[Senate Hearing 118-807]
[From the U.S. Government Publishing Office]
S. Hrg. 118-807
FRONT LINES OF THE FENTANYL CRISIS:
SUPPORTING COMMUNITIES AND
COMBATING ADDICTION THROUGH
PREVENTION AND TREATMENT
=======================================================================
HEARING
before the
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
__________
MAY 23, 2024
__________
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Finance
_______
U.S. GOVERNMENT PUBLISHING OFFICE
64-252-DF WASHINGTON : 2026
COMMITTEE ON FINANCE
RON WYDEN, Oregon, Chairman
DEBBIE STABENOW, Michigan MIKE CRAPO, Idaho
MARIA CANTWELL, Washington CHUCK GRASSLEY, Iowa
ROBERT MENENDEZ, New Jersey JOHN CORNYN, Texas
THOMAS R. CARPER, Delaware JOHN THUNE, South Dakota
BENJAMIN L. CARDIN, Maryland TIM SCOTT, South Carolina
SHERROD BROWN, Ohio BILL CASSIDY, Louisiana
MICHAEL F. BENNET, Colorado JAMES LANKFORD, Oklahoma
ROBERT P. CASEY, Jr., Pennsylvania STEVE DAINES, Montana
MARK R. WARNER, Virginia TODD YOUNG, Indiana
SHELDON WHITEHOUSE, Rhode Island JOHN BARRASSO, Wyoming
MAGGIE HASSAN, New Hampshire RON JOHNSON, Wisconsin
CATHERINE CORTEZ MASTO, Nevada THOM TILLIS, North Carolina
ELIZABETH WARREN, Massachusetts MARSHA BLACKBURN, Tennessee
Joshua Sheinkman, Staff Director
Gregg Richard, Republican Staff Director
(II)
C O N T E N T S
----------
OPENING STATEMENTS
Page
Wyden, Hon. Ron, a U.S. Senator from Oregon, chairman, Committee
on Finance..................................................... 1
Crapo, Hon. Mike, a U.S. Senator from Idaho...................... 3
Cantwell, Hon. Maria, a U.S. Senator from Washington............. 5
WITNESSES
Vezina, Tony, executive director, 4th Dimension Recovery Center
(4D), Portland, OR............................................. 6
Herron, Abigail J., D.O., vice president and chief behavioral
health officer, The Institute for Family Health, New York, NY.. 7
Banta-Green, Caleb J., Ph.D., MPH, MSW, research professor,
University of Washington School of Medicine, Seattle, WA....... 9
Perrone, Jeanmarie, M.D., professor, emergency medicine and
medical toxicology; and director, Center for Addiction Medicine
and Policy, University of Pennsylvania, Philadelphia, PA....... 11
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Banta-Green, Caleb J., Ph.D., MPH, MSW:
Testimony.................................................... 9
Prepared statement........................................... 47
Cantwell, Hon. Maria:
Opening statement............................................ 5
Crapo, Hon. Mike:
Opening statement............................................ 3
Prepared statement........................................... 49
Herron, Abigail J., D.O.:
Testimony.................................................... 7
Prepared statement........................................... 49
Responses to questions from committee members................ 53
Perrone, Jeanmarie, M.D.:
Testimony.................................................... 11
Prepared statement........................................... 55
Responses to questions from committee members................ 57
Vezina, Tony:
Testimony.................................................... 6
Prepared statement........................................... 60
Responses to questions from committee members................ 68
Wyden, Hon. Ron:
Opening statement............................................ 1
Prepared statement........................................... 69
Findings from the Investigation of Opioid Manufacturers'
Financial Relationships with Patient Advocacy Groups and
Other Tax-Exempt Entities, December 16, 2020............... 70
Communications
American Enterprise Institute.................................... 103
American Society of Health-System Pharmacists.................... 108
Global Health Advocacy Incubator................................. 110
Sparian Biosciences.............................................. 114
Western Governors' Association................................... 115
FRONT LINES OF THE FENTANYL CRISIS:
SUPPORTING COMMUNITIES AND
COMBATING ADDICTION THROUGH
PREVENTION AND TREATMENT
----------
THURSDAY, MAY 23, 2024
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:07
a.m., in Room SD-215, Dirksen Senate Office Building, Hon. Ron
Wyden (chairman of the committee) presiding.
Present: Senators Stabenow, Cantwell, Carper, Brown,
Bennet, Casey, Whitehouse, Hassan, Cortez Masto, Crapo,
Grassley, Cornyn, Cassidy, Daines, Barrasso, Tillis, and
Blackburn.
Also present: Democratic staff: Shawn Bishop, Chief Health
Advisor; Marielle Kress, Senior Health Advisor; and Joshua
Sheinkman, Staff Director. Republican staff: Kellie McConnell,
Health Policy Director; Charlotte Rock, Senior Health Policy
Advisor; and Gregg Richard, Staff Director.
OPENING STATEMENT OF HON. RON WYDEN, A U.S. SENATOR FROM
OREGON, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The Finance Committee will come to order.
Today, we are going to discuss the scourge of the deadly
synthetic opioid fentanyl. Fighting fentanyl requires fitting
together all the pieces in the puzzle. Already this year,
Congress has acted to disrupt the flow of fentanyl from
countries like China, thanks to the work of Senator Brown.
Today, what we are going to be digging into is the issue of
how the health-care piece fits in. These health-care issues
have not had the attention they deserve. My colleague from the
Pacific Northwest, Senator Cantwell, has been leading the way
in our region. I want to thank her for her attention to this
issue, and she has invited a guest who has some really
promising ideas for how we could have some real health-care
breakthroughs here.
The epidemic has hit communities in the Northwest like a
wrecking ball. The health-care puzzle piece is about real
people whose lives have been ripped apart by the devastating
disease of addiction. I am going to focus my remarks on just a
few areas that need immediate attention.
The first is prior authorization. Only one in five
Americans receive lifesaving medication treatment for opioid
use disorder, despite the evidence that it works. Two months
ago, Congress passed a law that I and others championed
requiring State Medicaid programs to cover medication-assisted
treatment. This approach, MAT, if we cover it on a permanent
basis, could really be the gold standard treatment for opioid
use disorder.
One of the reasons that we are digging into this issue this
morning is, I am concerned that big health insurers like
UnitedHealth and Aetna that contract with the Medicaid program
are using prior authorizations at high rates, and that is
causing delays and denial of this important treatment.
In the context of the opioid epidemic, private prior
authorization can be the difference between life and death. If
somebody walks in for treatment for their opioid use disorder
and gets stymied by prior authorization, they may just never
get back, never return, dying from an overdose before the prior
authorization is approved.
Last fall, we launched an investigation looking into how
these big insurance companies are ripping off taxpayers and
Medicaid--and patients--by using the Medicaid program as a
piggybank through tactics like prior authorization. As patients
suffer, as these mega-corporations post record profits, they
are also dragging their feet as the committee tries to get
answers about several of these tactics. These multibillion-
dollar companies owe answers to taxpayers about how these
Medicaid dollars are being used.
Next, I would like to talk about opioid use disorder for
individuals who are coming out of prisons and jails. I have
heard repeatedly now from law enforcement officials in rural
Oregon that these individuals need to be able to get adequate
treatment for the disease during and after their sentence.
Making these reforms is common sense. States are working on
their own initiatives to support access to care for people
before coming out of incarceration who need uninterrupted care.
I especially want to credit State legislators like Pam Marsh
from southern Oregon and the sheriffs from across Oregon, who
are leading the effort to get this done.
These reforms are a start toward being responsive to what
law enforcement officials are asking for: getting people off
their addiction before they get out of jail so they do not come
back.
I am going to wrap up by talking about prevention and
thoughtful approaches to pain management. More needs to be done
to head off opioid use in the first place, and encourage more
nonopioid pain management to be used in American health care.
There are promising new therapies in development that block
pain signals rather than flooding receptors in the brain with
opioids that create an addictive feedback loop. Members of this
committee are watching the development of these therapies
closely. I encourage this, and we are going to look for ways to
accelerate their entry into the health-care system. Every
single member of this committee understands the health-care
anguish and pain that opioids bring to our communities, from
one end of the country to another.
We have an excellent panel of witnesses. I will have a
special introduction for our friend from Oregon here in a
little bit. But I want to thank all our guests. We are talking
about ways to break down the remaining barriers to health-care
treatment in this crucial area, save lives, and get struggling
Americans the help they need.
Senator Crapo?
[The prepared statement of Chairman Wyden appears in the
appendix.]
OPENING STATEMENT OF HON. MIKE CRAPO,
A U.S. SENATOR FROM IDAHO
Senator Crapo. Thank you, Mr. Chairman.
The fentanyl crisis has devastated communities across this
country. Far too many families have experienced the pain of
losing a loved one from this deadly substance, and the threat
it poses to our communities and neighborhoods cannot be
overstated.
In Idaho, overdose deaths involving fentanyl increased
nearly fourteen-fold between 2017 and 2022, an alarming
statistic. It is important to note that this crisis and the
uncontrolled flow of fentanyl into our communities has not
occurred in a vacuum. In the last 2 decades, we saw an
unprecedented increase in the use of prescription opioids,
causing overdose deaths to rise dramatically.
Congress took critical steps to authorize programs to
reduce the use and supply of prescription opioids, and to
expand access to treatment for those who need it. In recent
years, as prescription opioids have become harder to obtain,
illicit fentanyl, a cheap, widely available, and potent drug
entered the drug supply, making overdoses even more
unpredictable and deadly.
According to the Administrator of the Drug Enforcement
Administration, fentanyl is the deadliest drug threat our
Nation has ever faced. While this hearing is focused on
prevention and treatment, we cannot ignore fentanyl's alarming
supply chain. It is well documented that China is a primary
source of fentanyl precursors and analogs. I joined several of
my colleagues on both sides of the aisle in pressing China on
its role in the fentanyl crisis on a trip to that region late
last year.
These precursor chemicals are shipped either directly to
the United States or to Mexico-based drug cartels and smuggled
across the southern border before they are pressed into
counterfeit pills, mixed into other illicit drugs, or
manufactured into powder form.
Any conversation about illicit fentanyl must acknowledge
the role of this administration's porous border policies, which
have given drug cartels easy access to our neighborhoods and
communities. Any efforts to bolster health-care services for
treatment and prevention cannot fully remedy the fentanyl
crisis unless we also eliminate its supply.
This committee has acted on a bipartisan basis to consider
a number of policies that expand access to mental health and
substance abuse disorder treatment for those who need it. This
includes consideration of the BETTER Act, legislation that was
passed out of this committee last fall. A number of policies
included in the BETTER Act were recently signed into law,
including permanent Medicaid coverage for medication-assisted
treatment, expanded access to residential substance use
disorder treatment, treatment for Medicaid patients, and
guidance to States to improve the availability of substance use
disorder services for those enrolled in Medicaid and CHIP.
I welcome continued consideration of policies that improve
the provision of care, including through the use of telehealth,
which has dramatically transformed the availability and
provision of mental health care and substance use disorder
services for millions of Americans.
This committee has made a lot of progress in expanding
access to care, and I look forward to working with my
colleagues on targeted policies that can make a difference and
address the root causes of the fentanyl crisis.
Thank you to our witnesses for being here today, and for
all the work that you do in our communities. I look forward to
your testimony.
Thank you, Mr. Chairman.
[The prepared statement of Senator Crapo appears in the
appendix.]
The Chairman. Thank you, Senator Crapo.
And Senator Crapo has highlighted that this crucial issue,
this crucial health-care issue, has always been bipartisan
here, and on my watch, we are going to continue that.
I am going to introduce several of our guests, and then I
am going to yield to my friend from Washington State to
introduce Dr. Caleb Banta-Green, who is doing extraordinary
work in the Pacific Northwest with what I think is a
breakthrough set of opportunities.
Mr. Vezina is the executive director of the 4th Dimension
Recovery Center in my hometown of Portland. He is also a person
in long-term recovery. Fourth Dimension is a recovery community
organization providing a variety of addiction recovery services
to adolescents and young adults.
I would also like to tell my colleagues how it is that Mr.
Vezina is sitting in that chair with us this morning. A few
months ago, I was shopping in our legendary grocery store in
the Pacific Northwest called Fred Meyer. I have had the honor
of having a chicken in every Fred Meyer in Oregon; there are
more than 50.
Senator Cantwell. How many?
The Chairman. There are just over 50. I have been to all of
them, and we can discuss that later. Mr. Vezina came up to me a
little bit stunned that I was standing there with him, and
started telling me some of the things that were crucial in
terms of health-care treatment in this area.
It was not politics; it was not the Democrats and
Republicans. He said, ``This is what we need to do.'' And so,
all of us try when we are home to get out and listen. Mr.
Vezina is here because he was in Fred Meyer when I was, and I
really thank him for coming.
The next guest will be Dr. Abigail Herron. She is vice
president and chief behavioral health officer at the Institute
for Family Health in New York. She is board-certified in adult
psychiatry, addiction psychiatry, and addiction medicine. These
are all going to be excellent witnesses.
And let me go to the end of my list and then yield to
Senator Cantwell. Dr. Jeanmarie Perrone is an emergency
medicine physician and toxicologist, as well as a professor in
the Department of Emergency Medicine, and the founding director
of the Center for Addiction Medicine and Policy at the
University of Pennsylvania.
She leads a very important program that I have learned
about, in the treatment of substance use disorders in the
emergency department, and she is also using telemedicine in a
very creative way, and we appreciate that.
Senator Cantwell, you have a terrific guest here, and why
don't you introduce him?
OPENING STATEMENT OF HON. MARIA CANTWELL,
A U.S. SENATOR FROM WASHINGTON
Senator Cantwell. Thank you. Thank you, Mr. Chairman, and
to Senator Crapo, for having this important hearing.
I would like to introduce Dr. Banta-Green, a research
professor in the School of Medicine at the University of
Washington, and adjunct research professor at the University of
Washington School of Public Health. He is also director of the
Center for Community-
Engaged Drug Education, Epidemiology, and Research within the
Addictions, Drug, and Alcohol Institute.
In his role, he leads research to generate evidence-based
solutions to the opioid crisis. He also serves on local, State,
and Federal working groups and committees related to
interventions for those who use illicit substances.
In 2012, he served as Senior Science Officer for the Office
of National Drug Control Policy in the Executive Office of the
President, and I am confident that his experience in developing
evidence-based treatment solutions for substance use will
generate much-needed insight during our hearing today.
Dr. Banta-Green participated in a roundtable that we had
about treatment models, but his research on what are community-
based treatment models and health engagement hubs--I kind of
say similar to how Senator Stabenow added mental health to the
community, on top of our already-existing infrastructure, so it
saved dollars.
But his research on these hubs has shown a 68-percent
reduction in overdose deaths. So to me, this is something we
need to understand; see if we can implement this. In King
County, we lost 1,000 people last year from opioid overdose, so
I look forward to the discussion today on how we leverage these
opportunities for community-based treatment, so we can get
something implemented as quickly as possible.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Cantwell. Thank you for
taking the lead in our part of the country. We have been so
hard-hit. We are really looking for breakthrough answers, and
to have Dr. Banta-Green and Mr. Vezina here today from the
Pacific Northwest is terrific.
So let us go right to our witnesses. We will make your
prepared statements a part of the record. If you all can take 5
minutes or so, we will begin with you, Mr. Vezina. Again, thank
you for that day when you came up to me and said, ``We ought to
do this.'' Welcome.
STATEMENT OF TONY VEZINA, EXECUTIVE DIRECTOR,
4TH DIMENSION RECOVERY CENTER (4D), PORTLAND, OR
Mr. Vezina. Yes; maybe we can get chicken after this.
[Laughter.]
The Chairman. You got it.
Mr. Vezina. Chairman Wyden, Ranking Member Crapo, and
members of the Senate Finance Committee, my name is Tony
Vezina. I am the executive director of 4D Recovery. I am also
the chair of Oregon's Alcohol and Drug Policy Commission,
though my remarks today do not represent these organizations.
It has been 11 years, 11 months, and 26 days since the last
time I used heroin or any other substance. On July 19th of
2012, I was arrested at a convenience store in Portland, OR for
possession of heroin, and I haven't used since.
I had wanted to quit for some time and had attempted
treatment several times before that. My motivation to get sober
was simple: it was for my daughter. I had made a promise to
myself at a young age that if I ever had a kid, they would not
know the isolation and despair I felt as a result of my
parents' addiction.
I was born in Idaho, but my mom fled when I was young to
Camas, WA to get away from the drugs and crime my father was
involved with. I partied in high school like other kids, but
unlike some of my peers, I had a predisposition to addiction. A
combination of genetic circumstances and my own personal
choices resulted in a 9-year opioid career which took off in
high school when my mother was prescribed an absurd amount of
OxyContin.
Everyone is aware of how OxyContin impacted our Nation, and
now we are facing a drug that is much more powerful, addictive,
and lacks government oversight: fentanyl, or what the kids that
I work with call ``fetti.'' According to the CDC, over 20
teenagers die every week from drug overdoses, and fentanyl is
the leading cause of death for this age group.
I can hope my testimony today moves this committee to
advance our Nation's response to our addiction crisis, because
I know people can and do recover when they are given the tools
to do so. This committee can address the crisis in many ways,
but I will highlight a few that draw from my personal and
professional experience.
Foremost, we need to protect our children by preventing
them from becoming addicted in the first place, with primary
prevention, and then swiftly intervene with school-based
interventions and connections to critical treatment recovery
services for those who have substance issues.
I believe we could utilize CHIP funds to bolster prevention
and school-based interventions. We can increase Medicaid rates
and provide startup funds for new treatment programs. According
to the Substance Abuse and Mental Health Services
Administration, 97 percent of adolescents with a substance
abuse disorder in 2022 did not receive care. And according to
the National Institutes of Health, the average wait time for an
adolescent residential treatment bed is 28 days. This is
unacceptable. We must capitalize on the opportunity to provide
treatment immediately when people seek it.
When I was addicted, if I had to wait for treatment, there
was a good chance I would not make my appointment, and with the
fentanyl risk of fatality, it is more important than ever to
create access on demand. We can increase access to peer-
delivered services by allowing Medicaid billing in recovery
centers, and also pretreatment engagements.
Recovery centers provide sober social hubs for people in
recovery to build relationships and access recovery support
groups. I still attend recovery meetings today, and they still
keep me sober. Pretreatment peer outreach services allow people
in recovery like me to go out and encourage people using to
seek help.
We can fund recovery residences, also known as ``sober
livings.'' After residential treatment, I moved into a sober
house and lived there for a few years. Being around other sober
people reinforced my commitment to recovery and provided time
for me to go to college, pay off debt, and purchase my first
home.
Last, we can increase access to medication-assisted
treatments. This is probably the quickest way to address the
issue. Some people balk at this proposition because they think
it's replacing one drug with another, and I used to think that.
But I realized that it is more like other replacement
therapies.
Take smoking cigarettes, for example. If a person wants to
quit smoking and switch to patches, nobody would say anything.
I have a large scar on my left forearm from an abscess I got
from injecting Vicodin. Apparently, you cannot do that. While I
was in the hospital and I was detoxing from heroin, I begged
the medical staff to prescribe me medication, which they did
not.
They did, however, later on have a priest stop by, which I
did appreciate, but I did not think you could exorcise the
addiction out of me. So I left the hospital daily to get well
on heroin. If that were me today, the likelihood I would have
overdosed would be exponential.
We must provide people with medication-assisted treatment,
especially those exiting jail. The vast majority of people in
jail have an associated addiction with their crimes. I am not
advocating for abolishing jail; you know, it saved my life. But
I do think we should rehabilitate people so that when they
exit, they can reenter society as contributing members.
This week, a classroom full of American teenagers will die
from drug overdoses. You know, I have three kids. They are very
important to me. The likelihood that they will have addiction
is pretty high, given my family. I just really hope and implore
you all to take swift action that expands access to care and
ultimately saves lives, because our kids depend on it.
Thank you.
[The prepared statement of Mr. Vezina appears in the
appendix.]
The Chairman. Thank you. You make Oregon proud, and
especially Portland.
Dr. Herron?
STATEMENT OF ABIGAIL J. HERRON, D.O., VICE PRESIDENT AND CHIEF
BEHAVIORAL HEALTH OFFICER, THE INSTITUTE FOR FAMILY HEALTH, NEW
YORK, NY
Dr. Herron. Chairman Wyden, Ranking Member Crapo, and
members of the committee, thank you for the opportunity to
speak with you today. As a psychiatrist specializing in the
treatment of addiction, I have had the privilege of caring for
individuals with mental health and substance use disorders for
the past 20 years. I am the chief behavioral health officer at
the Institute for Family Health, which is one of the largest
Federally Qualified Health Centers in New York State, where we
provide outpatient services for people affected by opioid use.
My career has been defined in many ways by the opioid
epidemic, and more recently the rise of illicit fentanyl, which
has catastrophically worsened this public health crisis.
Fentanyl is a synthetic opioid, a member of the class of
medications called opioid analgesics, which are used for pain
relief.
While opioids do have legitimate medical indications, they
carry a high liability for misuse, because they also produce
euphoria. Opioids can cause respiratory depression, which
suppresses the body's ability to breathe adequately. In an
overdose, this can progress to loss of consciousness, coma, and
death. Synthetic opioids, primarily fentanyl, are currently the
main driver of deaths due to overdose.
Fentanyl is highly potent, about 50 times stronger than
heroin and 100 times stronger than morphine. Taking even a
small amount of fentanyl can result in a fatal overdose.
Illicitly manufactured fentanyl is inexpensive to produce,
leading to the sharp increase in its availability.
Fentanyl is found in illicitly obtained opioids including
heroin and is also pressed into pills, where it may be marketed
and sold illegally as prescription opioids. It is also passed
off as nonopioid substances such benzodiazepines, cocaine, or
methamphetamine. When an individual has not used opioids and
therefore has no tolerance to the effects of them and they are
exposed to fentanyl, the risk of overdose is especially great.
Safe and effective treatment for opioid use disorder, such
as the prescription medications buprenorphine and methadone are
available. However, individuals can face barriers when
attempting to access this type of treatment. Addiction
treatment needs to be fully integrated into mainstream health
care so that we are prepared to welcome patients and to care
through multiple entry points.
At the Institute for Family Health, we practice an
integrated care model which allows patients to receive primary
care, behavioral health care, and addiction treatment in a
shared treatment setting. Colocated, integrated care increases
patients' acceptance of behavioral health care and reduces
stigma in accessing services.
There are challenges to the implementation and expansion of
the integrated care model, however. In New York and elsewhere,
same-day billing restrictions on medical and behavioral health
services prevent a single provider entity, such as a Federally
Qualified Health Center, from billing insurance for a medical
visit and a behavioral health visit provided to the same
patient on the same day. This creates barriers for patients who
face transportation and schedule limitations that can be common
in low-income populations. In addition, there is a tremendous
need for better reimbursement for case management, screening,
and preventive mental health services.
All health professionals should receive education and
training in substance use disorders and available treatments.
At the Institute for Family Health, we focus on training the
next generation of providers, ready and willing to incorporate
addiction treatment into community-based services. We have made
treatment of substance use disorders a core component of our
primary care residency training programs, and we operate an
accredited fellowship program in addiction medicine.
HRSA's Teaching Health Center Graduate Medical Education
program supports innovative community-based residencies like
the Institute for Family Health programs. Continued funding for
this program will ensure that medical, dental, and psychiatric
residents receive training in outpatient safety-net provider
settings.
The rise of telehealth over the past several years has led
to a great improvement in access. In addition to combating
workforce shortages, telehealth decreases delays in accessing
care, provides expanded availability outside of traditional
treatment hours, boosts communication between patients and
their clinicians, and enhances engagement and care.
During the COVID pandemic, many restrictions on telehealth
services were temporarily lifted, and reimbursement rates were
on par with in-person services. It is vital that we maintain
these flexibilities, including prescribing medications for
opioid use disorder via telehealth.
Telehealth payment parity is also a crucial component of
the ability to combat the fentanyl crisis. Full payment parity
for telehealth services, and not just coverage parity, will
require insurers, including Medicare, to pay for telehealth and
in-person services at equal rates. Underserved communities and
health center patients deserve access to telehealth. Without
payment parity, many health-care providers will be forced to
limit or eliminate telehealth services, because they cannot
afford to provide care at reduced reimbursement rates.
Thank you for allowing me this opportunity to share my
thoughts and experiences from throughout my career. On behalf
of the Institute for Family Health, I appreciate this
committee's commitment to combating addiction and expanding
access to treatment and recovery. I welcome your questions once
testimony has concluded.
[The prepared statement of Dr. Herron appears in the
appendix.]
The Chairman. Thank you very much. We will have questions
in a moment.
Dr. Banta-Green?
STATEMENT OF CALEB J. BANTA-GREEN, Ph.D., MPH, MSW,
RESEARCH PROFESSOR, UNIVERSITY OF WASHINGTON SCHOOL OF
MEDICINE, SEATTLE, WA
Dr. Banta-Green. Good morning, Chairman Wyden, Ranking
Member Crapo, and members of the committee. Thank you for the
opportunity to speak about this critical topic, and thank you
to Senator Cantwell, my Senator, for your consistent and
impactful leadership on addiction.
It is heartening to see the leadership of the Pacific
Northwest--Idaho, Oregon, and Washington--really demonstrating
their leadership by holding this hearing. As a health services
and public health researcher, it is an honor to participate.
My name is Caleb Banta-Green, and I have worked to support
individuals and communities impacted by opioid use disorder for
nearly 30 years. Over this time, the predominant opiate has
changed multiple times, and models of care and treatment
medications have evolved.
We have made a dent in the treatment gap--that is, the gap
between those with active opioid use disorder and those on the
medications methadone and buprenorphine. These medications are
the most evidence-based treatments for opioid use disorder.
They support ongoing recovery, and they reduce mortality by at
least 50 percent.
Unfortunately, the treatment gap persists, with
approximately three-quarters of those with opioid use disorder
not on lifesaving medications. Opioid treatment programs
primarily using methadone, and medical office-based treatment
using buprenorphine, are excellent models of care.
Yet, despite our decades of effort to expand these models
of care, they continue to serve the minority of people with
opioid use disorder. Policymakers and health-care systems
continue to improve these two models of care and expand access,
but it is clear we need a new third model of care as well.
Nonpharmaceutical fentanyl has exacerbated this need for a
new model of care. Fentanyl is a very potent and inexpensive
drug that presents substantial risk for rapid development of
opioid use disorder and high risk for overdose. Fundamentally,
we need to make it easier to access treatment medications than
it is to access fentanyl.
As part of our ongoing research, we regularly interview
people who use drugs and are accessing overdose and infectious
disease prevention services. Our published research shows that
80 percent of people who are misusing opioids do want to stop
or reduce their use. Seventy percent do want to be on these
lifesaving treatment medications, and yet most are not able to
access care in the traditional health-care and treatment
systems.
Further, three-quarters of these folks want to obtain
health care at community-based programs, at a place they know
and with people whom they trust. Over the last 10 years, we and
others have been developing and testing new models of care
based on clients' stated needs, health services and public
health data, and research-supported interventions.
We are combining a low-barrier clinical model with
community-based access points and a team-based model of care.
To support the treatment medication prescriber, we have added
nurse care managers, mental health care managers, and care
navigators. These folks provide the majority of face time with
clients, and they provide vital supports so that people can
start and stay engaged in care.
People recovering from opioid use disorder have served in
these medical and care navigator roles, and their insights and
ability to quickly build trust with clients have been
invaluable. This new care model has positively influenced the
care continuum that you are seeing up here.
We are finding that jails and emergency departments that
were once hesitant to start people on medications, because they
did not think they would show up for a medical appointment in
the next week or two, are now starting people on buprenorphine
because they know there is a place in the community providing
drop-in access to medications and other supports.
These community-based health hubs for people who use drugs
are showing positive outcomes, including in our research with
six rural and urban communities across Washington State, where
we have had significant increases in buprenorphine use and
significant declines in deaths. To date, these programs have
been funded with one-time funds including grant dollars.
What we need is a bundled care model, an alternative
payment model with adequate funding to pay for the complete
care team in these community-based settings. Again, we need the
flexibility in locating community care, and adequate funding
for the entire care team to manage this complex, chronic,
relapsing medical condition.
As one of our clients, an older unhoused woman with long-
time opioid use disorder in eastern Washington, told one of our
community staff, ``I've been in and out of treatment throughout
my life, and you are the first people to treat me well. So I
keep coming back, and I've brought my friends.''
Opioid use disorder with fentanyl is tough, but we have a
third model of care that can help us dramatically close the
treatment gap, support recovery, keep people alive, and help
restore the health of individuals and their communities.
Thank you very much for your time, and I look forward to
your questions.
[The prepared statement of Dr. Banta-Green appears in the
appendix.]
The Chairman. Well, Dr. Banta-Green, I am trying to recover
my jaw, because it has dropped sort of at the description you
have given of a promising new treatment plan. And we are just
going to probably turn you and Senator Cantwell loose to get
this done, because it is very exciting. I appreciate your being
here.
Dr. Perrone?
STATEMENT OF JEANMARIE PERRONE, M.D., PROFESSOR, EMERGENCY
MEDICINE AND MEDICAL TOXICOLOGY; AND DIRECTOR, CENTER FOR
ADDICTION MEDICINE AND POLICY, UNIVERSITY OF PENNSYLVANIA,
PHILADELPHIA, PA
Dr. Perrone. Chairman Wyden, Ranking Member Crapo, and
members of the committee, thank you for inviting me to share my
experiences as an emergency physician in a busy hospital in
Philadelphia. Although the statistics we have heard today are
dramatic, nothing is worse than facing a parent whose son or
daughter has been brought to our hospital after a fentanyl
overdose.
The struggles of a family battling opioid addiction and
navigating the health-care pitfalls in this chronic, relapsing
disease are heartbreaking. In the chaos of missed appointments,
we recognize that the emergency department can be a gateway to
same-day treatment, initiating the first dose of lifesaving
treatment with suboxone or methadone.
Multiple randomized control studies have built the evidence
demonstrating that treatment with these medications can reduce
the risk of fatal overdose by 65 percent. Yet only 11 percent
of people with opioid use disorder receive these medications.
Appointments, insurance, transportation, and pharmacies stand
in the way.
We started a program to provide these medications in our
emergency departments in 2018. My colleagues have been trained
in prescribing, and our nurses help to identify and support
patients to take that step.
Tuesday, overnight in the emergency department this week at
2 in the morning, I saw three patients with opioid use
disorder: one who was seeking treatment was started on
methadone; one who had been revived from a nonfatal overdose
with naloxone; and one young woman, particularly memorable, who
received her first dose of suboxone and was discharged with a
prescription alleviating her withdrawal symptoms and with
followup to our telehealth program, our peer-led model.
I would have liked to have started her on a long-acting
injectable medication, but that is not available. This is one
aspect of low-
barrier treatment, meaning that the patient does not need an
insurance card or an ID and does not need to wait weeks for an
appointment or be subject to various scrutiny, all of which can
derail early attempts at recovery.
Telehealth has now created a critical safety net, more cost
effective than the emergency department and more patient-
centered than other care settings. Our CareConnect warmline
offers free telehealth substance use navigation and same-day
clinician appointments to start treatment with suboxone.
We leveraged our peer-led model to staff 9 a.m. to 9 p.m.,
7 days a week. We have now treated over 2,000 patients,
including 10 percent of our patients who report release from
incarceration in the past 30 days. Implementing this important
safety net for citizens reentering the community mitigates this
high-risk period and is critical to closing the treatment gap
that patients face when they leave carceral settings.
We have also expanded other services for this vulnerable
population, including assistance navigating insurance
applications, phones, and transportation to future
appointments. A Ryan White funding model could be used to
establish regional networks of telehealth addiction bridge
treatment, to prevent gaps in care and continue patients on
medication during care transitions.
We have found that two-thirds of our telehealth patients
were recently on suboxone, yet were discharged from a care
setting without a timely follow-up, or lost insurance, or faced
a life event where their care was disrupted. Experiencing
opioid cravings without medications drives patients back to the
street, only to face the most lethal supply and, potentially,
overdose.
Creating low-barrier models such as telehealth bridges
enhances retention. Telehealth can also solve long appointment
wait times in rural areas due to provider gaps. We must sustain
current exceptions to Federal regulations for telehealth and
create billing parity for these services.
Telehealth can also address treatment access disparities.
In the Philadelphia area, there has been a 30-percent increase
in fatal overdoses in communities of color since 2020. Fentanyl
adulteration of the stimulant drug supply has yielded a new
cohort of patients with opioid exposures.
Qualitative interviews from our community share that they
want more privacy in their substance use treatment options.
They do not want to wait in lines outside of opioid treatment
programs. We need to focus on developing culturally informed
treatment, medication education, and harm-reduction tools to
address these disparities.
Telehealth can help establish care with privacy, and then
transition patients to a primary care integrated model, where
patients can receive their addiction care with their
hypertension and diabetes medication, all from one trusted
provider.
Our patients transition from our ED or telehealth visits to
our primary care practices. This integrated model needs to be
expanded and reimbursed to sustain discrete treatment options.
This requires investment in clinician workforce, including
expanding addiction medicine training in graduate medical
education, and support for expanding capacity for more trainees
for addiction medicine fellowships.
Our programs utilize the wisdom of peers like Mr. Vezina,
who build alliances with patients and help them navigate the
early treatment journey. Peer training provides a pathway to
employment for people in recovery. We must expand these
programs by developing billing and reimbursement strategies for
these services.
Their journeys destigmatize and provide role models to our
community members struggling with addiction and are a source of
inspiration. People do recover, and we need to share that
narrative.
Thank you again, and I look forward to your questions.
[The prepared statement of Dr. Perrone appears in the
appendix.]
The Chairman. Thank you. This has been a terrific panel.
Let me start with you, Mr. Vezina, and set the table this
way, because this committee has a lot of history in this. We
felt some time ago--Senator Crapo and I, Senator Stabenow,
Senator Cornyn--that one of the key pieces for the treatment
gap was schools, that you really had to get these services into
the schools.
So, when we dealt with the gun safety legislation here a
couple of years ago, Senator Crapo and I basically had black
letter law ready to go that we could give to Senator Stabenow
and Senator Cornyn. Those two did a terrific job as we molded
this gun safety legislation, in particular to pay for more
behavioral health services in the schools. That is essentially
what we were able to do, working with the leadership, Senator
Stabenow, and Senator Cornyn.
So my question to you is, here you are having battled this
for quite some time; what supports and services would have been
helpful to you in your youth to ward off the addiction? Just
put yourself in that kind of role, because your expertise would
be terrific. And as we started talking, earlier in the grocery
store, I think we really need to learn from our experiences.
Mr. Vezina. Sure. Chairman Wyden, Ranking Member Crapo, and
the other committee members, thanks for the question. I think
there are a few different things we could do in school-based
settings. You know first and foremost, like I said, we need
primary prevention strategies that educate kids and give them
the tools around drug use.
Second, I think we need to educate kids about recovery.
When I was in high school and I was using a lot of drugs, there
was a wrestling coach at my school. He was really good, and I
had found out that he was in recovery from addiction, and I had
looked down on him for that at that time, because I had no
concept of the disease model of recovery. It was not until I
got into recovery and I learned about the disease model, that I
realized it was not a moral failing. It was a disease that
could be put in remission.
And then I think having peers in schools would be good, to
talk to kids who exhibit symptoms of substance use disorder.
And then last, for kids who have substance use disorder
that is more chronic and severe, recovery high schools have
shown to be efficacious, and I helped start one in Oregon. We
have been working with those kids regularly.
Thank you.
The Chairman. Well, we will be following up with you,
because this issue is going to have to be tackled again. And I
remember my colleague Senator Stabenow with her Hallways to
Health, and that really summed it up. And so, this has been
part of our committee's kind of focus, to take our area of
jurisdiction where we could have an opportunity to make a
difference. And thank you for making the trek.
I know a little about most subjects, but I know everything
about airline schedules. It is hard to get here except for our
one nonstop.
Question for you then, Dr. Banta-Green. I think you could
tell from my comments earlier, I am outraged at the level of
abuse with this prior authorization. I think it is being used
too often by big insurance companies to basically pad their
pockets, and they are not doing what is needed for Medicaid and
for patients.
And I know from having talked with Senator Cantwell, you
have got some thoughts on this. Give us your sense about what
impact prior authorization has on access to treatments (A), and
then (B), what should we be doing to get more people
opportunities through Medicare and Medicaid--our committee's
jurisdiction--to get the help they need?
Dr. Banta-Green. Thank you for the question. You have heard
what a life-threatening condition we are talking about--in the
moment, every day. You know, people are often using fentanyl 10
or 20 times a day, and every time they are using it is a risk
for overdose.
So, any delay in accessing care with these medications--
methadone, buprenorphine--increases the chance of death. So
that is really the fundamental impact of prior authorization:
any delay in care can be life-threatening.
A somewhat more subtle point, but also important, has to do
with dosing, and which doses are allowed. We started off with
how we dosed buprenorphine in particular at fairly low doses,
and the research keeps showing that the higher doses you use,
the better folks do. The easier it is to get them started on
medications, the better they will stay engaged in it.
If we use low doses at the outset, people may have a bad
experience and think that buprenorphine does not work, when
perhaps the dosage was not working. And so, it has this
unintended consequence in that way. Another aspect of prior
authorization--which we know from an insurance perspective--has
to do with moral hazard. We think people are somehow going to
over-use or misuse that substance.
That does not make sense in this context. It is cost
containment. And one of the really important issues that was
brought up about all these long-acting, injectable forms of
buprenorphine that can last a week or a month is, these are
very expensive, and they are very effective.
We are hearing--it is really emerging in the last 6 to 12
months how much providers and patients are really liking these
medications, and doing really well on them. So that cost issue
in the long-acting injectables is also going to be a factor
when it comes to prior authorization.
The Chairman. Thank you.
Senator Crapo?
Senator Crapo. Thank you, Mr. Chairman.
And, Dr. Perrone, in recent years we have begun to see an
emerging pipeline of nonopioid medications and devices with
serious potential for pain management. In 2022, our committee
worked to advance access to these options by addressing
problematic reimbursement policies through the NOPAIN Act.
As safe and effective alternatives to opioids come to the
market, policymakers will need to continue identifying and
addressing potential barriers and disincentives. What steps,
legislative or otherwise, do you think would help ensure
providers and patients can access these nonopioid options as
they come to market?
Dr. Perrone. Thank you, Senator Crapo, for the question. We
have spent a lot of effort decreasing opioid prescribing. We
have done a lot of clinician education. There have been
policies put in place at the State level limiting the numbers
of opioids, which have been very effective. So, a typical
prescription might be previously for 30 pills and now is
limited to 10.
Those really help us divert from opioids to nonopioid pain
medications. Depending on the cost, we have a lot of very
effective nonopioid pain medications that were underutilized in
the opioid era. Medications like acetaminophen--Tylenol--and
ibuprofen are incredibly effective.
I can remember, I was a doctor at a summer camp, and there
were young women coming to camp with Percocet or oxycodone for
menstrual cramps. So we have moved very far away from the
overprescribing of opioids, but there have always been very
effective analgesics, like I mentioned, that can actually be
used.
If we have new, nonopioid, nonaddictive medications, we
would want to use them, but we also want them to be compared to
current nonaddictive medications that are very effective.
Senator Crapo. Well, thank you. And while I am visiting
with you, I would like to go to xylazine. DEA Administrator
Milgram recently stated that xylazine is making the deadliest
drug threat our country has ever faced, fentanyl, even
deadlier. While this hearing is focused on fentanyl, I am
concerned that the parallel rise in the presence of xylazine,
and FDA's warning that it is undetectable using routine
toxicology screens, is a problem.
How has this cooccurring rise in xylazine complicated your
ability to recommend and provide treatment for patients?
Dr. Perrone. Thank you again; very good question. In
Philadelphia, the fentanyl supply has been adulterated with a
veterinary tranquilizer called xylazine, sometimes called
``tranq,'' and it has been convincingly impacting our patient
population. It has been associated with wounds, really
significant wounds like Mr. Vezina mentioned: wounds on his
arm.
We are now seeing a different kind of wound, and these
wounds on patients who are housing-challenged really fester and
progress, so that when they finally come to the emergency
department because they have wounds, they actually need to be
hospitalized. And then after hospitalization, it is very
difficult to send them to rehabilitation facilities because
most of the rehabilitation facilities cannot accept patients
with wounds.
So, it is a big Catch-22 that is limiting our ability to
get the most vulnerable patients who need the help the most
into treatment. However, I do not want to misguide, and I think
as Ms. Milgram said in her statement, our deadliest drug is
fentanyl. Fentanyl stops people from breathing, and all of the
xylazine is accompanied by fentanyl.
So, we still have naloxone that reverses the fentanyl
component, so patients do get revived with naloxone. They may
still be sleepy, but they're breathing. So I want to keep the
focus on fentanyl as the most important drug we need to focus
on. We have one antidote that works incredibly effectively. We
do not need 10 antidotes.
I do not want to be distracted by all these other drugs
coming into the drug supply, because they are really mixed with
fentanyl, and fentanyl is the deadliest component of all of
this.
Thank you.
Senator Crapo. Thank you, and well said.
My last question, Dr. Banta-Green, will be to you. In 2023,
law enforcement seized a record number of counterfeit pills
containing fentanyl, more than double the amount in 2022. While
there are many people who knowingly consume fentanyl, I am
concerned by the number of fentanyl-involved overdose deaths
among young people, despite declining drug uses in that same
population.
How has the proliferation of fentanyl-laced counterfeit
pills impacted the efficacy of overdose prevention and other
harm reduction efforts?
Dr. Banta-Green. Thank you for the question. We are seeing
really profound differences in substance use disorder with
fentanyl for youth. We have just conducted research, and our
preliminary results show that the time from use to developing
use disorder for heroin averages 4 years. For fentanyl, it is
closer to 1 year, and in many cases, it is months. So it is
very, very fast.
I think what it really points to is the fact that we need
all of these messages simultaneously. We cannot just be doing
prevention and hope that works, and then later move into health
education and treatment and recovery. We have to have these
conversations simultaneously, so that people are aware of what
the whole bundle looks like.
So with youth, we are really looking at this rapid
development of use disorder. We are looking at substances that
are very potent and of unknown potency, so the overdose risk is
very high. We absolutely should be doing overdose education and
distributing naloxone. That will always have a small impact; it
is an emergency rescue medicine after an overdose has occurred.
So primary prevention, I would argue--really focusing on
physical and emotional pain and building resiliency to those
things in youth and their environments to reduce the emotional
pain--is going to be really important as well.
Senator Crapo. Thank you.
The Chairman. Thank you, Senator Crapo.
Senator Stabenow?
Senator Stabenow. Well, thank you. Thank you so much, Mr.
Chairman. Thank you to all of you for really providing
excellent testimony.
And, Mr. Vezina, speaking about the stigma and so much
around addiction, people just say, ``Well, just stop; just
stop.'' The reality is that this is physiological. I mean, it
is about health, and your brain changes in its patterns, and so
on, as you know.
And so, this is something that involves treatment and
support for people to be able to make the changes. So, the rise
of fentanyl has had a devastating impact, as we have been
talking about this morning, and certainly had a devastating
impact in Michigan.
In 2023, we had about 3,000 Michiganders who died of a drug
overdose, and three out of four of those were related to
fentanyl. So, it is pretty scary what is happening right now,
and it does not even come close to encapsulating the pain and
the tragedy Michigan families have faced, as I know families
have faced across the country.
