patient and any necessary adjustments to the patient’s treatment plan to 

address the underlying reasons for the overdose event. It would also be important to ascertain the substance(s) that led to the overdose to determine if these 

were licit or illicit so proper treatment could be determined and initiated. Medicare, by virtue of its coverage of medical services, should be able to identify 

these events and alert healthcare professionals who are providing care for these 

patients. 

9. When a prescriber writes a prescription for a controlled substance for 

a Medicare or Medicaid patient, they should be required to check the 

prescription monitoring program (PMP) prior to writing the initial prescription and regularly thereafter, at least annually. We routinely advocate for the regular use of PMPs by prescribers and dispensers, as they have 

the ability to be extremely valuable healthcare delivery tools. As healthcare delivery tools, PMPs can provide three benefits: (1) Reassurance that patients are 

using controlled substances as prescribed, allowing providers to prescribe and 

dispense as needed with less anxiety; (2) Identification of behaviors suggestive 

of a substance abuse problem, leading providers to more thoroughly assess patients and obtain appropriate treatment where indicated; and (3) Provision of 

a complete record of a patient’s controlled substance prescribing history, enhancing patient safety by enabling a provider to avoid potentially deadly combinations of medications.2 To best achieve all of these objectives, heath care providers must be provided with an understanding of the full spectrum of controlled substances a patient is taking, as far more medications than just opioid 

analgesics and benzodiazepines can have serious side effects, potential for 

abuse, and interactions with one another. If PMPs provide prescribers and dispensers with comprehensive information, and if providers check the PMP upon 

each initial visit from a patient, they should essentially be able to put a stop 

to simultaneous prescribing by multiple providers. The periodic checks that we 

suggest for ongoing patients will help to ensure that patients with legitimate 

medical needs for controlled substances continue to use their medication safely 

and effectively and that no medications, potentially prescribed by multiple providers, will negatively interact with one another. 

10. Medicare Part D should consider implementing a policy similar to that 

proposed in New York Assembly Bill 8601 (2016), which provides that 

the initial prescription or dispensing of a controlled substance for 

acute pain shall be limited to a small supply (7 days, for example), but 

then goes on to prohibit the imposition of an additional health insurance copayment if a subsequent prescription is issued for an aggregate 

of not more than a 30 day supply of such controlled substance. Anecdotally, we hear stories about people who only use a few, if any, of their prescribed opioids during an acute pain episode. We believe that in acute pain scenarios, dispensing fewer pills initially, with an option to fill the rest if needed, 

would allow people with pain to have access to needed medications, while also 

addressing the problems associated with an abundance of unneeded medications 

that can be potentially diverted. What’s more, in theory, this would save insurVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00100 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
97 

ers a great deal of money by only providing the number of pills needed to address serious acute pain. However, we admit that this proposal is a bit of a 

work around, as 21 CFR § 1306.13 does not allow for any partial fills of controlled substance prescriptions, which is why this proposal contemplates two 

prescriptions. Ideally, we would urge the DEA to change this regulation so as 

to allow for partial fills of controlled substance prescriptions. 

11. CMS should research post-operative pain and opioid use in order to 

identify how many pills are actually being used and are needed by this 

population. This could be done (1) through direct grants to researchers; or (2) 

as a part of the scope of work for Medicare Quality Improvement Organizations. 

As with acute traumatic pain, we often hear of post-operative patients being 

prescribed large amounts of opioid analgesic medications that they do not, ultimately, end up needing. Unfortunately, we currently have no way of knowing 

how much medication these patients are taking, and for how long they are needed, after the patients are released from the hospital. Studies would help to determine if post-operative patients, or more specifically, which post-operative patients, may be good candidates for smaller initial prescriptions of pain relieving 

medications. 

The undersigned stakeholders view these suggestions as vital components of a comprehensive approach to addressing the intertwined public health crises of undertreated pain and prescription medication abuse. 

Sincerely yours, 

American Academy of Pain Management 

Chronic Pain Research Alliance 

Foundation for Peripheral Neuropathy 

Global Healthy Living Foundation 

International Pain Foundation 

Interstitial Cystitis Association 

PAINS Project 

Reflex Sympathetic Dystrophy Syndrome Association 

The Pain Connection 

TMJ Association 

U.S. Pain Foundation 

AMERICAN ACADEMY OF PAS (AAPA) 

2318 Mill Road, Suite 1300 

Alexandria, Virginia 22314 

P 703–836–2272 

F 703–684–1924 

aapa@aapa.org 

www.aapa.org 

Statement for the Record 

On behalf of the more than 108,500 nationally-certified PAs (physician assistants) 

represented by the American Academy of PAs (AAPA), we appreciate the Senate Finance Committee’s interest in addressing the relationship between the nation’s 

opioid epidemic and the Medicare program, as well as the unique needs of families 

who are dealing with opioid addiction. AAPA believes combating this crisis will require an ‘‘all hands on deck’’ approach, and we look forward to working with the 

Committee as it examines these important issues. 

Every day, over 60 Americans die from an opioid-related overdose. According to the 

Substance Abuse and Mental Health Services Administration (SAMHSA), in 2014, 

1.9 million Americans over 12 years of age were addicted to prescription painkillers 

and 586,000 were addicted to heroin. While changes have been made to curb prescription drug abuse at both the healthcare provider and drug manufacturing level, 

they have had little impact on the overall epidemic. Worse, it appears that limiting 

the ability to access these drugs has led to a dangerous, unintended consequence: 

it has become cheaper and easier for many individuals who are dependent on 

opioids to turn to heroin to achieve similar effects. Yet, it is crucial to remember 

that there are many Americans who suffer from chronic pain, for whom access to 

opioids and hydrocodone products are necessary to effectively manage their symptoms. The majority of patients use these drugs without incident. AAPA believes a 

fine line must be maintained between fighting opioid abuse and ensuring patients 

who are in need of pain management are able to access it. 

98 

Accordingly, AAPA appreciates Congress’s work to combat the abuse, diversion, 

morbidity, and mortality associated with the misuse of opioids that is devastating 

families and communities across our nation while still ensuring access to these 

medications. We also support Congress’s desire to stop opioid addiction before it 

starts through the use of safe prescribing practices, patient monitoring, and screening for potential abuse. Unfortunately, federal healthcare programs like Medicare 

Part D have become targets for fraud and abuse, due in large part to a lack of continuity of care for Part D beneficiaries. In particular, there appears to be a need 

for better prescription drug monitoring in this population, as well as the establishment of patient review and restriction programs. AAPA believes PAs—who in many 

communities may be Medicare beneficiaries’ sole healthcare provider—must be included in these programs so they may provide the most appropriate care for their 

patients. 

We are also pleased the Committee is examining the effects of opioid abuse on families. AAPA supports the use of medication-assisted treatment for individuals who 

are struggling with opioid addiction, and we believe early intervention in these situations is vital, particularly when children are involved. However, we also believe the 

current epidemic will not improve without enlisting the help of additional providers 

to treat those who are addicted to opioids. In light of the current shortage of providers specializing in addiction medicine, AAPA believes PAs should be part of the 

solution to this problem. 

PA Education and Practice 

PAs receive a broad medical education over approximately 27 months which consists 

of two parts. The didactic phase includes coursework in anatomy, physiology, biochemistry, pharmacology, physical diagnosis, behavioral sciences, and medical ethics. This is followed by the clinical phase, which includes rotations in medical and 

surgical disciplines such as family medicine, internal medicine, general surgery, pediatrics, obstetrics and gynecology, emergency medicine, and psychiatry. Due to 

these demanding rotation requirements, PA students will have completed at least 

2,000 hours of supervised clinical practice in various settings and locations by graduation. 

The majority of PA programs award a master’s degree. PAs must pass the Physician 

Assistant National Certifying Examination and be licensed by a state in order to 

practice. The PA profession is the only medical profession that requires a practitioner to periodically take and pass a high-stakes comprehensive exam to remain 

certified, which PAs must do every 10 years. PAs must also complete 100 hours of 

continuing medical education (CME) every 2 years. 

PAs practice and prescribe medication in all 50 states, the District of Columbia, and 

all U.S. territories with the exception of Puerto Rico. They manage the full scope 

of patient care, often handling patients with multiple comorbidities. In their normal 

course of work, PAs conduct physical exams, order and interpret tests, diagnose and 

treat illnesses, assist in surgery, and counsel on preventative healthcare. The rigorous education and clinical training of PAs enables them to be fully qualified and 

equipped to manage the treatment of patients with opioid addiction. 

PA Prescribing Authority and AAPA Response to the Opioid Epidemic 

PAs are currently permitted to prescribe up to Schedule III controlled substances 

in 48 states and DC; 41 states and DC authorize PAs to prescribe Schedule II drugs. 

PAs frequently work with patients who struggle with opioid dependency. While 

some PAs may choose to specialize in addiction medicine, there are also approximately 30,000 PAs practicing as primary care providers on the ‘‘front lines’’ of patient care in hospitals, private practices, community health centers, rural health 

clinics, non-federally qualified public or community health clinics, prisons, behavioral healthcare facilities, and free clinics, where they commonly encounter patients 

who present with or are at risk of opioid addiction. This care is especially critical 

in rural and medically-underserved areas, where PAs may serve as the only primary 

care clinician or in areas where PAs own their own medical practices. 

AAPA has been proactive in ensuring PAs have access to CME and other coursework related to safely prescribing opioid medications, as well as the screening, prevention and management of prescription drug misuse. AAPA is an active partner 

in the Collaboration of REMS Education (CO*RE) Initiative to Address Extended 

Release/Long Acting (ER/LA) Opioids. Thousands of PAs have participated in the 

CO*RE educational activity on safely prescribing ER/LA opioid painkillers, and 

AAPA is pleased to be a partner among several other provider groups in continuing 

to create opportunities for inter-professional education in this area. AAPA also 

99 

works with the National Institute on Drug Abuse (NIDA) on a CME initiative regarding pediatric substance use and the Hilton Foundation on adolescent substance 

abuse and the treatment of adolescent opioid addiction. Additionally, AAPA has 

hosted multiple online and in-person CME courses addressing opioid abuse, pain 

management, and safe prescribing, and plans to remain active in encouraging PAs 

to remain up-to-date on current best practices surrounding the responsible prescribing of opioid medications and comprehensive assistance for those who become 

addicted. 

