[Senate Hearing 114-529]
[From the U.S. Government Publishing Office]





                                                        S. Hrg. 114-529

                    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

                               __________






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                          COMMITTEE ON FINANCE

                     ORRIN G. HATCH, Utah, Chairman

CHUCK GRASSLEY, Iowa                 RON WYDEN, Oregon
MIKE CRAPO, Idaho                    CHARLES E. SCHUMER, New York
PAT ROBERTS, Kansas                  DEBBIE STABENOW, Michigan
MICHAEL B. ENZI, Wyoming             MARIA CANTWELL, Washington
JOHN CORNYN, Texas                   BILL NELSON, Florida
JOHN THUNE, South Dakota             ROBERT MENENDEZ, New Jersey
RICHARD BURR, North Carolina         THOMAS R. CARPER, Delaware
JOHNNY ISAKSON, Georgia              BENJAMIN L. CARDIN, Maryland
ROB PORTMAN, Ohio                    SHERROD BROWN, Ohio
PATRICK J. TOOMEY, Pennsylvania      MICHAEL F. BENNET, Colorado
DANIEL COATS, Indiana                ROBERT P. CASEY, Jr., Pennsylvania
DEAN HELLER, Nevada                  MARK R. WARNER, Virginia
TIM SCOTT, South Carolina

                     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)
 
      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 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 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 Toomey-Portman 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.]

             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 doctor-shopping 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.
    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 out-of-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.
    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, 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.
    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 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.
    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-IN-CHARGE, 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-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. 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 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.*
---------------------------------------------------------------------------
    * State of Oregon v. Purdue Pharma L.P., Case No. O7C14241, 2007.
---------------------------------------------------------------------------
    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 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 doctor-shopping, 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 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 almost 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.
    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.
    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.
    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 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, 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 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.
    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 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?
    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.
    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.
    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?
    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.
    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 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?
    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 self-
reporting 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.
    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 
medication-
assisted 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.
    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 reality 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.]
    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 
third-party 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 is not the Federal Government coming in with 
sort of a one-size-fits-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.]

                            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 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.
---------------------------------------------------------------------------
    \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.

    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.

    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\
---------------------------------------------------------------------------
    \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.

    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\
---------------------------------------------------------------------------
    \3\ Medicare 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.

    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\
---------------------------------------------------------------------------
    \4\ Government 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.

    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.
        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.
---------------------------------------------------------------------------
    \5\ The Pew Charitable Trusts. Pew Urges Congress to Authorize 
Patient Review and Restriction Programs in Medicare, http://
www.pewtrusts.org/en/research-and-analysis/speeches-and-testimony/2015/
05/pew-urges-congress-to-authorize-patient-review-and-restriction-
programs-in-medicare.

    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\
---------------------------------------------------------------------------
    \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.
    \7\ Office of the Inspector General, ``Compendium of Unimplemented 
Recommendations'' (2015), http://oig.hhs.gov/reports-and-publications/
compendium/files/compendium2015.pdf.

    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.
---------------------------------------------------------------------------
    \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.


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                                 ______
                                 
          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.

    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 challenges 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 ``off-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\
---------------------------------------------------------------------------
    \1\ 4.0 per 100,000 in 2013; 1.4 per 100,000 in 2000.
    \2\ http://www.samhsa.gov/data/sites/default/files/
NSDUHStateEST2012-2013-p1/Change
Tabs/NSDUsaeShortTermCHG2013.htm.
    \3\ Unpublished Oregon PDMP data.

    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 
targeted 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 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.

    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 prescription 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 high-risk 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''

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.
---------------------------------------------------------------------------
    \1\ Proceedings 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.

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\
---------------------------------------------------------------------------
    \2\ Theresa 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.

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\
---------------------------------------------------------------------------
    \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.

      In 2012, the State of North Carolina, announced $5.2 million in 
savings from their state Medicaid DMP program.\6\
---------------------------------------------------------------------------
    \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.

      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\
---------------------------------------------------------------------------
    \7\ SoonerCare 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.

      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.
---------------------------------------------------------------------------
    \8\ Theresa 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.
    \9\ Sarah 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.

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\
---------------------------------------------------------------------------
    \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.

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.
---------------------------------------------------------------------------
    \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.

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 
---------------------------------------------------------------------------
[email protected].

Sincerely,

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 options 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

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 
[email protected].

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 at-risk 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 ``lock-in'' 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 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

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 
opioid-
related 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\
---------------------------------------------------------------------------
    \1\ Leadership 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.

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 
[email protected] 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
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.
---------------------------------------------------------------------------
    \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.

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.

    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. 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

4Dr. 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 non-medical 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\
---------------------------------------------------------------------------
    \1\ http://www.samhsa.gov/data/sites/default/files/
NSDUHStateEST2012-2013-p1/Change
Tabs/NSDUsaeShortTermCHG2013.htm.
    \2\ Unpublished Oregon PDMP data.

    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.

    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.

    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\
---------------------------------------------------------------------------
    \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.

    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 prescription 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.
---------------------------------------------------------------------------
    \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.
    \8\ Food 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.
    \9\ Marc R. Larochelle, et al., Opioid Prescribing After Nonfatal 
Overdose and Association with Repeated Overdose, Ann. of Intern. Med. 
(Jan. 5, 2016).
    \10\ Id.

    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\
---------------------------------------------------------------------------
    \11\ https://www.governor.ny.gov/news/governor-cuomo-announces-
progress-states-efforts-crack-down-prescription-drug-abuse.