So we know that, among other things, this is an all-hands-
on-deck moment for treatment, access to treatment. In addition
to what we have done moving forward in schools and the
legislation we passed in Safer Communities, we have begun to
transform behavioral health care in the community by fully
funding Community Behavioral Health Clinics on the exact same
model as Federally Qualified Health Clinics.
So, the FQHC model--full Medicaid reimbursement,
prospective payment, and so on--we now have 10 States, as
hopefully you know, that are fully funded through Medicaid. In
a couple of weeks, 2 or 3 weeks or so, the next 10 States will
be announced. And then we will keep going and going until we
have every State having the opportunity to have fully funded
clinics--not just individuals, but the cost of the clinics. It
is so important.
So, I do want to just note that, of the clinics that we now
have, 82 percent of the behavioral health clinics offer at
least one form of medication-assisted treatment for opioid use
disorder, compared to 56 percent of other types of clinics. So
these are comprehensive clinics. We want to see them all over
the country, and I'm anxious to work with all of you to do
that.
And so, Dr. Banta-Green, I wondered--you talked about
comprehensive community-based care in your testimony. I turned
to Senator Cantwell and said, ``He is describing CCBHCs,
Certified Community Behavioral Health Clinics,'' because that
is what we are talking about: primary care, comprehensive care,
addiction and mental health services--whoever walks in the
door, regardless of payment method, and so on.
But I wonder if you could speak a little bit more about
Community Behavioral Health Clinics, in terms of their role in
closing the gap for opioid use disorders.
Dr. Banta-Green. Thank you very much for the question. They
are really providing a very important access point for many
folks, and I think particularly folks with serious mental
illness. I think there is just a huge gap for those folks. It
is very difficult for them to access care, and I think in
particular, that is such a wonderful access point for them.
So, I think that is a great thing that is happening there.
It is a little--it overlaps and it is a little bit adjacent to
the model that I am describing, which is a bit different. We
are sort of purposely not using a clinic-based model. We are
really going into community settings, programs that are serving
folks who are unhoused, really getting out into these
community-based programs where folks already go, they already
have a relationship.
So it is a bit different in that way, and there is also
quite a bit of focus on infectious disease testing and
treatment, which is very important. And we are working toward
hepatitis C elimination and the great medications we have for
HIV. So there are definitely some parallels, but there are some
distinctions as well.
Senator Stabenow. Well, I think both are necessary. I think
it is terrific what you are doing. I would love to see a
comprehensive model that involved full funding--the capacity
for both--which is what we should be doing.
And I would just say quickly, as my time runs out, that,
Mr. Vezina, you talked about access to recovery services for
young people. Could you speak any more about school-based
support for--we have health clinics in many places, but not
necessarily mental health and addiction services. And sort of
broadly, what more should we be doing?
Mr. Vezina. Yes; thank you so much. It is a really good
question. I would start off by saying we could educate
teachers. Teachers spend a lot of time with our children, and
they need to be equipped with the skills to identify and then
properly refer kids to where they need to go.
Now, depending on the severity of the disorder, it could be
treated, eliminated, inside the school, or they are going to
need a referral out to a more specialized service. And so, one
thing that we see in Oregon is that there is not the
comprehensive care for kids.
And so, they may have some comorbidities with mental health
and addiction, but there are not services to serve them, so
they end up in places where the providers do not have the tools
for it. So we need to bolster kind of the entire system of care
and then intervene with kids in schools and get them at the
appropriate level that is going to serve them best.
Thank you.
Senator Stabenow. Thank you so much.
Thank you, Mr. Chairman.
The Chairman. And thank you for your years of work in this
area, Senator Stabenow, and particularly with Senator Cornyn.
Senator Grassley?
Senator Grassley. We hear this figure of 107,000 Americans
dying from a drug overdose. We learned just last week that more
than 321,000 children have lost a parent to a drug overdose in
the past decade. I am working to tackle the illegal production
and distribution of this deadly drug fentanyl from multiple
directions: through legislation to close loopholes, putting
pressure on the Biden administration to enforce the laws,
holding adversaries like China accountable, and securing the
southern border.
As cochair of the Senate Caucus on International Narcotics
Control, I am fighting to permanently classify fentanyl
knockoffs. Throughout much of the opioid epidemic, drug
kingpins have laced heroin and other drugs with highly potent
fentanyl. We must do more to proactively step up to stop the
spread of that.
Now I am going to follow up a question that Senator Crapo
asked about xylazine, and I am going to ask Dr. Perrone and Mr.
Vezina this question. First of all, I am leading a bipartisan
bill that recognizes this lethal threat and provides law
enforcement with tools to combat it.
Because it is a sedative and not an opioid, its effects
cannot be reversed by naloxone. That is the standard opioid
overdose treatment. So, to you two, what effects have you seen
in Philadelphia and Oregon on drugs laced with xylazine?
Dr. Perrone. Thank you for that question. As I think I
alluded to, it is a little bit confusing, but fentanyl and
xylazine are always going together. So 99 percent of our
exposures are fentanyl and xylazine. When a patient is
resuscitated from that kind of overdose with naloxone, they
will wake up, they will restore breathing, and they will be
revived.
They may be sleepy for a couple of extra hours, and so the
time to bring them to an emergency department to support them,
to have a peer like Mr. Vezina talk to them when they wake up,
is really valuable. There has been a lot of talk about
antidotes for xylazine. I do not think that that is necessary.
To make an analogy, there are medications like valium and
Xanax, which are benzodiazepines. They are not opioids. They
make patients sleepy, but they do not stop people from
breathing. We have an antidote for that, but we do not use it
because it would immediately cause withdrawal, which might be
life-threatening.
So, we have other antidotes for medications that cause
sleep, but we do not use them. So really, I want to focus back
on naloxone and fentanyl. Those are the deadly drivers of this
epidemic. Fentanyl is the cause of people stopping breathing
and dying.
That is the 107,000 number, the 80,000 number--we need
naloxone, and we need to focus on fentanyl. Xylazine has been a
problem, but I think it has been a little bit overestimated
relative to the huge impact that fentanyl continues to make.
Senator Grassley. Can you add anything to that, Mr. Vezina?
Mr. Vezina. Yes; thank you so much. What I would say from
engaging people in the recovery process, most people that we
work with are not targeting xylazine as their drug of choice.
Like the doctor said, it is just included in the fentanyl, and
what I have heard is, the strategy is to extend the legs of
fentanyl. What that means is to extend the effect.
You know, fentanyl wears off really quickly. When I was
using heroin, it would last me about 6 to 8 hours before I
would start to go through withdrawals. With fentanyl, people
are having to use every hour, and so I think it is a method, to
put xylazine in there, to extend the effect.
And so, I think we need to focus on what can we do to help
people discontinue fentanyl use. And again, medication-assisted
treatment is probably one of the quickest and most efficacious
ways to give people a chance to recover.
Thank you.
Senator Grassley. To the same two of you, this: a few years
ago--I suppose about 5 years ago, when I was chair here--I held
a hearing that included a discussion on distinguishing between
good treatment providers from bad treatment providers.
Since then, the Federal Government has published best
practices and guidelines for recovery providers. Five years
later, have we gotten better at weeding out good treatment
providers from the bad ones, and if not, why are ineffective
efforts and unaccountable treatment providers still in
business, and what should be done about it?
Dr. Perrone. The terms ``good'' and ``bad'' are difficult,
but I would say that it is easy, if any of us had a child who
was suffering from addiction, to think that you want to send
them somewhere and get them off of everything. That is kind of
a detox abstinence model. You may have friends or relatives who
have gone through treatment for alcohol. That is an abstinence-
based treatment model, and that is very effective for alcohol.
For opioid use disorder, we desperately need these medications.
Patients may succeed in becoming detoxed off of their opioids,
but within days to weeks they will have cravings, and they will
get back to that drug.
The death rates after treatment in rehab facilities that do
not offer medications are incredibly high. We know that the
evidence basis supports methadone and buprenorphine. So we can
incentivize only reimbursing places that offer these
medications.
In addition, these places might offer the medications, but
the patient alone may say, ``I do not want that. I do not want
to substitute one drug for another.'' So we need to reeducate
both treatment providers and patients in our communities,
because there is such a push to abstinence that people just do
not understand the evidence.
And that is on us, clinicians, to continue to educate
everyone. It is an immediate instinct to think you do not want
someone on any medication because you want them detoxed. But
that is really just ineffective, and our evidence really
suggests we desperately need medications.
The long-acting injectable medications that persons would
get once a month, would decrease their need to take a
medication every day, and that really is supported as well.
The Chairman. The time of my colleague has expired.
I do want to brag a little bit about Senator Grassley. He
mentioned when he was chairman, some tall guy from Oregon--kind
of obscure--was his ranking minority member.
Senator Grassley put together a very important report that
looked into the whole question of tax-exempt entities helping
to drive up opioid sales, while downplaying the risk of opioid
addiction.
In all seriousness, I was pleased to be able to join you as
the ranking minority member, and I ask unanimous consent to put
Senator Grassley's important report into the record at this
time. Without objection, so ordered.
Senator Grassley. Thank you.
[The report appears in the appendix beginning on p. 70.]
The Chairman. Senator Cantwell?
Senator Cantwell. Thank you, Mr. Chairman, and thank you
again to the witnesses.
Dr. Banta-Green, from 2022 to 2023, Washington State saw a
34-percent increase in drug overdose deaths, which is the
single highest increase in the United States. Overdose is now
the leading cause of accidental death in our State,
outnumbering firearms and car crashes.
Out of a report, ``Drug Overdose Deaths in 2022,'' 70
percent involved synthetic opioids like fentanyl. So I
definitely appreciated your opening statement about this model
that Washington State did as a demonstration program. It became
impressive with the number of results that I think you say
are--well, it implies that if King County had those hubs in
operation last year, the hubs could have saved over 600 lives.
But you are saying there has been a 68-percent reduction. I
think, almost to Dr. Perrone's point she just made, if you are
not into the treatment, then you are not into a solution
basically, because it is such an addictive product.
So, one of the things that you discussed in your testimony
was that low-barrier, community-based models and bundled care
basically solved two problems. One, they got people into
immediate treatment, and they got everybody else in the system,
including the jails, to start this process with you. So
basically, from the time of interaction with an individual, we
now have them on a path to treatment.
And then second, that bundling of care with those care
navigators also provided a support for the system. My guess is
though, we do not have all the numbers from your results.
We do have the information about how many lives are being
saved, but my guess is that this also is cost-saving. While it
might sound like a bundled care payment is similar to what
Senator Stabenow has done on community-based care, you are
literally saving dollars, because now you are not seeing the
same people over and over again.
You are definitely not seeing them in the emergency room.
You are definitely not housing them in our jails. Could you
speak to why this prospective payment model--I want to thank
Senator Cassidy though before you comment, because he has
agreed to help us demonstrate this also at the Federal level.
He has done great work on methadone oversight and trying to
make sure that our clinics expand on those issues. But could
you talk about why this prospective payment system is so
important?
Dr. Banta-Green. Yes. As you are hearing, we really need to
allow people to access care rapidly and stay engaged. The
process of recovery for alcohol and cannabis generally takes
about a year, per research from John Kelly. For opioids and
stimulants, it is about 3 years.
And during that process of recovery, people are often
returning to use, and they continue to use substances. So we
need a place where people can start today and come back
tomorrow no matter what. Just like the woman I was describing
in our program earlier, she kept coming back because she was
treated well.
We had another client tell us, ``In previous treatment
programs, when I relapsed, I did not go back to treatment,
because I knew they were going to kick me out. But this time
when I relapsed, I came back to care, because I knew you were
not. I knew you were going to keep caring for me.''
So this model of care, this easy access no matter what,
this open door while people work on building their recovery
over years, is really vital. And that takes the people and the
place, and it takes the model of care. It is all of those
things together.
That stat to me is particularly exciting, because we hear
these statistics--around a 50-percent or a two-thirds reduction
in mortality. This was a population that was largely unhoused.
This is a very vulnerable population. And these statistics--the
way we did our analysis is actually compared to other people
who were in standard models of care and also got medications.
So this reduction in mortality is really around high-risk
populations getting this complete model of care, and that is
what is really exciting, and why we need to package those
things together.
Senator Cantwell. And we are basically though tying into
existing infrastructure, which is also the cost savings of the
model.
Dr. Banta-Green. Right, and if you think about the cost
savings, we are building on existing infrastructure. We are
adding in things like nurse care managers and care navigators,
which can be very difficult to bill for. There can be ways to
bill for them in certain settings for certain types of
conditions. But here, they need to be sort of universally
folded into this bundle of services that are getting paid,
because they are the glue. They are the ones who are doing all
of this face time.
There have been multiple research studies that have shown
prescribers will see a lot more patients. They will start
seeing any patients, and they will see a lot more patients if
they have these care supports, because it makes their job
easier, and their patients do better.
Senator Cantwell. So, it is also--you are just saying it is
more streamlined. The whole system is streamlined.
Dr. Banta-Green. So, it is more streamlined. We haven't
even talked about the savings when you are actually able to
intervene, test, and treat someone's infectious diseases. I
mean, there are a lot of things that we are doing here. It is
not just treating the opioid use disorder. Opioid use disorder
almost never occurs in a vacuum. You know, it is also the
reason that we are able to bring people in who have mental
health issues, who have infectious disease issues.
We are going to realize those cost savings. They no longer
need to be stealing in order to obtain their substances. So
there are lots of different ways that we obtain those cost
savings.
Senator Cantwell. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you.
I want to make sure everybody understands that the package
that we produced in terms of what to do for kids and for
treatment and prevention did not happen by osmosis in 2022.
Senator Cornyn was particularly valuable as it related to
schools, and I remember you and I talking about telemedicine
provisions in terms of helping these kids, which largely came
from Senator Carper.
So, Senator Cornyn, you are on, and we thank you for your
past effort to make sure that the Republican leadership was a
key part of getting this done. It was a real breakthrough.
Senator Cornyn. Well, thank you for that testimonial, Mr.
Chairman.
The Chairman. I hope it does not hurt you. [Laughter.]
Senator Cornyn. Thank you all for being here and for your
contribution to our understanding of what is an extraordinarily
complex problem. I remember H.L. Mencken was quoted as saying,
``For every problem, there is a solution that is simple, neat,
and wrong.'' And so, I think we need to look at the whole
problem and not just parts of it, and we have tried to deal
with the mental health aspects of it.
Obviously, we are talking today about treatment issues. It
is important, I think, that we treat the people who are
suffering from these addictions with compassion. And, Mr.
Vezina, I just want to congratulate you personally, not only
for your personal recovery, but your example to show other
people that it is possible, and that ought to be a source of
hope and inspiration to others.
But there is something called the law of supply and demand,
and every time I go to Mexico City or somewhere like that and
complain to the Mexican Government about the drugs that come
across the border, they say, ``Well, if there wasn't a demand
in the United States, then there wouldn't be a supply.''
What can we do to address demand? Nancy Reagan had an
answer: ``Just say no.'' But that, I do not think, turned out
all that well. So, what could we do to address demand? Any of
you.
Dr. Perrone. Thank you for that question. I thought a lot
about this in thinking through an answer. I think that, you
know, we have two problems. Right now, we have an abundant
supply based on the price. The drug is incredibly cheap, and so
it is everywhere, and that is actually driving some demand
because they are putting fentanyl in other drugs including
stimulants and cocaine.
Many of the patients that we see who are now becoming
addicted are becoming addicted because, unintentionally, they
were exposed to these substances. So a big supply problem. I
think demand can be mediated primarily by medications for
opioid use disorder for patients who already have fentanyl
dependence, as well as, I think, primary prevention, which is
very complicated.
You know, Mrs. Reagan's ``just say no'' program was not
effective. I think we need to trust adolescents to understand
within their own communities how they want to take this on. You
know, for adolescent drug overdoses, if you look at who is
overdosing, a third of the patients have a substance use
disorder. A third of them have a mental health condition and
are just self-medicating with what they think might be Xanax,
and it contains fentanyl. And then a third are actually just
overdoses that are part of the inadvertent supply.
So we need to take those patients, those adolescents, and
learn from them and empower them to educate their own
communities with, obviously, more guidance about primary
prevention. So we need to listen to our teens and figure that
out.
Senator Cornyn. Well, in my much more limited experience
talking to parents who are grieving the loss of their children,
public awareness, both of the individual who consumes the drug
unwittingly--maybe they think they are taking something else,
only to have it contaminated with fentanyl--but also parents
and schools educating their students; that is, as the DEA's
slogan goes, ``one pill can kill.''
But it strikes me that we cannot just look at the treatment
side. We have to also look at the supply side, and
unfortunately, we have seen a tsunami of human beings coming
across the southern border, which is actually part of the
business model of the cartels. They get rich for every person
they can smuggle across the border, and then, when the Border
Patrol are occupied with processing migrants, maybe
unaccompanied children and the like, then here come the drugs
that killed 108,000 Americans last year alone.
I was just looking at the statistics, and in the last 3
years, about 200,000 Americans have lost their lives due to
fentanyl poisoning, and it seems to me we have been
extraordinarily naive and unsuccessful in dealing with the
supply side, primarily because our border is not controlled.
And if you go to places like Colombia, for example,
typically the source of cocaine or the heroin that comes from
Mexico and elsewhere, they say that their market share of those
drugs is actually going down for the very reason that you
mentioned, Doctor. It is because fentanyl is so cheap. You do
not have to grow a plant. You do not have to process it. You
just mix up the precursors in your sink or wherever, make it
look like a Xanax or Percocet, and there you go.
So, I think we have to look at the supply, which also
includes interdiction of those drugs coming across. I am not
suggesting that is the only answer. Obviously, it is a very
complex set of circumstances. But to just look at the treatment
without the supply, I think does not address the whole problem.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Cornyn.
Senator Carper?
Senator Carper. Thanks, Mr. Chairman and Mr. Crapo; thanks
to you and our ranking member for pulling this together, for
this important hearing.
Sometimes when witnesses come before us, they actually
bring a member of their family, and they sometimes will
actually ask to introduce members of their family.
But I am not going to do that today. It is pretty easy, Dr.
Perrone, to find the one who--because she looks just like you,
and she is sitting right behind you. So, we are watching to see
if her lips move when you speak. We will see who is calling the
shots here. [Laughter.] But welcome to any other family members
who might be here today. Welcome.
The substance use commonly, as we know, usually, oftentimes
begins during adolescence and compromises the well-being,
compromises the safety and the development of our young people.
When it comes to health care, I have long believed that we have
to meet the people where they are, and for our youth that is in
schools in many cases.
During the time I was privileged to serve as Governor for 8
years before I came here 22 years ago, I was proud to put a
school nurse in every Delaware public school, and a wellness
center in just about every high school in Delaware.
Mr. Vezina, you stated in your testimony that people with
substance use disorders can recover when they are provided the
tools to do so. I think that is what you said, and I would just
ask, Mr. Vezina, could you please speak further to the
importance of school-based supports in providing adolescents
the tools they need for the prevention and treatment of opioid
use disorder?
Mr. Vezina. Yes; thank you so much. You know, I would just
reiterate again that we need to prevent it from happening in
the first place. And from my limited understanding--I do not
run any prevention programs, but I do work with a bunch of
prevention advocates in Oregon, and they always make sure I say
``primary prevention,'' not preventing overdoses.
They do not have necessarily a reimbursable service model
like treatment does, and so it is hard for them to get their
services up and running. And so, I would ask this committee to
figure out a way to fund primary prevention for organizations
to go out and educate our kids and build resilience in our
kids.
There is one private organization that I work with that I
am on the board of called ``A Song for Charlie.'' It is led by
two parents who lost their son to fentanyl. They have done
incredible work with educating kids around the dangers of
fentanyl.
I recall a study before around the naivete of children with
fentanyl, where they thought cigarettes were more hazardous
than fentanyl, and that is a big problem. So we need to educate
our kids and give them the tools not to use. And again, when
they do develop the symptoms of a substance use disorder, we
have to be able to intervene and then get them to the services
that are going to best fit them.
And right now, at least in Oregon--and I assume it is like
this across the rest of the Nation--there is not an
infrastructure for adolescent care. From my understanding on
the Medicaid side, it is two parts: one is regulatory and
administrative burdens, and the other part is low reimbursement
rates for care. Those two things disincentivize individuals
like myself who have run treatment programs from opening up
care for kids.
Thank you.
Senator Carper. Okay; thank you.
I am going to follow up my question I just gave you with a
question for the record, and I would appreciate your comments
there.
A question on workforce readiness. In recent months, not
only has our health-care system in Delaware seen a greater
number of patients being treated for suspected overdoses, but
there has always been a significant increase in the severity of
the effects of overdoses. This severity is reflected in a
greater percentage of overdose patients needing a higher level
of care, including intubation, and requiring admissions to
intensive care units.
Dr. Perrone, my question is, can you speak to why we are
seeing such an increase in the severity of the effects of
overdoses? How can we work together to ensure that our first
responders are best equipped to address this growing crisis?
Dr. Perrone. Thank you for that question. The question was,
why are we seeing an increase in serious consequences of
overdose, and I think that goes back to these mixed substances.
So, a patient who overdoses on a typical bag of what
somebody thinks is fentanyl now contains three or four other
drugs, including xylazine, especially in Delaware where, you
know, the radius of xylazine concentration certainly extends to
the Delaware area.
So, patients may be quite sleepy after an overdose, despite
the fact that they got some naloxone. Their respirations or
their breathing might have been adequately restored, but in the
setting of continued sleepiness or somnolence as we call it,
they may undergo intubation. And once they have intubation,
meaning that they are on life support, then they end up in the
ICU because that is the only place in the hospital where we can
manage people on a ventilator.
They might be able to not be intubated and be managed in an
emergency department, but frankly, we have such boarding issues
in the emergency department. We are filled to the gills, 100
people in the waiting room. So sometimes moving a patient who
might be critical for the emergency department to manage back
to the ICU because they are intubated, is a good strategy
because the emergency department needs to manage new patients
coming in.
And so, I think for EMS, we need to continue to advise them
to use naloxone. They have the airway management skills. And
when a patient comes to the hospital, we could probably manage
some of them very closely without intubation and allow them to
wake up on their own.
Once you are on a ventilator, we actually often need to
give you additional sleepy medications to keep you on a
ventilator. So, it is a little counterintuitive. But we need
new research looking at these mixed substance overdoses and the
best way to manage them.
Senator Carper. Thank you very much.
The Chairman. I thank my colleague.
Mr. Vezina, very important point about getting the
architecture right for getting information to kids in schools
and the like. We are beginning to build it. I have been getting
out and talking about the benefits of the 2022 law in terms of
Medicaid.
But since you are here and you are doing so well, we are
going to get you involved in building out that architecture
too, because I think you said it very well.
Senator Cassidy?
Senator Cassidy. Dr. Perrone, in my medical practice--I am
a doctor too. In my medical practice, I worked in a hospital
for the uninsured and the poorly insured, which is a euphemism
for Medicaid.
I am recognizing that Medicaid, although it is coverage,
oftentimes pays so little that, frankly, people do not take it.
So, knowing that Medicaid is financing a lot of these treatment
programs, but as a poor payer, your business model somehow has
to accommodate for that. It might be a community health center,
et cetera.
If you look across our 51 jurisdictions, what is the kind
of uptake? Relate to me on some sort of a graph, if this is
Medicaid and this is the number of treatment programs relative
to population, how good is Medicaid doing in terms of
encouraging people to provide these programs?
Dr. Perrone. Thank you for that question. You know, we work
in a model where we are primarily--all of our patients are
Medicaid or no insurance, so we rapidly get them on Medicaid.
And fortunately, in Pennsylvania, we do have pretty rapid
access to Medicaid.
Whether or not that reimbursement is sufficient, it
certainly is not. You know, I work in an academic medical
center where the mission pays for----
Senator Cassidy. So you have less--you have some sort of
subsidy for good human work?
Dr. Perrone. Yes; yes.
Senator Cassidy. Now that said, then my question is not on
the particular, but rather on the statistical. If I were to
look at the average among States on a per capita basis--and the
capita is the number of people who need treatment. And knowing
that many of these are Medicaid patients, how well is Medicaid
doing in terms of financing this care?
Dr. Perrone. That is a difficult question for me to answer.
I can say Medicaid is the largest purchaser of addiction
services in the country. But I do not know what the gap is in
terms of people who are not getting appropriate addiction care.
Senator Cassidy. Can you just speak in general then about
what is the--well, okay. Let me just kind of drop that.
Mr. Vezina, again in my medical practice, I used to treat
patients in jails. I used to go to the prisons, so I am aware
of all this.
I am aware that somebody who is currently booked into jail
loses Medicaid benefits before being adjudicated. And so, they
may not have been guilty, but they still lost their Medicaid,
and they have to go through the whole rigamarole to get back on
Medicaid.
Now, something that we are working on in this committee,
Senator Wyden and I--two bills. One, the DUE PROCESS Act, which
would allow 7 days of coverage or 14 days, depending on the
version, for somebody with substance abuse to continue on
Medicaid once put into a jail. And then the Reentry Act, which
would allow the enrollment in Medicaid 30 days prior to
discharge from a prison.
So, any comments from your, kind of like, living the
experience, how might this help somebody either initiate or
continue therapy once on the outside, to aid that transition,
or never lose Medicaid so they never lose the coverage that
they would like to have?
Mr. Vezina. Yes, thank you so much. In the most general
terms I would say, you know, jail serves as a rehabilitation
place.
Senator Cassidy. It serves as a rehabilitation place?
Mr. Vezina. Right, and so we would want the services in the
jail, however we pay for them. That would give people
rehabilitative services. And knowing that the majority of
people in jail have a substance use issue and a lot of times
that drove their other criminal behavior, we would want to
address that first and foremost. And so, in the county jail
systems, a person loses Medicaid, and then the jail has to pay
for the services. I am not an expert on the criminal justice
budget, but I feel like they do not have the money to pay for
adequate services.
And so, leveraging Medicaid match for those behavioral
health services would be ideal from a cost savings perspective.
And then in prisons--I have been working with some guys in
prison. From what I understand, adults in custody are not
eligible for treatment until 6 months before they leave.
That does not make a lot of sense to me, because you'd
think you would want to treat them and get them support right
when they got there, so that they could----
Senator Cassidy. Hang on. But if somebody is in a prison,
therefore they are at least incarcerated for a year or more.
Mr. Vezina. Right.
Senator Cassidy. Theoretically, although we know there is
lots of contraband, they would not have access. Granted, as Dr.
Perrone says, that does not mean that they will not go back,
but in prison they will have less opportunity to go back.
Mr. Vezina. Yes, you would think that, but that is just not
the case. And so, what I would say is that we would want them
to have access to treatment right away.
Senator Cassidy. Do we know from data the degree of
fentanyl overdose within prisons?
Mr. Vezina. I am not able to answer that question today,
but I will say that it has been a problem in Multnomah County
that I am aware of, to the point where there is a passing of
the torch of who is going to help people who are addicted. So
jails may be less hesitant to take people if they have a risk
of overdose.
Senator Cassidy. I am out of time.
Dr. Herron, I had a question for you, but instead I have
kind of a critique. One of my favorite employees is sitting
right behind you--you stole him from me. I'll forgive you for
that, only because I want him to have a great opportunity. But
again, thank you for your good work, and, Mandar, great to see
you, man.
I yield.
The Chairman. Thank you, Senator Cassidy. Our work is going
to continue in this area relating to prisons, and particularly
because we have some exceptional sheriffs and law enforcement
officials in southern Oregon working with their State
Representative, Pam Marsh, on exactly the questions that you
are raising about this whole kind of proposition.
Because of the nuts and bolts of this--we are getting the
Medicaid match and all these related issues--you are going to
be a busy guy, Mr. Vezina, because this committee is going to
keep you, as an Oregonian, active on these issues, and I look
forward to it.
Senator Bennet?
Senator Bennet. Thank you, Mr. Chairman, and thank you to
you and the ranking member for having the hearing. Thank you
all for being here today and taking time out of your schedule
to be here.
Let's see. Dr. Banta-Green, I am not going to pick on you,
but I have a question for you. The opioid crisis continues to
devastate Colorado communities, especially our kids. Last year,
Colorado tied New Mexico for the second-highest number of
fentanyl pill seizures in the country, and Colorado has the
second-highest youth overdose rate, more than double the
national average for kids between 14 and 18.
Today in Colorado, and I would say across the country,
students are petitioning their school boards to allow school
nurses to provide naloxone in their office because without it,
their friends might die before an ambulance arrives.
I once was the Superintendent of Schools in Denver. It was
not that long ago, and that is not what kids had to spend their
time doing. But it is what they are spending their time doing
today.
When I heard a student had died back then--and it would
happen from time to time when I was Superintendent--I used to
ask whether that child had been in a car accident or whether
she was dying of cancer. But now when I hear a child has died,
the question that I ask myself is, did they die from guns, did
they die from suicide, or was it a fentanyl overdose?
Like tree rings, you can see--you know, at least I can--
that there was something very different about the world when I
was running the Denver public schools 15 years ago versus
today, and especially for our kids.
Historically, treatment for substance use disorder wasn't
focused on kids. It is clear to me that we need to do more to
address teen substance abuse. So, Dr. Banta-Green, could you
identify gaps in treatment or services for young users in this
country, and how do we recalibrate our approach, particularly
under the Medicaid program, to account for the rise in youth
substance use disorder?
Dr. Banta-Green. Thank you for the complex question. A few
things I will note on that. So, in terms of schools, I
understand why we want to work in schools. We know where many
youths are, and that is an important place to do this work. We
need to do this work in schools and support them.
We of course need to look at the social determinants of
health upstream of that, out in the community. How do we
support those families so they can have their own resiliencies,
so they can identify and address physical and emotional pain?
There is this idea in schools--and I have done many
trainings with school nurses about naloxone. Naloxone is great.
Naloxone is the floor of what we should be doing. Naloxone is
the gateway drug to talking about opioid use and opioid use
disorder. Those same school nurses have to know that this is a
treatable medical condition, and that buprenorphine will reduce
mortality by over 50 percent.
It is appropriate and authorized for adolescents, so it
absolutely should be used. We run a learning collaborative once
a month for adolescent medicine providers around treating
opioid use disorder. We have about 30 to 40 prescribers showing
up from across our State. So that is very important.
And then I just cannot say enough about what Dr. Perrone
said. If you think about these different time horizons--okay,
they have opioid use disorder. We know what to do. But why are
they using opioids? So, in the moment, they are often using in
the context of peer pressure. But what we find often is really
in the context of the same reason that adults are using
medications, which is pain, anxiety, and sleep problems.
Identifying those, and having those resources in schools,
is going to be very, very important, and then there are the
upstream factors as well. But those are just a couple of things
to think about with adolescents. We have to again be thinking
about what are all of the different opportunities to intervene.
Senator Bennet. I would like to talk about, what I think,
is a crisis that we are facing as a country. Teen suicide is at
an all-time high. Children's emergency room visits for mental
health have increased by 140 percent over the last 5 years. In
2021, 40 percent of Colorado's high school students reported
persistent sadness or hopelessness.
To Dr. Banta-Green's point, Dr. Perrone's point, Colorado
psychiatrists tell me in all their years of practice, nothing
has affected kids the way that social media has affected kids.
Parents and teachers tell me they feel absolutely hopeless to
address it. And I do not think that we can lay this all at
their feet, but when people ask me what is different about
schools today than when I was there, the answer is mental
health, mental health, mental health.
You can chart it back to when everybody ended up with one
of these phones in their hand, and social media is--one of the
leading law enforcement officials in America told me recently
that social media is the last mile for every fentanyl and meth
death in America.
Dr. Herron, could you elaborate on the intersection between
the mental health crisis and increasing substance use among our
youth, as Dr. Banta-Green was talking about? I am going to stop
there because I am out of time. So, if you could just take a
second, and then I will turn it back over to the chairman.
Dr. Herron. Thank you for the question, Senator. We see the
intersection between mental health and substance use disorders
as the primary focus of someone like me as an addiction
psychiatrist. The majority of individuals in either treatment
setting are contending with the other type of disorder as well.
So, if you look among mental health treatments, we see a
large group of people with substance use disorders and vice-
versa.
But primary prevention--where we teach people to recognize
that the feelings that they are experiencing, the anxiety, the
pain, are an illness, and there are treatments available--is
essential. And also, pushing those services into school-based
mental health treatment models, into pediatrician offices, into
family medicine offices, so that there is a recognition and an
ability to treat those things before they get into adulthood,
before they have more exposure to substance use, is really
essential to helping to impact the crisis.
Senator Bennet. Thank you.
Mr. Chairman, thank you. I apologize for going over.
The Chairman. Well, I want to apologize to our colleagues,
because we are doing some juggling here. If we could, let's go
with Senator Barrasso and Senator Brown. Nothing is going to
get in the way of that order.
Senator Barrasso?
Senator Barrasso. Thanks so much, Mr. Chairman. This is a
critically important hearing. I am so glad you are calling
this.
I just heard from Dr. Cassidy, a physician as well as a
member of the committee. I am a physician as well as a member
of the committee. Both of us are concerned, as we all are,
about the health and safety of our Nation--truly alarmed by the
fentanyl crisis facing our Nation. Clearly, nothing like that
existed when I was practicing medicine. It is everywhere. No
community is spared. A lethal dose is equivalent to just a few
grains of salt.
You know, across the country, the number of deaths has been
skyrocketing. In my home State of Wyoming, you would not think
there would be a problem there. We have had 81 opioid-related
overdose deaths this past year. It is double the number from 5
years ago--completely unacceptable. It is touching every
community across our Nation. You've got mothers, fathers,
brothers, sisters, all losing family members. I hear about it
all around the State.
Since President Biden took office, nearly 10 million
illegal immigrants have flooded into our Nation--Senator
Grassley touched on this a little earlier today--77,000 pounds
of fentanyl confiscated at the border over that time. You do
not know how much got through, but you can imagine, just based
on the statistics and the deaths, the number is high.
Whether it is from China or Mexico, the transnational
criminal networks that are producing, transporting, and
marketing these drugs are poisoning our country. Our Border
Patrol agents, who are supposed to be our first line of defense
in apprehending the drug smugglers, they cannot get their job
done to the level that it needs to be done. They are being
forced, I believe by this administration, to deal with
unaccompanied minors, asylum-seekers who are surging across the
border, which is making an increased opportunity for the
criminal cartels to get more drugs across.
Mr. Vezina, I read your story, heard what you had to say. I
really appreciate your ability to be here to speak on substance
use disorder care, because that is what we are looking for.
Care is needed now more than ever. Today, you have spoken about
the challenges that folks in recovery face when they do not
receive a full continuum of services.
It is not like there is one silver bullet on this. You need
the whole thing. Your experience as someone in recovery,
someone providing collaborative care, says that you need a
network: mental health counseling, substance use counseling,
peer support, case management, medication-assisted treatment--
all of those things.
So, given the frontier nature of my home State of Wyoming,
people are spread out. You do not have all of those services
available everywhere. There are only two towns with a
population that can support this level that you have described
in the specialty care. There is even less availability for
youth-focused programs like yours.
Are there existing programs, either State or Federal, that
you are aware of, that can help in rural communities where you
do not have that full continuum, even though we know that is
the best treatment?
Mr. Vezina. Yes; thank you so much. From what I can tell
you in Oregon, telehealth services have been able to meet some
of the gap. So, figuring out ways to fund telehealth services--
there are also some restrictions in kind of geographic capacity
that providers run up against when they are not reimbursed for
that. Sometimes there are standard reimbursement rates for care
that are really designed for when people walk into the office,
and they do not take into consideration some of the other
costs. Like some of the things that we do in Clackamas County
are, we have to drive all over the place, because it is part
urban and part rural.
And so, we have to either fundraise money or get additional
grant costs and stuff like that to cover our mileage, for
people to drive out and meet people where they are at. So that
is a couple of things I could think of.
Senator Barrasso. Dr. Perrone, a quick question. You know,
in February this year, the DEA reported on regions of the U.S.
being targeted by the Mexican drug cartels. I live in one of
those regions in Wyoming. They found that the cartels are
targeting States further away from the border. Highest areas of
focus are Native American reservations, they talk about in
those States.
Certainly, that is the situation in Wyoming. Our Eastern
Shoshone and Northern Arapaho, they live on the Wind River
Reservation: it is larger than the State of Connecticut. I
mean, we are talking about a big geographic area with low
population. It continues to experience one of the highest rates
of drug overdose deaths in the State.
I am deeply concerned about the cartels that are targeting
our Native American populations. A lot of that has to do with
the fact that the size of the geography and the smaller number
of people make it an area where they can really focus.
You know, can the Federal Government do things? How can we
best respond, from the Federal Government level, to counter the
efforts by the cartels?
Dr. Perrone. Thank you, Senator Barrasso, for that
question. I mean, in terms of supporting patient populations in
rural areas, I think telehealth can give more rapid access to
treatment. I think you are going to need some onsite care in
the Indian Health Service in order to provide support for this
population.
In terms of around the country, other groups have targeted
vulnerable populations. The drug companies that precipitated a
lot of this have also targeted populations in Appalachia and
other places that started the demand for opioids.
So we have a lot of work to do to unwind a lot of these
things. But I think resources and reimbursement for services
onsite would be really important, and perhaps expanding the
Native American health services with a focus on integrated care
models there would be helpful.
Senator Barrasso. Thank you.
It just seems to me--this is my last statement, Mr.
Chairman--that until we secure the border and protect
Americans, we are not going to be able to get to the bottom of
the root of the fentanyl problem.
The Chairman. The time of my colleague has expired.
Today, we are focusing on the bipartisan efforts on the
health aspects of fentanyl. Several of my colleagues have
mentioned the whole supply issue. If we are talking about
supply and fighting the cartels, that gentleman over there,
Senator Brown of Ohio, has written the FEND OFF Fentanyl bill,
the FEND Act, that is going to make a big difference on supply.
Senator Brown?
Senator Brown. Thank you, Mr. Chairman. Thanks for
mentioning that at the beginning of the hearing too.
Four hundred people die every month in my State, a
relatively large State. The problem is serious, of course. I
was in Toledo not too long ago talking to the former husband of
a woman who was an auto worker at the Jeep Cherokee assembly
plant in Toledo. And she had a workplace injury, and she
started taking opioids, and she developed an addiction. She
died of some kind of fentanyl poisoning, not sure where it came
from.
We know that those are human stories, not just statistics,
obviously, as, Mr. Vezina, you certainly know. And as the
chairman said, after fighting for a year, Congress passed my
bipartisan FEND Off Fentanyl Act, which focuses on targeting
and sanctioning the precursor chemical makers in China and the
manufacturers, the cartels in Mexico that put this stuff
together.
Cracking down, obviously on the supply, and at that level
going after where the big money is, is really important. But of
course, as the chairman said, it is an all-of-the-above
approach.
Let me start with this, Mr. Vezina. You discuss in your
testimony the importance of prioritizing interventions for
youth and young adults to prevent and treat substance use
disorders, and peer support workers or people who have a lived
experience with a substance use disorder or mental health
condition and work with people in recovery.
These services have been shown to be effective in helping
people recover. Mr. Vezina, as communities work to implement
various peer support models for addiction, what are the biggest
barriers in their doing that?
Mr. Vezina. Yes; thank you so much for the question.
Certification can be a barrier. Sometimes State license
certifications or licensed behavioral health providers have
really stringent background checks, and a lot of people like
myself in recovery have criminal histories. So that is a
barrier that we have faced.
Additionally, reimbursement rate models that are
commensurate with the actual activities that peers do, you
could look at that; for example, pretreatment engagement. So
this would be before somebody got an assessment and a
prescription for care. Allowing peers like myself to go out and
engage people and motivate them to seek recovery--that is
something that you could look at.
And then, I do not think it is within the jurisdiction of
this committee, but from my limited understanding, there are
issues with reimbursing peers on the commercial market as well.
Senator Brown. Okay. And Medicaid clearly has been a
lifeline. I was in Cincinnati at Talbot House, an iconic
treatment program and center for 60 years now, and I was
sitting with a man and his probably 30-year-old daughter, and
he put his hand on her arm and said she is alive today because
of Talbot House, which we are in because of Medicaid--and we
all know that.
How important is Medicaid in your mind when it comes to
patients accessing treatment services?
Mr. Vezina. Oh, it is incredibly important. You know, just
for myself, before the expansion of Medicaid, there was a
lottery system, and I was trying to get into treatment, but I
did not get selected for the lottery. And so, I had to wait,
and they had to prioritize other populations aside from me.
But after Medicaid expansion, I was able to get into
treatment immediately, any time I sought it for the most part,
in Oregon.
Senator Brown. And there is obviously the question of prior
authorization, which occurs in far too many cases. So, the
overuse of prior authorization is a burdensome process that
requires an insurance plan to approve services before a patient
can receive them.
For Dr. Perrone, how important is it for a patient who is
ready to get started with treatment to be able to access it
immediately? And in the face of the problems we have with prior
authorization, talk about that, if you would for a moment.
Dr. Perrone. Yes; thank you. Our care model has been built
on same-day treatment. So, when a patient comes for care, we
want to start them on medications immediately. Because I work
in the emergency department, prior authorization is not
necessary for me to give that medication. But for me to
prescribe it and for the patient ultimately to get it filled,
that was a big barrier.
In Pennsylvania, they did get rid of prior authorizations
for the initiation of buprenorphine a few years ago. They
recently also allowed us to write for higher doses, which have
been necessary in the fentanyl era, and which also required
prior authorizations until recently.
Senator Brown. Talk about that, why you write for higher
doses.
Dr. Perrone. So, because, as Mr. Vezina explained, the use
of heroin was often about four times a day, because it lasted 4
or 5 hours. Fentanyl lasts a couple of hours, so people are
using 8 and 10 times a day.
The degree of opioid dependence that people have developed
from fentanyl rivals anything I have ever seen, and there is a
tremendous need for medications at much higher doses to combat
that, both methadone and suboxone or buprenorphine.
So now we need to prescribe higher doses. The higher doses
were restricted to prior authorizations, but now that process
has actually been changed in Pennsylvania, but probably not in
a lot of other States. So we can prescribe 24 milligrams
instead of 16 milligrams a day, because that is what our
patients need.
Senator Brown. Thank you for the work you are doing in
Senator Casey's State. Thanks.
The Chairman. Thank you, Senator Brown.
Here is where we are. First, with respect to the comments
Senator Brown has made, I think this kind of highlights where
we are in this debate. We are going to have to tackle the
supply issue, and that is why Senator Brown's approach under
the FEND Act is going after the cartels.
I strongly support that effort, and we have got to come
back and deal with the medication issue, which is why he talked
about the prior authorization. Those two pieces are critical as
we sort out this puzzle, and I thank my colleague for doing it.
Here is where we are. I am going to have to run and vote.
Senator Crapo will run this until I get back. I think next in
the queue is Senator Whitehouse. But Senator Crapo will run
this, and we are getting close, colleagues, to wrapping this
up. I have an additional question, Senator Crapo may, but we
are getting close.
So, if the word can go out that we are almost there, we are
getting ready to finish----
Senator Crapo, we'll just call Senator Whitehouse.
Senator Whitehouse. Thank you, Mr. Chairman.
The Chairman. Thanks.
Senator Whitehouse. I heard my colleagues' comments about
the need for added border protection against fentanyl, and it
is timely to hear that, because we all have the chance today to
vote on a bipartisan border measure that would add
unprecedented levels of detection and enforcement at the
border. So it will be interesting to cross-reference the
comments and the votes.
Just a word on Rhode Island. I am pretty proud of what we
have done in this space. We were early leaders on getting
medication-assisted treatment into our correctional
institutions. That reduced opioid fatalities by over 60
percent, just that one measure.