The Role of PAs in Combating Opioid Abuse in Medicare Part D 

The Medicare Payment Advisory Commission (MedPAC) has found the majority of 

Medicare Part D beneficiaries who are prescribed opioid medications are either in 

treatment for cancer or in hospice care. There is little question most beneficiaries 

outside of these categories have legitimately been prescribed such medications; yet, 

the Government Accountability Office (GAO) has estimated as many as 170,000 

Medicare enrollees may suffer from opioid addiction. Meanwhile, the Centers for 

Disease Control and Prevention (CDC) has stated the death rate for individuals who 

either overdose on opioids or experience a deadly drug interaction involving opioids 

has more than tripled since 2000. As a result, it is important for all prescribers to 

have better access to information about what medications their patients have been 

prescribed, particularly those who see more than one healthcare provider or who are 

experiencing or at risk of addiction. 

One potential solution for this problem is to strengthen prescription drug monitoring programs (PDMPs). Earlier this month, Senators Richard Blumenthal (D–CT) 

and Dan Coats (R–IN) introduced S. 2479, the Expanding Access to Prescription 

Drug Monitoring Programs Act, which would encourage state PDMPs to allow PAs 

and nurse practitioners to view and update their patients’ prescription records. 

While some states allow this access, others do not—even though most states allow 

these practitioners to prescribe opioid drugs. AAPA supports this legislation, which 

would ensure PAs have all of the available information to make the best possible 

determinations about their patients’ care and quickly spot potential abuse or diversion issues. 

Additionally, Senator Pat Toomey (R–PA) has introduced S. 1913, the Stopping 

Medication Abuse and Protecting Seniors Act, which would allow prescription drug 

plans under Part D to establish patient review and restriction programs for beneficiaries who are at risk of misusing or diverting opioid drugs. These programs, 

which currently exist in nearly every state Medicaid program and a number of private insurance plans, identify beneficiaries with a history of drug abuse and require 

them to use one main prescriber and pharmacy to access controlled substances as 

a way to reduce the risk of ‘‘provider shopping.’’ AAPA supports coordination of care 

in this manner; however, it is important for any such efforts to include PAs. While 

S. 1913 is largely neutral when referring to ‘‘prescribers,’’ it includes a provision 

which requires participating drug plans to contact at-risk beneficiaries’ physicians 

in instances where there may be a question regarding the appropriateness of a prescription. In rural or medically-underserved areas, a PA may be a beneficiary’s main 

healthcare provider. As a result, if a PA is the prescriber, they ought to be the main 

point of contact to make such a determination and therefore need to be specifically 

named along with physicians in this provision. 

The Role of PAs in Treating Families Affected by Opioid Addiction 

Individuals who are struggling with opioid addiction often require personalized 

treatment plans which take into account a number of factors, including patients’ 

home and family situations, history of criminal behavior, and their likelihood of remaining in treatment over the long term. Typical treatment plans include abstinence, counseling and behavioral therapy; however, the use of medication-assisted 

treatment (MAT) is also appropriate for many patients. 

AAPA supports the use of MAT to assist individuals who are addicted to opioids. 

Both SAMHSA and the National Institute of Drug Abuse (NIDA) have found that 

individuals who are addicted to opioids often fare better if they have access to MAT, 

as well as traditional therapies. These patients have greater overall survival rates 

and treatment retention, and they show decreased criminal activity, allowing them 

to become and stay employed. Yet despite these positive outcomes, there is a public 

perception that MAT simply amounts to replacing one dependency with another. As 

a result, the stigma associated with these medications has deterred some qualified 

providers from seeking the ability to prescribe them. At the same time, current federal laws which limit the availability of these drugs and restrict the types of providers who may prescribe and dispense them has led to a severe shortage of proVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00103 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
100 

viders to assist patients with an opioid addiction. Additional providers are necessary 

to combat this growing epidemic, and PAs are part of the solution. 

Currently, PAs are authorized to prescribe and dispense three drugs used as part 

of MAT programs: 

• Methadone: Methadone is a synthetic opioid used to reduce withdrawal symptoms by blocking pain and reducing cravings. Due to the potential for misuse 

and dependence, methadone may only be dispensed through a certified opioid 

treatment program. PAs who are employed at these programs may dispense 

methadone and participate in the care and treatment of patients who are dependent on opioid drugs. • Naltrexone: Naltrexone blocks the euphoric effects of opioids. While it reportedly reduces cravings for these drugs, it differs from methadone in that it does 

not mimic the effects of opioid drugs or reduce withdrawal symptoms. 

Naltrexone is available in settings outside of opioid treatment programs, and 

it is not a controlled substance. As such, federal laws allow any licensed provider (including PAs) to prescribe and administer this drug. • Naloxone: Naloxone is a fast-acting drug which is used to reverse the effects 

of an opioid drug overdose. It is typically prescribed to high-risk MAT patients, 

including those who were taking high doses of opioids for chronic pain, those 

who are on complicated MAT regimens, and those who have already suffered 

an overdose. While naloxone is not a controlled substance, states have differing 

laws regarding the prescribing and dispensing of this drug. Forty eight states 

currently allow PAs to prescribe naloxone (subject to licensing and educational 

requirements). 

Despite PA presence in MAT programs, the Drug Addiction Treatment Act of 2000 

(DATA 2000) prohibits PAs from prescribing one of the most useful MAT drugs— 

buprenorphine—for the treatment of opioid addiction, even though they are allowed 

to prescribe this drug in 48 states and DC for pain management purposes. Legislation has been introduced in the Senate (S. 1455, the TREAT Act) which purports 

to add PAs to the list of providers who may prescribe buprenorphine as part of 

MAT. But it is problematic because the legislation neglects to recognize PA medical 

training and attempts to override state prescriptive authority by including only PAs 

who are ‘‘supervised’’ by physicians, while leaving out those who ‘‘collaborate’’ with 

them, based on state statute. As a result, the bill would arbitrarily exclude a number of PAs and potentially exclude many more as states update PA practice laws 

to use the term ‘‘collaborate’’ rather than ‘‘supervise.’’ Therefore, the legislation 

would result in continued lack of access in some of the most high-need areas of the 

U.S. In light of the shortage of providers who are currently able—and willing—to 

provide MAT to patients, AAPA recommends referring to state law rather than 

using terms which have the potential to continue to limit access to PA services to 

fight the opioid dependency crisis. 

AAPA Legislative Recommendations 

The opioid addiction epidemic is complicated, and its effects can be seen in myriad 

populations. Unfortunately, this means there is no one correct solution to cover all 

of those who are suffering. As such, AAPA offers the following policy recommendations: 

(1) Enact legislation to better allow providers—including PAs—to monitor high-risk Medicare Part D patients and provide them with the 

most clinically appropriate care. S. 2479 and S. 1913 represent approaches which allow healthcare practitioners to be fully aware of the medications their patients are taking, and to determine whether they are at risk for 

drug interaction, abuse, or diversion. 

(2) Support SAMHSA in encouraging state drug courts to allow participants to continue MAT. MAT is evidence-based treatment which is proven 

to improve outcomes for individuals who are struggling with opioid drug addiction. Yet, many state-based drug courts serving families in crisis remain 

resistant to this type of treatment due largely to stigma about how MAT 

works. AAPA supports the use of MAT, and we encourage the Committee to 

work with SAMHSA to ensure that individuals—and families—who are working to beat opioid addictions have access to all of the tools necessary to do 

so. 

(3) Update DATA 2000 to permit PAs to prescribe buprenorphine for the 

treatment of opioid addiction in any legislation addressing the opioid 

epidemic. Currently, federal law does not allow PAs to prescribe buprenorphine—a Schedule III controlled substance—for the treatment of opioid adVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00104 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
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diction, even though 48 states and D.C. already allow them to prescribe it for 

pain management purposes. By allowing PAs to prescribe buprenorphine, 

Congress can help eliminate one of the outdated federal barriers that contribute to the critical shortage of healthcare providers who are willing or able 

to prescribe MAT to their patients. Legislation like the TREAT Act (S. 1455), 

which fails to fully engage PAs in fighting opioid addiction also fails patients. 

Due to the evolving nature of state laws, it is critical federal legislation not 

qualify the prescribing of buprenorphine on the physician relationship. These 

types of conditions only serve as a barrier to utilizing all qualified providers 

to fight this epidemic. 

(4) Include PAs and AAPA in the dialogue surrounding the federal response to the opioid addiction crisis. PAs are highly-qualified healthcare 

providers who have a long history of prescribing medications, including 

opioids. As the Committee works towards solutions to the opioid problem, 

AAPA stands ready to serve as a resource. 

AAPA is committed to working to combat opioid addiction in the U.S., and we look 

forward to working with the Committee on this important issue. Please do not hesitate to contact Sandy Harding, AAPA Senior Director of Federal Advocacy, at (571) 

319–4338 or sharding@aapa.org with any questions. 

American Pharmacists Association (APhA) 

Improving medication use. Advancing patient care. 

2215 Constitution Avenue, NW, • Washington, DC 20037–2985 • 202–628–4410 Fax: 202–783–2351 • www.pharmacist.com 

February 26, 2016 

U.S. Senate Committee on Finance: Examining the Opioid Epidemic: 

Challenges and Opportunities 

On behalf of the American Pharmacists Association (APhA), and our more than 

62,000 members, we appreciate the opportunity to provide feedback on S. 1913, 

‘‘Stopping Medication Abuse and Protecting Seniors Act of 2015’’ and other efforts 

to address the opioid abuse epidemic. APhA, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 pharmacists, pharmaceutical 

scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in 

all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, managed care organizations, hospice settings and 

the uniformed services. 

APhA is committed to working with the Committee and other health professionals 

and stakeholders to identify ways to curb opioid abuse. We believe solutions will 

take everyone working together, including health care professionals, patients, and 

federal, state and local governments. As the Committee works toward a solution we 

urge the Committee to consider the possible effects that any policy change might 

have on legitimate patient access to prescription drugs. The Institute of Medicine 

(IOM) estimates that there are 100 million Americans living with chronic pain—a 

number that does not include the additional 46 million individuals the Centers for 

Disease Control and Prevention (CDC) estimates suffer from acute pain due to surgery. Given the sheer number of Americans impacted, policy changes that directly 

or indirectly restrict legitimate patient access to prescription drugs for pain will 

have far-reaching consequences. 

APhA supports education for health care professionals, including pharmacists and 

student pharmacists, to address issues of pain management, palliative care, and appropriate use of opioid reversal agents in overdose, drug diversion, and substancerelated and addictive disorders. APhA proposes the following recommendations regarding S. 1913 and opioid use and abuse. 

