[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
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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
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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.*
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* State of Oregon v. Purdue Pharma L.P., Case No. O7C14241, 2007.
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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\
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\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
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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
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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\
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\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\
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\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\
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\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\
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\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
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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\
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\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.
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\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\
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\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,
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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\''
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\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\
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\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\
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\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\
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\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\
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\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.
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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\
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\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:
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\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.''
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\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.
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\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
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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\
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\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.
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