And it has expanded beyond that. I am really proud of our
police chiefs in multiple police departments who have peer
recovery specialists, recovery coaches, recovery follow-up
after the night sheets come in, social workers engaging with
the police departments. It has really been pretty outstanding.
Some of our fire departments turn up after treatment, will
get you into treatment sites. Some States have difficulty
making that work. We made it work. We've got the 988 program
operating with a group called Behavioral Health, BH Link, so
that if you call, you are immediately on the phone to get the
resources you need, which can include vans that go to you.
So there is a lot going on. I want to really applaud the
Rhode Island treatment and recovery community, which has
stepped up to this in wonderful ways. And the behavioral health
centers that Senator Stabenow talked about are very often being
set up in Rhode Island in conjunction with the treatment and
recovery facilities that are already there.
So we even have a safe injection site that is doing full
wraparound services to try to get people off of their addiction
as quickly as possible. So there is a lot going on.
I think, as all the witnesses know, this is an ecosystem
that is being built piece by piece, and we need to build it out
more robustly and improve the coordination. But I have been
really impressed with what I have heard from all of you today.
I am very, very grateful for your work and your focus.
Dr. Perrone, one of the things that we are going to have to
face up to is that at the end of the year, the COVID telehealth
authorization for opioid treatment expires. I have a bill that
I hope will prevent that from happening. We have to get it
passed. In plain words, is there any upside to letting that
telehealth authorization expire?
Dr. Perrone. Thank you for that question. I also would
applaud the Rhode Island Department of Health and their many
innovations.
As COVID started, I was actually on the phone with my
colleague at the Rhode Island Department of Health, as we
rapidly pivoted to a telehealth strategy. And I would say,
``no.'' We definitely want the telehealth reimbursement parity,
the telehealth options that we have that were rapidly
innovated.
I would like to applaud all the people involved in allowing
us to provide telehealth during COVID as swiftly as it was
made, and we need to sustain that regulation, because it is
critical. We have treated 2,000 patients. I am sure Rhode
Island has treated a large proportion of people via telehealth.
Various other programs have popped up around the country.
But we could create a telehealth network that would be less
expensive than a lot of other onsite care, just for care
retention and gaps and people leaving carceral settings. So,
telehealth could be widely used more than it is, and save a lot
of lives.
Thank you.
Senator Whitehouse. In my last 30 seconds, I will add one
additional observation that I have heard repeatedly out of the
recovery and treatment community in Rhode Island--which we had
a witness here in the Finance Committee the other day also
volunteer--which is that the professionals who are dealing with
people in recovery not only saw telehealth as an important
functional advantage in terms of people being able to meet
their appointments and have the communications that they needed
to have, but that the actual substantive content of the
engagement improved, because people felt more comfortable being
able to engage telehealth from home, not have to drive across
town, not have to wait in the waiting room, not have to fill
out the stupid clipboard, not have to go into somebody's
office, but actually be able to engage from a place where they
felt considerable personal comfort.
So, I offer that closing thought, and thank you very much.
Senator Crapo [presiding]. Thank you.
Senator Hassan?
Senator Hassan. Thank you, Senator Crapo, and thanks to you
and the chair for holding this hearing. To all of our
witnesses, thank you not only for being here, but for the work
that you do.
I just wanted to start, Senator Crapo, commenting--because
we were both part of the bipartisan congressional delegation
that traveled to China, and I know you talked about that a bit.
We really pushed Chinese President Xi to stop illegal fentanyl
precursors from flowing out of China. China has said it would
work with the United States, and that was a really good first
step. But we need to see stronger actions from the Chinese
Government to disrupt drug trafficking that empowers
international cartels.
And while we continue to work to stem the flow of fentanyl
into our own country--and I would echo Senator Whitehouse--we
are voting on a bill this afternoon that would provide
extremely strong protections at the border, strengthen our
border, including strengthening the way we combat fentanyl at
the border. I hope my colleagues will join us in voting for
that bipartisan bill.
But we also need to continue to seek progress on treating
opioid addiction. So I wanted to ask all of you, because there
has been a line of questions about medication-assisted
treatment and the importance of Medicaid coverage to help
people get that treatment. Senator Brown and Senator Wyden both
talked about it.
Dr. Perrone, you talked about some of the barriers to
getting people access to medication-assisted treatment when
they need it, at the place they need it. Can we just--is there
anything that has not been mentioned that is a barrier, whether
it is through Medicaid or elsewhere, to getting that kind of
medication-assisted treatment? And I will start with Dr.
Perrone, and we will just go right down.
Dr. Perrone. I think we subtly mentioned stigma. People are
embarrassed. They are terrified. They have been treated poorly
in health-care settings. So back to telehealth. That is one of
the reasons why people feel more comfortable initiating care
over the phone, meeting a provider over the phone, and then
knowing that in a peer-led model they would see someone else as
a familiar face when they go into treatment. So I will just
stop there and let my other colleagues respond.
Senator Hassan. Yes, that would be helpful; thank you,
because time is limited.
Dr. Banta-Green. I will just mention a couple of quick
things on the same theme of stigma. We know that approximately
half of physicians still think of medications for opioid use
disorder as a replacement, in a negative way, for addiction. So
that is a very important factor that we need to be thinking
about.
And we really need to educate the general public that
opioid use disorder is a treatable medication condition, and
medications are the most evidence-based interventions we have.
And very importantly, they do not just reduce mortality, but
they actually support recovery.
I have had people who are on suboxone and cycled on and off
it because they thought while they were still on it, they were
still an addict. And the idea that you can be in recovery and
be on medications is important for everybody to know, because
if the family is not supportive, those folks may not start or
stay on medications.
Senator Hassan. Thank you.
Dr. Herron. Thank you for the question. You know, I will
just underscore again the importance of low-barrier access to
treatment: people working in integrated care settings having
the ability to receive patients at the moment that they are
ready to enter care.
Addiction is inarguably a disease. There is also a
behavioral component to this illness, and we need to be able to
catch and welcome patients into care at the time that they are
ready to do it, and have no wrong door, so that, if you are
with your primary care provider, your dentist, your
psychiatrist, anyone is able to do that.
I will also add, the fentanyl crisis in particular has
increased the need for higher doses of medication. That also
means that not everyone can adequately be treated with
buprenorphine. Buprenorphine was a revolution in providing care
by prescription so people did not have to travel to opioid
treatment programs.
I know, Senator, you are well aware and have a similar
position about expanding access to methadone. But that is a
serious geographic concern, where there are entire States,
hours of travel necessary for people to be able to engage in
methadone under the current treatment structure.
Senator Hassan. Just to follow up on that, would it be safe
to expand methadone treatment beyond certified methadone
clinics? I think we have now evidence because of the pandemic
that says that it is.
Dr. Herron. Absolutely. It should not be more difficult to
access treatment for a substance use disorder than it is to get
prescriptions for opioids.
Senator Hassan. Right; thank you.
Mr. Vezina. Yes, and I would just say it should be easier
to get medications that treat opioid use disorder than to
purchase drugs on the street. That seems like a no-brainer.
One thing that we run up against is, there is a need for
education around MAT for adolescents. Some people believe that
you cannot prescribe adolescents MAT, and then when we do have
those providers, there is lack of demand because people are not
educated in the fact that, hey, I have an addiction or my kid
has an addiction, or, hey, this is treatable and here is an
intervention than can work.
And then something that I fought really hard for when I was
student body president at Portland Community College was to
educate allied health professionals, and health professionals
in general, around substance use disorder and recovery. And so
we need to do a better job of educating our health-care system.
Senator Hassan. I appreciate that.
One last thing, Mr. Chair. First of all, Senator Markey and
I do have a bipartisan bill on modernizing opioid treatment
that would expand access to methadone outside of methadone
clinics. And also, we need to do a lot more to understand and
encourage doctors to do appropriate MAT for pregnant women who
are suffering from addiction as well. Thank you.
Thank you all for your testimony.
Senator Crapo. Thank you, Senator Hassan. I appreciate your
mentioning the fact that we were able to meet with President Xi
in person in China, and talk about this issue. You are leading
on that, so I congratulate you on that.
Senator Cortez Masto?
Senator Cortez Masto. Thank you, Mr. Chair, and thank you
to the panelists. I know it has been a long morning. You are
probably getting asked the same questions over and over and
over again. But I thank you, because the advocacy and your
experience, it matters to help us address here, at least at the
Federal level, what we can do to continue to address the
fentanyl crisis that we see in this country.
Can I ask this? There has been a lot of conversation about
integrating addiction treatment with mainstream health care. I
think that is where we need to go, for so many reasons. It is
so important for us to do it, and at the Federal level we are
working to try to incentivize that movement.
I will say, and I appreciate--Senator Cornyn and I, we
introduced the COMPLETE Care Act, which actually increased
Medicare payments to primary care doctors who incorporate
behavioral health into their practices, the first step of
incentivizing it. I thank my colleagues for helping us advance
this out of the committee.
But more needs to be done. The continuum of care, there are
gaps in it. We all know that, and my focus is how do we address
those gaps, because everybody plays a role, a key role here, at
the end of the day.
And so, Dr. Herron, can I start with you, because FQHCs--
there are some in my State as well, and despite being well
suited for integrated care models, the implementation, however,
is challenging for FQHCs. Can you talk a little bit about that,
what those challenges are and what we need to be aware of so
that we can help overcome those challenges for those clinics?
Dr. Herron. Thank you for the question. There are a variety
of challenges. Some come at the reimbursement level, where
there is difficulty for primary care providers, for example,
billing behavioral health codes and not being able to get
reimbursement for a depression visit versus a diabetes visit.
There are also challenges in education of the workforce,
and so putting training into primary care residency programs--
and I am an addiction doctor and an addiction medicine
specialist, so that is a lot of people who started in other
fields and then received additional training in addiction. But
really putting that type of education into medical school
curriculum and into residency programs, so that people are able
to have a base foundation of how to approach mental health, is
critical.
There is always going to be a need for specialty treatment.
Some people will need inpatient treatment. Some people will
need higher levels of care. Some people will need residential
sober living and things like that. But not everyone does, and
so being able to start at the level of outpatient practice and
to help the people who are able to be served in those settings
actually also helps to reduce stigma and reduce health-care
costs. People do not necessarily need to see a specialist for
everything, just like we can do basic hypertension care or
basic high cholesterol treatment, and only some people need to
see a cardiologist.
Really focusing those efforts on expanding the primary care
workforce and recognition help a lot. FQHCs, you know, vary,
and I am fortunate to be in New York, where we do have a lot of
flexibilities and encouragement around this. But there are also
a lot of regulatory hurdles. I am in a State that has multiple
different regulatory agencies for addiction versus mental
health versus primary care services.
And so, also integrating those and figuring out the
reimbursement, the licensure, the regulatory oversight of all
the different streams of services, I think have been daunting
for some communities and difficult for some health centers to
implement.
Senator Cortez Masto. So it is not--you said the Federal,
but it is the State and local. The State is a key partner here
when we are trying to build out this continuum of care.
Dr. Herron. Absolutely.
Senator Cortez Masto. And there are barriers to some extent
there. Maybe not intentional, but they do exist.
Dr. Herron. Yes, absolutely. And I mentioned earlier also
the same-day billing restrictions, that are again a State
decision. My understanding is that they are permissible under
Federal law, but it is up to the States to decide to do that or
not.
I am in a State that has same-day billing restrictions, and
so we have, despite having colocated care--I am fortunate as an
FQHC to be able to provide care even if I cannot be reimbursed
for it. We receive funding from other sources to help support
that.
But not everyone can afford to do that, and so people can
be in centers that offer both types of things, but not actually
be able to access different services in a day, and then have to
come back, which is going to just decrease the likelihood of
being in care.
Senator Cortez Masto. And I only have 20 seconds left, but
I am curious, just for the panel: anything you want us to hear
that we have not talked about today, that just strikes you as
important that you want us to take away from this conversation?
Or we have covered everything?
Mr. Vezina. Yes. The last thing I would just like to say is
that there are over 20 million people in America who are in
recovery. And in my early recovery, people would say stuff to
me like I am unique or one of a kind. But you know, not
everybody is vocal about their recovery like me, and so I just
want the public to know that if we fund services, people can
and will recover from substance use disorder.
Thank you.
Senator Cortez Masto. Thank you.
Senator Crapo. Thank you.
Senator Blackburn?
Senator Blackburn. Thank you, Mr. Chairman.
And last year in Tennessee, we had over 3,800 overdose
deaths, and these were primarily fentanyl. It was involved in
75 percent of those cases. Now, one of the things that I hear
from our health-care professionals and our law enforcement is
they cannot get their arms around this until the southern
border is secured.
And they talk about the uptick in using Narcan. They talk
about the need to address these smugglers. I have the Stop
Fentanyl Border Crossings Act, which would add drug smuggling
as a basis for title 42 immigration enforcement.
I know my colleagues have said there is a vote on the floor
later this afternoon to address the border. It is an
immigration bill. It is not a border security bill. And what
people want to see is for all of this trafficking to stop, and
stop pushing these drugs into our communities. And I appreciate
you all being here, and as you have heard, we have done a lot
of bipartisan work on medication-
assisted treatment.
Senator Hassan and I have worked on some provisions.
Senator Thune and I are working on allowing States to waive the
IMD exclusion for substance use disorder treatment. And I fully
feel that any treatment that we have has to include prevention
as well as the treatment. And then also enforcement, and making
certain that people have access to that continuum of care.
Recovery is not--as you have said in your testimony, this
is a long road, and not everyone is willing to talk about that.
But we have the Telehealth Response for E-prescribing Addiction
Therapy Services Act, the TREATS Act, and Senator Whitehouse
and I and others on the committee have worked on this, because
it would address some of those barriers that a lot of
individuals face as they are trying to get the care they need.
And it would give that critical support--Dr. Herron, you
just talked about this--in underserved and rural areas, and
getting that help to people. It would leverage telehealth
services.
So I want to come to you, Dr. Herron. When we talk about
the TREATS Act and how it would enhance that accessibility and
efficacy of these services and e-prescribing, talk a little bit
about how it would fill in those gaps in service, and why we
need to do this.
Dr. Herron. Thank you for your question, Senator.
Telehealth has been one of the greatest innovations to ever
come to behavioral health, and it is one of the good things
that came out of the terrible tragedy of the COVID pandemic. We
have seen incredible improvements in access, in engagement, and
quality of care through telehealth. As I mentioned earlier,
geographic restrictions----
Senator Blackburn. Yes. What about compliance?
Dr. Herron. People are much more likely to engage and
remain in treatment when they have multiple options to access
care.
Senator Blackburn. Okay.
Dr. Herron. So, hybrid treatment options are really
wonderful, where you do have the ability to still see a
treatment provider in person and are able to do certain things
that benefit from those face-to-face interactions, and the
combination of doing that with the ability to access remote
care.
People no longer have to arrange for child care, take off
time from work, figure out transportation, how to get there.
What could be a 30-minute--you know, really the whole time
face-to-face with a therapist was a 2-hour, 3-hour event to be
able to leave, travel, wait in the waiting room, do all of
those things.
So people are able to still get the same quality of care in
a much more efficient way. One of the things that is essential
about the TREATS legislation is the provision about audio-only
telehealth. I do want to stress--and it is hard for us all
sitting here on our smartphones to remember--many, many
Americans do not have access to high-speed Internet, to devices
with cameras, to phones with data plans that they can use to
access video.
And so, the addition of audio-only services as part of the
treatment landscape is really essential to maintaining access
for people.
Senator Blackburn. Thank you. I am almost out of time.
Dr. Perrone, I will send a question to you. I want to talk
about prescription opioids and those who are dealing with pain,
and as we look at the overuse in the prescription area, how
that affects the use of heroin and fentanyl. But I will do that
in writing.
Thank you, Mr. Chairman.
The Chairman. The time of the gentlelady has expired. I am
also interested, Senator Blackburn, in that question about the
prescriptions, so we will work with you on it.
Senator Casey?
Senator Casey. Thank you, Mr. Chairman. Thanks for the
hearing. Thank you and the ranking member for providing an
opportunity to have us be a part of it. I want to thank the
panel for your testimony, and your willingness to serve in the
trenches on these issues. Really important and difficult work
that you do.
Thursday is often a very busy hearing morning, so that is
why a number of us are in and out. But I want to direct maybe
just two questions to Dr. Perrone, because I know we are at the
end of the hearing.
Doctor, the first one is about barriers to treatment. In
your testimony, you mentioned that 11 percent of people with
opioid use disorder receive medication. That is due to several
factors including cost. I introduced a bill called the MORE
Savings legislation, which would eliminate cost for opioid
treatment and recovery support services for people with private
insurance plans, as well as people enrolled in a new Medicare
pilot program--so, those two groups of individuals. The bill
will also increase Federal funding for Medicaid treatment
programs.
Doctor, can you expand on some of the barriers to treatment
and explain how decreasing barriers and costs could result in
more patients getting access to needed care?
Dr. Perrone. Thank you, Senator Casey. So, just for
example, I mentioned a patient that I saw a couple of days ago
in the emergency department. We started her on buprenorphine.
That patient, when she goes to a pharmacy to fill that
prescription--she was a little bit far from our area. She was
previously from the Lehigh Valley.
So, at the pharmacy, they may say, ``You are not on my
list. You have never filled a prescription here; you are out of
this area. We are not going to fill it.'' So, the pharmacy
barriers we really haven't touched on today, but there is
tremendous stigma and other issues.
And then pharmacists are also driven by their fear of
regulatory compromise. So you know, it is a double-edged sword
on their end. But they are very reluctant to be as
collaborative as they could be, because they are really worried
about what happened in the opioid crisis with overprescribing
of opioids. So we need to mitigate that barrier.
I think incentivizing treatment is a great investment. Some
insurance companies have come to me and said, ``We are going to
pay additional reimbursement, because if you start a patient on
medications for opioid use disorder, that decreases our costs
as an insurance company.'' So, the ROI on medications is
tremendous, not to mention the lifesaving and other productive
components of the success of medications.
Senator Casey. Thank you, Doctor, for that.
The rate of substance use disorder among older adults over
the age of 65 has increased in recent years, with nearly 4
million older adults reporting a substance use disorder just in
2022. The number of older adults needing SUD treatment has
tripled from 2000 to 2020.
Unfortunately, older adults are often overlooked when
developing screening, prevention, and treatment strategies.
Compounding these challenges are the limitations of Medicare
coverage for substance use treatment and the dearth of data
available to promote understanding of how best to care for
older adults with substance use disorders.
What are some of the gaps in Medicare coverage that would
make it difficult for older adults to access care for substance
use disorders?
Dr. Perrone. That is a great question; thank you. You know,
most of my patients are covered by Medicaid, so most of what I
can speak about is access to filling prescriptions via
Medicaid, where it is generally covered in Pennsylvania,
whereas Medicare might not be covered, and the patients may not
have additional plans. So, including medications in some
component of a Medicare plan would be really important.
And a lot of older adults have resulted in opioid use
disorder primarily because they have been exposed to
medications in their journey of having more medical
consequences and being treated with these medications. And then
the medications are no longer prescribed, and then they
literally--we see patients quite commonly in that age group who
just go and buy something on the street because it is widely
available to treat their pain.
Senator Casey. Doctor, thanks very much.
Thanks, Mr. Chairman.
The Chairman. Thank you, Senator Casey. I look forward to
seeing your important legislation and having more discussions
about it.
Senator Daines will be our last member.
Senator Daines. All right. Mr. Chairman, thank you; Ranking
Member Crapo as well.
Just before I get into my line of questioning and my
comments, I think--I guess Senator Blackburn brought up the
point about what is going on with this vote this afternoon
regarding the border.
I think it is safe to say I have personally been to the
southern border more times than any member of this committee on
the other side of the dais, than the Democrats. I have spent a
lot of time on the southern border; I sometimes go on the night
shift from 10 p.m. to 6 a.m., watching what is happening.
This vote this afternoon is a political stunt. If we are
serious about solving the crisis on the southern border, the
Democrats should go down to the Commander-in-Chief, the Oval
Office, and ask President Biden for the reversal of the
policies that he put in place, the executive action after
President Trump left office.
It really is not that complicated, and so this is--this has
now become a political crisis for the Democrats. The border
crisis is a crisis, but now that it is a political crisis,
Leader Schumer has decided he is going to put this bill on the
floor so they can cut some commercials here to try to save some
of the Senators who have tough races back home, because the
American people see the disaster and the tragedy of this
invasion that is going on on the southern border.
And linked to that, because the Border Patrol agents do not
have enough resources--it is a zero-sum situation. They are
apprehending nearly 9 million illegals that come across the
border since President Trump left office, and that allows the
Chinese to ship the fentanyl precursors to the cartels. They
manufacture them and then ship them into the United States.
In fact, by the time it leaves the Rio Grande until it gets
to Montana is about 48 hours now, with the efficiencies of the
Mexican cartels. What is going to happen this afternoon,
frankly, will be seen by the American people as a political
stunt in trying to save an election.
Last month, I cohosted a discussion with Senator Cardin in
the Finance Health Care Subcommittee on the opioid epidemic in
our country. I am glad the full committee decided to spotlight
this issue as well. Driven by the man-made crisis at our
southern border, fentanyl manufactured by Mexican cartels,
using the precursor chemicals from China, has flooded across
the border. And they have been in every community in Montana
and sadly across the Nation.
We are a northern border State, but we also have now a
southern border crisis. In fact, in Montana alone, the State
crime lab has preliminarily reported 80 overdose deaths
involving fentanyl in 2023, an increase of 1,900 percent from
2017 when there were just four.
Although we have therapies and FDA-approved medicines for
treating substance use disorder, accessing this care has long
been outside the traditional health-care continuum, resulting
in a fragmented system and a challenge for patients to
navigate.
In the subcommittee's work last month, it was apparent to
me that the care provider for substance use disorder across the
country is often a reflection of each individual community, its
specific needs, and the community partners available to help
create local continuums of care.
Dr. Herron, could you share with the committee this hyper-
local aspect of providing substance use care, and the
importance of community partnerships as well as coordination to
treat patients?
Dr. Herron. Thank you for the question. Yes, I think I have
an interesting perspective, in that I work in a Federally
Qualified Health Center in New York that includes urban sites,
rural sites, and suburban sites, and the needs of each
community are both different and the same.
I think the access to evidence-based, high-quality, low-
barrier treatment is shared among all people with addiction.
But building those community partnerships in order to build
trust, to build connections with additional resources, with
schools, with recovery-
oriented communities, organizations that can help to do a lot
of the preventive services you have heard about today, are
really essential.
And so, understanding the needs of those different
communities, whether that be the variable access to technology,
to transportation barriers, differences in income levels and
insurance demographics, each of those communities really do
require a nuanced approach to the services they are providing
in that local environment.
Senator Daines. Dr. Herron, thank you.
I have one more question, a final question for Mr. Vezina.
When Senator Stabenow and I led the Finance Committee's efforts
on the Mental Health Workforce Working Group, one of the
proposals I worked on was increasing Medicare participation for
peer support for individuals with mental health or substance
use conditions.
Mr. Vezina, your organization provides a number of
resources to individuals struggling with substance use and
addiction, including peer support, as well as mentorship. Could
you speak briefly about the role of peer support in the
substance use disorder care continuum, especially for our youth
and our young adults?
Mr. Vezina. Yes. Thank you so much for the question. You
know, for hundreds of years, people in recovery have helped
other people recover, and it has been largely voluntary. The
first drug and alcohol counselors were a lot of people in
recovery.
A lot of the evolution of how we treat addiction has been
pushed by people in recovery. So, this peer support occupation
gives people in recovery a specific occupation to go out and
motivate people to change. That is what peers can do: they can
help motivate people. You know, people who have addiction are
oftentimes ambivalent. They want to quit and they want to use
at the same time, and that is a natural human kind of
condition. ``I want to stop eating candy, and I want to eat a
bunch of candy at the same time.'' I think everyone can share
that duality. And so, peers really can help motivate people to
change. And so at 4D, we have about 100 staff, and we have five
recovery centers, and that is all we do is go out and motivate
youth and young adults to get into recovery and to sustain
their recovery.
And so, you can put peers in pretty much any setting and
help people to get motivated to participate in the recovery
process.
The Chairman. The time of the gentleman has expired.
I want to thank all our witnesses. We have spent 2\1/2\
hours here today trying to learn about the enormous health-care
challenges. I underline ``health-care challenges,'' because we
are the committee with jurisdiction over health care, over
Medicare and Medicaid and these essential health-care programs.
And what I like the most about what we have done for 2\1/2\
hours is, overwhelmingly most of our time has been devoted to
looking at issues like best practices, state-of-the-art
treatment, prior authorization--which I think is a huge rip-off
led by insurance companies. All four of you have made a big,
big difference in terms of getting the focus on these health-
care issues, which frankly have not gotten the attention that
is warranted.
And without Mr. Vezina coming up on that day at Fred Meyer
in Oregon and saying, ``We have got to dig into these health-
care issues,'' all the headlines would be about something else.
So I really appreciate what you have done today in getting the
focus back on the fact that so many people are addicted.
We heard Senator Bennet talk about when he hears about a
death, he looks at it completely differently. My wife and I are
older parents, and I am going to close with this. We have twins
who are 16. Whenever they go out, I say, ``Come back here,
William and Ava. Come back here for a minute.'' And they go,
``Oh, God. Dad's going to give us the fentanyl lecture again.''
I say, ``Yes, I am going to give it to you, because this is
something you cannot play Russian roulette with. You cannot
just say, `Well, I am going to take a sample.' You cannot have
stuff at parties.'' You cannot do any of these kinds of things
that you all and specialists are warning us about.
So, you have helped us with getting the state of the art
with respect to health care, what this committee does. This
committee--to its credit, by the way--has focused in a
bipartisan way on these health-care issues. A lot of people did
not think it could be done, in terms of the gun safety bill.
They did not think we would be able to get these important
provisions that relate to the school issue. And, Mr. Vezina,
you are very, very thoughtful in terms of assessing how it
might have been different for you if we were moving in
healthier directions when you were a kid.
So, Godspeed. I may see you on the plane in a few hours,
Mr. Vezina, if we try to make the trek back. But thank you for
a particularly good hearing that zeroes in on the issues before
the committee.
With that, we are adjourned.
[Whereupon, at 12:24 p.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Caleb J. Banta-Green, Ph.D., MPH, MSW,
Research Professor, University of Washington School of Medicine
Good morning, Chairman Wyden and Ranking Member Crapo. Thank you
for the opportunity to speak to you about this critical topic. Thank
you to Senator Cantwell, my Senator, for your consistent and impactful
leadership on addiction. It is heartening to see the leadership from
the Pacific Northwest, Oregon, Idaho, and Washington, demonstrate their
leadership on the fentanyl crisis by holding this important hearing. As
a health services and public health researcher, it is an honor to
participate.
My name is Caleb Banta-Green, and I have worked to support
individuals and communities impacted by opioid use disorder for nearly
30 years. Over this time the predominate opioid has changed multiple
times and the models of care and treatment medications have evolved. We
have made a dent in the treatment gap, the gap between those with
active opioid use disorder and those on the medications methadone and
buprenorphine.\1\ These medications are the most evidence-based
treatments for opioid use disorder--they support ongoing recovery and
reduce mortality by at least 50 percent.\2\, \3\
Unfortunately, the treatment gap persists, with approximately three-
quarters of those with opioid use disorder not on medications.
---------------------------------------------------------------------------
\1\ Krawczyk N, Rivera BD, Jent V, Keyes KM, Jones CM, Cerda M.
``Has the treatment gap for opioid use disorder narrowed in the U.S.?:
A yearly assessment from 2010 to 2019.'' Int J Drug Policy. 2022
Dec;110:103786. doi: 10.1016/j.drugpo.2022.103786. Epub 2022 Aug 4.
PMID: 35934583; PMCID: PMC10976290.
\2\ Pierce M, Bird SM, Hickman M, Marsden J, Dunn G, Jones A,
Millar T. ``Impact of treatment for opioid dependence on fatal drug-
related poisoning: A national cohort study in England.'' Addiction.
2016 Feb;111(2):298-308. doi: 10.1111/add.13193. Epub 2015 Nov 25.
PMID: 26452239; PMCID: PMC4950033.
\3\ Larochelle MR, Bernson D, Land T, Stopka TJ, Wang N, Xuan Z,
Bagley SM, Liebschutz JM, Walley AY. ``Medication for Opioid Use
Disorder After Nonfatal Opioid Overdose and Association With Mortality:
A Cohort Study.'' Ann Intern Med. 2018 Aug 7;169(3):137-145. doi:
10.7326/M17-3107. Epub 2018 Jun 19. PMID: 29913516; PMCID: PMC6387681.
Opioid treatment programs, primarily using methadone, and medical
office based opioid treatment using buprenorphine are excellent models
of care.\4\ Yet despite our work for decades, they continue to serve a
minority of people with opioid use disorder. Policymakers and health-
care systems continue to improve these two models of care and expand
access, but it is clear we also need a new third model of care as well.
---------------------------------------------------------------------------
\4\ Mattick RP, Breen C, Kimber J, Davoli M. ``Buprenorphine
maintenance versus placebo or methadone maintenance for opioid
dependence.'' Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD002207.
doi: 10.1002/14651858.CD002207.pub4. PMID: 24500948; PMCID: PMC10
617756.
Nonpharmaceutical fentanyl has exacerbated this need for a new
model of care.\5\ Fentanyl is a very potent and inexpensive drug that
presents substantial risk for rapid development of opioid use disorder
and fatal overdose. Fundamentally, we need to make it easier to access
treatment medications other than nonpharmaceutical fentanyl.
---------------------------------------------------------------------------
\5\ Ciccarone D. ``The rise of illicit fentanyls, stimulants and
the fourth wave of the opioid overdose crisis.'' Curr Opin Psychiatry.
2021 Jul 1;34(4):344-350. doi: 10.1097/YCO.0000000000000
717. PMID: 33965972; PMCID: PMC8154745.
As part of our ongoing research, we regularly interview people who
use drugs and are accessing overdose and infectious disease prevention
services. Our published research shows that 80 percent of people with
opioid use disorder do want to stop or reduce their use, the majority
do want to be on medications, yet most are not able to access the
traditional health-care system.\6\ Further, three-quarters want to
obtain health care at the community-based services program, at a place
they know and with people they trust.\7\
---------------------------------------------------------------------------
\6\ Banta-Green CJ, Newman A, Kingston S. Washington State Syringe
Exchange Health Survey: 2017 Results. Alcohol & Drug Abuse Institute,
University of Washington, January 2018. http://adai.uw.edu/pubs/pdf/
2017syringeexchangehealthsurvey.pdf.
\7\ Kingston S, Newman A, Banta-Green C, Glick S. Results from the
2023 WA State Syringe Services Program Health Survey. Seattle, WA:
Addictions, Drug and Alcohol Institute, Department of Psychiatry and
Behavioral Sciences, School of Medicine, University of Washington,
April 2024. URL. https://adai.uw.edu/download/9208/.
Over the last 10 years we and others have been developing and
testing new models of care based on clients stated needs, health
services and public health data, and research supported
interventions.\8\, \9\, \10\ We are combining a
low barrier clinical model, with community-based access points, and a
team-based model of care. To support the treatment medication
prescriber, we have added vital staff including nurse care managers,
mental health-care managers, and care navigators. These care team
members provide the majority of face time with clients and provide
vital care and supports so that people start and stay engaged. We have
been fortunate to have people in recovery from opioid use disorder in
these medical and care navigator roles and their insights and ability
to quickly build trust with clients have been invaluable. This new care
model has positively influenced the care continuum; we are finding that
jails and emergency departments that were once hesitant to start people
on medications because they thought patients would never be able to
navigate the health-care system for follow-up care, are now starting
people on buprenorphine because they know there is a place in the
community providing drop in access to medications and other supports.
---------------------------------------------------------------------------
\8\ Komaromy M, Stone A, Peterson A, Gott J, Koenig R, Taylor JL.
``Facilitating exit from encampments: Combining low-barrier
transitional housing with stabilizing treatment for substance related
problems.'' Addict Sci Clin Pract. 2023 Oct 26;18(1):66. doi: 10.1186/
s13722-023-00420-y. PMID: 37884986; PMCID: PMC10601141.
\9\ Winograd RP, Wood CA, Stringfellow EJ, Presnall N, Duello A,
Horn P, Rudder T. ``Implementation and evaluation of Missouri's
Medication First treatment approach for opioid use disorder in
publicly-funded substance use treatment programs.'' J Subst Abuse
Treat. 2020 Jan;108:55-64. doi: 10.1016/j.jsat.2019.06.015. Epub 2019
Jun 26. PMID: 31277891.
\10\ Hood JE, Banta-Green CJ, Duchin JS, Breuner J, Dell W,
Finegood B, Glick SN, Hamblin M, Holcomb S, Mosse D, Oliphant-Wells T,
Shim MM. ``Engaging an unstably housed population with low-barrier
buprenorphine treatment at a syringe services program: Lessons learned
from Seattle, Washington.'' Subst Abus. 2020;41(3):356-364. doi:
10.1080/08897077.2019.1635557. Epub 2019 Aug 12. PMID: 31403907.
Community-based health hubs for people who use drugs are showing
positive outcomes, including in our research with six rural and urban
communities across Washington State where we found significant
increases in buprenorphine use and significant declines in deaths.\11\
To date these programs have been funded with one time funds including
grant dollars. What we need is a bundled care model with adequate
funding to pay for the complete care team in these community-based
settings. While there has been some movement that allows for paying for
nurse care managers and care navigators or peers in certain
circumstances, we need a comprehensive approach inclusive of the low
barrier community-based health hub treatment care model, flexibility in
community care settings, and adequate funding for the entire care team
to manage this complex, chronic, relapsing medical condition.
---------------------------------------------------------------------------
\11\ Banta-Green CJ, Owens MD, Williams JR, Sears JM, Floyd AS,
Williams-Gilbert W, Kingston S. ``Community Based Medications First for
Opioid Use Disorder--Care Utilization and Mortality Outcomes.'' Poster
presented at the College on Problems of Drug Dependence (CPDD) annual
meeting, Denver, CO, June 2023. https://adai.uw.edu/wordpress/wp-
content/uploads/community-based-meds-poster-2023.pdf.
As one of our clients, an older unhoused woman with long-time
opioid use disorder, told our community staff: ``I've been in and out
of treatment throughout my life, and you are the first people to treat
---------------------------------------------------------------------------
me well. So, I keep coming back, and I've brought my friends.''
Opioid use disorder with fentanyl is tough. But we have a third
model of care that can help us dramatically close the treatment gap,
support recovery, keep people alive, and help restore the health of
individuals and communities.
Thank you very much for your time. Please contact me with any
questions.
______
Prepared Statement of Hon. Mike Crapo,
a U.S. Senator From Idaho
The fentanyl crisis has devastated communities across the country.
Far too many families have experienced the pain of losing a loved one
from this deadly substance, and the threat it poses to our communities
and neighborhoods cannot be overstated.
In Idaho, overdose deaths involving fentanyl increased nearly
fourteen-fold between 2017 and 2022, an alarming statistic. It is
important to note that this crisis, and the uncontrolled flow of
fentanyl into our communities, has not occurred in a vacuum. In the
last 2 decades, we saw an unprecedented increase in the use of
prescription opioids, causing overdose deaths to rise dramatically.
Congress took critical steps to authorize programs to reduce the
use and supply of prescription opioids, and to expand access to
treatment for those who need it. In recent years, as prescription
opioids have become harder to obtain, illicit fentanyl, a cheap, widely
available and potent drug, entered the drug supply, making overdoses
even more unpredictable and deadly. According to the Administrator of
the Drug Enforcement Administration, fentanyl is the deadliest drug
threat our Nation has ever faced.
While this hearing is focused on the prevention and treatment, we
cannot ignore fentanyl's alarming supply chain. It is well documented
that China is a primary source of fentanyl precursors and analogues,
and I joined several of my colleagues on both sides of the aisle in
pressing China on its role in the fentanyl crisis on a trip to the
region late last year.
These precursor chemicals are shipped either directly to the United
States or to Mexico-based drug cartels and smuggled across the southern
border before they are pressed into counterfeit pills, mixed into other
illicit drugs, or manufactured into powder form.
Any conversation about illicit fentanyl must acknowledge the role
of this administration's porous border policies, which have given drug
cartels easy access to our neighborhoods and communities. Any efforts
to bolster health-care services for treatment and prevention cannot
fully remedy the fentanyl crisis unless we also eliminate its supply.
This committee has acted on a bipartisan basis to consider a number
of policies that expand access to mental health and substance use
disorder treatment for those who need it. This includes consideration
of the Better Act, legislation that was passed out of committee last
Fall.
A number of the policies included in the BETTER Act were recently
signed into law, including permanent Medicaid coverage for medication-
assisted treatment, expanded access to residential substance use
disorder treatment for Medicaid patients, and guidance to States to
improve the availability of substance use disorder services for those
enrolled in Medicaid and CHIP.
I welcome continued consideration of policies that improve the
provision of care, including through the use of telehealth, which has
dramatically transformed the availability and provision of mental
health care and substance use disorder services for millions of
Americans.
This committee has made a lot of progress in expanding access to
care, and I look forward to working with my colleagues on targeted
policies that can make a difference and address the root causes of the
fentanyl crisis.
Thank you to our witnesses for being here today, and for all of the
work that you do in your communities. I look forward to your testimony.
______
Prepared Statement of Abigail J. Herron, D.O., Vice President and
Chief Behavioral Health Officer, The Institute for Family Health
Chairman Wyden, Ranking Member Crapo, and members of the committee,
thank you for the opportunity to speak with you today.
introduction
As a psychiatrist specializing in the treatment of addiction, I
have had the privilege of caring for individuals with mental health and
substance use disorders for the past 20 years. I am the chief
behavioral health officer at the Institute for Family Health, one of
the largest Federally Qualified Health Centers in New York State, where
we provide outpatient services for people affected by opioid use, as
well as train clinicians to make this care more widely available. My
career as a psychiatrist and health-care administrator has been defined
in many ways by the opioid epidemic, and more recently the rise of
illicit fentanyl, which has catastrophically worsened this public
health crisis. The CDC estimates that 107,000 U.S. residents died of a
drug overdose in 2023.\1\
---------------------------------------------------------------------------
\1\ Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug
overdose death counts. National Center for Health Statistics. 2024.
---------------------------------------------------------------------------
age-adjusted rate of drug overdose rates by sex: united states 2002-
2022 \2\
---------------------------------------------------------------------------
\2\ Spencer MR, Garnett MF, Minino AM. Drug overdose deaths in the
United States, 2002-2022. NCHS Data Brief, no 491. Hyattsville, MD:
National Center for Health Statistics. 2024. DOI: https://dx.doi.org/
10.15620/cdc:135849.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
the fentanyl epidemic
Fentanyl is a synthetic opioid--a member of the class of
medications called opioid analgesics, which are used for pain relief.
While opioids have legitimate medical indications, they also carry a
high liability for misuse because they not only relieve pain, but can
also produce euphoria. Opioids can be misused when individuals use them
without a prescription, ingest them in ways other than prescribed (such
as taking excessive quantities, taking doses too frequently, or
consuming via other routes such as injection), and/or use them in
combination with other substances.
In addition to the desired effect of pain relief, opioids can also
produce respiratory depression, suppressing the body's ability to
breathe adequately. In an overdose, this can progress to loss of
consciousness, coma, and death.
Individuals who use opioids regularly will develop tolerance,
meaning they need to take greater or more frequent amounts over time in
order to get the desired effects and avoid symptoms of withdrawal.
Because tolerance varies among individuals, the amount of opioid that
will cause an overdose is also highly variable.
Synthetic opioids, primarily fentanyl, are currently the primary
driver of deaths due to overdose, with synthetic opioids involved in
over 74,000 opioid deaths in 2023.\3\
---------------------------------------------------------------------------
\3\ Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug
overdose death counts. National Center for Health Statistics. 2024.
---------------------------------------------------------------------------
age-adjusted rate of drug overdose deaths involving opioids,
by type of opioid: united states, 2002-2022 \4\
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Illicitly manufactured fentanyl has become prevalent in the
street drug supply throughout the U.S., and is extremely dangerous.
Fentanyl is highly potent--about 50 times stronger than heroin and 100
times stronger than morphine. Taking even a small amount of fentanyl
can result in overdose, respiratory depression, and death. Because the
illicit manufacturing is unregulated, the dosing of fentanyl is
extremely variable and unpredictable.
---------------------------------------------------------------------------
\4\ Spencer MR, Garnett MF, Minino AM. Drug overdose deaths in the
United States, 2002-2022. NCHS Data Brief, no 491. Hyattsville, MD:
National Center for Health Statistics. 2024. DOI. https://www.cdc.gov/
nchs/data/databriefs/db491.pdf.
Fentanyl is inexpensive to produce, which has led to the sharp
increase in its availability. Fentanyl is frequently found as a
contaminant in illicitly obtained opioids, including heroin. It is also
pressed into pills where it may be marketed and sold illegally as a
prescription opioid, or it may also be passed off as a nonopioid
substance such as a benzodiazepine, cocaine, MDMA, or methamphetamine.
When an individual who has not used opioids, and therefore has no
tolerance to the effects of opioids, is exposed to fentanyl, the risk
of overdose is especially great.
importance of treatment and prevention
Treatment and prevention are both essential components of
addressing this crisis. No one is immune to the risks posed by fentanyl
and other substances of abuse.
Medical treatment for opioid dependence is available and is known
to save lives. Prescription medications for opioid use disorder (MOUD),
such as buprenorphine (also known as Suboxone) and methadone, are safe
and effective. However, accessing this type of treatment can be
difficult. Individuals attempting to engage in care face stigma, lack
of available treatment providers, and inadequate insurance coverage.
In addition, health care and other human service providers have
several tools to help individuals at risk for overdose who are not yet
engaged in treatment. Education about the risks of opioids, as well as
the risk of contamination of nonopioid substances with fentanyl,
prepares individuals for the possibility of fentanyl exposure. Naloxone
is a lifesaving medication that can reverse opioid overdose. We need to
educate people to recognize the signs of opioid overdose, and provide
access and training in administering naloxone.
At the Institute for Family Health, we are able to utilize our
electronic health record to identify patients who may be at increased
risk due to a variety of factors such as current opioid prescriptions,
illicit substance use, or past history of overdose. We then provide
education regarding overdose prevention and dispense naloxone, which
can be used to reverse an opioid overdose. Last year, a student at a
high school where we operate a school-based health center experienced
an overdose while at school. Our onsite primary care provider was able
to administer naloxone and provide other medical attention, thus saving
the student's life. Partially in response to this incident, the New
York City Department of Education now requires all public-school
buildings to stock naloxone.\5\
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\5\ A local law to amend the administrative code of the city of New
York, in relation to requiring the Department of Education to stock
opioid antagonists in all school buildings. (New York City Council.)
Accessed May 21, 2024. https://legistar.council.nyc.gov/
LegislationDetail.aspx?ID=
5555536&GUID=F7A649E0-7DD7-4C5B-9B3F-
19A79ACA97F8&Options=Advanced&Search=.
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investing in the behavioral health workforce
In addition to expanding the workforce of addiction specialists,
all health professionals should receive education and training in
substance use disorders and available treatments. At the Institute for
Family Health, we focus on training the next generation of providers
ready and willing to incorporate addiction treatment into community-
based services. We have made treatment of substance use disorders a
core component of our primary-care residency training programs, and
operate an accredited fellowship program in addiction medicine.