I. S. 1913: Stopping Medication Abuse and Protecting Seniors Act of 2015 

A. Selection Process for Prescribers and Pharmacies 

APhA is a long-time advocate for making certain patient choice is included in 

health care policy. While we appreciate that S. 1913 requires prescription drug 

plans (PDPs) to ask for and consider beneficiaries’ preferences when limiting at-risk 

102 

1Mey, A., Know K., Kelly, F., Davey, A.K., Fowler, J., Hattingh, L., Fejzic, J., McConnell, D. 

and Wheeler, A.J. (2013). Trust and Safe Spaces: Mental Health Consumers’ and Carers’ Relationship with Community Pharmacy Staff, The Patient—Patient-Centered Outcomes Research, 

6(4),281–289. 2S. 1913, 114th Cong. Sec. 2(a)(1) adding ‘‘(5)(D) Selection of Prescribers’’ to Section 1860D– 

4(c) of the Social Security Act. 

patients to a particular prescriber and pharmacy, APhA remains concerned that the 

administration of these drug management programs and the final selection of providers is by PDPs. While the legislation provides patient safeguards such as notices 

and rights to appeal, health care is complex and many patients do not understand 

the vast array of information that is provided to them. 

APhA is a strong supporter of the benefit of patients receiving their prescriptions 

by a single pharmacy of their choice. Research has demonstrated, and CMS has recognized, that trusted relationships between patients and pharmacists are important, 

including in mental health-related care.1 Given the relationship between mental 

health, chronic pain and substance abuse, being sensitive to the provider preferences of at-risk patient becomes even more important. APhA is concerned that the 

legislation’s section discussing reasonable access may be interpreted to allow PDPs 

to minimize the importance of patient choice when selecting an at-risk beneficiary’s 

prescriber and pharmacy.2 This section states that a PDP sponsor’s selection take 

into account ‘‘geographic location, beneficiary preference, impact on cost-sharing, 

and reasonable travel time.’’ 

Because PDPs can have a financial interest in steering beneficiaries to certain 

pharmacies (e.g., better contracted rates, ownership interest), we recommend that 

choices related to restricting patients to a particular prescriber and pharmacy are 

not granted to the PDPs. However, if it is decided that PDPs will be the entity to 

make such decisions, we recommend that patient choice be the default and any deviation from a patient’s choice of prescriber and pharmacy must be justified in writing 

and allowed only upon approval by the Secretary. 

B. Pharmacists Role in At-Risk Determinations 

APhA is pleased that pharmacists are explicitly included in the list of stakeholders tasked with identifying criteria that will be used to distinguish beneficiaries 

who are at-risk for prescription drug abuse. While APhA believes the language requiring PDPs to verify with ‘‘providers’’ that the beneficiary is at-risk includes pharmacist, we recommend ‘‘including pharmacists’’ be added to remove any ambiguity. 

Pharmacists play a unique role in the care continuum as they are medication experts, and often the health care professional that a patient will see most often. 

Pharmacists advise patients on drug-drug interactions, review medication dosages 

for appropriateness, and have the ability to more frequently observe behaviors that 

may be of concern. In addition, the vast majority of states allow providers to engage 

in collaborative practice agreements with pharmacists for certain services, such as 

medication therapy management. Some pharmacists in team-based care settings are 

engaged in pain management with prescribing authority for opioid therapy when 

working with physicians under collaborative practice agreements. Since pharmacists 

play such an integral role in pain management, they possess valuable knowledge 

that can be critical in determining whether a beneficiary is at-risk. 

C. Clinical Contact 

APhA has concern with the provision of the bill requiring PDPs to contact the atrisk beneficiary’s physicians regarding whether prescribed medications are appropriate for the medical condition. Such a requirement without additional criteria related to risk would be overly broad, hinders the health professional’s judgement and 

could cause delay in treatment for patients with a legitimate need. 

D. Patient Privacy 

APhA is pleased that patient privacy has been addressed in the bill. However, we 

feel the need to highlight that the Substance Abuse and Mental Health Services Administration (SAMHSA) is currently in the process of modernizing 42 CFR Part 2 

which dictates confidentiality of substance use disorder patient records. Generally, 

42 CFR Part 2 gives patients who suffer from substance use disorders greater privacy protections than the Health Insurance Portability and Accountability Act. 

Since PDPs will be exchanging sensitive patient information, we recommend considering adherence to 42 CFR Part 2. 

103 

E. Education 

APhA supports comprehensive efforts to educate health care professionals, including prescribers and pharmacists about prescription drug abuse, and mechanisms to 

prevent it. As drafted, the bill requires the Secretary to provide education only to 

enrollees and providers regarding the drug management program. Although it is not 

clear which health care professionals are included in the term ‘‘providers,’’ we support improving the training and education of all health professionals related to prescription drug abuse, misuse and treatment and encourage that such efforts incorporate ways to identify patients susceptible to addiction, and behaviors of addiction, 

abuse, misuse or diversion. In addition, the training should also educate health care 

professionals on various ways prescription drugs are diverted, and the different 

ways abusers are manipulating and administering the drugs. 

Further, APhA supports incentivized patient education focused on prescription 

drug abuse beyond education limited to the drug management program. Pharmacists are accessible providers who are able to provide targeted patient education 

on the risks and benefits associated with taking prescription drugs with a potential 

for abuse. 

II. Alternative Policy Considerations 

A. Naloxone 

Making naloxone more widely available beyond hospitals/emergency rooms and 

emergency medical transport is a relatively recent occurrence and precipitated in 

part by the Substance Abuse and Mental Health Services Administration SAMHSA 

recommendations (2013–14). Due to the expansion of sites providing naloxone, there 

needs to be a corresponding growth in training related to the appropriate use and 

administration of naloxone. State pharmacy associations and other pharmacy stakeholders have already begun to develop naloxone educational programs for pharmacists. We encourage the development, dissemination, and incentivization of 

naloxone-related education to patients and caregivers as well as to all members of 

the health care team. 

For many patients, cost can be a significant barrier in accessing naloxone. In 

order to encourage patients and caregivers to obtain naloxone products, it is essential that payer policies allow for coverage of this potentially lifesaving product. Insurance coverage of naloxone varies, but some plans have implemented prior authorization requirements, limiting immediate access even with a prescription. On the 

supply side, pharmacies that want to stock naloxone may be required to purchase 

a large quantity of the product—resulting in a large amount of waste if the local 

demand is low and the excess product expires. Even if naloxone were to be made 

available over-the-counter, as some stakeholders have suggested, cost would continue to be a potential barrier for patients, especially because many insurers do not 

cover over-the-counter medications. 

Several states have looked to increase patient access to naloxone by allowing 

pharmacist prescribing of naloxone. Some states have taken the approach of instituting a statewide protocol while others have implemented programs that use existing pharmacist collaborative practice authority. Still others have authorized pharmacists to dispense naloxone without a prescription. It is important to note that 

changes in scope may not automatically mean patients will have coverage by government and private payers; therefore, while a pharmacist may be able to prescribe 

or otherwise provide naloxone, a patient’s insurance may not cover it. APhA advocates for pharmacists, an important member of the patient’s health care team, to 

be able to furnish opioid reversal agents to help prevent opioid-related deaths and 

insurance policies that cover naloxone prescriptions, from all providers, for patients 

and caregivers who need it. 

B. Improved Communication and Access to Information 

APhA strongly supports better collaboration and communication between pharmacists and physicians to identify potential substance abuse problems. Prescription 

drug monitoring programs (PDMPs) represent one tool that helps prescribers and 

pharmacists to identify and prevent drug misuse, abuse, and/or diversion. However, 

integrated PDMPs that can be accessed by health care professionals’ nationwide in 

a seamless manner with their workflow is necessary. In addition, there needs to be 

better communication between providers, states and their system so health care proVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00107 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
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3Drug Enforcement Agency (May 8, 2014), DEA’s National Prescription Drug Take-Back Days 

Meet a Growing Need for Americans, available at: http://www.dea.gov/divisions/hg/2014/ 

hg050814.shtml, last accessed: February 24, 2016. 

fessionals can have access to real-time information regardless of state lines. Every 

state should have a PDMP which is interoperable with those of other states. 

Expanding electronic prescribing (e-prescribing), which is the secure electronic 

transmission of prescriptions from prescribers to pharmacies, is also a means to 

combat prescription drug abuse, misuse, and diversion. The direct transmission of 

a prescription using electronic prescribing standards and technology reduces the potential for hard copy prescriptions in the patients’ possession to be altered, forged, 

reproduced, or otherwise misused for unlawful purposes. Additionally, the capability 

for interoperable data exchange of critical clinical information between pharmacists 

and prescribers is important to having meaningful systems to combat prescription 

drug abuse and misuse while decreasing heavy administrative burdens on busy 

health care professionals. Lastly, APhA would like to emphasize the importance of 

considering the role of pharmacists in policies regarding health information technology, and access to information. 

C. Increase Prescription Drug Take Back Programs 

APhA suggests increasing the public’s access to prescription drug take back opportunities to decrease the likelihood that controlled substances will be used by persons 

other than the person to whom they were prescribed. According to a Drug Enforcement Agency press release, by May 2014, seven take back days had been organized 

by DEA and an astonishing 4.1 million pounds (2,123 tons) of unwanted, unused 

and expired prescription medications had been removed from the public domain.3

Often an abuser’s initial exposure to controlled substance prescription drugs comes 

from a family member or friend’s prescription in their medicine cabinet. If take back 

programs were more publically accessible, individuals will be more likely to dispose 

of these unwanted drug products rather than storing them indefinitely. Therefore, 

we look suggest considering ways to increase participation in and effectiveness of 

take back programs. 

Thank you for your leadership and work on addressing prescription drug abuse. 

We appreciate the inclusion of pharmacists in several portions of the bill and strongly advocate for continuing to include pharmacists, the medication experts on the patient’s health care team, in discussions on ways to help combat prescription drug 

abuse and misuse. We look forward to supporting your efforts as the legislation 

moves through the process. If you have any questions please contact our Senior Lobbyist, Michael Spira, by e-mail at mspira@aphanet.org or phone (202) 429–7507. 