    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
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.
---------------------------------------------------------------------------
    \1\ Massachusetts Department of Public Health, Data Brief: Fatal 
Opioid-related Overdoses among Massachusetts Residents (Oct. 2015).
    \2\ SAMHSA, CBHSQ: Associations of Nonmedical Pain Reliever Use and 
Initiation of Heroin Use in the United States (Aug. 2013).
    \3\ Massachusetts Department of Public Health, Board of Health Care 
Safety and Quality, Report (Nov. 5, 2015).

    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.
---------------------------------------------------------------------------
    \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.

    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.
---------------------------------------------------------------------------
    \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).
    \6\ DMP Center of Excellence at Brandeis University, Briefing on 
PDMP Effectiveness at 3 (Sept. 2014).

    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.
---------------------------------------------------------------------------
    \1\ See Vital Signs: Overdoses of Prescription Opioid Pain 
Relievers--United States, 1999-2008; Morbidity and Mortality Weekly 
Report, Nov. 4, 2011.

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

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 long-time 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.
                       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).


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



    According to the 2014 National Survey on Drug Use and Health:

          10.3 million person non-medically used prescription 
painkillers in 2014 \1\
---------------------------------------------------------------------------
    \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.

        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 protective 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).
---------------------------------------------------------------------------
    \2\ The 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.''

    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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        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.

      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.
          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 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 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/.

                                 ______
                                 
      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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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 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 non-pharmacologic 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).''
---------------------------------------------------------------------------
    \1\  For state specific information, see: http://khn.org/news/
nearly-half-of-u-s-births-are-covered-by-medicaid-study-finds/.

        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 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 legislation 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;
          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 under- reporting. 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 welfare-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.
---------------------------------------------------------------------------
    \1\ 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. Retrieved from http://www.samhsa.gov/data/sites/
default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.pdf.

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 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\''
---------------------------------------------------------------------------
    \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&o
verview=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+a
ct
+2003%22%5D%7D&resultIndex=5.

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\
---------------------------------------------------------------------------
    \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.

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\
---------------------------------------------------------------------------
    \4\ Signed 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.
    \5\ Wilson, D. and Shiffman, John, ``Helpless and Hooked,'' 
December 7, 2015, http://www.reuters.com/investigates/special-report/
baby-opioids/.

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 
alcohol-affected 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 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.
---------------------------------------------------------------------------
    \6\ McPherson 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].

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\
---------------------------------------------------------------------------
    \7\ Many 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.

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \8\ The Encyclopedia of Children's Health, Fetal Alcohol Syndrome. 
Accessed March 20, 2016 from: http://www.healthofchildren.com/E-F/
Fetal-Alcohol-Syndrome.html.
---------------------------------------------------------------------------
     b.  Withdrawal as defined by neonatal abstinence syndrome \9\
---------------------------------------------------------------------------
    \9\ Kocherlakota, P. (2014), Neonatal Abstinence Syndrome. 
Pediatrics 134(2). Accessed March 25, 2016 from: http://
pediatrics.aappublications.org/content/134/2/e547.
---------------------------------------------------------------------------
     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 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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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:
      (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
    (5)  Ongoing support and age-appropriate interventions for children 
and adolescents (5-18) who may have neurodevelopmental or other 
effects.\11\
---------------------------------------------------------------------------
    \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.

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:
---------------------------------------------------------------------------
    \12\ Social Policy Report Volume 29, Number 1, 2015, ISSN 1075-
7031, www.srcd.org/publications/social policy-report.
    \13\ Mental 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.
    \15\ There 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-substance-abuse-treatment/.

    (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 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.
  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 Maternal 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 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 physical, social-emotional health and safety 
needs, as well as the mother's strengths and parenting capacity.\16\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
     (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 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\
---------------------------------------------------------------------------
    \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.

   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           Timely access to treatment is
 Disorders Prevention,             ensured by referrals and appropriate
 Intervention and Treatment        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
------------------------------------------------------------------------
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).


                                 ______
                                 

                             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: [email protected] 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 high-
quality 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.

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.
---------------------------------------------------------------------------
    \1\ Department of Health Care Policy and Financing. Summary of the 
Second Annual Evaluation Report for HCBS-SCI Waiver. 2014. Print.

 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 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 opioid-
related 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.
---------------------------------------------------------------------------
    \2\ Twillman, 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.

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 insurers 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 Sec. 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

                             [email protected]

                              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.

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 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 providers 
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 addiction, 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 [email protected] 
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 substance-related 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 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.''
---------------------------------------------------------------------------
    \1\ Mey, 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.
    \2\ S. 1913, 114th Cong. Sec. 2(a)(1) adding ``(5)(D) Selection of 
Prescribers'' to Section 1860D-4(c) of the Social Security Act.

    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 at-risk 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.

                              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 professionals 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.
---------------------------------------------------------------------------
    \3\ Drug 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.

    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 [email protected] 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

                 [email protected]

                           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 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.

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 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.

    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 medication-assisted 
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-to-door 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 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 
(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 Senator 
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 Opioid-
Awareness 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
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 significant 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\
---------------------------------------------------------------------------
    \1\ Gardner, 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.
    \2\ Wilson, 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.
    \3\ Patrick et al., JAMA 2012, Patrick et al., Journal of 
Perinatology 2015.

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 [email protected].

                                 ______
                                 
           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.

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 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 re-enter 
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 mail-back, 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.

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:

      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 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.

                                   [all]