HRSA's Teaching Health Center Graduate Medical Education (THCGME)
program supports innovative community-based residencies like the
Institute for Family Health's programs. Despite the proven success of
this innovative model, the THCGME program receives less than 1 percent
of the funding of traditional
hospital-based residencies. As the committee considers how to invest
Medicaid and Medicare funding in graduate medical education, I urge you
to consider the advantages of training medical, dental, and psychiatry
residents in outpatient, safety net provider settings:
Compared to traditional residencies, Teaching Health Center
graduates are more likely to practice in a rural location and
provide medications for opioid use disorder or behavioral
health care;\6\
---------------------------------------------------------------------------
\6\ Davis, et al. Evaluating the Teaching Health Center Graduate
Medical Education Model at 10 Years: Practice-Based Outcomes and
Opportunities, Journal of Graduate Medical Education (2022) 14(5):599-
605.
Teaching Health Centers attract residents from rural and/or
other under-
represented backgrounds;\7\
---------------------------------------------------------------------------
\7\ Talib, Z, Jewers, MM, Strasser, JH, Popiel, DK, Goldberg, DG,
Chen, C, Kepley, H, Mullan, Regenstein, M. Primary Care Residents in
Teaching Health Centers: Their Intentions to Practice in Underserved
Settings After Residency Training. Academic Medicine. 2018; 93(1): 98-
103.
Teaching Health Center graduates are also more likely to
continue to work in safety net clinics than residents who did
not train in those centers.\8\
---------------------------------------------------------------------------
\8\ Bazemore A, Wingrove P, Petterson S, Peterson L, Raffoul M,
Phillips RL Jr. Graduates of Teaching Health Centers Are More Likely to
Enter Practice in the Primary Care Safety Net. Am Fam Physician.
2015;92(10):868.
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expanding access to integrated, whole person care
Addiction treatment needs to be fully integrated into mainstream
health care so that we are prepared to welcome patients into care
through multiple entry points. At the Institute for Family Health, we
practice an integrated care model which allows patients to receive
primary care, behavioral health care, and addiction treatment in a
shared treatment setting. Integrated treatment allows individuals to
access care for substance use disorders from the same treatment teams
they already work with for their physical and mental health. Co-
located, integrated care increases patients' acceptance of behavioral
health care, and reduces stigma in accessing services.
There are challenges to the implementation and expansion of an
integrated care model. In New York and elsewhere, same-day billing
restrictions on medical and behavioral health services prevent a single
provider entity, such as a Federally Qualified Health Center (FQHC),
from billing insurance for a medical visit and a behavioral health
visit provided to the same patient on the same day. This creates
barriers for patients who face transportation and scheduling
limitations common in low-income populations. In addition, there is a
tremendous need for better reimbursement for case management,
screening, and preventive mental health services.
importance of telehealth flexibilities
The rise of telehealth over the past several years has led to a
great improvement in access for patients with substance use disorders.
There is strong support for telehealth from both patients and health-
care providers, and its value as an integral component of the health-
care system has been clearly demonstrated. In addition to combating
workforce shortages, telehealth decreases delays in accessing care,
provides expanded availability outside of traditional hours, boosts
communication between patients and their clinicians, and enhances
engagement in care. During the COVID pandemic, many regulatory agencies
and insurers removed restrictions on telehealth services and provided
for reimbursement rates that were on par with in person services. It is
vital that we maintain the flexibilities allowed during the public
health emergency for providing substance use treatment, including
prescribing medications for opioid use disorder via telehealth.
Telehealth payment parity is also a crucial component of the
ability to combat the fentanyl crisis. Full payment parity for
telehealth services, and not just coverage parity, will require
insurers--including Medicare--to pay for telehealth and in-
person services at equal rates.
Underserved communities and health center patients deserve access
to telehealth. Without payment parity, many health-care providers will
be forced to limit or eliminate telehealth services because they cannot
afford to provide care at reduced reimbursement rates.
conclusion
Chairman Wyden and Ranking Member Crapo, thank you for allowing me
this opportunity to share my thoughts and experiences from throughout
my career. On behalf of the Institute for Family Health, I appreciate
this committee's commitment to combating addiction and expanding access
to treatment and recovery. I welcome your questions once witness
testimony has concluded.
______
Questions Submitted for the Record to Abigail J. Herron, D.O.
Questions Submitted by Hon. Chuck Grassley
Question. Iowa's Maternal Health Death Review Committee has found
that a cooccurring condition in 36 percent of maternal health deaths is
substance use disorder. This is similar to data we see nationwide. We
know even basic interventions make a big difference. This includes
training providers on how to talk to patients with substance use
disorder and making sure patients know where treatment services are
located.
Can you share best practices for reaching out to pregnant moms with
substance use disorder?
Answer. Pregnancy provides a unique opportunity to provide medical
care for women, including treatment for addiction. Pregnancy is a time
of incredible behavioral change, and motivating factors for addiction
treatment during this time may include concerns about the baby's
health, readiness to stop substance use, concerns about custody of the
child, and a desire to have a more stable environment for the future
child. However, pregnant women can be very reluctant to acknowledge or
seek treatment for substance use disorder, fearing disapproval and
potential loss of parental rights.\1\ Pregnant women may also lack
information, or have misconceptions, about treatment during pregnancy
despite the availability of safe and effective options.
---------------------------------------------------------------------------
\1\ Frazer Z, McConnell K, Jansson LM. Treatment for substance use
disorders in pregnant women: Motivators and barriers. Drug Alcohol
Depend. 2019 Dec 1;205:107652. doi: 10.1016/j.drugalcdep.2019.107652.
Education among health-care providers about how to approach
conversations about substance use during pregnancy is an important step
towards helping to improve connections to care. Some key points include
the use of first-person language, allowing individuals to choose the
terms they use to describe themselves, and to focus on behaviors and
outcomes in recovery rather than just adherence to treatment. NIDA
(National Institute on Drug Abuse) offers education for clinicians
about stigma and the role of language in more effective communication
with women, families, and communities impacted by substance use
disorder.\2\
---------------------------------------------------------------------------
\2\ https://nida.nih.gov/nidamed-medical-health-professionals/
health-professions-education/words-matter-language-showing-compassion-
care-women-infants-families-communities-impacted-substance-use-
disorder.
Question. The 988 Lifeline responds 24/7 to calls or texts from
anyone who needs support for suicidal, mental health, and/or substance
use crisis, and connects those in need with trained crisis counselors.
Other online tools, such as Find
Treatment.gov, have been launched to help those needing treatment and
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their families find quality addiction treatment.
Have these tools and resources improved access to addiction
treatment? How do we measure that?
What information barriers still exist today preventing addicts from
getting treatment?
Answer. Significant gaps remain in the provision of substance use
disorder services for individuals in need. The 2022 National Survey on
Drug Use and Health found that among people aged 12 or older in 2022
who were classified as needing substance use treatment in the past
year, only about 1 in 4 (24.0 percent or 13.1 million people) received
substance use treatment during that period.\3\ There are a number of
barriers that prevent or delay treatment for addiction. Medical
treatment for opioid dependence is available and is known to save
lives. Prescription medications for opioid use disorder (MOUD), such as
buprenorphine and methadone, are safe and effective. However, accessing
this type of treatment can be difficult. Individuals attempting to
engage in care face stigma, lack of available treatment providers, and
inadequate insurance coverage. Stigma continues to impact individuals
with substance use disorder, resulting in patients who need care being
fearful of seeking it. Patients may conceal or minimize their substance
use due to fear of bias or mistreatment. Education among the public and
the health-care community regarding the disease model of addiction can
help towards normalizing the treatment of addiction as a chronic
illness.
---------------------------------------------------------------------------
\3\ McGovern MP, Lambert-Harris C, Gotham HJ, Claus RE, Xie H. Dual
diagnosis capability in mental health and addiction treatment services:
An assessment of programs across multiple State systems. Adm Policy
Ment Health. 2014;41(2):205-214. doi:10.1007/s10488-012-0449-1.
Patients may also face barriers when attempting access to care
because of cooccurring mental illness. While rates of cooccurring
substance use and mental illness are high, only a minority of substance
use treatment organizations have the capacity to treatment patients
with cooccurring mental illness.\4\ Addiction treatment needs to be
fully integrated into mainstream health care so that we are prepared to
welcome patients into care through multiple entry points. Integrated
care models allow patients to receive primary care, behavioral health
care, and addiction treatment in a shared treatment setting. Integrated
treatment allows individuals to access care for substance use disorders
from the same treatment teams they already work with for their physical
and mental health. Colocated, integrated care increases patients'
acceptance of behavioral health care, and reduces stigma in accessing
services.
---------------------------------------------------------------------------
\4\ Center for Behavioral Health Statistics and Quality. (2023).
2022 National Survey on Drug Use and Health Final Analytic File
Codebook, Substance Abuse and Mental Health Services Administration,
Rockville, MD.
The rise of telehealth over the past several years has led to a
great improvement in access for patients with substance use
disorders.\5\ There is strong support for telehealth from both patients
and health-care providers, and its value as an integral component of
the health-care system has been clearly demonstrated. In addition to
combating workforce shortages, telehealth decreases delays in accessing
care, provides expanded availability outside of traditional hours,
boosts communication between patients and their clinicians, and
enhances engagement in care. During the COVID pandemic, many regulatory
agencies and insurers removed restrictions on telehealth services and
provided for reimbursement rates that were on par with in person
services. It is vital that we maintain the flexibilities allowed during
the public health emergency for providing substance use treatment,
including prescribing medications for opioid use disorder via
telehealth.
---------------------------------------------------------------------------
\5\ Palzes VA, Chi FW, Metz VE, Sterling S, Asyyed A, Ridout KK,
and Campbell CI. (2023). Overall and Telehealth Addiction Treatment
Utilization by Age, Race, Ethnicity, and Socioeconomic Status in
California After COVID-19 Policy Changes. JAMA Health Forum, 4(5),
e231018. doi: 10.1001/jamahealthforum.2023.1018.
______
Question Submitted by Hon. Elizabeth Warren
Question. The manufacturing of fentanyl involves a global network
that often requires the purchase of precursors--the chemical substances
used in the illegal manufacture of drugs--that typically originate
outside of the United States.
Would a bill that closes loopholes in our anti-money laundering
rules and cuts off international drug suppliers and cartels from using
crypto to fuel their illegal businesses be helpful in stemming fentanyl
trafficking?
Are digital currencies making it harder to shut down fentanyl
trafficking?
Answer. I am unable to respond to these questions, as they are
outside the scope of my expertise.
______
Prepared Statement of Jeanmarie Perrone, M.D., Professor, Emergency
Medicine and Medical Toxicology; and Director, Center for Addiction
Medicine and Policy, University of Pennsylvania
Chairman Wyden, Ranking Member Crapo, and members of the committee,
thank you inviting me to share my experiences as an emergency physician
in a busy emergency department in Philadelphia, a city with the highest
overdose death rate of any city in the country. Although statistics are
dramatic, nothing is worse than facing a parent whose son or daughter
has been brought to our hospital after a fentanyl overdose.
The struggles and anguish of a patient or parent battling opioid
addiction and navigating the morass of lethal pitfalls in this chronic
relapsing disease is heartbreaking. In the chaos of missed
appointments, we recognized that the emergency department can be a
gateway to same day treatment: initiating the first dose of lifesaving
treatment with suboxone or methadone while still in the emergency
department. Multiple randomized control studies have built the evidence
demonstrating that treatment with these medications can reduce the risk
of fatal overdose by 65 percent.\1\ Yet, only 11 percent of people with
opioid use disorder (OUD) receive these medications due to provider and
patient level barriers to treatment.\2\ Appointments, insurance,
transportation, and pharmacies stand in the way of a first dose of this
life saving medication.
---------------------------------------------------------------------------
\1\ National Academies of Sciences, Engineering, and Medicine.
2019. Medications for Opioid Use Disorder Save Lives. Washington, DC:
The National Academies Press. https://doi.org/10.17226/25310.
\2\ https://ldi.upenn.edu/our-work/research-updates/lowering-the-
barriers-to-medication-treatment-for-people-with-opioid-use-disorder/.
We started a program to provide these medications in our emergency
departments in 2018 and have treated thousands of patients. My
colleagues have been trained in prescribing these medications and our
nurses and staff help to identify and support patients to take that
step. We have a grant funded peer led model that allows for someone
with lived experience to guide the patient while they consider
treatment options, and that peer can align with their next steps in
getting the patient to the pharmacy, transitioning to a primary care
doctor for continued medication, follow-up appointments,
transportation, reminders and insurance reinstatement. This is one
component of low barrier treatment, meaning that the patient doesn't
need an insurance card, or identification or a primary care doctor. He/
she doesn't need to wait weeks for an appointment or be subject to
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various scrutiny, all of which can derail early attempts at recovery.
In 2020, both COVID-19 and fentanyl combined to make the drug
epidemic more lethal. Patients feared coming to our emergency
departments for treatment while social isolation compounded the risk of
fatal overdose. Fentanyl was replacing heroin in the illicit opioid
supply so typical dosing was suddenly resulting in overdoses and as
fentanyl was more potent but shorter acting, patients were using more
frequently, resulting in more infections and hospitalizations. However,
swift changes in regulations allowed for temporizing treatment access
with telehealth which allowed us to shift some of our resources to a
virtual platform.
Telehealth has created a critical safety net more cost effective
than the emergency department and more patient centered than typical
care settings. Through funding from Philadelphia Department of Public
Health, our CareConnect warmline offers free telehealth substance use
navigation and same day clinician appointments to start treatment with
buprenorphine. We leveraged our peer led model to staff 9 a.m.-9 p.m. 7
days/week. We have now treated over 1,500 patients via telehealth,
including 10 percent of our patients who report release from
incarceration in the past 30 days. Creating this important medication
safety net for citizens reentering the community mitigates this high-
risk period and is critical to closing the treatment gap that patients
face when they leave carceral settings. We have also expanded other
services for this vulnerable population including assistance with food,
clothing, navigating insurance applications, phones and transportation
to future appointments.
A Ryan White funding model could be used to establish regional
networks of telehealth ``addiction bridge'' treatment to prevent gaps
in care and continue patients on medication during care transitions
such as hospitalization to outpatient, incarceration through release
and pregnancy to parenting. We have found that two-thirds of our
telehealth patients were recently on buprenorphine and were discharged
from a rehabilitation facility without a timely follow-up prescription
or lost insurance or faced a life event where their care was disrupted.
Experiencing opioid cravings without medications can drive patients
back to the street only to face the most lethal supply and potentially
overdose. Creating low barrier models such as telehealth bridges
enhance retention in buprenorphine treatment. Telehealth can also solve
long appointment wait times in rural areas due to provider gaps. We
must sustain current exceptions to Federal regulations for telehealth
and create billing parity for services provided via telehealth
comparable to in person.
Telehealth can also address important treatment access disparities.
In the Philadelphia area, there has been a 30 percent increase in fatal
overdoses in communities of color since 2020. Fentanyl adulteration of
the stimulant drug supply has yielded a new cohort of patients with
opioid exposures. Qualitative interviews from our community advisory
board share that they want more privacy in their substance use
treatment options--they don't want treatment in public addiction
clinics or opioid treatment programs. We need to focus on developing
culturally informed treatment options, medication preferences and harm
reduction tools to address these disparities. Telehealth can help
establish care with more privacy and then transition patients to a
primary care integrated model where patients can have their addiction
medication with their hypertension and diabetes medication all from one
trusted provider.
Our patients transition from our ED or telehealth bridge to our
primary care colleagues that have integrated addiction care into their
treatment expertise. This integrated primary care model needs to be
expanded and reimbursed to sustain discrete treatment options. This
will require investment in clinician workforce including expanding
addiction medicine training in graduate medical education as well as
support for expanding training programs and trainees for addiction
medicine fellowships.
federal strategies for consideration
As Congress considers next steps to addressing this issue, my
colleagues from Penn Leonard Davis Institute and I offer several points
for consideration:
1. Integration of Care and Lowering Barriers: Patients who use
substances present for care at a variety of touchpoints,
including hospitals and emergency departments, primary care
offices, harm reduction organizations, jails and prisons, and
many settings outside of traditional substance use treatment
settings. Patents may also have complex medical, behavioral
health and social needs that are not well addressed in the
current relatively siloed treatment system.
a. Increased funding, including higher levels of
reimbursement, for more integrated services at all of
these locations.
b. Requirements for specific settings such as post-
acute care and skilled nursing facilities to provide
needed medical and substance use care (e.g.,
medications for opioid use disorder like buprenorphine
and methadone).
c. Welcoming, patient-centered care for people with
substance use disorders at whatever locations they
happen to seek care, which may involve funding for
evidence-based stigma reduction continuing education
programs for staff.
d. Requirements for criminal legal system to provide
treatment for substance use disorders, including
buprenorphine and methadone, in their facilities.
2. Methadone Access: This is a dynamic area of policy with
recent changes in SAMHSA guidance and pending legislation about
expanding access for methadone. Although we remain hopeful that
legislative action will further expand access to methadone and
integrate it within the care continuum, there are many
opportunities within current regulatory standards to increase
methadone access and retention and to better integrate
methadone within the broader care continuum.\3\
---------------------------------------------------------------------------
\3\ Samet, J.H., Botticelli, M. and Bharel, M. (2018). Methadone in
primary care--one small step for Congress, one giant leap for addiction
treatment. N Engl J Med 2018; 379:7-8 DOI: 10.1056/NEJMp1803982.
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a. Improvement of existing methadone clinics requires
stronger mechanisms for quality assessment in line with
the most up-to-date scientific evidence, including
mandates that require clinics to adopt rapid access
protocols.
b. Consider policy changes allowing for methadone
access at primary care clinics and pharmacies, which
would significantly improve access and lessen the
burden on patients.
3. Billing: Current billing mechanisms that don't provide
reimbursement for registered nurses and certified recovery
specialists seriously limit robust,
evidence-based interdisciplinary approaches to substance use
disorder treatment.
a. Create billing mechanisms for reimbursement of
nursing and certified recovery specialist services.\4\
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\4\ Kaur, M., and Melville, R.H. (2021). Emergency department peer
support specialist program. Psychiatr Serv, 72(2), 230-230.
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b. Provide equal or higher reimbursement rates for
mobile or street-based substance use disorder care.
These settings reach patients where they are and
deliver essential care.
4. Harm Reduction: Harm reduction services such as syringe
access, overdose prevention,\5\ and drug checking are evidence-
based interventions in the substance use disorder treatment
continuum. These programs are vastly underfunded.
---------------------------------------------------------------------------
\5\ Walley, A.Y., Xuan, Z., Hackman, H.H., et al. (2013). Opioid
overdose rates and implementation of overdose education and nasal
naloxone distribution in Massachusetts: interrupted time series
analysis. BMJ, 346.
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a. Allow for Federal funding for every aspect of
syringe access programs, including safer use supplies
such as syringes and pipes.
b. Increase the availability of low-barrier small
grant programs that allow community organizations
without complex grant infrastructure to apply for
funding.
c. Expand drug checking and surveillance programs to
ensure that experts across the country can keep abreast
of changes to their local drug supplies.
In closing, I want to underscore the importance of funding
interventions that work at scale, through Medicaid, Medicare and
private insurance, and to focus on the importance of peer recovery
services. Our programs utilize the wisdom and experience of peer
recovery specialists, people in recovery from opioid use, who build
alliances with patients and help them navigate the early treatment
journey. Peer training programs provide a pathway to employment for
people in recovery. We must expand this workforce by developing billing
and reimbursement strategies for these services that can be initiated
in ED visits, primary care and inpatient hospitalizations so we can
grow opportunities for people with lived experience. Their journeys
destigmatize and provide role models to our community members and
patients struggling with addiction and are a source of inspiration--
people do recover and we need to share that narrative.
Thank you again for the opportunity to share this with you today,
and I look forward to your questions.
______
Questions Submitted for the Record to Jeanmarie Perrone, M.D.
Questions Submitted by Hon. Chuck Grassley
Question. In 2019, the Health Resources and Services Administration
began a concerted effort to train more peer support workers who have
experience with substance use. Peer support services can be effective
in bridging patients to treatment, especially in an emergency room
setting.
Where do we stand in the number of trained peer support workers
today, especially in the emergency department setting?
Has the Federal Government done all it can to remove barriers to
peer support services?
Answer. Peer support workers in the United States number at least
30,000, however the specific number of peers working as recovery
specialists for patients with substance use disorders in the emergency
department (ED), while growing, are not available. Estimates suggest
that there are several thousand peers employed in various health-care
settings including the ED. Studies have demonstrated positive outcomes
from the utilization of peer support workers in the ED. These benefits
include:
Reduced repeat visits to the ER.
Lower health-care costs.
Improved patient engagement in follow-up care.
Enhanced overall patient satisfaction.
Despite the progress, several barriers still hinder the full
integration of peer support workers into the ED setting:
Inconsistent Funding: Many peer programs rely on grants,
limiting the sustainability and career growth of these
positions.
Justice Involvement*: Individuals in the peer recovery
community often have prior justice involvement, which can limit
their job opportunities due to background checks.
---------------------------------------------------------------------------
* Barriers that could be addressed by the Federal Government.
---------------------------------------------------------------------------
Reimbursement*: Expanding peer support services is limited
by challenges in billing and reimbursement, essential for
employment pathways and job sustainability.
Varying State Regulations: The lack of standardized
regulations across States creates challenges in training and
certifying peer support workers.
Cultural Shifts: Integration into existing ED teams requires
cultural changes and buy-in from medical staff, which can be a
slow and challenging process.
Question. Iowa's Maternal Health Death Review Committee has found
that a cooccurring condition in 36 percent of maternal health deaths is
substance use disorder. This is similar to data we see nationwide. We
know even basic interventions make a big difference. This includes
training providers on how to talk to patients with substance use
disorder and making sure patients know where treatment services are
located.
Can you share best practices for reaching out to pregnant moms with
substance use disorder?
Answer. Pregnant individuals who use substances face substantial
obstacles to health-care access, ranging from lack of transportation to
fear of legal consequences, which may delay care. Black patients are
more likely to be tested for drug use during pregnancy and referred to
child protective services than their non-Black counterparts despite
equivalent rates of positive drug tests between the 2 groups. Caring
for pregnant individuals with substance use disorder (SUD) requires a
compassionate, equitable, and nonjudgmental approach.
Best practices:
Offer comprehensive care through a multidisciplinary team including
obstetricians, addiction medicine specialists, mental health providers,
social workers, and peer support.
Facilitate access to opioid agonist treatment (e.g., buprenorphine,
methadone) for opioid use disorder, which improves outcomes.
Connect patients to wraparound services including counseling, case
management, housing, and transportation assistance.
Avoid punitive actions such as criminal sanctions or automatic
reporting, as this deters prenatal care seeking. Build trust by
protecting confidentiality as allowed by law.
Provide education on harm reduction principles, which demonstrate
respect and focus on reducing negative consequences of substance use
during pregnancy.
Partner with community organizations, peer support groups, and
social services to identify and engage pregnant individuals with SUD
who may not be accessing prenatal care.
______
Question Submitted by Hon. Robert P. Casey, Jr.
Question. I've been working on legislation that would improve
implementation of plans of safe care, for infants and families affected
by substance use, to better provide substance use disorder treatment
and other services that support parents in their recovery and prevent
adverse experiences for children.
Can you speak to the need in your communities to ensure infants
affected by parental substance use disorder and their families receive
treatment and other support services that allow them to thrive while
also preventing the need for foster care?
Answer. Ensuring infants affected by parental substance use
disorder (SUD) and their families receive appropriate treatment and
support services to thrive while preventing foster care placement
requires a comprehensive, intersectoral approach. Here are some key
strategies:
early screening and intervention
Implement universal screening for prenatal substance exposure and
SUD during pregnancy and at birth to identify infants and families in
need of services early.
Provide immediate referrals to evidence-based interventions like
Plans of Safe Care and home visiting programs that support maternal
recovery and promote positive parent-child bonding. Expand access to
family-centered SUD treatment that allows the birthing parent to
receive medication for opioid use disorder (MOUD) treatment while
keeping infants with them.
Provide wraparound services like parenting support, counseling, and
care coordination to address families' complex needs. Utilizing peers
with experience as birthing parents to lead these services is
advantageous.
Ensure accessible care and resources for caretakers who are not the
birthing parent.
intersectoral collaboration
Foster collaboration between child welfare, health care, substance
use treatment, and other sectors to provide coordinated, comprehensive
services.
Cross-train providers across sectors on SUD, neonatal abstinence
syndrome,
trauma-informed care, and family preservation.
supportive policies and funding
Implement policies and funding streams that prioritize keeping
families together and providing community-based services over foster
care placement when safe.
Increase funding for SUD treatment, early intervention, home
visiting, and other family support services.
______
Questions Submitted by Hon. Elizabeth Warren
Question. A 2021 Government Accountability Office (GAO) study found
that crypto has ``been central to the rise of drug sales in the U.S.,''
specifically fentanyl and other synthetic opioids.
Are digital currencies making it harder to shut down fentanyl
trafficking?
What is your assessment of the role of cryptocurrency in
facilitating fentanyl trafficking?
Answer. My scope of work does not include any aspects of
interdiction. I cannot share expertise in this domain.
Question. Scheduling drugs can limit researchers' abilities to
study these chemical compounds, limiting the potential for discovering
new therapeutic indications or treatment options.
In the course of your work treating opioid addiction and mitigating
the risks of overdoses, have you identified a need for additional
research on fentanyl, fentanyl-related substances, or xylazine? If so,
what research is needed, including research into effective medicines
for reducing or reversing the effects of those substances?
Answer. There have been extensive investments to date in describing
the epidemiology of substance exposures in the forensic population
including fentanyl, xylazine, cocaine, methamphetamine and other
substances which may contribute to fatal overdose. However, less
resources and data are available about substances involved in nonfatal
overdose. Many hospitals are yet to include fentanyl testing in their
drug screening panels, which has slowed the assessment of the impact of
fentanyl on nonfatal overdose. Similarly, we know that xylazine has
been present in the drug supply since at least 2012 in some Eastern
states, however, it was clinically ``silent'' until recently as the
quantity and ratio of xylazine to fentanyl has increased. However,
without the ability to measure either of these substances in real time,
identification and management of substance use withdrawal, overdose and
other complications proceeds empirically and diagnostic and treatment
opportunities are missed.
Research is needed in:
Identifying drugs, patterns of use, phenotypes of people who use
drugs and their response to evidence-based medications including
methadone, buprenorphine, and naltrexone would help extend treatment to
greater populations with enhanced retention in treatment.
The role of naloxone in reversing the fentanyl (or any opioid)
component of any overdose is highly effective and lifesaving. The role
of higher dose or longer acting opioid reversal agents are not needed.
The role of xylazine reversal agents are also a lesser priority
because naloxone sufficiently reverses the fentanyl component of these
mixed substance overdoses restoring breathing; persistent sedation due
to xylazine or other sedatives can be managed supportively.
Exploring effective modalities to provide low barrier treatment
options such as care initiated in emergency departments, via telehealth
or via mobile vans to engage more patients into evidence based
treatment with methadone or buprenorphine.
Passing the MOTAA legislation (https://www.congress.gov/bill/118th-
congress/senate-bill/644) to liberalize methadone prescribing in
primary care by addiction medicine specialists; future research efforts
should assess the safety, efficacy and any unintended consequences as
new methadone access is implemented.
Scheduling of xylazine is being considered by multiple States.
Although this may help with tracking and accounting of xylazine
products by DEA and other law enforcement, concomitant increases in
criminal justice interventions for possession or use of these
substances should not be the goal or unintended consequence of these
efforts.
An additional reference for the xylazine fentanyl research
priorities authored by my colleagues and I:
Haroz, Rachel, M.D.; Huntley, Kristen, Ph.D.; Perrone, Jeanmarie,
M.D. Research Priorities to Improve Treatment of Patients Exposed to
Xylazine-fentanyl: Rapid Communication from a National Institute on
Drug Abuse Center for the Clinical Trials Network Meeting. Journal of
Addiction Medicine 18(1):p 1-3, \1/2\ 2024. DOI: 10.1097/
ADM.0000000000001235. https://journals.lww.com/journaladdictionmed
icine/abstract/2024/01000/
research_priorities_to_improve_treatment_of.1.aspx.
______
Prepared Statement of Tony Vezina, Executive Director,
4th Dimension Recovery Center (4D)
Chairman Wyden, Ranking Member Crapo, and U.S. Senate Committee on
Finance members, my name is Tony Vezina, and I am a person in long-term
recovery, which for me means I have not used any alcohol or drugs since
July 20, 2012. I serve as the executive director of 4D Recovery and
participate in various roles on boards and commissions, including
Oregon's Alcohol and Drug Policy Commission. My remarks do not
represent my titles; they are based solely on my personal and
professional experience. I hope to provide this committee with
testimony combining personal experiences, academic knowledge, and
professional insights that move you to take pragmatic steps to curb
addiction in America.
Combating the fentanyl epidemic is a paramount priority in the
United States, and I am humbled to support the Senate Committee on
Finance in exploring solutions that will ultimately increase general
welfare in America and spare innumerable deaths from unintentional
overdose. The fight for recovery isn't new. Americans started advocacy
for treating alcoholism as a health issue in the 1840s with America's
first large-scale peer recovery movement known as the Washingtonians.
They knew then what I know now: people with substance use disorders can
recover when they are provided the tools to do so. According to the
National Institutes of Health, a survey of recovering people concluded
that ``tens of millions of Americans (9.1 percent of Americans) had
successfully resolved an AOD (alcohol or other drug problem) using a
variety of traditional and nontraditional means.'' This demonstrates
that people can and do recover, and treatment services work.
recommendations
Improvements to the substance use service sector are vast and
complex, requiring regulatory changes and substantial financial
investments. The recommendations below align with Medicaid and target
Fentanyl and other opioid use disorders. Prioritizing youth
interventions, access to medication for opioid use disorder, expansion
of recovery supports, treatment services, and workforce development can
take critical steps in addressing the Fentanyl and addiction crises. My
passion is for youth and young adults; these recommendations reflect
that.
prioritize youth interventions
Adolescents and young adults in America who use substances are
underserved despite the incredible benefit to them and our society,
investments in substance use services would yield. Emerging research
from universities and multiple government and private entities
significantly demonstrate that investments in primary prevention and
substance use disorder treatment produce substantial economic returns,
reducing government burden spending in other sectors, e.g., the
criminal justice system, health-care costs, child welfare, etc. U.S.
lack of capacity creates vulnerabilities for our youth and our future.
The following data illuminate problems American teens face.
The percentage of people aged 12 or older with an SUD in the
past year was highest among young adults aged 18 to 25 (27.8
percent or 9.7 million people), followed by adults aged 26 or
older (16.6 percent or 36.8 million people), then by
adolescents aged 12 to 17 (8.7 percent or 2.2 million people).
(NSDUH, 2023)
Among the 1.8 million adolescents aged 12 to 17 in 2022 who
had an SUD in the past year and did not receive substance use
treatment in the past year, 97.5 percent (or 1.7 million
people) did not seek treatment or think they should get it
(NSDUH, 2024 and MHA, 2024). An estimated 0.5 percent of
adolescents with an SUD (or 8,000 people) sought treatment, and
2.0 percent of adolescents with an SUD (or 34,000 people) did
not seek treatment but thought they should get it. (NSDUH,
2024)
New reports from the CDC show that 22 U.S. teens die every
week from drug overdose. That is the equivalent of an entire
high school classroom dying every week. Fentanyl has become the
leading cause of death among American teens.
The finance committee can take steps to curb the crisis our youth
are experiencing, specifically:
prevent and intervene
Use CHIP and Medicaid funds to increase primary prevention,
screening, referral tools, and school-based support investments.
Despite the evidence of primary prevention, few public resources are
allocated, likely because of the lack of tangible outcomes.
expand access to evidence-based treatment and interventions
Expand access to residential treatment, outpatient, and peer
recovery services by increasing reimbursement rates, providing one-time
capacity-building funds, and allowing peer-based services that do not
require assessments. In the United States today, 23 States do not offer
adolescents whose families are receiving Medicaid services to access
treatment.
According to a National Institutes of Health-supported analysis,
teen residential capacity is lacking, and services are expensive. The
report found that 46 percent of facilities contacted had a wait list,
with the average time being 28 days. The study found that between
nonprofit and for-profit agencies, for-profit was more likely to have a
bed open immediately (77 percent versus 39 percent) but at roughly
triple the daily cost ($1,211 versus $395). Nonprofits were four times
more likely than for-profits to accept Medicaid.
Outpatient treatment is generally less costly and is used by more
individuals than residential treatment. Outpatients can provide various
levels of care, from simple education to rigorous interventions based
on the individuals' substance use severity. Additionally, outpatient
services are an adjunct to residential care as a level of care
titration that supports continued skill development and a reduction of
relapse tendencies, much like physical therapy is an adjunct to an
acute muscle injury.
Increasing peer support services such as Recovery Drop-In Centers
for teens provide them with critical social support that reinforces and
normalizes a life without the use of drugs or alcohol. Youth with
substance use disorders need positive peer reinforcement to maximize
success. Peer support services use the lived experience of people in
recovery and provide hope and guidance to those seeking recovery. Peer
support can increase a person's motivation to change behavior and
improve treatment outcomes.
Lastly, it is a necessity that medications for opioid use disorders
are widely available for youth, given the unprecedented increase in
deaths from overdoses. Increased education for prescribers will make
sure that they know these medications are successfully treating opioid
use disorders, and that access to these lifesaving drugs is available.
The Finance Committee can take other significant steps for adults
in America, such as the following.
expand recovery support services
Create access to recovery centers and recovery residences (sober
living) by creating specific funding models that facilitate service
durations aligned with chronic disease conditions and reimburse peer
support for pre-treatment and outreach engagement activities. According
to Facing Addiction in America, a report by the U.S. Surgeon General,
it can take more than 5 years of remission before the risk of relapse
drops below 15 percent. This demonstrates the need for services that
provide ongoing support post-treatment or incarceration.
Recovery Centers provide people in recovery with free daily access
to essential community-based and peer support services. This service is
extremely cost effective and leverages grassroots recovery supports
like 12-step Meetings. This service modality is currently being studied
closely by the Recovery Research Institute, a nonprofit organization of
Massachusetts General Hospital, an affiliate of Harvard Medical School,
dedicated to advancing addiction treatment and recovery. A Recovery
Center is typically open daily, offers 12-step and other recovery
meetings, organizes events for recovering people, and offers skill-
building workshops and one-on-one peer support services. Medicaid could
potentially fund or partially fund Recovery Centers on a per-member
basis.
Peer support services provide hope and encouragement to people
during recovery, and extensive research demonstrates other positive
outcomes, including reduced recidivism, lowered health-care costs, and
increased employment. Expanding Medicaid-covered for pre-treatment
outreach activities can increase treatment enrollment, especially for
those addicted to fentanyl.
invest in recovery residences
In decades past, recovery housing was considered a ``Treatment
First'' model, antithetical to the body of research supporting the
``Housing First'' model. Today, this is not the case. Recovery housing
now operates pre-treatment, post-detox, concurrent with treatment,
post-treatment, concurrent with medication-assisted treatment, and in
harm reduction practices with ``Stabilization Houses'' and ``Aid and
Assist Recovery Housing'' as a part of community restoration services.
Recovery housing now operates on a continuum and is supported by
over 100 research studies demonstrating its efficacy in supporting
recovery and enhancing treatment outcomes. Currently, NSTARR (the
National Study of Treatment and Addiction Recovery Residences) is
implementing the U.S.'s most extensive scale series of studies on the
efficacy of the Recovery Residence model through the ARG research
group. ARG has previously completed over 50 studies demonstrating the
efficacy of recovery housing.
SAMHSA's best practices manual summarizes that recovery housing
produces ``decreased substance use, reduced likelihood of return to
use, lower incarceration rates, higher income, increased employment,
and improved family relationships.''
Recovery housing is now endorsed by:
HUD (Recovery Housing Policy Brief, 2015);
White House ONDCP and LAPPA (Model Recovery Residence
Certification Act, 2021);
NCMW (Building Recovery: State Policy Guide for Supporting
Recovery Housing, 2018); and
SAMHSA (Best Practices for Recovery Housing, 2023).
NARR, the National Alliance of Recovery Residences, is the largest
accreditor of recovery housing in the U.S., active in 37 States. Like
CARF and JCAHO, NARR accreditation implements a credentialing process
with 105 research-based standards that recovery housing providers must
meet to obtain accreditation.
Increased funding to Recovery Residences will ensure individuals
addicted to fentanyl have supportive housing environments free from the
temptation of drugs. Medicaid can provide funding to NARR Accredited or
State-Licenced Recovery Residences to ensure low-income individuals
have access.
increase access to medication for opioid use disorders
Increasing access to Medication for Opioid Use Disorders is an
expedient option that can create an immediate impact on the fentanyl
crisis. The efficacy of this intervention is well researched, but
accessibility is limited, creating significant barriers to care.
Providing access in jail settings, through mobile clinics, in emergency
rooms, and via telehealth would drastically reduce overdose rates while
increasing engagement and retention in the recovery process.
expand substance use disorder treatment
According to the National Survey on Drug Use and Health, people
were classified as needing substance use treatment in the past year if
they had an SUD or received substance use treatment in the past year.
Among people aged 12 or older in 2022 who were classified as needing
substance use treatment in the past year, about 1 in 4 (24.0 percent or
13.1 million people) received substance use treatment in the past year.
Limited access to treatment creates system flow issues where the
linkage between complementary care is severed, leaving individuals at
high risk for relapse. For example, an individual exiting
detoxification services cannot enter residential treatment due to wait-
lists, so they return to their previous environment and risk using
again. This scenario is common, depending on individual States, and
perilous for fentanyl users.
Increasing reimbursement rates is a necessary and critical strategy
to expand access. Reimbursement rates that do not cover the costs of
detoxification and residential treatment disincentivize organizations
to establish or expand operations and create workforce barriers due to
low wages.
workforce development
A summary of research from the National Conference of State
Legislatures reveals that burnout rates among behavioral health
professionals are higher than among other types of workers.
The U.S. mental health crisis, fueled and synergized by newer
synthetic forms of methamphetamine, fentanyl, xylazine, and nitazenes,
is leading to extreme and profound psychiatric effects that have also
exacerbated the growing Aid and Assist population in the U.S. Court
system. These clients are challenging to work with due to growing
comorbid psychoses and are leading to increased rates of burnout among
staff.
In 2023, the Health Resources and Services Administration (HRSA)
reported that the shortage of addiction counselors is projected to last
until 2036. NSDUH estimated that 44 million people had SUDs in the past
year. According to HRSA, there are 86,794 addiction counselors in the
U.S., and we need 125,010 additional addiction counselors to fill the
need.
Reimbursement rates remain low, and wages remain very low for
workers who are being asked to work with individuals with severe
addiction and mental health conditions.
Expanding peer support services can help ameliorate the workforce
shortage.
Moreover, the Obama White House Report on Occupational Licensing
warned of the consequences of over-licensing in the United States and
called for voluntary certification instead. Licensing is often coupled
with irrelevant requirements, rules, and extreme background checks not
supported by research. The over-licensing of America has led to extreme
difficulties for military families to move from State to State due to
the inability to acquire reciprocity for their occupational license in
other States and discrimination that leads to workers of color. For
example, in Oregon, about 89 percent of licensed behavioral health
professionals are non-Hispanic White, compared to only 68 percent of
certified behavioral health workers.
The U.S. should support voluntary peer-run certification of peer
behavioral health workers with basic or adjustable background check
procedures that maximize the workforce while maintaining the safety of
those served.
addiction recovery autobiography
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Addiction is a reality that I, along with my family, am
intimately familiar with. Though I hail from Pocatello, ID, my
formative years were spent in Camas, WA. Eventually, I found myself
tethered to Portland, OR. My numerous relocations were not the result
of family military assignments, parental job obligations, or personal
academic aspirations. Rather, I moved around a lot because of drugs and
alcohol.
My family's history with addiction stretches back as far as I can
trace, but I'll begin with my parents. My mother was just 16 when she
had me. She left Idaho soon after, seeking to escape the drugs,
violence, and poverty that marked her life. She hoped to give me a
chance at a better life. Despite the odds, she succeeded, even though
her own life was tragically cut short due to her opioid addiction.
Growing up in the affluent town of Camas presented challenges for
me. We were not well-off financially, and my stepfather was an
alcoholic. Despite these hardships, I enjoyed playing soccer, football,
and basketball. I also loved fishing and bike riding. However, around
the age of 12, I began experimenting with alcohol and tobacco. Within a
few years, this experimentation escalated into regular partying,
leading to frequent run-ins with the law. My drug addiction
strengthened in High School, and I eventually dropped out. Around this
time (roughly 2002), my mother was diagnosed with fibromyalgia and
received a large prescription for Oxycotin, and I started using them. I
want to be frank: this was wrong, and I take full responsibility.
I soon became addicted to OxyContin, which I realized when I ran
out of the pills and thought I had the flu, but my friend told me it
was withdrawal. I knew at the time that I was in a tough spot because I
was unable to function for weeks without using a pill to ``get well.''
Opioid withdrawal for me was like getting bashed with a baseball bat
wrapped in barbwire, and I spent years trying to quit.
A couple of years into the OxyContin rush, my mother's prescriber
was shut down due to overprescribing. I later found that this office
was referred to as a ``pill farm,'' a location where people could
receive large amounts of various addictive medications. When the pill
farm shut down, the heroin dealers ramped up, leveraging an opportune
moment to capitalize on an emerging consumer base. Something strikingly
similar to the current fentanyl crisis, which will be addressed later.
With a vacuum in the Oxycotin market, many people I knew turned to
heroin to avoid the sickness. For many of us, it started with snorting
a liquid mixture, something shared by different types of ``users.''
Heroin soon became a viable option for various individuals, including
those dependent on pain management and young people like me, who were
naive to the supreme addictive nature of pain medication. We became
snared in a vicious cycle, and many did not make it out.
At some point, using drugs became a necessity: I've heard it
described by recovering addicts as being reduced to almost an animal
level, and I felt that way at times. I moved back to Idaho to live with
my grandma a few times; this is known as a geographic in the recovery
community, but every time, my addiction followed me. In January of
2007, my addiction took a turn for the worse after my mother died in a
fatal car accident, something I had long feared as she would regularly
fall asleep while driving because of her medication and heroin use. I
am not alone in this; a new report from SAMSHA states that 321,566
children in the United States lost a parent to drug overdose from 2011
to 2021, according to a study published in JAMA Psychiatry.
After my mom died, I completely caved to despair and began using
drugs intravenously. This was a pivotal moment in my drug use and the
beginning of the last chapter. Arriving back in Portland shortly after
my mom's death, my girlfriend became pregnant, and I began the long and
arduous journey to sobriety. Research estimates that it takes an
average of seven attempts to quit using substances, which seems
reasonable if you compare how humans struggle with sugar and fatty
foods.
My treatment attempts were mostly voluntary, though the one that
stuck was via a criminal justice intervention. The last time I used any
drugs or alcohol was July 19, 2012, when I was arrested due to my
erratic behavior within a convenience store related to my meth and
heroin use. In jail, I was held with early release to treatment. I left
jail and went to the Volunteers of America Men's Residential Treatment
Center, where I stayed for nearly 6 months.
While I partially attribute the criminal justice system
intervention to saving my life at age 27, I am not advocating for this
as a singular solution to the complex issue of addiction and fentanyl.