Sincerely, 

Thomas E. Menighan, BSPharm , MBA, ScD (Hon), FAPhA 

Executive Vice President and CEO 

City of Baltimore, MD 

Stephanie Rawlings-Blake, Mayor 

Health Department 

Leana S. Wen, M.D., M.Sc., FAAEM 

Commissioner of Health 

1001 E. Fayette St. 

Baltimore, MD 21202 

health.commissioner@baltimorecity.gov 

Tel: 410–396–4387 

March 8, 2016 

TO: Members of the Senate Finance Committee 

FROM: Dr. Leana Wen, Baltimore City Health Commissioner 

RE: Comments for the Record: Examining the Opioid Epidemic: Challenges and 

Opportunities, February 23, 2016 

Chairman Hatch, Ranking Member Wyden, and Members of the Committee: 

I thank the Committee for holding a hearing to examine the opioid epidemic that 

is sweeping across our country. Opioid abuse is an epidemic and a public health 

105 

emergency—one that is claiming the lives, the livelihoods, and the souls of our citizens. 

As the Health Commissioner of Baltimore City, I work every day with my dedicated 

staff at the Health Department and partners across our city to change the way we 

think about and treat opioid use. I appreciate that the Committee hearing focused 

not just on tougher enforcement, but also on concrete steps for more prevention and 

better treatment. 

Strengthening opioid prescribing best practices is essential to prevent addiction. Nationwide, over-prescribing and inconsistent monitoring of opioid pain medications is 

a major contributing factor to the overdose epidemic. The ‘‘lock-in’’ model referenced 

in Mr. Coukell’s testimony serves as just one example of effective prescribing practices that prevent addiction and overdose. 

While a focus on prevention is critical as we work to combat this epidemic, we must 

also bolster our treatment efforts for those who suffer from addiction. Dr. Young’s 

testimony on the effects of this epidemic on our foster care system goes to show how 

a lack of treatment is a burden on both the individual and their families. This hearing also detailed the importance of funding treatment so cities and states can increase access to treatment centers, medications, and innovative programs to meet 

patients where they are. 

I commend the Committee’s commitment to addressing the opioid epidemic, and 

would like to take this opportunity to share how we have addressed this epidemic 

in Baltimore, with the hope that other jurisdictions can learn from our experience. 

While many members of the committee noted that there are gaps in treatment 

available, specific programs and interventions to support treatment were not explicitly addressed. As Senator Stabenow pointed out, we need systems change to create 

treatment in our communities. We can learn from cities who have taken the lead 

across the country using innovative approaches to address this national issue; Baltimore City is one such city that is at the cutting edge of addiction prevention and 

treatment. 

The Opioid Problem in Baltimore 

With approximately 19,000 active heroin users in Baltimore and far more who misuse and abuse prescription opioid medications, our city cannot be healthy without 

addressing opioid addiction and overdose. In 2014, 303 people died from drug and 

alcohol overdose, which is more than the number of people who died from homicide. 

Drug addiction impacts our entire community and ties into nearly every issue facing 

our city including crime, unemployment, poverty, and poor health. It claims lives 

every day and affects those closest to us—our neighbors, our friends, and our family. 

To develop our framework to fight addiction and overdose in Baltimore, Mayor 

Stephanie Rawlings-Blake convened the Heroin Treatment and Prevention Task 

Force in October of 2014. Understanding that health is not just about physical 

health, but also behavioral health, the Mayor made this one of her administrations 

top priorities. She charged the Task Force with developing bold and progressive recommendations that could be implemented to turn the tide against addiction in our 

city. These recommendations serve as our roadmap and call to action, led by the 

Baltimore City Health Department, in close collaboration with public and private 

partners across the city, including our major partner, Behavioral Health System 

Baltimore, a nonprofit that is the designated behavioral health authority of the city 

(of which I serve as Chair of the Board). 

Baltimore’s Response to Addiction and Overdose 

Our work in Baltimore is built on three pillars: 

• First, we have to prevent deaths from overdose and save the lives of people suffering from addiction. 

• Second, we must increase access to quality and effective on-demand treatment 

and provide long-term recovery support. 

• Third, we need to increase addiction education and awareness for the public 

and for providers, in order to reduce stigma and encourage prevention and 

treatment. 

Our work in each of these areas is multifaceted because addressing a disease like 

addiction requires a comprehensive approach. We are glad to share these pillars 

with the Committee and appreciate the greater national public health focus on this 

issue. The opioid epidemic is affecting every part of our country. We are all in this 

together, and Baltimore is happy to share our innovations and lessons learned. 

106 

1. Preventing Deaths From Overdose 

In Baltimore, I have declared opioid overdose a public health emergency and led the 

charge in one of the most aggressive opioid overdose prevention campaigns across 

the country. 

a. The most critical part of the opioid overdose prevention campaign is expanding 

access to naloxone—the lifesaving drug that reverses the effect of an opioid 

drug overdose. Naloxone is safe, easily administered, not addictive, and nearly 

100% effective at reversing an overdose. In my clinical practice as an emergency physician, I have administered naloxone to hundreds of patients and 

have seen how someone who is unresponsive and about to die will be walking 

and talking within seconds. Since 2003, Baltimore City has been training drug 

users on using naloxone through our Staying Alive Program. Last year, we successfully advocated for change in State legislation so that we can train not only 

individuals who use drugs, but also their family and friends, and anyone who 

wishes to learn how to save a life. This is critical because someone who is overdosing will be unresponsive and friends and family members are most likely 

to save their life. 

Our naloxone education efforts are extensive. In 2015, we trained over 8,000 

people to use naloxone: in jails, public housing, bus shelters, street corners, and 

markets. We were one of the first jurisdictions to require naloxone training as 

part of court-mandated time in Drug Treatment Court. We have trained state 

and city legislators so that they can not only save lives, but also serve as ambassadors and champions to their constituents. We use up-to-date epidemiological data to target our training to ‘‘hotspots,’’ taking naloxone directly into the 

most at risk communities and putting it in the hands of those most in need. 

This was put into effect earlier this year, when we saw that 39 people died from 

overdose to the opioid Fentanyl between January and March of 2015. Fentanyl 

is many times stronger than heroin, and individuals using heroin were not 

aware that the heroin had been laced with Fentanyl. This data led us to target 

our messaging so that we could save the lives of those who were at immediate 

risk. 

Already, our naloxone outreach and trainings are changing the way our frontline officials approach addiction treatment, with a focus on assessment and action. In addition to training paramedics, we have also started to train police officers. The initial trainings were met with resistance from the officers who were 

hesitant to apply medical interventions that some did not see as part of their 

job description. However, in the first month of carrying naloxone, four police officers used naloxone to save the lives of four citizens. Recently, I attended a 

training where I asked the officers what they would look for if they were called 

to the scene for an overdose. In the past, I would have received answers about 

looking for drug paraphernalia and other evidence. This time, officers answered 

that their job was to find out what drugs the person might have taken, to call 

911 and administer naloxone, because their duty is to save a life. By no means 

is naloxone training the panacea for repairing police and community relations. 

However, it is one step in the right direction as we make clear that addiction 

is a disease and overdose can be deadly. We are changing the conversation so 

that all of our partners can join in encouraging prevention, education, and 

treatment. 

b. As of October 1, 2015, I have the authority to write blanket prescriptions for 

naloxone for the roughly 620,000 residents in Baltimore City, under a ‘‘Standing Order’’ which was approved by the Maryland State Legislature. This is one 

of the single largest efforts in the country to achieve citywide naloxone distribution. A Standing Order means that someone can receive a short training 

(which can be done in less than 5 minutes) and immediately receive a prescription for naloxone, in my name, without having seen me personally as their doctor. In February of 2016, we launched a first of its kind online platform to train 

Baltimore City residents how to use naloxone. Upon completion, residents will 

get a Standing Order certification that they can fill immediately at a pharmacy 

or receive medication from designated individuals, such as overdose response 

program trainees without a separate doctor’s prescription. We also successfully 

advocated for Good Samaritan legislation, which expanded protections for those 

who assist in the event of an overdose, and malpractice protection for doctors 

who prescribe naloxone. Finally, our state Medicaid program has agreed to set 

the co-pay for naloxone at $1. While we still struggle with the pricing for 

naloxone (see below), this has allowed us to provide prescriptions to patients 

107 

and others at a greatly reduced cost. We have to get naloxone into the hands 

of everyone who can save a life—which we believe is each and every one of us. 

Some people have the misconception that providing naloxone will only encourage a drug user by providing a safety net. This dangerous myth is not based 

on science but on stigma. Would we ever say to someone whose throat is closing 

from an allergic reaction, that they shouldn’t get epinephrine because it might 

encourage them to eat peanuts or shellfish? An Epi-Pen saves lives; so does 

naloxone, and it should be just as readily available. Our mantra is that we 

must save a life today in order for there to be a better tomorrow. 

2. Increasing Access to On-Demand Treatment and Long-Term Recovery 

Support 

Stopping overdose is only the first step in addressing addiction. To treat people with 

substance addiction, we must ensure there is adequate access to on-demand treatment. Nationwide, only 11% of patients with addiction get the treatment they need. 

There is no physical ailment for which this would be acceptable—imagine if only 

11% of cancer patients or 11% of patients with diabetes were being treated. If we 

do not increase access to quality treatment options we are merely treading water, 

waiting for the person who has overdosed to use drugs and overdose again. 

a. In Baltimore, we have started a 24/7 ‘‘crisis, information, and referral’’ phone 

line that connects people in need to a variety of services including: immediate 

consultation with a social worker or addiction counselor; connection with outreach workers who provide emergency services and will visit people in crisis at 

homes; information about any question relating to mental health and substance 

addiction; and scheduling of treatment services and information. This line is 

not just for addiction but for mental health issues, since these issues in behavioral health are so closely related and there is a high degree of co-occurrence. 

Those who are seeking treatment for behavioral health should be able to easily 

access the services they need, at any time of day. This 24/7 line has been operational since October 2015; already, there are nearly 1,000 phone calls every 

week. It is being used not only by individuals seeking assistance, but by family 

members seeking resources and providers looking to connect their patients to 

treatment. 

b. We have secured $3.6 million in capital funds to build a ‘‘stabilization center’’— 

also known as a sobering center—for those in need of temporary service related 

to intoxication. This is the first step in our efforts to start a 24/7 ‘‘Urgent Care’’ 

for addiction and mental health disorders—a comprehensive, community-based 

‘‘ER’’ dedicated to patients presenting with substance abuse and mental health 

complaints. Just as a patient with a physical complaint can go into an ER any 

time of the day for treatment, a person suffering from addiction must be able 

to seek treatment on-demand. This center will enable patients to self-refer or 

be brought by families, police, or EMS—a ‘‘no wrong door’’ policy ensures that 

nobody would be turned away. The center would provide full capacity treatment 

in both intensive inpatient and low-intensity outpatient settings, and connect 

patients to case management and other necessary services such as housing and 

job training. 

c. We are developing a real-time treatment dashboard to obtain data on the number of people with substance use disorders, near-fatal and fatal overdoses, and 

capacity for treatment. This will enable us to map the availability of our inpatient and outpatient treatment slots and ensure that treatment availability 

meets the demand. The dashboard will be connected to our 24/7 line that will 

immediately connect people to the level of treatment that they require—on demand, at the time that they need it. 

d. We are expanding our capacity to treat overdose in the community by hiring 

community-based peer recovery specialists. These individuals will be recruited 

from the same neighborhoods as individuals with addiction, and will be trained 

as overdose interrupters who can administer overdose treatment and connect 

patients to treatment and other necessary services. 

e. We have implemented the Screening, Brief Intervention, and Referral to Treatment (SBIRT) approach, which provides universal screening of patients presenting to ERs and primary care offices. Three of our hospitals are early pioneers in SBIRT; we are looking to expand it to all hospitals and clinics in the 

city to ensure delivery of early intervention and treatment services for those 

with or at risk for substance use disorders. 

108 

f. We are expanding and promoting medication-assisted treatment, which is 

evidence-based and highly effective method to help people with opioid addiction 

recover. This combines behavioral therapy with medication, such as methadone 

or buprenorphine, along with other support. Taking medication for opioid addiction is like taking medication to control heart disease or diabetes. When prescribed properly, medication does not create a new addiction, but rather manages a patient’s addiction so that they can successfully achieve recovery. Baltimore has been at the leading edge of innovation for incorporating medicationassisted treatment, including providing medications in structured clinical settings through the Baltimore Buprenorphine Initiative. This year, we expanded 

access to buprenorphine treatment by offering services in low-barrier settings, 

such as recovery centers, emergency shelters, and mental health facilities. Providing access to buprenorphine services in these settings allows us to engage 

people who are more transient or unstably-housed into much needed treatment. 

g. We are working to expand case management and diversion programs across the 

city so that those who need help get the medical treatment they need. In our 

city of 620,000, 73,000 people are arrested each year. The majority of these arrests are due to drug offenses. Of the individuals in our jails and prisons, 8 out 

of 10 use illegal substances and 4 out of 10 have a diagnosed mental illness. 

Addiction and mental illness are diseases, and we should be providing medical 

treatment rather than incarcerating those who have an affliction. Baltimore already has highly effective diversion efforts such as Drug Treatment Courts and 

Mental Health Treatment Courts. We are looking to implement a Law Enforcement Assisted Diversion Program, a pilot model that has been adopted by a select group of cities, which establishes criteria for police officers to identify eligible users and take them to an intake facility that connects them to necessary 

services such as drug treatment, peer supports, and housing—rather than to 

central booking for arrest. 

h. Finally, we are increasing our capability for case management services for every 

individual leaving jails and prisons. These individuals are at a highly vulnerable state, and must be connected to medical treatment, psychiatric and substance abuse treatments if appropriate, housing and employment support, and 

more. Our outreach workers already target a subset of this population; we need 

to expand capacity to every one of these individuals. Additionally, as mentioned 

above, we are deploying community health workers in order to reach people 

where they are in the community as well as provide a credible messenger. In 

deploying this tactic, we are also excited to bring jobs and opportunities to vulnerable individuals and neighborhoods that otherwise have limited employment 

opportunities. 

3. Providing Education to Reduce Stigma and Prevent Addiction 

In addition to treating patients, we must also change the dialogue around substance 

use disorder. The Baltimore City Health Department is leading a citywide effort to 

educate the public and providers on the nature of substance addiction: that it is a 

disease, recovery is possible, and we all must play a role in preventing addiction 

and saving lives. 

a. We have been at the forefront of changing public perception of addiction so 

those in need are not ashamed to seek treatment. We have launched a public 

education campaign ‘‘http://dontdie.org/’’ to educate citizens that addiction is 

a chronic disease and to encourage individuals to seek treatment. This was 

launched with bus ads, billboard ads, a new website, and a targeted door-todoor outreach campaign in churches and with our neighborhood leaders. 

We have also launched a concerted effort to target prevention among our teens 

and youth entitled ‘‘BMore in Control.’’ We have established permanent prescription drug drop boxes at all nine of the city’s police stations. This means that 

anyone can drop-off their unused, unwanted, or unnecessary prescription 

drugs—no questions asked. Drugs left in the home can end up in the wrong 

hands—spouses, elderly family members, or even our children. I have treated 

2-year olds who were dying from opioid overdose, again underscoring that all 

of us can be at risk and must play a role. 

b. We are targeting our educational efforts to physicians and other prescribers of 

opioid medications. Nationwide, over-prescribing and inconsistent monitoring of 

opioid pain medications is a major contributing factor to the overdose epidemic. 

According to the Centers for Disease Control, there were 259 million prescriptions written for opioids in 2014. That is enough for one opioid prescription for 

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every adult American. Every day, people overdose or become addicted to their 

prescription opioids. 

To address this, I have sent ‘‘best practice’’ letters to every doctor in the city and 

will also do so for all dentists and pharmacists. The letter addressed the importance of the Prescription Drug Monitoring Program and judicious prescribing of 

opioids, including not using narcotics as the first line medication for acute pain 

and emphasizing the risk of addiction and overdose with opioids. Importantly, 

this best practice requires co-prescribing of naloxone for any individual taking 

opioids or at risk for opioid overdose. Hospitals keep naloxone on hand if patients receive too much intravenous morphine or fentanyl. Patients must also 

receive a prescription for naloxone if they are to be discharged with opioid 

medications that can result in overdose. 

These best practices were developed through convening ER doctors, hospital 

CEOs, and other medical professionals in the city. To reach practicing doctors, 

we have been presenting at Grand Rounds, medical society conferences, and are 

also about to launch physician ‘‘detailing,’’ where we will employ teams of public health outreach workers and people in recovery to visit doctors to talk about 

best practices for opioid prescribing. We are working with providers to ensure 

best practices will be used when prescribing opioids and that we all play our 

part—as providers, patients, and family members—to prevent addiction and 

overdose. 

c. As part of our ‘‘best practices’’ recommendations, we are leading efforts to warn 

patients and prescribers against combining opioids and benzodiazepines. One in 

three fatal overdoses is due to this combination—a little known but extremely 

dangerous phenomenon. In February, I led a group of over 40 City Health Commissioner and State Health Directors across the country urging the FDA to require a ‘‘black box warning’’ on opioids and benzodiazepines that states that 

current use of the medications increases the risk of fatal overdose. Black box 

warnings appear on the labels of prescription drugs and call attention to serious 

or life-threatening risks. We started a public petition and have over 3,000 signatures from people showing their support for this public warning. 

While we wait for the FDA to require a ‘‘black box warning,’’ we are also calling 

on prescribers to warn patients about the risks of combined opioid and 

benzodiazepine use. Patients with chronic pain are often prescribed opioids to 

treat their pain and benzodiazepines to treat their associated symptoms, such 

as anxiety and sleep disorders. Educating patients about this potentially lethal 

drug interaction is an important step to reduce the toll of addiction and fatal 

overdose in communities across the country. 

Working With the Federal Government 

The Baltimore City Health Department, together with our partners across the city 

and state, has made significant progress in tackling the opioid epidemic. However, 

there are some areas where we face continued challenges. Though there is much 

that can be done on the city and state levels, the federal government plays a critical 

role in the campaign against addiction and overdose. We appreciate the opportunity 

to mention four specific areas that can be addressed: 

1. Expand Funding and Availability of On-Demand Addiction Treatment 

Service 

We must treat addiction as a disease and not a crime or a moral failing. In order 

to successfully treat the disease, we need to ensure there are sufficient high-quality 

treatment options available to those in need. 

a. Federal funding could expand treatment on-demand including 24/7 dedicated 

centers for substance addiction and mental health and proven intervention 

models such as LEAD and expand case management services for vulnerable individuals. These programs will help to ensure that those in need have a path 

to recovery. 

b. The Senate can push for equitable insurance coverage for addiction services. 

Medicare pays for pain medications that can lead to addiction, yet many states 

do not cover medication-assisted treatment and other evidence-based interventions for addiction recovery. The Senate can ensure that Medicaid, Medicare, 

and private payers cover on demand treatment for acute care (such as sobering, urgent care, and residential services), as well as ongoing treatment and 

services like medication-assisted treatment and case management. These rates 

should also be equivalent to mental health and physical health care rates 

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(which they are not currently, leading to a dearth of providers and inadequate 

care). 

c. The Senate can remove barriers to prescribing Buprenorphine. Buprenorphine 

is a medication-assisted treatment option with a much lower chance of overdose 

than methadone. Importantly, it can be administered by a primary care provider rather than in a designated drug-treatment clinic. This helps to increase 

the accurate perception that substance use disorder is a medical condition. Unfortunately, at the moment, only medical doctors can prescribe buprenorphine, 

and a doctor can only provide Buprenorphine to a maximum of 100 patients. 

This barrier does not exist for any other medication, and significantly limits the 

ability of patients to access a life-saving treatment option and leaves many patients with methadone as their only option for medication assisted treatment. 

Methadone requires administration in a designated treatment clinic, which are 

often a point of contention within the communities in which they operate due 

to the stigma associated with drug addiction. We strongly support current efforts underway at the Department of Health and Human Services to revise the 

limits on buprenorphine prescription in a given year, and urge further support 

of broadened access to this proven treatment including by requesting the Senate to consider broadening prescription authority of Buprenorphine to Nurse 

Practitioners and other providers. 

2. Provide Cities and States With Opportunity to Innovate Around Addiction Recovery 

There are many services not covered by Medicaid, Medicare, or other forms of insurance that are critical to addiction recovery. The Senate can provide funding to local 

jurisdictions and to States that can give grants and incentives to support innovative, 

evidence-based programs that do not simply focus on the medical component of addiction but the broader psychosocial components. These include: 

a. New care delivery models. There is research on new treatment options such as 

starting buprenorphine from ERs, mobile buprenorphine induction, or telemedicine treatment that would be not eligible for existing reimbursement yet offer 

much promise. These are examples of delivery models that local and state agencies should have the option of providing grant funding for, with the option of 

being included in Medicaid formulary after sufficient time and evidence. 

b. Peer recovery specialists. In Baltimore, we are aiming to provide a peer recovery 

specialist for every individual who presents for overdose or addiction-related 

condition to our ERs and other facilities. However, we are limited by the lack 

of funding for these individuals. There should be opportunities for expanded 

funding and reimbursement for services rendered by these trained community 

health workers; grant funding to local and state agencies can be one way to 

pursue this. 

c. Case management services. Individuals leaving incarceration or inpatient stays 

are at very high risk; they must receive wrap-around services that connect 

them immediately to needed medical and psychiatric assistance. These case 

management services have inconsistent reimbursement; innovative programs 

including with telemedicine and use of peer recovery specialists should be encouraged. 

d. Community resources for recovery. Recovery from addiction involves more than 

clinical treatment but also support and long-term care. Local and state agencies 

can also innovate with interventions such as recovery housing and reentry support; federal funding can assist in these necessary steps. 

e. Prevention. Grant support for tailored and targeted prevention support including public education and provider education must also be a critical component. 