There were many missed intervention opportunities for me that I will
highlight for the committee before discussing my post-use recovery
journey. I will not dwell on circumstances that have since been
rectified but focus on gaps I see persist today.
health-care interventions
I found myself in various health-care settings and was not
effectively engaged despite my obvious addiction symptoms, and I will
highlight two. First, I was removed by security guards several times
when seeking help, primarily for using heroin in the facility. I think
this could have been an opportunity for engagement and rapid medication
for opioid use disorder induction or referral to treatment. Second, I
was hospitalized for an abscess on my left forearm caused by my attempt
to inject Vicodin (apparently, you cannot do that). During my stay at
the ER, I begged and pleaded for a prescription of methadone but was
denied, although a priest did visit a couple of times. I was in
terrible withdrawal and kept leaving the hospital against medical
advice to get well.
youth-based care
I now know that I have several vulnerabilities for addiction--
genetics, socioeconomic, and family use patterns--but was never taught
this in school. I knew that drugs were illegal, but I also loved them
the first time I tried them. I didn't know about addiction either, at
least not as a health-care disorder; I knew there were drug addicts but
thought they were inept people. Primary prevention strategies may have
been effective in helping me. Additionally, school-based substance use
interventions and recovery services may have intervened on me earlier
and helped me avoid a lot of problems.
criminal justice interventions
I started going to jail at 15 years old, all related to my
substance use. I do not believe I was ever offered treatment while in
prison as an adolescent. I cycled in and out of county jail in multiple
States throughout my addiction but was never provided treatment while
in jail, including medication for opioid use disorders. The criminal
justice system is saturated with substance users who don't have much .
. . except for time. Investing in treatment and recovery services in
carceral settings would undoubtedly facilitate the rehabilitation
process.
Back to my story. I am 27 years old, exiting county jail to a
residential addiction program with no driver's license, no education,
no money, and no shoes, but I did have about 65 percent of my teeth
left and warrants in two States (Idaho and Washington). As I sat in the
lobby of the treatment center, I had a moment of clarity: instead of
leaving and going to get high one more time, I would stay long enough
to get as healthy as the men I saw eating in the chow hall.
While in treatment, I was required to do several things I was
reluctant towards. One was to attend GED classes on Tuesdays and
Thursdays at the Londer Learning Center, a program the criminal justice
system funded to help those on probation improve their education. This
ultimately led to me receiving my GED and being awarded a scholarship
to Portland Community College for 12 credits. I attended daily therapy
groups led by alcohol and drug counselors and met one-on-one with my
counselor every other week. Many of the counselors stated they were in
recovery, which eased my suspicions and cracked the door for learning.
Lastly, I was required to go to recovery meetings and build a support
group. While the cognitive therapy was impactful, the integration into
the recovery community was essential.
I enrolled in Portland Community College and started my educational
journey during my treatment stay. In my first semester, I attended a
recovery support group hosted in the women's resource center that gave
me one free credit. The allure of saving money kept me engaged, and I
met a faculty member who suggested that I start a recovery club. The
Recovery 101 Club's mission was to destigmatize addiction by organizing
community service events led by recovering students. Club organizing
introduced me to student government, where I became the president of
the Phi Theta Kappa Honors Society and later the student body
president. During my tenure at PCC, I also cofounded a nonprofit
organization called The 4th Dimension Recovery Center. I am still the
executive director today (I included our most recent annual report). My
leadership development at PCC was profound, and I am incredibly
grateful to the faculty and staff who shaped my aspirations.
I graduated from PCC and moved to Concordia University for the
social work program, discontinuing student government to pursue my
dreams at 4th Dimension Recovery Center, now 4D Recovery. 4D Recovery
is a nonprofit recovery community organization providing a variety of
treatment, peer-based recovery, and housing services for adolescents
and young adults with substance use disorders. As I attempted to grow
4D Recovery, I realized there needed to be more funding opportunities.
I began organizing, engaging in local and State politics, and
participating in service opportunities on boards, committees, and
commissions.
In 2017, I cofounded Oregon Recovers, a statewide advocacy group
charged with increasing services for substance use disorder. After
researching the actual gap in services for people who need them, I was
astonished by the contradiction that addiction is a treatable disease,
but services are lacking. I decided then that I would do everything I
could to change that in Oregon. Over the last 7 years, I have
participated in many great things in advancing recovery, which my
resume illustrates in the appendix.
As I grew professionally, I lived in recovery-supportive housing
for several years. This housing was inexpensive and right down the
street from my treatment center. Living with other sober people
provided a sanctuary from the onslaught of addictive substances
lingering outside the house and provided accountability and the
opportunity to develop financial skills. I exited recovery housing,
lived with recovery friends, and then rented a room until I bought my
first home.
fentanyl considerations
Quitting heroin was nearly impossible for me, but I cannot imagine
the difficulties associated with fentanyl, which is changing the
illicit drug market and related attempts to tackle it. Heroin and
fentanyl are similar to cocaine and crack in many ways. First, crack
was cheap and readily available, and the high peaked quickly and
evaporated just as fast. This means a person has to use it frequently
to maintain the desired effect. Fentanyl is similar in cost,
availability, and effect duration, but the fatality risk is much
higher, and it is consumed by a broader user market.
Where I once needed to use heroin every 6-8 hours to stay well, it
is being reported to me that people need to use it every hour. Because
of the fatality risk, this results in the frequency of potential
overdose increasing exponentially. The consumption frequency also
reduces the ``window of opportunity'' for intervention. Most people I
know in recovery describe stories of fleeting ambition to quit and even
sustained use despite knowing they need to quit. To be successful in
treating fentanyl addiction, we need rapid access to effective tools--
and one of the most effective tools is medication for opioid use
disorder.
We cannot treat people who die from overdose, and medications for
opioid use disorder curb the necessity to use and provide opportunities
to engage in service interventions. Access to MOUDs should be widely
available and accessible in multiple settings, including jails,
hospitals, and via telehealth.
Tackling the fentanyl crisis requires investments in prevention and
education, treatment, and recovery support services--the U.S. Senate
Finance Committee has the opportunity to expand critical access via
Medicaid and CHIP authority.
references
King, Caroline A., et al. ``Adolescent Residential Addiction Treatment
in the US: Uneven Access, Wait-lists, and High Costs.''
Health Affairs, vol. 43, no. 1, 1 Jan. 2024, pp. 64-71,
www.opb.org/pdf/2023-00777%20King%20FF--1704740798039.pdf,
https://doi.org/10.1377/hlthaff.2023.00777.
Substance Abuse and Mental Health Services Administration (U.S.);
Office of the Surgeon General (U.S.). Facing Addiction in
America: The Surgeon General's Report on Alcohol, Drugs,
and Health [Internet]. Washington (DC): U.S. Department of
Health and Human Services; 2016 Nov. PMID: 28252892.
Center for Medicare and Medicaid Services. ``The Biden-Harris
Administration Proposes New Standards to Help Ensure Access
to Quality Health Care in Medicaid and CHIP, CMS.''
www.cms.gov, 27 Apr. 2023, https://www.cms.gov/newsroom/
press-releases/biden-harris-administration-proposes-new-
standards-help-ensure-access-quality-health-care-medicaid.
Centers for Medicare and Medicaid Services. ``CMS Behavioral Health
Strategy, CMS.'' www.cms.gov, 2 Apr. 2024, https://
www.cms.gov/cms-behavioral-health-strategy.
Kelly, J.F., Bergman, B., Hoeppner, B.B., Vilsaint, C., White, W.L.
Prevalence and pathways of recovery from drug and alcohol
problems in the United States population: Implications for
practice, research, and policy. Drug Alcohol Depend. 2017
Dec 1;181:162-169. doi: 10.1016/j.drugalcdep.2017.09.028.
Epub 2017 Oct 18. PMID: 29055821; PMCID: PMC6076174.
``Widening Gaps and Disparities in the Treatment of Adolescent Alcohol
and Drug Use Disorders,'' Lu, Wenhua et al. American
Journal of Preventive Medicine, Volume 64, Issue 5, 704-
715. ``More than 321,000 U.S. Children Lost a Parent to
Drug Overdose from 2011 to 2021.'' samhsa.gov, 2024,
https://www.
samhsa.gov/newsroom/press-announcements/20240508/more-than-
321000-us-children-lost-parent-to-drug-overdose. Accessed
21 May 2024.
SAMHSA. ``2022 National Survey on Drug Use and Health (NSDUH)
Releases.'' samhsa.gov, 2022, https://www.samhsa.gov/data/
release/2022-national-survey-drug-use-and-health-nsduh-
releases#annual-national-report.
Health Resources and Services Administration. ``Review Health Workforce
Research, Bureau of Health Workforce.'' bhw.hrsa.gov, Dec.
2023, https://bhw.hrsa.gov/data-research/review-health-
workforce-research.
______
Questions Submitted for the Record to Tony Vezina
Questions Submitted by Hon. Chuck Grassley
Question. In 2019, the Health Resources and Services Administration
began a concerted effort to train more peer support workers who have
experience with substance use. Peer support services can be effective
in bridging patients to treatment, especially in an emergency room
setting.
Where do we stand in the number of trained peer support workers
today, especially in the emergency room setting?
Answer. I am a board member of Oregon's non-governmental peer
certification board, the Mental Health and Addiction Certification
Board of Oregon (MHACBO), who worked closely with SAMHSA on the
National Model document. In consultation with its executive director,
we have drafted the following response to peer support.
This is a difficult question to answer as there isn't, to the best
of my knowledge, a national database for peer support workers.
Additionally, States vary on practice standards and certification
requirements. Recently, the Substance Abuse and Mental Health Services
Administration published National Model Standards for Peer
Certification which will help standardize peer support practices
(certification and service delivery). This report, and effort, will
bring clarity to national peer capacity.
According to a National Institutes of Health article, it is
estimated over 30,000 peers are in America. We project that this number
has grown in recent years with the total number being closer to 50,000.
Estimating the number of peers working in emergency rooms is
unattainable, yet the concept is gaining popularity, but significant
barriers exist to expansion, mostly related to background checks and
reimbursement issues.
Question. Has the Federal Government done all it can to remove
barriers to peer support services?
Answer. Indeed, by permitting States to employ private peer-run
credentialing boards, the process has shifted from onerous background
checks to more streamlined ones. More States should move away from
State driven licensing/certification of peers to voluntary
certification as is recommended by the Obama White House Report on
Occupational Licensing. Moreover, by permitting Medicaid to reimburse
for peer services, the Federal Government has allowed the expansion of
peer services to lower-income American's, but from my understanding the
private insurance market lacks requirements for peer support benefits.
Question. In 2022, Congress passed my bipartisan Rural Opioid Abuse
Prevention Act. The law supports rural communities with a high level of
opioid overdoses in their efforts to improve prevention, treatment, and
recovery efforts.
What do successful rural efforts need to reduce overdoses and
deaths?
Answer. There are several efforts to address rural overdoses,
including:
Expanding access to medication-assisted treatment via mobile
clinics and longer prescription periods.
Increasing funding for outreach and engagement from peers.
Increasing funds to addiction recovery centers.
Expanding access to telehealth services.
Providing reimbursement rate models that support
transportation.
Provide workforce recruitment and retainment strategies,
including relocation costs and loan forgiveness for rural-based
work.
Question. The 988 Lifeline responds 24/7 to calls or texts from
anyone who needs support for suicidal, mental health, and/or substance
use crisis, and connects those in need with trained crisis counselors.
Other online tools, such as Find
Treatment.gov, have been launched to help those needing treatment and
their families find quality addiction treatment.
Have these tools and resources improved access to addiction
treatment? How do we measure that?
Answer. I have not read reports on the efficacy of these tools and
resources, but I am aware that finding treatment and navigating the
complex treatment service market is a significant barrier to care. I
suspect these tools will be helpful.
Question. What information barriers still exist today preventing
addicts from getting treatment?
Answer. One barrier is the lack of public understanding of
substance use disorder and the disease concept of recovery. Some
professionals in the substance use field reference ``stigma attached to
drug use,'' but I believe it is the stigma of the behaviors associated
with substance use disorders (especially severe addiction) that drive
negative attitudes and beliefs of ``addicts.'' It wasn't until I
understood that my addiction was a disease, one that was treatable, and
that I was responsible for, that I began to take steps to be a
functional member of society by quitting drugs and changing my life. By
increasing the publics awareness of addiction, the treatment of it, and
the result of recovery, we can get more people to participate, maybe
even earlier in their using careers.
In this process, we should be cautious of ``harm reduction''
philosophies that are rooted in beliefs that drugs are a human right,
and subsequently seek to normalize drugs use, establishing passive
approaches to addiction treatment engagement and even, at the extreme,
pursue illicit drug commercialization. Recovery should be normalized,
not addiction, and public funded efforts to help those addicted to
drugs, especially peers, should have clear expectations of increased
health and well-being.
references
Substance Abuse and Mental Health Services Administration, National
Model Standards for Peer Support Certification. Publication
No. PEP23-10-01-001. Rockville, MD: Office of Recovery,
Substance Abuse and Mental Health Services Administration,
2023.
Fortuna, K.L., Solomon, P., Rivera, J. An Update of Peer Support/Peer
Provided Services Underlying Processes, Benefits, and
Critical Ingredients. Psychiatr Q. 2022 Jun;93(2):571-586.
doi: 10.1007/s11126-022-09971-w. Epub 2022 Feb 18. PMID:
35179660; PMCID: PMC8855026.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
This morning the Finance Committee gathers to discuss the scourge
of the deadly synthetic opioid fentanyl. Fighting fentanyl requires
fitting all of the pieces of the puzzle together. Already this year,
Congress has acted to disrupt the flow of fentanyl from other countries
like China, thanks to the work of Senator Brown.
Today, the committee is looking at how the health-care piece fits
in. These health-care issues have not had the attention they deserve.
Senator Cantwell has been leading the way in our region, and I want to
thank her for her attention to this issue. This epidemic has hit
communities like a wrecking ball, especially in the Northwest in recent
years. The health-care puzzle piece is about people--real people--whose
lives have been ripped apart by the devastating disease of addiction.
I'm going to focus on a few areas that need attention. First is
prior authorization.
Only one in five Americans receive lifesaving medication treatment
for opioid use disorder--despite evidence that it works. Two months
ago, Congress passed a law that I championed requiring State Medicaid
programs to cover ``medication-assisted treatment'' or MAT on a
permanent basis, which is the gold standard treatment for opioid use
disorder. I'm very concerned that big health insurers like UnitedHealth
and Aetna that contract with Medicaid are using ``prior authorization''
at high rates, and that is causing delays and denial of this treatment.
In the context of the opioid epidemic, prior authorization can be
the difference between life and death. If someone walks in for
treatment for their opioid use disorder, and gets stymied by prior
authorization, they may never return, dying from an overdose before the
prior authorization is approved.
Last fall, I launched an investigation looking into how these
insurance companies are ripping off patients and taxpayers in Medicaid
by using the program as a piggy bank through tactics like prior
authorization. As patients suffer and these mega-
corporations post record profits, they are also dragging their feet
providing the committees with answers about these tactics. These
multibillion-dollar companies owe answers to taxpayers about how these
Medicaid dollars are being used.
Now I'd like to talk about opioid use disorder treatment for
individuals who are coming out of prisons and jails. I have heard from
law enforcement officials in rural Oregon time and time again that
these individuals need to be able to receive adequate treatment for
this disease during and after their sentence.
Making these reforms is common sense. States are working on their
own initiatives to support access to care for people before coming out
of incarceration who need uninterrupted care, including my State. I'm
working with State legislators like Pam Marsh from southern Oregon and
sheriffs across the State to get this done. These reforms are a start
towards being responsive to what law enforcement officials are asking
for: getting people help for their addiction before they get out of
jail so they don't come back.
Let's wrap up by talking about prevention and thoughtful approaches
to pain management. More needs to be done to head off opioid use in the
first place and encourage more nonopioid pain management to be used in
American health care. There are promising new therapies in development
that block pain signals rather than flooding receptors in the brain
with opioids that create an addictive feedback loop. Members of this
committee will be watching the development of these therapies closely
and looking for ways to accelerate their entry into the health-care
system if they prove to be safe and effective.
Every single member of this committee knows the anguish and pain
that opioids bring to our communities from coast to coast. I look
forward to hearing from our witnesses and members of this committee
about how to tear down the remaining barriers to treatment, save lives,
and get struggling Americans the help they need.
______
United States Senate
committee on finance
Washington, DC 20510-6200
To: Members of the Senate Finance Committee
From: Senator Chuck Grassley, Chairman of the Senate Finance
Committee Senator Ron Wyden, Ranking Member of the Senate Finance
Committee
Date: December 16, 2020
Re: Findings from the Investigation of Opioid Manufacturers'
Financial Relationships with Patient Advocacy Groups and Other Tax-
Exempt Entities
Dear Colleagues:
As the nation continues to respond to the COVID-19 pandemic, we
want to bring your attention back to another concerning public health
matter: our nation's opioid epidemic. Opioid overdoses claimed more
than 450,000 lives in the United States from 1999 to 2019, and
preliminary data from the Centers for Disease Control and Prevention
(CDC) suggests drug overdose deaths, including those attributed to
opioids, have accelerated since the pandemic began.\1\ Indeed, COVID-19
has increased risk factors associated with substance-use disorders
(SUDs) and opioid-use disorders (OUDs) like feelings of anxiety,
depression, loneliness, and an ongoing sense of uncertainty.\2\ For
individuals suffering from these diseases, COVID-19 has even presented
additional barriers to treatment and social support services as people
are urged to stay-at-home and social distance.\3\ We are concerned that
this will only worsen as our country continues to battle COVID-19 and
as social isolation and lack of access to SUD and OUD treatment
persists.
---------------------------------------------------------------------------
\1\ Opioid Overdose, Data Analysis and Resources, Ctrs. for Disease
Control and Prevention, https://www.cdc.gov/drugoverdose/data/
analysis.html (last viewed Dec. 10, 2020).
\2\ Alex Edelman, Overdose deaths appear to rise amid coronavirus
pandemic in U.S., NBC News (Oct. 20, 2020), https://www.nbcnews.com/
health/health-news/overdose-deaths-appear-rise-amid-coronavirus-
pandemic-u-s-n1244024; Jon Kamp and Arian Campo-Flores, The Opioid
Crisis, Already Serious, Has Intensified During Coronavirus Pandemic,
Wall St. J. (Sept. 8, 2020), https://www.wsj.com/articles/the-opioid-
crisis-already-serious-has-intensified-during-coronavirus-pandemic-
11599557401.
\3\ Jon Kamp and Arian Campo-Flores, The Opioid Crisis, Already
Serious, Has Intensified During Coronavirus Pandemic, Wall St. J.
(Sept. 8, 2020), https://www.wsj.com/articles/the-opioid-crisis-
already-serious-has-intensified-during-coronavirus-pandemic-
11599557401. See also Dep't of Health and Human Servs., Off. of
Inspector Gen., Opioid Treatment Programs Reported Challenges
Encountered During the COVID-19 Pandemic and Actions Taken to Address
Them (Nov, 2020), https://oig.hhs.gov/oas/reports/region9/
92001001.asp?utm_source=web&utm_medium=
web&utm_campaign=covid-A-09-20-01001.
As the opioid epidemic and its impact on programs within the
Finance Committee's jurisdiction shows no signs of abating, we write to
provide you with an update on the Committee's ongoing investigation
into the financial relationships between opioid manufacturers and tax-
exempt organizations. To date, the Committee has identified
approximately $65 million in payments that opioid manufacturers and
related companies have made to tax-exempt entities, which suggest that
manufacturers view these organizations as helpful extensions of their
sales and marketing efforts.
The Committee's Long-Standing Interest in the Opioid Epidemic
The opioid epidemic has directly impacted Federal health care
programs under the Committee's jurisdiction, and has been a long-
standing interest of its members.\4\ The increased use of opioid drugs
for long-term chronic non-cancer pain in the 1990s dramatically
increased the number of Medicare and Medicaid patients admitted to
hospitals for ``opioid overuse.''\5\ By 2017, Medicare and Medicaid
covered approximately 73% of 974,000 opioid-related inpatient hospital
stays.\6\ Furthermore, earlier this year, and before the COVID-19
pandemic, the Office of Inspector General at the Department of Health
and Human Services (HHS OIG) reported that 267,000 Medicare Part D
beneficiaries received high amounts of opioids in 2019, and 209,000
beneficiaries received medically assisted treatment.\7\ And, while the
HHS OIG found that opioid use in Medicare Part D had decreased in 2019
(when compared to the past 3 years) due to the efforts of the
Department of Health and Human Services (HHS) and others, it stressed
the critical need to remain diligent, especially during the COVID-19
pandemic.\8\
---------------------------------------------------------------------------
\4\ Senator Grassley, in his capacity as Ranking Member of the
health subcommittee, co-chaired the Committee's first hearing on the
opioid epidemic in 2012. Prescription Drug Abuse: How are Medicare and
Medicaid Adapting to the Challenge?, Hearing Before Subcomm. on Health
of the S. Fin. Comm. 112th Cong. (2012), https://
www.finance.senate.gov/hearings/prescription-drug-abuse-how-are-
medicare-and-medicaid-adapting-to-the-challenged.
\5\ The number of combined hospital inpatient stays among Medicare
and Medicaid beneficiaries increased from 126,500 in 1993 to 437,800 in
2012. See Hospital Inpatient Utilization Related to Opioids Overuse
Among Adults 1993-2012, AHRQ Table 2 (Aug. 2014), http://www.hcup-
us.ahrq.gov/reports/statbriefs/sb177-Hospitalizations-for-Opioid-
Overuse.pdf.
\6\ HCUP Fast Stats--Opioid-Related Hospital Use, AHRQ, https://
www.hcup-us.ahrq.gov/faststats/OpioidUseMap (last viewed Nov. 25,
2020).
\7\ Dep't of Health and Human Servs., Off. of Inspector Gen.,
Opioid Use in Medicare Part D Continued to Decline in 2019, But
Vigilance is Needed as COVID-19 Raises New Concerns (Aug. 13, 2020),
https://oig.hhs.gov/oei/reports/OEI-02-20-00320.asp.
\8\ Id.
Over the past eight years, we have used our leadership positions to
seek greater transparency into the financial relationships between
opioid manufacturers and tax-exempt organizations. Our work reveals
that opioid manufacturers have maintained extensive financial
relationships with tax-exempt organizations, including pain advocacy
groups, professional provider groups, and medical associations. In
turn, these groups have sought to influence opioid prescribing
practices and related Federal policy connected to opioid use and pain
care that directly affects Medicare and Medicaid. Given these ongoing
concerns, on June 28, 2019, we sent letters to 10 tax-exempt
organizations and requested information about their financial
relationships with opioid manufacturers.\9\ These groups included:
---------------------------------------------------------------------------
\9\ Press Release, Grassley, Wyden Press for Answers on Financial
Relationships Between Opioids Manufacturers and Tax-Exempt
Organizations (July 1, 2019), https://www.grassley.
senate.gov/news/news-releases/grassley-wyden-press-answers-financial-
relationships-between-opioid-manufacturers.
1. American Chronic Pain Association
2. American Pain Society
3. American Society for Pain Management Nursing
4. American Society of Pain Educators
5. Center for Practical Bioethics
6. Federation of State Medical Boards
7. The Joint Commission
8. American Academy of Physical Medicine and Rehabilitation
9. Alliance for Patient Access
10. International Association for the Study of Pain
We requested complete Internal Revenue Service (IRS) Form 990s
filed for each year between 2012 and 2019, as well as a detailed
accounting of all payments and transfers including, but not limited to,
contributions, grants, advertising, program scholarship, and other
revenue and remuneration.\10\ In a separate, but related inquiry,
Senator Wyden also requested information from the U.S. Pain Foundation
and the American Academy of Pain Medicine.\11\
---------------------------------------------------------------------------
\10\ Id.
\11\ Letter from Senator Ron Wyden to Dr. Jianguo Cheng, President,
American Academy of Pain Medicine (Mar. 12, 2019), https://
www.finance.senate.gov/imo/media/doc/
031319%20Wyden%20letter%20to%20AAPM.pdf; Letter from Senator Ron Wyden
to Nicole Hemmenway, Interim CEO, U.S. Pain Foundation (Dec. 18, 2018),
https://www.finance.senate.
gov/imo/media/doc/
121818%20Senator%20Wyden%20to%20the%20U.S.%20Pain%20Founda
tion.pdf.
The goal of our requests was to identify these groups' largest
pharmaceutical donors and to ascertain whether these payments
influenced the organizations' activities in any way, especially as they
pertain to opioids and opioid prescribing practices. This investigation
also built on work the Committee began in 2012, when then-Chairman Max
Baucus of the Senate Finance Committee and then-Ranking Member Chuck
Grassley of the Senate Judiciary Committee examined Purdue Pharma, Endo
Pharmaceuticals, and Johnson & Johnson's financial relationship with
tax-exempt medical groups, and included questions about payments made
to physicians who specialize in pain management.\12\ Ranking Member
Wyden subsequently sent letters to Secretary Burwell,\13\ Secretary
Price,\14\ Secretary Azar \15\ and the National Academy of
Medicine,\16\ raising concerns about conflicts of interest of various
members of Federal advisory panels who were financially linked to
industry or industry-backed groups that are the subject of this
investigation.\17\
---------------------------------------------------------------------------
\12\ Press Release, Baucus, Grassley Seek Answers About Opioid
Manufacturers' Ties to Medical Groups (May 8, 2012), https://
www.finance.senate.gov/chairmans-news/baucus-grassley-seek-answers-
about-opioid-manufacturers-ties-to-medical-groups.
\13\ Letter from Senator Ron Wyden to Sylvia Burwell, Secretary,
Department of Health and Human Services (Feb. 5, 2016), https://
www.finance.senate.gov/imo/media/doc/Wyden%20
Letter%20to%20HHS_Opioid%20Conflicts.pdf.
\14\ Press Release, Wyden Asks Price to Delay Federal Opioid
Workshop Until Industry Conflicts are Examined (May 8, 2017), https://
www.finance.senate.gov/ranking-members-news/wyden-asks-price-to-delay-
federal-opioid-workshop-until-industry-conflicts-are-examined.
\15\ Press Release, Wyden Reveals Opioid Industry Ties on HHS Task
Force, Probes Advocacy Group's Finances (Dec. 19, 2018), https://
www.finance.senate.gov/ranking-members-news/wyden-reveals-opioid-
industry-ties-on-hhs-task-force-probes-advocacy-groups-finances.
\16\ Press Release, Wyden Concerned by National Academy Ties to
Opioid Manufacturers (July 5, 2016), https://www.finance.senate.gov/
ranking-members-news/wyden-concerned-by-national-academy-committee-
ties-to-opioid-manufacturers.
\17\ Ranking Member Wyden's letters were based in part on
information contained in CMS's Open Payments database created by the
Physician Payment Sunshine Act that Chairman Grassley championed in the
Senate.
---------------------------------------------------------------------------
2012: The Investigation Begins
The financial information collected during the Committee's 2012
inquiry showed that Purdue Pharma, L.P., (Purdue), Endo Pharmaceuticals
(Endo), and Johnson & Johnson maintained strong financial ties to tax-
exempt organizations and, in some cases, paid millions of dollars to
them.\18\ For example, Purdue reported to the Committee that it had
made payments to a handful of tax-exempt organizations totaling more
than $18 million. Between 1997 and 2012, these payments included
approximately $3.6 million to the (now-defunct) American Pain
Foundation, $3.6 million to the Center for Practical Bioethics, and $3
million to the American Pain Society, which filed for bankruptcy in
2019.\19\
---------------------------------------------------------------------------
\18\ Letter from Theodore Hester, Counsel, King & Spalding, on
Behalf of Purdue Pharma, to Senator Baucus and Senator Grassley (June
8, 2012); Letter from Raymond V. Shepherd, Counsel, Venable, on Behalf
of Endo Pharmaceuticals, to Senator Baucus and Senator Grassley (June
15, 2012); Letter from Daniel Donovan, Counsel, King & Spalding, to
Senator Baucus and Senator Grassley (June 8, 2012); SFC0000000l; JJ-
SFC-00000001-10.
\19\ SFC00000001. See also Appendix A and B.
These payments were part of a broad strategy Purdue took to fund
tax-exempt groups. Between 2006 and 2010, an internal presentation
showed that the company spent $24.5 million on education grants and
donations, funding hundreds of requests annually.\20\ The company also
met with and closely tracked encounters with pain societies,
professional associations, and professional licensing boards and
``developed message points for internal and external
stakeholders.''\21\ (The same internal presentation shows that the
American Pain Foundation, American Pain Society, American Academy of
Pain Medicine, the American Board of Pain Medicine, and the American
Society of Pain Educators,\22\ were organizations with close ties to
Purdue at the time).\23\
---------------------------------------------------------------------------
\20\ SFC00002172, at SFC00002193.
\21\ Id. at SFC00002175-76, SFC00002179, SFC00002220, SFC00002186.
\22\ The American Society of Pain Educators was founded in 2004. It
operated as a tax-exempt organization from 2004 until 2012, when the
IRS revoked its status. ASPE's activities included providing tests that
certified providers as ``pain educators,'' and public tax records show
it was involved in a number of medical communications activities. ASPE
is closely associated with Aventine Co., a medical communications firm
based in New Jersey, which has done business as PainWeek, a conference
and communications franchise that features presentations from many
people with professional and financial ties to opioid manufacturers.
PainWeek was purchased by an Irish media company in 2015 in a multi-
million acquisition. Purdue was one of several pharmaceutical companies
that maintained ``corporate memberships'' with ASPE. See ASPE_000029-
30.
\23\ SFC00002172, at SFC00002175-76, SFC00002179, SFC00002220,
SFC00002186.
Such deep cooperation was on display at the American Pain
Foundation--a now-defunct, but once-influential non-profit. According
to the American Pain Foundation's 1998 business plan, ``most pain
sufferers are under-medicated'' and ``many [physicians] are reluctant
to prescribe opioids because they mistakenly think their patients will
become addicted to the drug or because they fear investigation and
sanctions by regulatory bodies.''\24\ The American Pain Foundation's
goal at the time was to reduce the ``percentage of Americans who agree
that it is easy to become addicted to pain medicine.''\25\
---------------------------------------------------------------------------
\24\ American Pain Foundation's 1998 Business Plan, at 3-2.
Emphasis added.
\25\ Id.
Purdue was the American Pain Foundation's largest funder during the
organization's early years of existence, and the company repeatedly
sent the organization checks exceeding $100,000, as well as other
financial assistance such as underwriting ``challenge grants.''
Documents also show that as the foundation solicited funds from Purdue,
it provided the company's top executives frequent and detailed updates,
including to its president, Richard Sackler.\26\ The accomplishments
memo sent to Mr. Sackler highlighted multiple initiatives, including
state and Federal lobbying efforts, and a public relations efforts to
fight ``misconceptions about [o]pioids in the [p]ress,'' noting that it
had sent background materials to 1,200 health journalists.\27\
---------------------------------------------------------------------------
\26\ See APF65-111, APF298-99.
\27\ APF65-69.
Similarly, in 2007, Purdue and the American Pain Foundation worked
closely to draft talking points for use during the Pain Care Forum, a
coalition of drug manufacturers and other advocacy groups that met
monthly to discuss opioid-related issues. According to these talking
---------------------------------------------------------------------------
points:
Overly restrictive regulatory policies impeded pain relief . .
. [and] other barriers to effective pain care include . . . the
public--including doctors and people with pain--often believe
that opioid medications are addictive and produce euphoria. The
fact is that when properly prescribed by a health care
professional and taken as directed, these medications give
relief--not a `high.'\28\
---------------------------------------------------------------------------
\28\ SFC00011527-29.
After reviewing these draft talking points, a Purdue Pharma
official wrote in track changes, ``Do we want an ethical message . . .
like if as a [health care provider] if you know the right thing to do
and you don't do it . . . or the moral obligation to treat
suffering????''\29\ An employee of the American Pain Foundation wrote
in a subsequent email that she ``amended the talking points to reflect
the Purdue Pharma official's suggestions.''\30\
---------------------------------------------------------------------------
\29\ Id.
\30\ SFC00011511.
In addition to its close financial relationships with the American
Pain Foundation, Purdue reported paying $2.1 million to the Joint
Commission for Accreditation of Health Organizations (now known as the
``Joint Commission''), a standard-setting body for the health care
industry. The data produced in response to the Committee's 2012
investigation shows that this organization also received ``support for
pain management activities'' from Johnson & Johnson, Ortho McNeill (now
Janssen), National Pharmaceutical Council, Endo, Pfizer, and Abbott
Labs.\31\ This financial support occurred primarily between 2000 and
2002, when the Commission was developing a pain care guide and other
materials that were distributed to providers.
---------------------------------------------------------------------------
\31\ Letter from Mark Chassin, President, The Joint Commission, to
Senators Baucus and Senator Grassley (June 29, 2012).
The pain care guide notes that ``[s]ome clinicians have inaccurate
and exaggerated concerns'' about addiction, tolerance and risk of
death, and that ``[t]his attitude prevails despite the fact there is no
evidence that addiction is a significant issue when persons are given
opioids for pain control.''\32\ The Commission's data further
disseminates these payments:
---------------------------------------------------------------------------
\32\ Thomas Catan and Evan Perez, A Pain-Drug Champion Has Second
Thoughts, Wall St. J. (Dec. 17, 2012), http://www.wsj.com/articles/
SB10001424127887324478304578173342657044
604.
In October 2001, Purdue funded the publication of a book for
``Pain assessment and management: an organizational approach,''
totaling $58,272. The company also funded two videos in August
2000 for ``Pain Management in Special Populations: Geriatric
and Disease Related Pain,'' totaling $85,000.\33\
---------------------------------------------------------------------------
\33\ Letter from Mark Chassin, President, The Joint Commission, to
Senator Baucus and Senator Grassley (June 29, 2012); Attachment A.
In 2001, Ortho McNeill (now Janssen) provided funding for
``Pain Management: An Overview for Clinicians
audioconference,'' totaling $66,000.\34\
---------------------------------------------------------------------------
\34\ Id.
The National Pharmaceutical Council paid $155,104 between
2001 and 2002 for the Joint Commission to develop ``a monograph
designed as a reference for clinicians, quality professionals,
researchers and others involved in performance assessment,
improvement, education, and policy decisions related to pain
management within health care organizations.''\35\
---------------------------------------------------------------------------
\35\ Id.
Such initiatives were lumped in with other sales and marketing
investments that opioid manufacturers made to expand the market
footprint of their products. For example, this approach was on display
in a pair of presentations created for Opana ER, an opioid drug
marketed by Endo. (The company would later stop marketing in response
to an unprecedented request from the Food and Drug Administration (FDA)
which determined that the ``benefits of the drug may no longer outweigh
its risks.'')\36\ Ten years earlier, Endo identified such a threat in a
multi-year business plan for Opana ER stating: ``increased awareness of
Rx abuse may lead to tighter governmental oversight and new
restrictions for opioid analgesics.''\37\
---------------------------------------------------------------------------
\36\ Press Release, FDA requests removal of Opana ER for risks
related to abuse (June 8, 2017), https://www.fda.gov/news-events/press-
announcements/fda-requests-removal-opana-er-risks-related-abuse.
\37\ SFC-00025042, at SFC-00025056.
Even though Endo knew of these risks, the company's business plan
for marketing Opana ER included ``utilize[ing] existing and newly
trained pain specialist speakers in an effort to provide a platform for
dialogue between pain specialists and the pain care physician community
to discuss the features and benefits of Opana ER.''\38\ The business
plan goes on to cite two physicians who served as speakers, including
Bill McCarberg, a physician who Endo reported paying more than $45,000
from the company for honoraria, sales support, and pain education from
2001 to 2006.\39\ McCarberg, who at one point led the American Academy
of Pain Medicine,\40\ has received over $700,000 from pharmaceutical
manufacturers since 1998, including opioid makers Johnson & Johnson,
Purdue, Pfizer, Collegium Pharmaceuticals and Janssen
Pharmaceuticals.\41\ Open Payments data further underscores the
importance manufacturers' place on these relationships. Endo has
provided more than $28 million to physicians, as well as sponsored
research and development initiatives since 2013.\42\ Similarly, Purdue
provided $89 million to physicians and sponsored research during the
same period.\43\
---------------------------------------------------------------------------
\38\ Id. at SFC-00025072-75.
\39\ SFC00000001.
\40\ SFC-00025042, at SFC-00025079.
\41\ Johnson & Johnson reported to the Committee that it paid
McCarberg more than $109,000 from 2003 to 2010 for promotional speaker
fees, advisory board work, and honoraria. Purdue Pharma reported paying
McCarberg nearly $51,000 from 1998 to 2005 for lecture programs,
consulting fees, and clinical research. Open Payments data further
shows that McCarberg was paid more than $504,000 from pharmaceutical
manufacturers from 2013 to 2019, including tens of thousands of dollars
while he was head of the American Academy of Pain Medicine. Open
Payments Data, Physician Profile for Bill McCarberg,
OpenPaymentsData.CMS.gov, https://openpaymentsdata.cms.gov/physician/
117086 (last viewed Dec. 2, 2020).
\42\ Endo Pharmaceuticals, Inc., OpenPaymentsData.CMS.gov, https://
openpaymentsdata.cms.
gov/company/100000000285 (last viewed Nov. 25, 2020).
\43\ Purdue Pharma, L.P., OpenpaymentsData.CMS.gov, https://
openpaymentsdata.cms.gov/company/100000005432 (last viewed Dec. 2,
2020).
Endo also heavily invested in tax-exempt organizations focused on
pain issues during this period. Endo reported that it made payments of
$5.9 million to the American Pain Foundation, $4.2 million to the
American Pain Society, $1.3 million to the American Academy of Pain
Medicine, and $369,000 to the Federation of State Medical Boards
between 1998 and 2012.\44\ An internal presentation created for Endo's
scientific affairs team in 2011 describes the company's interest in
such investments, and the importance of developing ``strategic
partnerships . . . that further advance the coordination of the
professional, patient, gov't and community advocacy efforts.''\45\ The
presentation also highlighted efforts to advocate for tamper resistant
opioids and the company's ``strategic third party partnerships'' with
the American Pain Society, American Academy of Physical Medicine and
Rehabilitation, American Academy of Pain Medicine, American Academy of
Pain Management, Advanced Pain & Spine Institute, the Arthritis
Foundation, National Council on Aging, and its membership in 17 State
Pain initiatives.\46\ It further notes that the company was
``indisputably recognized as leader by the Pain Community and primary
care for all pain therapeutic areas,'' citing its role in mobilizing a
``rapid response'' to an FDA proposal related to acetaminophen,
securing an author for a white paper in the journal Pain Medicine, and
leading in development of Risk Evaluation and Mitigation Strategies or
REMS.\47\
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\44\ Endo Pharmaceuticals, Inc. payments to organizations.
\45\ SFC-00057051, at SFC-00057069.
\46\ Id. at SFC-00057069, SFC-00057071. Data collected by the
Committee in 2019 shows that Endo's relationship with the organizations
continued. The company paid the American Academy of Pain Medicine
$149,950 from 2013 to 2016 for corporate memberships, and various
advertising at annual meetings. Endo also paid the American Academy of
Physical Medicine and Rehabilitation $30,000 to maintain a seat on the
organization's industry relations council from 2012 to 2014, and $8,500
to sponsor Risk Evaluation and Mitigation Strategies (REMS) at a 2012
annual assembly.
\47\ Id. at SFC-00057069.
Endo's business plan likewise noted the value of collaborating with
tax-exempt organizations, their executives, and their board members. It
identified conferences, and articles in their publications as
components of a multi-channel marketing strategy to increase
prescription volume.\48\ For example, a pocket card for managing pain-
and, endorsed by the American Society of Pain Educators \49\--was among
a list of ``valued added initiative[s]'' that ``Endo sales
representatives perceived as adding higher value than competitive
representatives.''\50\ During the two years leading up to the business
plan presentation, Endo made contributions and grants to the American
Society of Pain Educators totaling at least $45,000 \51\ and maintained
a corporate membership with the organizations, which involved paying
the organization at least $25,000.\52\ That same year, the American
Society of Pain Educators made over $175,000 in payments to other pain
advocacy organizations, including the American Association for Pain
Management and the American Pain Society.\53\
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\48\ SFC-00025042.
\49\ In 2016, the National Academies of Sciences, Engineering, and
Medicine removed an ASPE board member from a panel studying
prescription painkillers, following conflict of interest concerns
raised by Ranking Member Wyden. Andrea McDaniels, Painkiller panel
drops experts linked to pharma industry, Baltimore Sun (July 8, 2016),
https://www.baltimoresun.com/health/bs-hs-fda-pain-panel-20160708-
story.html. See also Press Release, Wyden Concerned by National Academy
Committee Ties to Opioid Manufacturers (July 5, 2016), https://
www.finance.senate.gov/ranking-members-news/wyden-concerned-by-
national-academy-committee-ties-to-opioid-manufacturers.
\50\ SFC-00025042, at SFC-00025106.
\51\ ASPE_001510. (On file with the Committee).
\52\ ASPE_000025-26; ASPE_000027-28.
\53\ ASPE Form 990 (2007). (On file with the Committee).
These industry-developed materials and talking points frequently
downplayed or distracted from the addictive nature of prescription
opioids. At the same time, companies sought to increase brand
allegiance among prescribers, and adherence among patients. Meanwhile,
prominent pain experts acknowledged that ``much remains unknown about
the number or types of chronic pain sufferer who will become addicted
as a result of medical care,'' and an FDA spokesperson said ``the risk
of addiction to chronic pain patients treated with narcotic analgesics
has not been well studied and is not well characterized.''\54\ These
efforts directly influenced the medical community, causing them to
widely believe that there was a low risk for addiction among patients
with chronic pain-a false narrative promoted by opioid manufacturers to
increase use of their opioid products.\55\
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\54\ Barry Meier, The Delicate Balance of Pain and Addiction, New
York Times (Nov. 25, 2003), https://www.nytimes.com/2003/11/25/science/
the-delicate-balance-of-pain-and-addiction.html.
\55\ Peter Whoriskey, Rising painkiller addiction shows damage from
drugmakers' role in shaping medical opinion, Washington Post (Dec. 30
2012), http://www.washingtonpost.com/business/economy/2012/12/30/
014205a6-4bc3-11e2-b709-667035ff9029_story.html.
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2019: Senator Grassley and Senator Wyden Expand Their Investigations
In 2019, the Committee broadened its investigation to examine the
financial relationships between a wider range of companies and non-
profit organizations. We requested and received IRS Form 990s, grant
contracts, and financial audits. These data were then compiled to
assess each organization's financial relationship to drug manufacturers
that marketed opioids and opioid-related products such as therapies to
treat opioid use disorder, opioid overdoses or opioid-induced
constipation. Committee staff further analyzed the data to understand
the timing and purposes of these payments.\56\ We also sought
presentations and other internal documents, which the Committee used in
combination with publicly available materials, to review and evaluate
the types of activities pursued by organizations that received large
sums of money from opioid manufacturers.
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\56\ These data were categorized for each type of donor (i.e.,
pharmaceutical company, biotech company, device company, government,
hospital, foundation, etc.), and the product developed by that donor
(i.e., opioids, opioid-related drugs, non-opioid pain drugs, other
drugs, or devices). Categories were also created to systematically
label each program type across all organizations. For example,
donations were labeled as: ``program,'' ``conference,'' ``membership
fees,'' ``grant,'' ``advocacy,'' ``advertising'' and ``education/
lecture.'' When possible, all payments were cross-
referenced with 990 forms and other financial statements to eliminate
duplicate observations [hereinafter ``payment data''].
Based on payment data collected for this investigation, between
2012 and 2019, drug manufacturers that marketed opioids or opioid-
related therapies paid almost $30 million to these organizations.\57\
As the money rolled in, these organizations conducted activities
similar to the ones that Purdue and Endo's internal documents
previously identified as helpful to their respective businesses. Data
collected by the Committee show that Teva Pharmaceuticals (Teva),
Pfizer, Inc. (Pfizer), and Purdue were among the largest funders of
these organizations. Teva led the way, having paid over $4.8 million,
the largest beneficiaries of which included the American Chronic Pain
Association, the International Association for the Study of Pain, the
American Academy of Pain Medicine, the American Pain Society, and the
U.S. Pain Foundation. Pfizer made payments of roughly $4.1 million, the
largest share of which went towards funding programs at the
International Association for the Study of Pain and the American
Academy of Pain Medicine. Purdue paid $2.8 million, with the majority
going to the American Association for Pain Medicine, the American
Academy of Physical Medicine and Rehabilitation, and the American
Chronic Pain Association. Other major funders included Daiichi Sankyo,
which made payments of nearly $2 million, Endo, which made payments of
almost $1.8 million, and AbbVie, which made payments of more than $1.6
million. In all, the Committee found that the tax-exempt organizations
had received money from more than 40 pharmaceutical companies that
market opioids or opioid-related products.
---------------------------------------------------------------------------
\57\ See Form 990s and accompanying Schedule Bs. (On file with the
Committee).
The data also shows that fees for opioid and opioid-related work is
one of the biggest sources of revenue for some of these organizations.
Together, Alliance for Patient Access, the American Academy of Pain
Medicine, the American Chronic Pain Association, International
Association for the Study of Pain, and the U.S. Pain Foundation
received $23 million--millions of which came in the form of grants from
drug and device manufacturers for opioid and opioid-related work. For
example, the International Association for the Study of Pain received
more than $4 million in funding from opioid manufacturers between 2012
and 2019. The Alliance for Patient Access came in at a close second,
---------------------------------------------------------------------------
receiving $4.2 million.
By contrast, the American Society for Pain Management Nursing,
Center for Practical Bioethics, and The Joint Commission all received
less than $600,000 in payments for opioid and opioid-related work
between 2012 and 2019. The Federation of State Medical Boards is the
only organization that did not report receiving any funding from drug
or device manufacturers between 2012 and 2019, opting instead to adopt
a policy which precludes its acceptance of any grants or funding from
pharmaceutical companies.\58\ The Federation of State Medical Boards
appears to have changed its policy shortly after the Committee's 2012
inquiry which showed that, between 2007 and 2012, the organization
received approximately $1.3 million from Purdue, Johnson & Johnson, and
Endo.\59\ The American Pain Society filed for bankruptcy the day it
received our June 28th letter due to legal costs related to opioid
litigation.\60\
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\58\ Letter from Humayun Chaudhry, President and CEO, Federation of
State Medical Boards, to Senator Grassley and Senator Wyden (July 29,
2019).
\59\ Letter from Raymond V. Shepherd, Counsel, Venable, to Senator
Baucus and Senator Grassley (June 15, 2012); SFCO000O00 1; JJ-SFC
00000001.
\60\ Alia Paavola, Ameriwn Pain Society files for bankruptcy as
legal costs mount, Becker Hospital Review (July 1, 2019), https://
www.beckershospitalreview.com/pharmacy/american-pain-society-files-for-
bankruptcy-as-legal-costs-mount.html.
---------------------------------------------------------------------------
The American Chronic Pain Association
The American Chronic Pain Association (ACPA) provides a clear
example of how a tax-exempt organization benefited from opioid
manufacturers funding its activities. The organization received funding
from opioid makers, medical device manufacturers, and companies that
market therapies for opioid-related conditions. These payments funded
materials that appear to help sell products sold by opioid
manufacturers, discussed opioid therapy while sidestepping the
addictive nature of the drugs, and attributed responsibility for
overdoses to people who misuse opioids.
For example, in recent years, the ACPA has received funding for
videos that promote ``abuse-deterrent formulation'' opioids. Daiichi
Sankyo, which sells an opioid with an abuse-deterrent label called
MorphaBond (morphine sulfate),\61\ paid the ACPA $75,000 to support the
organization's abuse deterrent activities in 2018. The payment appears
to be connected to a survey and video the company funded 1 month
earlier.\62\ The video that was subsequently posted on the ACPA's
website opens with the host saying ``pharmaceutical companies that make
opioid medications now offer versions of these drugs that are more
difficult to misuse,'' before moving to a series of questions and
answers with a pain doctor who, for the most part, hews closely to
warnings on the drug's FDA label.\63\ (It's important to note that
abuse-deterrent formulations have not been proven to be any less
addictive than other types of opioids).\64\ The doctor (Ajay Wasan, now
president of the American Academy of Pain Medicine) has received
$26,000 in payments from opioid manufacturers.\65\ At one point in the
video, Dr. Wasan appears to downplay the risk of addiction for patients
using abuse-deterrent opioids:
---------------------------------------------------------------------------
\61\ Press Release, Daiichi Sankyo, Daiichi Sankyo, Inc. and
Inspirion Delivery Sciences LLC Announce U.S. Licensing Agreement for
MorphaBondTM Formulated with SentryBondTM Abuse-
Deterrent Technology (Oct. 26, 2016), https://www.daiichisankyo.com/
media/press_release/detail/index_3394.html.
\62\ SFC_ACPA_0006. (On file with the Committee). See also
SFC_ACPA_0221-39.
\63\ Abuse Deterrent Formulation, American Chronic Pain Association
at 0:27 to 0:34, https://www.acpanow.com/apps/
search?q=Abuse+Deterrent+Formulation#/ (lasted viewed Nov. 27, 2020).
\64\ Abuse-Deterrent Opioids Analgesics, Food & Drug
Administration, https://www.fda.gov/drugs/postmarket-drug-safety-
information-patients-and-providers/abuse-deterrent-opioid-analgesics
(last updated June 11, 2019). (Here the FDA acknowledges that ADFs are
not addiction proof, and highlights that it is requiring manufacturers
with ADF labeling claims to conduct post-market studies to determine
the real world impact of their products). Id.
\65\ Open Payments Data, Physician Profile for Steven Feinberg,
OpenPaymentsData.CMS.gov, https://openpaymentsdata.cms.gov/physician/
1272772/general-payments (last viewed Nov. 27, 2020).
It is possible to get addicted to abuse-deterrent formulations.
It's unusual, but one way is if someone takes an opioid and
immediately feels a high. That is one possibility that can lead
to addiction. The other possibility is if someone misuses their
medications and takes extra medications over and over again.
That can also lead to addiction.\66\ (Emphasis added).
---------------------------------------------------------------------------
\66\ Abuse Deterrent Formulation, American Chronic Pain Association
at 2:21, https://www.acpanow.com/apps/
search?q=Abuse+Deterrent+Formulation#/ (lasted viewed Nov. 27, 2020).
In the February letter to Daiichi Sankyo, Penny Cowan, President of
the ACPA, notes that the manufacturer's money would support an
anonymous survey done on people with pain in order to ``investigate
general population knowledge, attitudes, beliefs and behaviors as it
relates to opioids and [abuse-deterrent formulation].''\67\ She goes on
to explain that the survey will inform the video content by
``address[ing] the misconceptions and help them understand what they
need to know about [abuse-deterrent formulations], so they are used,
stored and dispose[d] of properly.''\68\ She further states ``this
video will communicate all aspects of [abuse-deterrent formulations]
and the importance of their use,'' and would be posted to ACPA's
website as well as turned into a DVD for distribution to health care
professionals, at medical conventions, for patient education, and would
be incorporated into all of ACPA's presentations.\69\ The ACPA
estimated that around 50,000 people will view the video.\70\
---------------------------------------------------------------------------
\67\ SFC_ACPA_0221-39.
\68\ Id. at SFC_ACPA_0221.
\69\ Id. at SFC_ACP_A_0229.
\70\ Id. at SFC_ACPA_0233.
While much of the ACPA's funding came from opioid manufacturers,
companies that have a financial stake in opioid-based pain treatment
also contributed heavily to the organization. In turn, the organization
produced programming and materials that hewed closely to the company's
business interests, including at least one instance in which products
were referred to in the material.\71\ AstraZeneca, which markets
Movantik (naloxegol),\72\ a drug used to treat opioid-induced
constipation, heavily funded the ACPA's opioid-induced constipation
programming. In 2014, the same year that Movantik received FDA
approval,\73\ AstraZeneca was one of ACPA's corporate members that paid
the organization tens of thousands of dollars annually to maintain its
status. In addition, the company paid ACPA $215,000 in a 2-year span to
fund programming related to opioid-induced constipation.\74\ (During
the same time period, ACPA's expenses related to opioid-induced
constipation was $207,000, according to a financial audit).\75\ One
video produced by ACPA, titled ``Opioid Induced Constipation,''\76\
singles out AstraZeneca' s product, even though at least one study
published five months prior found that a competing product,
subcutaneous methyl naltrexone, ``was found to perform better than
other interventions for managing opioid-induced constipation.''\77\
---------------------------------------------------------------------------
\71\ See Opioid Induced Constipation, American Chronic Pain
Association, at 4:22. https://www.theacpa.org/pain-management-tools/
surveys/oic/ (last viewed Nov. 27, 2020). In this video, the narrator
states that, if over-the-counter medication and increasing hydration is
not enough, patients should consider methylnaltrexone or naloxegol, as
these are ``easier to take'' than other treatment options. Id. It's
important to note that naloxegol is manufactured under the trade name
MOVANTIKTM by AstraZeneca. See Press release, AstraZeneca,
FDA approves MOVANTIKTM (naloxegol) tablets C-11 for the
treatment of opioid-induced constipation in adult patients with chronic
non-cancer pain (Sept. 16, 2014), https://www.astrazeneca.com/media-
centre/press-releases/2014/fda-approved-movatnik-opioid-induced-
constipation-chronic-non-cancer-pain-patients-16092014.html#.
\72\ Press release, AstraZeneca, FDA approves MOVTAIKTM
(naloxegol) tablets C-11 for the treatment of opioid-induced
constipation in adult patients with chronic non-cancer pain (Sept. 16,
2014), https://www.astrazeneca.com/media-centre/press-releases/2014/
fda-approved-movatnik-opioid-induced-constipation-chronic-non-cancer-
pain-patients-16092014.html#.
\73\ Id.
\74\ SFC_ACPA_0127-41.
\75\ SFC_ACPA_0067, at SFC_APCA_0069, 0077, 0089, 00102.
\76\ See also Opioid Induced Constipation, American Chronic Pain
Association, https://www.theacpa.org/pain-management-tools/surveys/oic/
\77\ See Kannan Sridharan, Gowri Sivaramakrishnan, Drugs for
Treating Opioid-Induced Constipation: A Mixed Treatment Comparison
Network Meta-analysis of Randomized Controlled Clinical Trials, J. of
Pain and Symptom Management 55(22): 468-479(2018), https://
pubmed.ncbi.nlm.nih.gov/28919541/.
Other educational videos posted on the ACPA's website specifically
target conditions and treatments for pain. For instance, several videos
are dedicated to explaining implantable medical devices like medication
pumps and neurostimulators for treating pain. These videos are funded
by Medtronic, a device manufacturer of pain medication pumps and nerve
stimulators,\78\ which donated $100,000 for the production of a DVD and
web segment on implantable devices.\79\ Other videos walk the viewer
through how the devices work, as well as benefits, risks, goals for
treatment, what is involved in implantation procedures, what living
with a pump is like, and maintenance of the pump.\80\ One physician
featured in the video is an anesthesiologist who received 235 payments,
for a total of $113,830, from Medtronic between 2013 and 2018.\81\
---------------------------------------------------------------------------
\78\ Drug Infusion Systems, MEDTRONIC, https://www.medtronic.com/
us-en/healthcare-professionals/products/neurological/drug-infusion-
systems.html (last visited Nov. 27, 2020).
\79\ SFC_ACPA_572, at SFC_ACPA_573-75, 593.
\80\ Intrathecal Medication Pumps, American Chronic Pain
Association, https://www.
theacpa.org/pain-management-tools/videos/conditionstreatments/ (last
viewed Nov. 27, 2020).
\81\ Open Payments Data, Physician Profile for David Provenzano,
OpenPaymentsData.
CMS.gov, https://openpaymentsdata.cms.gov/physician/172676 (last viewed
Nov. 27, 2020).
---------------------------------------------------------------------------
Alliance for Patient Access
Some tax-exempt organizations also proved to be helpful vehicles
for opioid manufacturers to lobby the Federal Government. One example
is the Alliance for Patient Access (AfPA), an organization that
describes itself as ``a national network of physicians and other health
care providers dedicated to ensuring patient access to approved
therapies and appreciate clinical care.''\82\ In 2017, all of the
AfPA's approximately $2 million in revenue was generated from
contributions and grants, of which 90% were from pharmaceutical
manufacturers.\83\ Of these payments, three opioid makers accounted for
17% of contributions to the AfPA that year--Teva ($225,000),
Mallinckrodt ($75,000), and Pfizer ($40,000). Opioid manufacturers have
consistently made large contributions to the AfPA. Since 2012, the AfPA
has received at least $2.1 million in payments from opioid
manufacturers including AbbVie, Endo, Grunenthal, Mallinckrodt, Pfizer,
Purdue and Teva.
---------------------------------------------------------------------------
\82\ Letter from Sam Dewey, Counsel, McDermott Will & Emery, on
behalf of the Alliance for Patient Access, to Senator Grassley and
Senator Wyden (July 29, 2019).
\83\ AfPA Form 990 (2017). (On file with the Committee).
Open Payments data further shows that opioid manufacturers'
influence at the AfPA does not stop at direct payments to the
organization. Doctors who sat on the organization's board of directors
have received more than $5 million in payments from pharmaceutical
manufacturers and device manufacturers, of which more than $1.9 million
came from opioid makers.\84\
---------------------------------------------------------------------------
\84\ The majority of these payments overlapped with directors' time
on AfPA's board. In some instances, it was not clear when some
directors joined or left the board.
Since 2013, Director Srinivas ``Sri'' Nalamachu, alone, received
nearly $1.7 million in payments from pharmaceutical companies, of which
$792,000 came from opioid makers--Purdue ($231,000), Collegium
Pharmaceutical ($148,000), Endo ($113,000), Insys ($103,000), Assertio
($81,000), Pernix Therapeutics ($63,000) and Teva ($53,000).\85\
Similarly, Director Robin Dore received more than $2.1 million from
pharmaceutical manufacturers since 2013, including $538,000 from opioid
makers Pfizer ($286,000), AbbVie ($145,000), and UCB ($107,000).\86\
Opioid makers also paid Director Jack Schim $271,000 and Howard
Hoflberg $180,000.\87\ As the AfPA and its board received millions of
dollars from opioid makers, the organization lobbied executive branch
agencies and Congress on legislation related to opioids.\88\ The AfPA
also joined other organizations funded by opioid manufacturers that
sought to limit restrictions on opioid prescribing while promoting
expanded use of so-called ``abuse-deterrent formulations.''
---------------------------------------------------------------------------
\85\ Open Payments Data, Physician Profile for Srinivas Nalamachu,
OpenPaymentsData.
CMS.gov, https://openpaymentsdata.cms.gov/physician/158026/general-
payments (last viewed Dec. 3, 2020).
\86\ Open Payments Data, Physician Profile for Robin Kathleen
Doore, OpenPayments
Data.CMS.gov, https://openpaymentsdata.cms.gov/physician/209026/
general-payments (last viewed Dec. 3, 2020).
\87\ Open Payments Data, Physician Profile for Howard Hoffberg,
OpenPaymentsData.CMS.gov, https://openpaymentsdata.cms.gov/physician/
185850/general-payments (lasted viewed Dec. 3, 2020); Open Payments
Data, Physician Profile for Jack D. Schim, OpenPaymentsData.CMS.gov,
https://openpaymentsdata.cms.gov/physician/151945 (last viewed Dec. 3,
2020).
\88\ AfPA_SFC_000193-241.
For example, in October 2014, Brian Kennedy, Executive Director of
the AfPA, wrote to the National Institutes of Health (NIH) decrying the
agency's focus on ``the deleterious effects of treating pain with
opioids'' and urged the agency to explore ``how untreated or under-
treated pain affects patients and communities.''\89\ Mr. Kennedy also
suggested examples of studies the NIH might consider, including how
reducing access to opioid medications may lead to ``consequences of
restricting access for patients with legitimate medical need'' and
``higher rates of depression, increased risks of suicide, loss of
productivity and restricted mobility that requires additional care for
patients.''\90\ The letter pointed to the work of AfPA's ``Pain Therapy
Access Physicians Working Group,''\91\ arguing that ``undertreated pain
may result in impaired concentration, which may in turn increase the
risk of falls, fractures or motor vehicle injuries.''\92\ What went
unsaid is that Pfizer paid the AfPA $125,000 to fund the working group
from 2014 to 2018, and another$25,000 in 2012 to the Prescription Drug
Abuse and Diversion Education Initiative, part of more than $300,000
the company had paid the AfPA.\93\ The working group included Dr.
Nalamachu and Bob Twillman, who held leadership positions at the
American Academy of Pain Management (another group with strong ties to
opioid manufacturers).
---------------------------------------------------------------------------
\89\ Id. at AfPA_SFC_000233-34.
\90\ Id.
\91\ See Pain Management Working Group, AfPA, https://
allianceforpatientaccess.org/pain (last viewed Dec. 2, 2012).
\92\ AfPA_SFC_000193, at AfPA_SFC_000233-34.
\93\ Pfizer-Medical, Scientific & Patient-Education Grant
Transparency, Pfizer, https://www.pfizer.com/purpose/transparency/
transparency-in-grants (last viewed Nov. 28, 2020).
In another example, on August 27, 2015, Dr. Nalamachu wrote to the
FDA ``on behalf of AfPA . . . in support of the oxycodone extended-
release capsules for oral use submitted by Collegium
Pharmaceuticals.''\94\ Dr. Nalamachu wrote that he had been an
investigator for the Collegium drug and explained that the ``efficacy
of oxycodone is well established,'' and ``further, those of us in pain
medicine know how important extended-release formulations are for
patients who require around-the-clock pain management.''\95\ The
following year, Collegium Pharmaceuticals began making payments
directly to Dr. Nalamachu, who would receive more than $148,000 from
the company.\96\
---------------------------------------------------------------------------
\94\ AfPA_SFC_000193, at AfPA_SFC_000232.
\95\ Id.
\96\ Open Payments Data, Physician Profile for Srinivas Nalamachu,
OpenPaymentsData.
CMS.gov, https://openpaymentsdata.cms.gov/physician/158026/general-
payments (last viewed Dec. 3, 2020).
Again, on March 5, 2018, AfPA co-signed a letter with several
opioid manufacturers, including Purdue, Grunenthal GmbH, and Collegium
Pharmaceuticals, and other tax-exempt organizations funded by opioid
manufacturers, raising concerns about a CMS proposal to require prior
authorization and dosage limits for abuse-deterrent opioids in Medicare
Part D.\97\ The letter highlighted diversion (the practice of
transferring legally prescribed opioids to another person for illicit
use) as a driver of the opioid epidemic, while sidestepping the fact
that the U.S. has significantly higher rates of opioid prescribing when
compared to other countries.\98\ The coalition also told CMS that
``increasing the availability of [abuse-deterrent] opioids represents a
critical component of drug abuse prevention efforts,'' and repeatedly
touted their benefits to patients even while acknowledging that
``[o]pioids with abuse-deterrent properties are not abuse-proof and do
not prevent or reduce the risk of addiction.''\99\ The coalition went
on to urge CMS to ``review plan formularies to ensure adequate access
to [abuse-deterrent] opioids.''\100\ It was one of three letters AfPA
sent with the coalition.\101\ (Funders of the organization, including
Pfizer, Teva, and Purdue, marketed opioids with abuse-deterrent label).
---------------------------------------------------------------------------
\97\ AfPA_SFC_000193-97.
\98\ See Karim Ladha, et al., Opioid Prescribing After Surgery in
the United States, Canada, and Sweden, JAMA Network (Sept. 4, 2019),
https://jamanetwork.com/joumals/jamanetworkopen/fullarticle/. (An
original investigation published in the JAMA Network, which concludes
that the United States has the highest average dose of opioid
prescriptions for most surgical procedures when compared to Canada and
Sweden.)
\99\ AfPA_SFC_000193-97.
\100\ Id.
\101\ AfPA_SFC_000193-205.
Finally, the AfPA manages a coalition called the Alliance for
Balanced Pain Management, which it acquired from Mallinckrodt in
2016.\102\ At the time of the acquisition, Mallinckrodt paid AfPA
$200,000 to support the coalition and pay for an annual summit the
coalition hosts.\103\ The coalition, which was previously managed by
Green Room Communications,\104\ describes its mission as advocating
``for balanced pain management by supporting organizations and
individuals who share a common goal to reduce pain, reduce medicine
abuse and improve care.''\105\ Its members include patient groups such
as American Chronic Pain Foundation and the U.S. Pain Foundation, which
have strong financial links to opioid manufacturers, and is led by a
steering committee that includes several individuals who have received
roughly $480,000 from opioid manufacturers, according to CMS's Open
Payments data.\106\ The AfPA also told the Committee that the coalition
includes industry members, but did not identify them, and further noted
that ``Mallinckrodt's representative joined periodic membership calls
and had an opportunity to review the Alliance for Balanced Pain
Management's educational materials in response to a group invitation
for feedback.''\107\ However, the AfPA stated that it maintains sole
discretion to determine the coalition's ``advocacy efforts, annual
summit events, and educational materials.''\108\ According to the AfPA,
these efforts have explored ``issues such as the value of multimodal
analgesia--an opioid-sparing approach to surgical pain, technology-
based solutions for treating pain in patients who've battled opioid
addiction, and the value of non-pharmacologic interventions like
physical therapy, chiropractic care, and yoga.''\109\
---------------------------------------------------------------------------
\102\ Letter from the Samuel Dewey, Counsel, McDermott Will &
Emery, on Behalf of the Alliance for Patient Access, to Senator
Grassley and Senator Wyden (July 29, 2019). AfPA_SFC_000001-05.
\103\ Letter from the Samuel Dewey, Counsel, McDermott Will &
Emery, on Behalf of the Alliance for Patient Access, to Senator
Grassley and Senator Wyden (Jan. 29, 2020).
\104\ Greenroompr.com, https://www.greenroompr.com/ (last viewed
Dec. 7, 2020).
\105\ Letter from the Samuel Dewey, Counsel, McDermott Will &
Emery, on Behalf of the Alliance for Patient Access, to Senator
Grassley and Senator Wyden (Jan. 29, 2020). About AfBPM, Alliance for
Balanced Pain Management, https://alliancebpm.org/events/ (last viewed
Nov. 28, 2020).
\106\ Letter from the Samuel Dewey, Counsel, McDermott Will &
Emery, on Behalf of the Alliance for Patient Access, to Senator
Grassley and Senator Wyden (Jan. 29, 2020).
\107\ Letter from the Samuel Dewey, Counsel, McDermott Will &
Emery, on Behalf of the Alliance for Patient Access, to Senator
Grassley and Senator Wyden (July 29, 2019).
\108\ Id.
\109\ Id.
---------------------------------------------------------------------------
International Association for the Study of Pain
Between 2012 and 2018, fifteen opioid makers paid the International
Association for the Study of Pain (IASP) more than $4 million. These
funds were used to support conferences the organization hosted, such as
the World Congress on Pain, the International Symposium on Pediatric
Pain, the International Congress on Neuropathic Pain, special interest
group meetings, and various grants for activities such as the
development of a tool to connect ``healthcare professionals with access
to independently created online education.''\110\ During this time
period, Pfizer was the largest of these contributors, making payments
of more than $1.3 million to IASP, the majority of which were made in
the form of grants in 2018. Other opioid manufacturers that made major
payments included subsidiaries and affiliates of Mundipharma, (making
more than $1 million in payments combined),\111\ Teva ($627,000, of
which $300,000 was made in 2018)\112\ and Allergan ($161,000). Two
Grunenthal entities, and a third party connected to the company, also
paid IASP $601,000 during this time period.
---------------------------------------------------------------------------
\110\ IASP Submission Question 2 Attachment--Accounting Report. (On
file with the Committee).
\111\ IASP reported receiving payments during the 2012-2018 period
from Mundipharma International (UK), Mundipharma International Ltd.,
Mundipharma Pte, Mundipharma Pte Limited, MundiPharma PTY (Australia),
and Mundipharma Research GmbH.
\112\ The organization reported to the Committee that it received
$147,550 in payments from Teva in 2018. However, it reported receiving
$300,230 from Teva that year on its IRS Form 990. (On file with the
Committee).
Pfizer, which as noted above manufactures two extended-release
prescription opioids that the FDA designated as ``abuse-
deterrent,''\113\ made payments of nearly $4 million to various pain-
related tax-exempt organizations, according to payments reviewed by the
Committee.\114\ The largest share of these funds went to IASP. For
example, Pfizer provided a $527,000 education grant to the Japan
chapter of the IASP in 2018.\115\ (This was the single largest payment
to IASP from any company during the 2012-2018 time period). The grant
was intended to fund nursing student pain education programs, publish
medical school textbooks on pain, and develop a recurrent educational
program for physical and occupational therapists.\116\ That grant was
part of $918,000 the organization received from Pfizer that year.
---------------------------------------------------------------------------
\113\ Press Release, Pfizer, FDA Approves Abuse Deterrent Labeling
For Emeda (Morphine Sulfate and Natlrexone Hydrochloride) Extended-
Release (ER) Capsules CII, (Oct. 17, 2014), https://www.pfizer.com/
news/press-release/press-release-detail/; Press Release, Pfizer, FDA
Approves Troxyca (Oxycodone Hydrochloride and Naltrexone
Hydrochloride) Extended-Release Capsules CII with Abuse-Deterrent
Properties for the Management of Pain, Pfizer (Aug. 19, 2016), https://
www.pfizer.com/news/press-release/.
\114\ Based on IASP's Form 990s collected during this
investigation. (On file with the Committee).
\115\ IASP Submission Question 2 Attachment--Accounting Report. See
also Pfizer Independent Grants for Learning & Change (IGLC),
International Association for the Study of Pain, https://www.iasp-
pain.org/Education/GrantDetail.aspx?ltemNumber=7756 (last viewed Nov.
28, 2020).
\116\ According to IASP, ``Pfizer has no influence over any aspect
of the projects and only asks for reports about the results and the
impact of the projects in order to share them publicly.'' See Pfizer
Independent Grants for Learning & Change (IGLC), IASP, https://
www.iasp-pain.org/Education/GrantDetail.aspx?1temNumber=7756 (last
viewed Dec. 8, 2020).
IASP's activities also suggest that opioid manufacturers are
engaging in the same pattern of behavior in Asia and Europe. One such
initiative is the World Congress on Pain. Opioid manufacturers have
made more than $2 million in payments to IASP in connection with the
last four conferences, which in recent years have been held in Boston,
Massachusetts (2018), Yokohama, Japan (2016), Buenos Aires, Argentina
(2014), and Milan, Italy (2012).\117\ The meeting is advertised as the
preeminent global meeting devoted to sharing new developments in pain
research, treatment, and education, and attendees are predominantly
clinicians, researchers, students, and educators.\118\ Each year,
opioid manufacturers have made payments to fund the World Congress
events, accounting for up to 16% of the conferences' total
expenses.\119\
---------------------------------------------------------------------------
\117\ Past Congresses, IASP, https://www.iasp-pain.org/Meetings/
WorldCongressList.aspx (last viewed Nov. 28, 2020).
\118\ About the IASP World Congress on Pain, IASP, https://
www.iaspworldcongress.org/attend (last viewed Dec. 8, 2020).
\119\ IASP Form 990 (2012-2018). (On file with the Committee.).
In addition to its global conferences, IASP has also developed
region-specific programs to advance the availability and accessibility
of opioids. In 2018, Pfizer made a payment of approximately $190,000 to
a program titled, ``Develop, Equip, and Pilot: Guide for
Multidisciplinary Pain Clinics in South East Asia Project.''\120\ Other
programs like ``IASP Pain Management Camp'' are intensive courses that
are designed to provide ``information targeted to the educational and
organizational aspects of health-care services for pain management''
for health care professionals who want to start pain services or are
already working with patients with chronic pain.\121\ IASP's Latin
America Pain Camp received $25,000 from Grunenthal in 2014 and, three
years later, received a payment of $87,000 from Teva to support the
``independent development and execution'' of the event.\122\ In a
similar vein, IASP also offers ``pain schools'' which are held in North
America and Europe, which sezye as longer version of the camp program.
Sponsors to the North American Pain School include Grunenthal, Eli
Lilly, the Mayday Fund, and the American Pain Society.\123\
---------------------------------------------------------------------------
\120\ IASP Submission Question 2 Attachment--Accounting Report. (On
file with the Committee).
\121\ Latin American Pain Management Camp Leaves Students Smiling,
International Association for the Study of Pain (Nov. 2014), https://
www.iasp-pain.org/PublicationsNews/
JASPNewsletterArticle.aspx?ItemNumber=4009.
\122\ IASP Submission Question 2 Attachment--Accounting Report. (On
file with the Committee).
\123\ Sponsors, Organizers and Supporters, North American Pain
School, https://northamericanpainschool.com/ (last viewed Nov. 28,
2020).
Documents provided to the Committee also show that from 2012 to
2019, the IASP received a total of $1 million from Mundipharma, a
global affiliate of Purdue owned by the Sackler family.\124\ This
funding has gone towards World Congress on Pain events and special
interest group meetings held all over the world.\125\ Mundipharma has
reportedly been distributing marketing materials for OxyContin in
places like China, Australia, and Italy, and is using the same pitch
that Purdue admitted was false in the U.S. more than a decade ago.\126\
For instance, Mundipharma allegedly provided physicians with documents
that claimed the risks of opioid addiction were ``virtually non-
existent and that OxyContin's slow-release formulation made it even
safer.''\127\ Mundipharma is also allegedly targeting China with
aggressive sales teams who provide gift cards, complementary dinners,
all-expense paid trips to meetings, and compensated speaking events to
push opioid prescriptions.\128\
---------------------------------------------------------------------------
\124\ IASP Submission Question 2 Attachment--Accounting Report. (On
file with the Committee).
\125\ Id.
\126\ Erika Kinetz, Fake Doctors, pilfered medical records drive
Oxy China Sales, ABC News (Nov. 20, 2019), https://abcnews.go.com/
Business/wireStory/fake-doctors-misleading-claims-drive-oxycontin-
china-sales-67154163.
\127\ Id.
\128\ Id.
---------------------------------------------------------------------------
Conclusion
While we continue to evaluate the information produced to the
Committee, our initial review has revealed troubling instances in which
patient advocacy groups, provider groups, and other tax-exempt
organizations, their officers, and their board members have engaged in
initiatives that appear to echo and amplify messages to increase use of
opioid manufacturers' drugs, including abuse-deterrent opioids that
have not been proven to be any less addictive than other types
opioids.\129\
---------------------------------------------------------------------------
\129\ Abuse-Deterrent Opioids Analgesics, Food & Drug
Administration, https://www.fda.gov/drugs/postmarket-drug-safety-
information-patients-and-providers/abuse-deterrent-opioid-analgesics
(last updated June 11, 2019). (Here the FDA acknowledges that ADFs are
not addiction proof, and highlights that it is requiring manufacturers
with ADF labeling claims to conduct post-market studies to determine
the real world impact of their products). Id.
Consumers, health care providers, and policymakers seeking unbiased
information may not immediately recognize the significant industry ties
these groups possess, especially when they are cited as resources on
Federal health websites,\130\ testify before Congress,\131\ and have
officers that sit on Federal advisory boards.\132\ This is why the
Committee is releasing the financial information collected during the
2012 investigation, in addition to data collected over the past two
years, because we remain concerned that the opioid epidemic was driven,
in part, by misinformation and dubious marketing practices used by
pharmaceutical companies and the tax-exempt groups they fund.
---------------------------------------------------------------------------
\130\ See Resources/References, NIIH Pain Consortium--COEPEs, NIH
https://coepes.nih.gov/module/joan-pain-policy-analysis-and-advocacy/
resourcesreferences (lasted viewed Nov. 28, 2020).
\131\ Managing Pain During the Opioid Crisis, Hearing Before the S.
Comm. Health, Education, Labor & Pensions, 116th Cong. (Feb. 2019),
https://www.help.senate.gov/hearings/managing-pain-during-the-opioid-
crisis.
\132\ E.g., the FDA's advisory committee on analgesics, which
evaluate the safety of opioids includes Kevin Zacharoff who sat on the
ASPE board, and Lonnie Zeltzer who was the APS and APF boards. See
Anesthetic and Analgesic Drug Products Advisory Committee Roster, FDA,
https://www.fda.gov/advisory-committees/anesthetic-and-analgesic-drug-
products-advisory-committee/anesthetic-and-analgesic-drug-products-
advisory-committee-roster (last viewed Dec. 10, 2020).
Congress must continue to shed light on pharmaceutical and medical
device manufacturers' financial dealings with tax-exempt organizations.
While such financial entanglements are of particular concern in regards
to opioids, given their danger and addictive potential, such funding
and influence is not limited to this therapeutic class.\133\ This
investigation clearly shows that such payments are viewed as key
marketing and policy influencing tools, which, in the case of opioids,
contributed to addiction, sickness, and death for millions of
Americans. Therefore, Congress must continue to advocate for stronger
safeguards within tax-exempt organizations and within the Federal
Government. Steps we recommend taking:
---------------------------------------------------------------------------
\133\ See Drug Pricing in America: A Prescription for Change, Part
II: Hearing Before S. Comm. Fin. 116th Cong. at 70, 147, 477, 529, 716
(2019), https://www.finance.senate.gov/imo/media/doc/37143.pdf. See
also Alex Ruoff, AbbVie, Bristol-Myers Among Patient Advocacy Groups'
Big Backers, Bloomberg, https://about.bgov.com/news/abbvie-bristol-
myers-among-patient-advocacy-groups-big-backers/.
1. Expand CMS's Open Payments database to require
pharmaceutical manufacturers and device manufacturers to report
---------------------------------------------------------------------------
payments made to tax-exempt organizations.
2. Require the Secretary of HHS to develop guidelines and
procedures to increase transparency among members of Federal
task forces, as well as research groups and panels convened or
contracted by HHS.
In the next Congress, we plan to continue our work on these
important issues and we encourage my colleagues to do the same.
Charles Grassley Ron Wyden
Chairman Ranking Member
Senate Finance Committee Senate Finance Committee
______
Appendix A
This appendix contains payment data provided to the Finance
Committee by pharmaceutical companies in response to letters sent by
Senator Baucus and Senator Grassley in 2012. The data from Endo
Pharmaceuticals, Johnson & Johnson, and Purdue Pharma, L.P., show
payments made by the companies to tax-exempt organizations from 1997
through early 2012. In total, the companies reported paying the listed
organizations more than $36 million.
Endo/Johnson & Johnson/Purdue Payments (1997-2004)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Company/Organization 1997 1998 1999 2000 2001 2002 2003 2004
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $35,000 $215,055 $237,960 $272,853 $283,662 $361,850 $627,765
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Academy of Pain Medicine $20,090 $26,500 $22,000 $48,150 $46,200 $115,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Alliance of Cancer Pain $13,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Geriatrics Society $6,500 $750
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Foundation $20,000 $25,000 $20,000 $25,000 $15,000 $40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Society $20,000 $48,665 $55,935 $132,400 $152,162 $75,650 $393,015
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beth Israel Medical Center $15,000 $75,000 $50,000 $5,000 $5,000 $182,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federation of State Medical Boards $4,025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Joint Commission $37,500 $37,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
University of Wisconsin $37,800 $32,500 $55,953 $53,350 $43,000 $79,000
========================================================================================================================================================
Johnson & Johnson $189,715 $495,305 $206,735 $518,586 $239,683 $155,100 $108,285 $465,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Academy of Pain Medicine $43,500 $14,400 $135,140 $74,050 $66,764 $43,975 $33,000 $35,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Geriatrics Society $259,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Foundation $5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Society $146,215 $480,905 $71,595 $444,536 $158,000 $111,125 $75,285 $166,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Practical Bioethics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Joint Commission $14,919
========================================================================================================================================================
Purdue Pharma $172,286 $200,441 $764,617 $1,003,016 $2,261,102 $1,795,737 $2,161,197 $1,930,897
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Academy of Pain Medicine $36,800 $25,000 $32,300 $37,600 $80,272 $198,824 $382,295 $572,463
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Geriatrics Society $11,985 $24,481 $38,248 $78,446 $127,850 $68,750 $1,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Foundation $250,000 $606,500 $15,000 $461,056 $250,087
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Society $48,501 $75,960 $391,520 $108,065 $211,211 $383,530 $606,332 $311,603
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beth Israel Medical Center $40,000 $118,542 $25,000 $185,615 $96,334 $62,679
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Practical Bioethics $25,000 $17,500 $270,000 $250,000 $250,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federation of State Medical Boards $12,549 $75,363 $36,410 $6,345 $85,180 $199,895
--------------------------------------------------------------------------------------------------------------------------------------------------------
Joint Commission $560,000 $981,359 $582,649
--------------------------------------------------------------------------------------------------------------------------------------------------------
University of Wisconsin $75,000 $75,000 $175,000 $85,024 $280,000 $282,220
========================================================================================================================================================
Annual Total $362,001 $730,746 $1,186,407 $1,759,562 $2,773,638 $2,234,499 $2,631,332 $3,024,612
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endo/Johnson & Johnson/Purdue Payments (2005-2012)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2012
Company/Organization 2005 2006 2007 2008 2009 2010 2011 (Partial Grand Total
Year) 1997-2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $657,211 $792,948 $1,097,939 $760,628 $1,620,021 $2,545,277 $2,771,140 $1,286,405 $13,565,716
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Academy of Pain $137,000 $237,000 $125,000 $155,000 $80,000 $80,000 $85,000 $135,000 $1,311,940
Medicine
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Alliance of Cancer $13,500
Pain
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Geriatrics Society $95,000 $40,000 $112,585 $44,850 $17,100 $25,000 $341,785
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Foundation $5,000 $20,000 $138,000 $51,000 $671,012 $2,116,315 $2,080,171 $715,173 $5,941,671
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Society $319,961 $338,650 $523,038 $369,628 $748,178 $75,000 $528,969 $430,232 $4,211,484
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beth Israel Medical Center $57,250 $52,298 $24,316 $60,000 $35,981 $32,500 $40,000 $634,345
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federation of State Medical $40,000 $100,000 $100,000 $125,000 $369,025
Boards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Joint Commission $75,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
University of Wisconsin $43,000 $65,000 $75,000 $25,000 $40,000 $99,362 $12,000 $6,000 $666,965
========================================================================================================================================================
Johnson & Johnson $172,193 $51,255 $65,250 $101,580 $58,775 $424,509 $785,329 $40,500 $4,078,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Academy of Pain $21,300 $13,375 $42,050 $20,000 $5,000 $5,000 $9,500 $562,674
Medicine
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Geriatrics Society $126,383 $1,950 $158,209 $20,004 $565,626
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Foundation $5,000 $5,000 $75,000 $45,000 $235,300 $238,000 $25,000 $633,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Society $19,510 $35,930 $18,200 $6,580 $8,775 $21,000 $17,500 $12,500 $1,793,906
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Practical $5,000 $3,000 $8,000
Bioethics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Joint Commission $500,325 $515,244
========================================================================================================================================================
Purdue Pharma $1,682,095 $697,895 $823,630 $1,165,106 $1,185,040 $1,000,430 $1,785,575 $71,626 $18,700,690
American Academy of Pain $17,000 $14,000 $159,100 $78,500 $45,000 $88,695 $171,170 $96,500 $2,035,519
Medicine
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Geriatrics Society $6,000 $44,850 $40,988 $443,548
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Foundation $251,210 $177,037 $231,150 $375,000 $275,000 $456,500 $368,962 -$75,000 $3,642,502
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Pain Society $154,050 $102,858 $80,690 $121,430 $149,015 $137,190 $149,310 $60,000 $3,091,265
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beth Israel Medical Center $447 $4,190 $5,000 $70,000 $15,000 $120,375 $743,182
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Practical $250,000 $201,500 $100,000 $510,176 $525,000 $302,800 $934,770 $25,000 $3,661,746
Bioethics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federation of State Medical $339,000 $50,000 $100,000 $904,742
Boards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Joint Commission $2,124,008
--------------------------------------------------------------------------------------------------------------------------------------------------------
University of Wisconsin $670,388 $152,500 $142,500 $75,000 $76,175 $245 -$34,874 $2,054,178
========================================================================================================================================================
Annual Total $2,511,499 $1,542,098 $1,986,819 $2,027,314 $2,863,836 $3,970,216 $5,342,044 $1,398,531 $36,345,156
--------------------------------------------------------------------------------------------------------------------------------------------------------
Appendix B
This appendix contains payment data collected by Chairman Grassley
and Ranking Member Wyden from 2019 to 2020, when the Finance Committee
broadened its investigation to examine the financial relationships
between a wider range of pharmaceutical manufacturers, device
manufacturers, and the tax-exempt organizations they fund. In total,
the Committee identified $29.7 million in payments made to these
organizations by pharmaceutical companies that market or manufacture
opioids or opioid-related therapies.
The Committee requested and received IRS Form 990s, grant
contracts, and financial audits from the tax-exempt organizations.
These data were then compiled to assess each organization's financial
relationship to manufacturers of opioids and opioid-related products
(such as companies that market devices to deliver opioid medication, or
market therapies to treat opioid use disorder, opioid overdoses, or
opioid-induced constipation). Committee staff further analyzed the data
to understand the timing and purposes of these payments.
These data were categorized for each type of donor (i.e.,
pharmaceutical company, biotech company, government, hospital,
foundation, etc.) and the type of product developed by that donor
(i.e., opioids, opioid-related drugs, non-opioid pain drugs, other
drugs, or devices). Categories were also created to systematically
label each program type across all organizations. For example,
donations were labeled as: ``program,'' ``conference,'' ``membership
fees,'' ``grant,'' ``advocacy,'' ``advertising,'' and
``education/lecture.''
When possible, all payments were cross-referenced with IRS Form
990s and other financial statements to eliminate duplicate
observations. In cases when an organization reported payments from
multiple entities or affiliates of the same parent company, the
payments were attributed to the parent company.
The appendix contains payments made by pharmaceutical manufacturers
that market opioids and opioid-related products. It excludes the
American Society of Pain Educators, and the Joint Commission, both of
which reported receiving less than $100,000 from opioid manufacturers
prior to 2016. The Federation of State Medical Boards also is excluded
as it reported receiving no payments from pharmaceutical manufacturers
since 2012.