3. The Senate Can Monitor and Regulate the Price and Availability of 

Naloxone 

Naloxone is a generic medication that is part of the World Health Organization’s 

list of essential medications. Over the last 2 years, the price of naloxone has dramatically increased. In Baltimore, the cost per dose of naloxone has quadrupled— 

meaning that we can only save a quarter of the lives we could have saved. This is 

particularly problematic for cities and counties that must purchase naloxone for use 

by paramedics, police officers, and other front-line workers. Manufacturers have 

claimed that this price increase is related to increased demand. However, it is unclear why the cost of a generic medication that is available for much lower costs 

in other countries will be suddenly so expensive. The Senate can join efforts by SenVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00114 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
111 

ator Sanders and Congressman Cummings to call for investigation into the reason 

for the price increase, which would otherwise prohibit us from saving lives at a time 

that we need to the most. 

4. The Senate Can Push for National Stigma-Reduction and OpioidAwareness Campaign 

Many local jurisdictions like Baltimore have launched public education campaigns. 

There is much more education that must be done in order to encourage people with 

addiction into care and to disband stigmas that are leading many communities to 

avoid providing treatment altogether. Local jurisdictions are also limited by funding 

constraints. The Senate can push for the launch of a national campaign to reduce 

stigma and to increase awareness of opioid addiction. This national campaign will 

provide the spotlight this critical issue requires. 

Finally, as a part of this campaign, we urge the Senate to pass legislation requiring 

a ‘‘black box warning’’ on opioids and benzodiazepines. More patients than ever before are being prescribed both opioids and benzodiazepines, and more are running 

into serious problems from combined use. These warning labels will raise awareness 

about this dangerous trend that is fueling the overdose epidemic. 

Conclusion 

While some of the challenges facing Baltimore are unique, we join our counterparts 

around the country in addressing the epidemic of opioid addiction. According to the 

Centers for Disease Control, the number of people dying from overdose has quadrupled from 15 years ago. In many states, there are more people dying from overdose than from car accidents or suicide. 

There are some who say the opioid problem is too big and too complicated-that it 

cannot be solved. It is true that treating the opioid epidemic requires many approaches. However, this is an issue that requires our attention. According to the 

World Health Organization, treating opioid addiction saves society $12 for every $1 

spent on treatment. Treatment also impacts communities by reducing excess healthcare utilization, increasing productivity and employment rates, and decreasing poverty and unnecessary cost to the criminal justice system. Furthermore, treating addiction is a moral imperative and a matter of life and death. 

Baltimore has been fighting the heroin and opioid epidemic for decades and we continue to make progress with bold ideas and innovative strategies. Our efforts to address opioid addiction seek to change the face of Baltimore from the ‘‘heroin capital’’ 

to becoming the center of addiction recovery. We are glad to share our lessons with 

our counterparts around the country and with our national leaders. With dedicated 

partners like you in the U.S. Senate, we can fight the epidemic, save lives and reclaim people and their families. 

On behalf of the Baltimore City Administration, I want to thank you for calling this 

important hearing. We look forward to working with you to stop the epidemic of 

opioid addiction in the United States. Please feel free to call on me should you have 

any questions. 

Mike DeWine 

OHIO ATTORNEY GENERAL

Administration 

30 E. Broad Street, 17th Floor 

Columbus, OH 43215 

Office 614–728–5458 

Fax 614–466–5087 www.OhioAttomeyGeneral.gov 

February 23, 2015 

The Honorable Orrin Hatch 

Chairman 

Committee on Finance 

U.S. Senate 

Washington, DC 20510 

The Honorable Ron Wyden 

Ranking Member 

Committee on Finance 

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1Gardner, S. (2014) State-Level Policy Advocacy for Children Affected by Parental Substance 

Use, retrieved from: http://childwelfaresparc.org/wp-content/uploads/2014/08/State-Level-Policy-Advocacy-for-Children-Affected-by-Parental-Substance-Use.pdf. 

U.S. Senate 

Washington, DC 20510 

Dear Chairman Hatch and Ranking Member Wyden, 

Thank you for the opportunity to provide a letter of support for S. 1913.—The Stopping Medication Abuse and Protecting Seniors Act. This legislation will allow Medicare Advantage and Part D plan sponsors to identify and assist beneficiaries with 

addiction issues, with the added goal of reducing improper diversion of prescription 

medication. 

I share Senator Portman’s concern about prescription medication abuse and the 

opioid epidemic that is plaguing our communities. I have worked with law enforcement and regulatory agencies to crack down on improper prescribing and punish 

those responsible. My Heroin Unit works with communities to provide awareness 

about the opioid epidemic and educate the public about issues including naloxone 

and proper drug disposal. 

S. 1913 is a strong tool to help reduce doctor and pharmacy shopping. Diverted and 

abused prescription medication is strongly correlated with the increased use of illicit 

drugs nationwide and in Ohio. Reasonable efforts such as S. 1913 that help ensure 

proper prescribing and limit fraud should be supported. 

I applaud Senator Portman’s efforts in supporting this important piece of legislation, 

which will assist those struggling from addiction. Thank you for your leadership and 

the opportunity to address this vital issue. 

Very respectfully yours, 

Mike DeWine 

Ohio Attorney General 

FIRST FOCUS STATE POLICY ADVOCACY AND REFORM CENTER (SPARC) 

1110 Vermont Avenue NW, Suite 900 | Washington, DC 20005 | T: 202–657–0670 F: 202–657–0671 | www.childwelfaresparc.org 

STATEMENT FOR THE RECORD 

U.S. SENATE COMMITTEE ON FINANCE 

EXAMINING THE OPIOID EPIDEMIC: 

CHALLENGES AND OPPORTUNITIES 

February 23, 2016 

Chairman Hatch, Ranking Member Wyden, and Members of the Senate Committee 

on Finance, we thank you for the opportunity to submit this statement for the 

record on the hearing focused on addressing the opioid epidemic, currently posing 

a serious threat to children and families across the United States. 

The First Focus State Policy and Advocacy Reform Center (SPARC) is a coalition 

of state-based advocacy organizations committed to improving the safety, health and 

well-being of children and families involved in the child welfare system. Many of 

the SPARC state partners live in communities that are seriously impacted by the 

opioid crisis and concerned about its impact on children, particularly those at risk 

of entering the foster care system. The purpose of this statement is to draw the connections between the opioid crisis and challenges faced by state and county child 

welfare systems that serve as our nation’s safety net and offer recommendations on 

how to ensure better outcomes for families that struggle with substance abuse 

issues. 

Parental substance abuse and opioid use have long been identified as a factor that 

results in families and children becoming involved in the child welfare system. In 

2012, 30.5 percent of child removals—more than one of every four—were due to parental use of alcohol and other drugs. 66 percent of children in foster care have lived 

with someone with an alcohol or drug problem.1 In addition, as a recent Reuters 

series on the crisis highlighted, newborns exposed prenatally to opioids also face significant safety risks. Some are removed at birth, separating families and placing sigVerDate Mar 15 2010 14:20 Jan 10, 2017 Jkt 000000 PO 00000 Frm 00116 Fmt 6601 Sfmt 6621 R:\DOCS\23291.000 TIMD
113 

2Wilson, Duff, John, Shiffman. ‘‘The Most Vulnerable Victims of America’s Opioid Epidemic.’’ 

Reuters, Thompson Reuters, December 7, 2016, retrieved from: 

http://www.reuters.com/investigates/special-report/baby-opioids/#article-about-the-series. 

3Patrick et al., JAMA 2012, Patrick et al., Journal of Perinatology 2015. 

nificant strains on the child welfare system, while others may suffer abuse or neglect when they are sent home with parents abusing opioids.2 The National Institute on Drug Abuse estimates that 21,372 babies were born with neonatal abstinence syndrome (NAS) in 2012, 5 times the number born with NAS in 2000.3

States are taking actions to address the opioid crisis. Many states, including Massachusetts, Rhode Island, Indiana, Maryland, Michigan, North Carolina, Virginia, and 

West Virginia have formed state-level taskforces made up of experts who offer recommendations to the state Governors and Attorney Generals. State Legislatures 

have also introduced and enacted a significant number of bills to curb the use of 

opioids in their states. Common threads in these policies include: establishing electronic prescription drug monitoring programs (PDMP) to ensure that patients are 

not dispensed more medications than necessary; increasing access to naloxone, 

which counters the effects of opioid overdose; and increasing resources for treatment 

and services. However, many of these state-wide initiatives fail to draw the connections between the substance abuse and opioid problem and the risk for child abuse 

and neglect, as well as the impact on the foster care system. 

Importantly, there are also some states that are implementing evidence based, evidence informed, and promising programs to ensure better outcomes for both children 

and their parents who are struggling with opioid use, including: 

• Parent-Child Interaction Therapy and Parent-Child Psychotherapy in Nebraska, 

which promotes positive parenting and attachment between parents and their 

children; 

• Developmental assessments and therapy for prenatally exposed children, including post-natal follow-up services in Illinois; and 

• The Engaging Moms Program in Florida, which provides case management by 

specially trained caseworkers for mothers in treatment programs. 

We are pleased that the Family First Act proposal put forth by Chairman Hatch 

and Ranking Member Wyden recognizes that states need access to reliable federal 

funds so they can address parental substance use—before children face serious safety threats—to prevent children from entering the child welfare system. The Family 

First Act would allow states the flexibility to use title IV–E dollars for substance 

abuse treatment that works so that parents can receive effective services before they 

present safety concerns that prompt removal of their children from the home. 

The Family First Act would be a significant step forward to support and strengthen 

families who have addiction issues and are involved with the child welfare system. 