Alliance for Patient Access
--------------------------------------------------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 Grand Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Abbvie $175,000 $125,000 $405,000 $705,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
AstraZeneca $30,000 $30,000 $30,000 $50,000 $100,000 $240,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $10,000 $10,000 $5,000 $10,000 $35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
GlaxoSmithKline $50,000 $50,000 $100,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grunenthal $15,000 $15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mallinckrodt Pharmaceuticals $25,000 $25,000 $450,000 $75,000 $40,000 $615,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pfizer $25,000 $35,000 $90,000 $25,500 $115,000 $40,000 $100,000 $430,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purdue Pharma $15,000 $25,000 $25,000 $75,000 $25,000 $165,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sanofi Aventis $50,000 $250,000 $300,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $50,000 $125,000 $50,000 $10,000 $265,000 $500,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
UCB, Inc. $25,000 $25,000
========================================================================================================================================================
Annual Total $80,000 $150,000 $470,000 $405,500 $1,155,000 $730,000 $140,000 $3,130,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Academy of Physical Medicine and Rehabilitation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 2019 Grand Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Actavis, Inc. $8,150 $8,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
AstraZeneca $10,000 $12,500 $12,500 $35,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collegium Pharmaceutical $3,000 $3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Daiichi Sankyo $104,500 $275,400 $224,450 $12,500 $616,850
--------------------------------------------------------------------------------------------------------------------------------------------------------
Depomed \1\ $18,450 $5,000 $34,650 $15,000 $2,700 $75,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Egalet \2\ $88,450 $250 $88,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $18,500 $10,000 $10,000 $38,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Forest Pharmaceuticals \3\ $2,200 $500 $2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Janssen Pharmaceuticals $500 $500
--------------------------------------------------------------------------------------------------------------------------------------------------------
The Medicines Company $3,300 $3,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pernix Therapeutics $2,850 $5,700 $2,700 $3,100 $14,350
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pfizer $132,300 $25,000 $20,000 $25,000 $15,000 $15,000 $101,700 $334,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purdue Pharma $121,860 $107,450 $65,000 $145,850 $12,000 $452,160
--------------------------------------------------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $75,000 $75,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. WorldMeds Solstice $250 $5,300 $100 $4,050 $7,400 $250 $10,500 $9,300 $37,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zogenix $3,700 $3,700
========================================================================================================================================================
Annual Total $283,760 $166,700 $103,800 $290,700 $251,050 $306,300 $352,250 $34,300 $1,788,860
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Changed name to Assertio Therapeutics in August 2018.
\2\ Changed name to Zyla Life Sciences in June 2019.
\3\ Acquired by Actavis in July 2014.
American Academy of Pain Medicine \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 2019 Grand Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
AbbVie $7,500 $6,000 $13,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Allergan \2\ $2,750 $17,900 $3,000 $23,650
--------------------------------------------------------------------------------------------------------------------------------------------------------
AstraZeneca $78,750 $84,167 $50,000 $25,000 $237,917
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cara Therapeutics $67,000 $60,000 $73,625 $200,626
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cephalon \3\ $120,000 $120,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collegium Pharmaceutical $11,000 $28,500 $15,000 $17,700 $72,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Daiichi Sankyo $52,225 $329,510 $161,250 $147,000 $689,985
--------------------------------------------------------------------------------------------------------------------------------------------------------
Depomed $20,925 $57,000 $57,825 $46,000 $60,500 $53,500 $11,000 $7,500 $314,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $75,000 $10,000 $10,000 $6,400 $96,920 $26,630 $224,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
Insys Therapeutics $18,000 $19,200 $9,725 $5,800 $52,725
--------------------------------------------------------------------------------------------------------------------------------------------------------
Janssen Pharmaceuticals $83,475 $83,475
--------------------------------------------------------------------------------------------------------------------------------------------------------
Johnson & Johnson $7,500 $7,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
KaJeo $87,000 $75,000 $77,500 $239,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mallinckrodt Pharmaceuticals $17,900 $37,021 $8,350 $63,271
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nektar Therapeutics $92,400 $97,050 $24,000 $15,000 $15,000 $15,000 $258,450
--------------------------------------------------------------------------------------------------------------------------------------------------------
Novartis Pharmaceuticals $3,000 $3,000 $143,365 $149,365
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pernix Therapeutics $15,000 $82,000 $91,000 $76,500 $264,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pfizer $110,000 $127,125 $88,333 $75,000 $75,000 $83,333 $110,000 $668,791
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purdue Pharma $185,000 $164,250 $171,000 $117,000 $83,500 $42,500 $763,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salix Pharmaceuticals $5,500 $21,474 $0 $0 $7,000 $38,500 $10,000 $19,500 $101,974
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shionogi $5,000 $15,000 $50,000 $70,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $30,000 $129,900 $138,540 $323,185 $281,050 $95,500 $19,710 $1,017,885
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zogenix $95,800 $174,000 $84,800 $354,600
========================================================================================================================================================
Annual Total $512,650 $769,749 $1,003,719 $952,627 $964,195 $1,035,898 $398,750 $354,775 $5,992,363
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ During the final stages of the Committee's investigation, the American Academy of Pain Medicine (AAPM) provided additional data showing millions of
dollars in additional payments from opioid manufacturers to AAPM and an affiliated 501(c)(3) entity, the American Academy of Pain Medicine Foundation
(the Foundation). In addition to nearly $6 million AAPM received directly from opioid manufacturers, the organization reported $1.1 million in revenue
from the Foundation from 2013 to 2017. The additional data provided by AAPM shows that the Foundation, in turn, received $1 million in payments from
opioid manufacturers from 2013 to 2019.
\2\ Acquired by Actavis in November 2014.
\3\ Acquired by Teva in May 2011.
American Academy of Pain Medicine Foundation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 2019 Grand Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Collegium Pharmaceutical $10,000 $10,000 $20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Daiichi Sankyo $167,275 $47,425 $214,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Depomed $5,000 $100,000 $50,000 $148,265 $303,265
--------------------------------------------------------------------------------------------------------------------------------------------------------
Egalet $5,000 $5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mallinckrodt Pharmaceuticals $191,000 $9,600 $58,400 $259,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nektar Therapeutics $15,000 $25,000 $40,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pfizer $20,000 $20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Purdue Pharma $75,000 $75,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Salix Pharmaceuticals $45,000 $45,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $50,000 $50,000
========================================================================================================================================================
Annual Total $5,000 $90,000 $291,000 $115,000 $148,265 $207,275 $59,600 $115,825 $1,031,965
--------------------------------------------------------------------------------------------------------------------------------------------------------
American Chronic Pain Association
----------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 Grand Total
----------------------------------------------------------------------------------------------------------------
Abbvie $5,000 $5,000 $5,000 $15,000
----------------------------------------------------------------------------------------------------------------
AstraZeneca $20,000 $65,000 $215,000 $40,000 $840,000
----------------------------------------------------------------------------------------------------------------
Cephalon $10,000 $10,000
----------------------------------------------------------------------------------------------------------------
Collegium $15,000 $10,000 $15,000 $45,000 $85,000
Pharmaceutical
----------------------------------------------------------------------------------------------------------------
Daiichi Sankyo $10,000 $125,000 $135,000
----------------------------------------------------------------------------------------------------------------
Depomed $35,000 $5,000 $15,000 $12,500 $67,500
----------------------------------------------------------------------------------------------------------------
Egalet $5,000 $27,000 $10,000 $42,000
----------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $235,250 $49,000 $90,000 $874,250
----------------------------------------------------------------------------------------------------------------
Endo Labs $25,000 $25,000
----------------------------------------------------------------------------------------------------------------
Forest Laboratories $10,000 $10,000 $5,000 $5,000 $80,000
\1\
----------------------------------------------------------------------------------------------------------------
Janssen $25,000 $25,000
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Johnson & Johnson $30,000 $35,000 $25,000 $10,000 $10,000 $10,000 $120,000
----------------------------------------------------------------------------------------------------------------
Kaleo $5,000 $18,000 $65,000 $10,000 $98,000
----------------------------------------------------------------------------------------------------------------
Mallinckrodt $25,000 $5,000 $25,775 $55,775
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Pernix Therapeutics $10,000 $10,000 $5,000 $25,000
----------------------------------------------------------------------------------------------------------------
Pfizer $125,000 $34,875 $5,000 $20,000 $10,000 $20,000 $214,875
----------------------------------------------------------------------------------------------------------------
Purdue Pharma $206,500 $99,970 $35,000 $25,000 $20,000 $886,470
----------------------------------------------------------------------------------------------------------------
Sanofi Aventis $5,000 $5,000 $10,000 $20,000
----------------------------------------------------------------------------------------------------------------
Shionogi $10,000 $15,000 $25,000
----------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $65,000 $78,800 $401,000 $194,997 $200,578 $50,600 $15,000 $1,005,975
----------------------------------------------------------------------------------------------------------------
Tonix Pharma $5,000 $5,000 $10,000
----------------------------------------------------------------------------------------------------------------
Zogenix $5,000 $60,000 $18,950 $83,950
================================================================================================================
Annual Total $736,750 $362,645 $731,000 $564,722 $380,578 $208,100 $210,000 $3,193,795
----------------------------------------------------------------------------------------------------------------
\1\ Acquired by Actavis in July 2014.
American Pain Society
----------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 Grand Total
----------------------------------------------------------------------------------------------------------------
AstraZeneca $35,000 $35,000
----------------------------------------------------------------------------------------------------------------
Daiichi Sankyo $80,000 $44,711 $20,000 $144,711
----------------------------------------------------------------------------------------------------------------
Depomed $10,000 $10,000 $82,500 $61,500 $15,000 $179,000
----------------------------------------------------------------------------------------------------------------
Endo $429,307 $417,274 $150,000 $996,581
Pharmaceutica
ls
----------------------------------------------------------------------------------------------------------------
Janssen $60,000 $60,000
Pharmaceutica
ls
----------------------------------------------------------------------------------------------------------------
Kaleo $5,000 $5,000
----------------------------------------------------------------------------------------------------------------
Mallinckrodt $25,000 $25,000 $50,000
Pharmaceutica
ls
----------------------------------------------------------------------------------------------------------------
Mylan $9,375 $9,375
----------------------------------------------------------------------------------------------------------------
Nektar $60,000 $60,000
Therapeutics
----------------------------------------------------------------------------------------------------------------
Pfizer $37,000 $25,000 $35,000 $346,000 $217,500 $45,000 $705,500
----------------------------------------------------------------------------------------------------------------
Purdue Pharma $108,465 $93,480 $85,000 $20,000 $20,000 $326,945
----------------------------------------------------------------------------------------------------------------
Salix $5,000 $5,000 $10,000
Pharmaceutica
ls \1\
----------------------------------------------------------------------------------------------------------------
Teva $90,000 $90,000 $100,000 $179,500 $229,500 $60,000 $15,000 $764,000
Pharmaceutica
ls
----------------------------------------------------------------------------------------------------------------
Zogenix $5,000 $25,000 $30,000
================================================================================================================
Annual Total $747,772 $657,754 $425,000 $391,375 $717,000 $357,211 $80,000 $3,376,112
----------------------------------------------------------------------------------------------------------------
\1\ Salix was acquired by Valeant Pharmaceuticals in April 2015.
American Society for Pain Management Nursing
----------------------------------------------------------------------------------------------------------------
Grand
Company 2012 2013 2014 2015 2016 2017 2018 Total
----------------------------------------------------------------------------------------------------------------
AccreditEd/Salix $37,000 $37,000
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
AstraZeneca $65,000 $65,000
----------------------------------------------------------------------------------------------------------------
Collegium $1,500 $7,500 $9,000
Pharmaceutical
----------------------------------------------------------------------------------------------------------------
Depomed $7,500 $10,700 $18,200
----------------------------------------------------------------------------------------------------------------
Endo $10,000 $10,000
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Mallinckrodt $10,000 $10,000
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Pernix $6,500 $19,500 $26,000
Therapeutics
----------------------------------------------------------------------------------------------------------------
Pfizer $10,000 $15,000 $15,000 $1,000 $20,000 $61,000
----------------------------------------------------------------------------------------------------------------
Purdue Pharma $23,700 $92,200 $11,000 $35,200 $37,500 $199,600
----------------------------------------------------------------------------------------------------------------
Teva $3,500 $10,000 $13,500
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Annual Total $78,200 $102,900 $29,500 $135,200 $45,000 $61,000 $7,500 $469,300
----------------------------------------------------------------------------------------------------------------
Center for Practical Bioethics \1\
----------------------------------------------------------------------------------------------------------------
Grand
Company 2012 2013 2014 2015 2016 Total
----------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $1,000 $1,000
----------------------------------------------------------------------------------------------------------------
Janssen Pharmaceuticals $3,000 $10,000 $13,000
----------------------------------------------------------------------------------------------------------------
Johnson & Johnson $5,000 $5,000
----------------------------------------------------------------------------------------------------------------
Mallinckrodt Pharmaceuticals $30,000 $30,000
----------------------------------------------------------------------------------------------------------------
Pfizer $1,000 $25,000 $26,000
----------------------------------------------------------------------------------------------------------------
Purdue Pharma $25,000 $100,000 $15,000 $3,500 $500 $144,000
----------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $7,000 $105,000 $112,000
----------------------------------------------------------------------------------------------------------------
Zogenix $500 $500
================================================================================================================
Annual Total $36,000 $225,000 $136,000 $34,000 $500 $331,500
----------------------------------------------------------------------------------------------------------------
\1\ None of the payments reported by the Center for Practical Bioethics for 2017 or 2018 were made by opioid
manufacturers or other pharmaceutical manufacturers.
International Association for the Study of Pain
----------------------------------------------------------------------------------------------------------------
Company 2012 2013 2014 2015 2016 2017 2018 Grand Total
----------------------------------------------------------------------------------------------------------------
Acel Rx $62,500 $18,750 $81,250
----------------------------------------------------------------------------------------------------------------
AstraZeneca $63,105 $31,105 $45,000 $110,000 $249,210
----------------------------------------------------------------------------------------------------------------
Charleston $20,000 $20,000
Laboratorie
s, Inc.
----------------------------------------------------------------------------------------------------------------
Collegium $10,700 $10,700
Pharmaceuti
cal
----------------------------------------------------------------------------------------------------------------
Daiichi $70,300 $70,300
Sankyo
----------------------------------------------------------------------------------------------------------------
Eli Lilly $28,418 $51,034 $79,452
----------------------------------------------------------------------------------------------------------------
Excerpta $40,308 $40,308
Medical
(Agency for
Grunenthal)
----------------------------------------------------------------------------------------------------------------
Glenmark $600 $600
Pharmaceuti
cals
----------------------------------------------------------------------------------------------------------------
Grunenthal $65,943 $215,000 $92,000 $10,000 $20,000 $120,000 $522,943
----------------------------------------------------------------------------------------------------------------
Janssen $52,903 $52,903
Pharmaceuti
cals
----------------------------------------------------------------------------------------------------------------
Johnson & $52,903 $52,903
Johnson Ltd/
Janssen
Mumbai
----------------------------------------------------------------------------------------------------------------
Mallinckrodt $2,500 $2,500
Pharmaceuti
cals
----------------------------------------------------------------------------------------------------------------
Mundipharma $86,546 $228,130 $143,360 $251,580 $196,999 $22,401 $76,667 $1,005,683
----------------------------------------------------------------------------------------------------------------
Pfizer $29,100 $105,000 $141,000 $45,000 $114,865 $918,045 $1,353,010
----------------------------------------------------------------------------------------------------------------
Purdue $9,448 $20,000 $5,400 $34,848
Pharma
----------------------------------------------------------------------------------------------------------------
QRx Pharma $13,847 $13,847
Ltd.
----------------------------------------------------------------------------------------------------------------
Sanofi $47,000 $47,000
Aventis
----------------------------------------------------------------------------------------------------------------
Teva $71,460 $44,497 $30,000 $93,800 $87,680 $300,230 $627,667
Pharmaceuti
cals
----------------------------------------------------------------------------------------------------------------
Zibrant Ltd $2,001 $2,001
(agency for
Pfizer)
================================================================================================================
Annual Total $275,610 $691,229 $434,712 $472,680 $481,099 $427,850 $1,431,042 $4,214,222
----------------------------------------------------------------------------------------------------------------
U.S. Pain Foundation
----------------------------------------------------------------------------------------------------------------
Company 2012 2014 2015 2016 2017 2018 Grand Total
----------------------------------------------------------------------------------------------------------------
Abbvie $9,500 $310,000 $300,000 $300,000 $919,500
----------------------------------------------------------------------------------------------------------------
AstraZeneca $38,800 $145,000 $183,800
----------------------------------------------------------------------------------------------------------------
Collegium Pharmaceutical $9,500 $9,500
----------------------------------------------------------------------------------------------------------------
Daiichi Sankyo $14,500 $35,000 $50,000 $99,500
----------------------------------------------------------------------------------------------------------------
Egalet $32,500 $32,500
----------------------------------------------------------------------------------------------------------------
Endo Pharmaceuticals $25,000 $55,000 $50,000 $130,000
----------------------------------------------------------------------------------------------------------------
GlaxoSmithKline $9,500 $9,500 $19,000
----------------------------------------------------------------------------------------------------------------
Insys Therapeutics \1\ $2,900,000 $350,000 $3,250,000
----------------------------------------------------------------------------------------------------------------
Janssen Pharmaceuticals $7,500 $7,500
----------------------------------------------------------------------------------------------------------------
Johnson & Johnson $7,500 $9,500 $55,000 $40,000 $80,000 $192,000
----------------------------------------------------------------------------------------------------------------
Mallinckrodt $9,989 $9,989
Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Pfizer $50,000 $80,000 $40,000 $55,000 $60,000 $285,000
----------------------------------------------------------------------------------------------------------------
Purdue Pharma $25,000 $104,600 $120,000 $249,600
----------------------------------------------------------------------------------------------------------------
Shionogi $12,500 $12,500
----------------------------------------------------------------------------------------------------------------
Teva Pharmaceuticals $43,000 $266,000 $250,000 $110,000 $120,000 $789,000
----------------------------------------------------------------------------------------------------------------
UCB, Inc. $25,000 $25,000 $45,000 $25,000 $120,000
----------------------------------------------------------------------------------------------------------------
Zogenix $21,368 $21,368
================================================================================================================
Annual Total $125,500 $606,757 $536,000 $772,500 $3,410,000 $880,000 $6,330,757
----------------------------------------------------------------------------------------------------------------
\1\ Payments from Insys were in relation to a patient assistance program (PAP) operated by the U.S. Pain
Foundation. Ranking Member Wyden is continuing to investigate the U.S. Pain Foundation and the PAP. See Letter
from Senator Ron Wyden to Nicole Hemmenway, Interim CEO, U.S. Pain Foundation (Dec. 18, 2018).
Appendix C
Drug Companies
Endo Pharmaceuticals
1. Letter from Raymond V. Shepherd, Counsel. Venable, on
Behalf of Endo Pharmaceuticals, to Senator Baucus and Senator
Grassley (June 15, 2012), https://www.finance.senate.gov/
download/baucus_-grassley-letter-read.
2. Summary of payments made by Endo Pharmaceuticals between
1997-2012, https://www.finance.senate.gov/download/endo-
payments-to-organizations.
3. 2008-2012 Opana ER Business Plan, November 29, 2007 (SFC-
00025042), https://www.finance.senate.gov/download/sfc-
00025042.
4. Scientific Affairs Overview Business Plan 2011 (SFC-
00057051), https://www.finance.senate.gov/download/sfc-
00057051.
Johnson & Johnson
5. Letter from Daniel Donovan, Counsel, King & Spalding, to
Senator Baucus and Senator Grassley (June 8, 2012), https://
www.finance.senate.gov/download/060812_jandj_letter.
6. Summary of payments made by Johnson & Johnson between
1997-2012 (SFC00000001), https://www.finance.senate.gov/
download/jj-summary-of-payments_6-7-2012.
Purdue Pharma, L.P.
7. Letter from Theodore Hester, Counsel, King & Spalding, on
Behalf of Purdue Pharma, to Senator Baucus and Senator Grassley
(June 8, 2012), https://www.finance.senate.gov/download/letter-
purdue.
8. Summary of payments made by Purdue Pharma, L.P., between
1997-2012 (SFC00000001), https://www.finance.senate.gov/
download/sfc00000001.
9. Purdue payment details 1997-2012 (SFC000000002), https://
www.
finance.senate.gov/download/sfc00000002.
10. Health Policy Presentation by J. David Haddox, September,
9, 2010 (SFC00002172), https://www.finance.senate.gov/download/
sfc00002172.
11. Email from Pamela Bennett, Vice President, Purdue, re:
Pain Care Forum, March 2, 2007 (SFCO00l 1511), https://
www.finance.senate.gov/download/sfc00011511.
12. Email from Pamela Bennett, Vice President, Purdue, re:
Pain Care Forum, February 27, 2007 (SFC00011527), https://
www.finance.senate.gov/download/sfc00011527.
13. Attachment re: Pain Care Forum (SFC00011528), https://www.
finance.senate.gov/download/sfc00011528.
Tax-Exempt Organizations
American Chronic Pain Association
14. ACPA Financial Statements & Independent Auditor's Report
2012-2018, https://www.finance.senate.gov/download/acpa-67-102-
financial-statements.
15. ACPA-AstraZeneca Correspondence (SFC_ACPA_127), https://
www.
finance.senate.gov/download/acpa-127-141-astrazeneca-documents.
16. ACPA-Daiichi Sankyo Correspondence (SFC_ACPA_221), https:/
/www.
finance.senate.gov/download/acpa-221-239-daiichi-sankyo.
17. ACPA-Medtronic Correspondence (SFC_ACPA_572), https://www.
finance.senate.gov/download/acpa-572-612-medtronic-docs.
Alliance for Patient Access
18. AfPA-Mallinckrodt Agreement, January, 2016
(AfPA_SFC_000001), https://www.finance.senate.gov/download/
afpa_sfc_000001-05.
19. AfPA Letters to Federal Government, 2014-2018
(AfPA_SFC_000193-AfPA_SFC_000241), https://
www.finance.senate.gov/download/afpa_sfc_00
0193-241.
20. Letter from Samuel Dewey, Counsel, McDermott Will & Emery,
on Behalf of American's for Patient Access, to Senator Grassley
and Senator Wyden (Jan. 29, 2020), https://
www.finance.senate.gov/download/0130202011
3346.
21. Letter from Samuel Dewey, Counsel, McDermott Will & Emery,
on Behalf of American's for Patient Access, to Senator Grassley
and Senator Wyden (Oct. 10, 2019), https://
www.finance.senate.gov/download/afpa-second-production-to-sfc-
10-october-2019.
22. Letter from Samuel Dewey, Counsel, McDermott Will & Emery,
on Behalf of American's for Patient Access, to Senator Grassley
and Senator Wyden (July 29, 2019), https://
www.finance.senate.gov/download/afpa-sfc-29-july-2019.
American Pain Foundation (Defunct)
23. American Pain Foundation Business Plan, 1998, https://www.
finance.senate.gov/download/apf-1998-business-plan.
24. APF-Purdue Correspondence 2001-2005 (APF65), https://www.
finance.senate.gov/download/apf-purdue-correpondence-2001-2005-
apf65-111.
25. APF-Purdue Correspondence and Checks (2001-2004) (APF106),
https://www.finance.senate.gov/download/apf106_-apf-purdue-
correspondence-and-checks-2001-2004.
26. Report to Purdue on 2002 Accomplishments (APF254), https:/
/www.
finance.senate.gov/download/apf254_-report-to-purdue-on-2002-
accomplishments-to-purdue.
27. APF email re: briefing with Purdue officials (APF298),
https://www.
finance.senate.gov/download/email-regarding-briefing-with-
senior-purdue-officials-apf298-299.
28. APF Operating Plan and Budget for 2001 (APF394), https://
www.
finance.senate.gov/download/apf_-operating-plan-and-budget-for-
2001-apf-394-404.
American Society for Pain Educators
29. Letter from Noam Fischman, Counsel, Polsinelli, on Behalf
of American Society of Pain Educators, to Senator Grassley and
Senator Wyden (Nov. 11, 2020), https://www.finance.senate.gov/
download/1111-letter-from-aspe-to-senate-finance-committee.
30. Letter from Noam Fischman, Counsel, Polsinelli, on Behalf
of American Society of Pain Educators, to Senator Grassley and
Senator Wyden (Sept. 30, 2020), https://www.finance.senate.gov/
download/aspe-ltr-to-senate-finance-committee-930.
31. Endo Corporate Membership, December 2007 (ASPE_000027),
https://www.finance.senate.gov/download/aspe_000027-28_-endo-
pharmaceuticals-corporate-membership-dec-2007.
32. Endo Corporate Membership, October 2009 (ASPE_000025),
https://www.finance.senate.gov/download/aspe_000025-26_-endo-
corporate-membership-29-oct-2009.
33. Purdue Corporate Membership. February 2008 (ASPE 000029),
https://www.finance.senate.gov/download/aspe_000029-30_-purdue-
corporate-membership-13-feb-2008.
Federation of State Medical Boards
34. Letter from Humayun Chaudhry, President and CEO,
Federation of State Medical Boards, to Senator Grassley and
Senator Wyden (July 29, 2019), https://www.finance.senate.gov/
download/fsmb-response-to-senate-finance-committee-07292019.
International Association for the study of Pain
35. Letter from Lars Arendt-Nielsen, President, International
Association for the Study of Pain, to Senator Grassley and
Senator Wyden (Aug. 28, 2019), https://www.finance.senate.gov/
download/iasp-official-response-to-senate-finance-committee_-
ii.
36. Letter from Lars Arendt-Nielsen, President, International
Association for the Study of Pain, to Senator Grassley and
Senator Wyden (July 29, 2019), https://www.finance.senate.gov/
download/iasp-response-to-the-senate-finance-committee.
Joint Commission
37. Letter from Mark Chassin, President and CEO, The Joint
Commission, to Senator Grassley and Senator Wyden (July 29,
2019), https://www.
finance.senate.gov/download/7292019-senate-finance-letter.
38. Letter from Mark Chassin. President and CEO, The Joint
Commission, to Senator Baucus and Senator Grassley (June 29,
2012), https://www.
finance.senate.gov/download/joint-commission-letter-to-sens-
baucus-and-grassley-_june292012.
______
Communications
----------
American Enterprise Institute
1789 Massachusetts Avenue, NW
Washington, DC 20036
Main telephone: 202-862-5800
Main fax: 202-862-7177
https://www.aei.org/
The US Is Failing Substance-Exposed Infants
Sarah Font et al.
June 4, 2024
The stark human and societal cost of the drug epidemic is
undeniable, directly taking over 100,000 lives each year since 2021.\1\
Due to infrequent and inconsistent testing,\2\ there is no reliable
count of how many children are exposed to substances in utero, but,
even before the current drug epidemic began, researchers estimated that
400,000-480,000 children born each year were prenatally exposed to
drugs or alcohol.\3\ Because the estimated number of adults meeting
criteria for substance use disorder increased from 22 million in 2010
\4\ to 46 million in 2021,\5\ prenatal exposure has likely increased as
well. Recent data on drug and alcohol use among pregnant women,\6\
pediatric poisonings,\7\ Narcan administrations to infants,\8\ and
child fatalities \9\ all signal an unmitigated crisis. To date,
however, the US response has centered on parents and other adults
experiencing addiction with inadequate attention to the needs of the
infants and young children in their care.
---------------------------------------------------------------------------
\1\ National Institute on Drug Abuse, ``Drug Overdose Death
Rates,'' June 30, 2023, https://nida.nih.gov/research-topics/trends-
statistics/overdose-death-rates; and Centers for Disease Control and
Prevention, ``Provisional Drug Overdose Death Counts,'' March 13, 2024,
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
\2\ Rates of toxicology testing are typically below 5 percent.
Discretion in testing by medical professionals results in
disproportionate testing of low-income and racial minority mothers. See
Samuel Cohen et al., ``Disparities in Maternal-Infant Drug Testing,
Social Work Assessment and Custody at 5 Hospitals,'' Academic
Pediatrics 23, no. 6 (August 2023): 1268-75, https://
pubmed.ncbi.nlm.nih.gov/36754165; and Sebastian Schoneich et al.,
``Incidence of Newborn Drug Testing and Variations by Birthing Parent
Race and Ethnicity Before and After Recreational Cannabis
Legalization,'' JAMA Network Open 6, no. 3 (2023): e232058, https://
jamanetwork.com/journals/jamanetworkopen/fullarticle/2802124.
\3\ Rachel N. Lipari and Struther L. Van Horn, ``Children Living
with Parents Who Have a Substance Use Disorder,'' US Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, Center for Behavior Health Statistics and Quality,
August 24, 2017, https://www.samhsa.gov/data/sites/default/files/
report_3223/ShortReport-3223.html.
\4\ US Department of Health and Human Services, Substance Abuse and
Mental Health Administration, Center for Behavior Health Statistics and
Quality, ``Results from the 2010 National Survey on Drug Use and
Health: Summary of National Findings,'' September 2011, https://
www.samhsa.gov/data/sites/default/files/
NSDUHNationalFindingsResults2010-web/2k10Re
sultsRev/NSDUHresultsRev2010.htm.
\5\ US Department of Health and Human Services, ``SAMHSA Announces
National Survey on Drug Use and Health (NSDUH) Results Detailing Mental
Illness and Substance Use Levels in 2021,'' press release, January 4,
2023, https://www.hhs.gov/about/news/2023/01/04/samhsa-announces-
national-survey-drug-use-health-results-detailing-mental-illness-
substance-use-levels-2021.html.
\6\ US Department of Health and Human Services, Substance Abuse and
Mental Health Administration, 2020 National Survey on Drug Use and
Health: Women, July 2022, https://www.
samhsa.gov/data/sites/default/files/reports/slides-2020-nsduh/
2020NSDUHWomenSlides0725
22.pdf; and Lucinda J. England et al., ``Alcohol Use and Co-Use of
Other Substances Among Pregnant Females Aged 12-44 Years--United
States, 2015-2018,'' Morbidity and Mortality Weekly Report 69, no. 31
(August 7, 2020): 1009-14, https://www.cdc.gov/mmwr/volumes/69/wr/
mm6931a1.htm.
\7\ Julie R. Gaither, Veronika Shabanova, and John M. Leventhal,
``US National Trends in Pediatric Deaths from Prescription and Illicit
Opioids, 1999-2016,'' JAMA Network Open 1, no. 8 (2018): e186558,
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2719580.
\8\ John Cardinale, ``Bernalillo County Court Records Show Babies
Are Overdosing,'' KOAT Action News, June 15, 2023, https://
www.koat.com/article/bernalillo-county-court-records-show-babies-are-
overdosing/44214139.
\9\ Deb Erdley, ``Tiny Lives at Risk: `Frightening Rate' of
Children Dying Due to Parents' Drug Abuse,'' Trib Total Media, December
17, 2023, https://triblive.com/local/regional/frightening-rate-of-
children-dying-due-to-parents-drug-abuse.
Advocates have been highly successful in advancing nonpunitive
harm-reduction approaches to substance use and addiction. These
approaches, by definition, reject the involvement of the criminal
justice system and the use of strategies that coerce individuals to
seek or accept treatment.\10\ Although reducing the use of
incarceration as a response to addiction has broad public support,\11\
a majority of the public also wants the child protection system (CPS)
to respond to the needs of infants whose parents abuse drugs or
alcohol.\12\
---------------------------------------------------------------------------
\10\ National Harm Reduction Coalition, ``Principles of Harm
Reduction,'' https://harmreduction.org/about-us/principles-of-harm-
reduction/.
\11\ University of Maryland, School of Public Policy, Program for
Public Consultation, ``Large Bipartisan Majorities Favor Congress
Funding Substance Abuse Treatment for All Who Want It,'' August 31,
2022, https://publicconsultation.org/health-care/large-bipartisan-
majorities-favor-congress-funding-substance-abuse-treatment-for-all-
who-want-it.
\12\ Bipartisan Policy Center, Child Welfare Initiative 2023 Harris
National Poll Results, November 8, 2023, https://bipartisanpolicy.org/
download/?file=/wp-content/uploads/2023/11/BPC-Child-Welfare-
Initiative-2023-Harris-National-Poll-Results-v1.pdf.
Yet many states, with the encouragement of the federal government
and major foundations, seek to limit CPS responsibility for substance-
exposed infants.\13\ Several states are considering laws to prevent
doctors from conducting a toxicology test on a newborn child without
parental consent, even when there is reasonable suspicion that the
child was prenatally exposed.\14\ Without formal identification of
substance exposure, there is often an insufficient basis for a CPS
report.\15\ Even when substance exposure is detected, doctors may be
encouraged not to report, or their reports may be screened out.\16\ The
threshold for mandatory reporting of child maltreatment typically
includes ``imminent risk'' to the child--but policies in several states
are clear that a person with an untreated substance use disorder being
the sole caregiver of a newborn is not, in itself, sufficient to make a
CPS report.\17\ A small number of states, like Connecticut, have gone
even further, enacting policies to prevent CPS from even knowing the
identity of substance-exposed infants.\18\ Efforts are underway to make
deidentified notifications national policy.\19\
---------------------------------------------------------------------------
\13\ Casey Family Programs, ``How Can Plans of Safe Care Help
Infants and Families Affected by Prenatal Substance Exposure?,''
October 19, 2023, https://www.casey.org/infant-plans-of-safe-care; and
Legislative Analysis and Public Policy Association, Model Substance Use
During Pregnancy and Family Care Plans Act, March 2023, https://
legislativeanalysis.org/wp-content/uploads/2023/03/Model-Substance-Use-
During-Pregnancy-and-Family-Care-Plans-Act.pdf.
\14\ Sen. B. S320B, 2023-2024 Reg. Sess. (N.Y. 2023), https://
www.nysenate.gov/legislation/bills/2023/S320/amendment/B; and LLS 24-
0344.02, 74th Gen. Assemb., 2d Reg. Sess. (Colo. 2023), https://
leg.colorado.gov/sites/default/files/images/bill_3_24-0344.02.pdf.
\15\ Lex Talamo, ``Majority of Louisiana Babies Born to Addicted
Mothers Are Sent Home--by Law,'' Shreveport Times, February 15, 2018,
https://www.shreveporttimes.com/story/news/2018/02/15/majority-
louisiana-babies-born-addicted-mothers-sent-home-law/314127002/#::text
=Substance%2Dexposed%20newborns,extenuating%20circumstances%20also%20are
%20present.
\16\ Requirements to notify CPS and develop a plan of safe care
pertain to cases in which the child was identified as ``being affected
by substance abuse or withdrawal symptoms resulting from prenatal drug
exposure.'' The federal government allows states to define ``affected
by,'' and they may exclude substance-exposed infants who do not exhibit
immediate signs of harm upon their birth. US Department of Health and
Human Services, Administration for Children and Families, ``Guidance on
Amendments Made to the Child Abuse Prevention and Treatment Act (CAPTA)
by Public Law 114-198, the Comprehensive Addiction and Recovery Act of
2016,'' January 17, 2017, 3, https://www.acf.hhs.gov/cb/policy-
guidance/pi-17-02. See also, from Pennsylvania guidelines:
``[Question:] What if a delivering woman admits to substance use but
the baby does not exhibit any symptoms at birth? Must I make a
notification? [Answer:] No; under Act 54 and CAPTA, a health care
provider is required to make a notification when an effect on the
infant is detected.'' Pennsylvania Department of Human Services,
``Plans of Safe Care Frequently Asked Questions,'' 4, https://
www.dhs.pa.gov/KeepKidsSafe/Resources/Documents/POSC_FAQ.pdf; from New
York City guidelines: ``A positive toxicology result for a parent or a
newborn, by itself, does not constitute reasonable suspicion of child
abuse or maltreatment, and thus does not necessitate a report to the
Statewide Central Registrar of Child Abuse and Maltreatment (SCR).''
New York City Administration for Children's Services and Department of
Health and Mental Hygiene, ``Reporting and Planning Requirements for
Newborns Prenatally Exposed to Substances and Their Caregivers,''
November 12, 2020, https://www.nyc.gov/assets/acs/pdf/child_welfare/
2020/PositiveToxicology.pdf; and Stephanie Anne Deutsch et al.,
``Factors Associated with Child-Welfare Involvement Among Prenatally
Substance-Exposed Infants,'' Journal of Pediatrics 222 (July 2020): 35-
44, https://pubmed.ncbi.nlm.nih.gov/32418814/.
\17\ See, for example, New York City Administration for Children's
Services and Department of Health and Mental Hygiene, ``Reporting and
Planning Requirements for Newborns Prenatally Exposed to Substances and
Their Caregivers.''; Elise Takahama, ``WA Hospitals No Longer Required
to Report All Substance-Exposed Infants,'' Seattle Times, June 28,
2023, https://www.seattletimes.com/seattle-news/health/wa-hospitals-no-
longer-required-to-report-all-substance-exposed-infants; and Brittany
Costello, ``4 Investigates: Is CARA Helping or Hurting Families
Struggling with Substance Abuse?,'' KOB, January 18, 2024, https://
www.kob.com/new-mexico/4-investigates-is-cara-helping-or-hurting-
families-struggling-with-substance-abuse.
\18\ National Center on Substance Abuse and Child Welfare, ``How
States Serve Infants and Their Families Affected by Prenatal Substance
Exposure,'' https://ncsacw.acf.hhs.gov/files/prenatal-substance-
exposure-brief1.pdf; and Margaret Lloyd Sieger et al., ``Novel
Implementation of State Reporting Policy for Substance-Exposed
Infants,'' Hospital Pediatrics 12, no. 10 (October 2022): 841-48.
https://pubmed.ncbi.nlm.nih.gov/36093638/.
\19\ Legislative Analysis and Public Policy Association, Model
Substance Use during Pregnancy and Family Care Plans Act, 24.
The current alternative to CPS for substance-exposed infants is a
``Plan of Safe Care'' (POSC), also known as ``Family Care'' or ``Family
Recovery Plan''--positioned as a family-friendly approach to addressing
the needs of substance-exposed infants and their families without the
stigma and coerciveness of CPS.\20\ POSCs are often described as a
``public health'' or ``harm-reduction'' approach. The basic idea is
appealing--if addiction is a disease, then it should be treated with
the same type of compassionate, voluntary, and nonpunitive care
provided for diseases like cancer or diabetes.
---------------------------------------------------------------------------
\20\ Sen B. SB3136, 103rd Gen. Assemb., 2023-2024 Reg. Sess. (Ill.
2024), https://www.ilga.
gov/legislation/
fulltext.asp?DocName=&SessionId=112&GA=103&DocTypeId=SB&DocNum=31
36&GAID=17&LegID=152361&SpecSess=&Session=.
Proponents of this approach to substance use make four general
arguments: (1) Stigma and fear of CPS may deter people from seeking
help,\21\ (2) a drug test is ``not a parenting test,''\22\ (3) CPS is
ineffective or harmful in addressing the needs of children and families
affected by substance use, and (4) unwarranted variation in rates of
toxicology testing contributes to disproportionality in CPS
involvement. These arguments warrant serious consideration in policy
evaluation and reform, but POSCs do not directly address these
concerns. Moreover, it is not clear what other entity can respond when
parental substance use is likely to inhibit minimally adequate
caregiving and that parent rejects or does not benefit from a voluntary
offer of services.
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\21\ Joy D. Scheidell et al., ``Parenting and Childcare
Responsibilities, Harm Reduction Service Engagement, and Opioid
Overdose Among Women and Men Who Use Illicit Opioids in New York
City,'' Drug and Alcohol Dependence Reports 3 (June 2022): 100054,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9224239/; and Elizabeth
Peacock-Chambers et al., ``Engagement in Early Intervention Services
Among Mothers in Recovery from Opioid Use Disorders,'' Pediatrics 145,
no. 2 (February 2020), https://publications.aap.org/pediatrics/article/
145/2/e20191957/68257/Engagement-in-Early-Intervention-Services-Among.
\22\ Joyce McMillen quoted in Eran Chan Ding, ``Number of Children
Separated from Their Families Due to Parental Substance Use Has More
Than Doubled,'' Youth Today, November 18, 2022, https://youthtoday.org/
2022/11/number-of-children-separated-from-their-families-due-to-
parental-substance-use-has-more-than-doubled.
The term ``plan'' implies a set of objectives or steps that will be
implemented, but a POSC can be nothing more than a form \23\ that
documents services the mother or infant already received or were
referred to.\24\ The voluntary nature of POSCs may mean that the vast
majority of parents eligible for a POSC receive no substance use
treatment, as studies in New Mexico \25\ and Delaware found.\26\ In
addition, state and federal laws inhibit CPS or other agencies from
assessing or monitoring the uptake or efficacy of substance abuse
treatment.\27\
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\23\ See Nebraska Department of Health and Human Services,
``Comprehensive Addiction and Recovery Act (CARA),'' https://
dhhs.ne.gov/Pages/Comprehensive-Addiction-and-Recovery-Act.aspx;
Connecticut Clearinghouse, ``Template Plan of Safe Care,'' https://www.
ctclearinghouse.org/Customer-Content/www/topics/
CAPTA_POSC_template.pdf; and Pennsylvania Department of Human Services,
``Plan of Safe Care Template (Example),'' https://www.dhs.pa.gov/
KeepKidsSafe/Resources/Documents/POSC%20Template_PDF.pdf.
\24\ Child Welfare Information Gateway reports that 13 states
require child welfare agencies to monitor compliance with the plan of
safe care. Yet, it is not clear how that requirement is met when
deidentified notifications are used or the child welfare system does
not conduct an assessment. See Child Welfare Information Gateway and
Children's Bureau, ``Plans of Safe Care for Infants with Prenatal
Substance Exposure and Their Families,'' August 2019, https://cwig-
prod-prod-drupal-s3fs-us-east-1.s3.amazonaws.com/public/documents/
safecare.pdf?VersionId=SsISyD
YxLAtZdECsRRp5fX8QRj66iaFx.
\25\ New Mexico Legislative Finance Committee, Program Evaluation:
Implementation and Outcomes of the Comprehensive Addiction and Recovery
Act, October 27, 2023, https://nmlegis.gov
/Entity/LFC/Documents/Program_Evaluation_Reports/
Program%20Evaluation_Implementa
tion%20and%20Outcomes%20of%20CARA%20FINAL%20(1).pdf.
\26\ Stephanie Anne Deutsch et al., ``Impact of Plans of Safe Care
on Prenatally Substance Exposed Infants,'' Journal of Pediatrics 241
(February 2022): 54-61, https://www.jpeds.com/article/S0022-
3476(21)01025-8/abstract.
\27\ US Government Accountability Office, Substance-Affected
Infants: Additional Guidance Would Help States Better Implement
Protections for Children, January 19, 2018, https://www.gao.gov/
products/gao-18-196.
Individuals with substance use disorders may take many years to be
``ready'' for treatment, but there is no pause button on infants'
development. Beyond the effects of prenatal substance exposure
itself,\28\ the effects of untreated substance use disorders on
parenting are undeniable: Young children face increased risks of
fatality, poisonings, injuries, physical and sexual abuse, and severe
neglect, in addition to poor physical, cognitive, and emotional
development.\29\
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\28\ Effects of prenatal exposure include elevated risk of SIDS.
See Louise Makarious, Arthur Teng, and Ju Lee Oei, ``SIDS Is Associated
with Prenatal Drug Use: A Meta-Analysis and Systematic Review of 4 238
685 Infants,'' Archives of Disease in Childhood--Fetal and Neonatal
Edition 107, no. 6 (2022), 617-23, https://fn.bmj.com/content/107/6/
617.
\29\ Vincent C. Smith et al., ``Families Affected by Parental
Substance Use,'' Pediatrics 138, no. 2 (August 2016), https://
publications.aap.org/pediatrics/article/138/2/e20161575/52464/Families-
Affected-by-Parental-Substance-Use; Anthony N. Maluccio and Frank
Ainsworth, ``Drug Use by Parents: A Challenge for Family Reunification
Practice,'' Children and Youth Services Review 25, no. 7 (July 2003):
511-33, https://www.researchgate.net/publication/4823858_Drug_Use_by
_Parents_A_Challenge_for_Family_Reunification_Practice; Venla Berg et
al., ``Parental Alcohol and Drug Abuse and Offspring Mortality by Age
10: A Population-Based Register Study,'' European Journal of Public
Health 32, no.6 (December 2022): 933-38, https://academic.oup.com/
eurpub/article/32/6/933/6726391; Denise Hatzis et al., ``Quality of
Caregiving in Mothers with Illicit Substance Use: A Systematic Review
and Meta-Analysis,'' Substance Abuse: Research and Treatment, March 14,
2024, https://journals.sagepub.com/doi/full/10.1177/1178221817694038;
Nicole Landi et al., ``Maternal Neural Responses to Infant Cries and
Faces: Relationships with Substance Use,'' Frontiers in Psychiatry 2
(2011): 32, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3118477;
Amanda F. Lowell et al., ``Substance Use and Mothers' Neural Responses
to Infant Cues,'' Infant Mental Health Journal 41, no. 2 (March 2020):
264-77, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160016; Rebecca
Rebbe et al., ``Child Protection System Interactions for Children with
Positive Urine Screens for Illicit Drugs,'' JAMA Network Open 7, no. 3
(2024): e243133, https://jamanetwork.com/journals/jamanetworkopen/
fullarticle/2816598; and Stephanie Anne Deutsch et al., ``Impact of
Plans of Safe Care on Prenatally Substance Exposed Infants.''
As states and the federal government myopically prioritize the
avoidance of CPS as an end unto itself, POSCs have been applauded
without any evidence--or even requirements to collect evidence--as to
their actual efficacy in keeping children safe and ensuring that their
basic developmental needs are met. This is not compassion but instead
an abdication of responsibility. As an ideologically and experientially
diverse group of researchers, foundation leaders, and child welfare
professionals, we put forth four principles for better responding to
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the needs of substance-exposed infants and their parents.
1. Children must be at the center of policymaking. Children
are entitled to receive minimally adequate care and to be
protected from foreseeable harms. Parental addiction is a
foreseeable risk to infant health and safety that the state has
an obligation to mitigate.
2. A compassionate response to parents experiencing addiction
or engaged in problematic substance use can include CPS and
court-
ordered treatment. CPS involvement and the desire to maintain
or regain custody can be a powerful motivator for parents to
engage in treatment \30\ and is a critical safeguard for
children when parents are unable to provide minimally adequate
care.\31\ Policies or practices that generically discourage the
involvement of CPS, rather than incentivizing the right tool
for the situation, are misguided.
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\30\ Kristen D. Seay et al., ``Substance Abuse Treatment Engagement
Among Mothers: Perceptions of the Parenting Role and Agency-Related
Motivators and Inhibitors,'' Journal of Family Social Work 20, no. 3
(2017): 196-212, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC651
9925; Lisa Hines, ``The Treatment Views and Recommendations of
Substance Abusing Women: A Meta-Synthesis,'' Qualitative Social Work
12, no. 4 (July 2013): 473-89, https://journals.sagepub.com/doi/
10.1177/1473325011432776; Sugy Choi et al., ``Differential Gateways,
Facilitators, and Barriers to Substance Use Disorder Treatment for
Pregnant Women and Mothers: A Scoping Systematic Review,'' Journal of
Addiction Medicine 16, no. 3 (May 2022): 185-96, https://
journals.lww.com/journaladdictionmedicine/abstract/2022/05000/
differential_gate
ways,_facilitators,_and_barriers.28.aspx; Linda S. Kahn et al.,
``Treatment Experiences Among People Who Use Opioids: A Social
Ecological Approach,'' Qualitative Health Research 32, no. 8-9 (2022):
1386-98, https://journals.sagepub.com/doi/10.1177/10497323221104315;
and Dean Rivera, Donna Dueker, and Hortensia Amaro, ``Examination of
Referral Source and Retention Among Women in Residential Substance Use
Disorder Treatment: A Prospective Follow-Up Study,'' Substance Abuse
Treatment, Prevention, and Policy 16, no. 1 (2021): 2, https://
substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-
00357-y.
\31\ Janet U. Schneiderman, John Prindle, and Emily Putnam-
Hornstein, ``Infant Deaths from Medical Causes After a Maltreatment
Report,'' Pediatrics 148, no. 3 (2021): e2020048389, https://
publications.aap.org/pediatrics/article/148/3/e2020048389/181076/
Infant-Deaths-From-Medical-Causes-After-a; Alice Heath, ``Government
Reactions to Tragedy: How Maltreatment Deaths Impact Child
Protection,'' January 1, 2024, https://aliceheath.github.io/jmp; and
Max Gross and E. Jason Baron, ``Temporary Stays and Persistent Gains:
The Causal Effects of Foster Care,'' American Economic Journal: Applied
Economics 14, no. 2 (April 2022): 170-99, https://www.aeaweb.org/
articles?id=10.1257/app.20200204.
3. Timely and comprehensive treatment access is essential. At
the first sign of problematic substance use, pregnant women and
parents should be provided with immediate and comprehensive
substance use treatment and aftercare to maximize the odds that
they can safely and permanently care for their child or
children. The treatment array should include coresidential
treatment slots for parents and children, as well as robust
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outpatient treatment and recovery supports.
4. Data collection and evaluation are necessary to inform and
revise existing policy. Massive policy and practice changes
have been made without any systematic data collection or
evaluation to understand the relative harms and benefits to
children and families. Current evidence is insufficient to
determine whether, and under what circumstances, POSCs are an
effective or safe alternative to CPS. Practices such as
deidentified notifications preclude rigorous impact evaluations
of POSCs, thus inhibiting reforms or improvements.
Sincerely,
Sarah Font is an associate professor of sociology and public policy at
Pennsylvania State University.
Naomi Schaefer Riley is a senior fellow at the American Enterprise
Institute.
Brett Drake is the Professor of Data Science for the Social Good in
Practice at the Brown School of Social Work and Public Health,
Washington University in St. Louis.
Emily Putnam-Hornstein is the John A. Tate Distinguished Professor for
Children in Need at the University of North Carolina at Chapel Hill.
Maura Corrigan is a retired justice of the Michigan Supreme Court.
Maralyn Beck is a child welfare advocate.
John Walters is the president and CEO of the Hudson Institute and the
former director of the Office of National Drug Control Policy.
Cassie Statuto Bevan is a former staff member of the Committee on Ways
and Means, US House of Representatives.
Jerry Haag is the president and CEO of One More Child.
Herbie Newell is the president and executive director of Lifeline
Children's Services.
Tom Rawlings is the policy director at Fostering Impact.
Greg McKay is the CEO of A Found Future.
Jim Dwyer is the Arthur B. Hanson Professor of Law at the William &
Mary Law School.
Marie Cohen is the author of the Child Welfare Monitor Blog.
Ryan Hanlon is the president and CEO of the National Council for
Adoption.
Elizabeth Bartholet is the Morris Wasserstein Professor of Law,
emeritus, at Harvard Law School.
Sean Hughes is a managing partner of Social Change Partners, LLC.
Jeanne Banghart is the deputy county attorney of Boulder County,
Colorado.
Bob Bruder-Mattson is the president and CEO of FaithBridge Foster Care.
Rich Gehrman is the founder and executive director emeritus of Safe
Passage for Children of Minnesota.
Leslie Ford is an adjunct fellow at the American Enterprise Institute.
Jedd Medefind is the president of Christian Alliance for Orphans.
Ronald Richter is the CEO and director of JCCA and former New York City
family court judge and commissioner of New York City's Administration
for Children's Services.
Allicia Frye is the CEO of Jonathan's Place.
Eloise Anderson is the retired secretary of the Wisconsin Department of
Children and Families.
The American Enterprise Institute (AEI) is a nonpartisan,
nonprofit, 501(c)(3) educational organization and does not take
institutional positions on any issues. The views expressed in this
testimony are those of the authors.
______
American Society of Health-System Pharmacists
4500 East-West Highway, Suite 900
Bethesda, MD 20814
301-657-3000
https://www.ashp.org
The Hon. Ron Wyden
Chairman
United States Senate
Committee on Finance
221 Dirksen Senate Office Building
Washington, DC 20510-6200
The Hon. Mike Crapo
Ranking Member
United States Senate
Committee on Finance
239 Dirksen Senate Office Building
Washington, DC 20510-6200
Re: Hearing on Front Lines of the Fentanyl Crisis: Supporting
Communities and Combating Addiction through Prevention and Treatment.
Dear Chairman Wyden and Ranking Member Crapo:
Thank you for holding this important hearing on the fentanyl crisis.
The American Society of Health-System Pharmacists (ASHP) is the largest
association of pharmacy professionals in the United States,
representing 60,000 pharmacists, student pharmacists, and pharmacy
technicians in all patient care settings, including hospitals,
ambulatory clinics, and health system community pharmacies. Many of our
members play a critical role in treating and preventing addiction in
rural and underserved areas.
Fentanyl misuse has had a devastating impact on communities throughout
the country. According to recent Centers for Disease Control (CDC)
data, there were an estimated 81,083 deaths from synthetic opioids in
2023.\1\ While slightly down from 2022 numbers, fentanyl is 50 to 100
times more potent than morphine, and therefore the risk of overdose is
higher than with other opioids, particularly when the person consuming
the fentanyl is not aware of its presence or has not developed a
tolerance to it.
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\1\ https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2024/
20240515.htm.
Pharmacists' Role in Treating Addiction: Pharmacists play a critical
role with other providers in treating addiction. Since Congress
eliminated the X-waiver in January 2023, several states have empowered
pharmacists to prescribe medications for opioid use disorder (MOUD),
greatly increasing the overall access to care. Thirteen states
currently permit pharmacists to prescribe MOUD either independently or
via collaborative practice agreements.\2\ In the last year alone,
Nevada, Oregon, and Colorado have authorized pharmacists statewide to
prescribe MOUD. Finding additional opportunities for pharmacists to
provide addiction treatment, including for misuse of fentanyl, will
help reduce overdoses. Buprenorphine in combination with naloxone is a
highly effective form of medication treatment for MOUD. Access to MOUD
is associated with improved overall survival, fewer relapses, and
increased rates of employment among patients with a history of OUD.\3\
Buprenorphine-
containing MOUD has particular advantages in that it has a superior
overdose safety profile when compared with methadone and can be
obtained from community pharmacies.\4\
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\2\ WA, OR, CA, ID, MT, NV, UT, CO, NM, OH, NC, MA, and TN.
\3\ Callister C, Lockhart S, Holtrop JS, Hoover K, Calcaterra SL.
Experiences with an addiction consultation service on care provided to
hospitalized patients with opioid use disorder: A qualitative study of
hospitalists, nurses, pharmacists, and social workers. Subst Abus.
2022;
43(1):615-622; and Substance Abuse and Mental Health Services
Administration. Medication-Assisted Treatment (MAT), 2018, https://
www.samhsa.gov/medication-assisted-treatment.
\4\ Schesinger EB, Geminn W, Hohmeier KC, Burley HL Jr. Development
and Implementation of Tennessee Nonresidential Buprenorphine Treatment
Guidelines. Innov Pharm. 2018;9(3):1-4. Published 2018 Oct 19. https://
doi.org/10.24926/iip.v9i3.1317.
Despite a wealth of evidence supporting the efficacy and benefits of
MOUD, and the dire magnitude of opioid misuse in the United States,
lack of access to treatment overwhelmingly remains the primary barrier
to achieving remission for most patients. A 2022 analysis estimated
nearly 90 percent of U.S. individuals with OUD did not receive
evidence-based treatment in the prior year.\5\ We recommend Congress
direct the Department of Health and Human Services to use their
authority under the Public Readiness and Emergency Preparedness (PREP)
Act to authorize pharmacists, as part of a physician-led care team, to
initiate MOUDs, such as buprenorphine.
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\5\ https://patientengagementhit.com/news/nearly-90-of-patients-
with-opioid-use-disorder-lack-medication-access.
Support for Fentanyl Test Strips Legislation: Detection of fentanyl
adulteration is critical to avoiding overdoses. ASHP is a strong
supporter of providing access to fentanyl and xylazine test strips
(FTS) and has endorsed two pieces of legislation that would expand
access to these important countermeasure. Senator John Cornyn (R-TX)
introduced Fentanyl Safe Testing and Overdose Prevention Act (S. 2569),
that would clarify in the Controlled Substances Act that the
possession, sale, purchase, importation, exportation, or transportation
of FTS is not unlawful, making this countermeasure more available.
Senator Cory Booker (D-NJ) also introduced the Expanding Nationwide
Access to Test Strips Act (S. 2483), that would also decriminalize FTS.
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We recommend swift passage of S. 2569 and S. 2483.
ASHP thanks you for holding this important hearing and considering our
recommendations. We look forward to continuing to work with you to
ensure Americans have access to the life-saving pharmacy services in
rural and underserved areas. If you have questions or if ASHP can
assist your office in any way, please contact Frank Kolb at
[email protected].
Sincerely,
Tom Kraus
Global Health Advocacy Incubator
1400 I Street, NW, #1200
Washington, DC 20005
Statement of Libby Jones, Program Director,
Overdose Prevention Initiative
Thank you for the opportunity to provide this statement for the record.
At the Overdose Prevention Initiative, we recognize that to reduce the
overdose death rate in our country, we must address the federal
policies at the root of the crisis. It is our mission to ensure that
all Americans--regardless of race, class, or geography--have access to
lifesaving, evidence-based treatment and harm reduction services.
Our nation's overdose crisis has continued to escalate in recent years.
The increased availability of illicitly manufactured fentanyl, coupled
with the mental health effects of the COVID-19 pandemic contributed to
a surge of overdose deaths. In 2022 alone, more than 109,000 lives were
lost to overdose. Despite the effectiveness of methadone and
buprenorphine, two FDA-approved medications for opioid use disorder
(MOUD) that are proven to prevent overdose, this treatment remains out
of reach for a majority of the estimated 2.5 million Americans who
suffer from opioid use disorder. A recent study found that 88% of
individuals who would benefit from OUD treatment did not receive it.\1\
---------------------------------------------------------------------------
\1\ Krawczyk et al. (2022). Has the treatment gap for opioid use
disorder narrowed in the U.S.? A yearly assessment from 2010 to 2019.
International Journal of Drug Policy. doi.org/10.1016/
j.drugpo.2022.103786.
As the largest payer of substance use disorder (SUD) treatment in the
United States, Medicaid is perhaps the most influential federal program
affecting health outcomes for Americans with SUD. Medicaid policy plays
an outsized role in determining the availability and access to life-
saving treatments for millions of Americans. We urge this committee to
take up important legislation regarding MOUD that could make a
---------------------------------------------------------------------------
significant impact on overdose prevention.
The prevalence of illicitly manufactured fentanyl proves our drug
supply to be dynamic and demands more proactive solutions. The
interventions that previously slowed overdose death rates are losing
effectiveness as our supply changes. According to the DEA, fentanyl is
100 times more potent than morphine and 50 times more potent than
heroin.\2\ Every fentanyl-related death is a tragedy, but also
preventable. Congress has been successful in expanding access to
naloxone, the medication used to reverse drug overdoses, including
fentanyl. And it has proven worthwhile. Not only is naloxone effective
in reversing more than 93% of overdoses,\3\ every $1 spent on
community-based naloxone programs saves nearly $2,742 by preventing
overdose deaths.\4\ Additionally, the Mainstreaming Addiction Treatment
Act passed in December 2022 paved the way for making treatment more
accessible by removing the waiver needed to prescribe the MOUD
buprenorphine.
---------------------------------------------------------------------------
\2\ United States Drug Enforcement Administration. Fentanyl.
https://www.dea.gov/factsheets/fentanyl.
\3\ Weiner, S.G., MD, MPH, Baker, O., PhD, Bernson, D., MPH, &
Schuur, J.D., MD, MS (2022). One year mortality of patients treated
with naloxone for opioid overdose by emergency medical services.
Substance abuse, 43(1), 99-103. https://doi.org/10.1080/
08897077.2020.1748163.
\4\ Naumann, R.B., Durrance, C.P., Ranapurwala, S.I., Austin, A.E.,
Proescholdbell, S., Childs, R., Marshall, S.W., Kansagra, S., &
Shanahan, M.E. (2019). Impact of a community-based naloxone
distribution program on opioid overdose death rates. Drug and alcohol
dependence, 204, 107536. https://doi.org/10.1016/
j.drugalcdep.2019.06.038.
Congress must act quickly to continue passing legislation to prevent
overdose deaths. The following interventions in increased methadone
accessibility, removing treatment barriers like prior authorization,
and expanding treatment access for incarcerated populations are the
fastest way for Congress to reduce fentanyl-related deaths, as well as
reduce the costs associated with these tragedies.
Expanding Access to FDA-Approved Medications
Methadone Access
The U.S. Food and Drug Administration (FDA) has approved two
medications for opioid use disorder that have been found to prevent
overdose fatality--methadone and buprenorphine. Methadone remains
largely inaccessible when used to treat an opioid use disorder, despite
being effective and our greatest line of defense against illicitly
manufactured fentanyl.
FDA first approved methadone for the treatment of pain in 1947.\5\
Methadone first emerged as a maintenance treatment model for substance
use disorder in the mid-1960s, prompted by an increase in heroin
use.\6\ With methadone now primarily being used for addiction
treatment, the federal government took interest in preventing its
diversion and illicit use. In 1972, the FDA in conjunction with the
Drug Enforcement Administration (DEA) implemented strict federal
regulations specific to methadone to treat an opiate addiction.\7\
These additional regulations do not apply to methadone used for the
treatment of pain.
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\5\ Institute of Medicine (US) Committee on Federal Regulation of
Methadone Treatment; Rettig, R.A., & Yarmolinsky, A., editors. Federal
Regulation of Methadone Treatment. Washington (DC): National Academies
Press (US); 1995. Executive Summary. Available from: https://
www.ncbi.nlm.nih.gov/books/NBK232111/.
\6\ National Academies of Sciences, Engineering, and Medicine;
Action Collaborative on Countering the U.S. Opioid Epidemic; Health and
Medicine Division; Board on Health Care Services; Board on Health
Sciences Policy; Stroud, C., Posey Norris, S.M., & Bain, L., editors.
Methadone Treatment for Opioid Use Disorder: Improving Access Through
Regulatory and Legal Change: Proceedings of a Workshop. Washington
(DC): National Academies Press (US); 2022 Jul 15. 3, The History of
Methadone and Barriers to Access for Different Populations. Available
from: https://www.ncbi.nlm.nih.gov/books/NBK585210/.
\7\ Institute of Medicine (US) Committee on Federal Regulation of
Methadone Treatment; Rettig, R.A., & Yarmolinsky, A., editors. Federal
Regulation of Methadone Treatment. Washington (DC): National Academies
Press (US); 1995. Executive Summary. Available from: https://
www.ncbi.nlm.nih.gov/books/NBK232111/.
In the regulations, methadone used to treat substance use disorders may
only be prescribed by and dispensed from an Opioid Treatment Program
(OTP). OTPs require patients to receive their daily dose of methadone
in person. While the objective was to prevent diversion and illicit
use, the formation of OTPs was also born out of necessity, as the
medical community generally isolated and refused to treat substance use
disorders.\8\ As a result, requiring individuals to travel to a
physical location every day to receive methadone has created
significant barriers for people wanting to treat their substance use
disorder.
---------------------------------------------------------------------------
\8\ National Academies of Sciences, Engineering, and Medicine;
Action Collaborative on Countering the U.S. Opioid Epidemic; Health and
Medicine Division; Board on Health Care Services; Board on Health
Sciences Policy; Stroud, C., Posey Norris, S.M., & Bain, L., editors.
Methadone Treatment for Opioid Use Disorder: Improving Access Through
Regulatory and Legal Change: Proceedings of a Workshop. Washington
(DC): National Academies Press (US); 2022 Jul 15. 3, The History of
Methadone and Barriers to Access for Different Populations. Available
from: https://www.ncbi.nlm.nih.gov/books/NBK585210/.
Opioid use disorder is recognized as a chronic brain disease,\9\ and
our approach to the current overdose crisis must prioritize access to
treatment. Existing treatment gaps in the United States are well
documented, and with the increase in illicit fentanyl and fentanyl-
related overdose, methadone is our best line of defense.
---------------------------------------------------------------------------
\9\ https://www.yalemedicine.org/conditions/opioid-use-disorder.
Despite the known effectiveness of methadone, concerns regarding the
potential diversion of methadone have served as a barrier to improving
access to this treatment. These concerns are misguided, the rate of
diversion for methadone is lower than that of oxycodone or
hydrocodone.\10\ In fact, methadone used for substance use treatment is
most likely to be diverted when it is made harder to access this
treatment. The National Institute on Drug Abuse (NIDA) has reported
\11\ that methadone diversion is primarily associated with methadone
prescribed for the treatment of pain and is largely driven by lack of
access to medication. Among those using illicit methadone, the most
common reason was a missed medication pick-up from an OTP, which can be
contributed to the requirement that the medication be picked up in
person each day.
---------------------------------------------------------------------------
\10\ https://www.federalregister.gov/documents/2024/02/02/2024-
01693/medications-for-the-treatment-of-opioid-use-disorder#footnote-42-
p7531.
\11\ https://nida.nih.gov/publications/research-reports/
medications-to-treat-opioid-addiction/what-treatment-need-versus-
diversion-risk-opioid-use-disorder-treatment.
Additionally, the Centers for Disease Control and Prevention (CDC)
published a research study in 2022 that analyzed the impact of take-
home methadone on overdose during the COVID-19 Public Health Emergency
(PHE).\12\ At the start of the PHE, regulations were altered to allow
OTP patients to pick up a supply of take-home doses to comply with
social distancing practices. Findings from this period show that the
percentage of overdose deaths involving methadone declined, with 4.5%
of overdose deaths involving methadone in January 2019 declining to
3.2% by August 2021--indicating that relaxed regulations on methadone
dispensing did not lead to an increase in overdose deaths involving
methadone. Additional positive outcomes associated with take-home
methadone flexibilities include the finding that patients with more
take-home doses were more likely to remain on treatment and less likely
to use illicit opioids.\13\
---------------------------------------------------------------------------
\12\ Jones, C.M., Compton, W.M., Han, B., Baldwin, G., & Volkow,
N.D. Methadone-Involved Overdose Deaths in the US Before and After
Federal Policy Changes Expanding Take-Home Methadone Doses From Opioid
Treatment Programs. JAMA Psychiatry. 2022;79(9):932-934. doi:10.1001/
jamapsychiatry.2022.1776.
\13\ Hoffman, K.A., Foot, C., Levander, X.A., Cook, R., Terashima,
J.P., McIlveen, J.W., Korthuis, P.T., & McCarty, D. (2022). Treatment
retention, return to use, and recovery support following COVID-19
relaxation of methadone take-home dosing in two rural opioid treatment
programs: A mixed methods analysis. Journal of substance abuse
treatment, 141, 108801. https://doi.org/10.1016/j.jsat.2022.108801.
The recently enacted FY 2024 Consolidated Appropriations Act ensures
permanent Medicaid coverage of FDA-approved medications for opioid use
disorder, including methadone. However, to better ensure evidence-based
treatment is accessible to the individuals and communities that need
it, the Overdose Prevention Initiative supports the Modernizing Opioid
Treatment Act (MOTAA). MOTAA expands access to methadone nationwide by
allowing board-certified addiction specialists and addiction
psychiatrists to prescribe and allow pharmacies to dispense methadone,
in addition to the OTPs.
Prior Authorizations
Historically for MOUD, insurers have required prior authorization,
which is reported as a key barrier to MOUD prescribing.\14\ Prior
authorization describes the requirement by some health plans to review
a service, medication, or procedure before it is performed or received
to determine if they will cover it.\15\ The process varies by insurer
but generally requires administrative and clinical information from the
provider, and sometimes the patient.\16\
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\14\ Andraka-Christou, B., Golan, O., Totaram, R., Ohama, M.,
Saloner, B., Gordon, A.J., & Stein, B.D. Prior authorization
restrictions on medications for opioid use disorder: trends in state
laws from 2005 to 2019. Ann Med. 2023 Dec;55(1):514-520. doi: 10.1080/
07853890.2023.2171107. PMID: 36724766; PMCID: PMC9897778.
\15\ https://www.kff.org/policy-watch/examining-prior-
authorization-in-health-insurance/.
\16\ https://www.kff.org/policy-watch/examining-prior-
authorization-in-health-insurance/.
Flagging MOUD for prior authorization reinforces an already harmful
stigma and creates barriers that prevent providers from offering life-
saving medication--not because it is not effective treatment, but
because prescribing it is unnecessarily burdensome. Restrictive
policies like prior authorization have negative impacts on treatment
accessibility, with research indicating that Medicare Part D plans that
removed prior authorization had an associated increase in the use of
buprenorphine, whereas plans that added prior authorization had an
associated decrease in buprenorphine use.\17\ While some states have
passed legislation to eliminate the prior authorization for MOUD,
federal action must be taken to create uniformity across all federally
supported programs, including Medicaid, to reduce this barrier to
treatment.
---------------------------------------------------------------------------
\17\ Mark, T.L., Parish, W.J., & Zarkin, G.A. (2020). Association
of Formulary Prior Authorization Policies With Buprenorphine-Naloxone
Prescriptions and Hospital and Emergency Department Use Among Medicare
Beneficiaries. JAMA network open, 3(4), e203132. https://doi.org/
10.1001/jamanetworkopen.2020.3132.
---------------------------------------------------------------------------
Providing Treatment in Jails and Prisons
Nearly 65% of the U.S. prison population has a substance use disorder,
far greater than the general population.\18\ Not only are Americans
with substance use disorder overrepresented in the prison population,
but recently incarcerated individuals are at significantly increased
risk of fatal overdose. Recent studies found that individuals
reentering the community from incarceration are 40 times more likely to
die of a drug overdose during the two weeks following their release
than the general population.\19\ Providing MOUD during incarceration,
specifically buprenorphine and methadone, is associated with an 80%
reduction in overdose mortality risk for the first month post-
release.\20\ Furthermore, if an individual initiates treatment while in
a correctional setting, they have a greater chance of continuing care
upon reentry, which contributes to a 32% reduction in recidivism
rates.\21\
---------------------------------------------------------------------------
\18\ https://nida.nih.gov/publications/drugfacts/criminal-
justice#ref.
\19\ https://ajph.aphapublications.org/doi/10.2105/
AJPH.2018.304514.
\20\ Lim, S., Cherian, T., Katyal, M., Goldfeld, K.S., McDonald,
R., Wiewel, E., Khan, M., Krawczyk, N., Braunstein, S., Murphy, S.M.,
Jalali, A., Jeng, P.J., MacDonald, R., & Lee, J.D. (2022). Association
between jail-based methadone or buprenorphine treatment for opioid use
disorder and overdose mortality after release from New York City jails
2011-2017. Addiction (Abingdon, England), 10.1111/add.16071. Advance
online publication. https://doi.org/10.1111/add.16071.
\21\ Evans, E.A., Wilson, D., & Friedmann, P.D. (2022). Recidivism
and mortality after in-jail buprenorphine treatment for opioid use
disorder. Drug and alcohol dependence, 231, 109254. https://doi.org/
10.1016/j.drugalcdep.2021.109254.
The Supreme Court has affirmed that a failure to provide medical care
to inmates is a violation of an individual's constitutional rights (see
Estelle v. Gamble, 429 U.S. 97 (1976)), yet only an estimated 32% of
jails offer any form of MOUD,\22\ the established standard of care for
the treatment of opioid use disorder. For many jails and prisons, a
lack of funding and skilled workforce makes providing these basic
health care services impossible. With limited exception, states may not
spend federal Medicaid dollars on health care for individuals who are
incarcerated. The ``Medicaid inmate exclusion policy'' (MIEP) prohibits
the use of federal funds and services for medical care for ``inmates of
a public institution'' and prevents Medicaid-eligible incarcerated
individuals, regardless of whether they have been convicted, from
receiving services funded by Medicaid.
---------------------------------------------------------------------------
\22\ Sufrin, C., Kramer, C., Terplan, M., Fiscella, K., Olson, S.,
Voegtline, K., & Latkin, C. (2022). Availability of Medications for
Opioid Use Disorder in U.S. Jails. Journal of general internal
medicine, 10.1007/s11606-022-07812-x. Advance online publication.
https://doi.org/10.1007/s11606-022-07812-x?.
In recent years, Congress has passed two provisions that chipped away
at the MIEP. The SUPPORT Act prohibited the termination of Medicaid
eligibility for incarcerated individuals under the age of 21 (age 26
for individuals involved with the foster care system). The law also
required CMS to issue guidance on how states can use Section 1115
demonstration waivers to improve health care transitions for
individuals being released from jail. Given the magnitude of the
---------------------------------------------------------------------------
current crisis, Congress must now take those measures further.
To deliver effective treatment to incarcerated individuals, during and
after incarceration, the Overdose Prevention Initiative supports the
Due Process Continuity of Care Act led by Senator Cassidy. This
legislation would permit incarcerated individuals to remain eligible
for Medicaid benefits prior to conviction and is based on the
constitutional principle that all individuals are innocent until proven
guilty. Having Medicaid enrollment terminated after intake into a
correctional facility leads to disruption in care and it can take
individuals a significant amount of time to re-enroll after release.
Many states have already chosen to suspend Medicaid enrollment,
however, a mandate requiring this for all states would create a more
uniform system.
Additionally, the Overdose Prevention Initiative supports the Reentry
Act to ensure individuals re-enter the community having initiated or
maintained treatment for substance use disorder at a critical
intervention point. In complement with the Due Process Continuity of
Care Act, the Reentry Act would allow Medicaid-eligible individuals to
resume receiving Medicaid benefits thirty days prior to their release.
Allowing individuals to resume benefits prior to release increases
access to treatment, preventing risk of future overdose and reducing
the likelihood of recidivism. This policy allows for Medicaid benefits
to be reinstated at a critical time, ensuring that an individual is
stabilized on MOUD and connected to treatment providers in the
community.\23\
---------------------------------------------------------------------------
\23\ Wennerstrom, A., Sugarman, O.K., Reilly, B., Armstrong, A.,
Whittington, A., & Bachhuber, M.A. (2023). Health services use among
formerly incarcerated Louisiana Medicaid members within one year of
release. PloS one, 18(5), e0285582. https://doi.org/10.1371/journal.
pone.0285582.
Thank you again for this opportunity to provide a statement for the
record.
Sparian Biosciences
180 Varick St., Suite 615
New York, NY 10014
The Honorable Ron Wyden
Chairman
United States Senate
Committee on Finance
Washington, DC 20510
The Honorable Mike Crapo
Ranking Member
United States Senate
Committee on Finance
Washington, DC 20510
Dear Chairman Wyden and Ranking Member Crapo:
Sparian Biosciences is grateful for the opportunity to submit a
statement for the record for the May 23, 2024 hearing titled, ``Front
Lines of the Fentanyl Crisis: Supporting Communities and Combating
Addiction through Prevention and Treatment.'' We commend your
leadership and commitment to ending the fentanyl crisis, which is part
of the nation's ongoing substance use disorder (SUD) epidemic.
By the way of background, Sparian Biosciences is a clinical stage
biopharmaceutical company that is at the forefront of developing novel
therapeutics to combat fentanyl. One of Sparian's highest priority drug
programs is a novel therapeutic, dubbed SBS-371, that has the potential
to improve how fentanyl overdoses are reversed. In addition, SBS-371
could serve as a prophylactic agent or a bio-shield to protect first
responders and law enforcement from bioterror attacks deploying highly
potent synthetic opioids like fentanyl.
As Chairman Wyden noted in his opening statement, ``more needs to be
done to head off opioid use in the first place and encourage more non-
opioid pain management to be used in American health care.''\1\ Sparian
could not agree more; Sparian is working tirelessly to develop a non-
opioid pain treatment (SBS-1000 and SBS-147) for patients requiring
long-term pain management. This therapeutic is a first-in-class AEAr
agonist that is currently in Phase 1 clinical trials. Sparian is proud
to be working closely with the National Institutes of Health (NIH) and
National Institute of Drug Abuse (NIDA) to advance this much-needed
alternative to opioids.
---------------------------------------------------------------------------
\1\ https://www.finance.senate.gov/imo/media/doc/
0523_wyden_statement.pdf.
The collaboration between Sparian and NIH/NIDA is supported by the
Helping to End Addiction Long-term (HEAL) Initiative, which currently
supports 1,800 prevention, treatment and recovery projects focused on
fentanyl and other SUDs. HEAL Initiative funding is distributed across
all 50 States.\2\ Sparian is grateful for the Committee's longstanding
bipartisan support for HEAL and would encourage the Committee to
continue this support as it represents one of the federal government's
largest commitments to addressing fentanyl.
---------------------------------------------------------------------------
\2\ NIH Heal Initiative 2024 Annual Report: Research in Action,
https://heal.nih.gov/files/2024-02/nih-heal-initiative-annual-report-
2024.pdf.
Sparian is also greatly appreciative of the leadership of Chairman
Wyden and Ranking Member Crapo to enact bipartisan legislation that
will expand access to medication-assisted treatment
(MAT).\3\, \4\ As Chairman Wyden said in his opening
statement, MAT ``is the gold standard treatment for opioid use
disorder.''\5\ Sparian concurs with this is sentiment and is
expeditiously advancing, SBS-226, which would provide clinicians with a
new pharmacological treatment alongside buprenorphine and methadone to
use in MAT.
---------------------------------------------------------------------------
\3\ https://www.finance.senate.gov/imo/media/doc/
0523_crapo_statement.pdf.
\4\ https://www.finance.senate.gov/imo/media/doc/
0523_crapo_statement.pdf.
\5\ https://www.finance.senate.gov/imo/media/doc/
0523_wyden_statement.pdf.
As Ranking Member Crapo said in his opening remarks, the country needs
``targeted policies that can make a difference and address the root
causes of the fentanyl crisis.''\6\ Sparian strongly support this
position and would add that these targeted policies should involve
interdisciplinary approaches. To ensure appropriate use of federal
resources on targeted policies, Sparian would encourage the Committee
to support a whole-of-government initiative to tackle fentanyl that is
modeled after best practices from the bipartisan Operation Warp Speed
initiative. This collaborative approach would elevate the urgency of
the fentanyl crisis, pool public and private expertise as well as avoid
duplication of federal programs and resources.
---------------------------------------------------------------------------
\6\ https://www.finance.senate.gov/imo/media/doc/
0523_crapo_statement.pdf.
Sparian would also urge the Committee to consider making targeted
investments in bolstering the nation's SUD workforce. As the Committee
knows well from the work of its Bipartisan Medicare GME Working Group,
the U.S. has looming shortages of crucial healthcare roles.\7\ The
nation's SUD workforce, however, is already experiencing such
shortages, which will only get worse. The American Society of Addiction
Medicine, for instance, recently found the U.S. has about 4,400
physicians certified in addiction medicine, but this falls short of
6,000 currently needed.\8\ These shortages disproportionately affect
medically underserved and rural communities. To alleviate these SUD
workforce challenges, Sparian would encourage the Committee to direct
Medicare to set-aside additional residency slots for addiction
medicine, expand the National Health Service Corp's SUD loan repayment
program, among other initiatives.
---------------------------------------------------------------------------
\7\ https://www.finance.senate.gov/imo/media/doc/
052424_bipart_gme_policy_outline_for_feed
back.pdf.
\8\ https://www.asam.org/docs/default-source/advocacy/asam-
training-demo-one-pagerb1ff289
472bc604ca5b7ff000030b21a.pdf?sfvrsn=264348c2_2.
Thank you for the opportunity to share Sparian's perspective. Sparian
Biosciences shares your mission of ending the fentanyl crisis that has
claimed far too many lives and hurt millions of American families from
every walk of life. If Sparian can serve as a resource on these
matters, please do not hesitate to reach out to Sahil Chaudhary at
---------------------------------------------------------------------------
[email protected].
Sincerely,
Jeffrey Reich, MD
CEO
______
Western Governors' Association
1700 Broadway, Suite 500
Denver, CO 80290
(303) 623-9378
https://westgov.org/
May 29, 2024
The Hon. Ron Wyden The Hon. Mike Crapo
Chairman Ranking Member
Committee on Finance Committee on Finance
United States Senate United States Senate
221 Dirksen Senate Office Building 239 Dirksen Senate Office Building
Washington, DC 20510 Washington, DC 20510
Dear Chairman Wyden and Ranking Member Crapo:
In light of the Committee's May 23, 2024, hearing, Front Lines of the
Fentanyl Crisis: Supporting Communities and Combating Addiction through
Prevention and Treatment, attached please find Western Governors'
Association (WGA) Policy Resolution 2024-04, Combating the Opioid
Crisis.
In the resolution, Western Governors highlight unique challenges posed
by opioids, including fentanyl. The Governors discuss the importance of
addressing the causes and long-term prevention of substance use
disorder more fully and considering flexible programs and innovative
strategies that reflect the multiplicity of recovery approaches at the
federal level.
I request that you include this document in the permanent record of the
hearing, as it articulates Western Governors' collective and bipartisan
policy positions and recommendations on this important issue.
Thank you for your consideration of this request. Please contact me if
you have any questions or require further information.
Sincerely,
Jack Waldorf
Executive Director
______
Western Governors' Association
Policy Resolution 2024-04
Combating the Opioid Crisis
A. BACKGROUND
The opioid epidemic, initiated by the precipitous rise of potent
prescription opioids classified as painkillers in the 1990s, has become
one of the nation's most devastating and lethal public health and
safety crises. While federal investment to address this crisis has
increased drastically in recent years, so have rates of substance use
disorders (SUDs), overdoses, and deaths. Currently, the leading driver
of opioid-related overdose deaths is illicit fentanyl, a drug that is
30 to 50 times more powerful than heroin. Combating the opioid crisis
requires a comprehensive approach that reflects the complexity of the
problem--from the potency and availability of these drugs to the social
and economic damage that they impose--across all levels of government
and the continuum of care.
B. GOVERNORS' POLICY STATEMENT
1. Reducing the impact of the opioid crisis involves stemming the
supply of illegally produced opioids and limiting inappropriate and
nonmedical uses of prescription opioids. Western Governors urge the
federal government to provide financial support and reimbursement to
states for interdiction activities--including through the High
Intensity Drug Trafficking Areas Program--and work closely with
Governors to combat over-prescribing of opioids for inappropriate uses
and durations, illicit drug trafficking, and the manufacturing and
distribution of counterfeit medications.
2. Western Governors recognize that social and economic factors are
key drivers of substance use disorder (SUD). While SUD funding focused
on these upstream drivers has expanded, it has not kept pace with the
need. We advocate for increased federal support for population-level
public health strategies at the Centers for Disease Control and
Prevention (CDC) to address the causes and long-term prevention of SUD
more fully. Western Governors are especially interested in support for
Overdose Data to Action in States and Overdose Data to Action: Limiting
Overdose through Collaborative Actions in Localities (LOCAL) Grants,
supportive housing, and prevention and treatment for other diseases or
health issues that may arise from SUDs, such as hepatitis and sexually
transmitted infections.
3. The State Opioid Response (SOR) Program and the Tribal Opioid
Response (TOR) Program provide critical resources to states and tribes
to support the continuum of prevention, harm reduction, treatment, and
recovery services for opioid use disorder and other concurrent SUDs. In
addition, despite suffering disproportionately from high overdose
rates, some tribes offer free treatment services not only to their
members but to surrounding non-tribal communities as well. Western
Governors request that Congress continue to appropriate needed funding
to the SOR and TOR Programs and include ongoing support for
polysubstance programming and initiatives.
4. Emerging threats, such as the combination of fentanyl with
xylazine, have changed the nature of the opioid crisis over the years.
States and the federal government must stay apprised of these threats
to develop effective policy and programs to mitigate the crisis.
Western Governors urge the Administration and federal agencies to
coordinate more effectively with states and Fusion Centers and improve
the dissemination of information about emerging threats across all
levels of government.
5. Western Governors encourage the Drug Enforcement Administration
(DEA) or Congress to prohibit the distribution and use of xylazine for
human purposes while protecting its important applications in the
veterinary and livestock sectors. We recommend that the federal
government consider the perspectives of veterinary and livestock
stakeholders in the development and implementation of such legislation
or regulation.
6. Western Governors advise the Administration and Congress to
utilize available tools, including sanctions, against individuals and
groups involved in the illicit production and distribution of fentanyl
and other drugs.
7. Western Governors urge the Department of Health and Human Services
to expand state Medicaid waivers for opioid use disorder, especially
waivers that would increase access to new models to address prevention,
harm reduction, treatment, and recovery for incarcerated people and
other populations.
8. Education and awareness campaigns are necessary tools to foster
public dialogue and mobilize action across communities. Western
Governors encourage the federal government, in partnership with states,
to further develop a comprehensive, evidence-based, and culturally
competent national education and awareness campaign about the opioid
crisis, highlighting issues such as fentanyl and counterfeit
medication, and incorporating best practices from state campaigns.
Agencies should continue to target susceptible populations, including
youth. Western Governors also urge Congress to dedicate resources
directly to states to develop and disseminate targeted and culturally
specific opioid awareness and education campaigns that meet the unique
needs of our populaces, as such efforts are complementary to those at
the national level.
9. Teen overdoses involving fentanyl are a tragic problem that
continues to grow at an alarming rate. Western Governors request that
the federal government focus on strategies, funding, and other
resources to increase the use of naloxone among youth and relay
accurate information to teens who are experimenting with substances
about the dangers of fentanyl and the importance of only taking pills
prescribed to them and dispensed by a licensed pharmacy. More efforts
are also needed to increase the use of medications for opioid use
disorder (OUD) for teens with OUD, including messaging focused on
teens, parents, educators, and prescribers. In addition, federal
efforts should incorporate expanded upstream approaches for young kids,
such as social supports and coaching for parents, particularly for
those with at-risk kids, and prosocial activities in schools,
communities, and tribes.
10. The federal government should allocate more resources and release
updated guidance for treatment medications that reflect the challenges
raised by fentanyl. Western Governors support increasing access to the
full slate of treatment options that address patient needs and ensure
that they are not subject to outdated limits.
11. Western Governors acknowledge that recovery from SUD is a
process--one impacted by a number of conditions and context, including
economic status, geographical location, access to treatment, and
suitable support systems. We recognize the importance of all stages of
the recovery process, including harm reduction, outpatient and
inpatient treatment, and more. Effective treatment is not a one-size-
fits-all approach, and needs a diversity of voices, experiences, and
ideas to address the changing landscape of both the epidemic that we
are facing and the recovery options. We believe that the federal
government should design flexible programs and grant opportunities and
consider innovative strategies that reflect the multiplicity of
recovery approaches and increase public understanding about recovery.
12. Western Governors recommend creating and adequately investing in
federal programs and policies that enhance access to harm reduction
strategies at low costs, including opioid antagonists such as naloxone,
and provide training on the administration and use of these strategies.
13. The federal government should also ensure that permanent
regulations enacted by the DEA to govern the use of telemedicine for
medication-assisted treatment prescribing and monitoring--now that the
extension of COVID-19 flexibilities has expired--continue to permit the
use of telemedicine for both buprenorphine inductions and ongoing
medication management.
14. Western Governors emphasize the importance of treating and
preventing behavioral health conditions and increasing access to
services to reduce dependence on opioids. We have highlighted
substantive policy recommendations on behavioral health, including SUD,
in WGA's health care resolution.
C. GOVERNORS' MANAGEMENT DIRECTIVE
1. The Governors direct WGA staff to work with Congressional
committees of jurisdiction, the Executive Branch, and other entities,
where appropriate, to achieve the objectives of this resolution.
2. Furthermore, the Governors direct WGA staff to consult with the
Staff Advisory Council regarding its efforts to realize the objectives
of this resolution and to keep the Governors apprised of its progress
in this regard.
This resolution will expire in December 2026. Western Governors enact
new policy resolutions and amend existing resolutions on a semiannual
basis. Please consult http://www.westgov.org/resolutions for the most
current copy of a resolution and a list of all current WGA policy
resolutions.
[all]