Additional steps that can be taken at the federal level include: incentives for better 

cross-agency collaboration between substance abuse, child welfare and mental 

health systems; enforcement of provisions in the Child Abuse Prevention and Treatment Act (CAPTA) to report babies who are exposed to opioids prenatally to child 

welfare agencies; uniform practices for states in screening and recording substance 

abuse as an element of child maltreatment; prioritizing treatment for child welfare 

involved families; and strengthening family drug court programs to ensure courts 

are working with families holistically to ensure the safety and best interest of children living in families with substance abuse problems. 

We thank you again for the opportunity to submit this written testimony and look 

forward to working with you to implement policies that prevent children from harm 

because of substance abuse and opioid use. Should there be any questions regarding 

this statement, please contact Rricha Mathur, Senior Policy Advisor of Child Welfare and Child Rights at (202) 999–4852 or rricham@firstfocus.org. 

114 

NATIONAL ASSOCIATION OF CHAIN DRUG STORES (NACDS) 

1776 Wilson Blvd., Suite 200 

Arlington, VA 22209 

703–549–3001 

www.nacds.org 

Statement for United States Senate Committee on Finance Hearing on: 

‘‘EXAMINING THE OPIOID EPIDEMIC: 

CHALLENGES AND OPPORTUNITIES’’ 

February 23, 2016 

Introduction 

The National Association of Chain Drug Stores (NACDS) thanks Chairman Hatch, 

Ranking Member Wyden, and members of the Committee on Finance for the opportunity to submit a statement for the hearing on ‘‘Examining the Opioid Epidemic: 

Challenges and Opportunities.’’ 

NACDS and the chain pharmacy industry are committed to partnering with law enforcement agencies, policymakers, and others to work on viable strategies to prevent 

prescription opioid diversion and abuse. Chain pharmacies engage daily in activities 

with the goal of preventing the diversion and abuse of all prescription drugs. Since 

chain pharmacies operate in almost every community in the U.S., we support policies and initiatives to combat the prescription drug abuse problem nationwide. We 

believe that holistic approaches must be implemented at the federal level. 

Pharmacists take very seriously their role in helping to ensure safe use of medications—but they cannot do it alone. The time has come to bring about an overarching, collaborative approach to curb prescription opioid abuse and preserve patient access to their medically-necessary pain medications. 

We believe that there are a variety of ways to help curb prescription drug diversion, 

and chain pharmacies actively work on many initiatives to reduce this problem. 

Chain Pharmacy Initiatives 

Chain pharmacies extensively train their personnel and have strict policies and procedures to prevent prescription drug diversion. Our members rigorously comply with 

state and federal laws and regulations. Pharmacies and pharmacy personnel are 

among the most highly regulated industries and professions. 

Chain pharmacies have created a variety of extensive and robust loss prevention 

and internal security systems that are in place from our prescription drug distribution centers right down to the point of dispensing to the patient. We undertake initiatives to ensure that prescription drugs are accounted for every step along the 

way. We work with law enforcement to see that perpetrators are brought to justice. 

Chain pharmacies have zero tolerance for prescription drug diversion. In addition 

to developing, implementing, and maintaining our own policies and procedures, we 

support numerous other initiatives to mitigate and reduce the scourge of prescription drug diversion. Chain pharmacies are committed to ensuring that prescription 

drugs remain under tight control for the purposes of providing care to their patients, 

and are not diverted for nefarious purposes. Our members’ efforts are evidence of 

this commitment. 

DEA Regulations 

According to DEA regulations, the responsibility for the proper prescribing and dispensing of controlled substances is on the prescribing practitioner, but a corresponding responsibility also rests with the pharmacist who fills the prescription. 

DEA requires pharmacists to take on diverse and sometimes conflicting roles. On 

the one hand, pharmacists have a strong ethical duty to serve the medical needs 

of their patients in providing neighborhood care. On the other hand, community 

pharmacists are also required to be evaluators of the legitimate medical use of controlled substances. 

Pharmacies fully understand that controlled substances are subject to abuse by a 

minority of individuals who improperly obtain controlled substance prescriptions 

from physicians and other prescribers. Pharmacies strive to help to treat medical 

conditions and ease patients’ pain while simultaneously guarding against the abuse 

of controlled substances. The key is to guard against abuse while still achieving our 

primary goal of assisting patients who need pharmacy services. 

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Legislative Solutions 

NACDS and our members are focusing our energies on real, workable solutions that 

will address the problem of prescription drug abuse while also ensuring that legitimate patients are able to receive their prescription opioid pain medications. In line 

with this goal, we support H.R. 471/S. 483, the ‘‘Ensuring Patient Access and Effective Drug Enforcement Act of 2015.’’ This legislation would promote cooperation 

among key government agencies, such as DEA and FDA, to jointly identify obstacles 

to legitimate patient access to controlled substances, issues with diversion of controlled substances, and how collaboration between law enforcement agencies and 

healthcare stakeholders can benefit patients and prevent diversion and abuse of 

controlled substances. 

This legislation also facilitates open dialogue on issues related to prescription drug 

diversion and abuse by directing key federal agencies to consult with patient groups; 

pharmacies; drug manufacturers; common or contract carriers and warehousemen; 

hospitals, physicians, and other healthcare providers; state attorneys general; federal, state, local, and tribal law enforcement agencies; health insurance providers 

and entities that provide pharmacy benefit management services on behalf of a 

health insurance provider; and wholesale drug distributors. 

Pharmacy ‘‘Lock-In’’ Proposals 

NACDS does have concerns with proposals aimed at ‘‘locking in’’ patients to a certain pharmacy or pharmacies. Any such proposal must ensure that legitimate patient access to needed medications is not impeded. Policies to reduce overutilization 

must maintain access to prescription medications by the patients who need them 

most. 

We have specific concerns that a lock-in provision may actually be a barrier to care 

as supply chain issues exist around controlled substance medications that are beyond the pharmacy’s control. If a pharmacy is unable to obtain the medication for 

a lock-in patient, then it creates a barrier that could result in harm to the patient’s 

health. Mechanisms must be developed and executed to allow a pharmacy, in consultation with the prescriber, to fill legitimate prescriptions without needlessly delaying treatment. To minimize any potential harm and address supply issues, a patient should be allowed to use all locations for a pharmacy organization if that pharmacy uses a common database with an integrated patient profile. Additionally, to 

reduce the potential for further abuse and confusion, claim rejections should occur 

at the point of sale, otherwise pharmacies will have no way to determine whether 

a patient is enrolled in a lock-in program. 

Controlled Substance Prescription Monitoring Programs 

NACDS and chain pharmacies support controlled substance prescription monitoring 

programs (PMP) to help combat prescription drug diversion. Currently, all but one 

state have implemented a prescription monitoring program. Recognizing the role 

these programs have in helping to prevent prescription drug abuse and diversion, 

chain pharmacies actively support these programs. Pharmacies submit information 

on the controlled substances they dispense monthly, weekly, and daily depending on 

the particular state’s program requirements. This information includes information 

on the patient, prescribed drug dosage and quantity, and the prescriber. This information allows the state to conduct confidential reviews to determine any patterns 

of potential abuse or diversion. 

These monitoring programs offer many benefits to aid in curbing prescription drug 

diversion and abuse at the prescriber, pharmacy, and patient levels. These programs 

encourage appropriate intervention to determine if a person may have a drug addiction so that treatment may be facilitated. 

Yet, to promote continued operation of these programs and enhancements that improve the value of these programs to the healthcare system, law enforcement, and 

healthcare providers, NACDS encourages federal support for state prescription drug 

monitoring programs and program enhancements that integrate prescription drug 

monitoring information into healthcare systems. For example, we ask for federal 

support of policies that allow agents of pharmacists, prescribers, and other practitioners to access PMP data to assist with the integration of this data into health 

care delivery, and federal support of policies for increased interoperability of prescription drug monitoring programs across state lines, standardized data elements 

to harmonize programs, and seamless reporting. 

To create more robust public and private prescription monitoring programs, NACDS 

further supports efforts to accelerate the deployment of e-prescribing of controlled 

substances, including working with federal and state regulators and stakeholders to 

116 

encourage prescribers to issue all controlled substance prescriptions electronically. 

Encouraging greater use of this technology by practitioners could not only improve 

the timeliness of prescription monitoring program data, but also reduce the incidence of diversion throughout the country. Electronic prescribing of schedule II–V 

controlled substance prescriptions is permitted in all 50 states and DC. NACDS 

would support a policy that would establish a date for all prescribers to be compliant with state and federal e-prescribing laws for controlled substances, and the consideration of a mandate that all controlled substance prescriptions be issued electronically. 

Chain pharmacy supports the use of technology to electronically transmit controlled 

substances prescription information between prescribers and pharmacists. In addition to enhancing patient safety and operational efficiency, this practice serves to 

reduce prescription fraud. The DEA-approved process for electronic prescribing of 

controlled substances arguably provides much more protection from diversion than 

the legacy system of paper and oral prescriptions. 

Law Enforcement Authorized Programs for Return and Disposal of Unwanted Prescription Drugs 

NACDS supports specific principles for proper return and disposal of consumers’ unwanted medications. These include protecting patient health and safety by maintaining a physical separation between pharmacies and locations that take back consumers’ unwanted drugs. For example, drug take-back events sponsored by DEA 

provide for such separation and avoid the potential for returned medications to reenter the drug distribution supply chain. In addition, we support policies where consumers have a reliable and readily available means to return their unwanted medications such as mail back envelope programs. At various locations across the U.S., 

law enforcement partners with pharmacies to provide drug take-back events to give 

consumers means to return their unwanted medications. 

Until recently, consumers’ options for disposal of their prescribed controlled substances were limited. However, now DEA has issued final regulations (effective October 9, 2014) that provide additional options for consumers’ disposal of their unwanted prescribed controlled substances. The regulations implement the Secure and 

Responsible Drug Disposal Act (‘‘Act’’). The DEA regulations allow entities, which 

are DEA registered and authorized by the DEA, to voluntarily set up programs for 

disposal of consumers’ unwanted controlled substances. Both the Act and the DEA 

regulations expressly state that setting up programs is voluntary. No entity is required to set up a program. 

The DEA regulations allow a number of DEA registrants including drug manufacturers, distributors, reverse distributors, retail pharmacies, and hospitals and clinics 

with onsite pharmacies to set up disposal programs including mail-back and collection receptacles. Law enforcement may set up disposal programs including mailback, take-back events, and collection receptacles. In short, the DEA regulations 

allow a voluntary approach with each allowed DEA registrant deciding if and how 

they want to set up a program. 

Federal guidelines recommend consumers mix their unused drugs with undesirable 

substances such as coffee grounds before placing them in containers for disposal in 

their household trash. Additionally, various groups operate periodic events to collect 

consumers’ non-controlled unwanted medications. Similarly, DEA has operated a 

number of periodic collection events over the past several years where they collect 

both controlled and non-controlled substances from consumers. 

It is essential that establishing programs for taking back and disposal of consumers’ 

unwanted prescribed controlled and non-controlled medications be voluntary. Each 

entity must determine if operating such a program is feasible and workable for their 

particular setting. For instance, factors for a pharmacy to consider include public 

health and safety issues that arise if consumers bring their unwanted medications 

into the pharmacy where drugs are dispensed, patient health care services are provided, and consumers purchase other items such as health care products and food. 

Pharmacies must consider their space limitations and lack of design to take back 

consumers’ returned drugs. In addition, with pharmacists increasing role in providing healthcare services, such as immunizations and medication therapy management services, they are devoting space to provide these services. 

Voluntary drug take back and disposal programs allow the marketplace to determine what works and what does not work. Mandates, although not intended to do 

so, have the potential to disrupt the efforts to provide disposal programs. 

117 

Law Enforcement Initiatives 

NACDS and our member pharmacies support the mission and activities of numerous 

federal and state agencies and law enforcement bodies. NACDS interacts routinely 

with other state and federal officials to devise strategies to protect Americans from 

the dangers of prescription drug diversion and abuse. We support the mission and 

objectives of the National Association of Boards of Pharmacy (NABP), and have 

worked with them on a number of initiatives over the years, the most recent being 

the development of a consensus document to alert prescribers and pharmacists 

about potential ‘‘red flags’’ in the prescribing and dispensing of controlled substances. 

Target Illegitimate Internet Drug Sellers 

NACDS believes that an important strategy to stop drug diversion and abuse is addressing the problem of illegitimate Internet drug sellers. These illicit online drug 

sellers have websites that target U.S. consumers with ads to sell drugs often without any prescription required. They operate in clear violation of U.S. state and federal laws and regulations that protect public health and safety. They sell drugs to 

consumers without the safety precautions of a legitimate prescriber-patient relationship, a valid prescription, or a licensed U.S. pharmacy. 

We support targeting illegal Internet drug sellers by enabling entities such as domain name registrars that issue websites, financial entities that handle payment 

transactions, Internet service providers that show the illegitimate websites on the 

Internet, and common carriers that provide the mailing services to stop illicit transactions at their point of interaction with these bad actors. 

Shutting Down Rogue Pain Clinics 

As the number of domestic-based rogue Internet pharmacies has been declining in 

recent years, there has been an increase in the number of rogue pain clinics. According to DEA, the practitioners in these clinics are responsible for the dispensing of 

millions of dosage units of oxycodone, a schedule II opioid narcotic. NACDS supports 

the efforts of states that have enacted legislation to shut down these rogue clinics, 

such as restricting a physician’s ability to dispense oxycodone from a pain clinic. 

Conclusion 

NACDS and our members are committed to the health and welfare of our patients, 

as well as all Americans, including ensuring that they do not fall victim to prescription opioid abuse. The prescription drug abuse problem can be successfully curbed. 

However, chain pharmacy cannot solve this problem alone. There must be a holistic 

approach. All affected stakeholders must work proactively to tackle and resolve this 

problem. 

National Community Pharmacists Association (NCPA) 

Senate Committee on Finance 

‘‘Examining the Opioid Epidemic: Challenges and Opportunities’’ 

February 23, 2016 

Chairman Hatch, Ranking Member Wyden, and Members of the Committee: 

Thank you for conducting this hearing focusing both on the challenges and opportunities that may exist in the ongoing and pervasive opioid epidemic. In this statement, NCPA would like to present our thoughts and suggestions on strategies to 

curtail prescription drug abuse and address this public health issue. NCPA represents the pharmacist owners, managers and employees of nearly 23,000 independent community pharmacies across the United States. These pharmacies dispense approximately 40 percent of all community pharmacy prescriptions and are 

typically located in rural or very urban areas. 

Recommendations to Address Prescription Drug Abuse 

NCPA is committed to working collaboratively with the Department of Justice, 

DEA, other federal and state agencies, law enforcement personnel, policymakers, 

and other interested stakeholders in adopting viable solutions to prevent prescription drug abuse and diversion. We believe there are promising policies that could 

be scalable and have a positive impact on mitigating or preventing abuse, without 

compromising legitimate patient access to needed pain medications, such as: 

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• Expanded Consumer Access to Naloxone: This is a medication that is used 

to reverse the effects of opioids, especially in overdose. NCPA has begun work 

to support and advocate for pharmacists to participate in wider distribution of 

naloxone under protocols approved by state pharmacy and medical boards. 

• Enhanced Prescription Drug Monitoring Programs (PDMPs): Creating 

interoperable and robust electronic databases to track all prescriptions for controlled substances could identify improper prescribing and dispensing behavior 

as well as individuals at high-risk of overutilization. Making certain that prescribers, pharmacists, and law enforcement personnel have timely access to this 

information would ensure that drug users and/or seekers could not manipulate 

the system. 

• Formation of a Prescription Drug Abuse Commission or Working 

Group: Several lawmakers have proposed the formation of such a group to 

bring together the perspectives of law enforcement, health care providers and 

community advocates to discuss challenges and potential solutions. 

• Increased Health Care Provider Education: State medical licensing boards 

could require licensees to obtain continuing education certification on pain management and could also require that all licensees register with a state prescription drug monitoring program in order to obtain their initial license or renewal. 

• Increasing the appropriate use of Risk Evaluation and Mitigation Strategies (REMS): A REMS is a specialized set of instructions intended for prescribers and dispensers designed to enable professionals to more effectively 

manage a known or potential serious risk associated with a drug. Increasing 

more effective use of REMS information can help to decrease abuse, misuse, addiction and overdose death from opioid abuse. 

CMS Has Demonstrated Clear Success in Reducing Opioid Overutilization 

in Medicare Part D 

As part of a multifaceted response to address the growing problem of overuse and 

abuse of opioid analgesics (‘‘opioids’’) in the Part D program, the Centers for Medicare and Medicaid Services (CMS) adopted a policy in 2013 for Medicare Part D 

plan sponsors to implement enhanced drug utilization review. CMS is seeing real 

results from these efforts. From 2011 through 2014, there was a 26% decrease or 

7,500 fewer Medicare Part D beneficiaries identified as potential opioid overutilizers. This represents a 39% decrease in the share of beneficiaries using opioids 

who are identified as potential opioid overutilizers. 

In addition, in the recently released Part D ‘‘Call Letter’’—the annual document 

that provides guidance to all Part D plan sponsors for the next year—CMS clarified 

that they will now require all Part D plans to implement ‘‘both soft and hard formulary-level cumulative morphine equivalent dose (MED) point of sale edits.’’ This 

means that Part D plans will have to have certain computer systems in place that 

will automatically send a message from the Part D plan (payor) to the dispensing 

pharmacy during the claim adjudication process in the event that a prescription associated with a particular patient or beneficiary would put that patient over a 

threshold safe dosage of an opioid. Depending on the threshold amount, these edits 

will in some cases prevent certain prescriptions from being filled or processed. 

The success of CMS to date with regard to curbing opioid abuse in the Part D program clearly speaks to the suitability of CMS as the entity that should be tasked 

with the administration of any ‘‘lock-in’’ or other program designed to curb opioid 

abuse, given CMS’s experience and expertise on the matter. 

Concerns With Proposed Medicare Part D ‘‘Lock-In’’ Proposal 

NCPA would also like to take this opportunity to share our concerns regarding S. 

1913, a proposal that purports to address opioid overutilization in the elderly by requiring that ‘‘at-risk’’ individuals utilize a single prescriber and pharmacy for certain medications. NCPA would like to offer the following recommendations for 

changes to the proposal to improve oversight of such efforts and maximize beneficiary access to needed medical care and access to medications. 

• CMS, Not Individual Part D Plan Sponsors, Should Administer Any 

‘‘Lock-In’’ Program 

First, for the sake of consistency and to ensure that any such lock-in policy is 

being applied uniformly across all plan offerings, it is critical that CMS, the regulatory agency currently tasked with oversight of the Part D program, retains 

oversight over these efforts. In addition, CMS oversight would also ensure that 

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one entity has access to all of the data generated by ‘‘at-risk’’ individuals and 

is able to assess the overall success of these efforts across the entire Part D population. 

In addition, CMS oversight would eliminate concerns regarding potential PDP 

‘‘conflicts of interest.’’ As NCPA has articulated in the past, there are multiple 

PDP sponsors that have existing commercial relationships with large retail 

pharmacy chains (i.e., Humana-Walmart). The current language of S. 1913 still 

only refers to the ability of an ‘‘at-risk’’ individual to indicate his or her ‘‘preferences’’ for the single pharmacy and prescriber. In the absence of clear patient 

‘‘choice,’’ this language establishes the PDP sponsor as the ultimate arbiter of 

the chosen pharmacy and prescriber. 

• Beneficiaries Must Have the Ability to Choose Their In-Network Prescriber and Pharmacy 

It must be noted that in virtually all of the 46 Medicaid ‘‘lock-in’’ programs, it 

is the beneficiary that has the clear ability to choose both the in-network prescriber and pharmacy. These programs all clearly use the word ‘‘choice’’ rather 

than ‘‘preference.’’ In comparison, the current language of S. 1913 would only 

allow the beneficiary the ability to indicate ‘‘preferences for which the beneficiary would prefer the PDP sponsor select.’’ 

In addition, it should be noted that S. 1913 already includes language—that is 

similar to language that appears in many state Medicaid programs—that would 

allow the PDP sponsor to change the prescriber or pharmacy if it is determined 

that either entity is somehow contributing to the potential abuse or diversion. 

As long as this ‘‘fail safe’’ provision is in place, the beneficiary should be able 

to choose where and from whom they receive their in-network health care services. 

Conclusion 

In closing, NCPA stands ready to work with other stakeholders to stem the growing 

tide of opioid abuse and overdose and strongly believes that there are a number of 

potential strategies that can be utilized such as increased access to naloxone and 

enhanced prescription drug monitoring programs to address the problem. Moving 

forward, we note the success that CMS has had to date in reducing opioid overutilization in the Medicare Part D program and believe that the current ‘‘lock-in’’ proposal would need a number of key edits to ensure that it would be a coordinated 

and even-handed program. We appreciate the opportunity to provide our thoughts 

and suggestions. 

Æ